Recon: FDA issues refuse-to-file letter for Alkermes depression drug

• Alkermes stumbles as FDA refuses to review depression drug (STAT) (Fierce) (CNBC) (BioPharma Dive) (Endpoints) (First Word Pharma)
• Longtime Novartis exec takes the helm at Macrolide Pharma (Fierce) (Endpoints)
• Novartis Files Trade Secrets Lawsuit Against Former Executive Who is Now with Biogen (BioSpace)
• Bouncing back, MediciNova makes big gains after touting triglyceride data from a tiny study (Endpoints) (STAT-$) (Fierce)
• Drug Price Hike Sparks Senate Probe (WSJ-$)
• FDA Sends Record-Low Warning Letters To Device-Makers In 2017 As Agency Takes More Personalized Compliance, Enforcement Tack (Medtech Insight-$)
• Drug companies want Supreme Court to take eye drop dispute (ABC News)

• Compugen, AstraZeneca unit in cancer drug development deal (Reuters) (Fierce) (Endpoints)
• Why GSK Is Exploring The Sale Of Its Indian Consumer Arm (Bloomberg)
• CFDA Reorganization: Impact for medical device registrants (Emergo)
• Tata Trusts and Google explore cancer care pact (Economic Times) (Gadgets Now)
• Guidance on procedures for the analysis of organic products (ANVISA)
• To boost generic competition, analysis says, FDA should approve drugs OK’d by foreign regulators (STAT-$) (Focus)
• FDA/IMSN Summit with international drug regulators to discuss medication safety issues (FDA)
• FDA alerts consumers of a nationwide voluntary recall of topical drug products made by Industria Farmacéutica Andrómaco due to contamination (FDA)

• The drug pricing contract Express Scripts doesn't want you to see (Axios)
• PhRMA argues early notice of price hikes won't benefit patients (BioPharma Dive)
• Wholesale drug prices may be rising, but rebates are taking a bigger bite (STAT-$)
• While Hugin led Celgene, its PAC donated heavily to Menendez (Politico)
• Abeona taps ex-Alexion CCO as new chief, eyeing commercial operations (Fierce)
• Half-off sale at Eli Lilly as drug rebating climbs to 51% in 2017 (Fierce)
• Dendreon chairwoman figures Provenge growth, infrastructure can pave its way into CAR-T (Fierce)
• Johnson & Johnson, Bayer drop Fox show advertising after host belittles Parkland student (Fierce)
• TherapeuticsMD Announces Expansion of Board of Directors (Press)
• BioCryst Pharmaceuticals Files Definitive Proxy Statement in Connection with Pending Merger with Idera Pharmaceuticals (Press)
• RA Capital Management Opposes BioCryst Pharmaceuticals' Proposed Merger with Idera Pharmaceuticals (Press)

• FDA Acts to Remove the Rx Status of PEG 3500 (Lachman Consultants)
• The Lab Tests Behind Immuno-Oncology: Precise Enough? (Forbes)
• In salvage effort, Sellas cherry picks some positive mid-stage cancer vaccine data (Endpoints) (Press)
• Tired of finishing in last place, Eli Lilly’s new R&D chief wants to shake things up (Endpoints)
• CRISPR paper that sent stocks tumbling is retracted (STAT)
• Where marijuana is legal, opioid prescriptions fall, studies find (STAT) (Forbes)
• The 2-trial hurdle for drug approvals is steadily losing ground. Are we devaluing the industry’s R&D gold standard? (Endpoints-$)
• Using CRISPR to introduce beneficial but rare gene mutations in sickle cell (Fierce)
• PharmAbcine Announces FDA Orphan Drug Designation Granted to TTAC-0001 for Glioblastoma Multiforme (Press)
• Dr. Reddy's Laboratories and its U.S. subsidiary Promius Pharma announce the filing of an NDA for its migraine candidate (Press)
• Synlogic Doses First Patient in Phase 1b/2a Trial of SYNB1020 for Treatment of Hyperammonemia in Patients with Cirrhosis (Press)
• Twist Bioscience Completes $50 Million Financing to Fuel Advancement of Digital Storage in DNA and Drug Discovery (Press)
• Cerus’ RedeS Phase 3 Red Blood Cell Study Expands Into the Continental U.S. (Press)
• SanBio: Update on Development Progress of Regenerative Cell Medicine SB623 (Press)
• A CRISPR Way to Restore Hearing (NEJM)

• Using Outcomes-Based Pricing For Medical Devices To Improve Cardiovascular Disease Treatment Value (Health Affairs)
• Takeda’s debts raise doubts over its ability to finance Shire bid (The Telegraph)
• How Startup Parachute Health Is Bringing E-Commerce To Your Crutches (Forbes)
• Abiomed wins FDA nod for Impella CP with SmartAssist, taps Trapp as CFO (MassDevice) (Press)
• Dexcom CEO on ‘treading new ground’ with G6 glucose monitor (Drug Delivery Business News)
• Why partnerships between medtech companies and doctors are so important (Medical Design & Outsourcing)
• Motus GI's Pure-Vu system receives US patent for methods for cleaning body cavities (pharmabiz) (Press)
• Intersect ENT Announces Launch of SINUVA Sinus Implant, a New In-Office Treatment Option for Recurrent Nasal Polyps (Press)
• First Patient Treated on Mevion's Next Generation Proton Therapy System (Press)
• Beacon Tip Catheters Return to U.S. and Canadian Markets (Press)

• New York's Medicaid Drug Cap: A look at the state's new effort to manage pharmaceutical spending (Pew Charitable Trusts)
• The windfalls of secrecy (Axios)
• Health Plans Simplify Doctor Credentialing To Boost Medicaid Participation (Forbes)
• Alphabet's bets on health tech are paying off as portfolio companies go public (CNBC)
• Does CVS–Aetna Spell the End of Business as Usual? (NEJM)
• NIH rejected a study of alcohol advertising while pursuing industry funding for other research (STAT)
• Michigan Governor Snyder Signs Bill Facilitating Patient Access to Interchangeable Biologic Medicine (Michbio)
• DEA Announces Nationwide ‘Take Back’ Day to Collect Opioids, Unused Medications (E&C)
• Hospitals Fear Competitive Threat From Potential Walmart-Humana Deal (WSJ)
• Come for your drugs, leave with more shopping: Walmart's new growth strategy? (Reuters)
• Shulkin’s Firing Threatens Support for VA Health-Care Overhaul (Bloomberg)
• Massachusetts, a Health Pioneer, Turns Its Focus to Drug Prices. It’s in for a Fight. (NYT)
• Is the Trump administration undermining value-based care? (MedCity News)
• FTC Sending Refund Checks Totaling More Than $355,000 to Consumers Who Bought CogniPrin ‘Memory Improvement’ Supplement (FTC)
• Patient-Centered Outcomes Research Institute: Review of the Audit of the Financial Statements for Fiscal Year 2017 (GAO)

• FDA Advisory Committee Calendar

• Even facing Big Pharma together, countries still struggle to haggle (Politico)
• Supplement 9.4 of the European Pharmacopoeia in force (Swissmedic)
• All T34 ambulatory syringe pumps – risk of unintended pump shutdown and delay to treatment (MHRA)
• Mesna 100mg/ml solution for injection/infusion, 5 x 4ml - company led recall (MHRA)
• HyperMed Imaging, Inc. Announces CE Mark for New HyperView Product (Press)
• This London startup’s app assists orthopedic surgery patients (MedCity News)

• Progress preserved: why industry is balking at Japan’s new pricing reforms (BioCentury)
• Daiichi Sankyo partners with Crohn’s & Colitis Foundation to draw attention to iron deficiency (Fierce)
• Drug Risk Information of Ongoing Evaluation (PMDA)
• [First Announcment] PMDA-ATC GMP Inspection Seminar 2018 (PMDA)
• Introduction of Connectors that Prevent Misconnection (PMDA)
• Wize Pharma begins enrollment in phase IV study of LO2A for symptomatic treatment of DES in patients with Sjögren's syndrome (pharmabiz) (Press)
• Toshiba receives contract to supply heavy-ion therapy system to Yonsei University Health System (phamabiz) (Press)
• Myriad’s breast cancer diagnostic wins approval in Japan (Drug Delivery Business News) (Press)
• HIMSS Asia Pacific Soft to launch Innovation Hub (BioSpectrum) 

• Strides Shasun gets US FDA nod for ibuprofen capsules (pharmabiz) (Business Standard)
• At the helm at Dr. Reddy's, Erez Israeli will have his task cut out (Economic Times) (The Telegraph) (Business Line)
• Drug regulator plans national digital database of pharma manufacturers (Economic Times)            
• NPPA has fixed/revised ceiling prices/retail prices of 869 formulations under Drugs (Prices Control) Order, 2013 in related Notification /order dated 02.04.2018. (NPPA)
• Mankind to sell 10% stake to ChrysCap in Rs 2.3k-cr deal (Times of India)
• MedGenome concludes first Indian systematic study on non-invasive prenatal testing (pharmabiz)
• More children being diagnosed with type 1 diabetes in India (pharmabiz)
• India's antibiotics usage witnessed maximum rise among LMICs in 15 years: Study (Economic Times)
• Pharma sector may post single-digit growth in FY18-20: Report (Times of India)
• CDSCO: FAQ on Grouping Guidelines (CDSCO)

• Battle looms over rebates as Labor eyes changes to private health insurance (The Sydney Morning Herald)
• Labor alleges health insurance ‘cover-up’ (The Australian)
• Regulators, doctors in firing line after Senate report on pelvic mesh scandal. (The Area News)

• Dozens urged to see doctor after needle mistakenly reused at Scarborough health fair (CBC News)
• Lupin's Pithampur unit gets Health Canada clearance (Economic Times)
• GUEST COLUMN: Canadian health care — big bills, terrible system (Toronto Sun)
• COMMENTARY: How AI can prevent suicides in Canada (Global News)
• Health Canada approves 'Viagra for women’ pill, loosens restrictions on taking it with alcohol (Edmonton Journal)

• Health Care Innovation: Harnessing New Technologies To Benefit Patients (Forbes)
• Without a single solution, hospitals are taking different paths to interoperability (Fierce)
• People with sinus infections stay on antibiotics too long (Reuters)
• UnitedHealth's Optum And Humana In Blockchain Deal To Improve Doctor Directories (Forbes) (CNBC) (Healthcare IT News) (Modern Healthcare) (Fierce)
• Walmart and Humana: Why Seniors Are at the Center (Fortune)
• Why Walmart may have designs on Humana, and what it thinks it could get from a deal (CNBC)
• DNA tests for IQ are coming, but it might not be smart to take one (MIT Technology Review)