Recon: Novartis, Gilead CAR-T Therapies Win Swiss Coverage; FDA Reviewers Express Concerns About Correvio Heart Drug Ahead of Advisory Panel

• FDA Is Green-Lighting Drugs at Breakneck Speed and Raising Alarm (Bloomberg)
• FDA declines to approve Enzyvant regenerative therapy on manufacturing concerns (Reuters) (Fierce) (STAT)
• Correvio slumps after FDA staffers say benefits of heart drug do not outweigh risks (Reuters)
• Activists seek to block a Gilead patent extension on a lucrative HIV drug (STAT)
• Biogen Has More Hope Than Data for Alzheimer’s Drug (Bloomberg) (Financial Times) (Reuters) (Endpoints)
• Biohaven Pharma to continue late-stage study of Alzheimer's treatment (Reuters) (Press)
• The future of Ipsen’s new $1.3B drug is in doubt as safety fears force the FDA to slam the brakes on late-stage studies (Endpoints) (Fierce)
• FDA approves generic versions of Novartis blockbuster MS treatment (Reuters) (Endpoints) (FDA)
• McConnell, Grassley at odds over Trump-backed drug bill (The Hill)
• FDA approves Amgen's biosimilar to J&J's rheumatoid arthritis drug (Reuters) (Big Molecule Watch)

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• Swiss approve insurance cover for Novartis, Gilead cell therapies (Reuters)
• UniQure Aiming To Be First With Hemophilia B Gene Therapy (Scrip-$)
• Full approval for Eisai’s Lenvima in Japan (PharmaLetter)
• UCB buffs up in blockbuster psoriasis race as bimekizumab beats Humira in head-to-head (Endpoints) (Press)
• WHO decries 'collective failure' as measles kills 140,000 (Reuters)

• More hospital drug spending is going toward cancer immunotherapies (STAT)
• Veritas, genetics company founded by George Church, suspends US operations (STAT)
• Anti-vaccine groups take dangerous online harassment into the real world (NBC)
• We're not for sale, Alexion executives declare (BioPharmaDive)
• Cancer gene therapy backed by Blackstone gets trial win (BioPharmaDive)
• Biosimilars: US FDA Considering ‘Guardrails’ To Prevent Misinformation (Pink Sheet-$)
• Safety Problems Lead To Early End For Study Of 'Abortion Pill Reversal' (NPR)
• Tufts Removes Sackler Name Over Opioids: ‘Our Students Find It Objectionable’ (NYTimes)
• Innovative Trial Designs Are 'Life And Death Matter' For Pharma, Amgen Tells US FDA (Pink Sheet-$)
• On the heels of a PhIII implosion, cancer biotech Mologen is turned over to the liquidator (Endpoints)
• Black Diamond raises another $85M to bring new oncogene approach into clinic (Endpoints)
• Opinion: My wife’s life is priceless. But her chemotherapy drugs are too expensive (LA Times)
• A tiny pill saved my life, but at $180,000 a year (SF Chronicle)
• Bristol-Myers Squibb and Acceleron Pharma Provide Update on FDA Advisory Committee for Reblozyl® (luspatercept-aamt) (Press)
• One of Wall Street’s most high-profile hedge funds pushes Alexion's CEO to the auction block — and he's not budging (Endpoints)
• Ex-Celgene exec Terrie Curran puts her Phathom team in place; Caraway taps Martin Williams as CEO (Endpoints)

• With FDA review of its gene therapy underway, Ferring's $570M spinout delivers in PhIII bladder cancer readout (Endpoints)
• With EMA review in progress, Novartis unveils more positive data on asthma therapy (Endpoints)
• Enteris BioPharma's Licensing Partner, Cara Therapeutics, Announces Top Line Data from Phase 2 Trial of Peptelligence®-Engineered Oral KORSUVA™ for the Treatment of Pruritus in Patients with Advanced Chronic Kidney Disease (CKD) (Press)
• BioArctic's Partner Eisai Presents Data from the Ongoing BAN2401 Phase 2b Extension Study in Early Alzheimer's Disease (Press)
• FerGene Announces Pivotal Phase 3 Study of Nadofaragene Firadenovec Met Its Primary Endpoint With More Than Half of Patients With High-Grade Non-Muscle Invasive Bladder Cancer (CIS ± Ta/T1) Achieving a Complete Response at Three Months (Press)
• EIP Pharma Announces Presentation of Phase 2b Clinical Trial Results of Neflamapimod in Early-stage Alzheimer's Disease at Clinical Trials in Alzheimer's Disease (CTAD) meeting (Press)
• Curis Announces Positive Safety, Tolerability and Pharmacokinetic Data in Ongoing Phase 1 Study of Fimepinostat in Combination with Venetoclax (Press)
• Rocket Pharmaceuticals Announces First Patient Treated in Global Registrational Phase 2 Study of RP-L102 “Process B” for Fanconi Anemia (Press)
• Innovent Announces First Patient Dosed in Phase I Clinical Trial of Anti-LAG-3 Monoclonal Antibody in China (Press)

• EPA wants more data from ethylene oxide sterilizers, strikes device-friendly tone (MedtechDive)
• CryoLife wins CE Mark for E-nya thoracic stent graft (MassDevice)
• Vicarious' surgical robot gets FDA breakthrough status (MedtechDive)
• Boston Scientific afib device effective in reducing stroke (MedtechDive)
• Establishment Labs' breast implant opportunity to triple: Jefferies (MedtechDive)
• 3DBio Therapeutics wins FDA rare pediatric disease designation for outer ear reconstruction (MassDevice) (Press)

• Health Spending Grew Modestly, New Analysis Finds (NYTimes) (Reuters)
• The difficulty of number crunching on the Pelosi plan (Politico)
• New York doctor convicted of taking kickbacks from opioid maker Insys (Reuters)
• Scrutiny Of Patient Assistance Program Funding Is Rising (Law360-$)
• Trump tried to end Azar, Verma dispute (Politico)
• New Leader To Take Over At Bill & Melinda Gates Foundation, The Country’s Largest Private Foundation (Forbes) (Endpoints)
• FTC Stops Marketers from Making False Arthritis Treatment Claims (FTC)
• Statute That Overturned Weeks Actually Overturned Weeks (Drug & Device Law)

• FDA Advisory Committee Calendar

• Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 3-5 December 2019 (EMA)

• US flu season off to its earliest start in more than 15 years (STAT)
• US vaping-related deaths rise to 48, cases of illness to 2,291 (Reuters)
• Brief visit to severely polluted city can up biomarkers of heart disease (Reuters)