Recon: NICE Backs Roche’s Tecentriq for Routine Use in Pre-Treated Bladder Cancer

• Study Finds More Isn't Better for Roche Breast Cancer Drug (Bloomberg) (WSJ) (Reuters) (AP News) (NPR) (NYT)
• The first drug for opioid withdrawal has gotten the green light — and it targets risky symptoms that others ignore (Business Insider) (Focus) (Reuters) (Endpoints) (WSJ) (Pharmacy Times)
• FDA faults IQVIA for errors in opioid sales data, calls for quality review (Endpoints) (CNBC)
• Merck's Keytruda boosts response in hard-to-treat lung cancer (Reuters) (STAT-$) (CBS News)
• Allergan's besieged Restasis patents get smacked again, this time in retailer antitrust suit (Fierce)(Reuters) (Law360-$)
• Novo Nordisk expands cell therapy R&D, says type 1 diabetes cure a step closer (PMLiVE) (Fierce) (pharmaphorum) (The Pharma Letter-$) (Endpoints)
• FDA reverses course on a $4.2 million no-bid grant to a former commissioner (The Washington Post) (Endpoints) (STAT-$) (Politico)
• NEJM publishes second successful Epidiolex trial in LGS (PharmaTimes) (Business Insider)

• Korea approves first-ever AI-based medical device (The Korea Herald) (Korea Biomedical Review)
• NICE backs Roche’s Tecentriq for pre-treated bladder cancer (PharmaTimes) (The Pharma Letter)
• Ebola Outbreak Enters ‘New Phase’ as It Reaches Congolese City (Bloomberg) (NBC News) (BBC News) (CNN) (HuffPost) (NPR) (The Guardian) (The Independent)
• Cabinet approves MoU between India and Swaziland in health, medicine (Business Standard) (Deccan Chronicle) (BioSpectrum)
• Three Minnesota GOP congressmen back appeal for med-tech tariff reprieve (Minneapolis Star Tribune) (Financial Express)
• WHO to weigh declaration of international emergency over Ebola outbreak (STAT)
• International study suggests combination therapy may prevent stroke in certain people (NIH)
• An Ozone-Destroying Chemical Was Banned in 1987. Now Someone Is Producing It Again and Scientists Don't Know Who (Fortune)
• Notice of the Office of the State Drug Administration on the Project Amendment of the Medical Device Industry in 2018 (CFDA)

• Who really pays for prescription drugs (Axios)
• Roche says has had no contact with Trump lawyer Cohen (Reuters)
• How A Drugmaker Gamed The System To Keep Generic Competition Away (NPR)
• AARP Applauds Trump For Taking First Step In Cutting Prescription Drug Costs (Forbes)
• Many Drugs Could Come Equipped with Ingestible Sensors (Pharmacy Times)
• Celyad announces pricing of $47.3 million global offering (The Pharma Letter)
• Vectalys and FlashCell merge into Flash Therapeutics, loaded with RNA pipeline and manufacturing set-up (Endpoints) (Press)
• Will Shire’s top R&D talent bolt now that Takeda has struck a merger agreement? (Endpoints)
• Feds Show Valeant Jury Spending Records, Doctored Emails (Law360-$)
• To shame drugmakers, CMS publicizes price hikes (BioPharma Dive)
• Oncology boom spurs DTC advertising, and with it controversy (BioPharma Dive)
• After nerve-wracking eye surgery, the world comes into focus for early gene therapy recipient (STAT)

• 5 takeaways from the first look at cancer's biggest conference (BioPharma Dive)
• UPDATED: The top winners and losers on ASCO abstract night: Loxo, Blueprint, Jounce, Merck KGaA and more (Endpoints)Combination cancer immunotherapies take center stage at ASCO’s annual meeting (STAT-$)
• Combination cancer immunotherapies take center stage at ASCO’s annual meeting (STAT-$)
• Immuno-oncology at ASCO: survival data, combinations and new indications (PMLiVE)
• Loxo RET inhibitor shines in early-phase trial (Fierce)
• Jounce plunges after ASCO abstract reveal (Fierce)
• Nektar slips on reduced response rates for Opdivo combo (Fierce)
• Duke team IDs new target for fatty liver disease and prediabetes (Fierce)
• Roche immunotherapy combination increases lung cancer survival - study (Reuters) (Press)
• Microglia are key defenders against prion diseases (NIH)
• Male depression may lower pregnancy chances among infertile couples, NIH study suggests (NIH)
• OncoNano Announces $11.7 Million Series A Financing to Support Development of pH-activated Compound Platform for Disease Detection and Treatment (Press)
• LYRICA (pregabalin) Oral Solution CV Phase 3 Trial in Pediatric Epilepsy Meets Primary Endpoint (Press)
• Cerus Announces Additional BARDA Funding to Support Development of INTERCEPT Blood System for Red Blood Cells (Press)

• Analogic shareholder suit seeks to block $1B sale to Altaris (MassDevice)
• Maker Of Anti-Clot Device Must Face Suit Over Pierced Vein (Law360-$)
• A Quick Snapshot Of Boston Scientific's Rhythm Management & Neuro Segment (Forbes)
• Advancements in diagnostics now leads to accuracy in tests under antibiotics (Pharmabiz)
• FDA Exempts Surgical Apparel From 510(k) Requirements (Focus)

• FDA is asking for more information on application forms: Here’s why that’s good for innovation and improving health (MassDevice)
• FDA Announces Proposal to Amend Product Jurisdiction Regulation – A Bit Better But Not Good Enough (FDA Law Blog)
• On the other side of physician burnout (STAT)
• Seven Reasons Why Women Attorneys Thrive in Health Law (Bloomberg)
• Insurers Figured Out How to Make a Profit From Obamacare Last Year (Bloomberg)
• The Bezos-Buffett-Dimon joint venture to save health care is struggling to find a CEO (CNBC)
• These $500 medical records show why Apple could upend the health data industry (CNBC)
• FDA says harvest season over for E. coli-linked romaine lettuce (Reuters)
• Congressional Bill Would Add 1,000 Doctors To Fight Opioid Addiction (Forbes)
• Dems blast VA on EHR modernization progress, acting CIO controversy (HealthcareITNews)
• Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting (FDA)

• FDA Advisory Committee Calendar

• EU OKs first-line use of Ipsen’s Cabometyx (PharmaTimes)
• Experts warn: If Europe doesn’t innovate, it will lose manufacturing to pharmerging countries (in-PharmaTechnologist)
• A 2-pronged attack could improve targeted therapies for colon cancer (Fierce)
• Teleflex launches TrapLiner cath in the EU (MassDevice)
• StimGuard wins CE Mark for SNS overactive bladder treatment (MassDevice)
• European Commission prioritises tobacco, sacrifices global health in unhealthy trade negotiations with Latin America (European Public Health Alliance)
• Unlicensed Medicine Phenytoin 90mg/5ml Oral Suspension - company led recall (MHRA)
• Gambro Ultrafilter U9000 microbial water filter – updated instructions due to leaks during use resulting in risk of hypovolemia. (MHRA)
• Exelixis’ Partner Ipsen Announces European Commission Approval of CABOMETYX (Cabozantinib) for Previously Untreated Intermediate- or Poor-Risk Advanced Renal Cell Carcinoma (Press)
• Teleflex to Introduce the New TrapLiner Catheter in Europe and Showcase the Arrow AC3 Optimus  Intra-Aortic Balloon Pump (IABP) at the European Association for Percutaneous Cardiovascular Interventions Course (EuroPCR) 2018 (Press)

• WuXi and Sinobioway add capacity to nab expected wave of Chinese biologics (Fierce)
• Hong Kong Baptist University develops iridium(III)-based probes for detection of dopamine receptors (Pharmabiz)
• AI Healthcare Startup, UCARE.AI, Secures $8.2m of Funding (Press)

• Undiagnosed hypertension is one of the leading risk factors for deaths in India: WHO report (Pharmabiz)
• WHO’s first diagnostics list to quicken India’s efforts to create national EDL, consultative meeting set for August (Pharmabiz)
• SMPMA urges DCGI to act against NSQ drug manufacturers as per DCC guidelines (Pharmabiz)

• Important changes to the regulation of complementary medicines in Australia (Lexology-$)

• Led by 12-year-old leukemia survivor, pediatric cancer patients push Health Canada for funding (The Globe and Mail)
• Green Shield Canada Launches Digital Health Strategy for Chronic Pain Patients (Press)
• Innovus Pharma Announces the Launch of its Product Vesele in Canada (Press)

• Number of cryopreserved embryos grows 17% in the country (ANVISA)
• Check out the public consultations on Brazilian pharmacopoeia (ANVISA)
• Event promotes good practices in agencies and regulators (ANVISA)
• Varian inks Brazilian training, education deal (MassDevice) (Press)

• Paying the price for insulin (STAT)
• The biggest ethical issues for AI in medicine (Axios)
• Mental health support lacking in U.S. diabetes care (Reuters)
• Episode analytics now mission critical as outcomes meet incomes (Microsoft)
• Doctor visits about suicidal thoughts rose with '13 Reasons Why.' Handle Season 2 with care. (USA Today)
• Baby Booms and Strong Economies Usually Go Hand-in-Hand. So Why Did U.S. Fertility Just Hit a Record Low? (Fortune)
• Johns Hopkins unveils new computational method for precision oncology (HealthcareITNews)