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Amgen not done in quest to prove Repatha

A study set to begin in June will assess the cholesterol drug in patients who are at high risk of — but have not yet had — cardiovascular events like stroke.

Approval decision delay seen as positive for Karyopharm

The FDA pushed back its target decision date by three months and, in somewhat of a surprise, Wall Street analysts and the market cheered the news.

Amgen's top-selling Enbrel in balance as key court ruling nears

A decision could come as soon as this month in a court case pitting Amgen against Sandoz, which owns the only U.S. approval of an Enbrel biosimilar.

Celgene dodges Alvogen bid to overturn Revlimid patent

Alvogen's petition was the last inter partes review challenge facing Celgene, and its rejection could ease some concerns ahead of a key shareholder vote. 

Senate calls on PBMs to give 'patients an explanation,' following pharma CEO hearing

The Senate Finance Committee invited Cigna, CVS, Humana, UnitedHealth's OptumRx and Prime Therapeutics to testify next month.

UPDATED: March 19, 2019 at 4:42 p.m.

Key drugs from Merck, Roche win wider EU approvals

Label expansions for Hemlibra and Keytruda give the respective pharmas wider markets for their therapies.

Celgene's Abraxane fails late-stage pancreatic cancer study

A pivotal Phase 3 trial showed the drug combined with chemotherapy did not improve disease-free survival as an adjuvant treatment.

Aerie's eye drops win FDA approval

Branded as Rocklatan, the drops share an active ingredient with another intraocular pressure drug called Rhopressa that Aerie launched last year.

NCI Director Ned Sharpless to become acting FDA commissioner

President Trump will name Sharpless, currently the director of the National Cancer Institute, as acting FDA head, HHS Secretary Alex Azar said Tuesday.

UPDATED: March 12, 2019 at 1:52 p.m.

Biogen sells biologics plant to Fujifilm in $890M deal

After acquiring the site, Fujifilm will become Biogen's supplier, producing the biotech's multiple sclerosis drug Tysabri.

Lilly's Cyramza comes up positive in first-line lung cancer trial

A late-stage study of certain lung cancer patients found significantly longer progression-free survival for those who received Cyramza versus those who didn't.

Dupixent label expansion opens door to thousands more patients

A new approval in younger atopic dermatitis patients could increase the list of people eligible to use the immunology drug by 200,000, according to Sanofi.

AstraZeneca inks microbiome deal with Seres

The three-year research collaboration will explore whether the microbiome could predict which patients respond to cancer immunotherapies.

Pfizer's Herceptin biosimilar gets FDA approval as US entry nears

Trazimera is the fourth biosimilar cleared in the U.S. of Roche's top-selling cancer drug, which is already facing copycat competition abroad.

Roche wins first immunotherapy approval for triple-negative breast cancer

The FDA OK, however, is contingent on further study and is only for patients whose tumors express a biomarker called PD-L1.

Takeda's Entyvio beats AbbVie's Humira in head-to-head UC study

The Phase 3b trial found ulcerative colitis patients had more clinical responses when using Takeda's biologic rather than the world's top-selling drug. 

Axovant buoyed by early gene therapy data

After a damaging Alzheimer's setback, Axovant has bet its future on gene therapy. Its programs in Parkinson's and Tay-Sachs are its most advanced.

Cellectis to bring CAR-T manufacturing in-house with new plants

The cell therapy biotech, best known for its allogeneic ambitions, currently relies on contract manufacturers for its clinical trial supply.

Roche outbid competing biopharma to secure Spark deal

Spark reached out to three companies, including Roche, about possibly collaborating on its hemophilia A programs. The Swiss pharma, however, was more interested in an acquisition.

Pharmas, PBMs and payers all take a slice along drug supply chain, Pew finds

As debate over drug pricing continues, Pew's report seeks to document the share each player pockets as medicines move through the system.

Mylan's Advair generic pressures GSK with strong launch

Priced at a 70% discount, Mylan's copy of the blockbuster respiratory drug has quickly captured market share.

AMAG pregnancy drug's future in doubt after key study miss

A confirmatory trial designed to support Makena's approval failed, likely crimping its commercial prospects. Yet the drug may still remain on market. 

Sanofi's dengue vaccine gets mixed review from FDA panel

The committee voted narrowly against recommending U.S. approval for the French pharma's target population ranging from 9 to 45 years old, but supported it for a narrower age group.

How Scott Gottlieb changed the FDA

The agency head, who will leave after two years on the job, departs with a legacy as an outspoken leader who pushed the agency forward on several fronts.

FDA walks back plan to alter generic names of already approved biologics

Introduction of biosimilars in the U.S. has forced the FDA to evaluate how best to distinguish biologic products, a regulatory process with broader implications than it might seem.