Recon: Merck and Bristol-Myers Offer Positive Lung Cancer Data

• Merck Keeps Edge Over Bristol-Myers In Cancer Duel (Forbes) (WSJ) (CNBC) (FT-$) (NY Times-$) (Bloomberg) (Press)
• AZ’ Tagrisso offers sustained benefit in lung cancer (PharmaTimes) (PMLiVE) (pharmaphorum)
• FDA approves nivolumab plus ipilimumab combination for intermediate or poor-risk advanced renal cell carcinoma (FDA) (MSKCC) (OncLive)
• Boston Scientific snaps up nVision Medical in deal worth $275M (Fierce) (MassDevice)
• Move over right-to-try: FDA looks at improving clinical trial enrollment (Politico)

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• Shire sells cancer drugs to Servier for $2.4 billion as Takeda circles (Reuters) (PharmaTimes) (Financial Times) (WSJ) (Bloomberg) (BBC News)
• Newly prequalified Quality Control Laboratory in Ghana thanks to USP (World Health Organization)
• PhRMA Chief Warns of Serious Implications for Japan Market after 2018 Pricing Reform (Pharma Japan)
• More staff at China FDA will help propel market to half trillion dollars by 2020 (PharmaLetter)
• Canadian online pharmacy fined $34 million for selling counterfeit meds, but is it a ‘slap on the wrist’? (Stat-$) (The Hill) (AP)
• EpiPen shortages seen in Canada, UK but U.S. supply intact (Reuters)
• CRISPR Therapeutics Plans to Treat First Patients for Beta Thalassemia in Europe (BioSpace)

• Drug Company ‘Shenanigans’ to Block Generics Come Under Federal Scrutiny (NYT)
• Sanofi looks to trim down with divestments (Pharmafile)
• Q1 kicks off with J&J, Novartis, Glaxo results (BioPharma Dive)
• Little by Little: Real Life Lessons In Business Development (LifeSciVC)
• Inside California Stem Cell Agency’s Fledgling Industry Partnership (California Stem Cell Report)
• Whistleblower suit claims McKesson repackaged, sold cancer drug “overfill” (The Cancer Letter)

• ICER releases draft report on CGRP migraine drugs (BioPharma Dive)
• Let's Get Real – ANDA Approval Likely Takes More Than Two Years, US FDA Says (Pink Sheet-$)
• Pembrolizumab plus Chemotherapy in Metastatic Non–Small-Cell Lung Cancer (NEJM)
• Scientists teach computers how to analyze brain cells (NIH)
• Novartis' Entresto helps preserve kidney function in chronic heart failure patients (Pharmafile)
• Interview – Probiodrug hopes to avoid Alzheimer’s amyloid abyss (EP Vantage)
• AACR18 Day 2 Highlights (Biotech Strategy Blog-$)
• MediMergent and FDA team up to tackle medication adherence (Drug Delivery Business News)
• Antifungal ‘prodrug’ shows promise in bladder cancer: AACR (Fierce)
• Overall survival data for LYNPARZA (olaparib) in gBRCA-mutated HER2-negative metastatic breast cancer presented at AACR (Press)
• Boehringer Ingelheim and Lilly Announce an Academic Collaboration with University of Oxford to Investigate the Effects of Empagliflozin in People with Chronic Kidney Disease (Press)

• How Profiteers Lure Women into Often Un-Needed Surgery (NYT)
• Bristol-Myers Squibb, Illumina to develop companion diagnostics for immunotherapies (Mass Device)
• Companion Diagnostics: US FDA Streamlines Risk Determinations In Oncology (Pink Sheet-$)

• Scott Gottlieb Is Not A Free Market Firebrand (Reason)
• Trump to give drug pricing speech later this month (Axios)
• Can Washington fix the opioid crisis? (Washington Examiner)
• Qualification of Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ) – A Patient-Reported Outcome Instrument (FDA)
• FDA Says the Jolt is Too Much and Potentially Deadly – Caffeine Guidance Describes Restrictions (Lachman Consultants)

• FDA Advisory Committee Calendar

• MPs criticise NHS Digital/Home Office data sharing deal (PharmaTimes)
• Hungarian healthcare is underfinanced (The Pharma Letter-$)
• French biotech raises $44 million to fight NASH (The Pharma Letter)
• Brexit makes UK pharma market less attractive – can a more collaborative culture redeem it? (pharmaphorum)
• Essential EU Nomenclatures Under New Regs To Be Free Of Charge For Users, Document Says (Medtech Insight)
• Decision: Advertising investigations: February 2018 (MHRA)
• Collection: Advertising investigations by MHRA (MHRA)
• Guidance: Advertise your medicines (MHRA)
• SME Office annual report 2017 (EMA)
• Monthly statistics report: March 2018 Medicinal products for human use (cumulative figures for the year to date) (EMA)
• Technology networks awarded £3m to solve life science challenges (Medical Research Council)

• The 3rd Japan - India Medical Products Regulation Symposium (PMDA)

• Provisional TGA approval pathway - first determination decision for Lartruvo (The Pharma Letter) (TGA)
• Australian Public Assessment Reports for prescription medicines (AusPARs) (TGA)
• Updates to the Permissible Ingredients Determination for listed medicines (TGA)
• Upcoming changes to the Permissible Ingredients Determination (TGA)
• TGA presentation: Australasian Society for Biomaterials and Tissue Engineering Annual Conference, 3-5 April (TGA)

• Canadian medical student nearly loses residency over Health Canada red tape (CBC News)
• Updated Register of Certificates of Supplementary Protection and Applications (Health Canada)
• Updated Notice of Compliance (NOC) Data Extract (Health Canada)
• Drug and health product submissions under review (SUR) (Health Canada)
• Notice: Adjustments to Medical Device Single Audit Program (MDSAP) Transition (Health Canada) (Focus)

• A 32-Year-Old's Startup, Inspired By A Health Scare, Sells For $275 Million (Forbes)
• Google unveils vetting process for drug rehab ads (Reuters)
• Weighing the Pros and Cons of statins (NY Times-$)