Regulatory Recon: Tainted Scope Infections Re-emerge NICE Recommends Duchenne Drug (18 April 2016)

Posted 18 April 2016 | By Zachary Brennan 

Regulatory Recon: Tainted Scope Infections Re-emerge NICE Recommends Duchenne Drug (18 April 2016)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Zachary Brennan, @MichaelMezher and @RAPSorg on Twitter.

In Focus: US

  • Harvard Medical School Dean: Keeping a lid on drug prices (Boston Globe)
  • Why Medical Devices Aren’t Safer (NY Times)
  • FDA approves Boehringer’s Gilotrif for new indication (PR) (PharmaLetter-$) (OncLive)
  • FDA alerts health care professionals not to use sterile drug products from Pharmakon Pharmaceuticals (FDA)
  • FDA's Draft Guidance on Data Integrity: The Cupola on a Tower of Guidances (FDA Law Blog) (Focus)
  • Chiasma Craters on FDA Drug Rejection (TheStreet) (Xconomy) (Reuters)
  • Califf Lowering US FDA's Drawbridge To Work With External Expertise (SCRIP-$)
  • House E&C Committee to Mark Up Opioid Bills Next Week (E&C)
  • Pfizer-Allergan ruling sets a dangerous precedent (MedCity News)
  • Tainted scope infections far exceed earlier estimates (Kaiser Health News) (AP)

In Focus: International

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US: Pharmaceuticals and Biotechnology

  • After Gaffe, Biotech Firm Emphasizes Women (Not Just at Parties) (Bloomberg News)
  • Interview – UK cell therapy minnow squares up to Juno (EP Vantage)
  • Interview – Despite the many unknowns Celgene banks on CAR-T take-off (EP Vantage)
  • Vaccine switched in 'milestone' towards ending polio (BBC News)
  • Stem cell biotech BioCardia drops $50M IPO (FierceBiotech)
  • GLN: The Lowly Identifier That Could Kill The Use Of EPCIS For Pharma Regulatory Compliance (Rx  Trace-$)
  • GPhA: AbbVie's Petition On US Biosimilars A Ploy To Delay Interchangeables (SCRIP-$)
  • Attorney general investigating all insurers for Hepatitis C drug coverage (Albany Business Review)
  • Daiichi Sankyo Establishes New U.S. HQ (Contract Pharma)

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

  • AACR – Mage-A3 double-whammy hits Kite (EP Vantage) (Kite PR)
  • Loxo Cancer Drug Targets Gene Mutation With Durable Responses in Early Study (TheStreet) (Fierce Biotech) (Business Insider) (EP Vantage) (PR)
  • Bristol’s Opdivo Shows Benefits in Cancer Immunotherapy Trial (WSJ-$) (FierceBiotech) (PharmaTimes)
  • AbbVie looks to battle Gilead with new hep C data (Fierce Biotech) (PMLive)
  • Amyloid beta yielding data: Saying 'hola' to sola for AD heralds long-awaited win? (BioWorld)
  • The path of most resistance – causable human biology and the druggable genome (Plenge Gen)
  • Merck's Zepatier shows high response rates in hep C trials (Pharma Times)
  • Heptares, Kymab in Immuno-oncology Alliance (Contract Pharma)
  • Eli Lilly spurns a PhIII-ready diabetes drug, and Transition tanks (again) (FierceBiotech)
  • Bial and Eisai reveal positive data on Zebinix in epilepsy (PharmaLetter-$)
  • Gilead presents positive data on liver fibrosis treatments (PharmaLetter-$)
  • Boehringer Ingelheim exercises option on second OGAP oncology target (PharmaLetter-$)
  • Enumeral Announces Additional Data on Its Novel Class of PD-1 Antagonist to be Presented at the American Association for Cancer Research (AACR) 2016 Annual Meeting (PR)
  • Merck Receives Breakthrough Therapy Designation from U.S. Food and Drug Administration for KEYTRUDA® (pembrolizumab) in Classical Hodgkin Lymphoma (Merck PR)
  • ImmunoGen Announces Initiation of Clinical Testing of First-in-Class IMGN779 for Acute Myeloid Leukemia (PR)
  • AACR: Results from clinical trial of personalized cellular therapy in brain tumors (PR)
  • Penn Medicine presents evidence showing new drug combination may improve outcomes for women with advanced breast cancer when administered before surgery (PR)
  • Syros Pharmaceuticals Presents Data Demonstrating Significant Anti-Cancer Activity of SY-1425 in Preclinical Models of Acute Myeloid Leukemia (PR)
  • Tolero Pharmaceuticals Presents Data Demonstrating AXL Inhibition Leads to a Reversal of a Mesenchymal Phenotype Sensitizing Cancer Cells to Targeted Agents and Immuno-Oncology Therapies (PR)
  • Cellular trojan horse yields potential cancer treatment (PR)

US: Medical Devices

  • Theranos CEO Elizabeth Holmes: 'I feel devastated' (Business Insider) (CNBC)
  • FDA approves new leads for Nevro’s Senza spinal cord stimulator (Mass Device)
  • China’s Venus Medtech buys Transcatheter Technologies (Mass Device)
  • Siemens, Thermo partner for Molecular Testing (BioSpectrum)
  • Chronix’s new liquid biopsy approach show promise as early predictor of cancer therapies (Clinica-$)

US: Assorted and Government

Upcoming Meetings and Events              


  • Shire announces new $400 million biologics plant and 400 new jobs in Ireland (Pharmafile)


  • US refuses to release records on Chinese companies linked to deadly fentanyl trade (STAT)


  • India's Alkem Labs' shares fall on row over fudging trial data (Reuters) (Focus)
  • Roche sues Intas Pharma over patent dispute in India (Pharmafile)

Zika Virus

  • As cases and alarm grow, researchers seek ways to understand and stop Zika (Baltimore Sun)

General Health

  • The Patient Engagement Imperative (Health Affairs)
  • How grad students get paid affects where they work (Science)
  • Will Genetically 'Edited' Food Be Regulated? The Case Of The Mushroom (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.

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

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