Regulatory Focus™ > News Articles > Regulatory Recon: Fate of Health Care Act Uncertain as Vote Nears; GSK and Regeneron in Deal to Sequ

Regulatory Recon: Fate of Health Care Act Uncertain as Vote Nears GSK and Regeneron in Deal to Sequence Genes of 500,000 Britons (23 March 2017)

Posted 23 March 2017 | By Michael Mezher 

Regulatory Recon: Fate of Health Care Act Uncertain as Vote Nears GSK and Regeneron in Deal to Sequence Genes of 500,000 Britons (23 March 2017)

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

In Focus: US

  • GOP health-care plan hangs in balance as conservatives demand changes (Washington Post) (NYTimes) (Medpage) (CNN) (IHP-$)
  • As Scheduled Health Care Vote Looms, House GOP Remains Short on Support (NBC)
  • House Dems seethe at GOP plan for healthcare bill: 'Where the hell is it?' (The Hill)
  • If Health Bill Is Killed in the House, Ideology Will Be the Main Reason (NYTimes)
  • Trump fights for healthcare bill, makes headway with conservatives (Reuters)
  • US lawmakers seek pricing info on PTC Therapuetics' Duchenne drug (Reuters)
  • Uncertain fate of Obamacare causes some hospitals to halt projects, hiring (Reuters)
  • Crunch week looms for Sanofi, Roche and GSK at US drugs agency (Reuters)
  • Woodcock, Industry Groups Tell House E&C Committee PDUFA Reauthorization Delays Could be Dire (Focus)
  • Woodcock Notes 'Different Approach' To Funding PDUFA Reauthorization (BioCentury)
  • US Generic 'Breakthrough' Pathway Could Have Unintended Consequences (Pink Sheet-$)
  • Abbott Denied Early Win In GSK Suit Over HIV Drug Cost (Law360-$)
  • Shire's drug picked up from Baxalta given fast track designation (Pharmafile) (PharmaTimes)
  • After being pushed out of his FDA role, Califf becomes chair of new research group (Fierce)
  • The next horizon of innovation for pharma (McKinsey)
  • Merck must face renewed Fosamax warning claims: U.S. appeals court (Reuters)
  • Pharmacist guilty of fraud, not murder, in US meningitis outbreak (Reuters) (NYTimes) (DoJ)

Sponsored Content: IDMP is Delayed Again

In Focus: International

  • GSK and Regeneron to mine gene data from 500,000 Britons  (Reuters) (Pharmafile)
  • Breaking The Cold Chain: New Vaccine Doesn't Need Refrigeration (Forbes) (NPR)
  • Rise of superbug tuberculosis hampers global control efforts (Reuters)
  • Use of big data to improve human and animal health (EMA)
  • EMA Seeks Experts on Clinical Data Anonymization (Focus)
  • Mylan recalls 81,000 EpiPens outside US after reports of failure (Reuters)
  • UK Not Planning To Add to Regulatory Burden for Life Science Industry Post-Brexit (Pink Sheet-$)
  • NICE backs use of drugs for breast cancer prevention (PharmaTimes)
  • Romania bids to host EU drug agency after Brexit (Reuters)
  • Malta Bids For EMA, Citing Quality Of Life, Healthcare, And Small Pharma Industry (Pink Sheet-$)
  • Advent reportedly backs out of bid for Pfizer's Brazil plant (Pharmafile)
  • Injectable drug market to grow to $625 billion worldwide by 2021 (Pharmafile)
  • UK Judge Nixes Patent Extension For Merck HIV Drug (Law360-$)
  • WHO issues ethics guidance to protect rights of TB patients (WHO)
  • Drug prices set to increase on 'essential medicines' list in India (Pharmafile)
  • India Authorized Agent Role Changes under New Medical Device Rules (Emergo)
  • Canadian budget praised for 'focus on innovation and creating super clusters in biotech' (PharmaLetter-$)

US: Pharmaceuticals & Biotechnology

  • Treatment of Benzodiazepine Dependence (NEJM)
  • Guest Post: The importance of a modern FDA in drug discovery (PhRMA)
  • Lyrica Found Ineffective Against Sciatic Pain (Reuters) (Washington Post)
  • Founder steps down as Boston Biomedical gears up for FDA filings (PharmaLetter-$)
  • Scientists discover urinary biomarker that may help track ALS (NIH)
  • Intercept Hopes Statin Trial Will Lessen Ocaliva's Perceived CV Risk (SCRIP-$)
  • J&J taps Hannibal Buress to convince millennials to 'give a spit' about bone marrow donation (Fierce)
  • In clinical trials, hope new Alzheimer's biomarkers will point the way (PharmaLetter-$)
  • Fragmented CKD drugs market to reach $15.8 billion by 2024; Report (PharmaLetter-$)
  • Goodwin Biotech to work on opioid addiction vaccines project (BioPharmaReporter)
  • Avrobio launches gene therapy program for Gaucher disease (Drug Delivery)

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

  • Ultragenyx seizure drug fails mid-stage study (Reuters)
  • Symbiomix Therapeutics Announces FDA's Acceptance of New Drug Application for Solosec with Priority Review Status (Press)
  • Medicure Announces FDA Approval for Apicore's Generic Tetrabenazine (Press)
  • Confidential Data from Genervon ALS Phase 2A Clinical Trial Were Released and Published (Press)
  • Akcea and Ionis' familial chylomicronaemia syndrome study a success (EPR)

US: Medical Devices

  • Reducing Risk Through Materials Science: Shedding Light on Mysterious Design Failures (MDDI)
  • How to Exceed Customer Expectations by Rethinking Next-Gen IoT Medical Devices (MDDI)
  • Hologic closes $1.7B Cynosure buy (MassDevice)
  • Medtronic plans $2B debt flotation (MassDevice)
  • Medtronic wins FDA nod for CoreValve Evolut Pro (MassDevice) (Press)

US: Assorted & Government

  • Health Care Plan Championed By Trump Hurts Counties That Voted For Him (NPR)
  • On Health Reform, Democrats and Republicans Don't Speak the Same Language (ProPublica)
  • As Rivals Stand Silent, One Health Insurer Protests GOP Plan (NYTimes)
  • Disputed Federal Regulatory Duty Allows Federal Question Removal (Drug & Device Law)
  • Delay Is a Good Thing (FDA Law Blog)

Upcoming Meetings & Events

Europe

  • UK BioPharma Players Told 'Think Global, Act Local' For Post-Brexit World (Pink Sheet-$)
  • NHS trusts under growing pressure to make savings (PharmaTimes)
  • French drugmakers join forces on drug with potential to treat autism in children (PharmaLetter-$)
  • Concept paper on revision of the guideline on the requirements for clinical documentation for orally inhaled products (OIP) including the requirements for demonstration of therapeutic equivalence between two inhaled products for use in the treatment of asthma and chronic obstructive pulmonary disease (COPD) in adults and for the treatment of asthma in children and adolescents. (EMA)
  • Concept paper on revision of the guideline on the pharmaceutical quality of inhalation and nasal products (EMA)
  • Gamida Cell Receives Additional EMA Orphan Drug Designation for NiCord in Haematopoietic Stem Cell Transplantation (HSCT) (Press)

India

  • Taking steps to reduce dependence on API imports: Government (Economic Times)
  • Lupin receives US FDA approval for Novartis generic (Economic Times)

Australia

  • Scheduling delegate's final decisions, March 2017 (TGA)

General Health & Other Interesting Articles

  • The Forces Driving Middle-Aged White People's 'Deaths Of Despair' (NPR)
  • Antioxidant supplements don't lower dementia risk (Reuters)
  • Social Media, Math And The Mystery Of A Mumps Outbreak (NPR)

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

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