Regulatory Focus™ > News Articles > Regulatory Recon: CFDA Review Finds 80% of Chinese Clinical Trial Data is Fabricated; Teva Alleges F

Regulatory Recon: CFDA Review Finds 80% of Chinese Clinical Trial Data is Fabricated Teva Alleges Fraud in $2bn Acquisition (28 September 2016)

Posted 28 September 2016 | By Michael Mezher 

Regulatory Recon: CFDA Review Finds 80% of Chinese Clinical Trial Data is Fabricated Teva Alleges Fraud in $2bn Acquisition (28 September 2016)

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

In Focus: US

  • Shire bails out of Baxalta biosimilars, ends Coherus, Momenta deals (Fierce) (BioCentury)
  • Biotech IPOs: Outliers, Value Creation, And The Dispersion Of Returns (LifeSciVC)
  • Furor Over Drug Prices Puts Patient Advocacy Groups in Bind (NYTimes)
  • Controversy Erupts Around Baby With Three Biological Parents (Forbes) (Harvard Bill of Health) (MIT Technology Review) (NYTimes)
  • Separating hope from hype in the latest cancer treatment 'revolution' (STAT)
  • NIH Funds Second Round Of Controversial Chelation Trial (CardioBrief)
  • The Proposed Federal 'Right-To-Try' Law Is Not The Answer For Critically Ill Patients (Health Affairs Blog)
  • Google Translate Star Leaves Venter's Human Longevity For Illumina-Backed Grail (Forbes)
  • US Government Agencies Have Placed A Value On An Extra Year of Life And It's Higher Than You Think (Forbes)
  • I Saw Alphabet's Health Watch (MIT Technology Review)
  • Zuckerberg appoints AstraZeneca's Cornelia Bargmann (Pharmafile)
  • Ask a MacArthur genius: Just how cheap can cancer diagnosis get? (Washington Post)
  • A Public Health Framework for Legalized Retail Marijuana Based on the US Experience: Avoiding a New Tobacco Industry (PLOS)
  • Pfizer Completes Acquisition of Medivation (Press)
  • Tenofovir Pre-exposure Prophylaxis for Pregnant and Breastfeeding Women at Risk of HIV Infection: The Time is Now (PLOS, Study)
  • CDC whistleblower claims agency has been using wrong Zika test (Washington Post)
  • Americas Region Declared Free of Endemic Measles (NYTimes) (Reuters)
  • As hep C proves a 'flash in the pan' once again, Gilead's sales will 'erode massively': Analyst (Fierce)
  • A Tale Of Two Committees: Which Probed EpiPen Better? (Pink Sheet-$)
  • Boston Scientific to pay $210m for EndoChoice (MassDevice)

In Focus: International

  • The World Wakes Up to the Danger of Superbugs (NYTimes)
  • 80% of Chinese clinical trials' data fabricated (Pharmafile) (RadioFreeAsia)
  • Consultations on adoption of European Union guidelines in Australia (TGA)
  • Bluebird gene therapy granted EMA accelerated assessment status (BioPharmaReporter)
  • GSK offloads French drug discovery site, commits $40M to support transition (Fierce)
  • Mylan, Lupin Said to Weigh Bids for Bayer Dermatology Unit (Bloomberg)
  • Cipla aims to reach $1bn India sales through tie-ups (Economic Times)
  • What's A Fair Price for a Biosimilar in Europe? (SCRIP-$) (Pink Sheet-$)
  • Malaysian pharmaceutical market set to grow to $3.6 billion by 2020 (Pharmafile)
  • Japan To Become First Market For Troubled Brodalumab (SCRIP-$)
  • Teva Alleges Fraud In $2B Purchase Of Mexican Drug Co. (Law360-$)
  • Novartis Tests Global Manufacturing Process For CAR-T Therapy (Pink Sheet-$)
  • GSK's Immunology Strategy Edges Closer To Delivering (SCRIP-$)
  • NICE backs Bayer's Eylea to treat sight condition (PharmaTimes)

US: Pharmaceuticals & Biotechnology

  • Novartis oncology vet to head up cancer I/O startup Neon (Fierce)
  • Interview: Strategies For Bio Manufacturing Partnerships (SCRIP-$)
  • The Role Of Value And Cost In Prescription Drug Pricing (Law360-$)
  • Drug Company Accused of Price-Gouging Has Developed Deep Capitol Network Since 2010 (National Law  Review)
  • Mast cuts back after Phase 3 miss (BioPharmaDive)
  • New Rockefeller Prez Takes Stock of "Wildly Underdeveloped" NY Bio Scene (Xconomy)
  • MIT Accelerator STEX25 Launches With Five Boston-Area Startups (Xconomy)
  • Researchers: unpublished adverse reactions a 'serious problem' (OutsourcingPharma)
  • FDA Encourages Pediatric Master Protocols With Bayesian Approach (Pink Sheet-$)
  • FDA Hiring Campaign Continues; Goal Is Addressing Pending ANDAs (Pink Sheet-$)
  • Teva Announces Launch of Generic Epzicom® Tablets in the United States (Press)
  • ProNAi buys rights to cancer drug for up to $328.5 million (PharmaLetter-$)
  • Galapagos CEO confirms Gilead standstill agreement is active, quashing takeover talk (Fierce)
  • Galectin routed by PhIIa NASH failure (Fierce)
  • Gilead donates $20 million to enhance access to treatment for often fatal neglected tropical disease (PharmaLetter-$)

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

  • Fast track status for Duchenne MD drug ezutromid (PharmaLetter-$)
  • Lilly to Present Latest Data for Taltz® (ixekizumab) in Psoriasis at the European Academy of Dermatology and Venereology (EADV) Annual Congress (Press)
  • Bayer To start phase III study with Vericiguat (Reuters)
  • Two New Trials of Merck's KEYTRUDA® (pembrolizumab) as Monotherapy and in Combination with Chemotherapy for First-Line Treatment of Patients with Advanced Non-Small Cell Lung Cancer to be Presented During Presidential Session at ESMO 2016 (Press)
  • Galera Therapeutics Announces Presentation of One-Year Follow-up Data from a Phase 1b/2a Study of GC4419 In the Reduction of Severe Oral Mucositis (Press)
  • Moberg Pharma Begins Patient Enrollment in North America and Europe in Two Phase 3 Studies of MOB-015 in Onychomycosis  (Press)
  • Updated Phase 1 Data Reinforce the Clinical Profile of Epacadostat in Combination with Keytruda® (Pembrolizumab) (Press)
  • Kitov Reports Successful Results for Additional KIT-302 Pharmacokinetic Bioequivalence Study (Press)
  • First FDA Approved Cross-Linking Procedures Are Performed on Patients in the U.S. with Progressive Keratoconus (Press)

US: Medical Devices

  • FDA Finalizes Guidance Regarding Patient Preference Information for Medical Device Submissions (FDA Law Blog)
  • A Wireless Medical Device Manufacturer's Guide to Market Conformity (MassDevice)
  • Dialysis organizations team up with CDC to protect patients (CDC)
  • Medtronic touts 1st-in-human use of Sugar.IQ with Watson 'cognitive app' (MassDevice)
  • Siemens investors back Kaeser (MassDevice)
  • Phenox touts pREset thrombectomy device trial data (MassDevice)
  • Class 1 Device Recall Adaptor for SBD II (FDA 1, 2)
  • Abbott Receives FDA Approval for the FreeStyle Libre Pro™ System, a Revolutionary Diabetes Sensing Technology for Healthcare Professionals to Use with Their Patients (Press)

US: Assorted & Government

  • Making Sure 'Healthy' Means What It Says on Food Packages (FDA Voice)
  • Another Slam Dunk Infuse Win – Preemption and More (Drug and Device Law)
  • California Right to Try Act signed into law (BioCentury)
  • Cracks Appear In Blue Cross' Obamacare Fire Wall (Forbes)
  • Maryland group attacks high cost of prescription drugs (Modern Healthcare)

Upcoming Meetings & Events

Europe

  • Grünenthal research consortium receives €1.5m EU grant (PMLiVE)
  • Merck elects Isabel De Paoli as CSO (Pharmafile)
  • Plan to reduce health and care red tape burden (UK DOH)

Asia

  • Japan Approves Humira for Non-Infectious Uveitis (Press)
  • Japanese regulators approve Abiomed's Impella heart pumps (MassDevice)
  • Approval for Manufacturing and Marketing of "Micatrio® Combination Tablets," an Antihypertensive Drug -Japan's first ARB/CCB/diuretic three ingredients combination- (Press)
  • Astellas Receives Approval for Kiklin® Granules, a Treatment for Hyperphosphatemia, in Japan (Press)

India

  • Access to life saving medicines will be maintained: Govt (Economic Times)
  • Indian union plots mass protest against 'unfair' treatment of pharma sales reps (Fierce)

Australia

  • Performance statistics report: July 2015 to June 2016 (TGA)

Zika

  • Thailand rules out Zika link in two microcephaly cases; investigating two (Reuters)

General Health & Other Interesting Articles

  • Out of Africa: DNA Analysis Points to a Single Major Exodus (NIH Director's Blog)
  • Music therapy may help kids cope with immunization shots (Reuters)
  • CDC awards $13 million to establish the first Vector Control Unit in Puerto Rico (CDC)
  • Task force advises routine preeclampsia screening in pregnancy (Reuters)
  • WHO releases country estimates on air pollution exposure and health impact (WHO)

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.


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