| Editor's Note: The Fierce PM Tracker will be on a publishing break on Thursday in recognition of the Juneteenth federal holiday. We'll be back in your inbox on Friday. |
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Tuesday, June 24, 2025 | 1pm ET / 11am PT Join us for this one hour deep dive with a panel of experts and industry leaders to gain valuable insights and guidance on diagnostic and precision medicine testing. Register now.
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Today’s Big NewsJun 18, 2025 |
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Wednesday June 25, 2025 | 11am ET / 8am PT In this webinar, experts reveal how structured terminology and Real-World Data normalization are transforming patient identification and feasibility — slashing screen failure rates, accelerating site selection, and finally delivering measurable ROI on data spend. Register now.
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| By Zoey Becker The FDA signed off on Gilead's twice-yearly HIV pre-exposure prophylaxis injection Yeztugo. With the nod, the drug becomes the longest-acting agent in HIV prevention. |
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By Kevin Dunleavy “This is probably one of the toughest years to predict,” Arda Ural, Ph.D., EY Americas Life Sciences Sector Leader, said on a conference call last week. |
By Conor Hale The cancer testing company claimed a valuation of about $5.9 billion, while selling 23.5 million shares under the Nasdaq ticker CAI at $21 apiece. |
By Gabrielle Masson “I'm proud to report that we're on track to meet all the PDUFA targets, and that morale is good and improving at the agency,” FDA's Marty Makary said at this year’s BIO, an international convention that has attracted 23,000 attendees. |
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Tuesday, June 26, 2025 | 2:30pm ET / 11:30am PT Too many with treatment-resistant depression go undiagnosed and untreated. Join this webinar to see how AI and Real-World Data can transform detection, access, and outcomes in mental health. Register now.
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By Gabrielle Masson The Department of Health and Human Services is allegedly canceling clinical trial funding for biotechs with ties to certain foreign investors, Fierce Biotech has learned. |
By Angus Liu The value of priority review vouchers (PRVs) appears to be on the rise as concerns mount over declining supplies following the sunset of the rare pediatric disease PRV program. |
By Fraiser Kansteiner Following a disappointing performance from the company’s CAR-T candidate in an early-stage cancer trial, BioNTech is winding down cell therapy manufacturing at its inaugural U.S. plant in Gaithersburg, Maryland. In turn, the German company is laying off 63 technical operations staffers at the site. |
By Kevin Dunleavy The Trump administration is weighing measures that would make it more expensive for pharmaceutical companies to conduct direct-to-consumer (DTC) advertising, according to a report from Bloomberg. |
By Zoey Becker For the first time in years, a traditional pharma company has taken the top prize at Cannes Lions. Viatris and Ogilvy Health earned the Grand Prix with an unbranded Viagra campaign that sidestepped China’s ad restrictions through metaphor and craft, marking a departure from recent winners led by tech and device companies. |
By Angus Liu Two Democratic lawmakers have renewed accusations that large pharma companies have evaded paying U.S. taxes through a legislative loophole that drugmakers are allegedly lobbying to retain. |
By Darren Incorvaia A new biotech has come roaring to life in Wales with a $140 million series A and a lead candidate ready for phase 2 trials in major depressive disorder. Draig Therapeutics has emerged from a partnership between Cardiff University’s Medicine Discovery Institute and SV Health Investors to tackle unmet needs in neuropsychiatry. |
By Conor Hale Grail reported it collected positive initial findings from the latest large study of its multi-cancer early detection test, Galleri, with data the company said it will submit to the FDA as it seeks a full marketing approval. |
By James Waldron Scholar Rock’s investigational spinal muscular atrophy drug helped patients taking Eli Lilly’s obesity blockbuster Zepbound maintain muscle mass, offering another avenue to reach a key goal for the obesity market. |
Fierce podcastsDon’t miss an episode |
| | This week on "The Top Line," we unpack Fierce Medtech's Fierce 15 and spotlight startups reimagining healthcare. |
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Patients need innovative treatments to treat diseases and save lives, but today’s biopharmaceutical development and manufacturing environment presents multiple challenges for biopharma companies. Access this valuable resource for key insights on navigating the complex road to market, including quality standards, regulatory requirements, supply-chain disruptions, and more.
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| Executive SummaryBiotech innovation doesn’t slow down—and neither should your lab partner. This brief outlines how early scientific engagement, operational transparency, and integrated global lab services help reduce risk, stay on schedule, and deliver results. Whether you're navigating your first trial or scaling a growing pipeline, see how a purpose-built lab model can help you move smarter and faster. Sponsored by: IQVIA Laboratories |
| WhitepaperWe analyzed ~300 launches to identify the factors most correlated with commercial success & built a framework for peak go-to-market performance. Presented by Blue Matter, strategic consultants in the life sciences |
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