Regulatory Recon: Novo Diabetes Drug Succeeds in Key Trial; Generic Drugmakers Feel Pinch as Prices Crumble (17 August 2017)

Posted 17 August 2017 By Zachary Brennan

placeholder+image

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

In Focus: US

  • Novo Nordisk's diabetes drug succeeds in key trial (Reuters) (PMLive) (PharmaTimes) (Endpoints)
  • Generic drugmakers feel pinch as prices crumble (Financial Times-$)
  • Express Scripts to limit opioids; doctors concerned (AP)
  • Industry Awaits Two Important OGD/OPQ Documents – Keep the Faith? (Lachman Consultants)
  • FDA Guidance on Biosimilar Interchangeability Elicits Diverse Views (P&T)
  • Gottlieb perspective: A Nicotine-Focused Framework for Public Health (NEJM)
  • No Room for Camera Shyness: FDA Issues Another Warning Letter Citing Refusal to Permit Photography (FDA Law Blog)
  • J&J’s Alex Gorsky reverses course and jumps ship — just as Trump scuttles top CEO groups (Endpoints)
  • Trump Misdiagnoses the Opioid Crisis (New Yorker)
  • PhRMA Criticizes FDA's 'Unnecessary' Research on Drug Advertising and Promotion (Focus) (Stat) (PharmaMarketing Blog)
  • White House Reported to OK August CSR Payment (MedPage Today)
  • We've Already Got Socialized Medicine (Scientific American)

Sponsored Content: RWS Acquires LUZ

In Focus: International

  • The Night the Oxygen Ran Out in an Indian Hospital (NY Times-$)
  • Coagulation reversal agent Praxbind now being used in Brazil (PharmaLetter-$)
  • China’s embrace of embryo selection raises thorny questions (Nature)
  • China responds to pending U.S. trade investigation (BioWorld)
  • The Thai FDA's Approach To Biologics And Biosimilars (Biosimilar Development)
  • Top Korean pharma companies increase their R&D spending in H1 (BioSpectrum)
  • J&J Partners with India's IMTECH to Develop New Treatments for TB (GEN)
  • Harvoni Top-Selling Drug in Japan in FY2016, Opdivo Jumps but Drop Expected for FY2017: Jiho Tally (Pharma Japan-$)
  • GSK Opens API Facility in Scotland (InPharma)
  • BASF Outlines Plans for $50m R&D Facility in Mumbai (InPharma)

Pharmaceuticals & Biotechnology

  • On the Hudson, Two Developers Open NYC’s Latest Bio Startup Space (Xconomy)
  • FDA approval of Aerie Pharma glaucoma drug jeopardized by problems outside its control (Stat-$)
  • Supreme Court Biosimilar Decision — What Developers Need To Know (Biosimilar Development)
  • Top UCSF scientist Shaun Coughlin joins migration to Big Pharma, leaping to Novartis (Endpoints)
  • Independent research may change the immunotherapy game (Pharmafile)
  • Type 2 diabetes market set to soar to $64bn by 2026 (PMLive)
  • Quantum Pharma confirms Clinigen takeover bid (PMLive)
  • Tick and flea control agent Bravecto continues to be acceptably safe to use (EMA)
  • Poor implementation of online tracking of drugs at ports hits industry badly (PharmaBiz)
  • Valeant Receives FDA Confirmation Of Voluntary Action Indicated (VAI) Inspection Classification For Tampa Facility (Press Release) (Endpoints)
  • Cancer Genetics to Acquire Australian CRO (BioPharm International)
  • J&J, Woman Spar Over Science At Cancer Trial's Close (Law360-$)
  • MiMedx Group, Inc. v. Liventa Bioscience, Inc. (N.D. Ga. 2017) (Patent Docs)
  • Kiadis Pharma obtains up to €15 million debt financing from Kreos Capital (Press)
  • Medpace Holdings, Inc. Announces Stock Repurchase Agreement with Cinven (Press)

Pharmaceuticals and Biotechnology: Clinical Study Results, Filings & Designations

  • At Last, a Big, Successful Trial of Probiotics (The Atlantic)
  • Chess Study Revives Debate Over Cognition-Enhancing Drugs (JAMA)
  • Aspirin versus Placebo in Pregnancies at High Risk for Preterm Preeclampsia (NEJM-$)
  • Pediatric Intestinal Failure (NEJM Review Article)
  • Six-Month Response to Delamanid Treatment in MDR TB Patients (CDC Research Letter)
  • U.S. DOD to Start New Trial with Pluristem's PLX-R18 Cell Therapy Against ARS (GEN)

Medical Devices

  • Glytec gets FDA clearance for its insulin management technology (MobiHealthNews)
  • Minn. Justices Say Medtronic Investors Can Sue Over Merger (Law360-$)
  • 3rd Circ. Divides Stryker Poaching Suit Between Calif., NJ (Law360-$)

US: Assorted & Government

  • Public Opinion about the Future of the Affordable Care Act (NEJM)
  • Fewer Investigations Pursued by HHS Research Oversight Office (BNA)
  • Texas Improperly Received Medicaid Reimbursement for School-Based Health Services (HHS OIG)
  • Manchester Likely to File Its Own Lawsuit Against Opioid Companies (New Hampshire Public Radio)
  • Ohio “Drug Price Relief Act” Ballot Update (Policy and Medicine)

Upcoming Meetings & Events

Europe

  • Commission clears acquisition of Albany Molecular Research by Carlyle and GTCR (EC)
  • Risk Assessment by the Scientific Committees of the European Commission (EC)
  • MHRA successfully reclassifies Dovonex Psoriasis Ointment (MHRA)
  • Hikma Pharma shares plunge despite posting solid first-half 2017 growth (PharmaLetter-$)
  • Hikma statement on its ANDA for generic Advair Diskus (London Stock Exchange)
  • EMA plans biomarker and drug-matched guidelines (InPharma)

General Health & Other Interesting Articles

  • Opioid overdoses leading to more ICU admissions and deaths (Reuters)
  • Inpatient Naloxone Program: Pain Medicine News Report (MedPage Today)
  • From the jury selection process that took place over three days in June for the trial of Martin Shkreli (Harper’s Magazine)
  • Watch this soft robot heal like Wolverine (Science)
  • They Got Hurt at Work. Then They Got Deported. (ProPublica)

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? Send him an email at news@raps.org.

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

Share this article:

Categories: Biologics and biotechnology, Drugs, Medical Devices, News, US, Europe, Asia, FDA, EMA, EC, MHRA

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

Regulatory Exchange: Latest Updates From the Community