Regulatory Recon: Teva Sells Off Remaining Women's Health Assets for $1.38B; Fosun to Buy 74 Percent Stake in Gland Pharma (18 September 2017)

Posted 18 September 2017 By Michael Mezher

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

In Focus: US

  • FDA Clears Biotech Drug Copycats, But Buying Them Isn't So Easy (Bloomberg)
  • FDA plans new compounding pharmacy policy, agency head says (Reuters)
  • Costly drugs to weigh on US employers' expenses in 2018: survey (Reuters)
  • Closing in on cancer (The Economist)
  • Why Are Drug Prices So High? We're Curious, Too (NYTimes)
  • Amid Opioid Crisis, Insurers Restrict Pricey, Less Addictive Painkillers (ProPublica)
  • Rural Hospitals Struggle To Stock Expensive Drugs That Could Save Lives (NPR)
  • Race to Mine Fungi for Drugs Revs up as Verdine's LifeMine Gets $55M (Xconomy) (Endpoints)
  • Shares rocket up as Nabriva Therapeutics touts a PhIII win for antibiotic (Endpoints) (Fierce)
  • Market watch: Upcoming market catalysts in Q4 2017 (Nature)
  • Blind Patients to Test Bionic Eye Brain Implants (MIT Technology Review)
  • FDA adds two Roche studies to its growing list of partial clinical holds in wake of Keytruda deaths (Endpoints)

Sponsored Content: IVDR/MDR Challenges Top Roadshow Agenda

  • BSI's 6th Annual, full-day medical device Roadshow will guide participants to new EU Medical Device/In-Vitro Device Regulation compliance. The program examines key issues facing Med Dev Manufacturers under the new MDR/IVDR starting with an overview, then analyzing legacy products and transitional provisions. Implementation issues including conformity assessments, essential/clinical requirements, SPR, labeling and QMS impacts of these standards will be detailed.
  • Check here for specific dates, locations and the program agenda.

In Focus: International

  • Is there a future for a Zika vaccine? (STAT)
  • Shanghai Fosun to Buy Smaller Stake in Indian Drugmaker to Avoid Government Veto (Bloomberg) (Financial Times) (Pharmafile) (Economic Times)
  • Teva finishes women's health sale with deals worth $1.38B (Fierce) (Reuters)
  • France's Neovacs takes on GSK and AstraZeneca in battle to treat lupus (Reuters)
  • Factor VIII medicines: no clear and consistent evidence of difference in risk of inhibitor development between classes (EMA)
  • Standing together: Supercharging the clinical trial in Europe (Pharmafile)
  • Gates Foundation invests $40m in immune therapy research (Financial Times) (Endpoints)
  • EMA: UK Firms May Have Trouble Lifting GMP Non-Compliance Marks Post-Brexit (FDA News-$)
  • Bold Move To Embed Biosimilar Switching Aims To Bring Savings Of Up To £300m For NHS England (Pink Sheet-$)
  • India's NPPA says it will not revisit stent price caps until Feb 2018 (MassDevice)
  • Glenmark looks to file up to 25 product applications annually (Economic Times)
  • UK start-up Autolus starts 'living medicine' cancer trials (Financial Times)
  • Clinigen and Quantum Pharma offer lesson to entrepreneurs (Financial Times)

Pharmaceuticals & Biotechnology

  • Did he really just tweet that? Dr. Vinay Prasad takes on Big Pharma, Big Medicine, and his own colleagues — with glee (STAT)
  • US Government Asserts Biosimilars Act Preempts State Law (BioCentury)
  • NICE rejects first-line use of Roche's Gazyvaro (PharmaTimes)
  • Synthetic lethality screens point the way to new cancer drug targets (Nature)
  • The human microbiome: opportunity or hype? (Nature)
  • Sailing past the $2B mark, Flagship sets course for $500M-plus biotech fund, unveils a new startup (Endpoints)
  • Bidding war erupts over Dimension's gene therapy pipeline as Ultragenyx counters Regenxbio deal (Endpoints)
  • Cut loose from Biogen buyout option, Rodin preps for an early-stage shot at Alzheimer's (Endpoints)
  • Mustang picks up CD20 CAR-T from Fred Hutch (Fierce)
  • Caring at home for a child with cancer can leave family members with risky tasks (Washington Post)
  • When pain just won't stop, a specialty program might help (Washington Post)
  • Should people without depression take medication to prevent it? (Washington Post)
  • Precision Medicine for All? The Need for Disability Inclusion (Harvard Bill of Health)
  • Scholar Rock prise Regulatory Affairs director away from Biogen (Pharmafile)
  • Does Interoperability Change In 2023? (RxTrace)
  • State of Packaging in the Pharma Industry (Pharmaceutical Manufacturing)
  • Pfizer v. Pfizer: Sutent Indication Expansion Will Hinge On Conflicting Trials (Pink Sheet-$)
  • FDA Advisory Panel Splits on Pediatric Labeling for Opioid Patch (FDA News-$)
  • Precision Medicine In Psychiatry: Astellas Joins Search For Biomarkers, Drug Targets (SCRIP-$)

Pharmaceuticals and Biotechnology: Study Results, Filings and Designations

  • Generic for Liquid Tamiflu Approved (Medpage)
  • US FDA Approves New Indication for Ipsen's Somatuline® Depot (lanreotide) Injection for the Treatment of Carcinoid Syndrome (Press)
  • US FDA grants fast track designation to Pluristem's PLX-PAD for treating Critical Limb Ischemia (Reuters)
  • Sanofi And Regeneron Announce Positive Study Results For Dupixent® (Dupilumab) In Patients With Moderate-To-Severe Atopic Dermatitis (Press)
  • Lilly/Incyte's baricitinib musters mixed data in atopic dermatitis trial (Fierce) (Press)
  • FDA Grants "Fast Track" Status to Cancer Prevention Pharmaceuticals' Lead Drug CPP-1X/sul for Treatment of Familial Adenomatous Polyposis (Press)
  • Camurus Announces That FDA Grants Priority Review of NDA for Weekly and Monthly CAM2038 Buprenorphine Depots for Treatment of Opioid Use Disorder (Press)
  • ABIVAX: First Patient Dosed in Three-Month Cohort of Phase 2a Study of Oral ABX464 in HIV-Suppressed Patients (Press)
  • Principia Biopharma Presents Late-Breaking Interim Phase 2 Data of PRN1008 in Pemphigus at European Academy of Dermatology and Venereology Meeting (Press)
  • FDA Approves Symbiomix Therapeutics' Solosec™ (secnidazole) Oral Granules for the Treatment of Bacterial Vaginosis in Adult Women (Press)
  • Perrigo Announces Tentative FDA Approval For The Generic Version Of Acanya® Gel (Press)

Medical Devices

  • The 10 largest medtech employers – and what their workers really think (MassDevice)
  • Report: Five ways to bolster real-world evidence from mobile devices (MobiHealthNews)
  • Analysis: What's in an FDA recall? (Healthcare IT News)
  • Why Infusion Pumps Are So Easy to Hack (MDDI)
  • Data Boosts Support for Abbott, Gore PFO Closure Tech (MDDI)
  • Distraction isn't only way virtual reality might ease pain (Reuters)
  • Medtronic Announces FDA Approval and US Launch of Next Generation Spinal Cord Stimulator for Chronic Pain Management (Press)
  • AtriClip PRO V Left Atrial Appendage Exclusion System Cleared by FDA, Now Available in US (MedGadget)
  • Mevion Submits 510(k) Premarket Notification for the MEVION S250i Proton Therapy System with HYPERSCAN Technology (Press)
  • TransEnterix, Inc. Reports Progress on Senhance FDA Submission (Press)

US: Assorted & Government

  • Can the Graham-Cassidy bill even pass? (Politico)
  • Walgreens Said to Tweak Rite Aid Deal to Gain US Approval (Bloomberg)
  • Caution Warranted As VA Incorporates ICER Value Assessments Into Formulary Management Process (Health Affairs Blog)
  • Court Upholds $38 Million Judgment Against Abbott Over Epilepsy Drug (FDA News-$)
  • Allergan's Restasis Patent Transfer to Face Precedent-Setting Legal Battle (The Street)

Upcoming Meetings & Events

Europe

  • Help us understand your needs and priorities: MHRA launches customer survey (MHRA)
  • Endomag wins CE Mark for Magseed MIS breast cancer guide, inks 5-year distro deal (MassDevice)

Asia

India

  • Experts discuss issues related to timelines for compliance, guidelines under new Medical Device Rules, 2017 (PharmaBiz)
  • DoP directs NPPA to re-fix ceiling prices of clomiphene 100mg and 50mg tablets (PharmaBiz)
  • Gujarat registers maximum number of 170 medical devices units in the country under CLAA scheme (PharmaBiz)
  • Zydus' Nesher Pharma gets USFDA nod to market influenza drug (Economic Times)

Australia

  • Puritan Bennet 980 Series Ventilator (TGA)
  • Medical devices and IVDs: Suspensions from the ARTG (TGA)
  • Reminder: Planned process improvements for GMP Clearance (TGA)

Other International

  • Janssen Deal Could Signal Clinical Trial Revival In Argentina (Pink Sheet-$)

General Health & Other Interesting Articles

  • Paul Knoepfler: What Are The Unintended Consequences Of Human Gene Editing? (NPR)
  • Juan Enriquez: What Can Happen If Humans Control The Future Of Evolution? (NPR)
  • 'Every time it's a battle': In excruciating pain, sickle cell patients are shunted aside (STAT)
  • By the Numbers: Global Causes of Death (Medpage)

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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