Regulatory Recon: Biogen Draws Takeover Interest from Merck, Allergan US Begins Human Trial for Zika Vaccine (3 August 2016)

Posted 03 August 2016 | By Michael Mezher 

Regulatory Recon: Biogen Draws Takeover Interest from Merck, Allergan US Begins Human Trial for Zika Vaccine (3 August 2016)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan and @RAPSorg on Twitter.

In Focus: US

  • Pfizer chief plays down prospect of split (Financial Times)
  • Pfizer To Pay $486M To Settle Celebrex, Bextra Securities MDL (Law360-$)
  • Biogen Draws Takeover Interest From Rival Drugmakers (WSJ-$) (The Street) (Endpoints)
  • US Government Starts Test of Zika Vaccine in Humans (MIT Technology Review) (Nature)
  • The Next Health Fad? Blood Transfusions from Young People (MIT Technology Review) (Quartz)
  • Theranos plunges ahead into a murky future (STAT)
  • FDA Unveils IRB Draft Guidance on Written Procedures (Focus)
  • Precision Oncology: Nanoparticles Target Bone Cancers in Dogs (NIH)
  • FDA Continues Crackdown on Chinese Drug Manufacturers With new Warning for Xiamen (Focus)
  • What Drugs Really Cost: GAO Wants CMS to Find Out (Focus)
  • Florida to begin aerial spraying of insecticides to control Zika (Reuters)
  • CDC awards $16 million to states and territories to fight Zika (CDC) (Reuters)
  • Actelion does not see significant CVS hit to Opsumit sales (Reuters)
  • Amgen, Regeneron Forge New, Separate Cancer Immunotherapy Pacts (The Street) (BioCentury) (GEN) (Fierce 1, 2)
  • CVS Drops Coverage of 2 Branded Biotech Drugs in Favor of Copies (WSJ-$)
  • Pharmacy benefit managers are restricting access to lots of drugs next year (STAT)

In Focus: International

  • Brazil Aims to Calm Zika Worries Ahead of Olympics (WSJ-$)
  • Is Japanese Pharma Pulling out of the UK (PharmaPhorum)
  • Nature Interviews Jim O'Neill, the Economist Behind UK Antimicrobial Resistance Report (Nature)
  • UK Pharma's 'Brexit Playbook' Might Envision New Regulator Roles (Pink Sheet-$)
  • India Looks to Further Ease Process of Running Clinical Trials (Focus)
  • Cost of diabetes drugs to NHS nears £1 billion (PharmaTImes)
  • Brexit vote spurs UK review of clinical trial guidelines (AllTrials)
  • New EU Indication for Merck's Keytruda (PharmaLetter-$) (Press)
  • MHRA review shows sports supplement industry improvement (MHRA)
  • MHRA Raises Concerns Over Improper Biosimilar Marketing (Focus)
  • Galvani: GSK Goes "Bioelectronic" (In the Pipeline)
  • Asia Regulatory Roundup: Quality Issues Push TGA to Seek New Source for Angina Drugs  (Focus)
  • New biomedical fund launched by Australian government (PharmaLetter-$)
  • Shire lifts guidance as Baxalta spurs strong sales growth (Financial Times) (Endpoints)
  • New layout for EMA scientific guidelines (EMA)
  • EMA Scraps Guideline On Preclinical Testing Of Vaccines In Favor Of WHO's Approach (Pink Sheet-$)
  • Teva Completes $40 billion Allergan Generics Purchase, Seeks Growth Beyond Deal (Bloomberg) (Pharmafile) (Press)
  • NICE recommends Celgene's apremilast for NHS use (Pharmafile)

US: Pharmaceuticals & Biotechnology

  • Aptevo Therapeutics completes spin-off from Emergent BioSolutions (PharmaLetter-$)
  • Pfizer Dashes Hopes For A PCSK9 Pill (SCRIP-$)
  • Why is the FDA creating unnecessary obstacles to biosimilar drugs? (The Hill)
  • Piramal Pharma Solutions expands sterile manufacturing capacity in US (Manufacturing Chemist Pharma)
  • Astrazeneca might have created value but now it needs to deliver (EP Vantage)
  • Opioid Approval Standards Not Up For Debate, FDA Tells Advisory Cmte (Pink Sheet-$)
  • Biotech Pop-Up Party in Full Swing (The Street)
  • The Big Dirty Secret Every Doctor Knows (CardioBrief)
  • Egalet's Arymo ER Opioid Has Questionable Oral Abuse-Deterrent Effect (Pink Sheet-$)
  • OTC Monograph User Fees: FDA-Industry Talks Move From Basics To Details (Pink Sheet-$)
  • West: Amgen mAb approval helps validate drug delivery tech (InPharmaTechnologist)
  • Noted price-hiker Jazz feels the heat as PTO strikes Xyrem patents (Fierce)
  • Teva Pharmaceuticals Initiates Voluntary Nationwide Recall of Seven Lots of Amikacin Sulfate Injection USP 500 mg/2 mL (250 mg/mL) and 1 Gram/4 mL (250 mg/mL) Vials Due to Potential of Glass Particulate Matter (FDA)

US: Pharmaceuticals and Biotechnology: Clinical Study Results, Filings & Designations

  • US breakthrough status for Novartis' breast cancer drug (PharmaTimes) (Press)
  • Agilis Biotherapeutics Announces FDA Orphan Drug Designation for the Treatment of Friedreich's Ataxia (FA) (Press)
  • Archigen Biotech Seeks Fda Approval For Rituximab Phase I Clinical Trials (Big Molecule Watch)
  • VM BioPharma Announces Korea Food and Drug Administration Approval of Phase 2 Clinical Trial for Investigational Gene Therapy VM202 in Ischemic Heart Disease (Press)
  • ColonaryConcepts Initiates Phase 1 Study of New Approach to Treating Chronic Constipation (Press)
  • AMERIGEN announces final approval from FDA for generic version of Lysteda (Press)
  • PharmaMar initiates a phase III ATLANTIS study for small cell lung cancer (EPR)

US: Medical Devices

  • Draft Guidance: Medical X-Ray Imaging Devices Conformance with IEC Standards (FDA)
  •  Safety and Effectiveness Summaries for Recent Premarket Approval Applications (FDA)
  • FDA Streamlines Reviews Of Next Generation Sequencing Tests (Law360-$)
  • Over 750 biomarkers identified as potentials for early cancer screening test (MNT)
  • Alcyone Lifesciences seeks FDA nod for ReFlow neuro cath (MassDevice)
  • CyPass Micro-Stent, an Implant for Glaucoma, Approved by FDA (MedGadget)
  • Gore wins FDA nod for Tigris vascular stent (MassDevice)
  • Boston Scientific issues urgent field safety notice for select Lotus valves (MassDevice)
  • TransEnterix sells 1st ALF-X unit (MassDevice)
  • Foundation Medicine Pursuing Parallel Review by FDA, CMS for FoundationOne (GenomeWeb) (Press)
  • FDA expands use of PeriCoach at-home pelvic floor trainer device and smartphone app for sexual health (Press)
  • Luminex Corporation Receives FDA Clearance for New Molecular Test for Identification and Differentiation of Influenza A/B and Respiratory Syncytial Virus (Press)

US: Assorted & Government

  • Fed. Circ. Clarifies The Test For Patentable Subject Matter (Law360-$)
  • States' Efforts for Drug Price Transparency Stymied by the Pharmaceutical Industry (National Law Review)
  • Three Steps Congress Can Take To Accelerate Medicare's Delivery Transformation (Health Affairs Blog)
  • Are The Tables Turning Against The Government In Healthcare Fraud Probes? (Forbes)
  • Outpatient Services Are the Largest Driver of 2017 Premium Increases (Avalere)
  • Statewide Poll Shows Strong Support for Prop. 61 (YesOn61)
  • Thousands Of Prospective Plaintiffs Turn Up After Massive Talc Verdicts In St. Louis (Fobres)

Upcoming Meetings & Events


  • ReliantHeart's aVAD Gets CE Mark (MDDI)
  • Summary of Field Safety Notice - July 2016 (HPRA)
  • Two-year tariff 'can help stabilise NHS planning' (OnMedica)


  • Acino agrees to sell drug delivery patch business to Luye Pharma for $274m (InPharmaTechnologist)
  • Sorrento, Korea's Cha setting up global JV (BioCentury)



Other International

  • Facility-Based Delivery during the Ebola Virus Disease Epidemic in Rural Liberia: Analysis from a Cross-Sectional, Population-Based Household Survey (PLoS)

General Health & Other Interesting Articles

  • Remote heart monitoring can help detect emergencies (Reuters)

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.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @Michael_Mezher or send him an email at

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.

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