Top Regulatory News Stories – Week Ending September 28, 2018

Verastem announced that the U.S. FDA has approved COPIKTRA for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after at least two prior therapies. https://www.marketwatch.com/press-release/verastem-oncology-receives-fda-approval-of-copiktratm-duvelisib-capsules-2018-09-24

Eli Lilly announced that the FDA has approved Emgality (galcanezumab-gnlm 120 mg injection) for the preventive treatment of migraine in adults. https://www.nasdaq.com/article/fda-approves-lillys-emgality-for-preventive-treatment-of-migraine-in-adults-20180927-01236

Pfizer Inc.  announced that the FDA has approved VIZIMPRO (dacomitinib), a kinase inhibitor for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR). https://www.businesswire.com/news/home/20180927005974/en/U.S.-FDA-Approves-VIZIMPRO%C2%AE-dacomitinib-First-Line-Treatment

Cidara Therapeutics announced that the FDA has granted both Qualified Infectious Disease Product (QIDP) and Fast Track designations for the company’s prophylaxis (prevention) development program for lead antifungal product candidate, rezafungin for injection. https://www.businesswire.com/news/home/20180925005181/en/FDA-Grants-QIDP-Fast-Track-Designations-Cidara

CytoSen Therapeutics announced it has received a favorable response from the FDA to its pre-IND meeting package for the proposed Phase 2 trial of CytoSen’s adoptive NK cell therapy: https://www.businesswire.com/news/home/20180927005156/en

The FDA lifted a clinical hold on Sarepta’s Duchenne MD gene therapy, clearing the way to a quick launch of a pivotal trial. https://endpts.com/fda-lifts-clinical-hold-on-sareptas-dmd-gene-therapy-clearing-the-way-to-a-quick-launch-of-a-pivotal-trial/?utm

Epizyme is reporting that the FDA has lifted the partial hold it imposed on their clinical trial work for the lead drug tazemetostat, but it has some work yet to do before it gets all the studies back on track.  https://endpts.com/fda-gives-epizyme-a-green-light-on-trial-recruitment-but-tazemetostat-isnt-out-of-the-woods-yet/

Alnylam announced positive interim data from a trial of another gene-silencing treatment on Thursday and said it hopes to file with the FDA for accelerated approval of the drug, givosiran, likely by the end of the year. https://www.statnews.com/2018/09/27/alnylam-second-gene-silencing-drug/

FDA Commissioner Scott Gottlieb on Wednesday defended the agency’s approach to regulating digital health apps following the de novo classification and clearance of two software applications that add atrial fibrillation detection capabilities to the Apple Watch 4. https://www.raps.org/news-and-articles/news-articles/2018/9/gottlieb-defends-digital-health-approach?feed=Regulatory-Focus

In a letter to manufacturers of pen needles designed to be used with injectors, the FDA’s Center for Devices and Radiological Health (CDRH) called for labeling updates to address the adverse events associated with improper patient use. https://www.raps.org/news-and-articles/news-articles/2018/9/cdrh-requests-labeling-changes-on-certain-pen-need?feed=Regulatory-Focus

In other news…

Alexion Pharmaceuticals announced it will acquire Syntimmune, paying $400 million upfront and lining up to $800 million in milestone payments.  https://www.biopharmadive.com/news/alexion-to-buy-syntimmune-in-potential-12b-deal/533280/

Novartis has outlined plans to cut or move about 2,600 more jobs in Switzerland in another wave of global restructuring.  https://endpts.com/chopping-close-to-home-novartis-outlines-plans-to-ax-or-move-about-2600-more-jobs-in-another-wave-of-global-restructuring/

Geron reported that J&J has decided to end their collaboration on Geron’s late-stage program imetelstat:  https://endpts.com/jj-has-decided-pharma-giant-dumps-its-development-deal-on-gerons-imetelstat/

Novo Nordisk will cut around 250 jobs in the United States, a spokesman told Reuters on Friday, adding the drugmaker would also hire an as-yet undetermined number of staff to new positions. https://www.reuters.com/article/us-novo-nordisk-layoffs/novo-nordisk-to-cut-250-jobs-in-the-united-states-idUSKCN1M81FA

Gritstone Oncology had a successful IPO, reaping a $100 million windfall after upsizing its batch of shares and pricing its IPO on the high end of the range. https://endpts.com/gritstones-top-of-the-range-ipo-brings-weeks-biotech-nasdaq-tally-to-520m/

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   You can also visit us on LinkedIn at https://www.linkedin.com/company/dennis-partners/

 

 

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