Regulatory Recon: Pfizer Weighs Sale of Consumer Health Business; FDA Releases Briefing Documents for Spark Gene Therapy (10 October 2017)

Posted 10 October 2017 By Michael Mezher

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

In Focus: US

  • Pfizer weighs $15 billion sale of consumer healthcare business (Reuters) (WSJ) (Financial Times) (Press)
  • Spark Gene Therapy Improves Vision, at Least in Short Term-FDA (NYTimes) (Reuters) (Endpoints) (FDA)
  • Mylan, Biocon Neulasta Biosimilar Hit With Manufacturing-Related CRL (Fierce) (Economic Times) (Press)
  • Eli Lilly concedes a PhIII flop for abemaciclib as breakout strategy flounders (Endpoints) (Reuters) (Press)
  • Pharma Plants in Puerto Rico Gradually Resume Production (Medscape)
  • Angst about exclusivity:The potential cost of incentivizing makers of generic drugs (Nature)
  • California governor signs drug pricing transparency law (Reuters) (AP) (WSJ) (Sacramento Bee) (Senate.ca.gov)
  • Legal Fight Looms Over California's New Drug Pricing Law (Bloomberg)
  • Here's how a loophole in a transparency law can distort medical practices (STAT)
  • Driving cancer beyond the brink (C&EN)
  • Biotech Firm Incyte Finds The Right Chemistry For Success (Forbes)
  • Cancer-genome study challenges mouse 'avatars' (Nature)
  • House E&C Committee Hearing on 340B Drug Program Set for 11 October (E&C)

Preparing for the Spring 2018 RAC Exam?

In Focus: International

  • EU Drug lobby's market protections (Politico)
  • Pharma innovation Report (EurActiv)
  • Darzalex, Epclusa will be funded on NHS Scotland (PharmaTimes)
  • MSF Report on Access to New TB Drugs (MSF)
  • Medicines for Europe Announces New President, Launches Access to Medicines Campaign (Medicines for Europe)
  • Abbas Hussain swings from top GSK pharma post to powerhouse Chinese private equity player C-Bridge (Endpoints) (Fierce)
  • WHO to establish high-level commission on noncommunicable diseases (WHO)
  • Medtronic to Establish Innovation Center in Chengdu (Press)
  • Half Of All EU Fast-Track Requests Fail; AZ's Imfinzi Among Latest (Pink Sheet-$)
  • Cholera claims unborn children as epidemic spreads Yemen misery (Reuters)
  • Changes to Australian Medical Device Recall Process Set for Early 2018 (Emergo)
  • Avara buys AZ solid dose facility in France (InPharmaTechnologist)
  • Akcea's rare lipid disorder drug wins PIM status (PharmaTimes)
  • GSK ranked at bottom of UK 'good governance' report (Pharmafile)
  • New WHO Public Inspection Reports (WHOPIRs) published (WHO)

Pharmaceuticals & Biotechnology

  • Transcript of FDA Meeting on Bacteriophage Therapies (FDA 1, 2)
  • Flexion CEO: 'Absolutely thinking' about exploring additional uses for new non-opioid drug (CNBC)
  • Materials for FDA's Patient Engagement Advisory Committee 11-12 October Meeting (FDA)
  • AbbVie jumps on the oncolytics bandwagon, embracing Turnstone in new collaboration (Endpoints)
  • Giant Merck buddies up with little KalVista on lead drug, igniting stock with a $760M deal (Endpoints)
  • Teva scrambles to match 30% Copaxone discounts from Mylan's knockoff: analyst (Fierce)
  • FDA Warns Louisville Reproductive Center Over Zika, West Nile Screening Issues (FDA)
  • What's new on pharma's worry list? Cybersecurity, natural disasters and much more (Fierce)
  • Ex-FDA commissioner joins former Elan team at VC fund (Fierce)
  • GamaMabs licences AZ technology for new cancer therapy (PharmaTimes)
  • FDA blow for Polish myeloid leukemia drug candidate (PharmaLetter-$)
  • Richard Lehman's journal review—9 October 2017 (BMJ)
  • Liraglutide Generics May Need More Robust Analytical Methods After Novo Petition (Pink Sheet-$)
  • Hospitals scramble to avert saline shortage in wake of Puerto Rico disaster (Washington Post)
  • ScriptDrop Leverages Blockchain To Combat $300 Billion Cost of Prescription Drug Abandonment (Forbes)
  • Pfizer's Lyrica takes pharma TV spending crown from AbbVie's Humira for September (Fierce)
  • In Novartis' newest Cosentyx push, active, real-life patients take center stage (Fierce)
  • Goodbye to Belsomra's furry mascots. Merck's focusing on sleepless patients instead (Fierce)
  • Deerfield commits $50M-plus to translational drug R&D at the Broad (Endpoints)
  • California Gov. Jerry Brown appoints precision medicine advisory committee (Fierce)

Pharmaceutical and Biotechnology: Study Results, Filings and Designations

  • FDA grants orphan drug status to UniQure's Huntington's Disease treatment (PMLive)
  • Janssen's Darunavir-Based Single-Tablet Effective In Late-Stage Switching Study (SCRIP-$)
  • FDA grants Priority Review to Gilotrif® for uncommon EGFR mutations in advanced NSCLC (Press)
  • Clovis Oncology Submits Supplemental New Drug Application for Rucaparib as Maintenance Treatment for Patients with Platinum-Sensitive Recurrent Ovarian Cancer (Press)
  • H3 Biomedicine Granted Orphan Drug Designation of H3B-6527 for Treatment of Hepatocellular Carcinoma (Press)
  • Ansun BioPharma Announces Breakthrough Designation for its Experimental Drug DAS181 (Press)
  • GNI Group Announces Clearance of Investigational New Drug (IND) by FDA for F351 Clinical Trials in the Treatment of Liver Fibrosis (Press)

Medical Devices

  • Natural disasters take their toll on Medtronic (MassDevice)
  • FDA Clears Roche C. difficile Assay for Liat Platform (GenomeWeb)
  • Faxitron Announces FDA 510(k) Clearance of VersaVision, a Next Generation Digital Imaging System Designed to Increase Precision and Improve Workflow in Clinical Settings (Press)

US: Assorted & Government

  • Trump's Cuts to Health Law Enrollment Efforts Are Hitting Hard (NYTimes)
  • Publishers threaten to remove millions of papers from ResearchGate (Nature)
  • Grassley, Warren Welcome HHS Inspector General Recommendation to Add Medical Device Identifiers to Medicare Claims (Grassley)
  • OIG Report on FDA's Inspections of Domestic Food Facilities: Challenges Remain (FDA Law Blog)
  • Design Defect Claims Preempted In Eye Drop Litigation (Drug & Device Law)

Upcoming Meetings & Events          

Europe

  • UK Office for Life Sciences appoints new Director (MHRA)
  • EBE and EFPIA call on the EU Commission and Member States to improve transparency on Hospital Exemptions for Advanced Therapies (EFPIA)
  • XBiotech Says CHMP 'No' Was A Surprise, Despite The Signs (Pink Sheet-$)
  • NHS Scotland appoint new Chief Scientist (Pharmafile)
  • N4 shares perk up on new Viagra plans (Financial Times)
  • Scottish government reveals extra funding for mental health (Pharmafile)

Asia

  • Kyowa Hakko drops development of tivantinib (PharmaLetter-$)
  • MHLW Pharmaceuticals and Medical Devices Safety Information October 2017 (PMDA)

India

  • India pulls an about-face on Abbott's Xience Alpine stent (Drug Delivery)
  • Drug-makers may have to declare `ex-factory' price on medicine packs (Economic Times)
  • Piramal Pharma announces expansion of API manufacturing facilities (Economic Times)
  • Suven Life gets patent from New Zealand for neurological drug (Economic Times)
  • Lupin launches pain relieving generic tablets in US (Economic Times)

Other International

General Health & Other Interesting Articles

  • Aggressive breast cancer treatment tied to more missed work (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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