Recon: GSK Pulls Out of $20B Race for Pfizer Business

• The Cancer Immunotherapy Revolution: Special Issue (Science)
• Too much of a good thing? (Science) (Axios)
• Health-Care Firms Turn to Drugmaker Executives as Businesses Converge (WSJ-$)
• Karyopharm and Aveo hope data can satisfy US regulators (EP Vantage)
• An eyewitness gene therapy story, breaking down Incyte’s future, and was Gottlieb wrong to try? (Stat Podcast)
• GAO report on comparative effectiveness research (GAO)
• Senate and House Pass Omnibus Spending Bill With Boost in FDA Funding (Focus)
• House Passes ‘Right-to-Try’ Bill, Sending it Back to the Senate (Focus) (AP)

• Amgen employee in Denmark violated the law by posting a press release on LinkedIn (Pharmalot-$)
• Lead bidder GlaxoSmithKline drops out of Pfizer OTC race, dealing a blow to $20B sale ambitions (Fierce) (Reuters) (Pharmafile) (PMLive) (FT-$) (EP Vantage)
• New measures to avoid valproate exposure in pregnancy (MHRA)
• EMA’s CHMP Rejects Two Drugs Approved by US FDA in 2017 (Focus)
• Six new national standards are launched across UK (PMLive)
• MHLW Orders Label Revisions for Samsca Acute Liver Failure Added to Significant ADR List (PharmaJapan-$)
• The International Clinical Evaluation Coordination Project for International Medical Devices Initiated by China is Approved Unanimously (CFDA)

• Indivior vows to appeal US court ruling on generic Suboxone (Financial Times-$)
• Chutes & Ladders—Johnson & Johnson’s longest-serving CFO to retire (Fierce)
• Novo Nordisk backs up M&A pledge by appointing deal-minded board chair (Fierce)
• Poised for an FDA pitch, Novartis lays out all its PhIII cards on MS drug siponimod (Endpoints)
• MorphoSys files for $150M IPO to fuel its hopeful DLBCL drug launch (Endpoints) (Fierce)
• Tasigna cleared for use in children with rare leukemia (PharmaTimes)
• Another immunometabolism deal? Johns Hopkins spinout Dracen lands $36M investment from Deerfield (Endpoints)
• Two Really Big Fish That Got Away (LifeSciVC)
• Snippet roundup: Funding boosts the US NIH and could spawn a UK ubercorn (EP Vantage)
• Janssen’s Virtual Discovery (BioCentury-$)
• Daiichi taps Hitachi for regenerative medicine manufacturing (BioPharma Dive)
• Poll: Americans Aghast Over Drug Costs But Aren’t Holding Their Breath For A Fix (KHN) (Stat-$)
• AbbVie Must Be Sent Message, Jury Told In AndroGel Trial (Law360-$)
• Shire Wins Adderall Suit While Loser Gets Sanction Request (Law360-$)
• The Most Popular Drugs in America, State by State (GoodRx)
• Genentech antibody spotlights new target for antibiotic-resistant bacteria (Fierce)
• Global ethylene capacity maxed-out through 2022 (Chemical Week)
• Tergus Pharma Acquires EnDev Laboratories (Contract Pharma)

• Should p-value thresholds be cut to raise data standards? (Fierce)
• UNC pediatrics delivers investigational genome editing therapy in clinical trial (Press)
• Pfizer's quit-smoking Chantix treatment fails a safety and effectiveness study in teen smokers (Reuters) (Press)

• BD Updates Instructions for Use for Certain BD Vacutainer Blood Collection Tubes (FDA) (FDA)
• How 23andMe Quelled FDA Concerns About DTC Breast Cancer Gene Test (Forbes)
• 10 women medtech leaders you should know (Mass Device)
• Smiths Medical Announces US Launch of the DeltaVen Closed System Catheter and FDA Clearance (Press)
• Nevro wins FDA nod for MRI-conditional labeling on Senza SCS (Mass Device)
• Moll’s Auris wins FDA nod for Monarch robotic endoscopy platform (Press) (Mass Device)
• PhysioWave Receives FDA Clearance for Breakthrough Innovation (mHealthWatch)

• Getting medicines to market faster (Economist-$)
• Lawmakers ask Medicaid if it needs more power to fix drug misclassifications (Stat-$)
• Seema Verma previews Medicare agenda (Politico)
• Weekly Roundup (EyeonFDA)
• Weekly View (ICER)
• FDA continues its tobacco regulation overhaul. This time the focus is premium cigars (CNBC) (FDA)
• Agency Information Collection Activities; Submission for OMB Review; Comment Request; Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring (Federal Register)
• FDA announces mobile app (Healthcare Packaging) (FDA)

• FDA Advisory Committee Calendar
• Antimicrobial Drugs Advisory Committee; Notice of Meeting; Establishment of a Public (Federal Register)

• Statement in response to the EU Council ratifying the Brexit transition deal (EFPIA)
• Indivior loses another case in battle to protect opioid addiction drug (Reuters)
• NMD bags €38M to run orphan neuromuscular disease trials (FierceBiotech)
• MPs call on UK government to resolve Orkambi impasse (BioCentury)

• Japan approves Novo Nordisk’s once-weekly Type II diabetes drug (Reuters) (Pharmafile)

• India to generate 775.5 tonnes of medical waste daily by 2020: Study (Economic Times)

• Uganda embroiled in fake hepatitis B vaccine scandal (Securing Industry)

• How Genetics Is Changing Our Understanding of ‘Race’ (NY Times-$)
• Time for action on tuberculosis (Financial Times-$) (EC)
• The Second Amendment and a Well-Regulated Firearms Environment (JAMA)
• How Social Media Can Reveal Overlooked Drug Reactions (NPR)