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

Posted 16 April 2018 | By Ana Mulero Zachary Brennan 

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

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In Focus: International
  • 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)
Pharmaceuticals & Biotechnology
  • 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)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • 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)
Medical Devices
  • 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-$)
US: Assorted & Government
  • Scott Gottlieb Is Not A Free Market Firebrand (Reason)
  • Trump to give drug pricing speech later this month (Axios)
  • Can Washington fix the opioid crisis? (Washington Examiner)
  • Qualification of Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ) – A Patient-Reported Outcome Instrument (FDA)
  • FDA Says the Jolt is Too Much and Potentially Deadly – Caffeine Guidance Describes Restrictions (Lachman Consultants)
Upcoming Meetings & Events Europe
  • MPs criticise NHS Digital/Home Office data sharing deal (PharmaTimes)
  • Hungarian healthcare is underfinanced (The Pharma Letter-$)
  • 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)
Asia
  • The 3rd Japan - India Medical Products Regulation Symposium (PMDA)
Australia
  • 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)
Canada
  • 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)
General Health & Other Interesting Articles
  • A 32-Year-Old's Startup, Inspired By A Health Scare, Sells For $275 Million (Forbes)
  • Google unveils vetting process for drug rehab ads (Reuters)
  • Weighing the Pros and Cons of statins (NY Times-$)
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.

Need to contact the editor of Regulatory Reconnaissance? Send us an email at news@raps.org.

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