Recon: BMS' Opdivo-Yervoy Combo Succeeds in Phase III NSCLC Trial; Philippines Sues Sanofi Over Dengue Vaccine

Posted 05 February 2018 | By Michael Mezher 

Recon: BMS' Opdivo-Yervoy Combo Succeeds in Phase III NSCLC Trial; Philippines Sues Sanofi Over Dengue Vaccine

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

In Focus: US

  • Bristol-Myers says a key trial for its lung cancer drug succeeds (Reuters) (Endpoints) (Press) (Press)
  • Bristol-Myers Squibb Reports Fourth Quarter and Full Year Financial Results (Press)
  • Buyout buzz hits fever pitch on report that Nektar is 'exploring options' (Endpoints) (Fierce)
  • Intarcia Axes 60, Halts Studies after FDA Clinical Hold (GEN)
  • Real-world optics of biopharma price hikes (Bioworld)
  • Lengthy wish list for looming budget package (Politico)
  • Pfizer runs into yet another problem trying to ship opioid-filled syringes to hospitals (STAT)
  • Should pharma be allowed to give insurers key data before drugs are approved? (STAT) (Pink Sheet-$)
  • New report details misuse of antipsychotics in nursing homes (STAT) (The Guardian)
  • Allergan's Pipeline Matters More Than Its Earnings Do: RBC (The Street)
  • The flu vaccine is only 10 percent effective this year. Blame eggs. (CNBC)
  • Anatomy of a $9B buyout: Celgene's quick turn from Juno's close collaborator to new owner (Endpoints)
  • Slammed by a trial hold, Intarcia terminates studies and axes staff in wake of an FDA rejection (Endpoints)
  • Trump On Right-to-Try: Gottlieb's 'Heading It Up'? (Pink Sheet-$)
  • Why A Cancer Patient Opposes The 'Right To Try' Experimental Cancer Drugs (NPR)        

In Focus: International

  • Philippine lawyers sue Sanofi over dengue vaccine (Reuters) (Endpoints)
  • Merck's consumer health sale at risk as Nestle bows out – sources (Reuters)
  • Fentanyl Adds Deadly Kick to Opioid Woes in Britain (NYTimes)
  • UK breast cancer deaths drop 10 percent in five years (PharmaTimes)
  • EMA set to review Teva's migraine injection (PMLive)
  • Allergan completes restructuring, pushes hard in China (Reuters)
  • MHRA Grants 50th Promising Innovative Medicine Designation (MHRA)
  • 64% of antibiotics sold in India unapproved, finds UK study (Economic Times)
  • Road To Acquisition: How Belgian Biotech Ablynx Fits Sanofi's R&D Strategy (BioCentury)

Pharmaceuticals & Biotechnology

  • Hans Bishop gets a $287M payday as Juno execs see windfall fortunes — with a $922M payoff for Arch (Endpoints)
  • Stock plummets at EyeGate following Phase IIb flop for cataract surgery (Endpoints)
  • After FDA setback, Bellicum bolsters R&D team with ex-Genentech executive (Fierce)
  • FDA Adds Black Box Warning to Intercept's Liver Disease Medicine (FDA News-$)
  • The Gene-Tech Stock That Will Modify Your Portfolio (Forbes)
  • Stem Cell Therapy for Concussions: Is It for Real? (Medpage)
  • Anonymous bitcoin philanthropist donates $5 million to medicine foundation (Reuters)
  • Allergan roasts fad fat-fighting techniques in new 'Not Cool vs. Cool' campaign (Fierce)
  • Biosimilar oversight? Advocacy groups lobby Congress to increase patient safety (BioPharmaReporter)
  • Local Advantage: Theravance Nears Key Inflection Point For Its First Localized Immunology Candidate (BioCentury)
  • British biotech ReViral hits goals in early RSV test (Fierce)
  • Partnering for improved cancer care around the globe (Novartis)
  • Gericare Eye Wash by Kareway Products: Recall - Potential Product Contamination (FDA)

Pharmaceutical and Biotechnology: Study Results, Filings and Designations

  • Allergan's Avycaz breaks Gram-negative pneumonia antibiotic drought (PMLive)
  • TG Reports Updated Phase IIa MS Data For Anti-Cd20 mAb (BioCentury)
  • Spectrum Pharmaceuticals Announces ROLONTIS™ (eflapegrastim) Met the Primary Endpoint in the Phase 3 ADVANCE Study (Press)
  • Acticor Biotech Completed Its Phase I Clinical Trial with ACT017 Achieving Its Safety and Tolerability Primary Endpoints (Press)
  • Trethera Corporation Announces FDA Clearance of Investigational New Drug Application for TRE-515 (Press)

Medical Devices

  • Digirad closes $8m sale of medical device sales & services biz to Philips (MassDevice)
  • Developing a Diagnostic for Home Use? Assemble the Right Team and Consider These Issues (MDDI)
  • Apple Wants a Bigger Bite of the Healthcare Fruit (MDDI)
  • LivaNova wins CE Mark for PureFlex arterial cannulae (MassDevice)
  • FDA's first Pre-Cert workshops give industry and agency a chance to talk (mobihealthnews)
  • Medical Devices; Neurological Devices; Classification of the Percutaneous Nerve Stimulator for Substance Use Disorders (FDA)

US: Assorted & Government

  • Castlight Health CEO warns Jeff Bezos that health tech is a 'tough business' (CNBC)
  • Insurer Profits Rise As Trump Waves White Flag On Obamacare Repeal (Forbes)
  • Amgen's Suit To Shield Cancer Treatment Biosimilar Tossed (Law360-$)
  • Senators traded in tobacco stocks while sitting on health committee (STAT)
  • Philly DA Accuses Drugmakers Of Deceptive Opioid Marketing (Law360-$)

Upcoming Meetings & Events


  • ReWalk Robotics wins German reimbursement nod for Personal 6.0 exoskeleton (MassDevice)


  • Astellas Announces Management Changes, Restructuring (Press)
  • Cardiovascular Systems launches Diamondback 360 in Japan, touts 1st patient treated (MassDevice)


  • Danish regulators slam Indian API maker for GMP failings (InPharma)
  • How the Rs 3, 500 crore damages against Singh Brothers was arrived at (Economic Times)


  • Types of ingredients in listed and registered complementary medicines (TGA)

Other International

  • How Bill Gates and a top doctor are pushing health care solutions in developing nations (CNBC)
  • A Crowd Is Waiting For A Cervical Cancer Clinic On Wheels (NPR)

General Health & Other Interesting Articles

  • How DNA could store all the world's data in a semi-trailer (Financial Times)
  • High levels of cellphone radiation linked to tumors in male rats: U.S. study (Reuters) (NYTimes) (NIH)
  • Flu Patients Arrive in Droves, and a Hospital Rolls Out the 'Surge Tent' (NYTimes)
  • The Importance of Infants' Exposure to Microorganisms (NYTimes)

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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