Regulatory Recon: Allergan to Acquire LifeCell for $2.9 Billion; Biogen Appoints New CEO (20 December 2016)

Posted 20 December 2016 By Michael Mezher

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Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Missed yesterday's Recon? Read it here.

In Focus: US

  • Harnessing the U.S. Taxpayer to Fight Cancer and Make Profits (NYTimes)
  • US drug approvals plummet in 2016 (Nature)
  • Academic Medical Centers and FDA – Working Together for the Future (FDA Voice)
  • Postmarket Surveillance: The Truth Is Never Simple (Part 3—Legal Issues) (MDDI)
  • Biogen names top executive Vounatsos as CEO (Reuters) (WSJ) (The Street) (Press)
  • Allergan to Acquire Acelity L.P. Inc.'s LifeCell Corporation for $2.9 Billion (Press) (Reuters) (Endpoints)
  • Sun Pharma announces voluntary withdrawal of 28 ANDAs (Economic Times) (FDA)
  • Who Will Trump Pick to Helm the FDA? (Medpage)
  • Trump Administration Puts the U.S. at a Crossroad for Global Health Aid (NYTimes)
  • Novartis Withdraws Support For Controversial Entresto Contest (CardioBrief)
  • FDA Issues Long-Awaited Final Rule on Combo Product Postmarket Safety (Focus)
  • BIO Exec Worries User Fee Agreements Could See Setbacks Under Trump (Focus)
  • 2016: year of the US biosimilar approval, but not launch (BioPharmaReporter)
  • GSK's two-drug HIV therapy shines in two big studies (Reuters)
  • Acadia says Alzheimer's disease psychosis drug clears study (Reuters) (Press)
  • Akebia Gets $265M From Otsuka to Bankroll Anemia Drug Push (Xconomy)
  • Cures Act Changes Regarding the Regulation of Combination Products (Section 3038); Importing Hatch-Waxman Into Medical Device Approval/Clearance (FDA Law Blog)
  • The Patient Side of the CRISPR Patent Battle (Patent Docs)
  • 21st Century Cures Act Benefits Biopharma Co. Data Use (Law360-$)
  • Open letter to FDA: take action now on stem cell clinics before Trump (The Niche)
  • Juno Therapeutics claims win in CAR T-cell patent challenge (PharmaLetter-$) (Law360-$)

In Focus: International

  • EU Expected to Amend RoHS2 Directive for Used and Refurbished Medical Devices (Inside Medical Devices)
  • AstraZeneca opens £120 million UK manufacturing facility (Pharmafile)
  • Brexit, six months on: trying to decipher the headlines, hints and hazards (PharmaLetter-$)
  • GSK boosts board-level science as new CEO prepares to take over (Reuters)
  • Japan to step up drug price reviews in bid to curb healthcare costs (Reuters) (Pharmafile)
  • EMA Board Signs Off on 2017 Budget as Brexit Questions Linger (Focus)
  • Bristol pens 'armed' early-stage cancer virus deal with U.K.'s PsiOxus (Fierce) (Press)
  • Canada Fails to Reach Deal on Health Funding With Local Governments (WSJ)
  • US FDA has concerns about Granules - Ajinomoto OmniChem's Vizag API plant (InPharmaTechnologist)
  • NPPA to embark study on 'Impact analysis of price regulation of essential drugs' (PharmaBiz)
  • End-of-life and orphan drug assessments to be reformed in Scotland (Pharmaceutical Journal)

US: Pharmaceuticals & Biotechnology

  • Cellular Rejuvenation, For Real (InThePipeline)
  • Conatus to receive $50 million in liver drug deal with Novartis (Reuters) (Press)
  • FDA Wrong to Remove Chantix's Black Box Warning Based on One Flawed Study, Sets Dangerous Precedent for Future Medication Safety (Public Citizen)
  • Table: 2016 complete response letters (BioCentury)
  • FDA Finalizes DSCSA Guidance on "Identification of Suspect Product and Notification" with A Twist: Additional Draft Guidance (and Potential Obligations) Added for Manufacturers (FDA Law Blog)
  • Opioid drugs make pain tolerable, most long-term users say (Washington Post)
  • How is it that pharmacies still aren't checking for drug-drug interactions? (MedCityNews)

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

  • Astellas Announces FDA Fast Track Designation for ASP0892, DNA Vaccine for Mitigation of Severe Hypersensitivity Reactions due to Peanut Allergy (Press)
  • Novo Nordisk Receives FDA Approval of Tresiba® (insulin degludec injection 100 U/mL, 200 U/mL) for Use in Children and Adolescents With Diabetes (Press)
  • Juno Therapeutics' and Celgene Corporation's Investigational Drug JCAR017 Granted Breakthrough Therapy Designation from FDA and Priority Medicines Eligibility from EMA for Relapsed/Refractory Diffuse Large B-cell Lymphoma (Press)
  • Laser therapy with deep-sea drug kills prostate cancer in trial (Reuters)
  • Neos Therapeutics resubmits ADHD drug marketing application (Reuters)
  • Brainstorm readies phase III trial for NurOwn stem cell treatment for ALS (Drug Delivery)

US: Medical Devices

  • Career Opportunities at the Center for Drug Evaluation and Research (FDA)
  • MITA Urges House Members Of The 115th Congress To Support Repeal Of The Medical Device Tax In 2017 (MITA)
  • Pentagon Shelves Blast Gauges Meant To Detect Battlefield Brain Injuries (NPR)
  • Amedica re-files with FDA seeking approval for ceramic spinal implant (MassDevice)
  • Foundation Medicine Receives FDA Approval of FoundationFocus™ CDxBRCA as a Companion Diagnostic for Rubraca™ (rucaparib) for the Treatment of Women with Ovarian Cancer (Press)
  • OneTouch Vibe™ Plus Insulin Pump Earns FDA Approval and Health Canada License and is First Pump Integrated with the Dexcom G5® Mobile Continuous Glucose Monitor (Press)
  • Salutaris Medical Devices Receives 510(k) Clearance from U.S. FDA for SMD-Sr90-DA Radionuclide Brachytherapy Source (Press)
  • Instrumentation Laboratory Receives US FDA Clearance For New GEM® Premier™ 5000 Critical Care Testing System (Press)
  • Eyenovia Inc. Announces Completion of Second Phase II Study (Press)

US: Assorted & Government

  • DEA Sparks New Battle With Marijuana Extract Makers (Forbes)
  • Breaking Down The Final 2018 Letter To Issuers (Health Affairs Blog)
  • Stryker reaches new metal-on-metal hip implant settlement deal (MassDevice)

Upcoming Meetings & Events

Europe

  • UK must retain and attract 'scientific talent' post Brexit, insist Peers (OnMedica)
  • Questions and answers on the outcome of an extension of indication application for Inovelon (rufinamide) (EMA)
  • Patent Settlements and Antitrust: Update on the EU Position (FDA Life)
  • Amgen wins recommendation for single injection Repatha device (Drug Delivery)
  • European Medicines Agency post-authorisation procedural advice for users of the centralised procedure (EMA)
  • ClearLine IV Air Bubble Clearing System Cleared in Europe (medGadget)
  • Anika Therapeutics wins CE Mark for tennis elbow injection (MassDevice)
  • Serialization Expert Supply Chain Wizard Announces Partnership With Medicines For Europe (Medicines for Europe)

Asia

  • Public reporting as a prescriptions quality improvement measure in primary care settings in China: variations in effects associated with diagnoses (Nature)    

India

  • J&J's largest India site to finally operate by 2018 (Pharmafile)
  • Indian pharma views streamlined logistics key to successful supply chain management (PharmaBiz)
  • Glenmark Pharma draws up capex of USD 300 mn over next 3 years (Economic Times)
  • Strides Shasun buys Perrigo's US FDA-approved API plant in India (InPharmaTechnologist)

Canada

  • Notice: Release of Draft (Step 2) International Council for Harmonisation (ICH) Guidance: Q11 Questions and Answers: Selection and Justification of Starting Materials for the Manufacture of Drug Substances (Health Canada)
  • Regulatory decision summary for KYPROLIS (Health Canada)

Australia

  • Update on the proposal for the rescheduling of codeine products (TGA 1, 2, 3, 4)
  • TGA update on rare cancer associated with breast implants (TGA 1, 2

Zika

  • FDA Issues Emergency Use Authorization to Abbott Molecular for Zika Diagnostic (FDA)

Other International

  • Anti-Obesity Agent Belviq® Approved In Brazil (Press)

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.

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