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May 9, 2025

Verastem scores FDA nod for first-of-its-kind oral combination to treat rare form of ovarian cancer

Sanofi axes IGM pact, sparking 80% layoffs at the biotech and facility closures

Imperative Care launches dual-catheter stroke aspiration system

Roche pledges nearly $300M to establish new Vabysmo production plant in China

NIH terminated $1.8B in grants in 40 days under Trump administration: study

Featured

Verastem scores FDA nod for first-of-its-kind oral combination to treat rare form of ovarian cancer

By Kevin Dunleavy

Verastem Oncology has gained its first FDA approval, winning an accelerated nod for the combination treatment of avutometinib and defactinib for a rare form of ovarian cancer. With the commercial name of Avmapki Fakzynja Co-Pack, the combo becomes the first treatment specifically for patients with KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC). It affects between 6,000 and 8,000 women in the U.S. and 80,000 globally.

Sanofi axes IGM pact, sparking 80% layoffs at the biotech and facility closures

By Nick Paul Taylor

Sanofi has scrapped its collaboration with IGM Biosciences, eliminating the biotech’s last program in the process. IGM responded by laying off 80% of its staff and closing most of its lab and office facilities.

Imperative Care launches dual-catheter stroke aspiration system

By Conor Hale

The company said its Zoom DuoPort approach enables uninterrupted aspiration during thrombectomy by connecting two catheters to a single vacuum source.

Roche pledges nearly $300M to establish new Vabysmo production plant in China

By Fraiser Kansteiner

Roche is investing roughly $282 million to erect a new biomanufacturing hub in Shanghai. The plant, which will mark Roche’s second for branded medicines in the country, will mainly be used for domestic production of the eye med Vabysmo.,

NIH terminated $1.8B in grants in 40 days under Trump administration: study

By Nick Paul Taylor

The National Institutes of Health terminated $1.8 billion in grants in fewer than 40 days as part of a whirlwind of cuts early in the Trump administration, according to research published in JAMA.

AstraZeneca opens the door to Imfinzi expansion with trial win in high-risk bladder cancer patients

By Zoey Becker

The addition of Imfinzi to standard-of-care Bacillus Calmette-Guérin (BCG) induction and maintenance therapy helped patients live longer without their disease coming back, AstraZeneca said on Friday.

Vir's 'functional cure' candidate for hepatitis B misses mark in phase 2

By Gabrielle Masson

Vir Biotechnology’s sidelined hepatitis B candidate, designed to serve as a “functional cure,” has failed to achieve the efficacy results hoped for in a midstage study.

Fierce Pharma Asia—Enhertu's neoadjuvant win; Takeda eyes inflection point; Trump targets foreign plants

By Angus Liu

Enhertu delivered a trial win in early-stage breast cancer. Takeda spotlighted three late-stage readouts as a potential "inflection point" for the company. President Donald Trump is directing the FDA to go hard on foreign manufacturing facilities. And more.

Chutes & Ladders—Marty Makary names Vinay Prasad new CBER head

By Darren Incorvaia,Zoey Becker

In the wake of the high-profile departure of Peter Marks, M.D., Ph.D., the FDA has a new leader for its Center for Biologics Evaluation and Research. FDA Commissioner Martin Makary, M.D., has named hematologist-oncologist Vinay Prasad, M.D., to the post.

Fierce podcasts

Don’t miss an episode

Angela Hwang on her pivot from Big Pharma to biotech

This week on "The Top Line," Angela Hwang reflects on her leap from nearly 30 years at Pfizer to leading a biotech startup—and the career lessons that continue to guide her leadership and commitment to developing diverse talent.

ElevAAte and the push for East Asian American biopharma leaders

The rise of AI scribes: What’s the real-world impact?

Resources

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Best Practice Medical Affairs Organization Study Report

We interviewed 24 Medical Affairs leaders on the critical success factors for building a Best Practice Medical Affairs organization. This report shares what we learned.

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Through a CRO's perspective: Innovative, Agile Solutions In Vaccine Efficacy Testing

Typical vaccine development timelines have averaged 10 years, but the time from the SARS-CoV-2 genetic sequence’s release to the submission of the first vaccine clinical trial data for regulatory review was a mere 314 days. In IQVIA Laboratories’ Vaccine eBook we focus on how contract research organizations (CROs) can best leverage strategic partnerships with sponsors to prepare for the next pandemic.