Recon: Novo Wins US Approval for Oral Semaglutide; FDA AdComm to Review Accelerated Approval for Amag's Makena

• FDA approves oral diabetes drug from Novo Nordisk (Reuters) (Endpoints) (FDA) (Press)
• Novo Nordisk targets bigger slice of diabetes market with new tablet (Reuters)
• Statement on continued efforts to increase availability of all forms of naloxone to help reduce opioid overdose deaths (FDA)
• Generic makers claim Medicare Part D plans crowd them out, hurting seniors (STAT)
• FDA proposes rule over record-keeping for vape makers (Reuters) (FDA)
• Senators urge FDA to remove pod, cartridge-based e-cigarettes from market (Reuters)
• Can Trump get a drug-price deal? (Politico)
• The top drugs facing cuts under Pelosi's pricing plan (BioPharmaDive)
• To speed development, Mass. General to begin ALS trials that test several drugs at once (STAT)
• Sun Pharma shipped medicines into Alabama for two years without a permit (STAT)
• Senate Committee Advances Appropriations Bill With $80M Increase for FDA (Senate Appropriations)

• WHO signals alarm over possible unreported Ebola cases in Tanzania (STAT) (Reuters)
• Congo to deploy second Ebola vaccine (Reuters)
• EU tumor agnostic nod for Bayer's Vitrakvi (PharmaTimes)
• Aid group says WHO is restricting access to Ebola vaccines in Congo (Reuters)
• Health care investment needed to curb out-of-pocket spending: WHO (Reuters)
• NHS antidepressant suppliers admit to illegally sharing data (Financial Times)
• African scientists seek slice of global pharmaceutical industry (Financial Times)
• Drones deployed in Africa’s ‘leapfrog’ vaccine drive (Financial Times)
• Dr. Reddys halts worldwide supply of Ranitidine until FDA probe over (LiveMint)
• Drug Suppliers Admit To UK Market Fixing, Watchdog Says (Law360-$)
• Longer Medicine Supply Delays Expected In No-Deal Brexit (Pink Sheet-$)
• Understanding the opportunity in Japan’s biosimilar market (McKinsey)
• EMA's CHMP Recommends Three New Medicines (Focus)

• Amid Woodford debacle, Immunocore cuts valuation as it secures $74M from General Atlantic — report (Endpoints)
• FDA Guidance on New Opioids Roasted at Hearing (Medpage)
• Roche to present new data from its broad oncology portfolio at the European Society for Medical Oncology 2019 Congress (Press)
• FDA Consults on Abuse-Deterrent CNS Stimulants (Focus)
•  Bristol-Myers Squibb Company Announces Extension of the Expiration Date for Exchange Offers for Celgene Corporation Notes (Press)
• A long suffering Clovis makes a leap into radiopharmaceuticals, paying $12M in cash to beef up the pipeline (Endpoints)
• Gene therapy startup Passage Bio nabs Janssen neuro lead as CMO (Fierce)
• France’s Innate Pharma eyes $100m Nasdaq IPO (PMLive)
• Next-generation regulatory T cell therapy (Nature)
• Amid a political firestorm over pharma's pricing, net prices actually fell last quarter: report (Fierce)
• New Flagship biotech wants to unleash your genome (Endpoints)
• Genentech submits a big plan to expand its South San Francisco footprint (Endpoints)
• Drugmaker Amag Under Pressure From Activist Investors (Law360-$)
• US Setback For Lupin’s GxProAir But Application Has 'Moved Ahead' (Scrip-$)
• Vaccine Biomarkers: Don't Put Cart Before Horse When Designing Studies, US FDA Advises (Pink Sheet-$)
• Nimbus hires Loh from Kymera to lead biology team (Fierce)
• Humana CEO: Competition and innovation lower drug prices better than just putting a cap on them (CNBC)
• At Amazon’s PillPack pharmacy, new hires do ‘empathy training’ by sorting pills while wearing bulky gloves and glasses (CNBC)
• Can Synthetic Biology Make Insulin Faster, Better and Cheaper? (Forbes)
• Treat The Cow, Not The Herd: This Agtech Startup Wants To Prevent Overuse Of Antibiotics (Forbes)
• Ridley Block Operations Voluntarily Recalls a Batch of Ultralyx 2416-5 No Other Products are Affected; Distribution was Limited to Georgia and Florida (FDA)
• Updated: Torrent Pharmaceuticals Limited Expands Voluntary Nationwide Recall of Losartan Potassium Tablets, USP and Losartan Potassium / Hydrochlorothiazide Tablets, USP (FDA)

• Hovione Announces Successful End-of-phase 2 Meeting With the FDA and Outlines Phase 3 Program for Minocycline Topical Gel (Press)
• FDA Grants Orphan Drug Designation to Reneo Pharmaceuticals for REN001 for Treatment of Fatty Acid Oxidation Disorders (Press)
• GenSight Biologics Reports Sustained Efficacy and Safety at 96 Weeks in RESCUE Phase III Clinical Trial of GS010 for the Treatment of Leber Hereditary Optic Neuropathy (LHON) (Press)
• Ipsen announces positive results from Phase IIIb/IV ENGAGE study of the combination of Dysport® (abobotulinumtoxinA) with Guided Self-rehabilitation Contracts in adult patients with upper and lower limb spastic hemiparesis1,2,3,4 (Press)
• CStone announces preliminary results from Phase I trial of CS1002 demonstrating characteristics comparable to ipilimumab (Press)

• Insulet’s Omnipod DASH™ System Now FDA Cleared as an Alternate Controller Enabled (ACE) Infusion Pump (Press)
• Cologuard® Gains FDA Approval For Use In Younger Americans, Ages 45 To 49 (Press)
• Roche Gains FDA Clearance for Cobas Babesia Blood Test (GenomeWeb)

• GAO Report Illuminates Insurer Influence On Drug Discounts (Law360-$)
• FDA Appropriations: More Questions and More Answers … Once Again (Alliance for a Stronger FDA)
• Senate Wants Priority Review For 'Deemed' Biologics Not Approved By Deadline (Pink Sheet-$)
• Allergan Investor Tries To Block $63B AbbVie Deal Over Info (Law360-$)
• Pradaxa User's Win Could Doom Thousands Of Other Suits (Law360-$)
• Plaintiff’s Pyrrhic Pradaxa “Victory” (Drug & Device Law)
• Phigenix, Inc. v. Genentech, Inc. (Fed. Cir. 2019) (Patent Docs)
• Sanders unveils plan to eliminate Americans' medical debt (The Hill)

• FDA Advisory Committee Calendar
• Development of Best Practices in Physiologically Based Pharmacokinetic Modeling to Support Clinical Pharmacology Regulatory Decision-Making – 18 November 2019

• EMA’s work on new veterinary regulation advances (EMA)

• JCR pulls Japanese Temcell filing; gains approval for Darbepoetin Alfa (PharmaLetter-$)

• DBT to establish Clinical Trial Networks and to strengthen clinical trial capacity (PharmaBiz)
• Siemens Healthcare to bolster early diagnosis of chronic diseases in India through public private partnerships (PharmaBiz)
• Indoco Remedies gets 2 observations from UK health regulator for its Goa Facility (Economic Times)
• Lupin gets 3 observations from USFDA for its Tarapur facility (Economic Times)
• Zydus Cadila gets EIR from USFDA for Ankleshwar facility (Economic Times)
• Torrent Pharma plans to launch 12-15 products in US and Germany (PharmaBiz)