| Today’s Big NewsMar 1, 2024 |
| By Gabrielle Masson After investing heavily in COVID-19 over the last few years, Pfizer is pivoting to zoom in on cancer, with a laser focus on next-gen antibody-drug conjugates, small molecules and bispecific antibodies. |
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By Max Bayer We all aspire to have a boss who will just give you money for your next endeavor. Mathai Mammen, M.D., Ph.D., happens to have just that. J&J’s former pharma R&D chief, now the CEO of FogPharma, has brought on former J&J CEO Alex Gorsky as an investor in the company’s $145 million series E. |
By Gabrielle Masson Karuna Therapeutics is “vigorously” denying any deficiencies with a proxy statement filed last month that has become the focus of a shareholder lawsuit, though the biotech is producing supplemental information to address several of the allegations raised. |
Sponsored by The Dedham Group The influence of oncology pathways is growing. Here are the challenges and opportunities for biopharma companies in the clinical pathways landscape. |
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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. Sign Up Today! +(1)+(1).png)
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By Annalee Armstrong PTC Therapeutics has managed to slash through the regulatory jungle to find a path forward for Friedreich ataxia med vatiquinone after a pair of failures last year left the biotech reeling. |
Sponsored by Sengenics Revolutionizing Cancer Detection: The Power of Autoantibodies |
By Max Bayer,Annalee Armstrong Gritstone Bio is laying off 40% of employees after delaying the start of a phase 2 trial testing its COVID vaccine, which in turn pushed back the receipt of federal funds. |
Sponsored by ICON In this exclusive interview, ICON Biotech President Chris Smyth paints a picture of the operating environment facing biotechs in 2024. |
By James Waldron Three months after laying off most of its staff, SQZ Biotechnologies’ shareholders have opted to begin the process of liquidating and selling off what remains of the company’s assets to Stemcell Technologies for $11.8 million. |
By Helen Floersh New data suggest Vivani’s miniature exenatide implant, NPM-115, works as well as Novo Nordisk’s Wegovy and Ozempic for weight loss in mice. The implant delivers high doses of exenatide, a GLP-1 receptor agonist commercialized by AstraZeneca as Bydureon for treating Type 2 diabetes. |
By Max Bayer,Annalee Armstrong UK's MHRA CEO to depart after five years. Diem starts leadership post at Pfizer Ventures, replacing 16-year vet. Ionis calls on former exec for top strategy job. |
By Anastassia Gliadkovskaya When Joseph Schneier, a transgender man in his early 40s, started experiencing unusual spotting and elevated progesterone levels in 2021, his partner urged him to get checked out. They could not have known it would take a year for Schneier to find a willing gynecologist who did not turn him away. |
By Ayla Ellison,Angus Liu 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. |
By Angus Liu BeiGene expanded its global workforce by 1,400 over the past 12 months. Bristol Myers Squibb opened a large innovation hub in India. AstraZeneca has decided to hold onto Evrenzo in China and Korea while returning rights to FibroGen in the U.S. |
By Helen Floersh Headlands Research has added Pharmasite Research, a clinical trial site outside Baltimore that runs trials on psychiatric and central nervous system conditions, to its growing portfolio of trial sites in the U.S and Canada. |
Fierce podcasts Don’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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Thursday, March 7, 2024 | 1pm ET / 10am PT Join us for this timely look at the critical role a CDMO’s process development approach can play in shortening development timelines for biotherapeutics. Gain key insights on risk-mitigation strategies, utilizing flexible development platforms, optimizing integration, managing process development, and more. Register now. 
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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 |
Whitepaper This paper offers a detailed review of key events and developments in the oncology market during 2023. It’s a helpful “status report” that informs how the market is likely to evolve in 2024. It covers, vaccines, radiopharmaceuticals, ADCs, CAR-Ts, bi-specifics, & more. Presented by Blue Matter, strategic consultants in the life sciences |
Whitepaper Discover how to effectively classify highly potent APIs and the steps required to develop containment protocols and manufacturing processes that are both safe and efficient. Sponsored by: Catalent |
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