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• FDA's Draft Guidance on Data Integrity: The Cupola on a Tower of Guidances (FDA Law Blog) (Focus)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

• AstraZeneca mulls £7bn move for prostate cancer drug company Medivation (Telegraph) (FierceBiotech)
• NICE recommends PTC's Duchenne drug (Pharma Times) (First Word Pharma) (PMLive)
• China's Silicon Valley Dream Powers Rise of Health Startups (Bloomberg News)
• China’s Vaccine Scandal Threatens Public Faith in Immunizations (NY Times)
• Indian government to set up bulk drug manufacturing hubs (Economic Times)
• MHRA Drug Safety Update for April (MHRA)
• Recipharm to buy Kemwell's API and forumlations business for SEK1.7bn (InPharma-Technologist)
• British Biosimilars Association launches in UK (Pharmafile)

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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

• Request for Comments on National Bioethics Advisory Bodies (Federal Register)

Upcoming Meetings and Events              

• RAPS' FDA Advisory Committee Meeting Tracker

Europe

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

China

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

India

• 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)

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