Recon: FDA Approves Bavarian Nordic Vaccine for Monkeypox and Smallpox

• America is pharma's piggybank (Axios)
• FTC warns lawyers about deceptive ads for generating lawsuits over drug side effects (STAT)
• NIH funds centers for advancing the reference sequence of the human genome (NIH)
• Bayer to invest in Boston lab focused on chronic lung conditions (STAT)
• FDA approves Bavarian Nordic's monkeypox vaccine (Reuters) (Endpoints) (FDA)
• Genital herpes vaccine candidate heads for human studies (PMLive)
• Novartis' SMA gene therapy Zolgensma could struggle to hit blockbuster territory: report (Fierce)
• Nicotine patch pioneer says vaping needs to come through the FDA ‘front door’ like we did (CNBC)
• CDC expects hundreds more cases of vaping-related illness (Reuters)
• Arthritis group offers first guidelines for patients who use CBD for joint pain (NBC)
• Minnesota GOP legislator touts $25 insulin at Walmart; diabetics say it has drawbacks (Star Tribune)
• Startups are selling you pills through Instagram. Why don’t they say which ones? (Vox)

• Regulators throw up another hurdle to Roche’s $4.3B Spark acquisition as questions percolate over hemophilia market domination (Endpoints)
• European biotech firm BioNtech plans to raise nearly $304 million in U.S. IPO (Reuters)
• Aurobindo cofounder faces $3M fine for insider trading before Pfizer deal (Fierce)
• Biosim-focused Biocon picks up Pfizer R&D site in India with plans to employ 250 (Fierce)
• Gov't announces 'no deal' protection for UK nationals in EU (PharmaTimes)
• EMA Explains How To Use Electronic Devices For Direct Trial Data Capture (Pink Sheet-$)
• Celltrion Will Sell World's First Subcutaneous Infliximab Directly In Europe (Scrip-$)

• Novartis Blames Zolgensma Data Manipulation on Two Fired Senior Executives (Focus)
• FDA Compiles List of NDAs Transitioning to BLAs Next March (Focus)
• FDA Delays Verification Requirement for Salable Returned Drugs (Focus)
• Startup EPM launches, high off cannabinoid acid innovation (Endpoints)
• Novo's Rybelsus, check. Here are the major launches coming up next (Fierce)
• Greenleaf Health Expands Services to Support Cell & Gene Therapy (Press)
• Sygnature Discovery moves U.S. office to life science mecca Kendall Square (Fierce)
• Quiet biotech Amphivena nabs $62M funding round (Fierce)
• Merck, Pfizer execs explain how they tap sites for cancer trials (BioPharmaDive)
• Gene Therapy Shows Promise Repairing Brain Tissue Damaged by Stroke (NIH)
• Placebo-drug mix-up adds subplot to Helixmith phase 3 failure (Fierce)
• Reducing Pain Patients' Opioid Doses an Ongoing Challenge (Medpage)
• New Biologic-Device Combos Could Cut Costs, But Pose Reg Challenges (IHP-$)
• All hormonal birth control should be available over the counter, OB-GYN group says (NBC)
• Alder's migraine drug attracted plenty of dealmakers. The company, not so much (BioPharmaDive)
• Cerevel plots first late-stage move as Pfizer drug comes through in PhII Parkinson's trial (Endpoints)
• Opana IR Pediatric Labeling Supplement Faces US FDA Panel Review (Pink Sheet-$)
• Boehringer Ingelheim backs Max Planck spinout in taking a shot at tough class of cancer targets (Endpoints)
• Bay Area biotech hauls in $62M to pay the freight on early-stage CD33/CD3 T cell engager (Endpoints)
• UroGen steers towards its first commercial drug launch, armed with strong data on lead therapy (Endpoints)
• Eli Lilly dishes out first milestone payment for Alzheimer's deal; ADC Therapeutics, Viela Bio set terms for IPO (Endpoints)
• Coming out of Chapter 11, Aegerion jumps into welcome arms of Irish pharma with big plans, fresh $60M for its drugs (Endpoints)
• Hansa Biopharma Confirms Follow-up Meeting With FDA (Press)
• B. Braun Medical Inc. Issues Voluntary Nationwide Recall of one lot of one catalog item number of an Infusomat® Space Volumetric Infusion Pump Administration Set, Due to Potential Leakage (FDA)
• Recommendations for Sponsors of Medically Important Antimicrobial Drugs Approved for Use in Animals to Voluntarily Bring Under Veterinary Oversight All Products That Continue To Be Available Over-the-Counter; Draft Guidance for Industry; Availability (FDA)

• Amgen Announces Positive Results From Two Phase 3 BLINCYTO® (blinatumomab) Studies In Pediatric Patients With Relapsed Acute Lymphoblastic Leukemia (Press)
• Urovant Sciences’ vibegron meets Ph III goals (Pharmaletter-$)
• Hypoglycemia 'Epipen' clears Phase III, hurtles toward FDA decision (Endpoints)
• Cumberland Pharmaceuticals Announces FDA Orphan Drug Grant Award For New Phase II Clinical Program (Press)
• Tetraphase Pharmaceuticals to Present XERAVA™ (Eravacycline) Data at IDWeek 2019 (Press)
• Pierre Fabre to Present New Data from its Oncology Portfolio at the ESMO Annual Congress (Press)
• Glenmark Has An Orphan Ahead of Innovation Capital Raising Plan (Scrip-$)

• RAPS recap: Compliance issues for compiling Clinical Evaluation Reports (Emergo)
• FDA device head Shuren talks about getting to 2-week 510(k) reviews (Fierce)
• US FDA advances conformity assessment accreditation pilot program (Emergo)
• Pediatric biofeedback video game maker Mightier lands additional $250,000 (mobihealthnews)
• Enzo Clinical Labs Gets NY State Approval for HBV Assay (GenomeWeb)

• Second Appalachian Region Prescription Opioid Strikeforce Takedown Results in Charges Against 13 Individuals, Including 11 Physicians (DoJ) (Statement)
• Animal Use In Research: Federal Agencies Should Assess and Report on Their Efforts to Develop and Promote Alternatives (GAO)
• Broad Institute Takes Its Turn in Interference Motion Practice (Patent Docs)
• Petition for Formal Rule re Made in USA Claims (FDA Law Blog)
• Meet The Health Officials Who Alerted The World To The Alarming Vaping Illness (KHN)
• At Raucous Hearing, No Unity On Vaping Issues (KHN)
• Massachusetts imposes four-month ban on vaping product sales as mystery illness spreads (Reuters)
• CRO Does Not Have Same Rights As Sponsor, Court Says In Tossing Semler Suit Against US FDA (Pink Sheet-$)
• Shameless Plug: ACI Drug & Device Conference (December 10 – 11) (Drug & Device Law)
• J&J Unit Escapes Suit Over Breast Implant Warnings (Law360-$)
• Abilify MDL Judge Boots 149 Claimants From Settlement (Law360-$)

• FDA Advisory Committee Calendar

• MHRA Clarifies Licensing Status of Avastin for Intravitreal Administration (Focus)
• Labour Party takes aim at pharma, calls attention to Orkambi row (PMLive)
• Supply problems with total parenteral nutrition (TPN) bags – Calea UK site in Runcorn, Cheshire (MHRA)

• Asia Regulatory Roundup: TGA Adopts Risk-Based Model for Fecal Microbiota Transplants (Focus)
• OrbusNeich® Announces Japan Approval for COMBO® Plus Coronary Stent (Press)
• China Biologic Committee To Weigh $4.59B Take-Private Bid (Law360-$)

• Delegate-only final decisions and reasons: NCEs, September 2019 (TGA)

• WHO Takes On The Opioid Conundrum (Pink Sheet-$)