Regulatory Recon: FDA Rejects Teva Huntington's Disease Drug Lawsuit Alleges Gilead Could Have Made Safer HIV Drug Sooner (31 May 2016)

Posted 31 May 2016 | By Michael Mezher 

Regulatory Recon: FDA Rejects Teva Huntington's Disease Drug Lawsuit Alleges Gilead Could Have Made Safer HIV Drug Sooner (31 May 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

  • FDA Rejects Teva's Application For Huntington's Drug (WSJ-$) (Reuters)
  • AstraZeneca's ZS-9 Timeline Hit By FDA Complete Response Letter (Pink Sheet-$) (BioCentury)
  • Emmanuelle Charpentier's Still-Busy Life After Crispr (NYTimes)
  • Drug Prices Too High? Sometimes, They're Not Costly Enough (NYTimes)
  • Don't Believe the Valeant M&A Hype (Bloomberg)
  • Intercept's Liver Drug Wins FDA Approval To Treat Rare Disease (Xconomy) (FDA) (SCRIP-$)
  • Searching for Superbugs: The Lab Looking for the Next Big Threat (NBC)
  • A question of timing: A lawsuit claims Gilead Sciences could have developed a less-harmful version of its HIV treatment sooner (LA Times) (AHF)
  • Inside the Sausage Factory of Drug Approval: Nuplazid (pimavanserin) coverage didn't inspect closely enough (Health News Review)
  • How Wellcome and Gates charities profit from helping biotech (Reuters)
  • Biogen, AbbVie once-monthly MS injection wins US approval (Reuters) (BioCentury) (SCRIP-$) (FDA)
  • US Supreme Court rejects patent appeal over Cubicin drug (Reuters)

In Focus: International

  • Samsung Bioepis receives final European approval for its Remicade copy (Reuters)
  • Roche's MabTherea shot gets EU OK for chronic lymphocytic leukemia (Reuters) (Press)
  • Asia Regulatory Roundup: Serious Injuries Linked to Devices in China Almost Double (Focus)
  • Roche and Novartis face off in biosimilar drug battle (Reuters)
  • Amicus' Fabry disease drug gets European Commission approval (Reuters)
  • Alibaba tells vendors to halt drug sales online, cites government rule change (Reuters)
  • The new General Data Protection Regulation impact on medical devices industry (MedicalDevicesLegal)
  • GSK gets EU approval for first gene therapy for children (Reuters) (BioCentury)
  • Teva investors fret over $41bn generic drugs deal (Financial Times)
  • NICE turns down Lilly's lung cancer drug Portrazza (PharmaTimes)

US: Pharmaceuticals & Biotechnology

  • Back to Basics: 505(b)(2) FAQs Part 2: Clinical and Nonclinical Studies (The 505(b)(2) Blog)
  • NICE and Highly Specialised Technologies: three years on (PharmaPhorum)
  • Genetic Testing For Cancer Risk Is On The Rise But Is It Smart? (Forbes)
  • Implementation of Acceptable Full Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Blood and Blood Components (FDA)
  • Study Suggests Cutting Some Vaccine Boosters For Rare Diseases (NPR)
  • Riding The Gene Editing Wave: Reflections On CRISPR/Cas9's Impressive Trajectory (LifeSciVC)
  • Superbug Gene Isolated in U.S. (Medpage)
  • Multi-Indication Pricing: Big Hurdles And Actionable Options (Pink Sheet-$)
  • In Defense of Antidepressants (WSJ-$)
  • Umbilical cords longer in babies exposed to SSRIs (Pharmaceutical Journal-$)
  • Five Storylines To Watch At ASCO (Forbes)
  • Jazz Pharmaceuticals Nears Deal to Buy Celator for About $1.5 Billion (WSJ-$)
  • Researchers develop novel technology for customised tablets  (Economic Times)
  • Tighter blood pressure control may be advisable for elderly (Reuters)
  • People with celiac disease advised to consider pneumonia vaccine (Reuters)
  • Six medicines win backing for EU approval (PhaarmaTimes)
  • Prescription Pain Killers May Worsen And Lengthen Chronic Pain (Forbes)
  • Sanofi's Lixisenatide Shows Challenges Of Being Late Entrant In Class (Pink Sheet-$)
  • Myeloma Drug Access Limits Unlikely Near-term – Aetna, Express Scripts Say (Pink Sheet-$)

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

  • ARIAD Announces Initiation of Phase 1/2 Clinical Trial of AP32788, an Investigational Oral Inhibitor of EGFR and HER2, in Patients with Non-Small Cell Lung Cancer (Press)
  • Syros Pharmaceuticals Announces FDA Acceptance of IND to Advance SY-1425 Into Phase 2 Clinical Trial (Press)
  • U.S. FDA Accepts for Priority Review Supplemental New Drug Application for the Use of ORKAMBI® (lumacaftor/ivacaftor) in Children with Cystic Fibrosis Ages 6 to 11 who have Two Copies of the F508del Mutation (Press)
  • Regeneron Presents Positive Interim Data From Phase 2 Study Of Evinacumab (RTT news)

US: Medical Devices

  • Midday Report: Thermo Fisher Buys FEI; U.S. Stocks Inch Higher (The Street)
  • Diabetes: FDA panel to mull expanded indication for Dexcom G5 continuous glucose monitor (MassDevice)
  • FDA slaps Class 1 label on Medtronic Capnostream battery pack recall (MassDevice) (FDA)
  • FDA approves new diagnostic imaging agent to detect recurrent prostate cancer (Medpage) (Press) (FDA)
  • First PT/INR home self-testing device with Bluetooth technology enabling remote care programmes for anticoagulated patients (Press)
  • Bindex, a Radiation-Free Device for Osteoporosis Screening, FDA Cleared (medGadget)
  • All Patients in Presbia Flexivue Microlens FDA Study Complete 6-Month Post-Operative Visits (Press)

US: Assorted & Government

  • GHTC Calls on Senators to Oppose Provisions That would Cut DoD Medical Research Programs (GHTC)
  • Sanders, House Dems press USTR on Colombia license (BioCentury)
  • Bayer's Bid for Monsanto Disquiets St. Louis Area (WSJ-$)
  • In a Secret Meeting, Revelations on the Battle Over Health Care (NYTimes)
  • How DOJ got 500-plus hospitals to settle over cardiac implants (Modern Healthcare)

Upcoming Meetings & Events


  • EU Medicines Agency Chiefs and their IT Directors Head To Rotterdam (SCRIP-$)
  • Positive CHMP opinion for Adcetris in post-transplant Hodgkin lymphoma (EPR)
  • Done With Apple, Carl Icahn Makes A Bet On Tax-Inverter Allergan (Forbes)
  • NHS England orders national service to handle Soliris (PharmaTimes)
  • Safety board clears TxCell to restart Ovasave study that was halted last year (BioPharma-Reporter)
  • ICH guideline S3A: Note for guidance on toxicokinetics: the assessment of systemic exposure in toxicity studies - questions and answers (EMA)
  • Takeda Oncology Hopes Hit By CHMP Ninlaro Rejection; Appeal Planned (Pink Sheet-$)
  • AbbVie (NYSE: ABBV) on Tuesday said Imbruvica (ibrutinib) has secured European regulatory backing to treat chronic lymphocytic leukemia or CLL. (Pharmafile)
  • Draft guideline on the plant testing strategy for veterinary medicinal products (EMA)


  • Sun Pharma ends Daiichi umbrella pact (Economic Times)
  • Medtronic opens new APAC HQ in Singapore (BioSpectrum)
  • Daiichi Sankyo moves further to cut legacy Ranbaxy ties (Fierce)
  • Inflectra-maker Celltrion to expand biosimilar capacity by 170,000L (BioPharma-Reporter)
  • Japan's Chugai touts publication of PhI emicizumab study in NEJM (Fierce)


  • Stempeutics research gets DCGI nod for stem cell based product (Economic Times) (SCRIP-$)
  • CDSCO maps out new site inspection norms for safer medicines (Economic Times) (Focus)
  • Sun Pharmaceuticals summoned by US Department of Justice (Economic Times)
  • All irrational FDC drugs have been weeded out from medicine market in Tamil Nadu: TNCDA president (PharmaBiz)
  • ALIMCO to start manufacturing prosthetics by early 2017 (Economic Times)
  • Granules India gets Establishment Inspection Report from USFDA (Economic Times)
  • The Pharmacy That May Just Solve India's Prescription Services Problem (Forbes)
  • Biocon granted permission for $158m expansion at Indian biomanufacturing site (BioPharma-Reporter)
  • Govt to amend Rule 96 of D&C Rules to make it mandatory to label red vertical line on Schedule H1 drugs (PharmaBiz)
  • Maha FDA to prosecute chemists for selling steroid-laden creams in the state (PharmaBiz)
  • India plans drug industry foreign investment scorecard (Fierce) (Economic Times)
  • IDMA urges DCGI not to replace gelatin based capsules with cellulose based capsules (PharmaBiz)


  • Biotechnology front and center of Australia's economic transition (PharmaLetter-$)
  • TGA presentation: NSW Health Pathology, 20 May 2016 (TGA)
  • TGA presentations given at the ARCS Scientific Congress Sydney, 11-12 May 2016 (TGA)
  • TGA presentation: National Medicines Symposium, 19-20 May 2016 (TGA)


  • WHO public health advice regarding the Olympics and Zika virus (WHO)
  • Medical experts want Rio Olympics delayed or moved due to Zika (Reuters)
  • WHO advises eight weeks of safe sex after return from Zika areas (Reuters)

Other International

  • Sixty-ninth World Health Assembly update (WHO)
  • WHO agrees global effort to eliminate viral hepatitis by 2030 (PharmaPhorum)

General Health & Other Interesting Articles

  • Yesterday's Cell-Phone Cancer Scare Scares Me A Little About The Future Of Journalism (Forbes)
  • After a heart attack, people more likely to take statins as directed (Reuters)
  • Monsanto Cultivates a Rose That Doesn't Wilt (MIT Technology Review)
  • Hidden Heart Disease Is The Top Health Threat For U.S. Women (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.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @Michael_Mezher or send him an email at

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

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