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. https://www.biospace.com/News/ironwood-announces-fda-approval-of-duzallo/466949/source=MoreNews
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. http://ir.adamaspharma.com/releasedetail.cfm?ReleaseID=1038209
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. http://www.pharmaceutical-business-review.com/news/astrazeneca-merck-get-fda-approval-for-expanded-use-of-ovarian-cancer-drug-210817-5904965
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. http://regulatoryaffairs.pharmaceutical-business-review.com/news/european-commission-grants-new-indication-for-soliris-to-treat-refractory-generalized-myasthenia-gravis-220817-5905965
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. http://www.businesswire.com/news/home/20170822005087/en/
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: http://globenewswire.com/news-release/2017/08/23/1091441/0/en/Intra-Cellular-Therapies-Announces-Positive-Regulatory-Update-On-Schizophrenia-Program.html
Roche’s experimental hempohilia treatment emicizumab took a step closer toward winning U.S. approval, securing a Feb. 23 decision date from FDA http://www.biopharmadive.com/news/roche-emicizumab-february-23-pdufa-hemophilia-novo-shire/503405/
Syros Pharmaceuticals announced that the FDA has granted orphan drug designation to SY-1425 for the treatment of acute myeloid leukemia (AML). https://www.firstwordpharma.com/node/1498256
Jupiter Orphan Therapeutics has received notification from the FDA that its Orphan Drug Designation request for trans-Resveratrol has been granted. https://www.firstwordpharma.com/node/1498672
Epygenix Therapeutics has secured orphan drug status from the FDA for its EPX-300 to treat patients with Dravet Syndrome. http://processandproduction.pharmaceutical-business-review.com/news/epygenix-gets-fda-orphan-drug-status-for-epx-300-to-treat-dravet-syndrome-240817-5908023
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). http://www.raps.org/Regulatory-Focus/News/2017/08/18/28275/FDA-Singles-Out-Biologics-Company-for-Failing-to-Meet-Pediatric-Study-Requirement
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. http://www.newswire.ca/news-releases/cardiome-provides-us-regulatory-update-for-brinavess-641269743.html
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. http://www.pharmatimes.com/news/new_flu_vaccine_approved_for_uk_use_1202786
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. https://www.vbivaccines.com/wire/gbm-program-fda-ind/
Altimmune, Inc. announced that it submitted an IND application to the FDA for NasoVAX, their intranasally administered recombinant flu vaccine. https://globenewswire.com/news-release/2017/08/21/1090573/0/en/Altimmune-Submits-Investigational-New-Drug-Application-for-NasoVAX-in-Preparation-for-Phase-2-Trial.html
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. http://raps.org/Regulatory-Focus/News/2017/08/21/28284/FDA-Offers-Draft-Guidance-to-Further-Secure-Drug-Supply-Chain/
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. http://raps.org/Regulatory-Focus/News/2017/08/18/28276/FDA-Explains-Emergency-Expanded-Access-Application-Process
FDA said it will revise previously issued draft guidance on the pre-submission of certain information for ANDAs. http://raps.org/Regulatory-Focus/News/2017/08/22/28293/FDA-to-Revise-Pre-Submission-Draft-Guidance-Due-to-GDUFA-II
Also this week, CDER and OAR detailed plans for more efficient inspections and facility evaluations: http://raps.org/Regulatory-Focus/News/2017/08/24/28310/FDA-Details-Plans-for-More-Efficient-Inspections-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. http://drugdiscovery.pharmaceutical-business-review.com/news/samsung-bioepis-takeda-to-co-develop-multiple-novel-biologic-therapies-210817-5904988
After nearly a year and three term revisions, Accelerated Pharma is pulling its initial public offering. http://www.fiercebiotech.com/biotech/accelerated-pharma-puts-brakes-ipo
This is a weekly recap of selected industry news stories. You can read other additional blogs, see our recent job postings and learn more about us at www.dennispartners.com