Top Regulatory News Stories – Week Ending September 15, 2017

Here are the top regulatory news stories this week:

The FDA approved Amgen’s biosimilar to Roche’s cancer treatment Avastin (bevacizumab). Amgen’s biosimilar was approved under the brand name Mvasi (bevacizumab-awwb):

FDA commissioner Scott Gottlieb announced Tuesday that the agency will release guidance to close a loophole that allows companies to avoid their obligation to study pharmaceuticals in pediatric populations.

Tesaro announced that European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) is recommending that Zejula be approved as a maintenance treatment for ovarian cancer patients who had previously responded to platinum-based therapy.

 Checkpoint Therapeutics announced that the FDA has granted Orphan Drug Designation to CK-101 (also known as RX518), the company’s third-generation epidermal growth-factor receptor inhibitor, for the treatment of EGFR mutation-positive non-small cell lung cancer.

Reata Pharmaceuticals announced that the FDA has granted orphan designation to omaveloxolone for the treatment of Stage IIb through IV malignant melanoma.

The FDA has cleared a backlog of roughly 200 orphan drug requests and Commissioner Scott Gottlieb  also unveiled new measures for preventing requests from piling up in the future.

An FDA advisory committee has recommended the approval of GSK’s Shingrix vaccine for the prevention of herpes zoster (shingles) in adults aged 50 years and over.

In other news…

Genentech announced that its lampalizumab failed to meet its primary endpoint in a Phase III trial for geographic atrophy (GA) due to age-related macular degeneration (AMD)

AbbVie said on Monday two patients died in a late-stage trial of its rheumatoid arthritis drug but that the deaths were not linked to the drug, which met the study’s main goals.

Kura Oncology reported it had hit the mark in a phase 2 trial of lead drug tipifarnib in head and neck cancer—before the study was fully enrolled.

Boehringer Ingelheim and Gubra announce a collaboration and license agreement for the development of novel peptide compounds to treat obesity.

Alexion Pharmaceuticals is cutting about 600 jobs and moving its headquarters from New Haven, Connecticut, to Boston. The move is part of the company’s plan to restructure and reduce costs

Amicus Therapeutics said it would no longer invest in clinical trials of its drug for healing wounds after the experimental treatment failed a late-stage trial.

Otonomy reported that it is cutting 33% of its staff after their Phase 3 trial for Meniere’s Disease failed:

Inotek Pharmaceuticals announced that it has entered into a definitive merger agreement with US-based gene therapy company Rocket Pharmaceuticals.

Halozyme Therapeutics entered into a pair of licensing deals for its drug delivery technology:

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