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

Posted 23 March 2018 | By Zachary Brennan 

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

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

In Focus: US
  • 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-$)
  • Karyopharm and Aveo hope data can satisfy US regulators (EP Vantage)
  • An eyewitness gene therapy story, breaking down Incyte’s future, and was Gottlieb wrong to try? (Stat Podcast)
  • GAO report on comparative effectiveness research (GAO)
  • Senate and House Pass Omnibus Spending Bill With Boost in FDA Funding (Focus)
  • House Passes ‘Right-to-Try’ Bill, Sending it Back to the Senate (Focus) (AP)
In Focus: International
  • Amgen employee in Denmark violated the law by posting a press release on LinkedIn (Pharmalot-$)
  • 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-$)
  • The International Clinical Evaluation Coordination Project for International Medical Devices Initiated by China is Approved Unanimously (CFDA)
Pharmaceuticals & Biotechnology
  • Indivior vows to appeal US court ruling on generic Suboxone (Financial Times-$)
  • 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-$)
  • The Most Popular Drugs in America, State by State (GoodRx)
  • Genentech antibody spotlights new target for antibiotic-resistant bacteria (Fierce)
  • Global ethylene capacity maxed-out through 2022 (Chemical Week)
  • Tergus Pharma Acquires EnDev Laboratories (Contract Pharma)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • Should p-value thresholds be cut to raise data standards? (Fierce)
  • UNC pediatrics delivers investigational genome editing therapy in clinical trial (Press)
  • Pfizer's quit-smoking Chantix treatment fails a safety and effectiveness study in teen smokers (Reuters) (Press)
Medical Devices
  • BD Updates Instructions for Use for Certain BD Vacutainer Blood Collection Tubes (FDA) (FDA)
  • How 23andMe Quelled FDA Concerns About DTC Breast Cancer Gene Test (Forbes)
  • 10 women medtech leaders you should know (Mass Device)
  • Smiths Medical Announces US Launch of the DeltaVen Closed System Catheter and FDA Clearance (Press)
  • Nevro wins FDA nod for MRI-conditional labeling on Senza SCS (Mass Device)
  • Moll’s Auris wins FDA nod for Monarch robotic endoscopy platform (Press) (Mass Device)
  • PhysioWave Receives FDA Clearance for Breakthrough Innovation (mHealthWatch)
US: Assorted & Government
  • Getting medicines to market faster (Economist-$)
  • Lawmakers ask Medicaid if it needs more power to fix drug misclassifications (Stat-$)
  • Seema Verma previews Medicare agenda (Politico)
  • Weekly Roundup (EyeonFDA)
  • Weekly View (ICER)
  • FDA continues its tobacco regulation overhaul. This time the focus is premium cigars (CNBC) (FDA)
  • Agency Information Collection Activities; Submission for OMB Review; Comment Request; Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring (Federal Register)
  • FDA announces mobile app (Healthcare Packaging) (FDA)
Upcoming Meetings & Events Europe
  • Statement in response to the EU Council ratifying the Brexit transition deal (EFPIA)
  • Indivior loses another case in battle to protect opioid addiction drug (Reuters)
  • NMD bags €38M to run orphan neuromuscular disease trials (FierceBiotech)
  • MPs call on UK government to resolve Orkambi impasse (BioCentury)
Asia
  • Japan approves Novo Nordisk’s once-weekly Type II diabetes drug (Reuters) (Pharmafile)
India
  • India to generate 775.5 tonnes of medical waste daily by 2020: Study (Economic Times)
Africa General Health & Other Interesting Articles
  • How Genetics Is Changing Our Understanding of ‘Race’ (NY Times-$)
  • 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)
Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe. Each weekday morning, we aim to bring you the latest highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the latest trends with the potential to impact regulatory affairs professionals and the industry in which they work.

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