Top Regulatory Affairs News Stories – Week Ending August 25, 2017

There were a few new approvals this week, plus some new FDA guidances. Here are the top regulatory stories for you to follow this week…

Ironwood Pharmaceuticals announced FDA Approval of DUZALLO (Lesinurad And Allopurinol) for the treatment of hyperuricemia in patients with uncontrolled gout.

Adamas Pharmaceuticals reported that the FDA has approved GOCOVRI (amantadine) extended release capsules (previously ADS-5102) for treatment of dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy.

AstraZeneca and Merck have secured approvals from the FDA to expand the indication for their newly formulated Lynparza to cover a broader group of women suffering from ovarian cancer.

Alexion Pharmaceuticals announced that the European Commission (EC) approved the extension of the indication for Soliris (eculizumab) to include the treatment of refractory generalized myasthenia gravis in adults who are anti-acetylcholine receptor antibody-positive.

Octapharma USA said the FDA has approved new product strengths for NUWIQ Antihemophilic  Factor for Hemophilia A patients. NUWIQ was initially approved by FDA in 2015.

Intra-Cellular Therapies reported a positive update on their schizophrenia program lumateperone and indicated that they will be preparing for an NDA submission by mid-2018:

Roche’s experimental hempohilia treatment emicizumab took a step closer toward winning U.S. approval, securing a Feb. 23 decision date from FDA

Syros Pharmaceuticals announced that the FDA has granted orphan drug designation to SY-1425 for the treatment of acute myeloid leukemia (AML).

Jupiter Orphan Therapeutics has received notification from the FDA that its Orphan Drug Designation request for trans-Resveratrol has been granted.

Epygenix Therapeutics has secured orphan drug status from the FDA for its EPX-300 to treat patients with Dravet Syndrome.

FDA has determined that Organogenesis, Inc. has failed to meet the postmarketing requirement of the Pediatric Research Equity Act (PREA) for its BLA for Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen (GINTUIT).

Cardiome Pharma received a response from the FDA indicating that that their new data package would not be sufficient to support a resubmission of the BRINAVESS® NDA.

The UK Medicines and Healthcare products Regulatory Agency has cleared Seqirus’s  adjuvanted trivalent influenza vaccine Fluad for use in people aged 65 years or older.

VBI Vaccines Inc. announced that the FDA has accepted their IND for VBI-1901, a novel immunotherapy targeting Glioblastoma Multiforme (GBM), one of the most common and aggressive malignant primary brain tumors in humans.

Altimmune, Inc. announced that it submitted an IND application to the FDA for NasoVAX, their intranasally administered recombinant flu vaccine.

The FDA has released draft guidance ahead of the first of a series of public meetings to help companies meet the drug distribution security provisions of the Drug Supply Chain Security Act (DSCSA) of 2013.

The FDA has also laid out the process by which doctors can access an investigational drug for treatment in an individual patient in an emergency situation, both during and after normal business hours in a new Manual of Policies and Procedures.

FDA said it will revise previously issued draft guidance on the pre-submission of certain information for ANDAs.

Also this week, CDER and OAR detailed plans for more efficient inspections and facility evaluations:

 In other news

Samsung Bioepis has signed collaboration agreement with Takeda Pharmaceutical to jointly fund and co-develop multiple novel biologic therapies in unmet disease areas.

After nearly a year and three term revisions, Accelerated Pharma is pulling its initial public offering.

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