PODCAST

The Top Line

Fierce Life Sciences

Biopharma and medtech explained. Every week, journalists from Fierce Biotech, Fierce Medtech, and Fierce Pharma recount the latest industry trends and why they matter. We'll analyze the week's biggest business news, from mergers and marketing to drug R&D and device development. Available every Friday morning.


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July 1st, 2022
2d ago
July 1st, 2022
In preparation for the fall, FDA advisors resoundingly recommended that a component of the Omicron variant be added to future vaccine doses. But just what that new vaccine formula looks like will be up to the agency to decide. We'll discuss how the committee came to its decision and what the future holds. But thats not all. Two reports – one from Moody’s and the other from PwC – discuss the outlook for mergers and acquisitions in the biopharma industry. Both reports point to an uptick in activity in both the short and long term. We'll discuss what the report says regarding financial flexibility and why the time is right for an increase in deals. To learn more about the topics in this episode:  'Science at its hardest': FDA panel recommends incorporating omicron variant into future COVID boosters Pfizer joins the omicron data party, linking adapted vaccine to increased immune response ahead of FDA meeting M&A is down, but Big Pharma likely to line up 'multiple shots on goal' in 2nd half, PwC says BMS, Pfizer and Merck face steep patent cliffs but all have the financial flexibility for M&A: Moody's Lundbeck, Otsuka to seek new FDA approval for Rexulti after it reduced agitation in Alzheimer's patents Clover's COVID booster bolsters antibody levels against omicron 'Leaner and simpler': Novartis details plans to cut 8,000 jobs worldwide The Top Line is produced by senior multimedia producer Teresa Carey with editor-in-chief Tracy Staton, managing editor Querida Anderson and senior editors Annalee Armstrong, Ben Adams, Conor Hale and Eric Sagonowsky. The sound engineer is Caleb Hodgson. The stories are by all our “Fierce” journalists.  See omnystudio.com/listener for privacy information.
July 1st, 2022
2d ago
July 1st, 2022
In preparation for the fall, FDA advisors resoundingly recommended that a component of the Omicron variant be added to future vaccine doses. But just what that new vaccine formula looks like will be up to the agency to decide. We'll discuss how the committee came to its decision and what the future holds. But thats not all. Two reports – one from Moody’s and the other from PwC – discuss the outlook for mergers and acquisitions in the biopharma industry. Both reports point to an uptick in activity in both the short and long term. We'll discuss what the report says regarding financial flexibility and why the time is right for an increase in deals. To learn more about the topics in this episode:  'Science at its hardest': FDA panel recommends incorporating omicron variant into future COVID boosters Pfizer joins the omicron data party, linking adapted vaccine to increased immune response ahead of FDA meeting M&A is down, but Big Pharma likely to line up 'multiple shots on goal' in 2nd half, PwC says BMS, Pfizer and Merck face steep patent cliffs but all have the financial flexibility for M&A: Moody's Lundbeck, Otsuka to seek new FDA approval for Rexulti after it reduced agitation in Alzheimer's patents Clover's COVID booster bolsters antibody levels against omicron 'Leaner and simpler': Novartis details plans to cut 8,000 jobs worldwide The Top Line is produced by senior multimedia producer Teresa Carey with editor-in-chief Tracy Staton, managing editor Querida Anderson and senior editors Annalee Armstrong, Ben Adams, Conor Hale and Eric Sagonowsky. The sound engineer is Caleb Hodgson. The stories are by all our “Fierce” journalists.  See omnystudio.com/listener for privacy information.
June 24, 2022
Jun 24 2022
June 24, 2022
A Roche Genentech Alzheimer’s therapy failed an important clinical trial. At the press conference that followed, the scientists involved parsed over what when wrong and what should happen next. We'll discuss this conference and dive into what scientists are saying about an Alzheimer's moonshot. But that's not all. During a panel discussion at the BIO conference, a Fierce journalist witnessed a controversial take on a diversity—which led to a conversation on diversity in biotech. Lastly, we'll take a close look at the top winners in pharma, health and wellness at the Cannes Lions International Festival of Creativity. To learn more about the topics in this episode:  Will we ever land the Alzheimer's moonshot? Genentech's crenezumab partners reflect on failure Another knock back for amyloid: Roche's approach to presymptomatic Alzheimer's ends in failure BIO: 'Diversity candidates' and knowledge 'shortfalls': Women in biotech say 'I'm here to do my job' despite toxic tropes Bausch Health pulls the plug on Solta Medical IPO and 3-way company split FDA signs off on Pfizer, Moderna COVID-19 vaccines for kids 6 months and older Galapagos finally takes M&A plunge, spending $251M for 2 biotechs in CAR-T push Hot on Alnylam's heels, AstraZeneca racks up phase 3 win for Ionis-partnered rare disease drug Big Pharmas lose out at Cannes Lions as VMLY&R sweeps health categories with campaigns for Dell and Maxx Flash Winning agency behind Cannes Lions says its double health Grand Prix win shows a major shift in thinking Fierce Biotech NextGen Virtual Event The Top Line is produced by senior multimedia producer Teresa Carey with editor-in-chief Tracy Staton, managing editor Querida Anderson and senior editors Annalee Armstrong, Ben Adams, Conor Hale and Eric Sagonowsky. The sound engineer is Caleb Hodgson. The stories are by all our “Fierce” journalists. See omnystudio.com/listener for privacy information.
June 17, 2022
Jun 17 2022
June 17, 2022
While revenue reflects how well a company’s products are selling, profit is the financial metric that really matters. It tells investors how efficiently a company is managed and how healthy the business is overall. We’ve taken a look at these bottom line figures and compiled a list of the top 10 most profitable pharma companies. But that's not all. The FDA advisory committee meeting met last Thursday and Friday, and the stakes were high. Bluebird bio came away on top. The committee endorsed two of its gene therapy candidates. Lastly, we’re all celebrating here at Fierce because our team’s faces are plastered on billboards at BIO International Convention. And we sent one shoe-leather reporter on a wild goose chase to find them.  To learn more about the topics in this episode:  The top 10 most profitable pharma companies in 2021 Pfizer already agreed to delay supply of COVID-19 shots to EU, now the bloc wants more GSK hails phase 3 win for RSV vaccine in older adults, sparking race to regulators Rune Labs translates Apple Watch data into Parkinson's insights with FDA nod Bluebird gene therapy overcomes safety worries to snag a win at FDA advisory panel Bluebird scores 2nd straight win at high-stakes FDA gene therapy meeting Amid FDA delay, Amylyx scores conditional ALS drug nod in Canada Eli Lilly's Olumiant snags biopharma's first FDA green light for alopecia areata Alnylam's next-gen RNA drug Amvuttra wins FDA approval—and a Pfizer showdown may await Ekso Bionics nabs FDA exoskeleton clearance for multiple sclerosis rehabilitation Pfizer gives up on Paxlovid in less vulnerable COVID patients after data fail to impress The Top Line is produced by senior multimedia producer Teresa Carey with editor-in-chief Tracy Staton, managing editor Querida Anderson and senior editors Annalee Armstrong, Ben Adams, Conor Hale and Eric Sagonowsky. The sound engineer is Caleb Hodgson. The stories are by all our “Fierce” journalists.  See omnystudio.com/listener for privacy information.
June 10, 2022
Jun 10 2022
June 10, 2022
Another ASCO and more CAR-T data. Arcellx presented early results on its multiple myeloma therapy at last weekend’s ASCO annual meeting, and we dig into what it would take to stand up to J&J's Carvykti. But that’s not all. People were on their feet for the Enhertu breast cancer drug and its unheard-of results. We’ve got a lot to share about ASCO. Also under discussion is Fierce's special report on the rising stars in the medtech and healthcare fields and what they have in common. Lastly, we finally have boots-on-the-ground at an industry conference. Our reporter headed out to the first in-person ASCO since the pandemic started. She planned to learn about new data releases and discoveries, and also found out something surprising about herself.  <> To learn more about the topics in this episode:  Fierce Healthcare and Fierce Medtech's 17 rising stars in health tech ASCO: AstraZeneca, Daiichi’s Enhertu could transform breast cancer treatment with landmark HER2-low show ASCO: Gilead's Trodelvy limps forward in new breast cancer lane as below-par showing casts doubt ASCO: ‘Any way you slice’ it, Arcellx's CAR-T is matching J&J-Legend’s Carvykti, analyst says ASCO: Medidata links CAR-T's cytokine release syndrome risk to common biomarkers in new study ASCO: Black breast cancer patients want to participate in trials, but adequate information is hard to come by Emergent says J&J owes up to $420M for breach of contract. J&J: You want to talk breaches? ADA: Eli Lilly's stellar tirzepatide weight loss data tee up showdown with Novo Nordisk's Wegovy, analysts say ADA: With promising long-term data for its artificial pancreas, Medtronic aims to fully close the diabetes management loop UPDATE: Bristol Myers strikes up Roche rivalry with $4.1B Turning Point buy Eli Lilly wins key dispute over patient warnings in era of DTC advertising ASCO: Return to in-person 'zoo that it always was,' with added COVID challenges—and bad shoes The Top Line is produced by senior multimedia producer Teresa Carey with editor-in-chief Tracy Staton, managing editor Querida Anderson and senior editors Annalee Armstrong, Ben Adams, Conor Hale and Eric Sagonowsky. The sound engineer is Caleb Hodgson. The stories are by all our “Fierce” journalists.  See omnystudio.com/listener for privacy information.
June 3, 2022
Jun 3 2022
June 3, 2022
Bristol Myers Squibb is once again piling on the cash for Immatics, a German immunotherapy biotech. The Big Pharma has tripled down on the collaboration, which originally kicked off in 2019 and was added to in 2021. BMS is paying $60 million upfront and $700 million in biobucks down the line for at least two new programs. And there's more: Bristol expanded the 2019 collaboration, with another $20 million plus milestones and royalties. Also under discussion is Fierce Pharma’s special report on the world’s 20 top-selling drugs. COVID-19 vaccines by Pfizer and Moderna are listed among the top three. And COVID treatments from Regeneron/Roche and Gilead were also in the top 20. Lastly, we have bloopers. After just over a month of creating this podcast, we finally have some “behind-the-scenes" tape to share. To learn more about the topics in this episode:  The top 20 drugs by worldwide sales in 2021 ASCO preview: How Gilead, Pfizer, AstraZeneca-Daiichi breast cancer data may—or may not—change treatment practice ASCO: Mirati cedes to Amgen's Lumakras on durability in tight KRAS battle SKYLARK sings: Sage, Biogen hatch positive phase 3 data in postpartum depression GSK strikes $3.3B Affinivax buyout to MAP out challenge to Pfizer's blockbuster pneumococcal vaccine Pfizer, already flush with cash, will reap $16B from selling shares in GSK consumer health spinoff Roche's Evrysdi ramps up SMA rivalry with Novartis and Biogen thanks to FDA nod in newborns Novartis' Kymriah bags FDA nod to face off against Gilead's Yescarta in follicular lymphoma UPDATE: Bristol Myers triples-down on Immatics, bringing deal to $4.2B total biobucks. Why not just buy it? The Top Line is produced by senior multimedia producer Teresa Carey with editor-in-chief Tracy Staton, managing editor Querida Anderson and senior editors Annalee Armstrong, Ben Adams, Conor Hale and Eric Sagonowsky. The sound engineer is Caleb Hodgson. The stories are by all our “Fierce” journalists. See omnystudio.com/listener for privacy information.
May 27, 2022
May 27 2022
May 27, 2022
When unnamed Bloomberg sources said that Dexcom is in talks to buy Insulet in what could be the year's biggest medtech megamerger, stock prices went wild. And the American Society for Clinical Oncology annual meeting, the biggest cancer conference, will be held in June, but we have early news to share. Also under discussion is the new monkeypox outbreak, what the treatment options are and why health officials don’t seem concerned. Lastly, nominations are finally open for the annual Fierce 15 competition. We'll hear from the judges about what it takes to make your nomination stand out from the rest.    To learn more about the topics in this episode: Roche rolls out trio of PCR research tests for monkeypox Bavarian Nordic signs 'larger' monkeypox vaccine supply deal with unnamed country US to provide Bavarian Nordic's vaccine Jynneos to some at risk for monkeypox, CDC says Moderna tunes vaccine platform to next potential viral threat: monkeypox Monkeypox outbreak won't be the next global pandemic thanks to vaccines, drugs: analysts Dexcom, Insulet in talks to merge into a diabetes device behemoth: report Biohaven flunks first clinical test for rare disease drug post-Pfizer sell-off ASCO: Is another pan-tumor drug on the horizon? Johnson & Johnson thinks Balversa could be it ASCO: J&J, Legend reveal more CAR-T data and a look at Carvykti for earlier myeloma in a difficult population ASCO: J&J's multiple myeloma toolkit expands with bispecifics data ASCO: Novartis eyes full nod for Gleevec follow-on Scemblix thanks to new leukemia data GSK dodges UK strike with improved pay offer for staffers Calling all Fierce 15 fans: Nominations for the 2022 Fierce Biotech Fierce 15 are now open The Top Line is produced by senior multimedia producer Teresa Carey with editor-in-chief Tracy Staton, managing editor Querida Anderson and senior editors Annalee Armstrong, Ben Adams, Conor Hale and Eric Sagonowsky. The sound engineer is Caleb Hodgson. The stories are by all our “Fierce” journalists. See omnystudio.com/listener for privacy information.
May 20, 2022
May 20 2022
May 20, 2022
Anti-TIGIT drugs were once hailed as the future of immuno-oncology. But Roche's two recent clinical trial failures for tiragolumab are raising questions about whether Big Pharmas bet on the wrong horse. Also under discussion is the sector's impressive first-quarter revenue growth. Out of nearly two dozen biopharma companies, more than half generated double-digit growth, including eye-popping increases from mRNA stars Moderna and BioNTech. And Fierce journalists finally got together in person after more than two years. They share what it was like to be in a newsroom once again. To learn more about the topics in this episode: To TIGIT or not to TIGIT? Roche's latest trial flop casts shadow on Big Pharma's $6B bet Roche's TIGIT flop prompts GSK, iTeos to reevaluate next steps for rival drug Strike 2: Roche flunks another phase 3 lung cancer test to leave TIGIT space reeling Pfizer, Merck and AstraZeneca led Big Pharma's growth in Q1 but they couldn't match mRNA hotshots Labcorp's combo COVID, flu, RSV test nabs first green light for direct-to-consumer Pfizer holding on tight to supplies of COVID-19 drug Paxlovid, limiting the prospect of combination research: report GlaxoSmithKline is no more: Meet the scaled down 'GSK' Avanos Medical faces Class I recall for feeding tube system linked to 23 deaths since 2015 Lilly's highly anticipated diabetes drug Mounjaro wins FDA blessing The Top Line is produced by senior multimedia producer Teresa Carey, with editor-in-chief Tracy Staton, managing editor Querida Anderson, senior editors Annalee Armstrong, Ben Adams, Conor Hale and Eric Sagonowsky. The sound engineer is Caleb Hodgson. The stories are by all our “Fierce” journalists. See omnystudio.com/listener for privacy information.
May 13, 2022
May 13 2022
May 13, 2022
Biotechs have seen their valuations take a plunge, triggering layoffs and pipeline cuts, but Big Pharma is not yet tempted to go on an M&A spree. CEOs of many of the world’s biggest pharma companies point out that biotech prices still have a way to drop before they become truly attractive buys. Also under discussion is Fierce's annual report on the highest paid biopharma R&D executives. This year, the list doesn’t look anything like it has in the past except for the fact that it continues to be comprised of white men. And the quarterly earnings calls are the buzz around the newsroom this week—but not in the way you might think. To learn more about the topics in this episode: Big pharma resisting temptation for biotech M&A spree until prices drop further The top 10 highest paid biopharma R&D executives in 2021 Novavax executives' pay comes back down to Earth after 8-figure package in 2020 Starting gun? $11.6B M&A domino falls as Pfizer scoops up Biohaven for phase 3 migraine nasal spray Novartis halts US production of cancer radiotherapies, citing potential quality issues Eisai wraps filing for Biogen-partnered Aduhelm follow-up, hoping to regain 'credibility and trust' Illumina steps deeper into drug discovery with Deerfield, Janssen partnerships Seagen CEO Clay Siegall put on leave after domestic violence arrest Moderna's new CFO out the door after former employer discloses accounting probe Inovio CEO departs, leaving Jacqueline Shea in charge of 'particularly challenging period' in the DNA vaccine biotech's history Insulet to swap CEOs amid Omnipod 5 insulin pump rollout 'Who wants to make money?' Court documents outline wild fraud scheme targeting The Top Line is produced by senior multimedia producer Teresa Carey with Editor-in-Chief Tracy Staton, Managing Editor Querida Anderson, senior editors Annalee Armstrong, Ben Adams, Conor Hale and Eric Sagonowsky. The sound engineer is Caleb Hodgson. The stories are by all our “Fierce” journalists. See omnystudio.com/listener for privacy information.
May 6, 2022
May 6 2022
May 6, 2022
Biogen has been battling for a while now over Aduhelm's controversial FDA approval and subsequent narrow Medicare coverage decision. And those struggles have resulted in a significant company reorganization, including the CEO, Michel Vounatsos. After a five-year term, he is stepping down, and a hunt for his replacement is already underway. Also under discussion is the Fierce newsroom's assessment of the most influential people in biopharma—from CEOs to entrepreneurs, scientists and regulatory experts. And the Fierce Madness drug naming championship is the buzz around the newsroom this week, with names that sound like they're straight out of a Harry Potter spell. To learn more about the topics in this episode: Biogen sends CEO to the exit, abandons Aduhelm sales team in $1B overhaul Next Biogen CEO's most-prized expertise? Dealmaking experience, investors say Biogen shoves Aduhelm to the side. It's time for lecanemab Most influential people in biopharma—the CEOs AbbVie's cystic fibrosis long-game doesn't pay off, as Galapagos med fails in triple combo As superstar Revlimid fades faster than expected, BMS trims $600M from its 2022 sales projection Abbott's COVID test sales reach all-time high—and maybe for the last time, the company says As COVID testing cools, Thermo Fisher's biopharma services, clinical research revenues heat up Hologic's M&A deals aim to pick up the torch from COVID testing sales Siemens nearly doubles diagnostics forecast for the year amid renewed COVID testing surge BD tightens up revenue guidance after completing Embecta diabetes spinoff Bancel has 'never been as busy' amid M&A talks as Moderna preps for life after COVID Unwelcome surprise for Vertex as FDA slaps hold on phase 1/2 diabetes cell therapy study FDA plays tooth fairy, awards clearance to VideaHealth's cavity-spotting AI Wherefore Tavneos? ChemoCentryx and the Brand Institute explain how the #FierceMadness winner got its name ChemoCentryx’ Tavneos trounces BioMarin's Voxzogo to win #FierceMadness drug name tournament championship The Top Line is produced by senior multimedia producer Teresa Carey, with editor-in-chief Tracy Staton, managing editor Querida Anderson, senior editors Annalee Armstrong, Ben Adams, Conor Hale and Eric Sagonowsky. The sound engineer is Caleb Hodgson. The stories are by all our “Fierce” journalists. See omnystudio.com/listener for privacy information.
April 29, 2022
May 3 2022
April 29, 2022
Last year, as the public made Pfizer, Johnson & Johnson, and Moderna household names, pharmaceutical companies took their cue. They poured more cash into unbranded campaigns compared to past years. Also under discussion this week is an intriguing executive move at Novartis. CEO Vas Narasimhan created a new position to oversee the company’s corporate strategy—then hired a high-profile Wall Street analyst to take the lead. And a journalist from Fierce Life Sciences heads to the Azbee Awards. To learn more about the topics in this episode: The top advertisers in Big Pharma Novartis hires seasoned Wall Street analyst Ronny Gal as new M&A czar Pfizer signals big M&A plans with new CFO Denton, the money manager behind the CVS-Aetna merger Pfizer's blood pressure med recall creeps into US as testing flags carcinogen threat Ardelyx's Hail Mary caught, as FDA agrees on appeal to convene advisory committee for tenapanor Merck's C-suite shakeup logs another loss as marketing exec Garay leaves for Moderna Nektar guts workforce, weeks after $3.6B Bristol Myers immuno-oncology collaboration ends Abbott launches diabetes team-up with Ypsomed, CamDiab to bring artificial pancreas system to Europe SURMOUNT-able: Lilly's tirzepatide clears high bar set by Novo's Wegovy in obesity The Top Line is produced by senior multimedia producer Teresa Carey, with editor-in-chief Tracy Staton, managing editor Querida Anderson, senior editors Annalee Armstrong, Ben Adams, Conor Hale and Eric Sagonowsky. The sound engineer is Caleb Hodgson. The stories are by all our “Fierce” journalists.   See omnystudio.com/listener for privacy information.