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

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

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

Pfizer planning steep price hike for COVID-19 vaccine

The company is considering charging as much as between $110 and $130 per dose — roughly four times the vaccine’s current price — once sales transition to the private market.

By Ned Pagliarulo • Oct. 21, 2022

Bristol Myers takes aim at Merck with Opdivo results in early melanoma

New data could support approval in a setting for which Merck’s Keytruda is already available — the latest salvo in the longrunning battle between the two immunotherapy rivals.

By Kristin Jensen • Oct. 20, 2022

J&J, flush with cash, says high valuations remain a dealmaking hurdle

“We don’t have to do anything out of desperation,” said CFO Joseph Wolk on J&J’s second quarter earnings call. J&J holds $34 billion in cash and other liquid assets. 

By Christopher Newman • Oct. 18, 2022

The demand for nanoparticles in drug formulation is rising

Collaborating with an experienced partner, such as a Contract Development & Manufacturing Organization (CDMO), could prove to be invaluable in developing nano-based systems.

By Kate Silver • Oct. 17, 2022

5 questions facing drugmakers as third quarter earnings begin

The newly enacted drug pricing law, along with Eisai and Biogen’s Alzheimer’s study success, will bring questions for many of the industry’s top companies.

By Jacob Bell , Jonathan Gardner , Ned Pagliarulo • Oct. 17, 2022

Pfizer, BioNTech say updated COVID booster raised omicron antibody levels in trial

The findings, which were disclosed in a press release without specific data, are the first immune response results in humans for the reformulated shot targeting the BA.4 and BA.5 substrains. 

By Delilah Alvarado • Oct. 13, 2022

GSK sets high bar with trial results for RSV vaccine

With data expected for several other vaccines for the respiratory disease, GSK reported positive clinical trial results showing efficacy above 80%.

By Jonathan Gardner • Oct. 13, 2022

Merck pays $250M to license Moderna cancer vaccine

The drugmaker’s decision to grab rights to the shot deepens its ties with the COVID-19 vaccine developer and comes weeks before a key data release. 

By Kristin Jensen • Oct. 12, 2022

Merck cardiovascular drug succeeds in study, validating $11B buyout bet

Late-stage study results showed sotatercept, which Merck acquired via its Acceleron deal, benefited patients with PAH. The drug could help Merck fill an expected gap in revenue when patents on Keytruda expire.

By Jonathan Gardner • Oct. 10, 2022

Worried about provider consolidation? Learn about GoodRx engagement solutions

GoodRx has developed strong relationships with both patients and providers over the past decade and is helping pharmaceutical manufacturers address the changes resulting from this trend.

Oct. 10, 2022

Lilly looks to speed FDA review of new diabetes drug in obesity

A new fast track designation allows Lilly to begin the process of seeking approval of tirzepatide for obesity, though the drug will need to succeed in a second trial to get to market.  

By Jonathan Gardner • Oct. 6, 2022

Merck expands Singapore hub to support Keytruda, Gardasil

The company opened a packaging facility for its two top-selling products and began work on a plant that will produce next-generation inhalers.

By Christopher Newman • Oct. 6, 2022

Sanofi takes a chance on Provention’s diabetes drug with marketing deal

The pharma will invest in the biotech and co-promote its drug teplizumab if the FDA OKs the medicine as a first-of-its-kind diabetes treatment.

By Kristin Jensen • Oct. 6, 2022

BioNTech to build an mRNA hub in Australia

A new agreement with the Australian government will bring messenger RNA research and manufacturing capabilities to the country, adding to the COVID-19 vaccine developer’s global expansion efforts. 

By Delilah Alvarado • Oct. 6, 2022

GSK immunotherapy matches Keytruda in lung cancer trial

The British drugmaker said a mid-stage study of its PD-1 inhibitor Jemperli alongside chemotherapy showed “positive headline” results, which it will present in full later.

By Kristin Jensen • Oct. 5, 2022

Takeda to stop making parathyroid drug Natpara in 2024 after production challenges

The Japanese drugmaker said it was unable to resolve manufacturing problems that led to a 2019 recall of the drug, which treats hypoparathyroidism.

By Christopher Newman • Oct. 4, 2022

Pfizer says PARP inhibitor succeeds in prostate cancer study

AstraZeneca paved the way for PARPs in prostate cancer when it won an approval for Lynparza in advanced patients. Now Pfizer may have a combination treatment for earlier-stage disease.

By Jonathan Gardner • Oct. 4, 2022