Regulatory Recon: Gates Makes $100M Investment in Alzheimer's R&D; J&J, Zymeworks Enter Potential $1B Discovery Pact (13 November 2017)

Posted 13 November 2017 By Michael Mezher

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

In Focus: US

  • Trump: Former Eli Lilly Exec to be Nominated as Next HHS Secretary (Focus) (NYTimes) (Washington Post) (Politico) (The Hill) (Twitter)
  • Price investigation continues to roil HHS (Politico)
  • Gates makes $100m personal investment to fight Alzheimer's (Reuters) (Endpoints) (Financial Times) (Gates)
  • US Investments in Medical and Health Research and Development (Research America)
  • J&J antes $50M to get Zymeworks' 6th big bispecifics alliance underway, with $6B in total milestones on the table (Endpoints) (GEN) (Fierce) (Press)
  • Will a boom in genetic testing of tumors be a boon for Soon-Shiong? (STAT)
  • Juno uses lethal neurotox lessons to guide Goldilocks formula for its next-gen CAR-T (Endpoints) (Xconomy)
  • An explosion of PD-1/L1 checkpoint studies is crowding the industry pipeline — and that's a problem (Endpoints)
  • What Red States Are Passing Up as Blue States Get Billions (NYTimes)
  • The Hype of Virtual Medicine (WSJ)

In Focus: International

  • Pfizer Sells Stake in China's Hisun, Ending Drugs Joint Venture (Bloomberg) (Reuters)
  • Novo Nordisk cutting 185 jobs, adding another 70 in commercial revamp (Fierce)
  • EMA Headquarters: There's no place like home (Pharmafile)
  • EFPIA DG reiterates the importance of putting patients at the centre of the EMA relocation Decision (EFPIA)
  • Investment Plan backs medical diagnostics services in Germany (EC)
  • Red Cross: $6 Million for Ebola Fight Stolen Through Fraud (NBC)
  • As the eradication of polio nears, a new crisis for global health looms (STAT)
  • ICH Seeks To Resolve Impasse Over Q12 Legal Review This Week (Pink Sheet-$)
  • EU Confirms Sirukumab Filing Withdrawal, J&J Moves On (SCRIP-$)
  • Novartis spotlights its top 4 blockbuster late-stage pipeline projects (Endpoints)
  • Novartis posts eye drug data amid play for Eylea's turf (Reuters) (Endpoints)
  • Novartis co-opts Homology's gene-editing tech for R&D pipeline (Endpoints) (Fierce) (C&EN)
  • Incentives, IP and smaller companies – the story of Chiesi and Holostem (PharmaLetter-$)
  • Nigerian agency strongly contests that 70% of drugs are fake (Pharmafile)
  • Brazil's ANVISA Proposing Easier Market Pathway for Low-risk Medical Devices and IVDs (Emergo)
  • Notified Body Withdraws GI Dynamics' CE Certificate for Endobarrier (Press)
  • Did Zika Cause More Miscarriages Than Microcephaly? (NPR)

Pharmaceuticals & Biotechnology

  • Nektar takes the spotlight at SITC touting some promising early data for hard-to-treat cancers (Endpoints)
  • Pfizer Names Albert Bourla Chief Operating Officer (Press)
  • Advancing the Discussion of Real-World Evidence (DD&D)
  • Vinay Prasad on 'The Week in Health Law' Podcast (Harvard Bill of Health)
  • No Excuses, People: Get the New Shingles Vaccine (NYTimes)
  • BASF readies a medical food product (C&EN)
  • How can biotech companies avoid losing public's trust? (MedCityNews)
  • Brain Scientists Look Beyond Opioids To Conquer Pain (NPR)
  • Is There A Way To Keep Using Opioid Painkillers And Reduce Risk? (NPR)
  • Sawai Pharmaceutical to sell 20 pct stake in SAWAI AMERICA for $211 mln (Reuters) (PharmaLetter-$)
  • Manufacturers Should Generate Own Elemental Impurity Data To Comply With ICH Q3D (Pink Sheet-$)
  • Arcus Biosciences gains meaty $107M with help from Google (Fierce) (Press)
  • J&J CEO reveals the leadership lessons he learned at West Point (CNBC)
  • Dr. John Halamka voices thoughts on precision medicine and the road ahead (MedCityNews)
  • AmerisourceBergen Urges Policymakers to Support Regulator and Industry Data Transparency to More Effectively Combat Opioid Abuse (Press)
  • Q Biomed looks to dust off shelved cancer pain drug (Drug Delivery)
  • Moving beyond Cas9, Excision licenses CRISPR gene editors (Fierce)
  • CRISPR, Bayer JV tap CureVac for Cas9 mRNA constructs (Fierce)
  • Concept buy Aquila inks immuno-oncology deal with Macrophage Pharma (Fierce)

Pharmaceutical and Biotechnology: Study Results, Filings and Designations

  • Bayer, Janssen's Xarelto cuts risk of amputation, death (PharmaTimes)
  • BMS-Pfizer Alliance to Unveil Real-World Data Analyses - Cost, Safety and Comparative Effectiveness Findings Associated with Oral Anticoagulants in Non-Valvular Atrial Fibrillation (Press)
  • Sunovion Announces FDA Acceptance for Review of New Drug Application for Dasotraline for the Treatment of ADHD (Press)
  • Theravance Biopharma (TBPH) and Mylan (MYL) Submit NDA to FDA for Revefenacin in Adults with COPD (Street Insider)
  • Allergan Receives FDA Approval For Use of VRAYLAR™ (cariprazine) in the Maintenance Treatment of Schizophrenia (Press)
  • Kadmon Initiates Phase 2 Placebo-Controlled Clinical Trial of Tesevatinib in Autosomal Dominant Polycystic Kidney Disease (Press)
  • Aura Biosciences Announces Interim Phase 1b/2 Data on Light-Activated AU-011 for Primary Ocular Melanoma (Press)
  • IRX Therapeutics Announces Presentation of IRX-2 Phase 1b Biomarker Data in Early Stage Breast Cancer (Press)

Medical Devices

  • MDIC CEO Murray Stepping Down (Press)
  • Meta-analysis Does Not Establish Effectiveness of the Device (CHEST Journal)
  • Takeda, Lundbeck plan U.S. test for depression app in latest beyond-the-pill foray (Fierce)
  • Going Solo: Combo Products With Device But No Drug Sponsor To Get Hearing (Pink Sheet-$)
  • FDA's Digital Health Software Precertification (Precert) Program (FDA Law Blog)
  • Medtronic to Present New Clinical Data on Vascular Interventions and Key Symposia at VEITHsymposium 2017 (Press)
  • EMD Serono wins FDA nod for redesigned pen injector (Drug Delivery) (Press)
  • The Making of a Surgical Robot (MDDI)

US: Assorted & Government

  • Trump Health Agency Challenges Consensus on Reducing Costs (NYTimes)
  • The Insanity of Taxpayer-Funded Addiction (NYTimes)
  • How The Opioid Crisis Is Affecting Native Americans (NPR)
  • PTAB Life Sciences Report (Patent Doc)
  • West Virginia Plaintiffs Haunted by Past Excesses (Drug & Device Law)

Upcoming Meetings & Events

Europe

  • Redx resurrected after near-death experience (Financial Times)
  • The Difficulty Of Keeping Product Information Up To Date In Europe (Pink Sheet-$)
  • ABPI welcomes the Review Report Directive on the protection of animals used for scientific purposes (ABPI)
  • EFPIA Welcomes the Review Report Directive 2010/63/EU and Stresses the Importance of its Correct and Comprehensive Implementation (EFPIA)
  • UK antitrust watchdog turns eyes to investment consultants (Financial Times)
  • Cancer drug scandal: German pharmacist goes on trial (DW)
  • Lucid launches rare and specialist disease agency (PM Live)

Asia

  • Announcement of China Food and Drug Administration on Serving Advance Notice on Administrative Penalty and Notice on Hearing (CFDA)
  • How Quan Plans To Deploy Its Inaugural $150m Healthcare Fund (BioCentury)

India

  • Bayer Seeks To Ward Off Xarelto Infringers In India (SCRIP-$)
  • Smog chokes Indian capital as emergency measures fail to bring relief (Reuters)
  • IPC to conclude skill development programme on basics and regulatory aspects of pharmacovigilance (PharmaBiz)
  • NPPA to revisit its notification on fixing ceiling prices of coronary stents (PharmaBiz)
  • KSRPA objects to some key clauses in draft of Drugs (Sale and Distribution) Rules, 2017 (PharmaBiz)
  • TN govt violates Sec 42 of Pharmacy Act by allowing nurses to dispense drugs in public health centres (PharmaBiz)
  • DCGI mandates risk-based inspections for all Sch M units as grant of licenses becomes valid forever (PharmaBiz)

Canada

  • Dr. Reddy's launches generic Vidaza in Canada (DSN)

Australia

  • Medical Devices Safety Update Volume 5, Number 6, November 2017 (TGA)
  • Presentation: GP's role in quality use of medicines in Australia (TGA)

Other International

  • Mylan to withdraw from Tel Aviv Stock Exchange (Pharmafile)
  • In Africa, Rural Clinics Entice Pregnant Women With 'Baby Pictures' (NYTimes)

General Health & Other Interesting Articles

  • Legionnaires sickens 12 in California, including 9 at Disneyland (Reuters)
  • Mirror image: Researchers create higher-quality pictures of biospecimens (NIH)
  • Too many HIV-positive youth in US do not notify past partners (Reuters)
  • Psoriasis tied to higher risk of serious liver disease (Reuters)

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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