Regulatory Recon: FDA Expands Use of CF Drug; ASCO Abstracts Released (18 May 2017)

Posted 18 May 2017 By Zachary Brennan

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Welcome to Regulatory Recon, a daily regulatory news and intelligence briefing.

In Focus: US                                      

  • FDA expands approved use of Kalydeco to treat additional mutations of cystic fibrosis (FDA) (Spotlight)
  • House E&C to vote on user fees on Thursday (E&C)
  • Trump Reportedly Considering New Cuts to Biomedical Research (The Atlantic) (Stat) (MedPage Today) (SNL)
  • An "operating system for the brain" gets FDA approval (Axios)
  • Father of son who died in Juno clinical trial petitions FDA (Petition)
  • A New Orange Book Tool: Reference Listed Drugs by ANDA Reference Standard List (FDA Law Blog)
  • Drug Information Soundcast in Clinical Oncology (D.I.S.C.O.) (FDA)
  • U.S. pledges $526 million aid in 2017 to Tanzania to fight AIDS (Reuters)
  • The 340B Program Hits $16.2 Billion in 2016; Now 5% of U.S. Drug Market. Delayed (Drug Channels)
  • Final Rule on 340B Delayed Further (Federal Register)
  • FDA Warns on Faulty Lead Tests (Focus) (NY Times-$)
  • Stakeholders Push Gottlieb, Verma On UDI Incorporation In Claims (InsideHealthPolicy-$)

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In Focus: International

  • Major research funders and international NGOs to implement WHO standards on reporting clinical trial results (WHO)
  • G20 health ministers seek to avert return to "pre-penicillin era" (Reuters)
  • Canada to Amend Drug Pricing Regulations (Focus)
  • India's drug pricing regulator clamps down on drug cocktails (Reuters)
  • Tackling Ebola outbreak in remote Congo presents huge challenge: WHO (Reuters)
  • ANSM Raises GMP Issues at Brazil Plant (InPharma-Technologist)
  • Notice: Publication of Update to the Guidance Document: Data Protection under C.08.004.1 of the Food and Drug Regulations (Health Canada)
  • Clinical trials for medicines: apply for authorisation in the UK – updated examples (MHRA)
  • CFDA Vice Minister Wu Zhen meets Director General of the Food and Drug Administration of the Republic of the Philippines (CFDA)
  • China loosens grip on clinical trials, improves IP protection to boost innovation (PharmaLetter-$)
  • New Alliance to Drive and Measure Industry Progress to Curb Antimicrobial Resistance (IFPMA)
  • IFPMA Priorities At WHA: Election, Antibiotics, Cancer, Pandemics (IP-Watch-$)

Pharmaceuticals and Biotechnology

  • Vantage point – Are charities the best way to pay for costly drugs? (EP Vantage)
  • J&J, Abbott, Lilly lead pharma in diversity, says report (BioPharma Dive)
  • Industry admits lack of transparency spikes drug prices (Modern Healthcare)
  • Sanofi Wins False Claims Case Appealed by Rival Drugmaker (Bloomberg)
  • High Court Won’t Hear Dispute Challenging FDA Over J&J Drug (Bloomberg)
  • PTAB Invalidates Humira Patent In Coherus Challenge (Law360-$)
  • Pfizer, La. End Neurontin Antitrust Suit With $1M In Naloxone (Law360-$)
  • Express Scripts Says Kaléo Owes $14.5M In Naloxone Rebates (Law360-$)
  • Fed. Circ. Won't Put $455M Bayer Patent Award On Hold (Law360-$)
  • DelMar taps PRA Health Sciences to run pivotal brain cancer trial (FierceBiotech)

Pharmaceuticals and Biotechnology: Study Results, Filings and Designations

  • Incyte gets a boost from a series of positive data snapshots for its epacadostat/Keytruda combo (Endpoints) (TheStreet) (Reuters)
  • Key data on Shire's HAE drug bodes well for U.S. approval (Reuters)
  • Celgene, Agios Update Blood Cancer Drug Study Results in ASCO '17 Abstract (TheStreet)
  • Merck Keytruda-Chemo ASCO '17 Update Shows Lung Cancer Survival Trend (TheStreet) (Reuters)
  • ImmunoGen drug moving ahead in single-agent, combination trials (Reuters)
  • Pfizer drug from Medivation deal shows promise in breast cancer: study (Reuters)
  • Search 2017 ASCO abstracts (ASCO)
  • In ASCO abstracts, even progress illustrates nagging issues for cancer treatments (BioWorld)
  • FDA-approved drug helps treat rare immunologic disease, study finds (NIH)
  • Sage Therapeutics Receives Fast Track Designation for SAGE-217 for the Treatment of Major Depressive Disorder (Press)
  • Bayer lymphoma candidate wins FDA priority review (PharmaTimes)

Medical Devices

  • When hospital security lapses turn into digital malpractice (Stat) (Xconomy) (Bloomberg)
  • Myoscience wins FDA nod for Iovera knee osteoarthritis device (Mass Device)

US: Assorted and Government

  • Open Executive Session to Consider The Creating High-Quality Results and Outcomes Necessary to Improve Chronic (CHRONIC) Care Act of 2017 (Senate Finance)
  • United States Intervenes in Second False Claims Act Lawsuit Alleging that UnitedHealth Group Inc. Mischarged the Medicare Advantage and Prescription Drug Programs (DOJ)

Upcoming Meetings and Events             

General Health and Other Interesting Articles

  • The genetic microscope (Nature)

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.

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