Newsletter Tool

Today’s Big News

Feb 5, 2024

Preclinical gene editing biotech Metagenomi outlines modest $87M IPO ambitions

J&J’s $6.5B autoimmune drug hits phase 3 goal, teeing up approval talks and keeping heat on argenx, UCB

Former CRISPR Tx CMO finds new home at Takeda

Pliant’s liver disease treatment slowed progression at highest dose, but efficacy didn't improve stepwise

4DMT links gene therapy to drop in Eylea injections, fueling plans to enter phase 3

Pfizer funnels $15M into 3-year ACS initiative designed to tackle cancer care disparities

Valneva's R&D team gets $103M funding boost courtesy of priority review voucher sale

Featured

Preclinical gene editing biotech Metagenomi outlines modest $87M IPO ambitions

By James Waldron

With the IPO window now firmly wedged open, Metagenomi is the latest biotech to set out expectations for going public—even if they are slightly more modest than peer companies have seen in recent weeks.

J&J’s $6.5B autoimmune drug hits phase 3 goal, teeing up approval talks and keeping heat on argenx, UCB

By Nick Paul Taylor

Johnson & Johnson’s $6.5 billion autoimmune drug has hit the mark in a phase 3 trial. The success tees J&J up to talk to regulators about approving the anti-FcRn antibody in generalized myasthenia gravis (gMG), although questions about the competitiveness of the late-to-market asset remain unanswered.

Former CRISPR Tx CMO finds new home at Takeda

By Gabrielle Masson

After resigning from her role as medical officer at CRISPR Therapeutics, Phuong Khanh Morrow, M.D., is taking on the role of head of oncology therapeutic area unit at Takeda.

Biotech in 2024: Opportunities, Trends & Challenges

Pliant’s liver disease treatment slowed progression at highest dose, but efficacy didn't improve stepwise

By Max Bayer

The highest dose of Pliant's liver disease treatment passed a phase 2 data, showing that it was safe and tolerable. But exploratory efficacy failed to differentiate from lower doses.

4DMT links gene therapy to drop in Eylea injections, fueling plans to enter phase 3

By Nick Paul Taylor

4D Molecular Therapeutics has linked its gene therapy to a 90% reduction in treatment burden in wet age-related macular degeneration (AMD), emboldening it to start planning to enter phase 3 next year.

Pfizer funnels $15M into 3-year ACS initiative designed to tackle cancer care disparities

By Gabrielle Masson

Pfizer is putting down $15 million to launch a new program with the American Cancer Society aimed at improving access to cancer screening and clinical trials in medically underrepresented communities nationwide.

Valneva's R&D team gets $103M funding boost courtesy of priority review voucher sale

By James Waldron

Vaccine maker Valneva is giving its R&D unit a $103 million gift courtesy of selling an FDA priority review voucher for tropical disease.

The top 10 biopharma M&A deals of 2023

By Eric Sagonowsky,Kevin Dunleavy,Angus Liu,Fraiser Kansteiner,Zoey Becker

Last year, the value of the top 10 M&A deals in the biopharma industry came to $115.8 billion, outranking prior sums from 2022, 2021 and 2020, which came to $65 billion, $53 billion and $97 billion, respectively. This report breaks down the industry's 10 largest M&A agreements of the year.

Novo antes up $16.5B to poach CDMO giant Catalent amid Wegovy surge

By Fraiser Kansteiner

Late last month, Novo Holdings’ CEO Kasim Kutay hinted that the fund manager was eyeing buyouts as an outlet for its trove of Wegovy cash. Now, a major deal has materialized.

FDA counts another 111 deaths in 7K new Philips recall reports

By Andrea Park

That brings the total number of medical device reports received since April 2021 to more than 116,000, with 561 reported deaths.

FDA sets date for high-profile CAR-T adcomm for Bristol's Abecma, J&J's Carvykti

By Angus Liu

Mark your calendars, oncology drug and CAR-T therapy developers. The FDA has decided on a date for a highly anticipated advisory committee meeting for Bristol Myers' Abecma and J&J's Carvykti.

Fierce podcasts

Don’t miss an episode

'The Top Line': Navigating the future of medical AI

This week on “The Top Line,” Fierce’s Conor Hale interviews Peter Shen, the North American head of digital health at Siemens Healthineers, to explore what developers and regulators can do to ensure transparency in medical AI. He also dives into how the field could potentially benefit from a 21st-century update to the Hippocratic Oath.

'Podnosis': Catching up with the Fierce 15 of 2019

‘The Top Line’: Closing the $1 trillion women’s health gap

Resources

Whitepaper

The Oncology Market – 2023 Year in Review

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

Developing and Manufacturing Drugs with HPAPIs

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.