Sanofi wins US approval for myeloma drug key to its cancer ambitions

Sarclisa is the first cancer drug wholly owned by Sanofi to win an FDA OK in a decade — a milestone in the pharma's bid to play a larger role in oncology.

By Ned Pagliarulo • March 2, 2020

Sangamo sees vindication in Biogen gene-editing deal

Delivering products nearly ready for clinical testing has sparked greater dealmaking interest from big pharma, Sangamo's CEO told BioPharma Dive.

By Jonathan Gardner • Feb. 28, 2020

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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

Takeda's small celiac disease bet turns into acquisition

Phase 1 data triggered a takeout of PvP Biologics worth up to $330 million, giving Takeda access to a drug invented by a University of Washington team.

By Jonathan Gardner • Feb. 26, 2020

Amid coronavirus fears, a generics giant pledges price stability

For the roughly two dozen drugs Sandoz deemed essential, it will refrain from list price increases, rebate decreases or other actions that would increase commercial drug costs for healthcare systems.

By Jacob Bell • Feb. 26, 2020

Mallinckrodt offers $1.6B in deal to settle opioid claims

Under the proposed settlement, which has the support of state governments, Mallinckrodt's generics unit would file for bankruptcy protection.

By Jonathan Gardner • Feb. 25, 2020

As shortages draw spotlight, Sanofi to spin out drug ingredient business

The new company will launch with significant size, employing 3,100 and drawing from a network of six factories across Europe.

By Ned Pagliarulo • Feb. 24, 2020

Chinese biotech enlists GSK in coronavirus vaccine effort

Clover Biopharmaceuticals will pair GSK's adjuvant technology with a protein-based vaccine it recently began developing in response to the viral outbreak.

By Ned Pagliarulo • Feb. 24, 2020

Esperion adds more competition to cholesterol drug market

Following an FDA approval Friday, Esperion intends to sell bempedoic acid under the brand name Nexletol for a price of about $10 per day.

By Jacob Bell • Feb. 21, 2020

Teva's neuroscience drug falls short at the finish line

Austedo, a main growth driver for Teva, failed two late-stage studies that were supposed to get the drug approved as a treatment for tics in young patients with Tourette's.

By Jacob Bell • Feb. 20, 2020

Sanofi starts work on coronavirus vaccine, bringing scale to global research effort

The French drugmaker joins J&J as the second large pharmaceutical company to begin development of a vaccine against the virus that's spread quickly across China.

By Ned Pagliarulo • Feb. 18, 2020

Coronavirus weighs on AstraZeneca's China expansion

The British drugmaker cautioned the disease outbreak could impact its sales in the country, where restrictions on travel and commerce have been imposed to contain the virus' spread.

By Jonathan Gardner • Feb. 14, 2020

Bristol-Myers finds FDA receptive to speedy review of key cell therapy

The regulator agreed to decide by mid-August on approval of Bristol-Myers' CAR-T treatment liso-cel​, one of three drugs prominently featured in the pharma's buyout of Celgene last year.

By Ned Pagliarulo • Feb. 13, 2020

J&J bolsters coronavirus vaccine work with BARDA partnership

Notably, J&J said it would work to "upscale" its production and manufacturing capacity for any vaccine that might result from its research efforts.

By Ned Pagliarulo • Feb. 12, 2020

Merck builds case for Keytruda use in breast cancer

When added to chemo, Merck's immunotherapy kept a difficult-to-treat form of breast cancer from progressing, provided patients had an important biomarker.

By Jonathan Gardner • Feb. 12, 2020

Sanofi shrinks executive team as new CEO reshapes French drugmaker

Four members of Sanofi's top leadership will depart, including current chief medical and digital officer Ameet Nathwani.

By Ned Pagliarulo • Feb. 12, 2020

Bayer, looking to grow pharmaceutical sales, seeds new research center

The German drugmaker is transferring a "large part" of its small molecule research unit in Berlin to contract developer and manufacturer Nuvisan, with the aim of building a new facility on Bayer's R&D campus.

By Jacob Bell • Feb. 11, 2020

In Alzheimer's, a plan to treat patients earlier doesn't work out for Lilly, Roche

Results from the DIAN-TU study chip away at the amyloid hypothesis' foundation, just as Biogen prepares to file its drug aducanumab for approval.

By Jonathan Gardner • Feb. 10, 2020

AbbVie's plan to replace Humira is ahead of schedule

Sales of Skyrizi and Rinvoq, AbbVie's two new immunology drugs, jumped higher in the fourth quarter, leading the pharma to raise its 2020 forecasts for them by more than two-thirds. 

By Ned Pagliarulo • Feb. 7, 2020

Sanofi MS drug results set stage for extensive late-stage testing

The drug, a type of enzyme inhibitor that's proven valuable in cancer treatment, will soon head into four late-stage studies across various types of MS.

By Jacob Bell • Feb. 6, 2020

Merck joins peers in spinning off lower growth drugs

A yet-to-be-named new company will house Merck's women's health, biosimilar and legacy drugs, providing space and resources for the pharma's higher-growth businesses.

By Jacob Bell • Feb. 5, 2020

January price increases confirm slowing drug inflation

Pfizer, GlaxoSmithKline and Allergan were the most active, collectively raising list prices on some 450 drugs, according to one Wall Street analyst.

By Jonathan Gardner • Feb. 4, 2020

Bristol-Myers launches biotech targeting fibrosis, inflammation

Anteros Pharmaceuticals is the first company made via a partnership between Bristol-Myers and biotech accelerator BioMotiv. Its initial targets are liver and lung fibrosis, with one specific focus being IPF.

By Jacob Bell • Feb. 4, 2020

US cancels trial after finding vaccine doesn't prevent HIV

Research into preventive treatments will continue, however, as an NIH leader declared a vaccine "essential" to ending the widespread disease.

By Jonathan Gardner • Feb. 3, 2020

Amgen, Pfizer biosimilar sales pressure top drugs

Competition is heating up for copycats to Roche's top-selling cancer drugs, as the U.S. biosimilar market shows some modest signs of shifting.

By Jonathan Gardner • Jan. 31, 2020

Preventive Alzheimer's trial data due within weeks, Lilly says

Lilly's top scientist, however, set low expectations that solanezumab will show a benefit for patients with genetic mutations that drive early and severe disease.

By Jonathan Gardner • Jan. 30, 2020