Recon: CMS Quietly Quit Deal to Pay for Kymriah Performance

• 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)

• Vertex CEO to UK Prime Minister: You’re devaluing lives, passing up a great offer and threatening the country’s biotech industry (Endpoints) (STAT-$)
• Abingworth Raises €268M to Invest in Life Science Companies (labiotech) (Fierce) (Endpoints)
• Axovant, Benitec sign licensing deal for AXO-AAV-OPMD program (PBR) (GEN) (Fierce)
• Amryt Pharma’s heart drug gets approval from NHS England (Irish Times) (pharmaphorum)
• Janssen wins label extension for Simponi (The Pharma Letter) (EPM Magazine)
• Antibiotics should be restricted for COPD (NICE) (The BMJ)
• China’s Biopharma Rise: Opportunities and Threats (PharmExec)
• Pacemakers, ultrasound gear costs could rise from China trade tariffs (USA Today)
• Shares in Neurotech are going nuts after releasing details on a treatment for autism (Business Insider Australia)
• Red flags fly over Anavex: What’s stopping the drug maker from enrolling U.S., European patients in trials? (STAT-$)

• 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)

• 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)

• 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)

• 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)

• FDA Advisory Committee Calendar

• 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)

• 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)