FDA approves first RSV vaccine, clearing GSK’s Arexvy for older adults

The decision represents the first fruits of a scientific breakthrough a decade ago that gave drugmakers, among them GSK, Pfizer and Moderna, a blueprint for an effective shot against the virus.

By Delilah Alvarado • Updated May 3, 2023

Lilly drug slows Alzheimer’s decline in large study

The company plans to quickly submit an application for U.S. approval based on the trial results, which showed a consistent benefit to treatment with the drug, called donanemab.

By Jonathan Gardner , Ned Pagliarulo • Updated May 3, 2023

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

Pfizer turns focus to new drugs as COVID vaccine revenue falls

The drugmaker beat Wall Street’s first quarter forecasts despite a sales drop that puts pressure on it to succeed with upcoming market launches.

By Jonathan Gardner • May 2, 2023

FDA clears Pfizer’s pneumococcal vaccine for infants and children

Pfizer’s latest Prevnar shot covers 20 strains of the virus, more than the 13 covered by its previous version and the 15 by Merck’s Vaxneuvance.

By Delilah Alvarado • Updated May 3, 2023

AbbVie weathers first months of biosimilar challenge to top-selling Humira

While Humira sales declined, the drop was mostly due to price concessions AbbVie made to secure equal insurer access in the face of copycat competition.

By Ned Pagliarulo • April 28, 2023

Lilly plans dash to market for weight loss drug after trial win

The drugmaker will use a priority review voucher in a bid to secure FDA approval of Mounjaro in obesity by late this year or early next.

By Jonathan Gardner • April 27, 2023

Lilly drug Mounjaro succeeds in second weight loss study

Trial participants nearly 16% of their body weight in a finding that should help the closely watched GLP-1 drug gain an FDA approval for obesity.

By Jonathan Gardner • April 27, 2023

Bristol Myers’ Caforio stepping down as CEO in November

Commercial chief Christopher Boerner will take over after spending the next six months as chief operating officer. Giovanni Caforio will continue to serve as chair of Bristol Myers’ board.

By Jonathan Gardner • Updated April 26, 2023

Roche’s new eye drug pressures Eylea with strong launch

One year after its market debut, the company’s AMD drug Vabysmo is on track for blockbuster sales as Regeneron’s rival treatment faces new threats.

By Jonathan Gardner • April 26, 2023

Bristol Myers boosts cell therapy production with Novartis plant

Accessing the Illinois facility will expand Bristol Myers’ supply of viral vectors following manufacturing struggles with CAR-T drugs Abecma and Breyanzi.

By Kristin Jensen • April 26, 2023

Novartis trims 10% of drug pipeline in research cutback

The company cut about 20 early-stage projects, including nine solid tumor programs, after reviewing their strategic fit and commercial potential.

By Christopher Newman • April 25, 2023

J&J’s consumer health spinoff seeking $3B stock offering in test of IPO market

The planned IPO by the pharma’s consumer arm would value the new standalone company at over $40 billion.

By Ned Pagliarulo • April 25, 2023

Lilly sells emergency diabetes drug for $500M

The divestment of Baqsimi to Amphastar could net Lilly more than $1 billion if sales goals are met.

By Jonathan Gardner • April 24, 2023

Novartis plant cleared to produce in-demand cancer drug

The FDA has approved the pharma, which has had difficulty producing radiopharmaceutical drugs, to make its treatment Pluvicto at a New Jersey site.

By Delilah Alvarado • April 24, 2023

Ionis, AstraZeneca detail data backing rare disease rival to Alnylam drugs

A second-generation treatment called eplontersen halted nerve damage and improved quality of life in a late-stage study the companies are using to seek U.S. approval.

By Ned Pagliarulo • April 24, 2023

Partnership is key to caring for multiple sclerosis patients throughout their journey

Empowering people to live healthier goes beyond developing the right treatments.

By Anne Berger, Head of Alliance Development, Viatris • April 24, 2023

The rise of AI in pharma: make it work for you

 AI-derived data can range from insightful to useless. Learn how to get one and not the other.

April 24, 2023

FDA approves earlier use of Roche’s Polivy in common form of lymphoma

The agency’s decision also converts the biologic drug's approval from accelerated to full, confirming an earlier OK based on tumor responses.

By Jonathan Gardner • April 20, 2023

Appeals court sides with Amgen in patent fight over psoriasis drug Otezla

With the court victory, the biotech giant could stave off a set of generic competitors for the top-selling drug until 2028.

By Kristin Jensen • April 20, 2023

J&J leans on cancer drug sales to maintain first quarter growth

Revenue topped analyst forecasts on strong market performance from the pharma’s multiple myeloma treatments, as well as the last quarter of significant COVID-19 vaccine sales.

By Christopher Newman • April 18, 2023

GSK to buy Bellus Health and its chronic cough drug for $2B

The acquisition gives GSK a competitor to a similar drug being developed by Merck for the condition, which the companies estimate affects millions of people in the U.S.

By Ned Pagliarulo • April 18, 2023

Vaxcyte strengthens case for experimental pneumococcal vaccine

The company reported positive results from a second Phase 2 study of a shot that’s meant to challenge vaccines from Pfizer, Merck and GSK.

By Delilah Alvarado • Updated May 3, 2023

Navigate the complexities of cell and gene therapies

See how the effective use of CMC expertise helped guide a biopharma company’s development of a CGT product.

April 17, 2023

FDA again knocks back Alvotech’s Humira biosimilar

The agency rejected the partners’ copycat version of AbbVie’s blockbuster drug for a second time, citing problems spotted during the inspection of a manufacturing facility.

By Jonathan Gardner • April 14, 2023

Novo boosts sales outlook on strong demand for obesity drug

The Danish drugmaker nearly doubled the 2023 forecasts for Wegovy and Ozempic in the latest indicator of the sales potential of an emerging and competitive class of weight loss drugs. 

By Kristin Jensen • April 13, 2023