Regulatory Focus™ > News Articles > Regulatory Recon: Juno Halts Trial After 3 Deaths; Theranos CEO Banned From Running Lab for 2 Years

Regulatory Recon: Juno Halts Trial After 3 Deaths Theranos CEO Banned From Running Lab for 2 Years (8 July 2016)

Posted 08 July 2016 | By Zachary Brennan 

Regulatory Recon: Juno Halts Trial After 3 Deaths Theranos CEO Banned From Running Lab for 2 Years (8 July 2016)

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

In Focus: US

In Focus: International

  • European Commission Grants Marketing Authorization for Gilead’s Epclusa (Sofosbuvir/Velpatasvir) for the Treatment of All Genotypes of Chronic Hepatitis C (Press)
  • EU High Court Says Law Allows Royalties For Invalid Patents (Law360-$)
  • EMA’s CHMP Adopts Guideline on clinical investigation of medicinal products in the treatment of hypertension (EMA) (Overview of Comments)
  • EMA’s CHMP Adopts Guideline on clinical investigation of medicinal products in the treatment of lipid disorders (EMA)
  • EMA Adopts Guideline on clinical evaluation of medicinal products used in weight management (EMA) (Overview of Comments)
  • Applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use (EMA)
  • Cipla to Invest in South African Biosimilars Plant (India Times)
  • European Regulatory Roundup: Roche Awaits Outcome of Pharmacovigilance Infringement Procedure (Focus)
  • Brazil’s ANVISA updates modification process for lower-risk cadastro devices (Mass Device)
  •  MRA GMP clearance application processing timelines (Australia’s TGA)
  • CFDA Vice Minister Wu Zhen meets Japanese pharmaceuticals and medical devices delegation (CFDA)
  • "SINAQUA Dermal Glove" disposable washing gloves recalled due to the risk of bacterial infections (Swissmedic)
  • PDG (Pharmacopoeial Discussion Group) Stage 4 Drafts (Japan’s PMDA)
  • New Drug and Health Product Safety Reviews (Health Canada)

US: Pharmaceuticals and Biotechnology

  • Why cancer has not been cured (Economist)
  • Drug maker is warned over missing study about child opioids use (Stat)
  • Anti-HIV pill may not be reaching those most at risk (Reuters)
  • Pfizer Jumps At The Chance To Apply Bind’s Technology To Immuno-Oncology (Pink Sheet-$)
  • ‘Shark antibody’ biotech AdAlta seeks $7.5M IPO for fibrosis candidate (Fierce)
  • Biotech Roundup: Fighting Addiction, Obama Precision, Juno Deaths & More (Xconomy)
  • Biotech Stock Mailbag: Heron, Exelixis (TheStreet)

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

  • Pfizer, Merck launch late-stage ovarian cancer trial (Pharma Times)
  • Pfizer Announces Positive Top-Line Results From Phase 3 S-TRAC Trial of Sutent (sunitinib) as Adjuvant Therapy in Patients at High Risk of Recurrent Renal Cell Carcinoma (Press)
  • Review of Transporter-Related Postmarketing Requirement or Postmarketing Commitment Studies (Journal of Clinical Pharmacology)
  • Role of Transporters in Drug Development (Journal of Clinical Pharmacology)
  • The Application of Physiologically Based Pharmacokinetic Modeling to Predict the Role of Drug Transporters: Scientific and Regulatory Perspectives (Journal of Clinical Pharmacology)
  • Alnylam Initiates Phase 1/2 Clinical Trial for ALN-HBV, an Investigational RNAi Therapeutic for the Treatment of Chronic Hepatitis B Virus Infection (Press)

US: Medical Devices

  • FDA Cold On Freezing Treatments (Law360-$)
  • Study: St. Jude Medical’s CardioMEMS lowers all-cause admissions in HF patients (Mass Device)
  • St. Jude Medical settles lawsuit over CRM leads for $39m (Mass Device)
  • InspireMD closes $15m offering (Mass Device)
  • Device Hacks Becoming More Sophisticated, Targeted, Security Firm Warns (Gray Sheet-$)
  • Essential Medical Inc. Announces FDA Approval to Begin a U.S. Clinical Trial for the Manta Large Bore Vascular Closure Device (Press)

US: Assorted and Government

  • House Panel Passes Infectious-Disease Fighting Fund (Gray Sheet-$)

Upcoming Meetings and Events 

Europe                                                                                

  • European pharma ‘to grow 3.2% per year by 2022’ (PMLive)
  • EU allows paediatric use of Shire’s Restive (Pharma Times)
  • NHS England, PTC reach agreement on Duchenne drug (Pharma Times)
  • QT Vascular wins CE Mark for Chocolate Heart DCB (Mass Device)
  • Riociguat (Adempas): New contraindication in patients with pulmonary hypertension associated with idiopathic interstitial pneumonias (Bayer/EMA)
  • Eisai calls for immediate solution to CDF black hole (European Pharmaceutical Review)

India

  • Union govt needs to fast-track modern, patient centric new D&C Act and Rules with no delay: Bejon Misra (PharmaBiz)
  • Intertek approved as India’s first certification body for ICMED scheme (PharmaBiz)

China

  • Dehaier enters China’s elderly sleep apnea market (Mass Device)

Zika

  • A shameful partisan battle over Planned Parenthood threatens crucial Zika funding (LA Times Editorial)
  • CDC monitoring 320 U.S. pregnant women with Zika (Reuters)
  • GSK/NIH 'SAM' Strategy May Reap Benefits Beyond Zika (Scrip-$)

General Health and Other Interesting Articles

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? 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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