FirstTake on Pharma - Pharma News and Analysis Podcast

Virginia Li digs into more promising data for NK CAR cell therapy, this time from Nkarta who share price doubled on the announcement. We listen to an extract from this week's KOL View Live discussion between Michael Flanagan and Xianxin Hua, professor of cancer biology at the University of Pennsylvania's Perelman School of Medicine, about the progress of CAR-T therapies as potential treatments for solid tumours. And Simon King provides some early thoughts on key trends from first quarter earnings season, including uncertainty around future COVID-19-related revenues and Big Pharma's appetite for M&A.

On this week's episode FirstWord Pharma PLUS editors Virginia Li, Michael Flanagan and Simon King look ahead to the annual meeting of the American Association of Cancer Research (AACR) which is taking place this weekend in New Orleans.

On this week's episode Virginia Li discusses the closely watched FDA AdCom meeting for Amylyx's ALS therapy AMX0035, which saw experts vote narrowly against Amylyx having shown sufficient efficacy for the drug from a single clinical study. Simon King looks at two major clinical data announcements – for Almirall and Eli Lilly's atopic dermatitis drug lebrikizumab and Roche's potential cancer therapy tiragolumab. And FirstWord HealthTech's Tina Tan highlights some notable trends in health tech venture capitalist investments during the first quarter of 2022, ahead of an exclusive live event for FirstWord HealthTech PLUS subscribers next week where she will provide a more comprehensive overview of VC activity.

On this week's episode editors Virginia Li and Simon King discuss FDA approval of the first novel checkpoint inhibitor for eight years – Bristol Myers Squibb's LAG-3 inhibitor relatlimab – and evaluate positive data for Pfizer's etrasimod, which it gained via December's $6.7 billion acquisition of Arena Pharmaceuticals. In addition, FirstWord's Michael Flanagan speaks to Adam Brufsky – professor of medicine at the University of Pittsburgh School of Medicine and associate chief for the school's haematology/oncology division – to discuss the relevance of recent clinical and regulatory events that will impact the treatment of breast cancer.

On this week's episode FirstWord Pharma PLUS editors Virginia Li and Simon King discuss an unexpected corporate re-manoeuvring around Biogen and Eisai's controversial Alzheimer's drug Aduhelm and disappointing clinical data for Sanofi's breast cancer drug amcenestrant. Simon also catches up with FirstWord HealthTech's executive editor Tina Tan to find out about some recent oncologist surveys looking at the use of digital technologies to help combat pandemic-extended treatment waiting times and the mental wellbeing of cancer patients.

On this week's episode FirstWord Pharma PLUS editors Michael Flanagan and Simon King discuss why Gilead is getting flak for a positive cancer drug study, what's gone wrong at bluebird bio and why the FDA has been so quick to expand approval of Bristol Myers Squibb's Opdivo for the treatment of neoadjuvant lung cancer.

On this week's episode FirstWord Pharma PLUS editors Virginia Li, Michael Flanagan and Simon King discuss key developments in the field of gene editing, the approval of Janssen and Legend Biotech's Carvykti for multiple myeloma and whether interchangeability status will have a meaningful impact on future US market for Humira biosimilars.

This week FirstWord Pharma PLUS editors Michael Flanagan, Virginia Li and Simon King discuss confirmation of positive top-line data for AstraZeneca and Daiichi Sankyo's Enhertu in HER2 ‘low' breast cancer, the implications stemming from Amicus Therapeutics' decision to abort a gene-therapy spin out and whether GlaxoSmithKline and Sanofi's long-awaited COVID-19 vaccine has arrived too late to make a meaningful impact on the pandemic.

FirstWord Pharma PLUS editors Virginia Li and Simon King discuss Phase III clinical data for a new depression therapy being co-developed by Sage Therapeutics and Biogen, the FDA's new - but also old – commissioner, Robert Califf, whose reappointment five years after he first held the role was confirmed by the US senate this week and whether Regeneron can make its multi-billion dollar eye-disorder therapy Eylea an even more compelling product for physicians.

FirstWord Pharma PLUS editors Michael Flanagan, Virginia Li and Simon King discuss Eli Lilly's attempt to bring price disruption to the US cancer immunotherapy market, Pfizer and Amgen's future growth strategies and some new diabetes drugs to keep an eye on.

FirstWord Pharma PLUS editors Michael Flanagan, Virginia Li and Simon King discuss another setback for Biogen's Alzheimer's drug Aduhelm – this time at the hands of the Centres for Medicare and Medicaid Services – and highlight key takeaways from this week's JP Morgan Healthcare Conference.

FirstWord Pharma PLUS editors Michael Flanagan and Simon King discuss the biopharma news of their radars this week and look ahead to next week's JP Morgan Healthcare conference, which due to the pandemic will take place virtually for the second year in a row.

FirstWord Pharma PLUS editors Michael Flanagan, Virginia Li and Simon King discuss whether a spate of deals this week is evidence of an eventful year ahead for bio-pharma M&A, take a closer look at Pfizer's acquisition of Arena Pharmaceuticals and highlight some of the standout moments from the recent ASH conference.

FirstWord Pharma PLUS editors Michael Flanagan, Virginia Li and Simon King discuss preliminary data for Pfizer and BioNTech's COVID-19 vaccine versus Omicron, preview the upcoming annual meeting of the American Hematology Society (ASH) and review recent changes to China's National Drug Reimbursement List (NDRL).

FirstWord Pharma PLUS editors Matthew Dennis and Simon King discuss the potential impact of the Omicron variant on the efficacy of COVID-19 vaccines, how GlaxoSmithKline and Sanofi are making moves to keep their vaccines portfolios at the cutting edge of R&D and whether there is a meaningful future for Merck & Co.'s COVID-19 antiviral molnupiravir after this week's close-run AdCom vote.

FirstWord Pharma PLUS editors Virginia Li, Michael Flanagan and Simon King discuss more developments in the race to bring COVID-19 antivirals to patients, Bristol Myers Squibb's long term outlook and the pending departure of veteran Al Sandrock as Biogen's head of R&D.

FirstWord Pharma PLUS editors Virginia Li, Michael Flanagan and Simon King discuss impressive data for Pfizer's COVID-19 antiviral drug, its deal this week to partner up with migraine specialist Biohaven Pharmaceuticals, what the future holds for GlaxoSmithKline's renal anaemia drug daprodustat and Zai Lab's move into the neuroscience field.

FirstWord Pharma PLUS editors Virginia Li, Michael Flanagan and Simon King discuss Novartis' $20 billion windfall from the sale of its 33% stake in crosstown rival Roche, Big Pharma's increasing interest in protein degradation drugs, Pfizer's eye-watering COVID-19 vaccine sales and survey results outlining a more complex path forward for Aduhelm than perhaps Biogen would like to admit.

FirstWord Pharma PLUS editors Virginia Li, Michael Flanagan and Simon King discuss notable highlights from Big Pharma's third quarter earnings season and the formation of a new gene therapy consortium which includes the FDA and NIH among its founders.

FirstWord Pharma PLUS editors Michael Flanagan and Simon King discuss the early commercial performance of Biogen's Aduhelm, a setback in the field of COVID-19 antivirals and a landmark approval for the US biosimilars market.

In this episode editors Virginia Li, Michael Flanagan and Simon King talk about notable new disclosures in the field of allogeneic CART therapy, look at the approval of Eli Lilly's Verzenio for early stage breast cancer, gauge whether early data for drugs targeting OX40 could mark a paradigm shift in the treatment of moderate to severe atopic dermatitis and discuss rumours about the next FDA commissioner.

In this episode, FirstWord Pharma PLUS editors Virginia Li, Michael Flanagan and Simon King discuss the week's key industry news headlines, dig deeper into recent developments in the field of graft versus host disease and talk about the latest gene therapy safety concern.

In this episode, FirstWord Pharma PLUS editors Virginia Li, Michael Flanagan and Simon King share their post-ESMO thoughts on exciting new clinical data in HER2-positive breast cancer, further emergence of the KRAS inhibitors into colorectal cancer and multiple developments in the field of gastric cancer.

In this episode editors Virginia Li, Michael Flanagan and Simon King discuss AbbVie's deal to in-license an investigational gene therapy for age related macular degeneration from Regenxbio, an increasing focus on mRNA vaccines and therapeutics among Chinese biotech companies and why a new academic study may pose further challenges for Biogen's Aduhelm.

In this episode, editors Michael Flanagan and Simon King discuss Sanofi's latest acquisition, ongoing safety concerns around gene therapies and expert feedback on anti-Tau therapies for Alzheimer's disease.

In this episode editors Michael Flanagan and Simon King the FDA's new safety labelling for JAK inhibitors, impressive new data for Jardiance in heart failure and controversy around COVID-19 booster shots.

This week FirstWord Pharma PLUS editors Michael Flanagan and Simon King discuss US approval of the first new lupus therapy in a decade, Eli Lilly's optimistic body language about bringing a new Alzheimer's disease treatment to market next year and Sanofi's acquisition of messenger RNA specialist Translate Bio.

FirstWord Pharma PLUS editors Michael Flanagan and Simon King discuss Pfizer's projected COVID-19 vaccine revenues for 2021 and whether clinical data validates the commercial dominance of this product over AstraZeneca's competing vaccine, look at Keytruda's increasingly compelling profile as a treatment for early-stage and advanced triple-negative breast cancer (TNBC) and put Amgen's acquisition of Teneobio under the spotlight.

FirstWord Pharma PLUS editors Michael Flanagan and Simon King discuss the start of Q2 earnings season, including the receding impact of COVID-19 on drug sales and Biogen's claim of a misinformation conspiracy designed to derail adoption of Aduhelm. Also under the spotlight is the HIF-PH drug class and new cardiovascular data from Cytokinetics.

In this episode, editors Michael Flanagan and Simon King discuss key opinion leader (KOL) feedback on new heart failure data for Eli Lilly and Boehringer Ingelheim's SGLT-2 inhibitor Jardiance, look at Biogen's deal to in-license a Chinese developed BTK inhibitor in early stage testing for multiple sclerosis and talk about Eli Lilly's bid to upgrade first-generation KRAS inhibitors.

FirstWord Pharma PLUS editors Michael Flanagan and Simon King discuss the potential role of Eli Lilly and Boehringer Ingelheim's Jardiance as a future treatment for heart failure, the FDA's decision to narrow labelling for Biogen's Aduhelm, the pending departure of cancer R&D head Axel Hoos from GlaxoSmithKline and whether UCB's bimekizumab can disrupt the psoriasis market.

FirstWord Pharma PLUS editors Becky Simon, Michael Flanagan and Simon King discuss Sanofi's investment in mRNA vaccines, breakthrough data for Intellia Therapeutics' gene editing therapy NLTA-2001, the ongoing uncertainty around JAK inhibitors and whether CAR-T therapies are primed for earlier-line use.

FirstWord Pharma PLUS editors Becky Simon, Michael Flanagan and Simon King discuss Eli Lilly's decision to file its investigational Alzheimer's disease treatment donanemab for accelerated approval with the FDA, take a closer look at Intellia Therapeutics' pivot into CAR-T, question whether momentum is building for Big Pharma in-licensing deals and break down expert feedback on Sage Therapeutics depression drug zuranolone.

Earlier this week GlaxoSmithKline announced it will pay iTeos Therapeutics $625 million dollars upfront to gain exclusive co-marketing rights for the latter's anti-TIGIT monoclonal antibody EOS-448, as part of a deal potentially worth over $2 billion. The drug is currently in Phase I development for advanced solid tumours and this collaboration represents the latest move by GlaxoSmithKline to build out its cancer pipeline. FirstWord Pharma PLUS executive editor Simon King spoke to Jo Jenkins, chief medical officer at iTeos about the deal, EOS-448 and the competitive anti-TIGIT field where the likes of Roche, Merck & Co. and Bristol Myers Squibb are all active.

FirstWord Pharma PLUS editors Becky Simon, Michael Flanagan and Simon King discuss FDA approval of the first potentially disease modifying Alzheimer's disease treatment Aduhelm (aducanumab), which has dominated industry headlines this week. Simon also speaks to EQRx President and Chief Operating Office Melanie Nallicheri about the company's aspirations to disrupt pharmaceutical pricing and what describes as its “data coming out part” at ASCO this past weekend.

FirstWord Pharma PLUS editors Michael Flanagan and Simon King discuss FDA approval of the first KRAS inhibitor – Amgen's Lumakras, the emergence of OX40 as an increasingly sought after target for investigational atopic dermatitis treatments, more clinical data to support EQRx's price-disruptive push into oncology and look ahead to this weekend's virtual ASCO meeting.

FirstWord Pharma PLUS editors Michael Flanagan and Simon King discuss whether soaring revenue projections for Pfizer's COVID-19 vaccine will position the company as an aggressive deal-maker, assess yet another setback in the once-promising field of NASH and cast an eye over the potential opportunity for Cabometyx as a new treatment option for prostate cancer.

FirstWord Pharma PLUS editors Michael Flanagan, Simon King and Becky Simon discuss high profile clinical datasets which were released on Wednesday in abstract form ahead of this year's virtual annual meeting of the American Society of Clinical Oncology (ASCO) which will be held on June 4-8.

FirstWord Pharma PLUS editors Michael Flanagan, Simon King and Becky Simon discuss the latest COVID-19 vaccine headlines; look at biotech collaborations signed this week by Biogen and Eli Lilly; and highlight results from a new FirstWord survey showing that a steady increase in face-to-face interactions between pharma companies and physicians as accelerated since the turn of the year.

FirstWord Pharma PLUS editors Simon King and Becky Simon discuss Pfizer and Moderna's COVID-19 vaccine revenue forecasts for the year ahead, controversy around the potential lifting of intellectual property protection on COVID-19 vaccines and new, early-stage data for Sarepta Therapeutics' latest Duchene muscular dystrophy therapy.

FirstWord Pharma PLUS editors Michael Flanagan, Simon King and Becky Simon discuss new Phase III data for Bristol Myers Squibb's first-in-class psoriasis treatment deucravacitinib, the impact of the COVID-19 pandemic on Big Pharma's first quarter performance and this week's FDA AdCom meeting on accelerated cancer drug approvals.

FirstWord Pharma PLUS editors Michael Flanagan, Simon King and Becky Simon discuss the implications of two noteworthy news events in the field of gene therapy this week – bluebird bio's decision to walk away from Zynteglo reimbursement negotiations in Germany and Vertex's investment of $900m to increase its share of the economics in CTX001, a gene-editing sickle cell disease therapy being co-developed with CRISPR Therapeutics. They also discuss feedback from a key opinion leader who thinks Bristol Myers Squibb could be poised to lead the neoadjuvant non-small cell lung cancer market with its immunotherapy Opdivo and run the rule over Roche and Biogen's first-quarter results.

FirstWord Pharma PLUS editors Michael Flanagan and Simon King discuss fallout from the decision by US authorities to pause roll out of Johnson & Johnson's COVID-19 vaccine; take a look at new data for an investigational treatment being developed for essential tremor by Biogen and Sage Therapeutics; shed light on results from a physician survey suggesting safety concerns could dent confidence in JAK inhibitors for the treatment of atopic dermatitis; and ask whether GlaxoSmithKline can afford any further R&D slip-ups.

On this week's episode FirstWord editors Simon King, Michael Flanagan and Becky Simon delve into the potential implications of FibroGen's newly disclosed safety data for the investigational anaemia drug roxadustat ahead of an FDA advisory committee meeting, catch up with drug safety expert Anthony Cox to discuss the latest pharmacovigalence developments concerning AstraZeneca's COVID-19 vaccine in Europe and take a closer look at Acadia Pharmaceuticals' efforts to expand approval of the drug Nuplazid to treat dementia related psychosis.

FirstWord Pharma PLUS editor Simon King discusses the approval of Bristol Myers Squibb and bluebird bio's CAR-T therapy Abecma for multiple myeloma with senior Therapy Trends analyst Sarah Harris, speaks to Novartis' European gene therapy chief Mike Fraser about the launch of Zolgensma and asks FirstWord HealthTech's Tina Tan why the US Federal Trade Commission is looking to block Illumina's proposed acquisition of Grail in the cancer diagnostics market.

FirstWord Pharma PLUS editors Simon King and Michael Flanagan discuss this week's key industry news stories including more controversy for AstraZeneca's COVID-19 vaccine, a setback in the field of drug development for Huntington's disease and some important cancer immunotherapy updates. We talk to FirstWord HealthTech's Tina Tan about Amazon's plan to expand its role as a healthcare provider in the US.

FirstWord Pharma PLUS editors Simon King and Michael Flanagan discuss this week's key industry news stories, including safety concerns for AstraZeneca's COVID-19 vaccine in Europe, the FTC's plans to scrutinise pharma M&A more closely, Eli Lilly's latest Alzheimer's disease data and a noteworthy collaboration between Gilead and Merck in HIV.

FirstWord Pharma PLUS editors Michael Flanagan and Simon King discuss the week's most important news in pharma and biotech including suggestions that the FDA is suddenly taking a more cautious approach to some new drug approvals, negative data for Novartis' canakinumab in second-line non-small cell lung cancer and a preview of detailed Phase II results for Eli Lilly's Alzheimer's disease drug donanemab, which will be presented this weekend at the AD/PD 2021 virtual congress.

FirstWord Pharma PLUS editors Michael Flanagan and Simon King discuss the week's most important news in pharma and biotech including US emergency approval of Johnson & Johnson's COVID-19 vaccine and Merck & Co.'s role in manufacturing it, the FDA's less lenient stance on accelerated cancer drug approvals, what next for checkpoint inhibitors in China?, Amgen's $1.9 billion acquisition of Five Prime Therapeutics and more impressive clinical data for Eli Lilly's tirzepatide in diabetes.

FirstWord Pharma PLUS editors Michael Flanagan and Simon King discuss the week's most important news in pharma and biotech including imminent US approval of Johnson & Johnson's one-shot COVID-19 vaccine, encouraging real world evidence for Pfizer and AstraZeneca's vaccines, Moderna gearing up to tackle virus variants, the future for JAK inhibitors and Merck & Co.'s acquisition of Pandion Therapeutics.

FirstWord Pharma PLUS editors Michael Flanagan and Simon King discuss the week's most important news in pharma and biotech, including positive data for Keytruda and Lenvima in first-line renal cell carcinoma which was presented at ASCO-GU, more data for Eli Lilly's diabetes treatment tirzepatide, expanded approval for Novartis' Entresto and gene therapy concerns for bluebird bio.