Recon: EMA Chief Elected Chair of ICMRA; Sangamo Touts Early Hemophilia Gene Therapy Data

• Experimental gene therapy for hemophilia, developed by Pfizer and Sangamo, shows early promise (STAT) (Endpoints) (Press)
• As Sangamo Touts Data, BioMarin Preps Hemophilia Gene Therapy For FDA (Xconomy)
• Intra-Cellular drug fails bipolar depression study; shares fall 14% (Reuters) (Endpoints)
• FDA resists livestock lobby’s push on GE animals (Politico)
• Takeda, already a giant in Mass. biopharma, plans a bigger footprint (STAT)
• Trump Suggests Executive Order on Drug Prices, With a Scope That Is Unclear (NYTimes) (Endpoints)
• Trump misleadingly says prescription drug prices have gone down (The Hill)
• Sound, Fury and Prescription Drugs (NYTimes)
• Lawmakers grow impatient for FDA cannabis rules (The Hill)

• Guido Rasi elected chair of International Coalition of Medicines Regulatory Authorities (ICMRA) (EMA)
• Roche pushes back Spark merger deadline as US, UK antitrust reviews drag on (Fierce) (Endpoints)
• Worldwide reduction in MERS cases and deaths since 2016 (WHO)
• Europe urged to adapt faster to gene therapy challenges (PMLive)
• Handheld cluster headache device recommended by NICE (Pharmaceutical Journal) (NICE)
• Bayer seeks EMA approval to treat children with blockbuster drug Xarelto (Reuters)
• Evotec spins off cancer tech into new Breakpoint company (PMLive) (Endpoints)
• Government to set up express freight service for medicines in case of no-deal Brexit (Pharmafile)
• Australia Could ‘Look Worse Than Comparable Countries’ Under Proposed GCP Inspections (Pink Sheet-$)
• Oxford Nanopore opens DNA decoding kit factory (Financial Times)

• Teva unloads plant, U.S. OTC line to PL Developments (Fierce)
• Pledging a comeback, Acer axes pre-commercial ops, chops staffers in wake of CRL (Endpoints)
• USFDA issues 12 observations for 3 Biocon units in Malaysia (Economic Times)
• FDA Issues Guidance on Oral Oxitriptan Compounding (Focus)
• Cumulative CBER Regenerative Medicine Advanced Therapy (RMAT) Designation Requests Received by Fiscal Year (FDA)
• Estimated Changes in Manufacturer and Health Care Organization Revenue Following List Price Reductions for Hepatitis C Treatments (JAMA)
• Is Great Information Good Enough? Evidence from Physicians as Patients (NBER)
• Fattening the bankroll, Bill Haney adds cancer R&D powerhouse Merck to Skyhawk's roster of partners out to drug RNA (Endpoints)
• Array shows off the positive BEACON CRC data that helped spur Pfizer's $11.4B buyout offer (Endpoints)
• Celyad’s off-the-shelf CAR-T data in colorectal cancer early, but serious toxicities haven’t appeared (MedCity)
• Kymera: a systematic approach to protein degradation (BioCentury)
• As precision medicine grows, so does the importance of clinical trial diversity (MedCity)
• The chief scientist at German/US biotech hybrid Immatics is moving to the helm. Here's his to-do list (Endpoints)
• ‘Pause button’ for CAR-T cells may overcome a dangerous side effect of cancer therapy (STAT)
• Everyone agrees this superbug is a threat. Few are willing to fund research to stop it (STAT)
• Ready, aim, launch: Jazz targets docs, consumers with branded Sunosi campaigns (Fierce)
• US WorldMeds Seeks FDA Action on Generic Drug-Device Products (FDA News-$)
• The FDA’s Guidance on bispecific antibodies: Pharma’s concerns (PharmaLetter-$)
• Sol-Gel's rosacea drug clears late-stage hurdle; uniQure's hemophilia gene therapy impresses with PhII data (Endpoints)
• Altaire Pharmaceuticals, Inc. Issues Voluntary Recall of Multiple Ophthalmic Products Sold at Wal Mart (FDA)

• First Participant Enrolled in Second Cohort of BiondVax's Pivotal, Clinical Efficacy, Phase 3 Universal Flu Vaccine Trial (Press)
• Vivacelle Bio, Inc. Announces FDA Clearance to Enroll Patients into a Phase IIa Clinical Trial of VBI-S for Elevation of Blood Pressure in Subjects Who Have Shock Due to Sepsis (Press)
• Enanta Pharmaceuticals Initiates Phase 1 Clinical Study of EDP-514, its Lead Core Inhibitor for the Treatment of Hepatitis B Virus (HBV) (Press)
• AIVITA Biomedical Announces New Clinical Data in Ongoing Phase 2 Brain Cancer Trial (Press)
• Compass Therapeutics Announces First Patient Dosed in Phase 1 Trial of CTX-471 (Press)

• The Pros and Cons of Standardized Testing (MDDI)
• BIOTRONIK Receives FDA Clearance on Next-Gen Injectable Cardiac Monitor: BIOMONITOR III (Press)
• Medtronic HeartWare(TM) HVAD(TM) Implanted via Less Invasive Thoracotomy Shows 95 Percent Freedom from Disabling Stroke at Two Years (Press)

• Oral arguments imminent in Obamacare case (Politico)
• Drug Price Disclosure to Consumers: Current Legal Authority and Considerations for Congress (CSR)
• A Round Up of New State Laws to Control Drug Prices (FDA Law Blog)
• How Does Vagueness Affect Negligence Per Se Claims? (Drug & Device Law)
• Commentary: Convenience store group CEO says teen vaping would get worse under FDA plan (CNBC)
• A View From Inside Cigna's $67 Billion Acquisition Of Express Scripts (Forbes)
• Drug Importation Working Group Has Been Publicly Invisible As Buzz Grows On Proposal (Pink Sheet-$)

• FDA Advisory Committee Calendar

• EMA Issues Two Guidances on Drug Shortages (Focus)
• UK Advertising Watchdog Cites Sanofi for Instagram Promotion (Focus)
• NHS England scraps 7 more drugs on prescription (PharmaTimes)
• Rituzena - Withdrawal of the marketing authorisation in the European Union (EMA)
• How the implementation of Safety Features progresses 5 months in (MHRA)
• Class 4 Medicines Defect Information: Phenobarbital Sodium 30mg/ml Injection (MDR 48-02/19) (MHRA)

• Chinese NMPA update: eRPS, predicate device data, technical review guidelines (Emergo)

• Indian generic drugmakers getting more FDA approvals (PharmaLetter-$)
• NPPA fixes retail prices of 9 formulations under DPCO, 2013 (Pharmabiz)
• Indian Pharma to grow at 11-13% in financial year 2020: ICRA (Pharmabiz)
• AiMed expresses anguish over continued neglect of domestic medical device manufacturers by govt (Pharmabiz)

• CannTrust slumps after Health Canada finds unlicensed pot cultivation (Reuters)
• Consultation on the draft guidance document: The Distinction Between Promotional and Non-promotional Messages and Activities for Health Products (Health Canada)

• New Zealand Consults On Labeling Excipients That Cause Undesirable Reactions (Pink Sheet-$)