Regulatory Recon: Philips to Discontinue US Production of Some Defibrillators; Lupin Buys Symbiomix in $150M Deal (11 October 2017)

Posted 11 October 2017 By Michael Mezher

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

In Focus: US

  • Gottlieb skirts health secretary talk, says most effective at FDA (Reuters) (Endpoints) (The Hill)
  • Decoding cancer: hopes rise for a new age of precision medicine (Financial Times)
  • Philips sees profit hit from US defibrillator blow (Reuters)
  • The rise and fall and rise again of 23andMe (Nature)
  • Aerie's glaucoma drug effectively lowers eye pressure-FDA review (Reuters) (Endpoints) (Fierce)
  • FDA Allows Temporary Saline Imports to Deal With Shortages Caused by Hurricane Maria (Focus)
  • Amgen Puerto Rico Staff Keeping Plant Open Despite Personal Losses From Hurricane Maria (Forbes)
  • An old-school pharmacy hand-delivers drugs to Congress, a little-known perk for the powerful (STAT)
  • Melania Trump Says She Aims to 'Give a Voice' to the Victims of Opioids (NYTimes)
  • Glaxo Could Make a Nice Home for Pfizer's Consumer Division (NYTimes)
  • Shire, Pfizer antitrust lawsuits could rewrite the rules for formulary contracts: report (Fierce)
  • Express Scripts' $3.6B Deal Helps Answer Amazon Threat (Bloomberg) (CNBC)
  • Cancer-Drug Prices Are at a Tipping Point (Bloomberg)
  • Battle over drug prices shifts back to the states (The Hill)
  • California bans drug coupons when cheaper alternatives are available (STAT)
  • One Of Biotech's Hottest Names Embraces Pharma's Bygone Era (Forbes)
  • Merck pays $760M to buy into KalVista drug for diabetic eye disease (Fierce)
  • Trump names Eric Hargan as acting Health Secretary (Reuters)

Preparing for the Spring 2018 RAC Exam?

In Focus: International

  • Child and teen obesity soars tenfold worldwide in 40 years: WHO report (Reuters)
  • India's Lupin bags Symbiomix and its newly approved antibiotic for $150M-plus (Endpoints) (Economic Times) (Press)
  • UK lawmakers join protest tea party to support medicinal marijuana (Reuters)
  • European Commission Adopts Two Acts on GMPs for Medicines (Focus)
  • Global health must survive political upheaval: Dr Jeremy Farrar delivers MHRA annual lecture (MHRA)
  • Asia Regulatory Roundup: China Opens Door to Foreign Trial Data for Accelerated Approvals (Focus)
  • Pharma Buoyed By Preview Of 'Helpful Changes' To EMA's Signal Management Guide (Pink Sheet-$)
  • Astellas, Mitsubishi Tanabe Pharma, and Daiichi Sankyo Conduct "JOINUS," a New Drug Discovery Program Using Drug-Repositioning Compound Library (Press)
  • Takeda Eyes Irish Opportunities Despite Access Issues (SCRIP-$)
  • Myeloma UK trial to test novel myeloma treatment approach (PharmaTimes)
  • Ocrevus Tries Again For EU Approval Nod (Pink Sheet-$)

Pharmaceuticals & Biotechnology

  • Boehringer Questions FDA's Draft Guidance on Optional Child-Resistant Packaging Statements (Focus)
  • Merck's Gardasil 9 offers at least 6 years of cancer protection, data show (Fierce)
  • Mustang CAR-T brain tumor trial gets funds to expand (Fierce)
  • Durable end to the HIV/AIDS pandemic likely will require an HIV vaccine (NIH)
  • Shooting for PhIII, Spero tees up a new lead antibiotic in-licensed cheap as it lines up $86M IPO (Endpoints)
  • Depomed warns of Nucynta ER delays citing damage to Puerto Rico CMO (InPharma)
  • With just a little encouragement, biotech investors are ready to fall in love again (Endpoints)
  • Recursion, Takeda Enter Rare Disease Discovery Partnership (BioCentury)
  • Heart disease tears couples apart in Novo Nordisk's new awareness ads (Fierce)
  • Genfit seeks €150M to wrap up phase 3 NASH program (Fierce)
  • Gene Editing: Gold Nanoparticle Delivery Shows Promise (NIH)
  • Opioids And Psychic Pain: Alkermes Uses High-Profile Stage To Highlight Depression Drug (Pink Sheet-$)
  • Former FDA Senior Official Joins Greenleaf Health (Press)

Pharmaceutical and Biotechnology: Study Results, Filings and Designations

  • Janssen Submits New Drug Application to U.S. FDA for Apalutamide (ARN-509) to Treat Men with Non-Metastatic Castration-Resistant Prostate Cancer (Press)
  • U.S. FDA Grants Fast Track Designation to Astellas for Development of Gilteritinib in Relapsed or Refractory Acute Myeloid Leukemia (Press)
  • Astellas and Seattle Genetics Initiate Pivotal Trial of Enfortumab Vedotin for Patients with Locally Advanced or Metastatic Urothelial Cancer (Press)
  • Seattle Genetics Announces Additional Clinical Collaborations to Evaluate SGN-LIV1A in Triple Negative Breast Cancer (Press)
  • ANSM grants authorisation for phase I/II clinical study for retinitis pigmentosa (EPR)
  • Izun Pharmaceuticals Announces Positive Results from Phase 2 Double Blind Oral Mucositis Trial (Press)
  • Generon Receives Special Protocol Assessment for Global Phase 3 Trial of F-627 in Chemotherapy-Induced Neutropenia (Press)

Medical Devices

  • Class 1 Device Recall for Certain St. Jude ICDs Over Battery Depletion Issues (FDA 1, 2)
  • FDA Warns Swedish IVD Manufacturer (Focus)
  • How Abiomed became a major medical device company (Medical Design & Outsourcing)
  • Q&A: How to Pinch Pennies Without Stifling Innovation (MDDI)
  • Can insulin pumps work better than injections for kids with diabetes? (Reuters)
  • LivaNova wins FDA nod for SenTiva VNS epilepsy treatment (MassDevice)
  • FDA approves SenTiva nerve stimulation device for epilepsy therapy (MobiHealthNews)
  • MIT, Brigham and Women's researchers test inside-the-stomach flexible sensors (MobiHealthNews)
  • BioTime Announces First Patient in US Clinical Trial Treated for Facial Volume Deficit (Press)

US: Assorted & Government

  • Association health plans: Who wins under possible executive order? (Politico)
  • Patent Exhaustion and Pharmaceuticals (Patent Docs)
  • Allergan settles gender discrimination case for $4m (Pharmafile)
  • New Jersey AG's Proposal Would Add New Restrictions on Drugmaker's Gifts (FDANews-$)
  • The 340B Program: Mandatory Reporting, Alternative Eligibility Criteria Should Be Top Priorities For Congress (Health Affairs Blog)
  • Health insurers, hospitals and generic-drug makers ask Congress to examine Allergan patent deal (CNBC)
  • Ten big lobbying groups turn their guns on Allergan's controversial patent gambit (Endpoints)
  • Mental health groups look for new voice after Murphy resigns (Politico)
  • West Virginia gets approval to expand substance abuse treatment coverage (The Hill)
  • House GOP delays vote on children's health care funding to negotiate with Dems (The Hill)
  • Pharma Rights Transfer Sinks Tax Deficiency, 3rd Circ. Told (Law360-$)
  • The Bank Rejects Fosamax Folly (Drug & Device Law)

Upcoming Meetings & Events          

Europe

  • Marketing authorisations granted in September 2017 (MHRA)
  • Parallel import licenses granted in September 2017 (MHRA)
  • In the fight against infectious disease, now is not the time to be complacent (ABPI)

Asia

  • Medtronic breaks ground on western China Innovation Center (MassDevice)
  • China Biologic's human fibrinogen production cleared by CFDA (PharmaLetter-$)

India

  • Track and trace law expected to cover 80% of global drug supply by 2020 (PharmaBiz)
  • Centre to part finance new drug testing lab costing Rs. 45 cr at Vadodara in Gujarat (PharmaBiz)

General Health & Other Interesting Articles

  • 'Brilliant,' 41 and Lost to AIDS: The Theater World Asks Why (NYTimes)
  • Weight Loss Can Reduce Your Cancer Risk, Two New Studies Show (Forbes)
  • What's Behind the Link Between Type 1 Diabetes and Celiac Disease? (Medpage)
  • Many patients remain confused about medical hierarchy (Reuters)
  • Tests showing low egg reserves not linked to infertility (Reuters) (NIH)

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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