Regulatory Focus™ > News Articles > 8 > Recon: Regeneron and Bluebird Team Up; Pain Therapeutics Receives Another CRL

Recon: Regeneron and Bluebird Team Up; Pain Therapeutics Receives Another CRL

Posted 06 August 2018 | By Ana Mulero 

Recon: Regeneron and Bluebird Team Up; Pain Therapeutics Receives Another CRL

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

In Focus: US
  • Regeneron And Bluebird Team To Invent New Cell Therapies For Cancer (Forbes) (Endpoints) (STAT-$) (GEN) (PMLiVE) (Fierce)
  • The full Senate position on FDA appropriations (Alliance for a Stronger FDA)
  • Ovid’s snapshot of broad efficacy data for their PhII Angelman syndrome trial can’t stop a rout — shares crushed (Endpoints) (Forbes) (Fierce)
  • Pain Therapeutics CEO Lashes Out as FDA Rejects Company’s Remoxy (BioSpace) (Reuters)
  • Samumed, a $12 billion startup that wants to cure baldness and smooth out your wrinkles, just raised even more funding as it plots an IPO (Business Insider) (Endpoints)
  • Pfizer contracts with Antares to build a rescue auto-injector for an unnamed drug (Fierce)
  • Drug distributor Cardinal's profit beats on pharma unit strength (Reuters) (MassDevice)
Sponsored content: Arazy Group’s 2018 MedTech Regulatory Awards

This event is to honour regulatory affairs professionals in the MedTech industry and their efforts to improve global public health. Celebrate regulatory affairs achievements with your colleagues and the lasting impact of your work on people’s lives from making safe and advanced MedTech products and practices available to the public.

The event will take place this coming October in beautiful Vancouver, B.C. in the evening following the RAPS 2018 Regulatory Convergence. Your ticket includes light refreshments and a welcome drink. This invitation is extended to all medical device professionals and we encourage you to bring your friends and colleagues, as well!  

In Focus: International
  • How China Is Evolving From a Maker of Copycat Medicines Into a Producer of Complex Drugs (WSJ)
  • China drug scandals highlight risks to global supply chain (Financial Times)
  • Boehringer organizes a coalition in search of first CF gene therapy, working with research, manufacturing partners (Endpoints) (Fierce) (pharmaphorum) (PharmaTimes)
  • China to add more cancer drugs to reimbursement list, talks end in Sept: Xinhua (Reuters)
  • Novartis restrains local pharma Cos from making patent diabetes drug (Times of India)
  • Korean drugmakers rush to establish US subsidiaries (Korea Biomedical Review)
  • US proposal on drug pricing may shake up Indian pharma (The Hindu Business Line)
  • Ebola vaccinations in eastern Congo due to begin on Wednesday (Reuters)
Pharmaceuticals & Biotechnology
  • Biological Markers to Measure Pain Could Lead to Better Meds (Bloomberg)
  • Valeant Faces Wall Street in New Incarnation as Bausch (Bloomberg)
  • Anti-Vaccine Activists Have Taken Vaccine Science Hostage (NYT)
  • ICER Weekly View 08-03-18 (ICER)
  • Administering Health Innovation (Cardozo Law Review)
  • ​​​​​​​FTC Can't Block Theoretical Drugmaker Moves, Shire Says (Law360-$)
  • Digital technologies hold the key to streamlining and improving clinical trials (STAT-$)
  • Blumenthal to announce measures to fight skyrocketing drug prices (WTNH News)
  • Tinkering at the edges of drug prices won’t help (American Enterprise Institute)
  • Can FDA’s Drug Shortage Task Force Devise New Solutions to an Old Problem? (FDA Law Blog)
  • Taking Prime position? A look at Amazon’s potential impact on pharma (EPM Magazine)
  • 23andMe’s pharma deals have been the plan all along (Wired)
  • Blockbuster dreams quashed, Ironwood drops AstraZeneca’s $1.3B gout drug disaster (Endpoints)
  • Who are the most productive drug developers in biopharma? Our top-20 list has lots of surprises (Endpoints)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • Paratek antibiotic not inferior to current treatments: FDA staff (Reuters)
  • High replication rate of induced pluripotent stems cells appears to contribute to breaks in DNA (FDA)
  • Teva Announces Updated Indication and Vial Presentation for GRANIX (tbo-filgrastim) Injection in United States (Press)
  • Alzheon Scientists Discover Endogenous Substance in Human Brain That Inhibits Formation of Toxic Beta Amyloid Oligomers, Key Driver of Alzheimer’s Disease (Press)
Medical Devices
  • Ind. Court Tosses Surgery-Privacy Suit Against Stryker (Law360-$)
  • Questions Remain On FDA Opioid Device Innovation Challenge (Inside Health Policy-$)
  • 4 Risks consumers need to know about DNA testing kit results and buying life insurance (CNBC)
  • Severe Preeclampsia Heart Imaging Study Reveals Roots of Cardiac Damage in Pregnant Women (Johns Hopkins Medicine)
  • Castle study shows DecisionDx gene test predicts melanoma risks better than staging alone (Fierce)
  • Bionano files $30M IPO to fund its long base pair DNA sequencers (Fierce)
  • Fuse Medical snaps up second company in a year (Medical Design & Outsourcing)
  • GUDID Analytics August 2018 (FDA)
  • STRATA Skin Sciences Announces FDA Granted 510(k) Clearance for the Multi Micro Dose Tip for its XTRAC 308nm Excimer Laser (Press)
US: Assorted & Government
  • How Bill Gates Could Transform Alzheimer's Disease (Forbes)
  • Obamacare Helped Make This Doctor a Billionaire (Bloomberg)
  • Republicans eye another ACA repeal vote if midterms go their way (Axios)
  • Less documentation, E/M pay changes proposed in 2019 fee schedule (AMA)
  • Gawande says health venture is not seeking profits. But whose bottom line will it benefit? (STAT)
  • Crowdfunding for unproven stem cell procedures wastes money and spreads misinformation (STAT)
  • Science and Regulation of Live Microbiome-Based Products Used to Prevent, Treat, or Cure Diseases in Humans (FDA)
Upcoming Meetings & Events Europe
  • Ireland’s IP image may be hit by drug patent waiver, pharma body warns (Irish Times)
  • A Broken Arm in Italy: Waiting for Surgery (Forbes)
  • Britain plans for opt-out organ donation scheme to save lives (Reuters)
  • NHS faces legal action over fertility treatment for gender transitioning patients (pharmaphorum)
  • Updated: Medical devices: UK notified bodies (MHRA)
  • Veterinary medicines - information about market access during the implementation period following EU exit (MHRA)
  • jHub looks for medical ideas and innovations (Gov UK)
Asia
  • Janssen, Bayer to close plants in Korea (The Korea Times)
  • Prudential and Babylon join forces in Asia (pharmaphorum)
  • MFDS to inspect cholera vaccine for WHO (Korea Biomedical Review)
  • Chong Kun Dang gets license for generic immunosuppressant (Korea Biomedical Review)
  • Gangnam Severance gets patent for customized 3D bolus for breast cancer treatment (Korea Biomedical Review)
  • China National Drug Administration Approves Gilead's Genvoya (Elvitegravir, Cobicistat, Emtricitabine and Tenofovir Alafenamide), a Single Tablet Regimen for the Treatment of HIV-1 Infection (Press)
  • Can-Fite Signs Multi-Million Dollar Development and Distribution Agreement for Piclidenoson and Namodenoson in China with CMS Medical (Press)
India
  • Novo Nordisk and Signet collaborate to deliver quats to India (in-PharmaTechnologist)
  • CDSCO authorises SLAs to issue NOC for drug exports effective from August 20, 2018 (Pharmabiz)
  • DTAB asks health ministry to revoke ban on sale of oxytocin through retail chemists to ensure availability (Pharmabiz)
Australia Canada
  • Janssen and Immune Bioscience team up for oncology antibodies (PharmaTimes)
  • Sexual enhancement, workout supplements seized from Windsor store by Health Canada (CBC News)
General Health & Other Interesting Articles
  • How This Bacteria May Becoming More Resistant To Hand Sanitizer (Forbes)
  • The Illness Is Bad Enough. The Hospital May Be Even Worse. (NYT)
  • Special report: America’s greatest threat is a hurricane-force cyberattack (Axios)
  • An Appalachian odyssey: Hunting for ALS genes along a sprawling family tree (STAT)
  • Diet Hit A Snag? Your Gut Bacteria May Be Partly To Blame (NPR)
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? Email us at news@raps.org.

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.
 

Categories: Recon

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe