Atara, Pierre Fabre cell therapy rejected by FDA

Today’s Big News

Jan 16, 2025

Gilead settles with U.S. government in long-running patent dust-up over PrEP meds Truvada, Descovy 


Boehringer’s phase 3 schizophrenia program misses primary goal


Atara, Pierre Fabre hit a hurdle with Ebvallo in the US courtesy of manufacturing plant's shortfalls 


AbbVie maintains top TV ad spend spot with Skyrizi but sees Rinvoq fall behind J&J's Tremfya, Novo's Wegovy 


Bayer gears up for 'must-win battles' as Xarelto's decline is in full swing, pharma chief says 


Takeda spotlights 6 pipeline assets that could pull down up to $20B in collective peak sales

 

Featured

Gilead settles with US government in long-running patent dust-up over PrEP meds Truvada, Descovy

After a run of court victories in a patent dispute with the U.S. government, Gilead has agreed to settle to resolve the feds’ last-ditch appeal. Terms of the deal were not disclosed in the case, which involved the government’s patents on Gilead’s HIV drugs Truvada and Descovy for pre-exposure prophylaxis.
 

Top Stories

Boehringer’s phase 3 schizophrenia program misses primary goal

Boehringer Ingelheim’s investigational schizophrenia candidate has failed to improve cognitive impairment or functioning in a trio of late-stage trials.

Atara, Pierre Fabre hit a hurdle with Ebvallo in the US courtesy of manufacturing plant's shortfalls

The FDA has issued a complete response letter for Atara's biologics license application "solely related to inspection findings" at a third-party manufacturer, the biotech said.

AbbVie maintains top TV ad spend spot with Skyrizi but sees Rinvoq fall behind J&J's Tremfya, Novo's Wegovy

AbbVie closed out the year on a high note, as its blockbuster biologic Skyrizi once again claimed the top spot in 2024’s final monthly ranking of the biggest TV ad spenders in biopharma.

Bayer gears up for 'must-win battles' as Xarelto's decline is in full swing, pharma chief says

Although Bayer’s top-selling drug Xarelto lost market exclusivity in most geographies in 2024, the company still sees strong growth from the pharma business beginning in 2027.

Takeda spotlights 6 pipeline assets that could pull down up to $20B in collective peak sales

Among the myriad drugmakers laying out their plans for the future at this year’s J.P. Morgan Healthcare Conference, Takeda said it's laser-focused on six pipeline assets that could each reel in blockbuster-level sales down the line.

JPM25 tracker: Neurology need and lighter attendance this year?

Welcome to day 3 of the J.P. Morgan Healthcare Conference in San Francisco.

Gilead's Kite taps longtime Amgen alum as new global commercial head

Kite Pharma is flying high with the addition of a new member to its senior leadership team. Brian Heath has joined Gilead Sciences’ cell therapy subsidiary as a senior VP and head of global commercial, he announced on LinkedIn this week.

Google Cloud 'can't wait to see what's next' as Servier extends AI drug R&D pact

Servier is extending its pact with Google Cloud as the French biopharma points to 60 examples of how generative artificial intelligence (gen AI) could improve its drug development processes.

Avacta expands peptide-drug conjugate study after seeing 10% response rate

Avacta is stepping up development of its peptide-drug conjugate, kicking off expansion cohorts in multiple tumor types after seeing one partial response in 10 salivary gland cancer patients.

Serina sells AgeX assets to shareholder Juvenescence to become debt-free

Serina Therapeutics is shedding a subsidiary to start the new year off debt-free. The Alabama-based biotech has sold UniverXome Bioengineering to clear away $11.2 million in debt.

Aileron straps in for 2025 with a new name: Rein Therapeutics

Aileron Therapeutics pulled a hard pivot in 2023, merging with Lung Therapeutics to gain a new pipeline and investor base. Now, the biotech has distanced itself from its premerger form by rebranding as Rein Therapeutics.
 
Fierce podcasts

Don’t miss an episode

Breaking down the 55 new drug approvals of 2024

This week on “The Top Line,” we dive into 2024's batch of new FDA drug approvals, highlighting some potential blockbusters and shifts from previous years' lists.
 

Resources

Whitepaper

Communicating the Value of Biopharma Assets to Potential Investors

How can an emerging company attract the right partner for a therapeutic asset (& optimize its value in a transaction)? This paper offers some insights.
 

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