Recon: Trump Admin Cracks Down on Drug Price Hikes

• Azar, striking an aggressive tone, suggests Trump will call out drug companies behind major price hikes (STAT) (Reuters) (MedCity News)
• Bluebird adds targets, $500M in milestones to Medigene TCR pact (Fierce) (GEN) (Endpoints)
• A startup that wants to make treatments that edit single letters in our DNA just raised $87 million (Business Insider-$) (C&EN) (Endpoints) (Fierce) (Harvard Gazette)
• Lilly Continues Oncology Expansion with Plans to Buy AurKa Pharma for Up to $575M (GEN) (Fierce) (Reuters) (BioPharma Dive) (BioCentury)
•  Senate Democrat probing Novartis dealings with Trump lawyer (BioPharma Dive) (Bloomberg) (The Hill) (Endpoints) (STAT)
• Perrigo no longer expects to get approval for generic ProAir this year (CNBC) (Scrip-$) (Bloomberg) (Fierce)
• Ansun raises $85M in series A to fund phase 3 antiviral study  (Fierce) (BioCentury)
• Troubled aTyr axes 30% of its staff as it wipes a preclinical slate clean (Endpoints) (Fierce)
• FDA approves Novartis’ Gilenya for paediatric use (PharmaTimes) (Medscape) (pharmaphorum)
• ‘60 Minutes’ looks at lawsuits against Boston Scientific (Boston Globe) (CBS News) (MassDevice)

• Bayer expands label for Eylea in China (The Pharma Letter) (Pharmabiz) (The Financial)
• China’s plans to import Indian drugs fail to enthuse pharmaceutical firms (The Hindu) (Times  of India) (Economic Times) (Press Trust of India)
• Merck's experimental Ebola shot gets set to fight deadly new outbreak in Congo (Fierce) (STAT)
• WHO calls for elimination of trans fat in foods by 2023 (CNN) (NBC News) (Chicago Tribune) (WSJ) (Vox) (USA Today) (Fortune)
• Australia's Healthscope gets $3.3 billion Brookfield approach, sparking bid war hopes (Reuters) (The Sydney Morning Herald) (Australian Financial Review)
• Emergex wins Innovate UK grant to advance universal flu vaccine (PharmaTimes) (EPM)
• HSA raises alert on two health products containing potent steroid (Channel NewsAsia)
• GDPR Implementation & HIPAA Compliance: What you need to know (Microsoft)
• Eli Lilly Takes $7M Gamble On Global Health FWorking... In Indiana (Forbes)
• Novartis’ tone-deaf response to Michael Cohen: troubling, but not surprising (STAT)
• WHO says 19 dead, 39 infected so far in Congo Ebola outbreak (Reuters)
• ANVISA Changing Brazilian Market Pathway for Low-risk Medical Devices (Emergo Group)

• Blood, sweat and tears in biotech — the Theranos story (Nature)
• From old behemoth Lipitor to new king Humira: Best-selling U.S. drugs over 25 years (Fierce)
• Stephen Eck leaves Aravive CEO job to join Immatics (Fierce)
• Seven drug pricing proposals that will happen and a couple that won’t (EP Vantage)
• Vantage view – how biopharma is meeting the next payer challenge (EP Vantage)
• Why does Wall Street love Trump’s ineffective drug-price plan? (STAT)
• The holes in Trump's drug pricing plan (Axios)
• Trump's new prescription drug plan is incomplete -- here are two ways to make it better (Fox)
• Trump Drug Pricing Plan Outlines Rule Changes Pharma Can Live With (PharmExec)
• Trump’s drug price retreat adds to list of abandoned populist promises (The Washington Post)

• Viagra and many other drugs were discovered by chance. Now science is hoping to change that. (The Washington Post)
• Targeting the tricky PI3K pathway in cancer, MEI gets $75M to push program through registration study (Endpoints)
• Attacking the common cold by unshielding its genome (Fierce)
• Head of Biden Cancer Initiative draws on own diagnosis to speed research (STAT)
• RXi Pharma inks research pact with Iovance to evaluate potential synergies with new sd-rxRNA therapeutic compounds & autologous cell therapy based on TILs to treat cancer (Pharmabiz)
• Hemogenyx collaborates with undisclosed global pharmaceutical firm on CDX antibodies development (Pharmaceutical Business Review)
• Association of Pharmaceutical Industry Marketing of Opioid Products to Physicians With Subsequent Opioid Prescribing (JAMA)
• Vyaire Medical Recalls AirLife Resuscitation Devices and Broselow Convenience Kits Due to Risk of Malfunction Caused by Error in Product Design (FDA)
• Perrigo Confirms First To File Patent Challenge For Generic Version Of Ultravate Lotion (Press)
• Entasis Therapeutics Initiates Clinical Studies of the Oral Extended-Spectrum Beta-Lactamase Inhibitor ETX0282 (Press)
• ICON Announces Clinical Research partnership with DuPage Medical Group (Press)
• Beam Therapeutics Founded by Gene Editing Pioneers to Create Precision Genetic Medicines with Base Editing (Press)
• Arrowhead Doses First Hepatitis B Patients in Multiple Dose Portion of Phase 1/2 Study of ARO-HBV (Press)

• Google sister company Verily is working on a device that collects blood using tiny exploding needles (CNBC)
• SurModics acquires Embolitech thrombectomy tech for $5m (MassDevice) (Press)
• PAVmed licenses cell-sampling device, test to diagnose Barrett’s esophagus (Fierce) (Press)
• Pierre Fabre forms connected underwear collaboration (Fierce)
• Boston Scientific presents positive real-world data of SMART Pass on the S-ICD system at Heart Rhythm 2018 (Pharmabiz) (Press)
• NIH scientists develop novel technique to study brain disease (NIH)
• Medical Device Co. Owes $2M For Contract Breach, Suit Says (Law360-$)
• Immunicom's Immunotherapy Product Receives U.S. FDA Breakthrough Device Designation for the Treatment of Cancer (Press)
• CurveBeam Announces FDA 510(k) Clearance for LineUP Weight Bearing Multi-Extremity CT System (Press)
• QT Medical Receives U.S. FDA 510(k) Clearance for Home-use 12-lead ECG (Press)
• OrthoPediatrics Corp. Announces FDA 510(k) Clearance for its 25th Surgical System, Pediatric Nailing Platform |FEMUR (Press)
• Agilent Completes Acquisition of Genohm (Press)
• Baxter Announces U.S. FDA Clearance of New Spectrum IQ Infusion System (Press)
• Ancora Heart Expands Enrollment of U.S. Early Feasibility Study for the AccuCinch System for Left Ventricular Repair (Press)
• New Study Demonstrates Feasibility of Novel Mechanical Sensor in Medtronic Micra Transcatheter Pacing System to Detect Atrial Contractions and Restore AV Synchrony (Press)

• Addressing Needs of Patients While Stemming the Tide of the Opioid Crisis (FDA)
• Statement from FDA Commissioner Scott Gottlieb, M.D., on the Trump Administration’s plan to lower drug prices (FDA)
• June 12, 2018: Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting Announcement (FDA)
• HHS Secretary Remarks on Drug Pricing Blueprint (HHS)
• Blue districts have higher uninsured rates and more poverty (Axios)
• Questions Surround ‘America First’ Plan on Overseas Drug Prices (Roll Call)
• States Ease More Restrictions To Physician Assistants As Team Care Takes Hold (Forbes)
• Insulin Access and Affordability Working Group: Conclusions and Recommendations (American Diabetes Association)
• Kushner-backed health care project gets ‘devastating’ review (Politico)

• FDA Advisory Committee Calendar

• Price cuts secure NHS place for MS drugs (PharmaTimes)
• Coeliac UK, Innovate UK launch research competition (PharmaTimes)
• France extends cheese recall after E.coli cases in children (Reuters)
• Pharmacovigilance Risk Assessment Committee (PRAC): Draft agenda for the meeting on 14-17 May 2018 (EMA)
• Updated: Human and veterinary medicines: register of licensed manufacturing sites (MHRA)

• Manipal-TPG make fresh offer for Fortis Healthcare: Sources to ET Now (Economic Times)
• China's Sinobioway Biomedicine says it will invest nearly $500M on massive biologics site (Fierce)
• Oxford Performance Materials and JSR Corporation Announce Partnership to Advance OPM Technology Platform Throughout Asia (Press)

• Pharma exporters still waiting for Rs.1,000 crore IGST refund from govt (Pharmabiz)
• Industry faces new challenges with the implementation of GST: Badri Narayanan (Pharmabiz)
• Healthcare sector may touch Rs 8.6 tln by FY22: Report (Economic Times)
• The Worries of 'Log Kya Kahenge?' on Mental Health (The Wire)
• CGMP Violations Found at India Facility (PharmTech)
• Medical Devices Regulatory Priorities In India (Med Device Online)
• Local medical devices industry wants Modi to encourage indigenous manufacturing (Business Times)
• As sector grows, medical device makers cry for attention (The New Indian Express)

• Artificially intelligent doctors can help Australia lead world in health (The Australian)
• My Health Record opt-out date announced (Australian Associated Press)
• Aged-care residents to gain better mental health services from budget (The Sydney Morning Herald)
• Windfall of $500 million for genomics in Australia's federal budget (BioNews)
• B.C. homeopathy case revives concerns about largely unregulated field (The Globe and Mail)

• Canada's Innomar buys regulatory consulting firm Therapeutic Products (The Pharma Letter)
• Notice: Publication of Update to the Guidance Document: Patented Medicines (Notice of Compliance) Regulations (Health Canada)

• Preventing PTSD: calling Dr. Tetris? (STAT)
• The obvious way to reduce drug prices that the US is missing (CNBC)
• Patient Number One At The Front Door Of Free Healthcare In America (Forbes)
• Initiative Reduces Days Spent in Hospitals and Other Inpatient Facilities (NEJM)
• New coalition urges greater support for independent docs in value-based payment models (Modern Healthcare)