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

Posted 27 February 2018 | By Ana Mulero 

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

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

In Focus: US
  • 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)
In Focus: International
  • 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)
Pharmaceuticals & Biotechnology
  • 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)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • 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)
Medical Devices
  • 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)
US: Assorted & Government
  • 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)
Upcoming Meetings & Events Europe Asia
  • Hyland Healthcare Expands Sales Leadership in Asia Pacific Region (Press)
  • Collagen Matrix Launches OssiMend Spine and DuraMatrix Dural Repair Products in Asia (Press)
India
  • 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)
Australia
  • ‘Health system needs to pay for results, not appointments’ (The Australian)
  • WA health sector review recommends more prevention spending (ABC News)
Canada
  • 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)
General Health & Other Interesting Articles
  • 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)
Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe. Each weekday morning, we aim to bring you the latest highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the latest trends with the potential to impact regulatory affairs professionals and the industry in which they work.
 
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