Newsletter Tool

PM Tracker

Today’s Big News

Jul 11, 2025

‘Weak’ evidence and an ‘unpleasant’ odor: FDA sheds light on drug refusal process

FDA rejects Capricor’s DMD cell therapy, asks for more data

Jazz hits a sour note in back-to-back rebukes from UK marketing watchdog

Relmada terminates license agreement for troubled phase 3 depression asset

Quest Diagnostics to carry Fujirebio’s FDA-cleared Alzheimer’s blood test

Karyopharm lays off more workers as hunt for strategic alternatives turns up short

Non-opioid pain drug maker Pacira lays off 71 in California, retires facility in manufacturing upgrade

Biopharma layoffs aren't letting up

Featured

‘Weak’ evidence and an ‘unpleasant’ odor: FDA sheds light on drug refusal process

By James Waldron,Fraiser Kansteiner

Although many of the complete response letters uploaded by the FDA this week have been subtly disclosed in drug approval packages over the years, the consolidation of the rejection notices offers an in-depth view into the high-stakes discussions that decide whether a medicine will ever make it to market.

FDA rejects Capricor’s DMD cell therapy, asks for more data

By Nick Paul Taylor

The FDA has rejected Capricor Therapeutics’ filing for approval of a Duchenne muscular dystrophy cell therapy, raising questions about whether the agency's new leadership may be rowing back from some of the flexibility shown by the old regime. Capricor’s share price fell 38% to $7.11 in premarket trading.

Jazz hits a sour note in back-to-back rebukes from UK marketing watchdog

By Andrea Park

According to a pair of recent rulings by the U.K.’s Prescription Medicines Code of Practice Authority, Jazz Pharmaceuticals struck the wrong chord in presentations about its Epidyolex.

Relmada terminates license agreement for troubled phase 3 depression asset

By Darren Incorvaia

After prematurely ending two phase 3 depression trials last year, Relmada Therapeutics has formally given up on the asset they were testing. The Florida-based biotech terminated the license agreement for esmethadone on July 7, with all of their obligations under the deal set to expire on Oct. 5.

Quest Diagnostics to carry Fujirebio’s FDA-cleared Alzheimer’s blood test

By Conor Hale

The Lumipulse G blood test measures the ratio between specific tau and beta amyloid proteins, to find patients likely to have plaque buildups in the brain.

Karyopharm lays off more workers as hunt for strategic alternatives turns up short

By Gabrielle Masson

Karyopharm Therapeutics is laying off 20% of staffers as efforts to secure a strategic alternative have turned up short.

Non-opioid pain drug maker Pacira lays off 71 in California, retires facility in manufacturing upgrade

By Angus Liu

After years spent upgrading its manufacturing capabilities, Pacira BioSciences figures it’s time to retire a facility that has been running for more than a decade. Along with it, 8% of the company’s workforce is also headed for the exit.

Biopharma layoffs aren't letting up

By Ayla Ellison,Gabrielle Masson,Andrea Park

Biopharma layoffs have held steady through mid-2025, and in this episode of "The Top Line," we dig into the numbers, closures and policy changes shaping the trend.

Bayer scores first approval for hormone-free menopause drug Lynkuet in UK

By Kevin Dunleavy

Two years after Astellas became the first drugmaker to hit the market with a nonhormonal therapy for menopause symptoms, Bayer has followed suit, scoring its first worldwide nod for a similar treatment in the U.K.

Chutes & Ladders—Pfizer’s longtime reputation wrangler plans departure

By Darren Incorvaia,Zoey Becker

Sally Susman, the communications chief who has shepherded Pfizer’s reputation and branding for more than 18 years, is departing the pharma giant at the end of the year amid its ongoing cost-cutting efforts.

Novartis campaign celebrates teens with spinal muscular atrophy ‘SMAshing’ their limits

By Andrea Park

A new education and awareness campaign from Novartis shifts focus from the younger audiences that are typically the targets of such resources to the older teenagers and young adults who are going to college, starting careers and living independently while also managing spinal muscular atrophy.

Fierce podcasts

Don’t miss an episode

Biopharma layoffs aren't letting up

Biopharma layoffs have held steady through mid-2025, and in this episode of "The Top Line," we dig into the numbers, closures and policy changes shaping the trend.