Recon: Bluebird's gene therapy eliminates blood transfusions for some beta-thalassemia patients

• AstraZeneca's Tagrisso just got the lung cancer nod it needs to hit $3B in sales (Fierce) (Reuters) (Endpoints) (Business Insider)
• FDA staff raises safety concerns over Lilly/Incyte arthritis drug (Reuters) (Endpoints) (Bloomberg)
• Amgen exec moves to become Novartis CMO (The Pharma Letter) (Endpoints) (Fierce)
• Novartis CEO feels heat on U.S. generics, Cosentyx drop (Reuters) (The Pharma Letter)
• Medicine use and spending in the US – A review of 2017 and outlook to 2022 (IQVIA)
• AI pharma start-up BenevolentAI now worth $2 billion after $115 million funding boost (CNBC) (TechCrunch) (Reuters) (Business Insider) (Endpoints)
• Kleiner Perkins’ Beth Seidenberg bumps Tmunity’s cell therapy round to $135M (Endpoints) (Fierce) (Philadelphia Business Journal-$)
• Bluebird's gene therapy eliminates blood transfusions for some beta-thalassemia patients (Fierce) (Endpoints) (MIT Technology Review) (WSJ) (NPR) (NEJM)
• Why Procter & Gamble Is Buying Merck KGaA's Consumer Health Unit in a Whopper of a Deal (Fortune) (USA Today) (Fierce) (Merck KGaA)

• Exclusive: Allergan in talks to acquire Shire, competing against Takeda – sources (Reuters) (CNBC) (Bloomberg) (Endpoints) (WSJ)
• WHO panel urges caution on dengue vaccine, dealing blow to Sanofi (STAT-$) (Reuters)
• Universal pharmacare would provide better health care but costs a concern: health committee (The Canadian Press) (National Post) (CBC News)
• US Makes First Public Comments Against India’s Price Cap on Medical Devices (The Wire)
• India's Fortis Healthcare to form committee to assess binding bids (Reuters) (Nikkei Asian Review) (Business Standard)
• Unveiling vaccine hesitancy in the Federation of Bosnia and Herzegovina (World Health Organization)
• African scientists call for more control of their continent’s genomic data (Nature)

• Cancer and heart drugs boost Novartis sales (Financial Times)
• Gates backs gene technologies in fight to end malaria (Endpoints) (The Guardian)
• Amid tough respiratory competition, AstraZeneca inks Symbicort outcomes-based deals (Fierce)
• Cosentyx jitters weigh on Novartis (BioPharma Dive)
• GSK brings on Roche exec to lead pipeline growth (BioPharma Dive)
• Eye Drop Suit Must Stay Tossed, Pharma Cos. Tell 1st Circ. (Law360-$)

• In knockout IPO offerings, MorphoSys and Surface Oncology haul combined $316M in upsized deals (Endpoints)
• CNS Pharma turns to crowdfunding to advance glioblastoma drug (Fierce)
• Argos abandons kidney cancer vaccine after phase 3 fail (Fierce)
• 'Cell-free' CRISPR could improve cancer diagnostics, unravel how gene editing works (Fierce)
• Three Steps Toward a More Sustainable Path for Targeted Cancer Drugs (JAMA)
• GW’s Epidiolex takes a leap toward US approval (The Pharma Letter)
• FDA clears first therapy for inherited rickets (The Pharma Letter)
• FDA seeks info on DMD drug as hold remains (BioPharma Dive)
• Landmark IMPACT study published in NEJM shows significant benefits of Trelegy Ellipta for patients with COPD (Press)
• Biohaven Pharmaceuticals Announces Additional Phase 3 Rimegepant Data to be Released at Investor Event Held Concurrently with the 2018 American Academy of Neurology Meeting in Los Angeles (Press)
• Additional Clinical Studies Supporting the Benefits of OMIDRIA Presented at the American Society of Cataract and Refractive Surgery and American Society of Ophthalmic Administrators Annual Meeting (Press)
• Adamas Announces Final Results from the Two-Year Phase 3 Open-Label Study of GOCOVRI in Parkinson’s Disease Patients with Dyskinesia (Press)
• Tocagen and ApolloBio Enter License Agreement to Develop and Commercialize Toca 511 & Toca FC in the Greater China Region (Press)

• Artificial intelligence will put a premium on physicians’ knowledge and decision-making skills (STAT)
• FDA warns against endoscope connectors (MassDevice) (FDA)
• Emboline raises $10m Series B for TAVR embolism filter (MassDevice) (Press)
• Philips inks collab software integration deal with Sun Nuclear (MassDevice) (Press)
• (Don’t) Take the Long Way Home: FDA Issues Draft Guidance on Expansion of the Abbreviated 510(k) Program (Arnall Golden Gregory LLP)
• SpeeDx receives FDA clearance for Mycoplasma genitalium product (Press)

• U.S. appeals court says Ohio cannot block Planned Parenthood funds (Reuters)
• How doctors in the US prescribe opioids — four charts (CNBC)
• NIH abruptly changes course on industry opioids partnership after ethics flags raised (STAT)
• The FTC Appeals Shire ViroPharma Dismissal (FDA Law Blog)
• EEOC Sues Another Health Care Provider For Alleged Pregnancy Discrimination (Lexology)
• For Now, Hospitals Hang On Despite CVS, Optum And Walmart Threats (Forbes)
• Does The U.S. Biosimilar Space Have A Case Of "Progressophobia?" (Biosimilar Development)
• Federal Policy for the Protection of Human Subjects: Proposed Six Month Delay of the General Compliance Date While Allowing the Use of Three Burden-Reducing Provisions During the Delay Period (Federal Register)

• FDA Advisory Committee Calendar

• MHRA Guidance: E-cigarettes: regulations for consumer products (MHRA)
• New verification system will secure patient safety and support continuation of medicines supply (ABPI)
• TAV, scientific advice and Brexit in the focus of the meeting between PEI and the BPI (Paul-Ehrlich-Institut)
• Leading-edge healthcare: Industrial Strategy Challenge Fund (MHRA)
• Submission of comments on 'Draft qualification opinion on Proactive in chronic obstructive pulmonary disease (COPD) (EMA)
• Final NHS nod for Roche’s RoActemra (PharmaTimes)
• MPs slate rate of progress on NHS cyber security (PharmaTimes)

• Revisions of precautions: Omariglipin, etc. posted (PMDA)
• China-Denmark Drug Regulatory Thematic Seminar held in Beijing (CFDA)
• Chugai debuts Tecentriq in Japan for NSCLC (The Pharma Letter)
• Tecentriq Now in PD-1/L1 NSCLC Showdown, Lynparza Also Hits Japan Market (Pharma Japan)
• Biosimilar Use Essential to Sustain Universal Health Coverage: Society President (Pharma Japan)

• This app can help determine the risk of diabetes for people in rural India (Mashable)
• The Political 'Environment' of India's Mental Health (The Wire)
• Health ministry to name hospitals which do not perform under Kayakalp (Times of India)
• Foreign direct investment in Indian pharma sector causing concern (The Pharma Letter)
• Pharma funds may not outperform diversified equity funds any time soon: Sonam Udasi of Tata MF (Economic Times)
• Indian Pharma Inc shifts to high gear in filing patents (Pharmabiz)

• Fluad trivalent influenza vaccine: Safety advisory - risk to patients with latex allergy (TGA)
• Lives affected by motor neurone disease are changed by Australian medical technology (ABC News)
• Replacement for outgoing SA Health chief announced (ABC News)

• Final Notice: Classification of Dental Plaque-Disclosing Products as Drugs (Health Canada)
• Notice - Update on Health Canada’s efforts to support innovative human therapeutic products to combat antimicrobial resistance (AMR) and consultation on a proposed Pathogens of Interest List (Health Canada)

• Alzheimer’s disease starts in childhood, with symptoms found in babies less than a year old, study shows (Newsweek)
• The Menopause-Alzheimer’s Connection (NYT)
• Mirror Proteins Come Through (Science Translation Medicine)
• More E. Coli Infections Tied to Romaine Lettuce Have Been Reported, CDC Says (Fortune)