After more than a year of respirator recalls, it’s probably no surprise that Philips reported lower-than-expected revenues for the third quarter of this year. But that announcement also came with the revelation that the company is now laying off 4,000 workers and planning for even more restructuring. Fierce Medtech's Andrea Park discusses this latest news and digs into the long line of problems that led to this decision.

Philips' downward slide started last June, with the recall of CPAP and BiPAP machines used to treat sleep apnea. As of this July, the FDA tallied 168 related deaths, and as of mid-October there were at least 342 pending class action cases against the company.

• Philips cuts 4,000 jobs, with more restructuring on the way, amid slipping sales and rising costs
• With FDA decision penciled in for May, GSK powers ahead in RSV race with Pfizer
• Johnson & Johnson doles out $16.6B to snatch up miniaturized heart pump maker Abiomed
• Thermo Fisher ties up $2.6B deal for cancer diagnostics maker The Binding Site
• Alkermes joins Bristol Myers in IL-2 exit with oncology business spinoff
• Pfizer boosts COVID vaccine projection to $34B on the back of strong Comirnaty haul

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It’s earnings season again. Biogen offered a look at its second foray into Alzheimer’s disease during its investor call, but listeners were still left dubious. All eyes—and ears—are on whether its lecanemab partnership with Eisai can outperform the ill-fated Aduhelm. In this episode, we chat about what went down during the earnings presentation, including rumors of a shaky relationship between the two drugmakers.

We also explore AstraZeneca finally claiming an FDA approval for its long-troubled cancer immunotherapy Imjudo. The CTLA-4 drug has failed more than a few trials among different tumors over the years, and, now, it will enter a crowded and highly competitive liver cancer market. 

• UPDATED: Biogen insists Eisai relationship 'solid' as questions remain over lecanemab commercialization
• Despite Aduhelm cost cuts, Biogen still has Alzheimer's manufacturing firepower on deck, CFO says
• AstraZeneca's Imjudo finally snags first approval—only in an ever-crowded liver cancer field
• AIDS advocacy group hits out at 'Greediad' Gilead for drug pricing hikes
• J&J's BCMA bispecific Tecvayli wins FDA approval in multiple myeloma—but as a late-line therapy
• Medtronic to spin out respiratory, patient monitoring divisions amid flagging ventilator sales
• Sumitomo nets Myovant in $2.9B buyout, adding IVF asset to pipeline

"The Top Line" is produced by senior multimedia producer Teresa Carey with 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. Like and subscribe wherever you listen to your podcasts.

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We just released a special report on the top 10 vaccine companies. We haven’t published this report since 2017, when we only profiled five manufacturers. But five years and one COVID pandemic later, that order has been completely shuffled with many new faces. It’s clear that the vaccine industry is changing fast. In today's episode we'll discuss those global rankings, plus this week's headlines.

To learn more about topics in this episode: 

• The top 10 vaccine companies worldwide
• Pfizer takes Vyndaqel copay fight to Supreme Court, decrying 'staggeringly overbroad' anti-kickback rule
• Atara on verge of landmark approval for first allogeneic T-cell therapy
• J&J sets sights on $60B in pharma sales by 2025, targets 8 brands to deliver growth
• As FDA rule takes effect, Lucid Hearing launches over-the-counter line of hearing aids

The Top Line is produced by senior multimedia producer Teresa Carey with 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. Like and subscribe wherever you listen to your podcasts.

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The world’s most productive biopharmas have gone through some major changes in the past five years. In Fierce Pharma’s latest analysis, BioNTech and Moderna beat their biopharma peers with the highest 2021 revenues per employee. The 2021 cohort as a whole showed improved productivity over 2016, although several companies experienced declines. In this episode, we'll discuss our special report on the most productive pharmas.

Also under discussion is Biogen's tumultuous year, which was spurred by its disastrous Alzheimer’s disease drug launch. Now Biogen is reportedly considering Theravance co-founder Mathai Mammen , M.D., Ph.D>, as its new CEO. The company supposedly wants to emphasize scientific know-how in choosing its next leader. 

To learn more about topics in this episode: 

• The top 10 most productive biopharma companies
• J&J research vet Mathai Mammen a top contender in Biogen's hunt for a new CEO: Stat
• Merck nails phase 3 sotatercept win, making good on its $11.5B Acceleron buy
• AstraZeneca's COVID-19 nasal vaccine spray comes up a bust in small study
• Fitbit embeds health, activity data into Pretaa's substance abuse recovery app
• Merck & Co., in busy morning, taps Moderna's therapeutic cancer vaccine, Royalty in schizophrenia deal 
• Orthofix, SeaSpine to combine into $700M orthopedics player in merger of equals

The Top Line is produced by senior multimedia producer Teresa Carey with 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. Like and subscribe wherever you listen to your podcasts.

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Eisai and Biogen's Alzheimer’s disease drug lecanemab did surprisingly well in a phase 3 trial. The results support the idea that an anti-amyloid drug like lecanemab could be a way to treat Alzheimer’s—a hypothesis that has been under fire since Biogen's debacle with its approved anti-amyloid med, Aduhelm. And, while lecanemab's approvability isn't being debated—unlike the case with Aduhelm after its phase 3 program read out—commercial reimbursement could still be a challenge for the Eisai drug.

We'll also talk about football, or at least Pfizer's COVID vaccine ad campaign that kicked off during the NFL season. The company's marketing strategy over the last almost two years has changed over time and with various approvals. Recently, Pfizer ramped up its campaign with branded advertising for shots in teens, but its NFL season push is focused on its new, tweaked booster vaccine and takes a more subtle approach but with big money behind it.  

To learn more about topics in this episode: 

• It's a hit: Eisai springs 'major surprise' with phase 3 win for Biogen-partnered Alzheimer's drug 
• Eisai and Biogen's phase 3 Alzheimer's win puts amyloid back in the driver's seat, for now
• Editor's Corner: Eisai and Biogen need to meet CMS halfway after lecanemab's Alzheimer's clinical trial win
• NFL season sees Pfizer kick off major Comirnaty COVID vaccine ad offensive for teens, boosters 
• Pfizer offers a soft sell with a strong message on vaccines in first COVID ad
• The inside story behind Pfizer and BioNTech's new vaccine brand name, Comirnaty
• Sign of the times? US stocks up on Amgen's radiation sickness drug Nplate 
• Capacity to spare: US has manufacturing firepower to crank out more essential medicines, researchers say 
• Illumina pitches $200 genomes with new line of DNA sequencers 
• Novo Nordisk ready to submit once-weekly insulin to FDA after scoring final phase 3 win 
• Ocaliva fails NASH trial just as Intercept charts path toward FDA application

The Top Line is produced by senior multimedia producer Teresa Carey with 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. Like and subscribe wherever you listen to your podcasts.

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Every year, our Fierce Biotech team evaluates hundreds of early-stage companies from around the world. Only the most promising are selected for our annual list of Fierce 15 honorees. That list is based on a variety of factors like the strength of the company’s technology, partnerships, venture backers and a competitive market position. This year’s 15 honorees were recognized at the Fierce Biotech Summit. In this episode, we'll hear directly from them about their company’s work, what makes it unique, and what drives them.  

We'll also take you to the Fierce Biotech Summit. It happened in Boston on September 19 and 20, and covered drug development from the earliest stage of research to FDA approval. So if you missed the summit, this episode covers some event highlights including a panel moderated by Fierce Pharma senior staff writer Angus Liu on the future of gene editing and a session moderated by managing editor Querida Anderson on battling biotech's bear market.

To learn more about topics in this episode: 

• Special Report: Fierce Biotech's 2022 Fierce 15
• The Fierce Biotech Summit: Where Biotech Innovation Happens 
• Fierce Biotech Summit: As the biotech market teases turning a corner, stakeholders say we're in a 'new normal' 
• Servier severs CAR-T collab with Allogene, handing back rights outside the US to 3 candidates
• Months after exiting clinical hold, Pfizer readies to resume dosing in phase 3 gene therapy trial
• ESMO: BioNTech's CAR-T response rate falls in fresh cut of early-phase data

The Top Line is produced by senior multimedia producer Teresa Carey with 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. Like and subscribe wherever you listen to your podcasts.

See omnystudio.com/listener for privacy information.

Two Big Pharma companies, GSK and Takeda, made moves this week to bolster their environmental sustainability efforts. GSK is focusing on its supply chain and Takeda on its electrical sources in the U.S. In GSK’s case, the development is part of a larger trend of companies focusing on emissions from outside of their direct operations. Fierce's Fraiser Kansteiner and Eric Sagonowsky will discuss what we can expect on environmental sustainability at Big Pharmas.

To learn more about topics in this episode: 

• GSK puts suppliers on the hook as it amps up sustainability crusade 
• A $3M gene therapy: Bluebird bio breaks its own pricing record with FDA approval of Skysona
• Merck finally gets FDA nod to relaunch HIV trials, but drops preventive therapy plans
• FDA plans advisory committee meeting to discuss racial bias built into pulse oximeters
• Smartphone cameras could replace pulse oximeters to measure blood oxygen at home: study
• Rise of the machines: Novo Nordisk pledges $200M to create first quantum computer for life sciences

The Top Line is produced by senior multimedia producer Teresa Carey with 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. Like and subscribe wherever you listen to your podcasts.

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Medical conferences often are a platform to showcase new clinical trophies. But that wasn't the case for Merck at this year’s European Society for Medical Oncology meeting. The Big Pharma presented a series of trial flops for its megablockbuster cancer immunotherapy, Keytruda. We'll discuss if the Merck checkpoint inhibitor has reached a bottleneck or if it was just bad luck. 

Also under discussion is the monkeypox test Emergency Use Authorization. Because monkeypox continues to spread in the U.S. and worldwide, the FDA granted its first EUA for a diagnostic test. This regulatory path was also used for COVID-19 tests. But the FDA learned a few lessons from the pandemic and hopes the new guidelines will help avoid the problems seen then.  

To learn more about topics in this episode: 

• ESMO: AstraZeneca, Merck tout Lynparza's 'clinically meaningful' ovarian cancer survival edge but lose one in prostate cancer
• ESMO: Roche eyes untouched newly diagnosed lung cancer market for solo Tecentriq
• ESMO: Adding bempeg to Opdivo lowered response rate in Bristol Myers-Nektar failed cancer trial
• ESMO: GSK keeps the faith in anti-TIGIT plans; it's 'not always about being first'
• UPDATED ESMO: Amgen's Lumakras confirmatory lung cancer data leave door open for KRAS competitors
• ESMO: Gilead's Trodelvy makes surprise comeback with above-par breast cancer survival showing
• Here we go again: FDA opens up emergency authorizations to monkeypox tests
• Moderna sizes up private COVID vaccine market in US, where shots could cost $100 a pop
• Sony dives into nascent over-the-counter hearing aid market with WS Audiology partnership
• OTC birth control could be on the way from Perrigo, as FDA gathers expert panel
• Altimmune sees phase 1 success in tricky NASH indication with GLP-1 agonist
• Oramed phase 2 insulin drug data 'paint an exciting picture' in rocky NASH landscape
• Akero hits endpoints in midphase NASH trial, linking candidate to improvements in fibrosis
• BMS’ preferred drug in its $74B Celgene buy is set to pay dividends, winning its first FDA nod

The Top Line is produced by senior multimedia producer Teresa Carey with 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. Like and subscribe wherever you listen to your podcasts.

See omnystudio.com/listener for privacy information.

The FDA has given Sarepta Therapeutics the green light for its phase 2 Duchenne muscular dystrophy clinical trial after slapping the biotech with a clinical hold in June. The hold came after a grade 3 adverse event was reported in the midstage trial. Now, only a few months later, the agency has lifted the hold, and we'll discuss why there was a quick turnaround on the hold and what to expect next. 

To learn more about topics in this episode: 

• Sarepta picks up momentum as FDA lifts hold on phase 2 DMD trial 
• As EU challenge intensifies, Illumina clocks a stateside win in FTC antitrust case over Grail buy 
• EU blocks Illumina's yearslong quest for Grail 
• Philips recalls 17M CPAP and BiPAP machine masks due to potential magnet interference 
• GSK helps SpringWorks double payday from boosted combo deal as it also reels $225M in new funding 
• BMS-backed Arsenal Bio pulls trigger on $220M series B, touting potential fleet of gene-edited cell therapies 
• Amylyx's ALS drug faces tough FDA scrutiny ahead of 2nd advisory panel meeting

The Top Line is produced by senior multimedia producer Teresa Carey with 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. Like and subscribe wherever you listen to your podcasts.

See omnystudio.com/listener for privacy information.

In Alzheimer’s, three drug candidates capture most of the industry's attention these days, and for good reason. They’re all in late-stage development and have the likes of Biogen, Eisai, Genentech and Eli Lilly backing them. But in this week’s episode, we step away from the big three. The Alzheimer’s Association found that there are 143 drugs in the pipeline. If fully enrolled, these trials would involve 50,575 people and more than 3.8 million participant weeks. We’ll dive into these details and more tidbits from AA’s report.

And that’s not all. As we gear up to publish our annual Fierce 15 report honoring biotechs with the most exciting technologies, we’re also taking the time to look back at our 2012 class of Fierce 15. By now, several companies have fallen off the map, but many others were part of blockbuster deals or continue to plug away at their pipelines. We profile all of them, what they’ve been up to and what’s coming next.

To learn more about topics in this episode: 

• Beyond headlines and amyloid, the Alzheimer's pipeline chugs along
• Where are they now? Tracking down 2012's Fierce 15

The Top Line is produced by senior multimedia producer Teresa Carey with 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. Like and subscribe wherever you listen to your podcasts.

See omnystudio.com/listener for privacy information.