Regulatory Recon: CVS to Buy Aetna for $69B; FDA Approves Heart Protection Claims for Amgen's Repatha (4 December 2017)

Posted 04 December 2017 By Michael Mezher

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

In Focus: US

  • A Whirlwind Year For The Drug Industry (C&EN)
  • Senate Republicans Pass Sweeping Tax Bill (NYTimes) (The Economist) (Washington Post)
  • Tax bill: What comes next for health care (Politico)
  • This Company Is About to Flood the US With Cheap HIV Drugs (Bloomberg)
  • CVS to Buy Aetna for $69 Billion, Combining Major Health-Care Players (WSJ) (Reuters) (NYTimes) (Bloomberg) (Forbes)
  • Pfizer tops Dow's intellectual heap, with J&J and Merck close behind: study (Fierce)
  • Is It Time For The FDA To Consider A Differentiated Approval System? (Health Affairs)
  • FDA approves heart protection claims for Amgen cholesterol drug (Reuters) (PharmaTimes) (SCRIP-$)
  • Biohackers Disregard FDA Warning on DIY Gene Therapy (MIT Technology Review) (Gizmodo)
  • New research on cancer-killing CAR-Ts and curative gene therapies on tap at this year's ASH meeting (STAT)
  • Cancer drugs can make surviving cells more aggressive, but study finds a potential fix (STAT)
  • J&J adds PhIII hypertension drug to the pipeline with $230M-plus cash deal for Idorsia (Endpoints) (Pharmafile)
  • CRISPR/Cas9 pioneer Chad Cowan enlists in Mustang Bio's CAR-T quest (Endpoints)
  • GOP Medicaid work rules imperil care for opioid abusers (Politico)
  • Ultragenyx shares surge as blockbuster hopeful burosumab continues to perform in pivotal study (Endpoints)
  • Dana-Farber Cancer Institute CEO Wants To Tax Biopharma To Pay For The NIH (Forbes)
  • Prescription video games help children with ADHD in trial (Reuters)
  • Moffitt Cancer Center Touts First Commercial Patient Treated with Yescarta (Press)

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In Focus: International

  • Drugs giants warn of Brexit 'disruption' to their supply chain (The Telegraph)
  • Poor regulation, dodgy pills spur plan for African drugs agency (Reuters)
  • Cuba battling medicine shortages in wake of cash crunch (Reuters)
  • Philippines orders probe into Sanofi dengue vaccine for 730,000 children (Reuters) (Reuters)
  • Brazil recommends restrictions on Sanofi dengue vaccine (Reuters)
  • Sanofi ends development of C. difficile vaccine (Reuters)
  • Sanofi leads charge against counterfeit drugs (Financial Times)
  • US-based fund to invest $1bn in UK biotech (Financial Times)
  • Strengthened cooperation against vaccine preventable diseases (EC)
  • EMA starts review of Esmya for uterine fibroids (EMA)
  • Nestle, Stada prepare rival bids for Germany's Merck consumer health: sources (Reuters)
  • Denmark's Alk Abello suspends dividend to support North America investment (Reuters)
  • Active Bio and Teva's laquinimod strikes out again, this time in progressive MS (Fierce)
  • Therapix expects to have results of Tourette's drug trial by end of first quarter (Reuters)
  • 1.4 million vaccines from global stockpile support yellow fever control in Nigeria (WHO)
  • Cholera could resurge in Yemen due to lack of aid, fuel: WHO (Reuters)
  • Israel's Atox Bio raises $30 mln in Arix Bioscience-led round (Reuters)
  • Hungary's Richter says no link seen between Esmya drug and liver damage (Reuters)

Pharmaceuticals & Biotechnology

  • A New Antibiotic Weakness—Drugs Themselves Help Bacteria Survive (Scientific American)
  • US FDA May Create Immunology, Neuroscience Centers Of Excellence (Pink Sheet-$)
  • Drug Watch International Files Citizen Petition Seeking to Block THC from future OTC Use (Petition)
  • Investors see big money in infertility. And they're transforming the industry (STAT)
  • FDA panel recommends Zika testing of donated blood be relaxed (Reuters)
  • Loxo, Bayer maintain 90%-plus response rate in cancer trial (Fierce)
  • Pharma-backed Outpost nabs Mitsubishi, Pfizer exec Ian Mills (Fierce)
  • The Rise Of The Digital Factory – Sanofi's Story (SCRIP-$)
  • OrbiMed, Peter Thiel back NASH mAb biotech (Fierce)
  • ViiV starts 'Moving Forward' into first branded TV ads for HIV treatment (Fierce)
  • Drugs firms join fight against opioid deaths epidemic (The Guardian)
  • Regeneron CEO Schleifer, a year after public Pfizer spat, slams Allergan for tribal deal (Fierce)
  • A novel immuno-oncology approach to treating a rare childhood brain cancer (Fierce)
  • PEPFAR: FDA Approves 200th HIV/AIDS Therapy (FDA Voice)
  • Stealthy Silverback recruits Seattle Genetics' Eric Dobmeier as CEO, filling C-suite with oncology talent (Endpoints)
  • Atox Bio closes $30M round as it speeds through late-stage trials (Endpoints)
  • Research Organizations Lay Out Guidance for Gene Drive Science (GenomeWeb)
  • California Stem Cell Agency Invests $16.4 Million to Test Great New Ideas Targeting Cancer, Vision Loss and Parkinson's disease. (CIRM)
  • Biogen Agrees To Outcomes-Based Contract For MS Portfolio (BioCentury)
  • Flexion CEO: Setting Zilretta up to succeed with a history lesson (Drug Delivery)
  • Problems of clinical trial design in pancreatic cancer identified by new report (PharmaLetter-$)
  • Receipt of Notice That a Patent Infringement Complaint Was Filed Against a Biosimilar Applicant (Regulations.gov)

Pharmaceutical and Biotechnology: Study Results, Filings and Designations

  • Seres Therapeutics Announces FDA Orphan Drug Designation for SER-287 in Treatment of Pediatric Ulcerative Colitis (Press)
  • Lilly's Taltz (ixekizumab) Receives U.S. FDA Approval for the Treatment of Active Psoriatic Arthritis (Press)
  • Sanofi's Toujeo Met Main Objective In Head-To-Head Study Versus Insulin Degludec (Press)
  • AbbVie: Risankizumab Meets Primary Endpoints In Fourth Phase 3 Psoriasis Study (RTT)
  • Ra Pharmaceuticals Announces Positive Interim Results from Phase 2 Study of RA101495 SC in Paroxysmal Nocturnal Hemoglobinuria (Press)
  • Risankizumab Meets All Primary Endpoints Reporting Positive Results in Fourth Pivotal Phase 3 Psoriasis Study (Press)
  • Ironwood Reports Top-line Phase IIa Data for IW-1973 Demonstrating Positive Cardiovascular, Metabolic and Endothelial Effects (Press)
  • Foresee Pharmaceuticals Announces Results from Phase 1 Clinical Studies (Press)

Medical Devices

  • Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 048 (Federal Register)
  • FDA Opens A Door For Consumer Genetic Tests (FDA Law Blog)
  • ReWalk, Ekso Race to Sell Exoskeletons in Tough Rehab Market (Xconomy)
  • Ra Medical co-founder Burstein touts innovation, planning and caring as keys to success for medtech execs (MassDevice)
  • New US FDA Guidance: How to Utilize the Dual 510(k) and CLIA Waiver IVD Market Pathway (Emergo)
  • Anatomy of a Medtech Breakthrough (MDDI)
  • CareFusion warns customers about Alaris syringe pump alarm (MassDevice)
  • Merz North America Announces New FDA Clearance for DESCRIBE® PFD Patch (Press)

US: Assorted & Government

  • Hearing titled "Addressing the Opioid Crisis in America: Prevention, Treatment & Recovery" (Appropriations)
  • US Senate tax bill accomplishes major Obamacare repeal goal (Reuters)
  • FDA's Focus On Competition May Boost FTC Enforcement (Law360-$)
  • Pfizer Tells 2nd Circ. Feds Lack Immunity In $8.3M Tax Row (Law360-$)
  • Washington State DoH Commission Supports Telemedicine to Boost Access, Lower Costs (Policy)
  • No One's Interests Would Be Served by a Shutdown (Alliance for a Stronger FDA)
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  • Food and Drug Administration Fiscal Year 2017 Performance Review Board Members (Federal Register)
  • Latest Batch of 2017 Updates to Ediscovery for Defendants Cheat Sheet (Drug & Device Law)
  • Drug Co. Wants FOIA Answers From NIH Over Biotech Ties (Law360-$)

Upcoming Meetings & Events

Europe

  • Call for patient organisation representatives to join the Committee for Orphan Medicines (EMA)
  • Guideline on the evaluation of anticancer medicinal products in man (EMA)
  • Recipharm commences new supply contract and completes purchase of facility in Spain (Pharmafile)
  • EMA Stands By Recommendation To Suspend Modified-Release Paracetamol From Market (Pink Sheet-$)
  • Budget Pact, Not Compulsory Licensing Is Solution To Pricing Woes, Says Dutch Pharma (Pink Sheet-$)

Asia

  • Opening The Gates In China (BioCentury)
  • Novocure nabs reimbursement for Optune in Japan (Drug Delivery)
  • FiercePharmaAsia—Takeda's assets spinoff, AstraZeneca's China JV, Biocon's biologics plant (Fierce)
  • MDD drug Brintellix approved in China (PharmaLetter-$)

India

  • New expert committee to consult on drug pricing, new drug launches (Economic Times)
  • India's top 20% pharmaceutical workforce is on par with global standards: Uma Nandan Misra (PharmaBiz)
  • DCGI initiates measures to ensure smooth processing of applications for grant of manufacturing licenses (PharmaBiz)
  • IMA urges finance ministry to reduce GST on medical devices & drugs to 5% from 12% (PharmaBiz)
  • Qualified PV personnel nurtured under PvPI skill development programme to strengthen AMCs (PharmaBiz)

Canada

  • Canada seeks regulatory change to lower drug prices (PharmaLetter-$)

Australia

  • New search function to identify new and updated Product Information (TGA)

Other International

  • PAHO, UNAIDS call for stepping up HIV prevention efforts and offering all available options to prevent new infections (PAHO)

General Health & Other Interesting Articles

  • Why a Lot of Important Research Is Not Being Done (NYTimes)
  • Doctors rarely discuss end-of-life care for chronic lung conditions (Reuters)
  • Smoking, drinking worsen prognosis for head and neck cancers (Reuters)
  • First US birth for woman with transplanted uterus occurs in Texas (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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