Lykos still aiming at MDMA approval

Today’s Big News

Jan 17, 2025

‘Own JP Morgan, don't let JP Morgan own you’: Biopharma—and Jill Biden—show up for JPM25 


Notch begins 'significant' layoffs, blames tough environment for preclinical cell therapy biotechs


Lykos still plotting path to approval for rejected MDMA therapy after 'productive' FDA meeting


Chutes & Ladders—Apellis COO stepping down to take first CEO job


Fierce's forecasts for the next year in biopharma

The Top Line Podcast: Don’t miss out on the newest episode. Listen now.

 

Featured

‘Own JP Morgan, don't let JP Morgan own you’: Biopharma—and Jill Biden—show up for JPM25

This year’s JP Morgan struck a different tone than previous years—a very pleasant one, despite higher security anxieties following the fatal shooting of UnitedHealthcare’s CEO in December.
 

Top Stories

Notch begins 'significant' layoffs, blames tough environment for preclinical cell therapy biotechs

Notch Therapeutics is making “significant” layoffs to conserve its cash while the cell therapy biotech seeks out new partners or investors.

Lykos still plotting path to approval for rejected MDMA therapy after 'productive' FDA meeting

One of the biggest stories of last year was Lykos Therapeutics’ failure to get its MDMA candidate over the finish line for post-traumatic stress disorder. But the biotech has reminded us this week that it hasn’t given up hope yet.

Chutes & Ladders—Apellis COO stepping down to take first CEO job

After six years at Apellis, Chief Operating Officer Adam Townsend is saying goodbye to take on his first CEO job. The veteran exec will depart on Feb. 21 to lead a private biotech company.

Fierce's forecasts for the next year in biopharma

This week on “The Top Line,” we explore the trends that defined the industry in 2024 and predict how 2025 might shake out for biopharmas big and small.

Novo Nordisk touts 'superior' weight loss results in study of high-dose Wegovy

In the phase 3b STEP UP study, an experimental 7.2-mg semaglutide dose helped patients lose more weight on average at 72 weeks compared to placebo or semaglutide 2.4 mg, which is currently the highest dose of Novo Nordisk's drug marketed under the Wegovy brand for obesity.

Government watchdog recommends tweaks to FDA accelerated approval program

A government watchdog examining the FDA’s accelerated approval pathway has released a report concluding that the agency’s controversial endorsement of Biogen’s failed Alzheimer’s treatment Aduhelm was generally an outlier. But the OIG also suggested tweaks to the approval program.

Biden names GLP-1 drugs Ozempic, Wegovy for price negotiation program

Likely to be the last defining health policy act as president, the Biden administration unveiled its list of 15 drugs for the second annual round of drug price negotiations, made possible through the Inflation Reduction Act.

Fierce Pharma Asia—AbbVie's $1B pact with Simcere; Takeda's launch map; Samsung Bio's growth plans

As the J.P. Morgan Healthcare Conference started in San Francisco on Monday, AbbVie linked up with Simcere with a $1 billion deal for the Chinese biopharma's phase 1 T-cell engager. Later during the conference, Takeda CEO Christophe Weber laid out the company's top pipeline prospects, a group of 6 drugs that could collectively generate $20 billion at peak. Plus more.
 
Fierce podcasts

Don’t miss an episode

Fierce's forecasts for the next year in biopharma

This week on “The Top Line,” we explore the trends that defined the industry in 2024 and predict how 2025 might shake out for biopharmas big and small.
 

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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