Top Regulatory News Stories – Week Ending November 8, 2018

The US FDA has approved AcelRx Pharmaceuticals’ DSUVIA, despite abuse concerns. DSUVIA is indicated for the management of acute pain in adults that is severe enough to require an opioid analgesic in certified medically supervised healthcare settings, such as hospitals, surgical centers, and emergency departments.

Coherus BioSciences announced that the FDA has approved UDENYCA™ (pegfilgrastim-cbqv), the first pegfilgrastim biosimilar approved by both the FDA and the European Commission (EC) for patients with cancer receiving myelosuppressive chemotherapy.  UDENYCA™ is Coherus’ first drug to receive FDA or EC approval.

Trevena, Inc. announced that it has received a Complete Response Letter from the FDA regarding the New Drug Application for oliceridine.

Kala Pharmaceuticals announced that it has submitted a NDA to the FDA for KPI-121 0.25%, a topical product candidate for the temporary relief of signs and symptoms of dry eye disease.

Heron Therapeutics announced the submission of its NDA to the FDA for HTX-011, an investigational, long-acting, extended-release formulation of the local anesthetic bupivacaine in a fixed-dose combination with the anti-inflammatory meloxicam for the management of postoperative pain.

An FDA advisory committee voted 17-1 in favor of Sage Therapeutics’s experimental treatment for postpartum depression, Zulresso, saying the benefits of the drug outweighed risks.

SpringWorks Therapeutics announced that the FDA has granted Orphan Drug designation for PD-0325901, an investigational, oral, small molecule selective inhibitor of MEK1 and MEK2, for the treatment neurofibromatosis type 1.

Partner Therapeutics announced that the FDA has granted orphan drug designation to Leukine (sargramostim), a yeast-derived recombinant human granulocyte-macrophage colony stimulating factor (rhu-GM-CSF), for the treatment of pulmonary alveolar proteinosis (PAP).

Rocket Pharmaceuticals announced the FDA clearance of their IND application for RP-L102, the Company’s lentiviral vector (LVV)-based gene therapy for the treatment of Fanconi Anemia.

With the FDA expected to run out of National Drug Code (NDC) numbers in the next decade, the agency is now exploring options for how to amend the code:

In other news…

Merrimack Pharmaceuticals will lay off more than half of its employees as part of a restructuring plan that will also end research on its leading drug candidate.

Achaogen will be making another round of staffing cuts in order to stay afloat:

Bristol-Myers has laid off the last 63 staffers at ZymoGenetics this week and shuttered the Seattle operations.

IRX Therapeutics announced that the company’s assets have been acquired by the newly formed Brooklyn ImmunoTherapeutics LLC.

Trevena Inc. is reducing its workforce by approximately one-third and is undertaking additional cost saving initiatives that in total are expected to save more than $3.5 million a year.


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