Regulatory Focus™ > News Articles > Regulatory Recon: TauRX Alzheimer's Drug Fails in Phase III; GSK to Invest £275m in UK Manufacturing

Regulatory Recon: TauRX Alzheimer's Drug Fails in Phase III GSK to Invest £275m in UK Manufacturing Sites (27 July 2016)

Posted 27 July 2016 | By Michael Mezher 

Regulatory Recon: TauRX Alzheimer's Drug Fails in Phase III GSK to Invest £275m in UK Manufacturing Sites (27 July 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

  • Recent Off-Label Drug Cases Are A Road Map For The Future (Law360-$)
  • FDA Lowers ANDA Fee Rates for 2017 (Focus)
  • TauRx Alzheimer's drug fails in large study; some benefit seen (NYTimes) (The Street) (Reuters)
  • Lilly CEO Lechleiter to retire; David Ricks to succeed (Reuters) (Bloomberg) (Press)
  • Here's Why the Biotech Sector Is Due for a Pullback (The Street)
  • Insurers May Share Blame For Increased Price Of Some Generic Drugs (NPR)
  • FDA Explains Plans to Use Real-World Data in Medical Device Regulatory Decisions (Focus)
  • FDA Finalizes Guidance on Adaptive Designs for Device Studies (Focus)
  • The Importance Of Precision Medicine In Mental Health (Forbes)
  • U.S. wary on biotech advances; gene editing, CRISPR 'raising urgency' (Fierce) (Pew)
  • Pharma Researcher Must Face Investor Suit Over Outage (Law360-$)
  • Court Ends Amgen's 'Pointless' Biosimilar Suit Against Sandoz (Bloomberg)
  • FDA to Reevaluate Gay Blood Donor Guidance (Focus)
  • J&J feeling biosimilar impact but no plans to outsource Remicade production (BioPharmaReporter)
  • Eminence Based Medicine And Cardiac Surgery (CardioBrief)
  • Amgen Still Has Many Ways to Win (The Street)
  • Top three therapy areas dominate pipelines (PharmaTimes)
  • The Payment Reform Landscape: A Road Map For States To Bring Their Transparency 'A' Game (Health Affairs Blog)
  • Kite grabs a stem cell biology 'breakthrough' in race for off-the-shelf T cell therapies (Endpoints)

In Focus: International

  • Bayer beats expectations in 2nd-qtr results; raises guidance (PharmaLetter-$) (Pharmafile) (Press)
  • Orkambi deemed not suitable for NHS use (Pharmafile)
  • Dr Reddy's Laboratories may file applications  in Latin America, APAC, North Africa  (Economic Times)
  • WHO Weighs Dropping Transgender Identity From List of Mental Disorders (NYTimes)
  • US' Gilead faces competition from Bangladesh's Beacon pharma (Economic Times)
  • MHRA Drops Pharmacovigilance Compliance Reporting Requirements (Focus)
  • GSK says Britain is still an attractive place to invest (The Guardian) (Pharmafile) (Manufacturing Chemist)
  • GSK outlook brightens as Brexit brings currency windfall (Reuters) (Forbes)
  • GSK chases next biotech asthma drug with $230 million J&J deal (Reuters)
  • Asia Regulatory Roundup: India Caps Prices of Drug-Eluting and Bare-Metal Stents (Focus)
  • Countries should reduce use of colistin in animals to decrease the risk of antimicrobial resistance (EMA)

US: Pharmaceuticals & Biotechnology

  • Setting the Stage for PDUFA VI: Recap of Stakeholder Briefing (BIO)
  • Doctors not sure we all need routine skin cancer screening (Reuters)
  • FDA enhances warnings on group of strong antibiotics (Reuters) (FDA)
  • Recro Pharma's intravenous painkiller succeeds in trial, shares soar (Reuters)
  • Naloxone Eases Pain of Heroin Epidemic, but Not Without Consequences (NYTimes)
  • Warning: Government Listing Of Clinical Trials Doesn't Disclose Costs To Patients (KHN)
  • Your Phone Could Help Cure Zika - And TB, Ebola, And Other Devastating Infections (Forbes)

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

  • Neurovance Announces Positive Centanafadine Phase 2b Results for Adult ADHD, and Plans for Phase 3 Trials (Press)
  • FluGen Initiates a Phase 1 Clinical Trial of the RedeeFlu™ Universal Influenza Vaccine in Healthy Subjects (Press)
  • LSK BioPharma Announces Successful Outcome from End-of-Phase 2 meeting with FDA (Press)

US: Medical Devices

  • With reference pricing, patients spend less on diagnostic testing (Reuters)
  • The Future of Robotic Surgery: Snake-Like Bots That Glide Into Orifices (IEEE Spectrum)
  • Sight Sciences wins IDE for Visco 360 (MassDevice) (Press)
  • Edwards shares rise on Street-topping Q2 (MassDevice)
  • Vascular Solutions shares soar, raises guidance on Q2 earnings release (MassDevice)
  • Bard Q2 earnings top estimates (MassDevice)
  • FDA clears U.K. start-up Cydar's surgical guidance software (MassDevice)
  • CryoLife reports Q2 earnings, turns from loss to profit (MassDevice)

US: Assorted & Government

  • Vertex Ignored Red Flags In Clinical Trial, 1st Circ. Told (Law360-$)
  • HHS to fund cybersecurity information exchange (Modern Healthcare)
  • It's time to simplify health data regulation. Don't hold your breath (MedCItyNews)
  • Express Scripts grows profit despite processing fewer drug claims (Modern Healthcare)
  • Valeant, Par End Patent Suit Over Colitis Treatment (Law360-$)

Upcoming Meetings & Events

Europe

  • Learning from mistakes in the NHS: a special report by the Parliamentary and Health Service Ombudsman (PHSO) into how the NHS failed to investigate properly the death of a three-year-old child. (Harvard Bill of Health)
  • ALK shares slide as Merck & Co ends partnership (PharmaLetter-$)
  • Software MEDDEV 'updated' (Medical Devices Legal)

Asia

  • Symcel secures Phase I Horizon 2020 grant (BioSpectrum)
  • China's Fosun to buy KKR backed Gland Pharma for $1.4 billion (Economic Times)

India

  • Pharma sector receives Rs 4,975-crore FDI in FY16: Government (Economic Times)
  • Dr Reddy's post 14% 1st-qtr FY2017 sales decline (PharmaLetter-$)
  • Over six lakh people die due to cancer in India: Government (Economic Times)
  • Lupin in talks with Japan's Astellas, Shionogi to buy their off-patent drug brands (Economic Times)
  • Delhi govt puts a cap of Rs 600 for test for dengue (Economic Times)

Australia

  • Glyceryl trinitrate tablets (Anginine and Lycinate) (TGA)

Zika

  • CDC adds Saba to interim travel guidance related to Zika virus (CDC)
  • Honduras detects 8 cases of babies with Zika-related defect (Reuters)

General Health & 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? 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.


Categories: Recon, Regulatory News

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