Regulatory Recon: SoftBank Bets $1.1B on US Biotech Roivant; Mylan Delays Product Launches Over Uncertainty (9 August 2017)

Posted 09 August 2017 By Michael Mezher

placeholder+image

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

In Focus: US

  • SoftBank bets $1.1B on Roivant CEO Vivek Ramaswamy's brash new biotech strategy (Endpoints) (TechCrunch) (Wired) (Financial Times) (Business Insider)
  • Mylan Defers Product Launches Amid Regulatory Uncertainty (WSJ) (Bloomberg) (STAT) (Financial Times)
  • Generic Drug Prices Are Declining, But Many Consumers Aren't Benefiting (ProPublica)
  • Juno executives investigated over trial deaths disclosure by law firm (Fierce)
  • Generic Drugs in 2017: FDA on Track for Most Approvals Ever (Focus)
  • Proposed and Final FDA Rules: What's Left in 2017 (Focus)
  • Amgen Remains A Standout Among Biotechs (Forbes)
  • Thermo Fisher Prices $1.5B Public Offering (GenomeWeb)
  • Drugmaker Endo cuts full-year sales forecast, shares slide (Reuters) (Fierce)
  • Pfizer spinoff Zoetis ups 2017 guidance, eyes more M&A for future growth (Fierce)
  • Rundown of the Major Provisions in User Fee Reauthorization Package (Lexology)
  • Trump vows to 'win' against opioid epidemic, offers no new steps (Reuters) (NPR) (Politico)
  • Abuse-deterrent opioids aren't effective enough and are too expensive, ICER report says (STAT)
  • New Hampshire Is Latest State to Sue OxyContin Manufacturer (NYTimes) (Reuters)
  • First Responders Spending More On Overdose Reversal Drug (NPR)
  • Why it's so much easier to get an opioid prescription in the US than in Europe or Japan (CNBC)

Sponsored Content: FDA Recommendations for Cybersecurity in Life Sciences

In Focus: International

  • Teva Ramps Up Sales With Medis, Respiratory Units (Bloomberg) (The Street)
  • Aurobindo Pharma's Q1 Profit Misses Estimates (Bloomberg)
  • China Joins ICH in Pursuit of Global Harmonization of Drug Development Standards (FDA Voice)
  • China biotech bags a $57M round as it races to complete R&D, manufacturing site (Endpoints)
  • EMA Reports Rise in Pharmacovigilance Inspections in 2016 (Focus)
  • Asia Regulatory Roundup: CFDA Seeks Feedback on Guidance for Medical Device Clinical Trial Sites (Focus)
  • Trying to turn a new leaf, Valeant 'blockbuster' can't shed an R&D jinx (Endpoints)
  • Adapting To Changing China Regulations Propels Sanofi But How Far? (SCRIP-$)
  • Plans For East African Drug Regulator Begin To Take Shape (Pink Sheet-$) (EMA)
  • Japan tells Pfizer, Bayer, Daichi and others to expand drug warnings (InPharmaTechnologist)
  • Report: Indian regulator echoes warnings on Abbott's Absorb resorbable stent (MassDevice)
  • DCGI mulls alternatives to China active pharmaceutical ingredients (Economic Times)
  • Hep B vaccine supply issues at Merck & Co and GSK prompt UK to prioritize access (BioPharmaReporter)
  • Thousands more people could be offered drugs to prevent bone fractures because of osteoporosis (NICE)

Pharmaceuticals & Biotechnology

  • Melinta beefs up its antibiotics pipeline after a merger with troubled Cempra (Endpoints)
  • Ibuprofen linked to slight risk of kidney damage in ultramarathoners (Reuters)
  • FDA Drafts Guidance on Postapproval Manufacturing Changes for Biologics (Focus)
  • Expiration Dates for Solid Oral Drugs: FDA Revises Draft Guidance (Focus)
  • Word to the Wise (Drug Manufacturer): Don't Use Your Manufacturing Equipment to Produce Toxic, Non-Pharmaceutical Products (FDA Law Blog)
  • NIH accelerates the use of genomics in clinical care (NIH)
  • Investors Are Hooked on This Drugmaker Battling Opioid Abuse (Bloomberg)
  • Vantage Point – Does Roche have the haemophilia X factor? (EP Vantage)
  • For one health-care venture capitalist, the search for 'another miracle' turns personal (CNBC 1, 2)
  • Warring with ex-CEO, options shrinking, Aeterna Zentaris turns to a strategic review(Endpoints)
  • Humira may spend most on TV, but Xeljanz, Taltz and Breo notch highest view rates (Fierce)
  • Struggling Ardelyx cuts staff as it places bets on its late-stage pipeline (Fierce)
  • Esperion hits goal in LDL trial, pulls forward NDA target date (Fierce)
  • Payer coverage in place, Allergan gets ready to ramp Rhofade promotion (Fierce)
  • Merck KGaA, Baylor join together in vaccine work against neglected diseases (Fierce)
  • Novo Nordisk shares rise on solid Q2 results (MassDevice)
  • Sellas snags Nasdaq listing in reverse merger with Galena (Fierce)
  • Bayer 'All Hands On Deck' For US Consumer Business Turnaround (Pink Sheet-$)
  • Large Employers Exploring Value-Based Contracting For Specialty Drugs (Pink Sheet-$)

Pharmaceuticals and Biotechnology: Study Results, Filings and Designations

  • Ocugen Receives FDA Orphan Drug Designation for OCU300 (brimonidine tartrate) for the Treatment of Ocular Graft Versus Host Disease (Press)
  • FDA awards orphan status to new brain cancer vaccine (Pharmafile)
  • Allegro Ophthalmics Announces Positive Topline Results from DEL MAR Phase 2b Stage 2 Trial Evaluating Luminate® in Patients with Diabetic Macular Edema (Press)
  • Bonti Announces Topline Results of EB-001 Phase 2A Clinical Study in Glabellar Lines (Press)
  • Can-Fite Completes Patient Enrolment for its Phase II Study of Namodenoson in the Treatment of Liver Cancer (Press)
  • Rebiotix launches late-stage superbug trial for microbiome-based drug (Drug Delivery)
  • MOLOGEN AG: Results of the Extension Phase of the Exploratory Phase Ib/IIa Study in HIV (Press)
  • FDA Allows WIN Consortium to Proceed with Targeted Tri-Therapy Clinical Trial in First Line Treatment of Metastatic Non Small Cell Lung Cancer (Press)

Medical Devices

  • Using Laser Marking to Meet UDI Requirements (MDDI)
  • Serious medical device recalls nearly doubled in Q2 (Medical Design & Outsourcing)
  • Why the medtech contract manufacturing M&A trend isn't slowing down (MassDevice)
  • Bard shareholders approve $24B merger with BD (MassDevice)
  • Zimmer Biomet slips on HHS subpoena (MassDevice)
  • In2Bones wins FDA nod for 2 foot repair systems (MassDevice)
  • Aum Cardiovascular wins FDA clearance for Cadence heart device (MassDevice)
  • Optovue wins FDA nod for optical epithelial thickness mapping system (MassDevice)
  • Stimwave Receives FDA 510(k) Clearance for the First Full-Body MRI Scan Ready Wireless Peripheral Nerve Stimulator (PNS) System (Press)

US: Assorted & Government

  • We still haven't solved the health care cybersecurity problem (Axios)
  • FDA to launch campaign against e-cigarette use among youth (Reuters) (FDA)
  • The FDA Must Continue To Regulate E-Cigarettes To Protect Children (Health Affairs Blog)
  • Andy Slavitt Wants to Unite America on Health Care (NYTimes)
  • CVS Health CEO Doubts Amazon Entry Into Pharmacy (Forbes)
  • How US states have used emergency declarations to fight the opioid epidemic (STAT)
  • Expect a Big Pharma ripple effect from United Therapeutics' $210M settlement talks with feds: expert (Fierce)
  • Athena Diagnostics, Inc. v. Mayo Collaborative Services, LLC (D. Mass. 2017) (Patent Docs)
  • The Luck of The Draw: A Strong Preemption Ruling from an Anticoagulant MDL (Drug & Device Law)
  • Top 5 Reasons Why Every Healthcare Company Should Invest in Blockchain (Forbes)
  • Sanofi brings another insulin glargine patent suit against Merck (Drug Delivery) (Press)
  • Daiichi's Plexxikon goes after Novartis cancer med Tafinlar in BRAF patent suit (Fierce)
  • Generic Giants Ask Fed. Circ. To Nix Vimpat Patent (Law360-$)
  • Apotex Wants In On Orphan Drug Suit To Protect Generic (Law360-$)
  • Employers Will Escape Obamacare-Sized Rate Hikes In 2018 (Forbes)

Upcoming Meetings & Events

Europe

  • EMA's PRAC Recommends New Label Warnings for Several Products (FDANews-$)
  • New revision of the template for Risk Management Plan (Lakemedelsverket)
  • New Russian pharma giant to be formed by merger (PharmaLetter-$)
  • Russia may legalize parallel imports of drugs next month (PharmaLetter-$)
  • Lupin receives USFDA nod for cholesterol drug (Economic Times)

India

  • India's top 100 pharma cos post single digit growth in sales & profit during 2016-17 (PharmaBiz)
  • Maha FDA busts another illegal abortion drug racket at Aurangabad followed by Mumbai (PharmaBiz)
  • Implementation of rules & policies for cell based therapies takes long time: BN Manohar (PharmaBiz)

Canada

  • Changes in Manufacturer's Name and/or Product Name (Health Canada)

Australia

  • Novocure wins Austrian reimbursement for Optune (MassDevice)
  • ACCM meeting statement, Meeting 17, 23 May 2017 (TGA)
  • TGA presentation: 2017 Pharmaceutical Society of Australia Conference (PSA17), 30 July 2017 (TGA)

General Health & Other Interesting Articles

  • Death rates from colon cancer are increasing for white Americans under 55 (Washington Post)
  • A secret, supervised place where users can inject drugs has been operating in the U.S. for three years (Washington Post)

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.

Share this article:

Categories: Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence, News

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

Regulatory Exchange: Latest Updates From the Community