Regulatory Recon: Lilly, Incyte RA Drug Baricitinib Rejected; FDA Ends REMS Requirement for Amgen Anemia Drugs (14 April 2017)

Posted 14 April 2017 By Michael Mezher

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Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

In Focus: US

  • FDA Issues Complete Response Letter for Baricitinib (Press) (Endpoints) (Business Insider)
  • FDA Ends REMS Requirement for Anemia Drugs (Medpage) (FDA)
  • FDA Officials Question Lack of New Cancer Drugs Developed in Combination With Radiation (Focus)
  • Abbott, Alere Advance Contentious Merger With Reduced Price (WSJ)
  • Pfizer Says Execution Drugs Sold to Arkansas Without Knowing (Bloomberg)
  • 2 companies seek to block Arkansas from using their lethal injection drugs (Chicago Tribune)
  • With FDA strong arming, Hyland's recalls homeopathic teething products (ArsTechnica) (STAT)
  • FDA sends St. Jude a warning over two high-profile device issues (Star Tribune) (Focus) (Reuters) (NYTimes)
  • Patient Input Comes Full Circle: Ex-FDAer Gives Feedback To FDA (Pink Sheet-$)
  • Neurocrine's US Label For Ingrezza Should Provide Edge Over Teva's Austedo In TD (Pink Sheet-$)
  • What Precision Medicine Can Learn from the NFL (Forbes)
  • 'It will help us with our product': Emails show how a billionaire's philanthropy boosted his business (STAT)
  • Patrick Soon-Shiong, channeling Trump, uses Twitter to vent anger over attacks (Fierce)
  • Trump administration issues final rule on stricter Obamacare enrollment (Reuters)
  • Examining The Final Market Stabilization Rule: What's There, What's Not, And How Might It Work? (Health Affairs Blog)
  • Trump's Obamacare Subsidy Threat Is Bad Timing For Insurers (Forbes)
  • New CRISPR tool can detect tiny amounts of viruses (Science) (Washington Post)
  • Venture capital continues to flow for biopharma (EP Vantage)
  • When do pharmas disclose launch prices up front? When they're pricing at a discount (Fierce)
  • University of California/Berkeley Appeals Adverse CRISPR Decision by PTAB (Patent Docs)

In Focus: International

  • Cipla, Sandoz Gearing For Seretide Challenge In Australia? (SCRIP-$)
  • Turkish Industry Group Builds New Platform To Support Biotech (SCRIP-$)
  • Emerging China Compliance Issues Warrant Closer Watch: Experts (Pink Sheet-$)
  • EMA Offers Draft Guideline on Trial Master Files (Focus)
  • European Regulatory Roundup: EMA Offers Guidance on Assessing Periodic Safety Update Reports (Focus)
  • Health workforce coordination in emergencies with health consequences (WHO)
  • Improving the prevention, diagnosis and clinical management of sepsis (WHO)
  • Global vector control response (WHO)
  • Cancer prevention and control in the context of an integrated approach (WHO)
  • US pharma warns on IP protection, points finger at China, Australia (PharmaLetter-$) (PhRMA)
  • Moldova Gets Help To Join EU Medicines Network As Equal Partner (Pink Sheet-$)
  • Regulatory filing for biosimilar Herceptin in Japan (PharmaLetter-$)

US: Pharmaceuticals & Biotechnology

  • Sorrento drops 39% before Easter after shares offering (Fierce)
  • Public Members needed for FDA's Institutional Review Board (FDA)
  • Novartis' Gilenya patent loss sets MS market up for battle with early generics (Fierce)
  • Abuse-Deterrent Opioids: Postmarketing Data Eyed As Development 'Anchor' (Pink Sheet-$)
  • How Darzalex could surge clear of its multiple myeloma rival (EP Vantage)
  • Persistent sterile injectable drugs shortages put patients at risk (Modern Healthcare)
  • What Doesn't Kill You Can Maim: Unexpected Injuries From Opioids (NPR)
  • Ex-CEO Da Silva chalked up $19M-plus in 2016 pay before Endo sent him packing (Fierce)
  • Gilead stock downfall takes a bite out of CEO's $13.9M pay package (Fierce)
  • AbbVie recruits 'Dancing with the Stars' champ to put the 'ME' in 'endometriosis' (Fierce)
  • Equivalence of complex drug products (GaBI)
  • Sunovion's Dasotraline To Be Filed In US For ADHD Despite Uncertainties (SCRIP-$)
  • California vaccination rate hits new high after tougher immunization law (Washington Post)
  • Innoviva to review costs, executive pay following Sarissa pressure (Reuters)
  • Speed, yield and quality critical for cell line development, says ATUM (BioPharmaReporter)

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

  • Relmada Announces FDA Fast Track Designation for d-Methadone for Adjunctive Treatment of Major Depressive Disorder (Press)
  • Icon Bioscience Submits NDA for DEXYCU, a Potential Transformational Drug Therapy for Treating Inflammation Associated with Cataract Surgery (Press)

US: Medical Devices

  • New Round of Class I FDA 510(k) Exemptions: Limited Impact (Emergo)
  • How Boston Sci is getting drug-eluting stents and balloons into legs (Medical Design & Outsourcing                          )
  • Philips receives FDA clearance to market Philips IntelliSite Pathology Solution for primary diagnostic use in the U.S. (Press)
  • Advanced Cooling Therapy Receives 510(k) Clearance from FDA for Use with New Control Unit (Press)
  • Additive Orthopaedics Announces FDA Clearance of their Locking Lattice Plating System for the Global Extremities Market (Press)

US: Assorted & Government

  • Protection? Fairness? Hardly. (The Health Care Blog)
  • Is Medicare's Value-Based Reimbursement Rewarding Low Quality Hospitals (Forbes)
  • Lawmakers propose $2B prize fund for new antibiotics—if developers waive exclusivity (Fierce)
  • Trump signs resolution allowing U.S. states to block family planning funds (Reuters)
  • Dems petition FDA to ban potentially toxic chemical from shampoos, body wash (The Hill)
  • Another One Bites the Dust: Plaintiff's Causation Expert Excluded in Hernia Mesh Litigation (Drug & Device Law)

Upcoming Meetings & Events

Europe

  • Small-cap focus: UK regions (Financial Times)
  • Seeking a lift, Novo launches ultrafast-acting insulin in European markets (Fierce)

India

  • Fresh PILs filed against 18 hospitals at Delhi HC for overcharging cardiac stents (PharmaBiz)
  • Wockhardt gets favourable ruling from DoP on its review plea against ceiling price of dicyclomine injection (PharmaBiz)

Canada

  • Canada on track to legalize recreational pot by July 2018 (Reuters)

General Health & Other Interesting Articles

  • More gay, bi men with HIV receiving care, disparities remain (Reuters)
  • Rates of new diagnosed cases of type 1 and type 2 diabetes on the rise among children, teens (CDC)
  • Mistreated: Why We Think We're Getting Good Health Care and Why We're Usually Wrong (Forbes)

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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