Regulatory Recon: Sage Rises as Depression Drug Succeeds in Phase II; Edwards to Buy Harpoon for $250M (7 December 2017)

Posted 07 December 2017 By Michael Mezher

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

In Focus: US

  • Sage's new depression drug hits mark in clinical trial, though effects fade over time (STAT) (Endpoints) (Reuters) (Xconomy) (Press)
  • Spark, Pfizer pass another milestone with impressive results treating hemophilia B (STAT) (Endpoints)
  • Edwards Buys Harpoon for up to $250 Million (MDDI) (MassDevice) (Press)
  • US Health Spending Rose at a Slower Pace in 2016 (WSJ) (KHN) (Pink Sheet-$) (Fierce)
  • There are 2,004 cancer immunotherapies crowding into the pipeline. Now what? (Endpoints)
  • Alexion lines up $40M upfront deal with Halozyme to develop a better, easier next-gen followup to Soliris (Endpoints)
  • Speed, Safety, and Industry Funding — From PDUFA I to PDUFA VI (NEJM)
  • FDA's Frey Reflects on Final Year of PDUFA V (Focus)
  • FDA Unveils Six-Part Toxicology Roadmap to Expand Predictive Capabilities (Focus)
  • More Efficient Rare Pediatric Drug Development: FDA Drafts Guidance (Focus)
  • FDA Puts Opioids, Compounding, Stem Cells at Forefront of Enforcement Efforts (Focus)
  • Five Industry Trends for US Drug Wholesalers in 2018 (Drug Channels)
  • In Supreme Court petition, Merck argues that FDA power shields against liability (Fierce)
  • FDA opens door to multiarm, multicompany clinical trials (Fierce)
  • Viagra: Get Ready For It To Become Generic, Cheaper, And More Available (Forbes)
  • Shutdown politics: Health care priorities are getting pushed (Politico)
  • Apple's health boss leaves for new start-up, fulfilling a promise he made to his sick sister (CNBC)
  • New forecast shows 6 million with Alzheimer's disease, cognitive impairment (NIH)
  • Research on the world's deadliest microbes will soon begin at a Boston lab (Boston Globe)

RAPS Book Release: Fundamentals of EU Regulatory Affairs, Eighth Edition

  • Get the new, updated ultimate reference guide which includes the latest information on the new Medical Device and In Vitro Device Regulations, developments in implementation of the Clinical Trial Regulation and a number of new topics.
  • Learn more and shop now.

In Focus: International

  • Australia, Canada, Switzerland, Singapore Test Simultaneous Authorizations For Generics (Pink Sheet-$)
  • Roche touts its pivotal success for Tecentriq combo in front-line lung cancer (Endpoints) (Reuters 1, 2) (Press)
  • European Regulatory Roundup: EU Stands Firm on Demand for UK to Pay for EMA's Exit (Focus)
  • AAA board presses go on $3.9bn Novartis takeover (PMLive)
  • In Young Women With Metastatic Breast Cancer, Kisqali Delays Tumor Growth And Relieves Symptoms (Forbes)
  • China's goal to become an innovation hub is good news for Germany's Merck (CNBC)
  • Philippines threatens Sanofi with legal action over dengue vaccine (Financial Times)
  • Chinese R&D sector takes 'significant step' as outsourcing demand increases (Outsourcing Pharma)
  • Russian demand for pharma products outweighs isolationist policy (InPharma)
  • Varian Medical wins Brazilian regulatory nod for Halcyon system (MassDevice)
  • Indonesia fights 'extraordinary' diphtheria outbreak that has killed 32 (Reuters)
  • Diphtheria is spreading fast in Cox's Bazar, Bangladesh (WHO)

Pharmaceuticals & Biotechnology

  • FDA-Required Studies of Approved Drugs Make a Big Difference for Public Health (FDAVoice)
  • Study confirms higher breast cancer risk with hormone-based contraception (Reuters)
  • Fewer Pain Pills May be Best After Surgery (NYTimes)
  • Regulations And Politics Rain On Pharma M&A Parade (Forbes)
  • Prescription Drug User Fee Act VI Commitment to Assess Current Practices of the Food and Drug Administration and Sponsors in Communicating During Investigational New Drug Development (FDA)
  • JAMA study shows how surgeons successfully reduced prescribed opioids (MedCityNews)
  • Pharmaceutical company paid a dozen doctors with known disciplinary problems to promote its drug (Fierce)
  • FDA Animal Drug Safety Communication: FDA warns of eye injuries reported with the use of certain ear medications for dogs (FDA)
  • Juno Licenses Gamma Secretase Inhibitor, Related IP (BioCentury)
  • Arrowhead Pharma Reveals Data It Hopes Will Aid New Hepatitis B Drug (Xconomy)
  • Draft Guidance: Abbreviated New Drug Applications for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of Recombinant Deoxyribonucleic Acid Origin (FDA)
  • Taking on gamma delta T cells, bluebird pays $16M for TC BioPharm's tumor invading tech platform (Endpoints)
  • FDA Issues Draft Guidance Documents on Expedited Programs & Devices Used with RMATs (Part II of "The FDA's Comprehensive Regenerative Medicine Policy Framework") (FDA Law Blog)
  • Clinical trial transparency research reveals progress, but more to be done (Pharmafile)
  • Rich Heyman's Metacrine grabs a $22M round in search of a superior NASH drug (Endpoints)
  • Getting precision treatments over the line will be a team effort, not an individual bolt for glory (Pharmafile)
  • Metacrine Raises $22M to Advance New Drugs for Chronic Liver Disease (Xconomy)
  • Old anti-drinking drug shows potential as cancer treatment (Pharmafile)
  • Should pharma embrace the dark side? If that means dark social, definitely, agency says (Fierce)

Pharmaceutical and Biotechnology: Study Results, Filings and Designations

  • Roche's Hemlibra every four weeks controlled bleeds in phase III study in haemophilia A (Press)
  • FDA Accepts New Drug Application (NDA) for Buprenorphine Sublingual Spray from INSYS Therapeutics (Press)
  • Puma Biotechnology Presents Interim Results of Phase II CONTROL Trial of Neratinib in Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer at the 2017 San Antonio Breast Cancer Symposium (Press)
  • New England Journal of Medicine Publishes Phase 3 Clinical Study of PREVYMIS (letermovir), Merck's New CMV Prophylaxis Medicine (Press)
  • Chugai's Emicizumab Every Four Weeks Showed Positive Interim Results in Phase III Study (Press)
  • Vedanta Biosciences Announces Initiation of Phase 1a/1b Trial for New Drug Class of Rationally-Defined Bacterial Consortia Derived from the Human Microbiome (Press)
  • Vertex Announces Positive Results from Open-Label Phase 3 Study of KALYDECO (ivacaftor) in Children with Cystic Fibrosis Ages 1 to 2 Years (Press)
  • Dicerna Announces First Human Dosed in Phase 1 Clinical Trial of DCR-PHXC for Treatment of All Forms of Primary Hyperoxaluria (Press)
  • Seattle Genetics Presents Updated Phase 1 Data for Ladiratuzumab Vedotin (SGN-LIV1A) in Patients with Triple Negative Breast Cancer at 2017 San Antonio Breast Cancer Symposium (Press)
  • Aerogen Pharma and Lyomark Pharma Partner to Develop Inhaled Surfactant, Begin a Phase 2 Clinical Trial (Press)
  • Lumicell Presents Phase 2 Clinical Data Showing LUM System Provided Complete and Immediate Detection of Residual Cancer in Tumor Cavity During Lumpectomy Surgery (Press)
  • BlackThorn Therapeutics Presents Preclinical and Clinical Data From Its First-in-Class NOPR Antagonist at American College of Neuropsychopharmacology Annual Meeting (Press)
  • Concentric Analgesics Receives FDA Fast Track Designation for CA-008 for Post-Surgical Pain (Press)

Medical Devices

  • Guest post – Observations on FDA 3D Printing Guidance (Drug & Device Law)
  • Designing Effective Warnings for Medical Devices (Emergo)
  • Biocompatibility Testing: Are You Considering Interactions Between Packaging and Devices? (MDDI)
  • 3D printed organ models are getting way better: Here's how (Medical Design & Outsourcing)
  • FDA Clears DxNA's Valley Fever Molecular Test (GenomeWeb)
  • Hologic Receives 510(k) Clearance for AdV/hMPV/RV Assay on Panther Fusion System (GenomeWeb)
  • Camber Spine Announces FDA Clearance Of Spira-C Open Matrix Cervical Interbody (Press)
  • Nemaura Medical touts precision data for non-invasive glucose monitor (MassDevice)

US: Assorted & Government

  • Sign-ups pick up in week five of 2018 Obamacare open enrollment: US (Reuters)
  • Obamacare insurance options dwindle for neediest US patients (Reuters)
  • The surgeon general and his brother: A family's painful reckoning with addiction (STAT)
  • Former Owners of Sleep Study Clinics in Northern Virginia and Maryland Charged With Health Care Fraud and Tax Evasion (DoJ)
  • GNC Among Critics of FDA Proposal to Develop List of Old Dietary Ingredients (Natural Products Insider)
  • Allergan Says Shire Suit Upends 'Very Fabric' Of Antitrust Law (Law360-$)
  • FDA Considers 'Vicarious' Criminal Liability for Senior Company Officials (FDANews-$)
  • Janssen's Remicade Biosimilar Infringement Case Against Samsung Bioepis Dismissed (FDANews-$)
  • Court dismisses class action suits against Novocure (Drug Delivery)

Upcoming Meetings & Events

Europe

  • Member states contact points for translations review (EMA)

Asia

  • Minutes of 20th Asian Harmonization Working Party Technical Committee (AHWPTC) Meeting, 24 Nov 2016, Cebu, Philippine (AHWP)

India

  • Max Super Specialty made excessive profits on disposable syringes: CCI (Economic Times)
  • Dr. Reddy's Labs fails to get favourable ruling from DoP on review petition against pricing of omeprazole capsule (PharmaBiz)
  • Lupin, Cadila Healthcare recall drugs in US (Economic Times)
  • Serum Institute to launch 4 vaccines, enter US, Europe markets (Economic Times)

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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