Regulatory Focus™ > News Articles > Regulatory Recon: Medicare Fund Will Run Out in 2028, IPAB Expected in 2017; A Look at Today's Immun

Regulatory Recon: Medicare Fund Will Run Out in 2028, IPAB Expected in 2017 A Look at Today's Immuno-Oncology Pipeline (22 June 2016)

Posted 22 June 2016 | By Michael Mezher 

Regulatory Recon: Medicare Fund Will Run Out in 2028, IPAB Expected in 2017 A Look at Today's Immuno-Oncology Pipeline (22 June 2016)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan and @RAPSorg on Twitter.

In Focus: US

  • Immuno-Oncology: The Strategic Supernova In Cancer Today (Forbes)
  • Medicare Fund to Run Short in 2028; IPAB Still Projected in 2017 (Bloomberg) (Brookings) (CMS)
  • FDA Commissioner Meets With Tennessee Pharmacy School, Health Care Officials on Opioid Addiction (Johnson City Press)
  • Inside the US Army Lab Racing to Create a Zika Vaccine (Wired)
  • House Republicans Unveil Long-Awaited Replacement for Health Law (NYTimes) (Reuters) (Forbes)
  • First CRISPR clinical trial gets green light from US panel (Nature) (Science Mag) (BioCentury)
  • Deadly Superbugs Can Masquerade as Ordinary Bacteria (Bloomberg)
  • Draft scoping document for ICER review of drugs for NSCLC posted for public comment (PharmaLetter-$) (ICER)
  • FDA Withdraws Document Calling on Biosimilar Developers to Submit 10 Random Suffixes (Focus)
  • FDA Taps New Office of Device Evaluation Director From Industry (Gray Sheet-$)
  • Infinity's Research, From Someone Who Was There (In the Pipeline) (Omics Blog)
  • Senators Urge FDA to End 'Discriminatory' Blood Donation Policy (NBC)
  • Maybe Pharmaceutical Reps Actually Aren't Bribing Doctors (Bloomberg)
  • New shots fired in drug pricing war (The Hill)
  • FDA Warns Questionable Cancer Clinic Again for CGMP Violations (Focus)
  • At 31, she runs one of the hottest biotech companies in the country (STAT)
  • Senators, Experts Weigh Bipartisan Bill to Stop REMS Abuses (Focus)

In Focus: International

  • Nordic drugmakers raise $29M to expand cancer clinical trial programs (Fierce)
  • India to revise drugs law, draft new rules for medical devices (Reuters) (MassDevice)
  • Three drug wholesalers have failed GDP checks according to Czech regulator (In-PharmaTechnologist)
  • Regulatory decision summary: MSM Blood Donor Deferral (Health Canada)
  • Stem cell scientist suspected of involuntary manslaughter (STAT)
  • EMA reviewing Santhera's Raxone for DMD (BioCentury) (PharmaTimes)
  • Nacimbio launches complex program for antiretroviral drugs production with Cipla (PharmaLetter-$)

US: Pharmaceuticals & Biotechnology

  • Amgen developing Soliris biosimilar (BioPharma-Reporter)
  • Biosimilars Hold Promise, Questions (Medpage) (Focus)
  • FDA approves OPKO Health's Rayaldee for new indication (PharmaLetter-$)
  • Value Assessment 2.0: The Next Generation of Tools to Address the Patient Perspective (Faster Cures)
  • NIH issues multi-site research policy to streamline IRB review (Outsourcing-Pharma) (Focus)
  • The 7 Absolutely Definitive Reasons Why Biotech Stock Prices Fell Yesterday (Forbes)
  • Jardiance label claim is the next milestone for booming SGLT2 class (EP Vantage)
  • Interview – F2G's novel antifungal brings in the bucks (EP Vantage)
  • Interview: GSK's subcutaneous formulation for Benlysta may help cut down hospital visits (PharmaFile)
  • To Outperform In Pharma, Go Deep – Not Broad (In Vivo-$)
  • Impax shells out $586 million in Teva's generics sell-off (PharmaLetter-$) (Pharmafile)
  • Adaptimmune inks 10-year deal with Thermo Fisher for T Cell expansion tech (BioPharma-Reporter)
  • VGXI plant expansion to support Inovio's Zika DNA vaccine development (BioPharma-Reporter)
  • Roche's Tecentriq may dominate bladder cancer market  (BioSpectrum)
  • FDA under pressure to clarify off-label rules (PharmaLetter-$)
  • Pharmaceutical companies increasingly looking to innovate high-risk, first-in-class products (BioSpectrum)
  • Measles, Mumps and Missing the Moment (ICT)
  • The Customer Isn't Always Right in Healthcare (Medpage)
  • Eliminating Blood Test Could Safely Increase Number of Donor Hearts for Transplant (Washington Post)

US: Pharmaceuticals and Biotechnology: Clinical Study Results, Filings & Designations

  • Axon's Alzheimer's vaccine hits Phase II as it seeks to prove efficacy (Fierce)
  • Priority Review for Nicox's eye drop (BioCentury)
  • Genexine HPV vaccine shows Phase II efficacy (BioCentury)
  • PAVmed Successfully Completes CarpX™ Pre-Clinical Study (Press)
  • AXON's Pioneering Tau Vaccine against Alzheimer's Started Phase II (Press)
  • Agenus Announces Commencement of Phase 1/2 Clinical Trial of anti-GITR Checkpoint Antibody INCAGN1876 in Patients with Solid Tumors (Press)
  • First patient treated in Phase I UCART19 trial in paediatric B-ALL (EPR)

US: Medical Devices

  • New device could reduce radiation in 3-D breast cancer imaging (Fierce)
  • Final Guidance from US FDA on ISO 10993 and Biological Evaluation of Devices (Emergo)
  • Professor: FDA needs category that allows certain medical devices over the counter (Fierce)
  • Brain Scanning Just Got Very Good—and Very Unsettling (IEEE Spectrum)
  • Rosetta FISH Cancer Assays Receive NY Department of Health Clearance (GenomeWeb)
  • IsoRay touts brachytherapy brain cancer trial (MassDevice)
  • AtriCure launches cryoanalgesia study (MassDevice)

US: Assorted & Government

  • Florida Blue To Provide Costly Hep C Drug After Lawsuits (Law360-$)
  • Two Pharmacists Sentenced to Prison for Adulteration of Drugs in Connection with Alabama-Based Compounding Pharmacy (DoJ)
  • DEA Should Take Additional Actions to Reduce Risks in Monitoring the Continued Eligibility of Its Registrants (GAO)
  • U.S. officials to unveil Medicare fraud crackdown at 11 a.m. EDT (Reuters)
  • BIO's Statement Regarding SCOTUS Patent Review Decision (BIO)
  • Americans spent $30.2 billion out-of-pocket on complementary health approaches (NIH)
  • Where health costs are headed next year (Politico)
  • A Look At Fed. Circ. Induced Infringement Ruling In NuVasive (Law360-$)
  • Highmark Health Seeks Buyer for Vision Unit (WSJ-$)
  • Trump's 'Mad Men' are also medical device execs (MassDevice)
  • VA Inspector General Finds Patient Wait Times Manipulated in Houston (WSJ-$)
  • We Want You to Help Report on the Red Cross (ProPublica)
  • Health Affairs Study On Hospital Profitability Gives Us Some Important Factors To Watch Going Forward (Health Affairs Blog)

Upcoming Meetings & Events

Europe

  • Scancell stops dosing in long-term trial of cancer vaccine SCIB1 (In-PharmaTechnologist)
  • Inhaled pain drug Penthrox approved for marketing in France (PharmaLetter-$)
  • EU IVD Regulation: A New Scrutiny System For Diagnostics (Gray Sheet-$)
  • IQWiG considers added benefit of Tagrisso and Entresto (PharmaLetter-$)
  • Nomenclature For Eudamed Could Be Free With New EU Regs: Impact On GMDN? (Clinica-$)
  • Novartis to bring biomanufacturing 'all under one roof' with $1bn Sandoz investments (BioPharma-Reporter)
  • Give us UK wide opt-out system for organ donation, say doctors' leaders (OnMedica)
  • TxCell gains CAR-Tregs patent for autoimmune and inflammatory diseases (PharmaLetter-$)
  • New report finds that more Europeans are surviving cancer and cancer services and treatments are delivering better outcomes than ever (EFPIA)
  • NeuroMetrix Submits CE Mark Application for Quell Wearable Pain Relief Device (Press)
  • Polyganics wins CE Mark approval in the European (MassDevice)

Asia

  • Japanese firms form monoclonal antibody manufacturing JV with an eye on biosims (BioPharma-Reporter)
  • Ascletis' HCV regimen moving along in Taiwan, China (BioCentury)
  • Novacap subsidiary starts work on pharma-grade sodium bicarbonate plant in Singapore (In-PharmaTechnologist)
  • China Regulatory Changes Benefit Lee/RegeneRx Ophthalmic Alliance (PharmAsiaNews-$)

India

  • Lupin gets USFDA nod for fungal infection drug (Economic Times)
  • Pharmexcil starts issuing exemption to pharma cos from barcoding for exports (PharmaBiz)
  • 2,839 bottles of Sun Pharma Inc being recalled in US (Economic Times)

Canada

  • Health Canada approves biosimilar infliximab for additional indications: Crohn's Disease, Fistulising Crohn's Disease And Ulcerative Colitis (Biosimilar News)   
  • British Columbia Declares Public Health Emergency Over Fentanyl Overdoses (NPR)

Australia

  • ACPM meeting statement, Meeting 309, 1 April 2016 (TGA)

Zika

  • C.D.C. and States Ponder Plans to Keep Ahead of Zika (NYTimes)
  • First Zika Vaccine Will Be Tested in Humans Sooner Than Expected (MIT Technology Review)
  • Rory McIlroy Says He Won't Attend Olympics Over Zika Concerns (NYTimes)

Other International

  • Two die in suspected anthrax outbreak in Kazakhstan (Reuters)

General Health& Other Interesting Articles

  • Alzheimer's Disease as an Adventure in Wonderland (NYTimes)
  • Let's Stop Making Excuses For Egregious Medical Errors (Health Affairs Blog)

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.


Categories: Recon, Regulatory News

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