Tarver lands official spot leading FDA devices center

Today’s Big News

Oct 22, 2024

UPDATED: Starboard wants to hold Pfizer leadership 'accountable' for overpaid M&A deals, poor return on R&D investment


Roche tosses out tau prospect, returning rights to UCB 4 years after placing $120M bet


It’s official: Michelle Tarver named director of the FDA's devices center


Telix unveils radiopharmaceutical spinoff Rhine Pharma following string of nuclear medicine acquisitions


Sangamo slashes time to market for Fabry gene therapy as FDA agrees to accelerated approval package


Senators probe whether Pfizer, Lilly DTC platforms create ‘potential for inappropriate prescribing’

 

Featured

UPDATED: Starboard wants to hold Pfizer leadership 'accountable' for overpaid M&A deals, poor return on R&D investment

Activist investor Starboard Value is baring its teeth at Pfizer management, more openly going after CEO Albert Bourla’s job in a new presentation.
 

Top Stories

Roche tosses out tau prospect, returning rights to UCB 4 years after placing $120M bet

Roche has returned the rights to UCB’s anti-tau antibody bepranemab, walking away from a $120 million bet on the Alzheimer’s disease drug candidate on the cusp of the release of phase 2a data.

It’s official: Michelle Tarver named director of the FDA's devices center

Tarver had held the interim position since late July, when Jeff Shuren announced his retirement after 15 years in the post.

Telix unveils radiopharmaceutical spinoff Rhine Pharma following string of nuclear medicine acquisitions

Telix on Tuesday unveiled the spin-off of Rhine Pharma—a new entity born from a collaboration between Telix and Germany’s Heidelberg University Hospital—which is setting out on a mission to expand access to radiopharmaceuticals for cancer treatment and imaging.

Sangamo slashes time to market for Fabry gene therapy as FDA agrees to accelerated approval package

Sangamo Therapeutics has identified a shortcut to market for its Fabry disease candidate, aligning with the FDA on a pathway that could slash three years from the time to market and free it from the need to run an additional registrational study. Shares in Sangamo jumped 33% to $1.22 in the wake of the news.

Senators probe whether Pfizer, Lilly DTC platforms create ‘potential for inappropriate prescribing’

A group of U.S. senators are digging into the direct-to-consumer telehealth platforms launched by Eli Lilly and Pfizer this year, in search of any indication that the services could create conflicts of interest for prescribers.

FDA grants de novo clearance to airway stent covered with human tissue

Peytant Solutions’ AMStent system has a metal frame encased in a processed material made of amnion, the pliable membrane that helps form the amniotic sac. It holds open the airways of patients who may have trouble breathing due to growing tumors.

AstraZeneca's Breztri TV spot sets sail, creating tailwind for COPD drug's cruise up the sales charts

AstraZeneca has rolled out a fresh TV spot for its blockbuster-to-be Breztri, hitting the message that the product frees chronic obstructive pulmonary disease patients to leave their bad days behind and cruise into a brighter future.

DOJ challenges Johnson & Johnson's talc bankruptcy attempt in Texas

In federal bankruptcy court in Houston, Texas, the U.S. Trustee—the Department of Justice’s unit that oversees bankruptcy cases—has filed a motion to dismiss a Johnson & Johnson subsidiary's Chapter 11 bid to settle more than 60,000 talc lawsuits.

Reckitt’s Mucinex inspires consumers to swipe left on cold and flu symptoms with Mr. Mucus’ Tinder debut

The upcoming winter months bring with them the annual cold and flu season, as well as “cuffing season” for singles everywhere, and consumer health giant Reckitt is capitalizing on both occurrences.

Editas prioritizes in vivo gene therapies, looks to partner reni-cel

Editas Medicine is pushing its in vivo gene therapy strategy to the top of its agenda, boasting proof-of-concept data and signing a $238 million biobucks pact at the same time as it searches for a partner for its more advanced ex vivo sickle cell disease (SCD) medicine.

Dotmatics debuts antibody engineering R&D software platform

Geneious Luma aims to focus on monoclonal and multispecific antibodies. It’s the first part of what Dotmatics describes as a multimodal suite for biopharma researchers.

AvenCell secures $112M series B to flick 'switchable' CAR-Ts in the clinic

AvenCell Therapeutics has secured $112 million in series B funds as the Novo Holdings-backed biotech seeks clinical proof that it can generate CAR-T cells that can be turned “on” once inside a patient.

Leo Pharma tells doctors to 'Talk to the Hand' in new dermatology campaign

Leo Pharma is launching a new U.S. healthcare awareness campaign aimed at doctors to boost their understanding of a specific type of eczema.
 
Fierce podcasts

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'The Top Line': Where are they now? Catching up with past Fierce 15 honorees

In this week’s episode of “The Top Line,” we catch up with three past Fierce 15 honorees to gain their insights, experiences and visions for the evolving biotech landscape.

 

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Unlock the Future of Biotherapeutics with Catalent Biologics!
 

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