Recon: Fresenius' $4.3B Purchase of Akorn Threatened by Data Integrity Probe

• Taking New Steps to Meet the Challenges of Rare Diseases — FDA Marks the 11th Rare Disease Day (FDA Voice) (BioCentury) (Focus)
• Apple is launching medical clinics to deliver the 'world's best health care experience' to its employees (CNBC)
• Google sister-company Verily is plotting a move into a fast-growing corner of the health insurance industry (CNBC)
• On Drug Pricing, States Step In Where Washington Fails (The New York Times)
• A Look at Drug Spending in the U.S. (The Pew Charitable Trusts)
• Fresenius' $4.3B buyout of Akorn threatened by data integrity probe (FiercePharma) (Reuters) (Press)
• Why Was This Year's Flu Shot So Weak? FDA Wants to Know (US News)(FDA statement)
• FDA proposes allowing medical device makers to summarize malfunctions (Star Tribune)
• A South Texas county drags PBMs into nationwide lawsuit over opioids (Stat News)

• Sanofi knew of Dengvaxia risks in 2015 (ABS-CBN News) (Rappler)
• Automated cleaning of surgical instruments: apply for funding (MHRA)
• Database of section 19A approvals to import and supply medicines to address medicine shortages (TGA)
• EU Health Commissioner meets Iranian Minister of Health and Medical Education (EC)
• Hoskins steps down as health minister to head national pharmacare strategy (Toronto Star) (CTV News)
• Fujifilm building $37m facility to support liposome drugs (in-PharmaTechnologist)

• Grey Hair In the C-Suite: Experience, Age, And IPOs In Biotech (Life Sci VC)
• STING fever is sweeping through the cancer immunotherapy world (C&EN)
• Endo, Glaxo to Settle Suits Over Testosterone Drug (Bloomberg)
• Lilly breast cancer drug wins expanded U.S. approval (Reuters) (Press) (FDA)
• Quest Diagnostics and Rutgers University Announce Sports Science Research Collaboration to Advance Athletic Performance (Press)
• This could be the next $1 billion drug, if patients get on board (MarketWatch)
• Senti Biosciences Secures $53 Million Series A to Build the Future of Gene and Cell-Based Therapies (Press)
• AmerisourceBergen could be the next victim of the opioid crisis, says Teamsters' general secretary-treasurer (CNBC)
• 'Pharma bro' Shkreli to be held responsible for $10.4 million in losses: U.S. judge (Reuters)
• Did Horizon Pharma fire an employee for being a whistleblower against Aegerion? (Stat News)
• Value-Based Contracts May Lower Patients’ Out-of-Pocket Costs by 28 Percent (Press)
• Interesting Feedback on Elemental Impurities (Lachman Consultants)
• Allergan was blasted for its unusual Mohawk patent license, and now it's a total flop (FiercePharma)
• RHS to be acquired by US giant PerkinElmer amidst growing M&A momentum in biotech (Small Caps) (Press)
• TP Therapeutics Appoints Lewis Shuster to Board of Directors (Press)
• New Drug Channels Institute Report Analyzes Complex Economics of Pharmacies and PBMs in the U.S. Pharmaceutical Supply Chain (Press)
• Hauling in a $100M mega-round, gene therapy startup Generation Bio builds alternative to potentially risky viral vectors (Endpoints News)

• Summit’s DMD drug cuts muscle inflammation in POC trial (FierceBiotech)
• 1 year after IPO, ObsEva’s IVF drug shows promise in phase 3 (FierceBiotech)
• The 'gold standard' of preclinical research yields ‘highly unreliable’ results, study finds (Outsourcing-Pharma)
• Sierra Oncology and Janssen Sign Supply Agreement for Prostate Cancer Study (Press)
• Edico Genome and InterSystems Partner To Streamline Clinical Next-Generation Sequencing Workflows (Press)
• Lilly touts Ph3 data for once-weekly Type II diabetes medication (Drug Delivery Business News) (Press)
• TESARO Announces Collaboration to Evaluate Combination of ZEJULA (Niraparib) and Anti-PD-L1 Cancer Immunotherapy in Metastatic Bladder Cancer (Press)
• Actinium Pharmaceuticals Announces Activation of Sixteenth Clinical Trial Site in the Pivotal Phase 3 SIERRA Trial for Iomab-B (Press)
• NIH researchers find a potential treatment for disorders involving excess red blood cells (NIH)
• OSE Immunotherapeutics Granted Approval to Resume Patient Accrual in U. S. for Phase 3 Tedopi Clinical Trial in Advanced Non-Small Cell Lung Cancer Patients Following Immune Checkpoint Inhibitor Treatment (Press)
• Endocyte to Begin Trial of Prostate Cancer Treatment (Press)
• Aldeyra Therapeutics Announces Agreement with Johnson & Johnson Innovation to Advance Novel Immune-Modulating Drugs for Systemic Inflammatory Diseases (Press)
• Revisiting and expanding the largest genetic study of schizophrenia (Cardiff University)
• Risk/Benefit in Pediatric Phase 1 Cancer Trials: Noble Lie? (part 1) (STREAM)

• Abbott, Surmodics ink $25m deal for drug-coated balloon tech (Drug Delivery Business News) (Press)
• Designing for healthcare robotics: 2 things you need to consider (Medical Design & Outsourcing)
• Fitbit posted a weaker-than-expected quarter and its shares are crashing (TechCrunch)
• Therakos Cellex Photopheresis System Safety advisory – risk of blood clots (TGA)
• Samsung and UCSF Introduce My BP Lab, a Smartphone App for Blood Pressure and Stress Research (Press)
• CardioFocus launches trial for next-gen HeartLight device (MassDevice) (Press)
• Report: FDA Removed More Than 2500 Medical Device Establishments from Database (MedTech Intelligence)
• VolitionRx’s blood test spots 80% of early colorectal cancers (FierceBiotech)
• Pacemakers at risk of hacking (Newsweek)
• Brexit - what’s next for medical devices? (Lexology)
• Could single-use devices help reduce healthcare costs? (Packaging Digest)
• Medtronic thinks these clinics could be the future of diabetes care – here’s why (Drug Delivery Business News)

• Basic Research: Building a Firm Foundation for Biomedicine (NIH)
• FCC publishes net neutrality repeal order, so what's next? (HealthcareITNews)
• FDA objects to kratom compound intended for use as an alternative to prescription opioids and promoted with unproven claims to treat addiction (FDA In Brief)
• Ohio accuses drug distributors of helping fuel opioid epidemic (Reuters)
• NIH Did Not Always Administer Superfund Appropriations During Fiscal Year 2015 in Accordance With Federal Requirements (OIG)
• FTC can play a critical role in making health care more affordable (The Hill)
• Drug makers lobby for antibiotic incentives in pandemic preparedness bill (Stat News)

• FDA Advisory Committee Calendar

• Genetics researchers close in on schizophrenia (Medical Research Council)
• Administrative changes, documentation and requirements (MHRA)
• ‘Pill School’ project launched to teach children how to swallow tablets (The Pharmaceutical Journal)
• Research reveals levels of inappropriate prescriptions in England (MHRA)
• Dementia Action Plan for Wales looks at antipsychotic use (The Pharmaceutical Journal)

• Hyland Healthcare Expands Sales Leadership in Asia Pacific Region (Press)
• Collagen Matrix Launches OssiMend Spine and DuraMatrix Dural Repair Products in Asia (Press)

• Leading Nephrology Care Center in India Adopts Masimo Technologies Across Continuum of Care (Press)
• Monitoring of price movement of notified medical devices as 'Drugs' under the Drugs and Cosmetics Act,1940 and the Drugs and Cosmetics Rules ,1945. (NPPA)
• NPPA has fixed/revised ceiling prices/retail prices of 14 formulations under Drugs (Prices Control) Order, 2013 in related Notification /order dated 23.02.2018. (NPPA)

• ‘Health system needs to pay for results, not appointments’ (The Australian)
• WA health sector review recommends more prevention spending (ABC News)

• Canada has an opportunity to lead the G7 on global health equity (Toronto Star)
• Could Canada see measles outbreaks like Europe? (CTV News)
• Updated: Guidance Document Administrative Processing of Submissions and Applications: Human or Disinfectant Drugs (Health Canada)

• Why unlikely partnerships will spark the health-care revolution (CNBC)
• A marijuana startup is listing on a major US stock exchange for the first time — here's what you need to know (Business Insider)
• Major EPA reorganization will end science research program (The Hill)
• Warren Buffett's Health-Care Goals Are Easier Set Than Met (Bloomberg)