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Unlock the key to seamless eCOA integration for your next clinical trial with IQVIA’s comprehensive Licensing Guide. From understanding licensing requirements to optimizing integration, our guide is your roadmap to streamlined eCOA implementation.
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Today’s Big NewsMar 4, 2024 |
| By James Waldron With the FDA mulling whether to approve BridgeBio’s acoramidis as a rival to Pfizer’s blockbuster heart disease drug Vyndaqel, Bayer has decided to pay out $310 million to scoop up the European rights. |
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By Max Bayer Apparently C4 Therapeutics' protein degradation tech brings all the Mercks to the yard. The Massachusetts biotech has signed on Merck KGaA in a $740 million biobucks partnership to find two degraders for cancer. |
By Conor Hale It’s one thing to design an experiment that succeeds in the lab. It’s another to design one that works in every lab—and every hospital, every doctor’s office, every home, or in the hands of every surgeon, every nurse and every patient. |
Sponsored by Wacker Biotech Sitting down with Guido Seidel, Managing Director of Wacker Biotech, we explore some of the key challenges, opportunities and innovations for pharmaceutical companies to consider in mRNA manufacturing. |
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March 18-20, 2024 | Savannah, GA The Fierce TMF Summit is the must-attend event for clinical document management professionals to learn, network and connect. Gain invaluable insights from unique case studies, panels, and workshops, and access the best networking the industry has to offer. Secure 50% off Your Fierce TMF Summit Pass | LIMITED Passes Available: Use Promo Code LAST25. Secure your spot Today!
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By Nick Paul Taylor Akero Therapeutics’ roller coaster ride has lurched once again. After a whiplash rise and fall, the biotech has bounced back with 96-week data linking its FGF21 analog efruxifermin to significant improvements in liver scarring in metabolic dysfunction-associated steatohepatitis. |
Sponsored by NYCEDC Ready to shape the future of life sciences? Discover how NYC's strategic investments are driving change. |
By James Waldron The notoriously tricky indication of Alzheimer’s disease has defeated another candidate, with Vivoryon Therapeutic’s lead asset missing all endpoints in a phase 2 trial and sending the company’s stock plunging 90%. |
Sponsored by ICON Biotech ICON Biotech survey shows that although challenges remain, optimism returns to strategically savvy biotech innovators |
By Annalee Armstrong BioCardia’s data safety monitoring board already warned that the phase 3 CardiAMP cell therapy heart failure trial was not going to make the primary endpoint. And so the California biotech is showcasing some other endpoints instead, hoping to persuade investors that the autologous cell therapy has a future. |
By James Waldron Iovance Biotherapeutics ended 2023 on a downer courtesy of a partial clinical hold from the FDA, but the situation has been resolved relatively quickly. |
By Gabrielle Masson,Annalee Armstrong,Max Bayer Welcome to Fierce Biotech's Fundraising Tracker, 2024's version. |
By Kevin Dunleavy Less than three weeks after a Texas judge tossed a lawsuit by industry lobbying group PhRMA that challenged the constitutionality of the Inflation Reduction Act, a federal court in Delaware has done the same with a similar action brought by AstraZeneca. |
By Conor Hale Boston Scientific has received FDA approval for its Agent drug-coated balloon sized to fit within blocked or constricted coronary arteries, nearly a decade after it made its European debut. |
By Max Bayer Moderna is laying off some employees within its manufacturing unit after shaving COVID production costs. The company previously disclosed plans to rightsize its COVID vaccine production footprint. |
By Nick Paul Taylor Teva has found out the hard way about the scope of the U.K. advertising code. The drugmaker refuted complaints about the alleged promotion of its drugs in an earned media article, only for the panel to rule it responsible for the content and find it guilty of discrediting the pharma industry. |
By Paige Minemyer As the disruption caused by the cyberattack at Change Healthcare stretches beyond its tenth day, cybersecurity experts say that the incident could spur greater emphasis on enhancing protocols—and greater oversight from the feds. |
Fierce podcastsDon’t miss an episode |
| | The FDA recently asked the six marketed CAR-T therapies to add a new boxed warning item on their labels to reflect the risk of secondary T-cell cancers. This week on "The Top Line," Fierce Pharma’s Angus Liu talks with regulatory experts to understand the rationale behind the FDA’s decision and to discuss its implications for CAR-T candidates and their developers down the line. |
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| Whitepaper This paper assesses the current state of the broad CNS market, reviewing key expectations for 2024. It addresses Alzheimer’s disease, biomarkers, and advances in psychiatry in detail. It also provides a high-level look at the pain market and the evolving regulatory environment. Presented by Blue Matter, strategic consultants in the life sciences |
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