Regulatory Focus™ > News Articles > Regulatory Recon: HHS Inspector General Ups Focus on Drug Pricing; Witty Warns of 'Tremendous Disrup

Regulatory Recon: HHS Inspector General Ups Focus on Drug Pricing Witty Warns of 'Tremendous Disruption' if EMA Leaves UK (11 November 2016)

Posted 11 November 2016 | By Michael Mezher 

Regulatory Recon: HHS Inspector General Ups Focus on Drug Pricing Witty Warns of 'Tremendous Disruption' if EMA Leaves UK (11 November 2016)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Missed yesterday's Recon? Read it here.

In Focus: US

  • Bremberg to lead Trump's healthcare transition (Modern Healthcare) (Inside Health Policy)
  • What the Incoming Trump Administration may Mean for FDA, Biopharma and Device Companies (Focus) (SCRIP-$)
  • Trump Faces Legal Challenges In Dismantling Obama's Legacy (Forbes)
  • Donald Trump sends a vaguely worded love letter to biopharma as stock rally continues (Endpoints) (Fierce)
  • Trump presidency could prove a salve for pharma merger deals (Reuters)
  • A Sense of Whiplash About the Affordable Care Act (NYTimes)
  • Affordable Care Act Enrollment Surges Following Trump Election (WSJ) (Reuters)
  • Patent Legislation Has Uncertain Path In Trump Presidency (Law360-$)
  • What The GOP Win May Mean For Your Health (Forbes)
  • Women Rush To Get Long-Acting Birth Control After Trump Wins (NPR) (Washington Post)
  • Saving Heroin Users With a Nasal Spray Is an $80 Million Business (Bloomberg)
  • HHS watchdog office steps up focus on drug pricing (STAT)
  • Gilead gets FDA nod – and boxed warning – for new hepatitis B drug (PharmaLetter-$) (BioCentury) (Press)
  • The Use of Social Media in Recruitment for Medical Research Studies: A Scoping Review (JMIR)
  • FDA Withdraws Proposed Rule on Public Disclosure of Info on Unapproved Gene Therapies (Focus)
  • FDA clears Opdivo for head and neck cancer (PharmaTimes) (BioCentury) (Press)
  • Pfizer offers cut-price pneumonia shot for humanitarian crises (Reuters) (First World Pharma) (Press)
  • Appeals court sends NuVasive spat with Medtronic back to patent office (MassDevice) (Patent Docs)
  • FDA Tones Down MDR Reporting Recommendations in its Final Guidance (FDA Law Blog) (Focus)
  • Putting the False in False Claims Act Cases (Drug and Device Law)
  • California insurance board subpoenas Valeant (Drug Delivery)

In Focus: International

  • Commissioning must seek max value not minimum cost, says LSE report (PharmaTimes)
  • Will 'Businessman' Trump See The Value In Indian Generics? (Pink Sheet-$)
  • PTC shares rocket up as European regulators offer a thumbs-up on Duchenne drug marketing (Endpoints) (The Street)
  • Trump Victory To Breathe Life Into Korean Biopharmas? (SCRIP-$)
  • Policy Changes Needed To Make Turkey A 'Pacesetter': AIFD Head (SCRIP-$)
  • European Regulatory Roundup: Lead Brexiteer Dismisses Need for UK to Stay in EU Regulatory System (Focus)
  • Witty warns of 'tremendous disruption' if EMA exits London (Fierce)
  • Lilly's Lartruvo get EU nod for soft tissue sarcoma (PharmaTimes)
  • Life-threatening superbug spreads globally in cystic fibrosis patients (Reuters)
  • Valeant, looking for a reputation fix, could change its name, Ackman says (Fierce)
  • Japanese Medical Device Premarket Review Timeframes Improving (Emergo)

US: Pharmaceuticals & Biotechnology

  • The challenges and benefits of financial transparency in clinical trials (OutsourcingPharma)
  • Expensive new cancer drugs have little effect on survival of many cancers (MNT)
  • Why We Still Don't Have Birth Control Drugs for Men (MIT Technology Review)
  • Mylan boasts of 16 biosimilars in portfolio after Mabion rituximab deal (BioPharmaReporter)
  • Immunotherapy moves to the front lines in fight against lung cancer (Washington Post)
  • Bristol-Myers, Johns Hopkins pen I/O research pact (Fierce) (Press)
  • Calpain research for drug discovery: challenges and potential (Nature)
  • Off-Label Communication Growth: Could FDA Afford To Police It? (Pink Sheet-$)
  • Broad Institute and IBM Begin Cancer Drug Resistance Research (PharmTech)
  • The Varying Number of Company-Driven Medical Education Events by Product Type (Cutting Edge Info)
  • A Study Tests the Safety of Women Using Abortion Pills Sent by Mail (NYTimes)
  • Parallel Review – Forcing Manufacturers to Go All In (Epstein Becker Green)
  • Edward Manookian (Also Known as Ed Manning): Debarment Order (FDA)
  • SSB's new US bioanalysis lab open for business (BioPharmaReporter)

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

  • The Medicines Company to Host Conference Call and Webcast to Review Data from Ongoing ORION-1 Phase 2 Study of PCSK9si (Press)
  • Bristol-Myers Squibb to Showcase New Data Spanning Rheumatoid Arthritis and Other Autoimmune Diseases at 2016 American College of Rheumatology and Association of Rheumatology Health Professionals Annual Meeting (Press)
  • Sanofi And Regeneron To Present Data From Phase 3 Praluent® (Alirocumab) Injection Clinical Trials At AHA Scientific Sessions 2016 (Press)
  • Genexine, Merck to study HPV vaccine combo (BioCentury)
  • Elcelyx's Metformin DR meets Phase IIb diabetes endpoint (BioCentury)
  • Amgen, J&J planning Kyprolis-Darzalex combo studies (BioCentury)
  • Phase 3 Trial Show Promise in Treating Multi-Drug Resistant HIV-1 (MPR)

US: Medical Devices

  • Prominent cardiologist calls for a halt to Watchman implants (MassDevice)
  • Coating issue rears its head for Concert Medical's Galeo Pro guidewire  (MassDevice)

US: Assorted & Government

  • Washington Scientists Forge Ahead Amid Uncertainty (Xconomy)
  • Access To Abortion Could Be Curtailed Under Trump Administration (NPR)
  • U.S. DEA temporarily bans synthetic opioid 'pink' after 46 deaths (Reuters)

Upcoming Meetings & Events

Europe

  • Bird flu hits Europe, France raises checks to counter virus (Reuters)
  • Wockhardt to up manufacturing capacity at Wrexham site (InPharmaTechnologist)
  • The Queen opens new Francis Crick Institute building (MRC)

India

Asia

  • Lilly grants Eddingpharm antibiotic rights in China (BioCentury)
  • CFDA Vice Minister Sun Xianze attends Global Conference on Pharmacy and Pharmaceutical Sciences Education (CFDA)

Canada

Australia

  • Fees and charges: summary - from 1 July 2016 (TGA)

Other International

  • Measles jab saves over 20 million young lives in 15 years, but hundreds of children still die of the disease every day (WHO)

General Health & Other Interesting Articles

  • Cancers linked to tobacco use make up 40% of all cancers diagnosed in the United States (CDC)

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