Top Regulatory News Stories – Week Ending November 10, 2017

Hi folks.  I am posting a day early since I will be out of the office tomorrow.  The big news this week was the approval of a new molecular entity for Merck along with new indication approvals for both Genentech and Keryx. Here is my summary of the top stories this week:

Merck announced that the FDA has approved PREVYMIS™ (letermovir) for prevention of cytomegalovirus infection and disease in adult allogeneic stem cell transplant patients

FDA approved Genentech’s Zelboraf for the treatment of Erdheim-Chester Disease in patients with BRAF V600 mutation, a rare blood disease. Zelboraf was initially approved in 2011 to treat people with metastatic melanoma with BRAF V600E mutation.

 Keryx Biopharmaceuticals announced that the FDA had approved Auryxia for an additional indication. The expanded approval is for the treatment of iron deficiency anemia in adults with chronic kidney disease (CKD) not on dialysis.

Artemis Therapeutics announced that the FDA granted orphan drug designation for Artemisone, the Company’s lead product candidate, for the treatment of malaria.

Krystal Biotech, Inc. reported that the FDA has granted Orphan Drug Designation to the Company’ lead product candidate, KB103, currently in preclinical development for dystrophic epidermolysis bullosa, or DEB.

According to TherapeuticsMD, the FDA said it would drop its previous demand for a 12-month safety trial for TX-004HR, agreeing to a resubmission of the Florida company’s New Drug Application in an in-person meeting earlier this month.

Sarepta Therapeutics and Nationwide Children’s Hospital announced U.S. FDA clearance of their IND Application for the GALGT2 Gene Therapy Program

Stemline Therapeutics announced positive topline data from its pivotal Phase 2 trial of SL-401 in blastic plasmacytoid dendritic cell neoplasm and is on track to file a BLA for approval in Q4/17 or early Q1/18.

The FDA gave French biotech Cellectis SA a green light to resume two Phase 1 studies of its allogeneic CAR-T candidate, lifting a clinical hold that had been imposed following a patient death in late August.

An experimental drug developed by Sage Therapeutics significantly eased symptoms of postpartum depression in two Phase 3 studies of women with either moderate or severe forms of the disorder, and they plan to file for approval of the drug, known as brexanolone, sometime next year.

On Thursday FDA Commissioner Scott Gottlieb indicated that the agency will expand generic drug priority reviews:

In other news…

Valeant Pharmaceuticals will sell a women’s sexual health company (Sprout Pharmaceuticals) which it bought for $1 billion two years ago back to its previous owners following a tumultuous launch of its main drug, Addyi.

Principia Biopharma has signed a deal worth up to $765 million with Sanofi for the development of a multiple sclerosis drug candidate.

Two biotech giants — Amgen and Genentech — are laying off a combined 330 people at California facilities, both citing “organizational changes” as the primary reason for the cuts.

Puma Biotechnology has received up to $100 million in term loan funding to support the research and sale of a breast cancer drug approved this summer, company officials announced.

Nearly four months after issuing a voluntary recall of all lots of unexpired sterile drug products, Cantrell Drug Company has filed for bankruptcy.

Eli Lilly has reported that more than 2,300 employees at the company’s U.S. operations had accepted voluntary buyouts as part of their worldwide company reorganization.

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