Alkermes narcolepsy drug headed for late-stage testing

Part of a class of therapies that boost “orexin” proteins, the drug just scored positive results in a Phase 2 trial. Analysts have guessed it could ultimately generate billions in sales.

By Jacob Bell • July 21, 2025

AstraZeneca rare disease drug fails key trial tests

Anselamimab, which AstraZeneca acquired via Caelum Biosciences, missed its primary goal in two late-stage trials, but appeared to have some benefit in a subgroup of patients.

By Gwendolyn Wu • July 16, 2025

Explore the Trendline➔

Oncology's research boom

More than one quarter of the medcines cleared by the FDA's main review office since 2015 have been cancer drugs, a tally that reflects the advent of cancer immunotherapy as well as continued progress in matching treatment to genetics.

By BioPharma Dive staff

Hengrui, Kailera say dual-acting obesity shot succeeds in China study

The results position Hengrui to seek approval of the Zepbound-like drug in China, and Kailera, a well-funded startup, to begin global late-stage testing.

By Ben Fidler • July 15, 2025

AstraZeneca blood pressure drug succeeds in late-stage trial

Baxdrostat, which AstraZeneca acquired in a 2023 buyout of CinCor Pharma, could become a new treatment for people whose hypertension is either uncontrolled by or resistant to existing medicines.

By Ned Pagliarulo • July 14, 2025

Takeda to seek approval of new kind of narcolepsy drug after study data

Positive late-stage study results position the company to file for clearance of what could be the first narcolepsy drug that targets orexin proteins. 

By Ben Fidler • July 14, 2025

From data to decisions: How pharma can move faster without sacrificing trust

Pharma's speed advantage depends on trust. Is your data foundation strong enough?

By Pankit Bhalodia, Partner at West Monroe Life Sciences • July 14, 2025

Apogee touts positive data for atopic dermatitis drug

The antibody treatment could compete with Sanofi’s Dupixent and Eli Lilly’s Ebgylss, while offering the potential for less frequent dosing.

By Delilah Alvarado • July 7, 2025

Study results boost Cogent’s case for rare disease drug

One analyst described Cogent’s data as a “home run scenario” for bezuclastinib, which the company is positioning as a competitor to Blueprint Medicines’ Ayvakit.

By Gwendolyn Wu • July 7, 2025

[Podcast] Trial Trailblazers: Behind clinical breakthroughs

Explore how innovative clinical trials are transforming treatments for children with rare diseases in this compelling podcast.

By BioPharma Dive's studioID • July 7, 2025

Organon drug for endometriosis falls short in mid-stage study

Company executives had seen the drug as a potential multi-billion dollar opportunity in women’s health.

By Kristin Jensen • July 2, 2025

Atai and Beckley, set to merge, reveal study success for psychedelic drug

Positive study results in Phase 2 lead to a green light for the companies’ combination and plans to move their nasal spray into pivotal testing.

By Kristin Jensen • July 1, 2025

Sodium channel blockers for pain: New opportunities after Vertex’s ‘watershed’ moment

The success of Vertex's opioid alternative Journavx could aid a group of biotechs that aim to take a similar path with NaV1.8 and NaV1.7 inhibitors.

By Jacob Bell • July 1, 2025

Moderna flu shot outperforms marketed vaccines in large late-stage trial

The mRNA drug developer said it will begin discussing approval with the FDA, which has adopted stricter vaccine review standards.

By Jonathan Gardner • June 30, 2025

New Amgen obesity drug data disappoint Wall Street

Full Phase 2 study results showed side effects that led people to stop treatment with MariTide, as well as weight loss effects that weren’t as strong as previously reported.

By Jonathan Gardner • June 24, 2025

Chasing rivals, Nuvalent to seek approval of targeted lung cancer drug

New study results position Nuvalent to bring forward what it claims is a differentiated treatment for ROS1-positive lung cancer, a crowded indication with uncertain sales potential.

By Ben Fidler • June 24, 2025

Relentless innovation: Bold exploration in advancing therapeutic options for every patient, every discovery

Can rethinking risk in R&D unlock breakthroughs for rare and hard-to-treat diseases?

By Dr. Claude P. Bertrand, Executive Vice President Research & Development, Chief Scientific Officer, Servier • June 23, 2025

Compass’ big psychedelic study doesn’t impress investors

While positive, results from a late-stage clinical trial appear to be raising questions about how useful the company’s version of psilocybin could be as a depression treatment.

By Jacob Bell • June 23, 2025

Scholar Rock drug preserves muscle in obesity trial

While the results were an important proof point for so-called anti-myostatin drugs, Scholar Rock executives indicated the company may look for a partner in obesity while focusing on rare diseases.

By Kristin Jensen • June 18, 2025

FDA to speed reviews for drugs supporting ‘national interests’

A new pilot program announced by FDA Commissioner Martin Makary would award vouchers that could cut drug reviews to one or two months — but only for products that meet a special criteria.

By Jonathan Gardner • Updated June 18, 2025

Roche, waving off study failures, commits to Phase 3 trials for Parkinson’s drug

The Swiss drugmaker said it was “encouraged” by the signs of effectiveness of the drug, developed by biotech Prothena, showed in two earlier studies that missed their main goals.

By Jonathan Gardner • June 16, 2025

Novo, searching for a spark, plans late-stage trials for amylin drug

The Danish drugmaker, which is grappling with a share decline and competition from Eli Lilly, unveiled planned trials of an obesity medication that works differently than its popular Wegovy. 

By Jonathan Gardner • June 13, 2025

NewAmsterdam says cholesterol drug may also combat Alzheimer’s

A "sub-study" of a large clinical trial found the drug, obicetrapib, significantly reduced levels of a type of tau protein linked to Alzheimer's development.

By Jacob Bell • June 9, 2025

Metsera shares climb on early data for amylin-targeting obesity shot

Early-stage study results suggest that a single shot of the company’s therapy, which works differently than GLP-1 medicines, might have effects that last at least four weeks.

By Jonathan Gardner • Updated June 9, 2025

Merck claims study success with PCSK9 cholesterol pill

Enlicitide, which could be the first oral medication that blocks the protein PCSK9, helped cut cholesterol levels in a pair of closely watched trials.

By Ben Fidler • June 9, 2025

The risk plan you forgot about: 3 considerations for your recruitment and enrollment strategy

It’s a truth that all clinical teams are aware of: risk mitigation is a core part of clinical trial success. But, what does that mean for your enrollment plan?

June 9, 2025