FDA approves nose spray EpiPen alternative

Today’s Big News

Aug 9, 2024

On doorstep of FDA decision, Gilead pays J&J $320M to exit licensing deal for seladelpar


Zimmer Biomet scoops up OrthoGrid to expand hip portfolio


Regulatory tracker: FDA greenlights EpiPen alternative in ARS Pharmaceuticals’ neffy nasal spray


AbbVie taps Melissa Joan Hart to explain it all at annual ‘Science of Skin’ event


Legend Biotech CEO takes ‘close look at business’ amid geopolitical risk, M&A rumor


Merck pays $700M for bispecific, spying autoimmune opening and chance to challenge Amgen in cancer


Gilead looks to 'redefine' HIV PrEP market with 2025 launch of long-acting Sunlenca

 

Featured

On doorstep of FDA decision, Gilead pays J&J $320M to exit licensing deal for seladelpar

With Gilead on the verge of an FDA decision for its liver disease drug seladelpar, the company has paid Johnson & Johnson $320 million to exit an 18-year-old licensing agreement on the compound. The buyout removes Gilead’s obligation to pay an 8% royalty on sales of seladelpar.
 

Top Stories

Zimmer Biomet to acquire AI surgical guidance company OrthoGrid Systems

Zimmer Biomet plans to acquire AI surgical guidance company OrthoGrid Systems to expand its market share in hip replacement procedures.

Regulatory tracker: FDA greenlights EpiPen alternative in ARS Pharmaceuticals’ neffy nasal spray

In this tracker, Fierce Pharma is recording the regulatory progress of in-market products, including expansions into key geographies and new indications. Some of these updates may not meet the bar for standalone stories, but we think they are still worth mentioning.

AbbVie taps Melissa Joan Hart to explain it all at annual ‘Science of Skin’ event

To brew up the latest iteration of its ongoing initiative to provide deeper education around chronic skin conditions, AbbVie sought help from a onetime teenage witch.

Legend Biotech CEO takes ‘close look at business’ amid geopolitical risk, M&A rumor

Legend Biotech CEO Ying Huang, Ph.D., already had a lot on his plate when speculations of a potential geopolitical crackdown and the option of a buyout emerged.

Merck pays $700M for bispecific, spying autoimmune opening and chance to challenge Amgen in cancer

Merck & Co. is paying $700 million upfront to challenge Amgen in a blood cancer market. The deal will give Merck global rights to Curon Biopharmaceutical’s CD3xCD19 bispecific, positioning the Big Pharma as a rival to Amgen and AstraZeneca in oncology and Cullinan Therapeutics in autoimmune disease.

Gilead looks to 'redefine' HIV PrEP market with 2025 launch of long-acting Sunlenca

The HIV-focused drugmaker looks to position its long-acting Sunlenca as a prime PrEP option after the med aced a phase 3 study.

As Novavax comes full circle, it's 'actively exploring' sale of Czech manufacturing plant

As Novavax presented its quarterly earnings, finance chief Jim Kelly said the company was “actively exploring” the sale of its manufacturing facility in the Czech Republic. Novavax purchased the site in May of 2020 for $167 million with the intent of it producing more than 1 billion doses annually there. It was part of a dizzying scale up when the company—fueled by government funding—was awash with outsized expectations. 

Chutes & Ladders—Biogen CMO Maha Radhakrishnan joins Sofinnova

Former Biogen Chief Medical Officer Maha Radhakrishnan, M.D., is now an executive partner at healthcare investment firm Sofinnova Investments.

Crinetics, eyeing a 2025 acromegaly drug launch, rolls out new disease treatment campaign

Crinetics is seeking to change the way acromegaly is treated. Ahead of its hopes for a 2025 U.S. drug launch, the biotech is looking to spread awareness about how to treat the condition.

AN2 halves head count, stops phase 3 trial after data disappoint

AN2 Therapeutics is rethinking its business in response to lackluster midphase data, vowing to lay off half its employees and stop a phase 3 study as part of a pivot to early-stage projects.
 
Fierce podcasts

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A closer look at Fierce Biotech's Fierce 15

In this week's episode of "The Top Line," we’re diving into Fierce Biotech’s annual Fierce 15 special report.
 

Resources

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Launching a Product in Europe: Understanding Supply Chain Cost Drivers

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2024 Life Sciences Industry Outlook

The definitive report on the state of our industry.  Readers will gain an understanding of key indicators to monitor, future predictions, and guidance for investors and founders navigating the therapeutic enabling tools and services, healthtech and techbio sectors through 2024 and beyond.
 

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