Regulatory Recon: Experts Decry Tying Medical Research Funds to FDA Changes BMS' Immuno-Oncology Combination Gets EU Approval (12 May 2016)

Posted 12 May 2016 | By Michael Mezher 

Regulatory Recon: Experts Decry Tying Medical Research Funds to FDA Changes BMS' Immuno-Oncology Combination Gets EU Approval (12 May 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

  • Theranos Executive Sunny Balwani to Depart Amid Regulatory Probes (WSJ-$) (NYTimes)
  • Valeant Promised Price Breaks on Drugs. Heart Hospitals Are Still Waiting. (NYTimes)
  • Senate negotiators zero in on Zika virus funding (Reuters)
  • Learning From the Lazarus Effect (NYTimes)
  • Secret rebates, coupons and exclusions: how the battle over high drug prices is really being fought (Washington Post)
  • Bill Ackman parts ways with man who introduced him to Valeant (CNBC)
  • Califf: Leveraging Real World Evidence is 'Top Programmatic Priority' for FDA (Focus)
  • Kentucky judge orders release of secret OxyContin records sought by STAT (STAT)
  • Streamlining Medicine and Saving Lives (WSJ-$)
  • Experts Decry Tying Medical Research Funds to FDA Standards Changes (WSJ-$)
  • Industry Calls for More Guidance From FDA on New Clinical Trials Technology (Focus)
  • Ex-FDA head and Sanofi call for harmonized drug regulation (Reuters) (Focus)
  • Of Mice And Men: Translation In Psychiatric Disease (LifeSciVC)
  • Provider Opposition To Medicare Part B Demo Will Get House Hearing (Pink Sheet-$) (Energy and Commerce)

In Focus: International

  • Patent not to affect hepatitis C drug price in India: Gilead Sciences Inc (Economic Times)
  • European Commission Approves BMS' Immuno-Oncology Combination (Press)
  • Early access to medicines scheme (EAMS): how the scheme works (MHRA)
  • NICE says 'no' to Opdivo for non-squamous NSCLC (EPR) (Pharmafile)
  • EMA Warns PRIME Applicants Over Missing Pediatric Investigation Plans (SCRIP-$)
  • European Regulatory Roundup: MHRA, UK Biopharma Industry Warn Against Brexit (Focus)
  • India updates on manufacture suspension for antifungal therapy (Fierce)
  • WHO recommends new test, treatment plan for superbug strains of TB (Reuters) (WHO)

US: Pharmaceuticals & Biotechnology

  • Schedules of Controlled Substances: Temporary Placement of Butyryl Fentanyl and Beta-Hydroxythiofentanyl into Schedule I (DEA)
  • Biopharma's Narrowed Patent Protection May Find Relief In Trade Secret Law (SCRIP-$)
  • Presidential Commission on Bioethics Lays Out Roadmap for Tackling Tough Ethical Questions (
  • Doctors need to know if patients are skipping pills (Reuters)
  • Baxter emerges as frontrunner to buy KKR-backed Gland Pharma for $1.1-1.2 billion (Economic Times)
  • Eli Lilly's Taltz set to reach blockbuster status by 2020, analyst predicts (PharmaLetter-$)
  • Mandatory flu shots tied to surge in health worker vaccinations (Reuters)
  • Cigna makes deals with Amgen, Sanofi for pricey cholesterol drugs (Reuters)
  • Allergan's Fishing For Deals, But Don't Expect A Big Catch (Pink Sheet-$)
  • FDA Renews Pulmonary-Allergy Drugs Advisory Committee (FDA)
  • Antibiotic Discovery Hurdles: Could Data Sharing, Research Hub Solve Problem? (Pink Sheet-$)
  • Jubilant, Cyclopharm terminate pact for Technegas in US market (Economic Times)
  • Cigna's Bradbury Talks PCSK9 Contracts And Value Versus Volume (Pink Sheet-$)
  • Hopes rise for FDA approval of Zafgen's fat-busting drug among analysts, investors (Boston Business Journal)
  • An Inside Look At The World's Largest Charitable Funder of Cancer Research (Geeks Talk Clinical)
  • Trakcel integrates cell therapy thawing tech in deal with Biocision (BioPharma-Reporter)
  • Schedules of Controlled Substances: Placement of Brivaracetam into Schedule V (DEA)
  • UK cell and gene therapy capacity hike signals long-term role says CGT (BioPharma-Reporter)

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

  • AstraZeneca drug wins orphan status in thyroid cancer (Reuters)
  • Bayer Terminates Phase II Study with Riociguat in Patients with Pulmonary Hypertension Associated with Idiopathic Interstitial Pneumonias (Press)
  • Merck to Present Phase 3 Data on Investigational Medicines Ertugliflozin and MK-1293 at the 76th Scientific Sessions of the American Diabetes Association (Press)
  • Kitov Receives Pre-NDA Meeting Response From FDA for KIT-302, Supporting its NDA Submission (Press)
  • Dermira's acne drug hits the spot in phase II (EP Vantage)
  • NLS Pharma Announces Submission of Investigational New Drug (IND) Application to FDA for Its Controlled-Release Mazindol for the Treatment of Adults with Attention-Deficit/Hyperactivity Disorder (Press)
  • CASI Pharmaceuticals Receives Approval From CFDA To Conduct Phase 2 Clinical Trial With ENMD-2076 For Fibrolamellar Carcinoma (Press)

US: Medical Devices

  • Benefit-Risk Profiles: Pharmaceutical And Device Products' Electronic Medical Records (Cutting Edge Info)
  • Smartphone app may help AFib patients take fewer blood thinners (MedCityNews)
  • FDA Issues Much Anticipated Draft Guidance on Additive Manufactured ("3D-Printed") Devices (FDA Law Blog) (Drug and Device Law) (Focus)
  • FDA Chief Counsel Addresses Staff Turnover, Device Bans (Gray Sheet-$)
  • InVivo adds 20th clinical site to Inspire study (MassDevice)
  • Biotronik launches Orsiro drug-eluting stent trial (MassDevice)
  • Adhesys inks licensing deal for surgical adhesive (MassDevice)
  • FDA Clears Next-Generation Version of EndoGastric Solutions' EsophyX Device (Press)

US: Assorted & Government

  • House passes bill to aid children born into opioid dependency (Reuters)
  • FDA: Frosted Flakes Healthier Than an Avocado (WSJ)
  • Guidance: Frequently Asked Questions about Medical Foods; Second Edition (FDA)
  • Slavitt Admits Gov't Failed in Health IT Push (Medpage) (Fierce)
  • U.S. to Post Employer Data About Workplace Injuries, Illnesses (WSJ-$)
  • Veterans' Health Care: Proper Plan Needed to Modernize System for Paying Community Providers (GAO)
  • Medicare Advantage: Action Needed to Ensure Appropriate Payments for Veterans and Nonveterans (GAO)
  • Aetna plans to remain in Obamacare markets, may expand (Reuters)
  • Planned Parenthood sues Ohio over plan to restrict funds (Reuters)
  • Louisiana legislature passes 72-hour waiting period for abortions (Reuters)

Upcoming Meetings & Events


  • Senseonics receives CE Mark for implantable continuous glucose monitoring system (mobihealthnews)
  • Pharma Taken By EU Pilot On Merging MRP/DCP Lines (SCRIP-$)
  • NHS England promises world-class cancer services (OnMedica)
  • Bristol-Myers Squibb and AbbVie Announce European Commission Approval of Empliciti (elotuzumab) for the Treatment of Multiple Myeloma in Adult Patients Who Have Received at Least One Prior Therapy (Press)
  • Ablynx burns more cash in first-quarter on higher R&D costs (Reuters)
  • Almost 9 in 10 CCGs not implementing NICE guidelines on antibiotic resistance (Pharmafile)
  • Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 11-14 April 2016 (EMA)
  • Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-28 April 2016 (EMA)
  • Corvia Medical lands CE Mark for heart shunt (MassDevice)
  • ANSM says Medreich plan will bring non-compliant Bollaram plant up to code (In-PharmaTechnologist)
  • MHRA information on TPP and QRISK 2 (MHRA)


  • China's Regulators Come Knocking Again At Pharma's Door (Forbes)
  • Takeda appoints new chief financial officer (Pharmafile)


  • Sanofi recalls some batches of painkiller Combiflam in India (Economic Times)
  • Ranbaxy whistleblower Dinesh Thakur may join PIL in Supreme Court (Economic Times)
  • Novartis Obtains Indian Patent On Composition For Psychiatric Disorders (24 Insight)
  • Watson Gains ANDA Approval For Natazia (24 Insight)
  • India's Glenmark Pharma Slapped with Form 483 (Pharmaceutical Manufacturing)
  • Health groups decry patent to US drug company Gilead Sciences for blockbuster hepatitis C drug sofosbuvir (PharmaBiz)
  • Experts push for common entity to reform all professional regulatory bodies in healthcare & not just MCI (PharmaBiz)
  • Drugs for BP, cancer among 54 to see up to 55% price cut (Economic Times)


  • Post-Authorization Activity Table (PAAT) for Trulicity (Health Canada)


  • Scheduling delegates' interim decisions and invitation for further comment: ACCS/ACMS, March 2016 (TGA)
  • Updated list of 'permissible ingredients' for use in listed medicines - list of affected ingredients (TGA)


Other International

  • WHO Raises Yellow Fever Warnings (Medpage)
  • NZ's PHARMAC to list Janssen's Sirturo and Sylvant for rare disorders (PharmaLetter-$)

General Health & Other Interesting Articles

  • Abortion rates fall to historic low in wealthy countries, little changed elsewhere (Reuters) (NYTimes)
  • Rise in heat waves tied to kidney disease 'epidemics' (Reuters)
  • Picking Up an Infection in the Hospital (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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