Regulatory Focus™ > News Articles > Regulatory Recon: India Bans Nearly 350 Fixed Dose Combination Drugs, GW Reports Positive Results fo

Regulatory Recon: India Bans Nearly 350 Fixed Dose Combination Drugs, GW Reports Positive Results for Cannabis-Derived Phase III (14 March 2016)

Posted 14 March 2016 | By Michael Mezher 

Regulatory Recon: India Bans Nearly 350 Fixed Dose Combination Drugs, GW Reports Positive Results for Cannabis-Derived Phase III (14 March 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

  • FDA Offers New Guidance on Interpretation of BPCIA (Focus) (FDA Law Blog)
  • FDA Grants Expanded Use of Pfizer Cancer Drug Xalkori (WSJ-$) (Reuters) (FDA) (Press)
  • GW Pharma soars as cannabis drug succeeds in epilepsy trial (Reuters) (WSJ-$)
  • Bristol-Myers Bucks Trend Toward Precision Medicine (WSJ)
  • Apple plots smartphone-based medical device application for Apple Watch (Fierce) (Patent Filing)
  • Rattled by drug price increases, hospitals seek ways to stay on guard (Washington Post)
  • Latest From SXSW: Big Pharma's Big Bet on Electroceuticals (IEEE Spectrum)
  • Good INNtentions? Naming debate hindering US biosimilar acceptance, expert (BioPharma-Reporter)
  • Ban Drug Ads on TV? Some Positive Outcomes Would Be Lost (NYTimes)
  • Jennifer Doudna: The Promise and Peril of Gene Editing (WSJ-$)
  • When Gene Tests for Breast Cancer Reveal Grim Data but No Guidance (NYTimes)
  • Teleflex Recalls Kit for Heart Patients (WSJ-$) (FDA)
  • Three Easy Lessons on Ruining Innovation and Drug Markets (Huffington Post)

In Focus: International

US: Pharmaceuticals & Biotechnology

  • Look Before Leaping To Reorganize FDA – Former Commissioner McClellan (Tan Sheet-$)
  • Maria Sharapova and the Pharmaceutical Quest for an Edge (NYTimes)
  • Studies Spotlight Role Of Triglycerides, Put HDL In The Background (CardioBrief)
  • Notes from this week's Virtue Insights 8th Biosimilars Congress; market progressing but significant uncertainty remains (Biosimilarz Blog)
  • The First Amendment And Pharmaceutical Promotion (Health Affairs Blog)
  • FDA: 'No Significant Impact' to Environment From Genetically Engineered Mosquito Trial (Focus) (STAT) (Press) (Forbes) (NYTimes)
  • PDFUA-MDUFA Update March 2016 (Policy and Medicine)
  • Industry Need FDA 'Engaged' Before Investing In Observational Studies (Pink Sheet-$)
  • Real-World Evidence: Efficacy Assessments Await FDA Clarity, Pilot Projects (Pink Sheet-$) (Focus)
  • Endo Pharmaceuticals' ads bring awareness to penile curvature (MedCityNews)
  • Continuous Manufacturing/QbD Relationship Explored by Industry and Regulators at FDA/PQRI Conference (IPQ)
  • Pharma Manufacturers are Making Progress Down the Six Sigma Pathway (IPQ)
  • Off-Label Preclearance Process Eyed As Potential Fix For FDA's Policy Dilemma (Pink Sheet-$)
  • Off-Label Questions Linger: How Much Data Needed To Be 'Truthful'? (Pink Sheet-$)
  • Consumer-Focused Off-Label Promotion Seems Possible After Amarin Settlement (Pink Sheet-$)
  • CMS "Retail" Insurance Model: How Prescription Drugs Fit In (Pink Sheet-$)
  • Off-Label Preclearance Process Eyed As Potential Fix For FDA's Policy Dilemma (Pink Sheet-$)
  • Off-Label Questions Linger: How Much Data Needed To Be 'Truthful'? (Pink Sheet-$)
  • Consumer-Focused Off-Label Promotion Seems Possible After Amarin Settlement (Pink Sheet-$)
  • FDA Inspections Ombudsman Could Help Foreign Manufacturers (Pink Sheet-$)
  • What's Next For Single-Use Technology In Bioprocessing (Bioprocess Online)
  • Opioid REMS Advisory Committee May Tackle Mandatory Education (Pink Sheet-$)
  • Emerging applications of metabolomics in drug discovery and precision medicine (Nature-$)

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

  • Bass Wins Review Of Ampyra Patents, Denied Enbrel (SCRIP-$)
  • Alnylam Initiates Fitusiran (ALN-AT3) Dosing in Hemophilia A and B Patients with Inhibitors in Ongoing Phase 1 Study (Press)

US: Medical Devices

  • What Entrepreneurs Can Learn From Abbott's Efforts To Develop A Stent That Absorbs Back Into Body (Forbes)
  • Should FDA Overlook Evidence Gaps for Life-Saving Devices? (MedpageToday)
  • Life Spine wins FDA 510(k) for Prolift interbody fusion system (MassDevice)
  • Boston Scientific wins FDA nod for 1st open-irrigation ablation catheter (MassDevice)
  • Oscar 2 Ambulatory Blood Pressure Monitor with SphygmoCor Inside FDA Cleared (medGadget)

US: Assorted & Government

  • Trouble in Texas?: The Latest Pinnacle Hip Implant Trial Goes to the Jury (Drug and Device Law)
  • Drug Co. May Hide Assets Instead Of Hire Attys, Investor Says (Law360-$)
  • Donald Trump Got Medicare Wrong Again Last Night (Forbes)
  • Horizon Pharma slapped with securities lawsuit over patient assistance programs (Fierce)

Upcoming Meetings & Events

Europe

  • EMA Proposes Significant Changes To Guidance On Risk Management Plans And Template (SCRIP-$)
  • Use of antidepressants in children soars by 50% in the UK (Pharmaceutical Journal-$)
  • Global drugmakers may refuse from further imports of cheap drugs to Russia (PharmaLetter-$)
  • European Medicines Agency (EMA) Publishes Proactive Disclosure Guidance (National Law Review)

Asia                                                                                              

  • China FDA's troubled system to root out fake drugs gets high-level scrutiny (Fierce)
  • China NHFPC drug price pilot signals volume for cost-cuts formula (Fierce)
  • Another Successful Pig-to-human Cornea Transplant Performed In China (RTT News)

India

  • Need for Indian mfg units to modernise as per current GMP standards: Experts (Pharmabiz)
  • Top 30 pharma cos post net sales growth of 10% in 9 months ended Dec 2015 (Pharmabiz)
  • Government mulls hefty fines to curb drug overpricing (Economic Times)
  • Pharmaceutical sector posts 12% growth in Feb: Report (Economic Times)
  • Maharashtra to have 250 more Jan Aushadhi stores soon (Pharmabiz)

Canada

  •  A Tragedy Leads To Scrutiny Of 'Natural' Treatments In Canada (Forbes)

Zika Virus

  • Fauci: Tenuous Zika Funds Risks Branding NIH 'Unreliable' (SCRIP-$)
  • CDC's revised travel notices estimate Zika risk using elevation information (CDC)
  • Brazil's mothers left to raise microcephaly babies alone (Reuters)

Other International

  • Israeli researchers design device to improve survival chances after stabbing (Fierce)
  • U.S. doctor with Lassa fever en route to Atlanta from West Africa (Reuters)

General Health & Other Interesting Articles

  • Delayed Flu Outbreak Hits New York Hard (Bloomberg)
  • Medical Risks Associated With Daylight Saving Time (Forbes)
  • Largest Single-Center Concussion Study Launched At Trauma Center In Minnesota (Forbes)

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 news@raps.org.

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


Categories: Recon, Regulatory News

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe