Regulatory Focus™ > News Articles > 5 > Recon: NICE Backs Roche’s Tecentriq for Routine Use in Pre-Treated Bladder Cancer

Posted 17 May 2018 | By Ana Mulero 

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

3223 Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

In Focus: US
  • 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)
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In Focus: International Pharmaceuticals & Biotechnology
  • 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)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • 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)
Medical Devices
  • 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)
US: Assorted & Government
  • 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)
Upcoming Meetings & Events Europe
  • 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)
General Health & Other Interesting Articles
  • 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)
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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