Top Regulatory News Stories – Week Ending September 7, 2018

Merck announced that the U.S. FDA has approved two new HIV-1 medicines:  DELSTRIGO and PIFELTRO:

Tetraphase Pharmaceuticals announced that the FDA has granted approval of XERAVA™ (eravacycline) for the treatment of complicated intra-abdominal infections (cIAI).

Bayer announced that the FDA approved Jivi® (BAY94-9027, antihemophilic factor [recombinant] PEGylated-aucl) for the routine prophylactic treatment of hemophilia A in previously treated adults and adolescents 12 years of age or older.

Sunovion Pharmaceuticals announced that the FDA issued a Complete Response Letter for the NDA for dasotraline, a novel dual-acting dopamine and norepinephrine reuptake inhibitor (DNRI), for the treatment of attention-deficit hyperactivity disorder (ADHD).

Akcea Therapeutics an affiliate of Ionis Pharmaceuticals announced that they received a Complete Response Letter (CRL) from the FDA Division of Metabolism and Endocrinology Products regarding the NDA for WAYLIVRA™(volanesorsen).

The FDA said it would need an additional three months to make a decision on Roche’s Tecentriq in first-line lung cancer:

Novartis has received European approval for Kymriah, its gene-modifying therapy for blood cancer:

Trovagene announced that the European Commission (EC) has endorsed the positive opinion of the Committee for Orphan Medicinal Products (COMP) and has granted Orphan Drug Designation for Onvansertib for the treatment of patients with Acute Myeloid Leukemia (AML).

Recro Pharma plans to resubmit their NDA for IV meloxicam, a non-opioid pain medicine by the end of September:

In other news…

MannKind Corp entered into a $105 million collaboration agreement with United Therapeutics to use its tech to develop a dry powder formulation of the pulmonary arterial hypertension drug treprostinil.

LEO Pharma and Bayer announced the completion of the relevant closing conditions to allow the transfer of Bayer’s prescription dermatology business to LEO Pharma in the United States.

Theranos Inc., the blood-testing company accused of perpetrating Silicon Valley’s biggest fraud, will soon cease to exist.

GlaxoSmithKline is cutting 650 jobs as the pharma giant slowly looks to funnel more money to the R&D side of the business.

Akcea Therapeutics is laying off 10 percent of its workforce, a move that follows the FDA’s rejection of the company’s rare disease drug.

Novartis will sell off about 300 products from its Sandoz US division to Aurobindo Pharma for up to $1 billion

A FDA recruitment official said that the Trump administration restrictions on hiring those who have lived outside of the United States, has made it difficult for the agency to attract top talent.

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