Novo builds heart failure case for semaglutide; Ventyx CFO departs

A new analysis showed semaglutide reduced the risk of worsening heart failure. Elsewhere, the FDA OK’d a vaccine for mpox and a biotech planned layoffs.

By BioPharma Dive staff • Aug. 30, 2024

Keytruda fails lung and skin cancer trials, limiting further expansion

The trial setbacks for Merck’s best-selling drug, which faces patent expiration in 2028, are a blow to the company’s plans for further indication expansion.

By Jonathan Gardner • Aug. 29, 2024

Explore the Trendline➔

Top 5 stories from BioPharma Dive

Looming patent expiries this decade and intensifying competition from China are forcing drugmakers to adapt, while new opportunities open up in oncology and in neuroscience.

By BioPharma Dive staff

J&J submits touted autoimmune disease drug for FDA approval

Nipocalimab is one of several drugs J&J has forecast for multi-billion dollar sales. The company’s initial application is for its use in myasthenia gravis.

By Kristin Jensen • Aug. 29, 2024

Pfizer launches DTC service for migraine, COVID drugs

The platform is similar in concept to a service launched this year by Eli Lilly, and aims to give consumers easier access to Pfizer’s migraine, COVID-19 and flu treatments.

By Delilah Alvarado • Aug. 27, 2024

Lilly rolls out Zepbound vials at a discount price

The launch of a single-use vial form of the popular weight loss medicine could help Lilly improve supply and compete with telehealth companies offering compounded versions.

By Ned Pagliarulo • Aug. 27, 2024

RA Capital-backed startup raises $100M; UCB sells China business

New biotech Navigator is working on drugs for immune diseases. Meanwhile, UCB sold its neurology and allergy business in China, and J&J's Peter Fasolo will retire this year.

By BioPharma Dive staff • Aug. 27, 2024

Regeneron gains European approval for bispecific lymphoma drug

Regulators in Europe granted approval based on remission rates, while the FDA sought more progress in confirmatory trials when it rejected Ordspono.

By Jonathan Gardner • Aug. 26, 2024

FDA to convene immunotherapy panel; Tome scales back operations

Agency advisers will discuss whether use of Keytruda and Opdivo should be limited in gastric cancer. Elsewhere, a buzzy genetic drug startup is exploring “strategic options.”

By BioPharma Dive staff • Aug. 23, 2024

Regeneron confirms FDA won’t approve myeloma drug over manufacturing issues

Company executives had warned investors that a delay was likely due to issues at a facility run by a third-party manufacturer.

By Kristin Jensen • Aug. 21, 2024

Lilly’s tirzepatide cuts diabetes risk, study data show

Treatment with the GLP-1 drug, which Lilly sells as Mounjaro and Zepbound, lowered the risk of Type 2 diabetes progression by 94% versus placebo.

By Ned Pagliarulo • Aug. 20, 2024

As Bristol Myers’ schizophrenia drug nears approval, AbbVie and others hope to provide competition

A new wave of antipsychotics could improve patient adherence. The race to corner this large projected market is already getting tight.

By Kelly Bilodeau • Aug. 19, 2024

Pfizer, BioNTech stumble in effort to develop combination flu, COVID shot

The vaccine didn’t spur a strong enough immune response against a particular flu strain in a Phase 3 trial, leading the companies to ponder adjustments. 

By Delilah Alvarado • Aug. 16, 2024

Lilly opens R&D hub; Ovid and Lexicon lay off staff

Lilly’s new center in Boston will focus on genetic medicine research and provide lab space for startups. Elsewhere, two biotechs cut jobs and two others advanced psychedelic medicines.

By BioPharma Dive staff • Aug. 13, 2024

Merck bets $700M on an antibody drug’s potential in immune diseases

The deal hands Merck a cancer medicine already in human testing, but that the company sees as a potential treatment for autoimmune conditions, too.

By Ben Fidler • Aug. 9, 2024

Merck TIGIT drug fails another trial; Intellia therapy succeeds in HAE study

Merck stopped a Phase 3 TIGIT study for futility. Elsewhere, shares in Cabaletta Bio sank on safety worries and Vertex secured Casgevy reimbursement in England.

By BioPharma Dive staff • Aug. 8, 2024

Zepbound shortages ease, but Lilly cautions pharmacy availability may remain ‘choppy’

After months of supply strains, Lilly has begun to catch up with demand. Consumers may still need to wait for their prescriptions to be filled, however.

By Delilah Alvarado • Aug. 8, 2024

Lilly boosts outlook on rising Zepbound revenue

Sales of the in-demand obesity drug crested $1 billion in the second quarter as improved Lilly production helped the company fulfill wholesaler backorders.

By Ned Pagliarulo • Aug. 8, 2024

Amgen talks obesity drug ‘differentiation’; Servier brain cancer drug approved by FDA

Executives at Amgen had few updates on their drug MariTide, but defended what they see as the once-monthly shot’s competitive profile.

By BioPharma Dive staff • Aug. 7, 2024

Novo shares tumble on lower-than-expected obesity drug sales

Quarterly revenue from Ozempic and Wegovy missed Wall Street estimates by about 9%, concerning some analysts and causing a stock sell-off costing the Danish drugmaker tens of billions in market value. 

By Kristin Jensen • Aug. 7, 2024

Zepbound, Mounjaro back in supply as Lilly resolves shortage

All doses of the in-demand GLP-1 medicines are now available in the U.S., Lilly said ahead of reporting second quarter earnings later this week.

By Ned Pagliarulo • Aug. 5, 2024

Bristol Myers sends TIGIT drug back to Agenus

The decision makes Bristol the latest pharma to pull back on research into a type of cancer immunotherapy that’s drawn significant investment in recent years.

By Ben Fidler • Aug. 5, 2024

Why pharma should invest in evidence-based physician education

For years, many manufacturers have assumed that pre-market physician education was not strictly necessary unless their brand was the first to market or had a novel mechanism of action. With the advent of precision medicine, however, ongoing disease state education has become increasingly critical...

By Dr. Shrinal Patel and Carolyn Zele • Aug. 5, 2024

Vir retreats from infectious disease; Vertex shelves AATD drugs

The one-time drug developer is pivoting to cancer research. Elsewhere, Neurocrine reported a strong quarter and venBio raised half a billion dollars for biotech investing.

By BioPharma Dive staff • Aug. 2, 2024

Lilly obesity drug shows heart benefit in late-stage trial

The drug led to a 38% reduction in the risk of death or complications from a type of heart failure, a finding that compared favorably to available treatments.

By Ben Fidler • Aug. 1, 2024

Moderna shares fall amid lower sales outlook for RSV, COVID shots

The biotech cited competitive pressure and “very low” expected sales in Europe for its latest guidance cut, which sent shares down by nearly 20%. 

By Delilah Alvarado • Aug. 1, 2024