Regulatory Recon: Google, Novartis Back Medicxi's $300M Biotech Fund; China's Rise in Biotech (15 June 2017)

Posted 15 June 2017 By Michael Mezher

placeholder+image

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

In Focus: US

  • Senior Trump officials to huddle on drug price executive order Friday(Politico)
  • The Score is Even (The Hastings Center)
  • Top 55 Lifesciences Patent Holders of 2016 (Patent Docs)
  • J&J unveils new obesity, arthritis collaborations, shares its molecule library (Fierce)
  • FDA warp speed RMAT approval nukes stem cell clinic excuses (The Niche)
  • States Launch Bipartisan Probe of Opioid Marketing and Addiction (WSJ)
  • How Merck hopes to win in I/O combos: Q&A with Roy Baynes (BioPharmaDive)
  • AstraZeneca, Boehringer cry 'no class effect' after Johnson & Johnson's Invokana doubles amputations in study (Fierce)
  • Study: Nearly 1 million jobs lost if House bill takes effect (Politico)
  • Senate may keep some Obamacare taxes in US healthcare overhaul (Reuters) (MassDevice)
  • FDA Used Real-World Evidence in Heart Valve Approval (Focus)
  • FDA Offers Biomarker Qualification Case Studies (Focus)
  • Cancer patient sues Celgene for thwarting generic versions of its pricey meds (STAT)
  • PTAB Tosses Two More Humira Patents; Will Supreme Court Eliminate IPR Proceeding? (Pink Sheet-$)
  • With Kite's PDUFA date looming, federal court tosses Juno's CAR-T patent challenge — for now (Endpoints) (Juno)

Sponsored Content: Going Digital with RIM

In Focus: International

  • With Novartis and Google jumping in, Medicxi unveils a $300M late-stage biotech fund with a transatlantic scope (Endpoints) (Google) (Fierce) (Financial Times) (Bloomberg)
  • China rises as a biotech powerhouse, developing drugs to treat the world (STAT) (In The Pipeline)
  • Baby Genome Sequencing for Sale in China (MIT Technology Review)
  • Peruvian Regulators Push for Reduced Medical Device Approval Timeframes (Emergo)
  • 62% of Medicines Dispensed in Europe are Generic, According to IMS New Data (Medicines for Europe)
  • What's next for pharma in emerging markets? (McKinsey)
  • Caribbean Regulatory System Begins Recommending Generic Drugs (Focus)
  • Final NICE nod for Takeda's Adcetris in Hodgkin's lymphoma (PharmaTimes)
  • NICE rejects Pfizer's antibody drug for leukaemia (PMLive)
  • QuintilesIMS partners with NHS Cancer Vanguard (PharmaTimes)
  • Brexit Alliance forms to protect UK patients, healthcare (PharmaTimes)
  • LifeArc, née MRC Technology, sets up high-risk seed fund (Fierce) (Endpoints) (GEN) (PharmaTimes)
  • EMA lags behind FDA on continuous manufacturing regulation (Pharmafile) (InPharmaTechnologist)
  • Clinical Trial Applications In Denmark Fail To Match 2015 High (Pink Sheet-$)
  • This Italian Academic-turned-CEO also Launched 7 Cancer Drugs at GSK (Labiotech)
  • Hep C And Other High-Cost Drugs Behind 10% Rise In Canadian Medicines Spend (Pink Sheet-$)

Pharmaceuticals & Biotechnology

  • Why Alexion's Gain In the C-Suite Doesn't Bode Well For Biogen Takeout Prospects (The Street)
  • Mallinckrodt responds to probe into pricey injection pain-killer (Drug Delivery)
  • Opko insists that 'outliers' screwed up its big PhIII study on a Pfizer-partnered therapy (Endpoints)
  • No near-term cure for Repatha and Praluent discontents (EP Vantage) (Pink Sheet-$)
  • BMS's Fouad Namouni On The Future Of Immuno-Oncology (Press)
  • ICML – Novartis's non-infusion mystery centres on Juliet's design (EP Vantage)
  • Oh No, Another BE Guidance Revision – Reaction from Industry (Lachman Consultants)
  • BIO, PhRMA and Others Urge Further FDA Clarity on Drug Compounding (Focus)
  • After a sharp plunge, Epizyme bounces back on some bonny forecasts as shares go on a roller coaster ride (Endpoints)
  • Braeburn names former Teva exec as new president, CEO (Drug Delivery)
  • Sanofi Genzyme exec jumps ship to join Biogen (PharmaLetter-$)
  • Pharma And Intermediaries Split Money Spent On Drugs, Study Shows (SCRIP-$)
  • Merck Wins PTAB Review Of Pfizer Pneumonia Vax Patent (Law360-$)
  • US FDA lifts hold on Inovio's cancer vaccine trials after firm answers device questions (InPharmaTechnologist)
  • Baxter Announces Agreement with Dorizoe Lifesciences to Further Expand Generic Injectables Pipeline (Press)
  • Irvine Scientific says it will build a media R&D lab at its Orange County site (BioPharmaReporter)
  • Phillips Company Issues Voluntary Worldwide Recall of All Topical Products Due to Concerns of Manufacturing Practices (FDA)
  • Request for Nominations for Individuals and Consumer Organizations for Advisory Committees (FDA)

Pharmaceuticals and Biotechnology: Study Results, Filings and Designations

  • Novartis' Cosentyx shines in ankylosing spondylitis and psoriatic arthritis (Pharmafile)
  • Celgene's oral lupus candidate shows 'trend to improvement' in small test (Fierce)
  • pSivida implant meets primary endpoint in late-stage trial (Drug Delivery)
  • Galera Therapeutics Completes Enrollment in Phase 2b Clinical Trial with Lead Compound GC4419 for Treatment of Oral Mucositis (Press)
  • Kindler's Centrexion posts knee pain data as phase 3 nears (Fierce)
  • Positive BELMONT Phase 2 Trial Results Published in Dermatologic Surgery (Press)
  • Seattle Genetics and Bristol-Myers Squibb Highlight Interim Phase 1/2 Data Evaluating Combination of ADCETRIS® (Brentuximab Vedotin) and Opdivo® (Nivolumab) in Relapsed Hodgkin Lymphoma at the International Conference on Malignant Lymphoma (Press)
  • Generon Announces the Initiation of a Phase I Clinical Study for A-337, a CD3-Activating Bi-Specific Antibody Targeting EpCAM to Treat Solid Tumors (Press)

Medical Devices

  • Will A New FDA User Fee Discourage Innovation In Medical Devices? (Bloomberg)
  • I <3 Intended Use (and why some new technologies may fall within FDA jurisdiction) (Stanford Law & Biosciences Blog)
  • Alere says Justice Dept. closed pain lab probe as Q1 losses soar (MassDevice)
  • Latest Legislative Salvos on Medical Equipment Servicing (MDDI)
  • More than a third of heater-cooler devices used in open heart surgery may be contaminated with deadly bacteria (Press)
  • Request for Nominations for Voting Members on a Public Advisory Committee; Technical Electronic Product Radiation Safety Standards Committee (FDA)
  • Hologic Receives Expanded FDA 510(k) Clearance to Market Cynosure's SculpSure® for Non-Invasive Body Contouring (Lipolysis) of Back, Inner and Outer Thighs (Press)

US: Assorted & Government

  • Widow Unleashes Court Fight Against Scope Maker Olympus Over Superbug Outbreak (KHN)
  • Health Affairs Web First: State Health Spending, 1991-2014 (Health Affairs Blog)
  • On AHCA, CMS Actuary Finds Smaller Coverage Losses, Smaller Spending Reductions Than CBO (Health Affairs Blog)
  • HHS is considering changes to OCR's 'wall of shame'—and experts are divided on the impact (Fierce)
  • VA Information Technology: Pharmacy System Needs Additional Capabilities for Viewing, Exchanging, and Using Data to Better Serve Veterans (GAO)
  • FTC Approves Final Order with Kidney Dialysis Chain DaVita, Inc. that Preserves Competition to Provide Outpatient Dialysis Services in New Jersey and greater Dallas area (FTC)
  • Buckman Preemption and Cake (Drug & Device Law)
  • FDA Sued Over its Delay of the Menu Labeling Compliance Date and Reconsideration of the Regulations (FDA Law Blog)
  • Theranos, Walgreens Get Blood Test Suit Largely Axed (Law360-$)
  • Alembic Pharma Gets Win In Generic Gilenya Patent Case (Law360-$)

Upcoming Meetings & Events

Europe

  • Gov't names two new health ministers (PharmaTimes)
  • Thermo Fisher opens single-use tech testing centre in UK (BioPharmaReporter)
  • Pfizer Receives Exclusive Commercialization Rights in Europe for CRESEMBA, a Novel Treatment for Potentially Life-Threatening Fungal Infections Among Immunocompromised Patients (Press)

Asia

  • China's Venus Medtech snaps up TAVR device developer InterValve (MassDevice)

India

  • Top Indian Official Hints At Drug Price Regulation To Curb 'Profiteering' (Pink Sheet-$)
  • Health ministry appoints agency to procure equipment for mini drug testing labs (PharmaBiz)
  • Dr Reddy's says US FDA has closed Miryalaguda plant audit (InPharmaTechnologist)
  • Aurobindo Pharma gets USFDA nod for oral suspension (Economic Times)
  • Zydus Cadila gets USFDA nod for anti-viral drug (Economic Times)

General Health & Other Interesting Articles

  • Alternative Science and Human Reproduction (NEJM)
  • Artificial intelligence may help doctors keep up with new research (Reuters)
  • Too Many Opioids After Cesarean Delivery (NYTimes)

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