Regulatory Focus™ > News Articles > 6 > Recon: GBT Sees Positive Trial Data; FDA Panel Rejects Abuse-Deterrent Opioid

Recon: GBT Sees Positive Trial Data; FDA Panel Rejects Abuse-Deterrent Opioid

Posted 27 June 2018 | By Ana Mulero 

Recon: GBT Sees Positive Trial Data; FDA Panel Rejects Abuse-Deterrent Opioid

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

In Focus: US
  • Aquinox to stop development of bladder pain drug; shares slump (Reuters) (Endpoints)
  • AstraZeneca/Merck hope for expanded ovarian cancer drug use (pharmaphorum) (Reuters)
  • Positive pivotal data in hand, GBT is hustling to the FDA in search of a quick OK for sickle cell drug — but that’s no easy task (Endpoints) (Reuters) (STAT-$)
  • Neon Therapeutics to Launch IPO at $15 Per Share (BioSpace) (Endpoints)
  • FDA panel rejects Pain Therapeutics’ abuse-deterrent opioid Remoxy (Fierce) (Endpoints)
  • Penn invests $50 million in biotech in a bold bid to build Philly's innovation cluster (The Inquirer)
  • BioTechne snaps up Exosome Diagnostics in $250M deal (Minneapolis Star Tribune) (Fierce)
Sponsored Content: In-Depth IVDR/MDR Kick Starter Kit In Focus: International Pharmaceuticals & Biotechnology
  • Trump administration plays regulatory hardball in drug-price talks (Washington Examiner)
  • The pharma industry tilt of the FDA (Axios)
  • Why The Woman Behind Controversial Drug Addyi Won't Stop Fighting For Women (Forbes)
  • The problem with high drug prices isn't 'foreign freeloading,' it's the patent system (CNBC)
  • A flu drug — shown to reduce the duration of symptoms — could upend treatment in U.S. (STAT)
  • Price of Pfizer's smoking-cessation drug Chantix doubles in just 5 years: report (Fierce)
  • Theranos Founder’s Stay Bid Nixed As Judge Scolds Counsel (Law360-$)
  • Pharma, DEA Push To Keep Opioid MDL Data Under Wraps (Law260-$)
  • Rubius Therapeutics Looks to Raise $200 Million in IPO for Red-Cell Therapies (BioSpace)
  • The Real Test For Gene Therapy Is Yet To Come (BioSpace)
  • DIA18: Value-based contracts pose more questions than answers (BioPharma Dive)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • Sunovion’s Parkinson’s disease drug is a step closer to approval (pharmaphorum)
  • With AstraZeneca on its heels, J&J, AbbVie's Imbruvica speeds toward new nod in Waldenström's (Fierce)
  • Amgen Announces Top-Line Results From Phase 3 Study Of ABP 710, Biosimilar Candidate To Infliximab (Press)
  • Cara Therapeutics Reports Positive Top-Line Data from Adaptive Phase 2/3 Trial of I.V. CR845 in Patients Undergoing Abdominal Surgery (Press)
  • Lynparza significantly delays disease progression in Phase III 1st-line SOLO-1 trial for ovarian cancer (Press)
  • Oyster Point Pharma Announces FDA Clearance of Investigational New Drug Application for the Treatment of Dry Eye Disease (Press)
  • Pivot Pharma To File Investigational New Drug (IND) Application With U.S. FDA For PVT-005 (Press)
Medical Devices
  • Nova Oculus owner Peter Pocklington hires Cosby defense lawyer to fend off SEC fraud charges (Fierce)
  • HeartFlow wins UnitedHealthcare coverage for FFRct analysis (MassDevice)
  • PAVmed Provides Business Update (Press)
US: Assorted & Government
  • Senate pushes for stronger drug-pricing policy than Trump proposal(Modern Healthcare)
  • HHS: "Several hundred" children have been reunited with parents (Axios)
  • It’s time to reform the process for determining what Medicare covers (STAT)
  • Most Americans support the Trump idea to force pharma to advertise drug prices (STAT-$)
  • New York State may force drug makers to pay for drug take-back programs (STAT-$)
  • Express Scripts Tells Court It Owns Pharmacies' Patient Data (Law260-$)
  • Tech companies deflect blame for opioid crisis ahead of FDA summit (Wired)
  • Oklahoma voters approve medical marijuana despite opposition (AP News)
Upcoming Meetings & Events Europe
  • EMA demands more data from Amicus, denting stock (Fierce)
  • EU Probes BASF's €1.6B Deal For Solvay's Nylon Biz (Law360-$)
  • NHS ‘worse than average’ in treating common causes of death (pharmaphorum)
  • Updated: The Yellow Card Scheme: guidance for healthcare professionals (MHRA)
  • Amicus Therapeutics Announces European Regulatory and Clinical Updates for AT-GAA in Pompe Disease (Press)
Asia India
  • India's Fortis Healthcare quarterly loss widens on impairment charges (Reuters)
  • India can reduce maternal deaths (Hindustan Times)
  • Indian government plans to foster SMEs and bulk drug industry (The Pharma Letter)
  • Maha FDA to start risk based inspections of Sch M units towards meeting global compliance levels (Pharmabiz)
Australia
  • Clinuvel completes NDA submission for rare genetic blood disorder drug (The Pharma Letter)
  • Electronic submission of individual case safety reports (TGA)
  • Health cap to leave insurers on the brink (The Australian)
Canada
  • Ottawa urges drug makers to end opioid marketing (The Globe and Mail)
  • Health Canada to propose post-market amendments to Medical Devices Regulations (Lexology-$)
  • ICH S9 Guideline: Nonclinical Evaluation for Anticancer Pharmaceuticals, Questions and Answers (Health Canada)
General Health & Other Interesting Articles
  • Using the principles of evolution to treat and prevent cancer (STAT)
  • Individuality In Healthcare Part 3 -- More Insights, Better Experience Across The Continuum of Care (Forbes)
  • University Hospitals is hitting mark with proton therapy (Modern Healthcare)
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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