Podcasts about Sarepta

CONTINUA LA MISSIONEQuesta domenica abbiamo parlato del messaggio di Gesù in Luca 4:14-29 e di come Isaia 61 riveli le persone per cui Egli è venuto: i poveri, i cuori spezzati, i prigionieri, i ciechi e gli oppressi.Gesù non guarda solo alle condizioni materiali, ma soprattutto alle povertà e alle prigioni interiori fatte di freddezza, dipendenze, rigidità e cecità spirituale. Come la vedova di Sarepta, siamo chiamati a mettere Dio al primo posto e a vivere con gratitudine per la libertà che Cristo ci ha dato, testimoniando ciò che Lui ha fatto nella nostra vita.Past Catherine Labate16-11-2025

Seguimos ahondando en la vida del profeta Elías. Dios se muestra de tres maneras en la vida de este hombre de Dios. En primer lugar veremos cómo Dios cuida de él cumpliendo así su palabra, pues Dios honra a los que le honran. En segundo lugar veremos cómo Dios prepara a su enviado curtiéndolo con nuevas y transformadoras experiencias. Finalmente descubriremos que Dios es siempre justo y castiga a Israel con el fin de procurar su arrepentimiento y restauración posterior. El mismo Señor Jesús hizo referencia a los hechos que hoy analizaremos cuando afirmó en Nazaret, la tierra en la cual se crió, que Dios no envió a Elías a ninguna de la viudas de Israel en la época de gran sequía (física y espiritual) sino a la viuda de Sarepta que hoy aparece en este relato.

A viúva de Sarepta nos ensina que fé verdadeira não é medida pela abundância, mas pela disposição de obedecer mesmo na escassez. Deus não exige o que não temos, Ele honra a disposição de entregar o pouco com fé. Quando priorizamos o que é espiritual, o essencial se multiplica. Sua obediência abriu as portas para um milagre contínuo: o sustento diário em meio à seca. #conscienciacrista #CC2025 #EUSOU #vidacrista #obediencia #prioridade #migalhas #sustento

Acquisitions have ticked up this month as all eyes were on Pfizer and Novo's fight over Metsera. The past week saw that deal finalized with Pfizer as the winner plus a handful of other M&A stories, including Merck's $9.2 billion buyout of Cidara Therapeutics and Johnson & Johnson's $3 billion bet on Halda Therapeutics. Additionally, a separate bidding war has broken out between Lundbeck and Alkermes for sleep biotech Avadel Pharmaceuticals. Outside of M&A, the FDA dominated headlines again this week. The agency effectively closed the loop on one of the messiest stories of the year—Sarepta's gene therapy Elevidys—when it formally added a black box warning for serious liver toxicities and risk of death and removed the nonambulatory indication from the label. The agency will also require that the company complete a postmarketing observational study of around 200 patients. This happened just as Richard Pazdur accepted the role of director of the Center for Drug Evaluation and Research (CDER) that was recently vacated by George Tidmarsh amidst conflict with Center for Biologics Evaluation and Research (CBER) Director Vinay Prasad. By all accounts, Pazdur, a 26-year FDA veteran, is a highly respected and thoughtful regulator, and sources told BioSpace that if Prasad tries to supersede Pazdur's authority, “there will be hell to pay and resignations to be handed in.” In other FDA drama, FDA Commissioner Marty Makary is apparently butting heads with Health Secretary Robert F. Kennedy Jr. Meanwhile, the agency revealed details of its plausible mechanisms pathway teased by Makary earlier in his tenure. Finally, in Biopharm Executive this week, check out our deep dives into GLP-1 pricing. Coming off Trump's deal with both Eli Lilly and Novo Nordisk to offer their GLP-1s at a lower cost through the president's new direct-to-consumer platform, Novo CEO Maziar Mike Doustdar announced a sale on its company's products. Bargain bin pricing like this so early in a drug's market life is unprecedented. It's changing the investment calculations for the next-generation of obesity treatments. 

Does God Discriminate? Part 3Luke 4:26“But unto none of them was Elias sent, save unto Sarepta, a city of Sidon, unto a woman that was a widow.”King James Version (KJV)Message From Emmanuel is a weekly audio ministry of Emmanuel Baptist Church in Irvine, KY. We sincerely hope God blesses you as you listen!Follow us on Facebook: ebcky15Follow us on Twitter: ebckyCheckout our website! http://ebcky.com Send us a textFollow us on Facebook: ebcky15Follow us on Twitter: ebckyCheckout our website! http://ebcky.com

Dans ce numéro du Journal des biotechs, on continue le suivi des dossiers Medincell et Nanobiotix avec Jamila El Bougrini. L'analyste chez Invest Securities revient aussi sur la déception autour de Sarepta et sur la bataille boursière qui s'est déroulée autour de Metsera.L'entretien est consacré à Alessandro Riva. Le PDG de Transgene fait le point complet sur l'actualité récente de la biotech et sa stratégie. Hébergé par Audion. Visitez https://www.audion.fm/fr/privacy-policy pour plus d'informations.

On this week's episode, Graig Suvannavejh, Paul Matteis, Brian Skorney, Yaron Werber, Chris Garabedian, and guest Adam Feuerstein open with a discussion on George Tidmarsh's departure from the FDA and the uncertainty it has caused in the markets. Next, the co-hosts discuss the shifting policies of the FDA and Sarepta's Phase 3 ESSENCE trial of casimersen for DMD with the group debating if the drug actually works. Biohaven's complete response letter for its new drug application for its spinocerebellar ataxia drug is also mentioned. The co-hosts also overviewed the FDA's decision deeming Uniqure's Huntington's disease therapy data inadequate, and the read through for other companies like Stoke Therapeutics. The conversation shifts to company news where Novo Nordisk and Pfizer's bidding war for Metsera is noted as a positive for biotech investors. Next the co-hosts discuss Soleno Therapeutic's stock moves amid questions about its growth trajectory. The episode concludes with a look ahead to ASH 2025 with a preview of Terns Pharmaceuticals CML data. *This episode aired on November 7, 2025. 

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we explore a series of groundbreaking advancements and strategic collaborations that promise to transform drug development and patient care.In the autoimmune space, Boehringer Ingelheim has made a significant move by securing a $570 million agreement with CDR-Life. This deal centers on a trispecific antibody, a novel therapeutic approach that targets multiple pathways simultaneously, potentially revolutionizing treatments for autoimmune diseases. Boehringer's commitment to these cutting-edge modalities highlights their strategy to leverage novel technologies for more effective therapeutic solutions.Similarly, Celltrion has entered a $744 million collaboration with Kaigene, focusing on two preclinical autoimmune drugs. This partnership marks Celltrion's strategic shift from biosimilars to novel biologics, positioning the company at the forefront of biologic therapeutics. By investing in early-stage research, Celltrion aims to introduce transformative therapies for autoimmune conditions, showcasing the industry's willingness to bet on groundbreaking scientific advancements.In gene editing, Azalea Therapeutics is gaining attention with its focus on permanent genome editing using a dual-vector approach. Backed by $82 million in funding and support from CRISPR pioneer Jennifer Doudna, Azalea is poised to develop potentially curative solutions through single-dose treatments. The credibility lent by a Nobel laureate adds anticipation to their research outcomes, with the potential to significantly impact gene therapy.Shifting focus to clinical trials, Sarepta Therapeutics faces challenges after missing the primary endpoint in its confirmatory trial for Duchenne muscular dystrophy drugs. Despite this setback, Sarepta is pursuing full FDA approval, emphasizing the complex interplay between clinical data and regulatory strategies. This situation underscores the critical importance of robust confirmatory trials in securing drug approvals and ensuring patient access to new therapies.Merck is making strategic moves in oncology by regaining full control over an early-phase asset and securing $700 million from Blackstone for its oncology pipeline. This dual focus on asset acquisition and financial fortification reflects Merck's aggressive growth strategy aimed at expanding its cancer treatment offerings.Emerging from stealth mode, Neok Bio has secured a $75 million investment to advance bispecific antibody-drug conjugates into clinical trials. These bispecific ADCs represent the forefront of targeted cancer therapies, aiming for precision targeting of cancer cells while minimizing off-target effects. Neok Bio's progress could significantly enhance oncology treatment paradigms through improved therapeutic indices.Turning to regulatory landscapes, Teva's recall of over half-a-million bottles of prazosin hydrochloride due to potential carcinogenic impurities highlights ongoing challenges in ensuring drug safety and quality control within manufacturing processes. Such recalls underscore the critical importance of maintaining high standards in pharmaceutical production.In broader industry developments, we see dynamic trends where scientific innovation meets strategic business decisions and regulatory considerations. The potential impact on patient care is profound, with breakthroughs in autoimmune treatments, gene editing technologies, and targeted cancer therapies poised to alter therapeutic landscapes significantly.UCB has achieved another milestone with FDA approval for Kygevvi, an ultra-rare disease medication marking their third approval in rare conditions within three years. This success underscores UCB's strategic focus on niche markets that offer less competition but significant patient impact. Advancements in genetic research aSupport the show

Many of the top stories of 2025 are currently being written. We're on the edge of our keyboards, watching and waiting as Pfizer and Novo Nordisk duke it out over the right to acquire glittery obesity startup Metsera. In the latest development, Pfizer raised its original bid of around $7.27 billion to about $8.1 billion on Monday—only to be usurped again by the indefatigable Novo, which upped its own bid to a cool $10 billion.  Meanwhile, the unprecedented drama in the uppermost ranks of the FDA—another top story of 2025—continues as CDER Director George Tidmarsh exits the agency. Tidmarsh reportedly resigned Sunday after being placed on administrative leave amid an investigation into his “personal conduct” at the agency. On Monday, however, Tidmarsh told Endpoints News that he was “second-guessing” his decision.  Speaking of the FDA, the regulator appears to have done its own 180—on uniQure's investigational gene therapy for Huntington's disease, three-year data from which sent the biotech's stock into the stratosphere just five weeks ago. Despite previous agreements on protocols and statistical analyses, the agency “no longer agrees” that Phase I/II data for AMT-130 are adequate to provide primary evidence for the application, uniQure said, throwing the timeline for the BLA into question.  Another gene therapy player, Sarepta Therapeutics, took a hit this week, as two of its Duchenne muscular dystrophy drugs, Vyondys 53 and Amondys 45, failed a confirmatory trial. Sarepta still plans to file for full approval of the two exon-skipping therapies, however, based on what it called “encouraging trends” in efficacy. Finally, on the genetic medicine front, CBER director Vinay Prasad teased an upcoming paper that will detail the regulator's thinking and a new approach to gene editing approvals.  On top of all that, Q3 earnings continue to roll in, with Pfizer, Eli Lilly, Vertex, Bristol Myers Squibb, AbbVie, and more reporting results.  One more thing: Have you ever wanted to know more about the inner workings of the Biogen-Eisai Alzheimer's partnership? Check out this profile on BioSpace 40 under 40 honoree Neena Bitritto-Garg, Eisai alum and current CEO of Ensho Therapeutics. 

Does God Discriminate?Luke 4:26“But unto none of them was Elias sent, save unto Sarepta, a city of Sidon, unto a woman that was a widow.”King James Version (KJV)Message From Emmanuel is a weekly audio ministry of Emmanuel Baptist Church in Irvine, KY. We sincerely hope God blesses you as you listen!Follow us on Facebook: ebcky15Follow us on Twitter: ebckyCheckout our website! http://ebcky.com Send us a textFollow us on Facebook: ebcky15Follow us on Twitter: ebckyCheckout our website! http://ebcky.com

Mensaje predicado el 12/10/2025

====================================================SUSCRIBETEhttps://www.youtube.com/channel/UCNpffyr-7_zP1x1lS89ByaQ?sub_confirmation=1======a==============================================DEVOCIÓN   MATUTINA PARA ADULTOS 2025“CON JESÚS HOY”Narrado por: Exyomara AvilaDesde: Bogotá, ColombiaUna cortesía de DR'Ministries y Canaan Seventh-Day Adventist Church ===================|| www.drministries.org ||===================13 de OctubreSolidaridad sin fronteras«Y en verdad os digo que muchas viudas había en Israel en los días de Elías, cuando el cielo fue cerrado por tres años y seis meses, y hubo una gran hambre en toda la tierra; pero a ninguna de ellas fue enviado Elías, sino a una mujer viuda en Sarepta de Sidón» (Luc. 4: 25-26).Si hay una verdad bíblica repetida múltiples veces es que «Dios no hace acepción de personas, (Deut. 10: 17; Hech. 10: 34: Rom. 2: 11; Gál. 2: 6; Efe. 6: 9; Col. 3: 25; cf. Sal. 68: 59).De la familia de mi tía María, hermana de mi abuelo paterno, recuerdo especialmente una historia que solía contarnos de pequeños sobre la providencia divina durante la guerra civil española (1936-1939). Por aquel entonces la familia vivía, con sus cuatro hijos todavía pequeños, en una zona rural de Andalucía en la que había un convento de monjas. Ya en plena guerra, llevadas por la necesidad, una pareja de monjitas llamó a casa de mis tíos pidiendo algo de comer. Mis tíos no disponían de muchos recursos, pero cultivaban un pequeño huerto de donde sacaban las hortalizas y verduras necesarias para su subsistencia.De una buena cosecha del año anterior, mi tía conservaba una gran tinaja llena de alubias blancas (frijoles), de las que compartió con las monjas todo lo que le cabía en una olla, que vació en el delantal de una de ellas. Las monjas sabían que mis tíos eran adventistas y mis tíos sabían que las monjas eran católicas, en un contexto de hostilidad contra los «herejes» que se había saldado con el supuesto envenenamiento, muy cerca de allí, por el clero local, del primer misionero adventista en España, Walter Bond.Al cabo de unas semanas, las monjitas volvieron a pedir ayuda. De nuevo mi tía les entregó el contenido de una olla llena de las alubias de la tinaja. Y así durante varios meses. Hasta que un día, cuando llegaron las monjas, mi tía tuvo que decirles que esa sería la última vez que las podía ayudar porque se habían terminado las legumbres. Ese día, justamente, terminaba también la Guerra Civil.Las reservas de la viuda de Sarepta duraron todo el tiempo que Eliseo necesitó su hospitalidad (1 Rey. 17: 8-16). Y la reserva de alubias de mi tía duró mientras hizo falta y mientras estuvo dispuesta a compartir con las monjas.Dame, Señor, disposición para compartir con gozo con quien necesite mi ayuda, sea quien sea. Si tú no haces acepción de personas, que yo no la haga tampoco. 

1 Reyes 17:8-248 Vino luego a él palabra de Jehová, diciendo: 9 Levántate, vete a Sarepta de Sidón, y mora allí; he aquí yo he dado orden allí a una mujer viuda que te sustente. 10 Entonces él se levantó y se fue a Sarepta. Y cuando llegó a la puerta de la ciudad, he aquí una mujer viuda que estaba allí recogiendo leña; y él la llamó, y le dijo: Te ruego que me traigas un poco de agua en un vaso, para que beba. 11 Y yendo ella para traérsela, él la volvió a llamar, y le dijo: Te ruego que me traigas también un bocado de pan en tu mano. 12 Y ella respondió: Vive Jehová tu Dios, que no tengo pan cocido; solamente un puñado de harina tengo en la tinaja, y un poco de aceite en una vasija; y ahora recogía dos leños, para entrar y prepararlo para mí y para mi hijo, para que lo comamos, y nos dejemos morir. 13 Elías le dijo: No tengas temor; ve, haz como has dicho; pero hazme a mí primero de ello una pequeña torta cocida debajo de la ceniza, y tráemela; y después harás para ti y para tu hijo. 14 Porque Jehová Dios de Israel ha dicho así: La harina de la tinaja no escaseará, ni el aceite de la vasija disminuirá, hasta el día en que Jehová haga llover sobre la faz de la tierra. 15 Entonces ella fue e hizo como le dijo Elías; y comió él, y ella, y su casa, muchos días. 16 Y la harina de la tinaja no escaseó, ni el aceite de la vasija menguó, conforme a la palabra que Jehová había dicho por Elías.17 Después de estas cosas aconteció que cayó enfermo el hijo del ama de la casa; y la enfermedad fue tan grave que no quedó en él aliento. 18 Y ella dijo a Elías: ¿Qué tengo yo contigo, varón de Dios? ¿Has venido a mí para traer a memoria mis iniquidades, y para hacer morir a mi hijo? 19 Él le dijo: Dame acá tu hijo. Entonces él lo tomó de su regazo, y lo llevó al aposento donde él estaba, y lo puso sobre su cama. 20 Y clamando a Jehová, dijo: Jehová Dios mío, ¿aun a la viuda en cuya casa estoy hospedado has afligido, haciéndole morir su hijo? 21 Y se tendió sobre el niño tres veces, y clamó a Jehová y dijo: Jehová Dios mío, te ruego que hagas volver el alma de este niño a él. 22 Y Jehová oyó la voz de Elías, y el alma del niño volvió a él, y revivió. 23 Tomando luego Elías al niño, lo trajo del aposento a la casa, y lo dio a su madre, y le dijo Elías: Mira, tu hijo vive. 24 Entonces la mujer dijo a Elías: Ahora conozco que tú eres varón de Dios, y que la palabra de Jehová es verdad en tu boca.---------------------------Creemos en el poder de la generosidad y en el impacto positivo que podemos tener en la vida de los demás. Tu apoyo a través de donaciones desempeña un papel vital en nuestra misión de extender el amor de Cristo y dar ayuda a quien más lo necesitan.⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠https://iglesiaguerrero.org/⁠⁠⁠⁠⁠

4:14 And Jesus returned in the power of the Spirit into Galilee: and there went out a fame of him through all the region round about. 4:15 And he taught in their synagogues, being glorified of all. 4:16 And he came to Nazareth, where he had been brought up: and, as his custom was, he went into the synagogue on the sabbath day, and stood up for to read. 4:17 And there was delivered unto him the book of the prophet Esaias. And when he had opened the book, he found the place where it was written, 4:18 The Spirit of the Lord is upon me, because he hath anointed me to preach the gospel to the poor; he hath sent me to heal the brokenhearted, to preach deliverance to the captives, and recovering of sight to the blind, to set at liberty them that are bruised, 4:19 To preach the acceptable year of the Lord. 4:20 And he closed the book, and he gave it again to the minister, and sat down. And the eyes of all them that were in the synagogue were fastened on him. 4:21 And he began to say unto them, This day is this scripture fulfilled in your ears. 4:22 And all bare him witness, and wondered at the gracious words which proceeded out of his mouth. And they said, Is not this Joseph's son? 4:23 And he said unto them, Ye will surely say unto me this proverb, Physician, heal thyself: whatsoever we have heard done in Capernaum, do also here in thy country. 4:24 And he said, Verily I say unto you, No prophet is accepted in his own country. 4:25 But I tell you of a truth, many widows were in Israel in the days of Elias, when the heaven was shut up three years and six months, when great famine was throughout all the land; 4:26 But unto none of them was Elias sent, save unto Sarepta, a city of Sidon, unto a woman that was a widow. 4:27 And many lepers were in Israel in the time of Eliseus the prophet; and none of them was cleansed, saving Naaman the Syrian. 4:28 And all they in the synagogue, when they heard these things, were filled with wrath, 4:29 And rose up, and thrust him out of the city, and led him unto the brow of the hill whereon their city was built, that they might cast him down headlong. 4:30 But he passing through the midst of them went his way, 4:31 And came down to Capernaum, a city of Galilee, and taught them on the sabbath days. 4:32 And they were astonished at his doctrine: for his word was with power. 4:33 And in the synagogue there was a man, which had a spirit of an unclean devil, and cried out with a loud voice, 4:34 Saying, Let us alone; what have we to do with thee, thou Jesus of Nazareth? art thou come to destroy us? I know thee who thou art; the Holy One of God. 4:35 And Jesus rebuked him, saying, Hold thy peace, and come out of him. And when the devil had thrown him in the midst, he came out of him, and hurt him not. 4:36 And they were all amazed, and spake among themselves, saying, What a word is this! for with authority and power he commandeth the unclean spirits, and they come out. 4:37 And the fame of him went out into every place of the country round about. 4:38 And he arose out of the synagogue, and entered into Simon's house. And Simon's wife's mother was taken with a great fever; and they besought him for her. 4:39 And he stood over her, and rebuked the fever; and it left her: and immediately she arose and ministered unto them. 4:40 Now when the sun was setting, all they that had any sick with divers diseases brought them unto him; and he laid his hands on every one of them, and healed them. 4:41 And devils also came out of many, crying out, and saying, Thou art Christ the Son of God. And he rebuking them suffered them not to speak: for they knew that he was Christ. 4:42 And when it was day, he departed and went into a desert place: and the people sought him, and came unto him, and stayed him, that he should not depart from them. 4:43 And he said unto them, I must preach the kingdom of God to other cities also: for therefore am I sent. 4:44 And he preached in the synagogues of Gali...

Good morning from Pharma and Biotech Daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.Roche has made a significant move in the pharmaceutical industry by acquiring 89bio for $3.5 billion, with a contingent value right of $6 per share. The acquisition includes pegozafermin, an analog in late-stage development for metabolic dysfunction-associated steatohepatitis. Meanwhile, former CDC director Susan Monarez spoke to the Senate about her firing, alleging that Health Secretary Robert F. Kennedy Jr. accused CDC employees of "killing children." In other news, Roivant and Pfizer's therapy shows promise in a rare inflammatory condition, BMS and Novo Nordisk have announced layoffs in New Jersey, and Sino Biological has developed a high-throughput platform for AI-driven antibody discovery. Additionally, Lexicon has backed phase III decision for a non-opioid pain medication, and Rosnilimab shows promise as a potential next-generation treatment for rheumatoid arthritis. The pharmaceutical industry is navigating uncertainty during turbulent times, with companies like Arsenal and X4 laying off staff to cut costs.The FDA is cracking down on pharmaceutical advertisements in a new regulatory initiative, targeting loopholes in direct-to-consumer ads. Experts believe the FDA is focusing on the wrong issues and should instead address the lack of regulations for compounder drug ads. Akeso, a biotech company in China, has seen success under CEO Michelle Xia's leadership. Other news in the pharmaceutical industry includes the rise of predictive care powered by consumers and AI, ongoing prescriptions of Sarepta's DMD gene therapy despite safety concerns, and companies like Sanofi pulling back from the UK market. Pharma companies are facing challenges in navigating uncertain times amidst layoffs and regulatory crackdowns. Stay tuned for more updates on the latest developments in the industry.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. Novo's amylin analog drug, cagrilintide, has shown a significant 11.8% weight loss in a phase III trial, with improved safety data to address past tolerability issues. The FDA is set to make a decision on the drug, with significant stakes for the company and the Barth Syndrome community. Additionally, Sarepta's DMD gene therapy is still being prescribed by doctors despite safety concerns, and new members have been appointed to the ACIP panel. Stealth Biotherapeutics is awaiting a verdict on their potential treatment for Barth Syndrome, while Sino Biological's high-throughput platform for AI-driven antibody discovery offers promise for advancing therapeutic candidates. Novo and Lilly are competing for market leadership in obesity treatment, while Sanofi and other pharma companies are pulling back from investments in the UK. The pharmaceutical industry is navigating uncertainty during turbulent times.

A global shift may be underway in biopharma as the White House prepares legislation that would would place restrictions on drugs brought to the U.S. from China, and pharma companies exit the U.K. in droves. President Donald Trump is reportedly writing an executive order that would clamp down on the pharmaceutical industry's ability to buy new molecules from biotechs based in China, while Sanofi, Merck and more have canceled or suspended investments in the U.K. following a sizeable increase in a mandatory levy in the region. In other business news, Novo Nordisk's newly appointed CEO Maziar Mike Doustdar hit the ground running, cutting around 9,000 employees and informing those who remained that they would need to return to the office. Novo's headcount had climbed 81% in five years as its revenue soared—and then fell. The obesity juggernaut has been a key presence at the European Association for the Study of Diabetes' annual meeting this week, announcing that it would seek FDA approval for a high-dose formulation of Wegovy, and presenting new data for long-acting amylin analog cagrilintide. Meanwhile, Reuters reported that Eli Lilly's orforglipron could potentially qualify for the FDA's recently launched Commissioner's Priority Voucher, which could see the oral obesity candidate approved this year.  The gene therapy space was hit with more bad news as Capsida Biotherapeutics reported the death of a patient being treated with its investigational gene therapy for epileptic disorders. This follows an unfortunate trend in 2025 that has also seen deaths attributed to Sarepta's approved Duchenne muscular dystrophy gene therapy Elevidys and a monoclonal antibody used for lymphodepletion in a study of Allogene's CAR T cell therapy cema-cell. According to a new analyst survey, however, doctors are still prescribing Elevidys to ambulatory patients.  Meanwhile, on the regulatory front, FDA Center for Drug Evaluation and Research Director George Tidmarsh reportedly told two separate groups last week that he “would like to get away” from advisory committee meetings, but quickly appeared to walk the comments back in a statement to Endpoints News.  Finally, in BioPharm Executive, BioSpace takes a deep dive into the FDA's new crackdown on pharmaceutical drug ads, and spotlights Akeso CEO Michelle Xia who built the biotech from a $3 million angel fundraising round to its current $15 billion valuation.  

LEITURA BÍBLICA DO DIA: DEUTERONÔMIO 10:17-20 PLANO DE LEITURA ANUAL: PROVÉRBIOS 16–18; 2 CORÍNTIOS 6  Já fez seu devocional hoje? Aproveite e marque um amigo para fazer junto com você! Confira: Ao fugir da guerra, milhares de ucranianos chegaram à Berlim e se depararam com uma surpresa: famílias alemãs segurando cartazes oferecendo refúgio em suas casas. “Posso hospedar duas pessoas!” e “Quarto grande [disponível]”, diziam alguns. Ao ser questionada sobre o motivo de oferecer hospitalidade a estranhos, uma mulher disse que sua mãe precisou de refúgio quando fugiu dos nazistas e ela queria ajudar outros também. No livro de Deuteronômio, Deus convoca os israelitas a cuidar dos que estão longe de sua terra natal. Por quê? Porque Ele ama o órfão, a viúva e o estrangeiro (v.18), e porque os israelitas sabiam o que significava estar vulnerável: “pois, em outros tempos, [tinham sido] estrangeiros na terra do Egito” (v.19). A empatia deveria motivá-los ao cuidado com eles. Mas há um outro lado também. Quando a viúva de Sarepta acolheu Elias como estrangeiro em sua casa, foi abençoada (1 REIS 17:9-24). Abraão foi abençoado por seus três visitantes estrangeiros (GÊNESIS 18:1-15). Muitas vezes, Deus usa a hospitalidade para abençoar o anfitrião, não somente o hóspede. Acolher estranhos em casa é difícil, mas essas famílias alemãs talvez sejam as verdadeiramente beneficiadas. Quando acolhemos os vulneráveis com a empatia de Deus, podemos nos surpreender com as dádivas que Ele nos dá por meio deles.  Por: SHERIDAN VOYSEY 

Meditación del Evangelio según San Lucas 4, 16-30 por el biblista P. Norberto Padilla, misionero claretiano.Lunes 1/sept/2025, Me ha enviado para dar la Buena Noticia a los pobres... Ningún profeta es bien mirado en su tierra.Canción: Espíritu (2020), de Jesús Cabello----------Lectura del santo evangelio según san Lucas 4, 16-30En aquel tiempo, fue Jesús a Nazaret, donde se había criado. Entró en la sinagoga, como era su costumbre los sábados, y se puso en pie para hacer la lectura. Le entregaron el libro del profeta Isaías y, desarrollándolo, encontró el pasaje donde estaba escrito: "El Espíritu del Señor está sobre mí, porque él me ha ungido. Me ha enviado para dar la buena noticia a los pobres, para anunciar a los cautivos la libertad, y a los ciegos la vista; para dar libertad a los oprimidos, para anunciar el año de gracia del Señor." Y, enrollando el libro, lo devolvió al que le ayudaba y se sentó. Toda la sinagoga tenía los ojos fijos en él. Y él se puso a decirles: "Hoy se cumple esta Escritura que acaban de oír." Y todos le expresaban su aprobación y se admiraban de las palabras de gracia que salían de sus labios. Y decían: "¿No es este el hijo de José?" Y Jesús les dijo: "Sin duda me recitarán aquel refrán: 'Médico, cúrate a ti mismo, haz también aquí en tu tierra, lo que hemos oido que haz hecho en Cafarnaún'". Y añadió: "Les aseguro que ningún profeta es bien mirado en su tierra. Les garantizo que en Israel habían muchas viudas en tiempos de Elías, cuando estuvo cerrado el cielo tres años y seis meses, y hubo una gran hambre en todo el país. Sin embargo a ninguna de ellas fue enviado Elías, mas que a una viuda de Sarepta en el territorio de Sidón. Y muchos leprosos había en Israel en tiempos del profeta Eliseo; sin embargo, ninguno de ellos fue curado, mas que Naamán, el Sirio". Al oír esto, todos en la sinagoga se pusieron furiosos y, levantándose, lo empujaron fuera del pueblo, hasta un barranco del monte donde se alzaba su pueblo, con intención de despeñarlo. Pero Jesús se abrió paso entre ellos y se alejaba.Palabra del Señor... Gloria a ti, Señor Jesús#SoyClaretiano #Evangelio #MisionerosClaretianos #CMFAntillasIntro: Lámpara Es Tu Palabra, de Ain Karem

+ Evangelio de nuestro Señor Jesucristo según san Lucas 4, 16-30      Jesús fue a Nazaret, donde se había criado; el sábado entró como de costumbre en la sinagoga y se levantó para hacer la lectura. Le presentaron el libro del profeta Isaías y, abriéndolo, encontró el pasaje donde estaba escrito:        "El Espíritu del Señor está sobre mí,        porque me ha consagrado por la unción.        Él me envió a llevar la Buena Noticia los pobres,        a anunciar la liberación a los cautivos        y la vista a los ciegos,        a dar la libertad a los oprimidos        y proclamar un año de gracia del Señor.      Jesús cerró el Libro, lo devolvió al ayudante y se sentó. Todos en la sinagoga tenían los ojos fijos en él. Entonces comenzó a decirles: «Hoy se ha cumplido este pasaje de la Escritura que acaban de oír».       Todos daban testimonio a favor de él y estaban llenos de admiración por las palabras de gracia que salían de su boca. Y decían: «¿No es este el hijo de José?».      Pero Él les respondió: «Sin duda ustedes me citarán el refrán: "Médico, cúrate a ti mismo". Realiza también aquí, en tu patria, todo lo que hemos oído que sucedió en Cafarnaúm».      Después agregó: «Les aseguro que ningún profeta es bien recibido en su tierra. Yo les aseguro que había muchas viudas en Israel en el tiempo de Elías, cuando durante tres años y seis meses no hubo lluvia del cielo y el hambre azotó a todo el país. Sin embargo, a ninguna de ellas fue enviado Elías, sino a una viuda de Sarepta, en el país de Sidón. También había muchos leprosos en Israel, en el tiempo del profeta Eliseo, pero ninguno de ellos fue curado, sino Naamán, el sirio».      Al oír estas palabras, todos los que estaban en la sinagoga se enfurecieron y, levantándose, lo empujaron fuera de la ciudad, hasta un lugar escarpado de la colina sobre la que se levantaba la ciudad, con intención de despeñarlo. Pero Jesús, pasando en medio de ellos, continuó su camino.Palabra del Señor.

Lc 4,16-30.Jesús fue a Nazaret, donde se había criado; el sábado entró como de costumbre en la sinagoga y se levantó para hacer la lectura.Le presentaron el libro del profeta Isaías y, abriéndolo, encontró el pasaje donde estaba escrito:El Espíritu del Señor está sobre mí, porque me ha consagrado por la unción. El me envió a llevar la Buena Noticia a los pobres, a anunciar la liberación a los cautivos y la vista a los ciegos, a dar la libertad a los oprimidosy proclamar un año de gracia del Señor.Jesús cerró el Libro, lo devolvió al ayudante y se sentó. Todos en la sinagoga tenían los ojos fijos en él.Entonces comenzó a decirles: "Hoy se ha cumplido este pasaje de la Escritura que acaban de oír".Todos daban testimonio a favor de él y estaban llenos de admiración por las palabras de gracia que salían de su boca. Y decían: "¿No es este el hijo de José?".Pero él les respondió: "Sin duda ustedes me citarán el refrán: 'Médico, cúrate a ti mismo'. Realiza también aquí, en tu patria, todo lo que hemos oído que sucedió en Cafarnaún".Después agregó: "Les aseguro que ningún profeta es bien recibido en su tierra.Yo les aseguro que había muchas viudas en Israel en el tiempo de Elías, cuando durante tres años y seis meses no hubo lluvia del cielo y el hambre azotó a todo el país.Sin embargo, a ninguna de ellas fue enviado Elías, sino a una viuda de Sarepta, en el país de Sidón.También había muchos leprosos en Israel, en el tiempo del profeta Eliseo, pero ninguno de ellos fue curado, sino Naamán, el sirio".Al oír estas palabras, todos los que estaban en la sinagoga se enfurecierony, levantándose, lo empujaron fuera de la ciudad, hasta un lugar escarpado de la colina sobre la que se levantaba la ciudad, con intención de despeñarlo.Pero Jesús, pasando en medio de ellos, continuó su camino.

San Lucas 4, 16 – 30Jesús fue a Nazaret, donde se había criado; el sábado entró como de costumbre en la sinagoga y se levantó para hacer la lectura. Le presentaron el libro del profeta Isaías y, abriéndolo, encontró el pasaje donde estaba escrito: El Espíritu del Señor está sobre mí, porque me ha consagrado por la unción. Él me envió a llevar la Buena Noticia a los pobres, a anunciar la liberación a los cautivos y la vista a los ciegos, a dar la libertad a los oprimidos y proclamar un año de gracia del Señor. Jesús cerró el Libro, lo devolvió al ayudante y se sentó. Todos en la sinagoga tenían los ojos fijos en él. Entonces comenzó a decirles: "Hoy se ha cumplido este pasaje de la Escritura que acaban de oír". Todos daban testimonio a favor de él y estaban llenos de admiración por las palabras de gracia que salían de su boca. Y decían: "¿No es este el hijo de José?". Pero él les respondió: "Sin duda ustedes me citarán el refrán: 'Médico, cúrate a ti mismo'. Realiza también aquí, en tu patria, todo lo que hemos oído que sucedió en Cafarnaún". Después agregó: "Les aseguro que ningún profeta es bien recibido en su tierra. Yo les aseguro que había muchas viudas en Israel en el tiempo de Elías, cuando durante tres años y seis meses no hubo lluvia del cielo y el hambre azotó a todo el país. Sin embargo, a ninguna de ellas fue enviado Elías, sino a una viuda de Sarepta, en el país de Sidón. También había muchos leprosos en Israel, en el tiempo del profeta Eliseo, pero ninguno de ellos fue curado, sino Naamán, el sirio". Al oír estas palabras, todos los que estaban en la sinagoga se enfurecieron y, levantándose, lo empujaron fuera de la ciudad, hasta un lugar escarpado de la colina sobre la que se levantaba la ciudad, con intención de despeñarlo. Pero Jesús, pasando en medio de ellos, continuó su camino.……………….Además puedes escuchar el Evangelio diario en las siguientes plataformas:Spotify: https://open.spotify.com/show/2M0Ubx3Jh55B6W3b20c3GOApple podcast: https://podcasts.apple.com/us/podcast/evangelio-del-d%C3%ADa/id1590423907 Para más información puede consultar nuestro sitio: https://www.vozcatolica.com o escríbanos a info@vozcatolica.com .Si quiere colaborar con este Apostolado lo puede hacer dirigiéndose a: https://vozcatolica.com/ayudanos . Desde ya muchas gracias.

Muchos más recursos para tu vida de fe (Santo Rosario, Oración, etc.) en nuestra web https://sercreyente.com________________Lunes, 1 de septiembre de 2025 (22ª Semana del Tiempo Ordinario)Evangelio del día y reflexión... ¡Deja que la Palabra del Señor transforme tu vida! Texto íntegro del Evangelio y de la Reflexión en https://sercreyente.com/el-espiritu-del-senor-esta-sobre-mi/[Lucas 4, 16-30] En aquel tiempo, fue Jesús a Nazaret, donde se había criado, entró en la sinagoga, como era su costumbre los sábados, y se puso en pie para hacer la lectura. Le entregaron el rollo del profeta Isaías y, desenrollándolo, encontró el pasaje donde estaba escrito: «El Espíritu del Señor está sobre mí, porque él me ha ungido. Me ha enviado a evangelizar a los pobres, a proclamar a los cautivos la libertad, y a los ciegos, la vista; a poner en libertad a los oprimidos; a proclamar el año de gracia del Señor». Y, enrollando el rollo y devolviéndolo al que lo ayudaba, se sentó. Toda la sinagoga tenía los ojos clavados en él. Y él comenzó a decirles: «Hoy se ha cumplido esta Escritura que acabáis de oír». Y todos le expresaban su aprobación y se admiraban de las palabras de gracia que salían de su boca. Y decían: «¿No es este el hijo de José?». Pero Jesús les dijo: «Sin duda me diréis aquel refrán: “Médico, cúrate a ti mismo”, haz también aquí, en tu pueblo, lo que hemos oído que has hecho en Cafarnaún». Y añadió: «En verdad os digo que ningún profeta es aceptado en su pueblo. Puedo aseguraros que en Israel había muchas viudas en los días de Elías, cuando estuvo cerrado el cielo tres años y seis meses y hubo una gran hambre en todo el país; sin embargo, a ninguna de ellas fue enviado Elías sino a una viuda de Sarepta, en el territorio de Sidón. Y muchos leprosos había en Israel en tiempos del profeta Eliseo, sin embargo, ninguno de ellos fue curado sino Naamán, el sirio». Al oír esto, todos en la sinagoga se pusieron furiosos y, levantándose, lo echaron fuera del pueblo y lo llevaron hasta un precipicio del monte sobre el que estaba edificado su pueblo, con intención de despeñarlo. Pero Jesús se abrió paso entre ellos y seguía su camino.________________Descárgate la app de SerCreyente en https://sercreyente.com/app/¿Conoces nuestra Oración Online? Más información en: https://sercreyente.com/oracion¿Quieres recibir cada día el Evangelio en tu whatsapp? Alta en: www.sercreyente.com/whatsappTambién puedes hacer tu donativo en https://sercreyente.com/ayudanos/Contacto: info@sercreyente.com

+ Del Evangelio según san Lucas +En aquel tiempo, Jesús fue a Nazaret, donde se había criado. Entró en la sinagoga, como era su costumbre hacerlo los sábados, y se levantó para hacer la lectura. Se le dio el volumen del profeta Isaías, lo desenrolló y encontró el pasaje en que estaba escrito: El Espíritu del Señor está sobre mí, porque me ha ungido para llevar a los pobres la buena nueva, para anunciar la liberación a los cautivos y la curación a los ciegos, para dar libertad a los oprimidos y proclamar el año de gracia del Señor. Enrolló el volumen, lo devolvió al encargado y se sentó. Los ojos de todos los asistentes a la sinagoga estaban fijos en él. Entonces comenzó a hablar, diciendo: "Hoy mismo se ha cumplido este pasaje de la Escritura, que ustedes acaban de oír". Todos le daban su aprobación y admiraban la sabiduría de las palabras que salían de sus labios, y se preguntaban: "¿No es éste el hijo de José?" Jesús les dijo: "Seguramente me dirán aquel refrán: Médico, cúrate a ti mismo, y haz aquí, en tu propia tierra, todos esos prodigios que hemos oído que has hecho en Cafarnaúm ". Y añadió: "Yo les aseguro que nadie es profeta en su tierra. Había ciertamente en Israel muchas viudas en los tiempos de Elías, cuando faltó la lluvia durante tres años y medio, y hubo un hambre terrible en todo el país; sin embargo, a ninguna de ellas fue enviado Elías, sino a una viuda que vivía en Sarepta, ciudad de Sidón. Había muchos leprosos en Israel, en tiempos del profeta Eliseo; sin embargo, ninguno de ellos fue curado sino Naamán, que era de Siria". Al oír esto, todos los que estaban en la sinagoga se llenaron de ira, y levantándose, lo sacaron de la ciudad y lo llevaron hasta una barranca del monte, sobre el que estaba construida la ciudad, para despeñarlo. Pero él, pasando por en medio de ellos, se alejó de allí.Palabra del Señor.

La vida no se mide en décadas o en grandes logros, sino en la fidelidad de cada día. Dios habló de los “muchos días” de Elías en Sarepta para recordarnos que la vida se construye paso a paso, con disciplina diaria en la oración, en la Palabra y en la obediencia. El futuro de tu matrimonio, tus hijos, tu salud y tus finanzas se decide en lo que haces hoy. Aprende a vivir un día a la vez y a contar tus días con sabiduría para que cada jornada glorifique a Dios.

La viuda de Sarepta había visto un milagro, pero cuando su hijo murió culpó a Elías y hasta a Dios. El profeta no discutió: llevó al niño a su lugar secreto y clamó al Señor. Dios lo resucitó, y entonces la mujer declaró: “Ahora sé que eres un hombre de Dios”. La fe verdadera se reconoce no solo por lo que decimos, sino por cómo vivimos y cómo confiamos en el Dios vivo. ¿Pueden los que están cerca de ti ver a Cristo en tu vida?

La historia de la viuda de Sarepta nos enseña que la obediencia a Dios siempre va acompañada de fe. Elías llegó a una mujer que solo tenía un puñado de harina y un poco de aceite para preparar su última comida, pero obedeció la palabra del profeta y confió en Dios. El resultado fue un milagro: nunca faltó alimento en su casa. Así es el camino de la fe: no se basa en lo que vemos, sino en la fidelidad del Dios vivo. ¿Quieres ver milagros en tu vida? Empieza a obedecer, aunque parezca imposible.

In der heutigen Folge sprechen die Finanzjournalisten Lea Oetjen und Holger Zschäpitz über Börsen-Non-Event Alaska, eine hoffnungsvolle Softwarestudie mit 6 Top Picks und einen neuen Chart of Doom. Außerdem geht es um CoreWeave, Salesforce, Siemens Energy, Cisco Systems, Palo Alto Networks, ProSiebenSat.1, Novo Nordisk, AstraZeneca, AbbVie, Siemens Healthineers, Sonova, Medtronic, Haleon, iShares Aging Population ETF (WKN: A2ANH1), Boston Scientific, Glaukos, Exelixis, Sarepta, Swisscanto Healthy Longevity Fund (WKN: A40L0T), Eli Lilly, Abbott, UnitedHealth, Microsoft, Amazon, Nvidia, Meta, Netflix, Coreweave, Oracle, Carvana, TSMC, Roblox, Crowdstrike, Opendoor Technologies, Alibaba, PDD, Petroleo Brasileiro, Teva Pharmaceutical, Robinhood, Northrop Grumman, RTX, Lululemon, Mercadolibre, Talen Energy, GE Vernova, Broadcom, Vistra, Micron, Alphabet, Somnigroup International, Flutter Entertainment. Und hier gibt es die Tickets zum Finance Summit am 17. September! https://veranstaltung.businessinsider.de/FinanceSummit Wir freuen uns an Feedback über aaa@welt.de. Noch mehr "Alles auf Aktien" findet Ihr bei WELTplus und Apple Podcasts – inklusive aller Artikel der Hosts und AAA-Newsletter. Hier bei WELT: https://www.welt.de/podcasts/alles-auf-aktien/plus247399208/Boersen-Podcast-AAA-Bonus-Folgen-Jede-Woche-noch-mehr-Antworten-auf-Eure-Boersen-Fragen.html. Der Börsen-Podcast Disclaimer: Die im Podcast besprochenen Aktien und Fonds stellen keine spezifischen Kauf- oder Anlage-Empfehlungen dar. Die Moderatoren und der Verlag haften nicht für etwaige Verluste, die aufgrund der Umsetzung der Gedanken oder Ideen entstehen. Hörtipps: Für alle, die noch mehr wissen wollen: Holger Zschäpitz können Sie jede Woche im Finanz- und Wirtschaftspodcast "Deffner&Zschäpitz" hören. +++ Werbung +++ Du möchtest mehr über unsere Werbepartner erfahren? Hier findest du alle Infos & Rabatte! https://linktr.ee/alles_auf_aktien Impressum: https://www.welt.de/services/article7893735/Impressum.html Datenschutz: https://www.welt.de/services/article157550705/Datenschutzerklaerung-WELT-DIGITAL.html

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. Sarepta has released new safety data for their gene therapy Elevidys, showing zero ambulatory deaths in patients with Duchenne muscular dystrophy. This data confirms the therapy's positive risk/benefit profile. Meanwhile, Novo Nordisk's rapid rise and fall was driven by GLP-1s like Ozempic and Wegovy, leading to a plummet in stock value. Insmed has received FDA approval for the first bronchiectasis drug and DPP1 blocker, Brinsupri. Texas has accused Eli Lilly of "bribing" prescribers to push their drugs Mounjaro and Zepbound, leading to a new lawsuit. Genscript is entering a new era of innovation and trust, offering exclusive promos and events. Additionally, Tang Capital is on a buyout binge in the biotech industry, while a top ARPA-H official has departed in protest of cuts to mRNA funding. The biotech industry continues to see contractions with companies like AbSci, Fate, and Oric downsizing. In career advice, loyalty is seen as a flawed strategy that can cost individuals opportunities.Arrowhead, a biotech company, has emerged as a savior in the RNA interference (RNAi) pipeline after Sarepta faced troubles unrelated to Arrowhead's assets. Concentra Biosciences, a biotech shell company, has been on a buying spree, acquiring four biotechs in the past month and seven so far this year. President Trump's most favored nation drug pricing policy is seen as unfavorable for all parties involved. Novo Nordisk experienced a rapid rise and fall due to the success of ozempic and wegovy. Lilly is facing drug pricing pressure while defending its injectable GLP-1 empire. Novartis is rumored to be considering acquiring RNA specialist Avidity. Despite safety concerns, Sarepta beat Q2 estimates, but not due to sales of its product Elevidys. Various biotech companies are downsizing while others are receiving significant investments.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. ## Bayer has secured a $1.3 billion deal with Kumquat Biosciences for exclusive access to their small-molecule KRAS G12D blocker. Meanwhile, Arrowhead has navigated through the Sarepta storm and experienced a drop in stock prices, despite having no direct ties to Sarepta's issues. In other news, a medical journal stands firm in refusing to retract a vaccine study, HHS has put a freeze on Vaxart's oral COVID-19 vaccine, and GenScript is celebrating a new era of innovation.## Additionally, discussions surround obesity leaders defending their injectable GLP-1 empires, recent layoffs at Merck, and the hurdles faced by oral obesity drugs. Opinion pieces delve into the skepticism towards mRNA technology and the potential repercussions of dismissing the head maha implementor following an mRNA purge. Stay tuned for more updates on upcoming events and job opportunities in the industry.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.Vinay Prasad has returned to his position as director of the Center for Biologics Evaluation and Research at the FDA after a sudden exit less than two weeks ago. The FDA has restricted the patient pool for bluebird's Skysona gene therapy due to safety concerns, and Sarepta's AAV gene therapy platform has come under scrutiny following patient deaths from liver injuries. Genscript is celebrating a new era of innovation and trust.The text discusses the scrutiny faced by AAV gene therapy technology following patient deaths related to Sarepta Therapeutics' platform. There is a push for improvement in the technology, while some are looking to move on to other options. The article also highlights the importance of mRNA technology in cancer research and the need for continued investment in this area. Additionally, it mentions the FDA's decision on Biogen and Eisai's Alzheimer's drug, as well as five oral obesity drugs that could rival Lilly's Orforglipron. Other topics covered include cancer drug developments, gene therapy news, and upcoming industry events.Stay tuned for more updates on the latest news in the pharmaceutical and biotechnology industries.

Good morning from Pharma and Biotech Daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. Eli Lilly is facing significant drug pricing pressure, with issues ranging from the pricing of their weight loss pill Orfoglipron to market battles with competitors like Novo Nordisk. Despite the challenges, Lilly's executives see opportunities for their products in the real world. Jazz Pharmaceuticals received FDA approval for Dordaviprone, making it the first new treatment for an ultra-rare brain tumor. In other news, Sarepta beat Q2 estimates despite not holding an investor call, and Trilink Biotechnologies is offering process development services for nucleic acid therapeutic development. Lotte Biologics is expanding its global CDMO operations, while a big pharma-backed mRNA startup raised $153 million in funding. Novo Nordisk's new CEO is focusing on obesity and diabetes, Pfizer is in talks with Trump on most favored nation drug pricing, and Bayer expects more layoffs. These developments in the pharma and biotech world showcase the ongoing challenges and opportunities in the industry. Stay tuned for more updates on the latest news and trends in this rapidly evolving sector.

It's nearly impossible to discuss the private health insurance landscape in America without referencing the killing of UnitedHealthcare CEO Brian Thompson last December.The shooting unleashed a wave of antipathy directed at insurers and brought deep-seeded, longstanding grievances against these for-profit health entities to the fore.In the intervening months, UnitedHealth Group and the broader insurer class have suffered significant damage not only to their respective bottom lines, but also their corporate reputations.Given the current state of play, we wanted to hear how medical marketers are navigating this uniquely challenging situation.Reporter Heerea Rikhraj speaks with Shannon Langrand, CEO of her namesake agency, about how health insurers are being marketed in 2025 as well as what challenges are lingering in the payer space.For our Trends segment, we parse through the Sarepta Therapeutics saga and pull out some key takeaways. Step into the future of health media at the MM+M Media Summit on October 30th, 2025 live in NYC! Join top voices in pharma marketing for a full day of forward-thinking discussions on AI, streaming, retail media, and more. Explore the latest in omnichannel strategy, personalization, media trust, and data privacy—all under one roof. Don't wait—use promo code PODCAST for $100 off your individual ticket. Click here to register! AI Deciphered is back—live in New York City this November 13th.Join leaders from brands, agencies, and platforms for a future-focused conversation on how AI is transforming media, marketing, and the retail experience. Ready to future-proof your strategy? Secure your spot now at aidecipheredsummit.com. Use code POD at check out for $100 your ticket! Check us out at: mmm-online.com Follow us: YouTube: @MMM-onlineTikTok: @MMMnewsInstagram: @MMMnewsonlineTwitter/X: @MMMnewsLinkedIn: MM+M To read more of the most timely, balanced and original reporting in medical marketing, subscribe here.Music: “Deep Reflection” by DP and Triple Scoop Music.

Good morning from Pharma and Biotech Daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. BioNTech is focusing on infectious diseases as vaccine rates drop, with expectations that the US COVID-19 vaccination rate will decrease slightly. Glioblastoma research is seeing increased funding and interest from companies like Merck and Jazz Pharmaceuticals. The FDA's rejection of Replimmune's melanoma drug, despite staff consensus, has caused a drop in the company's stock. Sarepta and Capricor learned of regulatory decisions through media leaks, causing confusion for patients and families. Trilink Biotechnologies offers process development services for nucleic acid therapeutic development. Lotte Biologics is expanding globally, Allogene is discontinuing an immunosuppressive antibody after a patient death, and NIH funding cuts are impacting biotech. Pharmas are increasing investment in AI despite challenges in the industry. Trump urges pharma companies to address drug pricing, while Merck plans to cut 6,000 jobs to save $3 billion.

Over a whirlwind three weeks, Sarepta Therapeutics has faced tough safety questions around its commercial gene therapy Elevidys and growing scrutiny over the company’s transparency following multiple patient deaths. In this week’s episode of "The Top Line," we explore Sarepta’s brief standoff with the FDA over Elevidys, a short-lived marketing pause, and the regulator’s surprise reversal on the treatment. Fierce Pharma’s Fraiser Kansteiner and Angus Liu sit down with Fierce Biotech’s Gabrielle Masson to recap the story and discuss the broader implications the Elevidys saga may have for gene therapy, the FDA and the pharmaceutical industry. To learn more about the topics in this episode: Sarepta pivots to siRNA and lays off 500 staffers as Elevidys gets box warning Sarepta LGMD trials all hit by FDA hold amid newly surfaced safety concerns over gene therapy Sarepta, bowing to FDA pressure, pauses shipments of Duchenne gene therapy Elevidys FDA takes U-turn on Sarepta's Elevidys, backing Duchenne gene therapy again in ambulatory patients Analysts demand transparency after Sarepta's roundabout disclosure of 3rd patient death Roche won't throw in the towel after DMD gene therapy Elevidys' rebuff in Europe See omnystudio.com/listener for privacy information.

Empaveli approved to treat two rare kidney diseases; Elevidys available again for ambulatory patients; Mounjaro shows benefit in cardiovascular disease; wearable cardiac monitor gets clearance; upadacitinib trial shows hair regrowth in individuals with alopecia areata.

Howie and Harlan discuss Dr. Vinay Prasad's departure from the FDA after a backlash against his decisions on Sarepta's Duchenne muscular dystrophy gene therapy. Also examined: AI in clinical settings, changes in NIH grantmaking, and the 60th anniversary of Medicare and Medicaid. Links: Sarepta and the FDA “STAT breaks down the confusing, heartbreaking Sarepta saga” “Sarepta Therapeutics' Duchenne therapy faces ‘arduous' path back to market, senior FDA official says” “For many Duchenne families, halt to gene therapy is heartbreak upon heartbreak” “FDA launches probe into new Elevidys death as Sarepta, Roche stress gene therapy not at fault” “FDA Recommends Removal of Voluntary Hold for Elevidys for Ambulatory Patients” “FDA takes U-turn on Sarepta's Elevidys, backing Duchenne gene therapy again in ambulatory patients” “Controversial FDA official Dr. Vinay Prasad departs agency” “Top F.D.A. Vaccine Official Resigns, Citing Kennedy's ‘Misinformation and Lies'” “Vinay Prasad Is a Bernie Sanders Acolyte in MAHA Drag” “Timeline: The Rise and Fall of Vioxx” “What have we learnt from Vioxx?” THC in pizza dough “C.D.C. Ties 85 Cases of THC-Related Symptoms to Wisconsin Restaurant” “Tetrahydrocannabinol Intoxication from Food at a Restaurant — Wisconsin, October 2024” NIH funding “NIH is shrinking the number of research projects it funds due to a new Trump policy” NIH: Supporting Fairness and Originality in NIH Research Applications “Fearful of AI-generated grant proposals, NIH limits scientists to six applications per year” “Trump budget draft proposes NIH consolidation and 40% spending cut” Raw milk “Outbreak of Salmonella Typhimurium Infections Linked to Commercially Distributed Raw Milk — California and Four Other States, September 2023–March 2024” “The Dangers of Raw Milk: Unpasteurized Milk Can Pose a Serious Health Risk” AI in healthcare update “Ambience Healthcare Announces $243 Million Series C to Scale its AI Platform for Health Systems” “As ambient scribes face off, Doximity lures doctors with a free option” Aidoc: “AI Empowering Radiologists” “Clinical Implementation of a Combined Artificial Intelligence and Natural Language Processing Quality Assurance Program for Pulmonary Nodule Detection in the Emergency Department Setting” “Large Language Models as an Inexpensive and Effective Extra Set of Eyes in Radiology Reporting” “Current Trends in Remote and Flexible Work Options in Radiology and Perception of Impact on Radiologist Well-being” Medicare and Medicaid 60th anniversary CMS' program history “Medicare and Medicaid turn 60 – and face historic cuts decades in the making” UnitedHealth and Medicare Advantage “UnitedHealth says 2025 earnings will be worse than expected as high medical costs dog insurers” “UnitedHealthcare to exit certain Medicare Advantage markets as costs balloon, impacting 600K enrollees” “Novo Nordisk slides further on US competition, new CEO concerns” “Dems Must Really Fix Medicaid, Not Just Undo Trump's Damage to It”   Learn more about the MBA for Executives program at Yale SOM. Email Howie and Harlan comments or questions.

The morning after the FDA's vaccine regulator Dr. Vinay Prasad announced his resignation, FDA Commissioner Dr. Marty Makary shares the agency's position on the measles vaccine, Sarepta's Duchenne therapy, and the addictive kratom-derived compound OH-7. Booking Holdings CEO Glenn Fogel discusses the impact of geopolitics on travel to the U.S. While Canadians and Europeans are still traveling, the operator of Agoda, Priceline, and Kayak says they're going to Mexico and Asia, instead of the U.S. Plus, Wall Street remembers the lives lost in Monday's shooting, the first tsunami waves from Russia's 8.8 earthquake have hit Hawaii's shores, and CNBC's Eamon Javers reports on his conversation with Treasury Secretary Scott Bessent about trade talks with China. Eamon Javers - 07:24Dr. Marty Makary - 18:51Glenn Fogel - 36:48 In this episode:Eamon Javers, @EamonJaversJoe Kernen, @JoeSquawk Becky Quick, @BeckyQuickAndrew Ross Sorkin, @andrewrsorkinKatie Kramer, @Kramer_Katie

Audio roundup of selected biopharma industry content from Scrip over the business week ended July 25, 2025. In this episode: Sanofi's Vicebio buy; Sarepta halts US Elevidys shipments; Novartis warning over Europe; US CRL for Genentech's Columvi; and an interview with Novavax. https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-U4IN5X7DRVFLVIBJ4Q72VTAJUY/ This episode was produced with the help of AI text-to-voice and voice emulation tools. Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

The end of a huge week for earnings and record highs on the S&P: Carl Quintanilla, Sara Eisen, and David Faber reacted to breaking commentary from President Trump top of the hour, before getting Apollo Global Chief Economist Torsten Slok's take… who's warning of stagflation ahead tied to tariffs: arguing there's “no free lunch”. Big Tech a key part of the recent rally – longtime investor Dan Niles broke down his top picks ahead of results next week from Apple, and why he sees clouds on the horizon come September. Plus: a number of individual stock movers… The team discussed what's driving huge declines in shares of Charter and Sarepta, Volkswagen's latest warning on tariffs – and what it means for the rest of the automakers, and new numbers out of one luxury retailer who's down big on the year.   

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith and Editor-in-Chief Nielsen Hobbs discuss the issues awaiting George Tidmarsh, the new director of the US Food and Drug Administration's Center for Drug Evaluation and Research (:24), as well as the next steps for the agency and Sarepta amid the ongoing problems with its gene therapy Elevidys (delandistrogene moxeparvovec) (23:49). More On These Topics From The Pink Sheet Will Tidmarsh's Industry Experience Translate As US FDA's Chief Drug Regulator?: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/breaking-news-pharma-ceo-george-tidmarsh-named-director-of-us-fdas-drug-center-2HXJJCPAIVB2RFNGDDU5NZVNQQ/ Business Background Of New CDER Director George Tidmarsh: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/business-background-of-new-cder-director-george-tidmarsh-BROCYQDUYFE3LIQDJ2JNBDWD6Y/ US FDA Cancer Reviewers Heading For The Exits, Potentially Impacting Review Timelines: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-cancer-reviewers-heading-for-the-exits-potentially-impacting-review-timelines-YMOFTXDFDZBGVGBIKFXHJY5XTY/ US FDA's Biologics Center Departures Grew Before More Than 100 RIFs Exited: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fdas-biologics-center-departures-grew-before-more-than-100-rifs-exited-2LR3ZFYOBND3DLIWXSFFWWLFYE/ After Sarepta Reversed Course On Elevidys, Could An Adcomm Be Next?: https://insights.citeline.com/pink-sheet/product-reviews/post-marketing-regulation-and-studies/after-sarepta-reversed-course-on-elevidys-could-an-adcomm-be-next-ZA5ODQB3DJF4LBDFODMB52DM3M/ Sarepta Refuses To Stop Elevidys Shipments After Third Death Linked To Gene Therapy Vector: https://insights.citeline.com/pink-sheet/advanced-technologies/cell-and-gene-therapies/us-fda-asks-sarepta-to-stop-elevidys-shipments-after-third-death-linked-to-gene-therapy-vector-GLJ2YJDJGNBPLD3SSKKE6UVM34/

Howie and Harlan are joined by public health communicator Katelyn Jetelina for updates on COVID-19 and other issues, and to discuss how her emails to students and colleagues in the early days of the pandemic turned into a platform with global reach. Harlan looks at how AI is being used on both sides of the battle between providers and insurers over claims; Howie reports on a setback with a promising gene therapy for Duchenne muscular dystrophy. Links: Insurance Claims, AI, and Wearables “Elevance Health Reports Second Quarter 2025 Results” “Elevance lowers profit outlook, warns things will get worse for health insurers ““Blue KC wrongfully denied medical diagnoses, hospital alleges in AI-driven claims lawsuit” “Oscar Health cuts full-year guidance, estimates 2025 loss as ACA marketplace stumbles” Whoop “WHOOP Delivers Innovative Blood Pressure Insights for a Deeper Look at Your Well-Being” “Introducing Heart Screener: A smarter way to stay connected to your heart health” “Whoop says FDA is ‘overstepping its authority' with warning about blood pressure feature” FDA: WARNING LETTER, WHOOP, Inc. “RFK Jr. wants everyone to use wearables. What are the benefits, risks?” “Apple to Sell Watches With Blood-Oxygen Feature Disabled After Legal Setback” Your Local Epidemiologist Your Local Epidemiologist “Poll: Trust in Public Health Agencies and Vaccines Falls Amid Republican Skepticism” “Popular epidemiologist lays out future path of public health communication” Yale School of Public Health: PopHIVE Katelyn Jetelina: “NIH: The quiet engine of science is being dismantled” Katelyn Jetelina: “Covid-19 in pockets, sugar cane isn't better, ticks march on, rescission cuts (vs. everything else), bright spots, and more” Mayo Clinic: Norovirus infection Katelyn Jetelina: “The show must go on...” Katelyn Jetelina: “Harassment against scientists is out of control” Katelyn Jetelina: “Medicaid cuts: The how and why” CDC: H5 Bird Flu: Current Situatio CDC: Current Epidemic Trends (Based on Rt) for States” CDC: Measles Cases and Outbreaks Treating Duchenne Muscular Dystrophy Cleveland Clinic: Duchenne Muscular Dystrophy (DMD) “FDA approves Sarepta's Duchenne gene therapy for nearly all patients” “AAV gene therapy for Duchenne muscular dystrophy: the EMBARK phase 3 randomized trial” “Patient dies in Sarepta gene therapy trial, adding to safety concerns” “FDA Requests Sarepta Therapeutics Suspend Distribution of Elevidys and Places Clinical Trials on Hold for Multiple Gene Therapy Products Following 3 Deaths” “In surprise reversal, Sarepta Therapeutics says it will pause shipments of Duchenne gene therapy” “Sarepta to lay off about 500 employees after Duchenne gene therapy setbacks” Learn more about the MBA for Executives program at Yale SOM. Email Howie and Harlan comments or questions.

Last week's public disclosure that a gene therapy from Sarepta had caused a third death led FDA to ask the company to stop distributing its DMD gene therapy Elevidys, a move the biotech has resisted. The deaths, and disputes between FDA and Sarepta, raise questions about the future of AAV gene therapies, as well as the future of FDA's platform technology designation. On the latest BioCentury This Week podcast, BioCentury's analysts unpack the events surrounding Sarepta's gene therapies and discuss how FDA, industry and patient groups should come together to learn the lessons from the tragic, avoidable deaths.BioCentury's analysts also assess Monday's appointment of Stanford professor and biotech executive George Tidmarsh to lead FDA's Center for Drug Evaluation and Research, and check in on the latest trends in venture financings. This episode of BioCentury This Week is sponsored by IQVIA Biotech.View full story: https://www.biocentury.com/article/656537#biotech #biopharma #pharma #lifescience #GeneTherapy #AAVTherapy #Sarepta #Elevidys00:01 - Sponsor Message: IQVIA Biotech02:03 - Gene Therapy17:59 - Leading CDER27:00 - Venture ReportTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text

Audio roundup of selected biopharma industry content from Scrip over the business week ended July 18, 2025. In this episode: – J&J delivers in Q2 despite Stelara drop; Sarepta cuts jobs as Elevidys slumps; AI is inevitable but needs to be applied appropriately; China's mid-cap companies thrive; and a look behind Glenmark's landmark trispecific deal. Article links: https://insights.citeline.com/scrip/podcasts/scrips-five-must-know-things/quick-listen-scrips-five-must-know-things-HYQOHZ42CNCQRPF6HCKGLTHUKM/ This episode was produced with the help of AI text-to-voice and voice emulation tools. Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Google riding high ahead of earnings, with potential for its longest win streak in years. Japan's election results have the Yen strengthening against the dollar. And Sarepta's slide continues as the drug developer rebukes the FDA's request to halt shipments of its gene therapy drug. Why one Wall Street analyst says the stock could head to zero. Fast Money Disclaimer  

Another morning of record highs on the S&P and NASDAQ ahead of a make-or-break week for stocks: Sara Eisen and Carl Quintanilla started the hour with a look at the major earnings coming this week (Alphabet, Tesla, Intel, and more), and what we've heard from key companies so far. Barclays Head of U.S. Equity Strategy arguing this will be the first quarter to show the impact of tariffs – but the headwinds just haven't shown up yet. Plus: a deep dive on new numbers out of Domino's with an analyst who calls the stock a buy, as their CFO says they've seen no geopolitical impact to their business.  Also in focus: hear from the CEO of the credit bureau FICO as his company comes under fire for being a “monopoly” – why he says it's just the most efficient way for the market to operate, how he's using AI in the business, and more… and the latest on the biggest movers of the day, from Sarepta to Apple to LVMH.Squawk on the Street Disclaimer

Chevron CEO Mike Wirth joined Carl Quintanilla and Sara Eisen at Post 9 in a "First on CNBC" interview. They discussed the oil giant completing its $55 billion acquisition of Hess. Shares of Netflix pull back from all-time highs despite better-than-expected quarterly results. One analyst offers his take on where the stock and the streaming wars go from here. New record intraday highs for the S&P 500 and Nasdaq -- a chief investment strategist joins the discussion about what's next for the rally. Also in focus: Reaction to earnings from the likes of American Express, Sarepta tumbles, President Trump vs. Fed Chair Powell, the House of Representatives passes landmark crypto legislation, CBS cancels Stephen Colbert's "Late Show."   Squawk on the Street Disclaimer

Jamie is out of town, so John's wife, Sarepta, made her debut in the studio. She even came prepared with questions.

Carl Quintanilla, David Faber and Sara Eisen kicked off a new week of trading with stocks rebounding sharply and oil prices giving back some of Friday's huge gains  -- despite the ongoing Israel-Iran conflict. President Trump approved U.S. Steel's deal with Nippon Steel, with terms requiring a "golden share" for the U.S. government. Guggenheim's Tesla analyst joined the program nearly a week after his "sell" rating on the stock.  Also in focus: Trump at the G7 in Canada, Meta's WhatsApp to roll out ads directly on its platform, Sarepta plummets, Roku surges on its partnership with Amazon, Circle up 400% since its early June IPO.   Squawk on the Street Disclaimer

Reports this morning that Iran has signaled it wants to de-escalate hostilities with Israel – and restart talks with the US: Carl Quintanilla, Sara Eisen, and David Faber broke down the latest along with key market implications ahead of another rate decision from the Fed on Wednesday – and as energy prices remain surprisingly steady. Plus: A live read from the ground in Alberta, as the G-7 summit begins in Canada.  Rockefeller International's Ruchir Sharma brought his outlook for equities – fresh off an Op-Ed in the Financial Times arguing to not underestimate the Chinese as trade talks continue… Plus: hear from Former Deputy Secretary of State – and lead negotiator for the nuclear agreement with Iran under the Obama Administration – Wendy Sherman's take on what comes next here. Also in focus: Meta rolls out ads on Whatsapp, boosting shares; Sarepta stock plummets after a 2nd death tied to an experimental gene therapy; an exclusive with the CEO of aerospace maintenance company StandardAero, live from the Paris Air Show; and the rumors around AWS that are boosting AMD shares to fresh highs. Squawk on the Street Disclaimer