Recon: FDA Approves Alexion’s Ultomiris and Stemline Therapeutics’ Elzonris

• FDA approves Alexion Pharma's rare blood disorder drug (Reuters)
• FDA approves Stemline Therapeutics' rare blood disease treatment (Reuters)
• After Sarepta, going after the genetic causes of epilepsies at Stoke (STAT)
• ICER says gene therapy may be more cost effective for spinal muscular atrophy (Endpoints) (STAT)
• In last-ditch move, lawmakers push to renew pandemic preparedness bill before end of year (STAT)
• Sen. Hatch to colleagues: Don’t let Trump tie drug prices to what other countries pay (STAT) (The Hill)
• Biotech billionaire Hiroshi ‘Mickey’ Mikitani doubles down on quest to build a pharma company, closing round at $284M (Endpoints)
• New details emerge about a stealth startup backed by Flagship Pioneering (STAT)
• CRISPR babies spur NIH director to call for public debate, new oversight (Washington Post)
• FDA approves new protocol for study on Bayer's birth control device (Reuters) (MassDevice)
• US Farm Bill opens door on hemp; FDA to consider new cannabis policy (Reuters) (CNBC) (FDA Law Blog) (Law360-$) (FDA)

• Canada ends a probe into three big drug makers accused of thwarting generic competition (STAT)
• Vertex and the UK government are at an impasse over a pricey cystic fibrosis drug — again (STAT) (BioCentury)
• Drugs group Perrigo hit with €1.64bn Irish back tax bill (Financial Times)
• Emma Walmsley, a fast-talker shaking up GSK (Financial Times)
• Indian regulator orders J&J to stop using raw material to make Baby Powder in India (Reuters)
• As Ebola threatens mega-cities, vaccine stockpile needs grow (Reuters)
• Sierra Leone fruit bats infected with Ebola-like Marburg virus (Reuters) (NBC)
• US to help South Korea get flu drugs to North despite stalled nuclear talks (Reuters)
• Novartis Oncology CEO steps down after 11 months (Pharmafile)
• Novartis seeks to acquire French CAR-T contract manufacturer (BioPharmaDive)

• Does the Gut Microbiome Ever Fully Recover From Antibiotics? (NYTimes)
• Gilbert Foundation to Pursue Gene Therapy for Neurofibromatosis (Xconomy)
• Aristea Therapeutics Raises $15M to Develop Anti-Inflammatory Drugs (Xconomy)
• Tesla loses former Gigafactory boss to start-up that makes 'designer molecules' for food and drugs (CNBC)
• CD36 plays a critical role in proliferation, migration and tamoxifen-inhibited growth of ER-positive breast cancer cells (Nature)
• Pharmaceutical Manufacturers Testing Use of Verification Router Services To Process Saleable Returns Under DSCSA (Pink Sheet-$)
• What’s The Plan? US FDA Drug Development Tool Qualification Process Requires “Cultural Change” (Pink Sheet-$)
• Cash, pipeline-rich Ionis gives COO Monia top job in 2020, as founder and chief Crooke transitions to board chairman (Endpoints)
• Boehringer offloads an mTOR cancer drug as Xynomic plots a quick advance in the clinic (Endpoints)
• NeuClone announces its sixth biosimilar candidate of pertuzumab (BiosimilarNews)
• Study finds elevated risk of certain rare blood cancers after chemotherapy for most solid tumors (NIH)
• Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP (FDA)
• Labeling of Red Blood Cell Units With Historical Antigen Typing Results; Guidance for Industry; Availability (FDA)

• Jazz gets new PDUFA date for drug for excessive sleepiness (Seeking Alpha)
• Incyte Announces First Patient Treated in Phase 3 Clinical Trial Program for Ruxolitinib Cream in Atopic Dermatitis (Press)
• Merck Provides Update on KEYTRUDA® (pembrolizumab) Supplemental Biologics License Application (sBLA) for KEYNOTE-042 Trial (Press)
• Pfizer discontinues Staphylococcus aureus vaccine trial due to futility (PharmaLetter-$) (Press)
• Kodiak Sciences Announces Completion of 12-Week Phase 1a Study of KSI-301 in Patients with Diabetic Macular Edema Demonstrating Safety and Durability of Responses Following Single Dose of Intravitreal Anti-VEGF Antibody Biopolymer Conjugate (Press)
• Transgene Completes Safety and Tolerability Assessment of TG4001 in Combination with Avelumab in Phase 1b Part of Trial in HPV-Positive Cancer Patients (Press)

• NIH-developed test detects protein associated with Alzheimer’s and CTE (NIH)
• Novartis unit Alcon picks up Tear Film Innovations (MassDevice)
• Cepheid HBV Viral Load Test Gets CE-IVD Clearance (GenomeWeb)
• Becton Dickinson Gets FDA Clearance for Enteric Viral Panel (GenomeWeb)
• GenMark Diagnostics Receives FDA Clearance for ePlex BCID Gram-Positive Panel (GenomeWeb)
• Avinger touts preliminary Pantheris OCT vascular imaging analysis data (MassDevice)
• Reprieve Cardiovascular touts early ADHF therapy study data (MassDevice)
• Determination of Regulatory Review Period for Purposes of Patent Extension; ABSORB GT1 BIORESORBABLE SCAFFOLD (FDA)
• Bovie Medical Corporation Files 510(k) Submission with the FDA for a New Indication to Market and Sell J-Plasma/Renuvion for Use in Dermal Resurfacing Procedures (Press)
• CathWorks FFRangio™ System Receives U.S. FDA Clearance (Press)

• Shutdown is looming, and so are FDA furloughs (Politico)
• Purdue Says Texas Can't Slip Out From Opioid MDL (Law360-$)
• Healthcare providers should be ready for nerve agent attacks, experts say (Reuters)
• Juul now has '800-pound gorilla' to fight FDA, experts warn (NBC)
• Rotten Tomatoes − The Worst Prescription Drug/Medical Device Decisions of 2018 (Drug & Device Law)

• FDA Advisory Committee Calendar

• Fabian +nCPAP evolution, Fabian Therapy evolution and Fabian HFO – Risk of total loss of patient ventilation (MDA/2018/037) (MHRA)

• Singapore court dismisses Singh brothers' appeal against Daiichi Sankyo's arbitration award (Economic Times)
• Chugai broadens label for Hemlibra in Japan (PharmaLetter-$)

• Aurobindo Pharma to launch potassium chloride pills in US (Economic Times)
• Sun Pharma arm gets USFDA nod for epilepsy drug (Economic Times)
• CDSCO tightens safety & labelling rules for acne drug isotretinoin, prescription mandatory (Pharmabiz)
• Pharma industry upset with govt’s hike in fee for drug licenses, but welcomes import duty hike (Pharmabiz)
• Maha FDA urges CDSCO to place intraocular lenses under NLEM to prevent overcharging (Pharmabiz)

• Australian TGA Explains Reasons Behind 2019 Fee Increases (Pink Sheet-$)
• Review of the Narcotic Drugs Act 1967 - Public meetings (TGA)
• Medicine shortages/discontinuations - Electronic notification form: User guide (TGA)
• TGA statement on Allergan breast implant withdrawal in Europe (TGA)
• Breast implant associated cancer (or BIA-ALCL) (TGA)

• Caribbean Court Sides With Sinovac In Board Dispute (Law360-$)