Under FDA pressure, GSK limits use of ovarian cancer drug

The drugmaker’s decision is the latest fallout from safety concerns that have emerged in testing of so-called PARP inhibitors, resulting in withdrawals by Merck & Co., AstraZeneca and Clovis Oncology. 

By Jonathan Gardner • Nov. 11, 2022

EMA backs restrictions on certain immune-regulating drugs

Once the European Commission signs off, use of several so-called JAK inhibitors sold by Eli Lilly, Pfizer and other drugmakers will be limited among smokers and patients who are at high risk of certain health complications. 

By Christopher Newman • Nov. 11, 2022

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

Pharma earnings outline drug law’s looming impact on sales, development

While companies remain unsure of the Inflation Reduction Act's effects, some began to warn investors about the likelihood of lower sales and reduced profits.

By Christopher Newman • Nov. 9, 2022

Ipsen drug shows benefit in pancreatic cancer, lifting shares of ghost company

Adding Onivyde to chemotherapy helped patients live longer, a finding that could result in increased payouts to shareholders in the drug’s developer, Merrimack, which laid off all of its employees in 2019. 

By Jonathan Gardner • Nov. 9, 2022

Early data hint at benefit for Amgen’s obesity drug

Newly released study results suggest treatment could lead to quicker weight loss, on less frequent dosing, than therapies from Eli Lilly and Novo Nordisk.

By Jonathan Gardner • Nov. 8, 2022

Novavax details trial results for omicron-targeting booster shots

A reformulated booster aimed at an earlier omicron subvariant outperformed Novavax’s current vaccine, but a bivalent version did not significantly raise antibody levels.

By Delilah Alvarado • Nov. 8, 2022

Viatris to buy two eye drug developers in deals worth up to $750M

The generics company is acquiring Oyster Point Pharma and the privately held Famy Life Sciences in a move aimed at creating an ophthalmology business.

By Delilah Alvarado • Updated Nov. 7, 2022

GSK myeloma drug comes up short in confirmatory test

The drug, Blenrep, did not outperform a standard treatment in relapsed or refractory multiple myeloma, setting back GSK's plans to confirm the conditional approval it received in 2020.  

By Ned Pagliarulo • Nov. 7, 2022

Amgen’s Lumakras launch slows, shifting attention to other drugs

Sales of the closely watched lung cancer medicine fell short of analysts’ projections, adding to doubts about its market opportunity. 

By Christopher Newman • Nov. 4, 2022

Pfizer, BioNTech data support new Covid booster’s advantage over original vaccine

Follow-up data show the omicron-adapted shot boosted antibodies against the variant in older adults by more than the companies’ original version.

By Delilah Alvarado • Nov. 4, 2022

Moderna cuts sales forecasts for its COVID-19 vaccine

The biotech dialed back its financial projections after reporting lower-than-expected sales for the shot, which currently remains the company’s only marketed product. 

By Delilah Alvarado • Nov. 3, 2022

Novo obesity drug sales lag as manufacturing problems persist

Manufacturing problems continue to weigh on Novo’s Wegovy launch as competition looms from Eli Lilly’s fast-selling diabetes medicine Mounjaro.

By Jonathan Gardner • Nov. 2, 2022

Pfizer gets first positive result for an RSV vaccine in pregnant women

The shot kept newborns from getting severe respiratory infections in a Phase 3 trial, paving the way for the drugmaker to seek approval before its top rivals.

By Jonathan Gardner • Nov. 1, 2022

Lilly sales of new diabetes drug accelerate on rising patient demand

Company executives highlighted the “viral nature” of demand for Mounjaro, which was approved in May for diabetes and has also shown a strong weight-loss benefit in clinical testing.

By Ned Pagliarulo • Nov. 1, 2022

J&J to buy heart device maker Abiomed for $16.6B

The deal is the biggest by J&J since its $30 billion buyout of Actelion in 2017, and comes as the company works to split its consumer health business from its pharma and medtech units. 

By Elise Reuter • Nov. 1, 2022

With positive trial results, Bristol Myers looks to widen use of blood disease drug

Reblozyl, one of the drugmaker’s key assets, outperformed an older anemia drug in early-stage myelodysplastic syndrome, which could double the number of potentially eligible patients. 

By Jonathan Gardner • Oct. 31, 2022

Inflation Reduction Act: What are the healthcare implications?

The Inflation Reduction Act helps support American families by lowering prescription drug prices and reducing overall healthcare costs.

Oct. 31, 2022

EMA looks to follow the FDA in limiting use of certain immune-regulating drugs

The new recommendations could further curtail use of so-called JAK inhibitors, though restrictions imposed in Europe are less severe than in the U.S.

By Christopher Newman • Oct. 28, 2022

Sanofi reveals setback for cancer drug acquired in Synthorx buyout

Disappointing study results have led the French pharma company to take a $1.6 billion impairment charge and plan new early-stage trials for a drug executives once called a potential “foundation” for newer immunotherapy combinations.

By Ben Fidler • Oct. 28, 2022

GSK shelves filing plans for arthritis drug after trial results

GSK said the drug, formerly a top prospect licensed from German biotech Morphosys, showed “limited efficacy” in a Phase 3 study of patients with rheumatoid arthritis.

By Delilah Alvarado • Oct. 27, 2022

Merck reveals chairman succession as earnings beat forecasts

CEO Robert Davis will take over leadership of the board from Ken Frazier on Dec. 1, one and a half years after being named the company’s chief executive.

By Ned Pagliarulo • Oct. 27, 2022

J&J wins approval of new kind of multiple myeloma drug

The treatment, which will be sold as Tecvayli, is the first bispecific antibody cleared for the disease. It joins a group of medicines on market that target a protein called BCMA. 

By Kristin Jensen • Oct. 26, 2022

Novartis sales of Zolgensma gene therapy slow as market shifts

Treatment is now mostly of infants newly diagnosed with spinal muscular atrophy, as many of those previously eligible either already received Zolgensma or other drugs from Biogen and Roche.

By Ned Pagliarulo • Oct. 25, 2022

AstraZeneca’s persistence pays off with Imjudo approval

After failing multiple studies, the company’s immunotherapy tremelimumab is cleared to treat liver cancer as part of a regimen that could challenge a similar drug combination from Bristol Myers Squibb.

By Jonathan Gardner • Oct. 24, 2022

Novartis rival to AstraZeneca rare disease drugs succeeds in study

The pharma said iptacopan, one of its top pipeline prospects, outperformed Alexion’s Soliris and Ultomiris in certain patients with a disease called PNH.

By Ned Pagliarulo • Oct. 24, 2022