Regulatory Recon: UK High Court Invalidates Humira Patents; Germany to Abandon Plans to Lower Prices of New Drugs (6 March 2017)

Posted 06 March 2017 By Michael Mezher

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

In Focus: US

  • Seattle Genetics to resume trials as FDA lifts clinical hold (Reuters) (Press)
  • Dear Mr. President: Your view of the FDA is misguided. Here's why (STAT)
  • Will Drug Prices Come Down As Donald Trump Promised? His Regulators Help Pharmaceutical Companies Block Shareholder Questions About Rising Drug Prices (IBT)
  • 'Right-To-Try' Laws Expose Dying Patients To Exploitation, Ethicists Warn (KHN)
  • Will US FDA User Fee Reauthorization Bring More RATS? (Pink Sheet-$)
  • US Generic Reviews: Would Pre-Submission Meetings Be Better Than Six-Month Priority Review? (Pink Sheet-$)
  • Race Tightens for Next Wave of Cancer Drugs (WSJ)
  • Medical device makers stand to gain if Neil Gorsuch approved for Supreme Court (Star Tribune)
  • FDA OKs Noctiva, First Treatment for Nocturnal Polyuria (Medscape) (FDA)
  • Sanofi, Regeneron say latest Dupixent eczema drug tests positive (Reuters) (Fierce) (Press)
  • Orphan Drug Access Threatened By Medicaid Transformation, NORD Says (Pink Sheet-$)
  • Vertex to Pay Up to $250m for Concert Pharmaceuticals' Cystic Fibrosis Candidate  (The Street) (Fierce) (Press)
  • Lilly posts impressive psoriasis results in comparison study (Pharmafile) (Press)
  • Phase 3 data for Janssen psoriasis drug shows efficacy over Humira (Pharmafile)
  • GAO: Drugmakers Want More Clarity on Antibiotic Incentives (Focus)
  • FDA to Discuss Autism and Available Treatments in May (Focus)
  • TG Therapeutics' leukemia drug clears key study, shares soar (Reuters) (Fierce) (Press)
  • US Republicans expected to unveil healthcare bill this week (Reuters)
  • The Obamacare Sticking Points Behind Closed Doors (NYTimes)
  • 'Really Sick and Really Scared' Voters Temper Action on Health Law (NYTimes)
  • Repeal of Health Law Faces a New Hurdle: Older Americans (NYTimes)

In Focus: International

  • UK High Court rules against AbbVie's Humira patents (Pharmafile) (CNBC) (The Korea Herald)
  • Germany to scrap plan to lower prices of new drugs: lawmakers (Reuters)
  • South Korean Regulators Clarify Medical Device UDI, KGMP Rules (Emergo)
  • Brave New World: The Mutual Recognition of CGMP Inspections (FDA Law Blog)
  • This is it: MDR and IVDR texts now ready for final voting (MedicalDevicesLegal)
  • New Report Investigates Drivers of Off-Label Prescribing in the EU (Focus)
  • Merck and Pfizer Announce U.S. FDA and EMA Filing Acceptances of Three Marketing Applications for Ertugliflozin-Containing Medicines for Adults with Type 2 Diabetes (Press)
  • Negotiating the EU pricing system: How the financial crisis has encouraged closer-knit cooperation between member states (Pharmafile)
  • Otsuka to acquire Neurovance in potential $250 million deal (Pharmafile) (The Street)
  • Roche, Novartis Lose French Court Battle Over Off-Label Use Of Avastin In AMD (Pink Sheet-$)
  • Turkey: Produce Selected Drugs Locally Or Lose Reimbursement (Pink Sheet-$)
  • IQWiG finds no added benefit for breast cancer drug Ibrance (PharmaLetter-$)
  • Australian drugs cost 3.7 times more than global benchmark, says report (The Guardian)
  • Investors press GlaxoSmithKline to slash incoming CEO Walmsley's pay package (Fierce)
  • Russia approves first ever biosimilar of Serono's MS drug Rebif (BioPharmaReporter)
  • Polluted environments kill 1.7 million children a year: WHO (Reuters)

US: Pharmaceuticals & Biotechnology

  • Zacks US pharma industry outlook: drug pricing and biosimilars focus (PharmaLetter-$)
  • How Patients Are Creating the Future of Medicine (Harvard Bill of Health 1, 2, 3, 4, 5)
  • Gilead Executive Says Pharmacy Benefit Managers Keep Prices High (Bloomberg)
  • ICER's Final Report on Disease-Modifying Therapies for Multiple Sclerosis Finds Most Drugs are Over-Priced in Relation to Benefits for Patients (ICER)
  • The Wearables Revolution: Personal Health Information as the Key to Precision Medicine (Harvard Bill of Health)
  • Activist Investor Wins Control of Immunomedics Board Following Shareholder Vote (The Street)
  • Sartorius ups bioanalysis business with $320m Essen acquisition (BioPharmaReporter)
  • Blood clots halt Scynexis' trial of antifungal injection (Fierce)
  • Celgene, BMS, Novartis expected to top 2022 orphan drug market worth $209B: report (Fierce)
  • Glaxo serves up 20% payer discounts on Advair to soften generic blow (Fierce)
  • Mylan CEO Heather Bresch says diversification is boosting company after EpiPen controversy (CNBC)
  • To improve drug development, it's time to rethink clinical trial site engagement (MedCityNews)
  • Valerion develops antibody delivery method for Pompe disease therapy (Drug Delivery)
  • Socrates, Gene Editing And Electronic Dance Music: How To Teach Entrepreneurship In Biotech (Forbes)
  • Exciting Microbe Research? Temper That Giddy Feeling in Your Gut (NYTimes)
  • Amgen Clinical Trials Set State for Further Upside (The Street)
  • Does Valeant have the ad dollars to keep Siliq competitive in psoriasis? (Fierce)
  • Advaxis gets green light for trial of Amgen-partnered neoantigen cancer vaccine (Fierce)
  • Determination That FLONASE (Fluticasone Propionate) Nasal Spray, 0.05 Milligram, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness (FDA)

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

  • Bristol-Myers Squibb and Pfizer to Present New Analyses of Eliquis (apixaban) Clinical and Real-World Data at the American College of Cardiology 2017 Scientific Session (Press)
  • Exelixis' Cabozantinib Granted Orphan Drug Designation for the Treatment of Hepatocellular Carcinoma (Press)
  • PTC Therapeutics Announces FDA Acknowledgment of New Drug Application Filing for Translarna™ for the Treatment of Nonsense Mutation Duchenne Muscular Dystrophy (Press)
  • Revance Announces BELMONT Phase 2 Clinical Data to Be Presented at the 2017 American Academy of Dermatology (AAD) Annual Meeting (Press)
  • CEL-SCI Gives Update on Partial Clinical Hold on Phase 3 Head and Neck Cancer Study with Multikine (Press)
  • Concert Pharmaceuticals Presents CTP-543 Phase 1 Results at American Academy of Dermatology Annual Meeting (Press)
  • FDA Approves Increased Shelf Life and In-Use Storage at Room Temperature for Orfadin (nitisinone) (Press)
  • Deciphera Pharmaceuticals Initiates a Phase 1 Clinical Trial of DCC-3014 in Patients with Advanced Malignancies (Press)
  • Viamet Presents Positive Results from Phase 2b Trial of VT-1161 in Onychomycosis at the American Academy of Dermatology Annual Meeting (Press)
  • Aimmune Therapeutics Presents Clinical Data on Phase 3 Screening and Phase 2 Adherence for AR101 for Peanut Allergy at the 2017 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting (Press)
  • Oral OTEZLA (Apremilast) Demonstrated Significant Improvement versus Placebo in Trial of Patients with Moderate Plaque Psoriasis Who Were Naïve to Systemic and Biologic Therapy (Press)

US: Medical Devices

  • 5 tips to survive an FDA inspection (MassDevice)
  • 5 predictions for the medical device industry (MedCityNews)
  • OncoCyte says study confirms accuracy of lung cancer blood test (Reuters)
  • Class 1 Device Recall LIFEPAK 1000 defibrillator (FDA)
  • MITA Pushes For Medical Device Tax Repeal (MITA)
  • Nanoengineers 3D-print biomimetic blood vessel networks (Medical Design & Outsourcing)
  • Hitachi's Aloka Medical wins $162.8m DoD contract for radiology equipment (MassDevice)
  • FDA Gives Thumbs Up to Side Branch Stent for Bifurcation Lesions (TCTMD) (Press)
  • Izun Pharmaceuticals Announces Approval of Curasite Hydrogel Wound Care Product by FDA (Press)
  • FDA approval in hand, Tryton Medical inks distro deal with Cardinal Health's Cordis (MassDevice)
  • William Demant to boost share of fast-growing hearing implants market (MassDevice)

US: Assorted & Government

  • Hearing on Saving Lives Through Medical Research (Senate Appropriations)
  • J&J Gets Its First Win In Mo. Talcum Powder Trials (Law360-$) (MassDevice)
  • Fresenius Wins Bellwether Trial Over Dialysis Treatment (Law360-$)
  • An Intelligent Treatment of "Mass Actions" in Pennsylvania (Drug & Device Law)
  • More on Missouri – What To Expect and Not To Expect After Norfolk Southern v. Dolan (Drug & Device Law)
  • Myths About The Medicaid Expansion And The 'Able-Bodied' (Health Affairs Blog)
  • Massachusetts Governor Vows to Shield Planned Parenthood Funding (NYTimes)

Upcoming Meetings & Events

Europe

  • European pharma industry funds project to promote biologics development (PharmaLetter-$)
  • NICE backs new treatment for chronic liver disease (PharmaTimes)
  • PwC analysis highlights economic footprint of UK Life Sciences (ABPI)
  • NxStage wins CE Mark for next-gen System One hemodialysis system (MassDevice)
  • Concept paper on the need for revision of note for guidance on quality of water for pharmaceutical use (H+V) (EMA)
  • COCIR and EFOMP Announce Partnership (COCIR)

Asia

  • Second Ascletis HCV Therapy Gets Expedited CFDA Review (BioCentury)

India

  • Cipla halts HIV drug production due to delayed government funding (Pharmafile)
  • How the NPPA has transformed itself into a watchdog with teeth under Bhupindra Singh (Economic Times)
  • NPPA to meet stent makers on March 7 to discuss availability of stents at ceiling prices (PharmaBiz)
  • Few more drugs to come under price control: NPPA (Fierce)
  • DoP rejects review plea of IPCA against price fixation of "paracetamol tablet" (PharmaBiz)
  • Indian Court Lifts Curbs On Herceptin Biosimilars; Roche Sticks To Guns (Scrip-$)

Canada

  • Summary Safety Review - Zydelig (idelalisib) - Assessing the potential risk of serious infections (Health Canada)

Australia

  • Consultations on adoption of European Union guidelines in Australia (TGA)
  • Infections associated with heater-cooler devices (TGA)
  • Medicines Australia rejects latest Grattan report findings (PharmaLetter-$)
  • Flu vaccine: 2017 seasonal influenza vaccines for use in children (TGA)
  • Stability testing for prescription medicines (TGA)

Other International

  • Candidates for Director of the Pan American Sanitary Bureau to be nominated between 1 March and 1 May (PAHO)
  • Israel's BrainStorm names Biogen senior executive Kern as COO (Reuters)
  • Cipla divests animal health business in South Africa, sub-Saharan Africa (Economic Times)

General Health & Other Interesting Articles

  • Forbidding Forecast For Lyme Disease In The Northeast (NPR)
  • Dr. Thomas E. Starzl, Pioneering Liver Surgeon, Dies at 90 (NYTimes)

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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