FDA approves bispecific drug from Pfizer for multiple myeloma

Elrexfio is the third bispecific antibody cleared to treat the cancer, and will compete with other therapies that target the “BCMA” protein on myeloma cells.

By Jonathan Gardner • Aug. 14, 2023

FDA delays decision on Valneva’s chikungunya vaccine

The agency needs more time to settle with Valneva the design of a post-marketing study for the shot, which could become the first preventive therapy for chikungunya available in the U.S.

By Delilah Alvarado • Aug. 14, 2023

Explore the Trendline➔

Alzheimer's disease

Many companies hope to follow in the footsteps of Biogen, Eisai and Eli Lilly by developing new therapies for the debilitating disease, which affects tens of millions of people and costs healthcare systems hundreds of billions of dollars each year.

By BioPharma Dive staff

The rise of the new pharma marketer in an evolving commercial model

Meet the pharma marketer of the future, primed for personalization and powered by technology.

Aug. 14, 2023

Novo hikes sales outlook on rising potential for obesity, diabetes drugs

The success of Wegovy in a landmark heart disease study has fueled higher sales projections, even though the Danish drugmaker is still struggling to maintain a big enough supply. 

By Jonathan Gardner • Aug. 10, 2023

J&J grows cancer drug portfolio with newly approved bispecific

The drug, which will be sold under the brand name Talvey, is now cleared by the FDA to treat multiple myeloma, a blood cancer that J&J has identified as a research priority.

By Jacob Bell • Aug. 10, 2023

Astellas to expand presence in Massachusetts with new research hub

The planned facility in the biotech hotspot of Cambridge will include incubator space for startups and adds to Astellas’ R&D footprint in the Boston area.

By Delilah Alvarado • Aug. 10, 2023

Novartis says drug helps control chronic hives in studies

The studies are another example of drugmakers exploring how so-called BTK inhibitors can be used to treat diseases outside of blood cancer. 

By Kristin Jensen • Aug. 9, 2023

Lilly market value soars on higher sales, obesity drug potential

The Indianapolis drugmaker’s value rose past $500 billion, higher than any other pharmaceutical company, as analysts project lucrative markets for its obesity and Alzheimer's drugs.

By Ned Pagliarulo • Updated Aug. 8, 2023

Novartis sickle cell drug’s approval formally revoked by EU regulators

The company said it would withdraw the drug, Adakveo, from the EU market after the European Commission endorsed an earlier EMA recommendation.

By Ned Pagliarulo • Aug. 4, 2023

RSV antibody from Sanofi, AstraZeneca backed by CDC for use in infants

The treatment, which won FDA approval in July, is expected to be available by the start of the typical RSV season this fall.

By Delilah Alvarado • Aug. 4, 2023

Moderna looks to new COVID booster, RSV shot to curb falling sales

Sales of the company’s COVID-19 vaccine plummeted 94% year over year. But executives believe newer products can help revenue rebound.

By Delilah Alvarado • Aug. 3, 2023

GSK broadens use of cancer immunotherapy with latest FDA OK

The pharma’s drug Jemperli was cleared for patients with newly diagnosed endometrial tumors, but could soon face competition from Merck’s Keytruda.

By Jonathan Gardner • Aug. 1, 2023

Pfizer weighs cutting costs as COVID drug sales ebb

Revenue in the second quarter declined by 53% year over year due to lower sales of Pfizer’s coronavirus vaccine and antiviral, which have been less in demand this year.

By Ned Pagliarulo • Aug. 1, 2023

Merck, chasing Pfizer, claims study success for new pneumonia vaccine

The pharma said its latest shot, which covers 21 strains of bacteria, cleared two Phase 3 trials and in some cases spurred a stronger immune response than Pfizer’s Prevnar 20. 

By Kristin Jensen • July 27, 2023

GSK confident in RSV vaccine launch, but sets expectations for ‘steady build’

GSK expects its respiratory syncytial virus vaccine will be a multibillion dollar product. But at the beginning, it’s predicting a slower launch than for its fast-selling shingles shot.

By Delilah Alvarado • July 27, 2023

Biosimilar makers split strategies in bid to take on top-selling Humira

In challenging AbbVie for share of a $19 billion drug market, competitors are testing whether high upfront discounts or behind-the-scenes rebates can win them an advantage.

By Jonathan Gardner • July 26, 2023

Teva strengthens ties with biosimilar maker Alvotech

Despite setbacks with a Humira biosimilar, the partners have expanded an existing alliance, with Teva agreeing to purchase bonds while Alvotech pursues a stock sale.

By Jonathan Gardner • July 24, 2023

Bavarian Nordic to scrap RSV vaccine after study setback

The shot failed to meet a key goal of Bavarian Nordic’s Phase 3 study, a finding that separates it from marketed vaccines developed by Pfizer and GSK.

By Delilah Alvarado • July 24, 2023

EMA backs Pfizer’s RSV vaccine for use during pregnancy

The regulator’s recommendation for approval of Pfizer’s shot as a maternal immunization comes ahead of the FDA, which is currently reviewing that indication.

By Delilah Alvarado • July 21, 2023

J&J shares jump on strong sales, boosted outlook

The pharmaceutical giant raised its guidance for the year as it predicts “above market” growth to continue for its prescription drug business.

By Ned Pagliarulo • July 20, 2023

Novartis raises drug sales forecast, plans new stock buybacks

The pharma company, which will soon split off its generic drug unit, plans to repurchase up to $15 billion of its shares through the end of 2025.

By Ned Pagliarulo • July 18, 2023

The rise of the new pharma marketer in an evolving commercial model

Meet the pharma marketer of the future, primed for personalization and powered by technology.

July 17, 2023

First nonprescription birth control pill approved by FDA

The oral contraceptive’s maker, Perrigo, said the pill will be available in drug and grocery stores early next year, but did not disclose its planned price.

By Delilah Alvarado • July 13, 2023

EMA expands probe of possible suicide risk to popular weight loss, diabetes drugs

The European drug regulator says it now has 150 reports of possible cases involving self-injury and suicidal thoughts among people taking GLP-1 medicines like Ozempic.

By Kristin Jensen • July 12, 2023

Takeda withdraws FDA approval application for dengue vaccine

While the shot is approved in the EU, Takeda wasn’t able to address data collection issues raised by the U.S. regulator in its current review cycle.

By Delilah Alvarado • July 11, 2023