Regulatory Focus™ > News Articles > 7 > Recon: CMS Quietly Quit Deal to Pay for Kymriah Performance

Recon: CMS Quietly Quit Deal to Pay for Kymriah Performance

Posted 09 July 2018 | By Ana Mulero 

Recon: CMS Quietly Quit Deal to Pay for Kymriah Performance

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

In Focus: US
  • CMS quit test of pricey cancer treatment (Politico)
  • Cytori shares surge on mixed results for its PhI erectile dysfunction study (Endpoints) (Fierce)
  • Regulus stock plummets as company faces 60% staff cuts (The Pharma Letter-$) (Endpoints)
  • CTI Biopharma's cancer drug fails late-stage trial, shares tumble (Reuters) (Endpoints)
  • Fed. Circ. OKs $14M For Gilead After Merck's Patent Lies (Law360-$) (The Pharma Letter)
  • Mylan launches generic drug-delivery patch for dementia patients (DDBN) (Mylan)
  • Theranos? Whatever. Healthcare Startups Have Raised $15 Billion So Far This Year (Forbes)
  • A new messaging tactic on the left: Drug prices rise, as pharma prospers from tax law (STAT)
In Focus: International
  • Vertex CEO to UK Prime Minister: You’re devaluing lives, passing up a great offer and threatening the country’s biotech industry (Endpoints) (STAT-$)
  • Abingworth Raises €268M to Invest in Life Science Companies (labiotech) (Fierce) (Endpoints)
  • Axovant, Benitec sign licensing deal for AXO-AAV-OPMD program (PBR) (GEN) (Fierce)
  • Amryt Pharma’s heart drug gets approval from NHS England (Irish Times) (pharmaphorum)
  • Janssen wins label extension for Simponi (The Pharma Letter) (EPM Magazine)
  • Antibiotics should be restricted for COPD (NICE) (The BMJ)
  • China’s Biopharma Rise: Opportunities and Threats (PharmExec)
  • Pacemakers, ultrasound gear costs could rise from China trade tariffs (USA Today)
  • Shares in Neurotech are going nuts after releasing details on a treatment for autism (Business Insider Australia)
  • Red flags fly over Anavex: What’s stopping the drug maker from enrolling U.S., European patients in trials? (STAT-$)
Pharmaceuticals & Biotechnology
  • Seeking to unleash immunotherapies on solid tumors, biotech homes in on cell receptors (STAT-$)
  • Gilead’s senior clinical research director joins Nimbus to help lead drug discovery (Fierce)
  • A roaring Rubius sets out to snag $1.8B market cap in $200M IPO (Endpoints)
  • Drugmakers Call Experimental Alzheimer’s Drug Study Positive (The Washington Post)
  • What Does a Drug Cost? It Depends on Where You Live. (NYT)
  • Plugging the Drug-Supply Gap (NYT)
  • Report: NY Doctors Increased Opioid Prescriptions After Pharma Payments (Epoch Times)
  • Berkeley boy was ‘Patient X’ in first FDA-approved medicine derived from marijuana (San Francisco Chronicle)
  • A child took some psychiatric drugs on his own. And 470,000 drug packs got recalled (Miami Herald)
  • Why medical affairs is the most important role in the future of pharma (PharmaTimes)
  • Ocular Looks To Kick Investor Suit Over Eye Drug Approval (Law360-$)
  • 2018 Is a Hot Year for Biotech Startups, IPOs and M&A Activity (BioSpace)
  • Movers and Shakers in the Biopharma Industry for July 9 (BioSpace)
  • Seattle Cancer Care Alliance One of Only 51 Centers Certified for CAR-T Therapy (BioSpace)
  • Digital therapeutics, medication adherence, clinical trials were key pharma interests in Q2 (MobiHealthNews)
  • Drug prices keep rising despite efforts to address problem (The Connecticut Mirror)
  • MabVax Therapeutics and Boehringer Ingelheim Sign Asset Purchase and License Agreement and Related Agreements for an Antibody Development Program Targeting Multiple Solid Tumor Cancers (Press)
  • Pluristem Signs Collaboration Agreement With Thermo Fisher Scientific (Press)
  • Amphastar Announces Expansion of Amphastar Nanjing Pharmaceuticals Inc. (Press)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • Vivek Ramaswamy's Enzyvant Asks FDA To Approve Treatment For Dying Babies (Forbes)
  • Antibiotic-Antigen Conjugates Bring Immunotherapy to Deadly Bacteria (GEN)
  • Biogen Alzheimer's drug success: A big step because almost every dementia trial before it has ended in failure (CNBC)
  • Senolytic drugs reverse damage caused by senescent cells in mice (NIH)
  • FDA Grants Eagle Seven Year Orphan Drug Exclusivity for BENDEKA (bendamustine hydrochloride injection) (Press)
  • OBI Pharma Granted FDA Orphan Drug Designation for OBI-3424 for the Treatment of Hepatocellular Carcinoma (HCC) (Press)
  • Seattle Genetics and Astellas Announce Progress in Enfortumab Vedotin Urothelial Cancer Clinical Development Program (Press)
  • Emmaus Life Sciences Announces FDA Acceptance of IND Application for Clinical Study of L-glutamine for Treatment of Diverticulosis (Press)
  • Catabasis Pharmaceuticals Announces Plans for Edasalonexent Phase 3 POLARIS DMD Trial in Duchenne Muscular Dystrophy (Press)
  • Johnson & Johnson Announces Publication in The Lancet Highlighting Robust Immune Response to Janssen’s Mosaic-based Preventive Vaccine Regimen for HIV (Press)
  • PTC Therapeutics Announces Positive Data from its Translarna Phase II Clinical Trial in Children as Young as Two Years with Nonsense Mutation Duchenne Muscular Dystrophy (Press)
  • KemPharm Announces Top Line Results from KP415.E01 Efficacy and Safety Trial in Children With ADHD (Press)
Medical Devices
  • BD closes TVA Medical buy (MassDevice)
  • Companion Medical wins FDA nod for Android version of smart pen app (DDBN)
  • Bovie Medical to deal core electro-cautery biz to Symmetry Surgical for $97m (MassDevice)
  • Potrero raises $26.6M to help meet demand for its sensor-laden urinary catheter (Fierce)
  • Symmetry Surgical inks $97M deal for Bovie electrosurgical unit (Fierce)
  • Biodesix acquires Integrated Diagnostics and its lung nodule blood test (Fierce)
  • "Smart" Bandage for Hands-Free Monitoring and Treatment of Chronic Wounds (GEN)
  • Cybersecurity upgrades eyed for 740000 St. Jude-made defibrillators (Minneapolis Star Tribune)
  • Nevro Patents Likely Nixed From Row With Boston Scientific (Law360-$)
  • Fed. Circ. Backs Wright Medical's Patent Win On Surgical Tool (Law360-$)
  • Long-acting Reversible Contraception—Highly Efficacious, Safe, and Underutilized (JAMA)
  • Oculocare's Alleye Receives FDA 510(k) Clearance for Monitoring Eyesight in AMD (Press)
  • Biotricity Provides Fiscal 2018 First Quarter Updates for Shareholders (Press)
  • Masimo Announces Vital Signs Check Application for the Root Patient Monitoring and Connectivity Platform (Press)
  • New 3M Tegaderm Antimicrobial I.V. Advanced Securement Dressing Helps Make Peripheral Lines a Central Part of Infection Risk Reduction Programs (Press)
US: Assorted & Government
  • Insurers warn of rising premiums after Trump axes Obamacare payments again (Reuters)
  • As Atul Gawande steps into a risky health CEO role, here are five challenges he faces (STAT)
  • New DOJ Policy Purports to Prevent Piling-On of Penalties (FDA Law Blog)
Upcoming Meetings & Events Europe
  • Use of “Smart Drugs” on the Rise (Scientific American)
  • DYSIS Medical lands $25M investment to expand in U.S., U.K. and other markets (Fierce)
  • NHS England clears specialised treatments for NHS use (PharmaTimes)
  • Vertex, NHS England no closer to Orkambi settlement (PharmaTimes)
  • PAH patients in England denied access to Actelion’s Uptravi on NHS (PharmaTimes)
  • Clovis’ PARP inhibitor Rubraca under EU review in maintenance setting (PharmaTimes)
  • Richard Lehman’s journal review—9 July 2018 (The BMJ)
  • EMA provides regulatory and scientific support to foster development of new and innovative medicines – from the early phases in the laboratory all the way to the patient. (EMA)
  • Axonics Receives CE Mark for its Sacral Neuromodulation External Trial System (Press)
  • China vows to accelerate cancer drug price cuts (Financial Times)
  • Proposed Changes to Chinese Medical Device Regulations would Benefit Importers (Emergo Group)
  • Investment Bankers Leave Firms for Roles in Hong Kong Biotech Companies (BioSpace)
  • Japan: Balancing Cost and Innovation through Pricing (PharmExec)
  • iBio Establishes Strategic Commercial Relationship with CC-Pharming Ltd. of Beijing, China (Press)
  • Tocagen Closes Previously Announced License Agreement with ApolloBio to Develop and Commercialize Toca 511 & Toca FC in Greater China (Press)
  • Pharma sector may post 17% revenue growth in June quarter: Report (Economic Times)
  • Cost cut: New cap for medical device rates (Deccan Chronicle)
  • India's medical export-import policy under scanner (BioSpectrum)
  • Use auto-disable syringes to prevent infection: Medical devices industry official (Hindustan Times)
  • Prescription medicines: registration of new generic medicines and biosimilar medicines (TGA)
  • Prescription medicines: new or extended uses, or new combinations of registered medicines (TGA)
  • Prescription medicines: registration of new chemical entities in Australia (TGA)
  • Health Canada Approves GAZYVA for Previously Untreated Advanced Follicular Lymphoma  (Press)
  • 100th Surgical Implantation of ZIP ULTRA MIS Interspinous Device Performed in Canada (Press)
General Health & Other Interesting Articles
  • From Gene-Editing Cures to Bioweapon Nightmare (Bloomberg)
  • The path to fixing health care starts with employers (CNBC)
  • Will The Cost of Health Care Devour Your Retirement Income? (Forbes)
  • Team mix affects operating room social behavior (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.
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