Regulatory Focus™ > News Articles > Recon: Flu Season May Peak in Next Several Weeks

Recon: Flu Season May Peak in Next Several Weeks

Posted 25 January 2018 | By Zachary Brennan 

Recon: Flu Season May Peak in Next Several Weeks

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

In Focus: US
  • J&J out of race for Pfizer's $20 billion consumer unit as deadline looms (Reuters)
  • Flu season may peak in coming weeks, FDA chief says in Davos (CNBC)
  • The US Food and Drug Administration’s Approach for Safe Innovation of Medical Devices in Dermatology (JAMA)
  • Big Pharma Greets Hundreds Of Ex-Federal Workers At The ‘Revolving Door’ (Kaiser Health News)
  • Big pharma's lobbying spree in Trump's first year (Axios)
  • Senate Confirms Azar as Next HHS Secretary (Focus)
  • FDA, FTC Warn Companies Over Illegal Opioid Cessation Products (Focus)
  • FDA Renews Pharmaceutical Science and Clinical Pharmacology Advisory Committee Charter (Federal Register)
  • FDA placed Solid Biosciences’ gene therapy on partial clinical hold in Nov 2017 (SEC Filing)
  • An FDA panel is ruling on a new Philip Morris product that could upend the cigarette market (Vox)
  • CDRH Issues Revised Replacement Reagent Policy (FDA Law Blog)
In Focus: International
  • Big Pharma Suppliers Are Dumping Toxic Waste in the Environment, Investor Alleges (WSJ-$)
  • In a scientific first, cloned monkeys are born. Will they accelerate biomedical research? (Stat) (BioWorld)
  • For Chinese fentanyl sellers, USPS is the ‘virtually guaranteed’ route to not get caught (Stat) (Reuters)
  • Lilly receives EU Marketing Authorisation for Taltz (ixekizumab) for the Treatment of Active Psoriatic Arthritis (Press)
  • UK's biotech sector raised twice as much through IPOs in 2017 than 2016 (City AM)
  • EMA Surveys Drugmakers on Brexit Preparedness (Focus)
  • Shanghai Pharma seeking deals to drive overseas expansion (Fierce Biotech)
  • 15 years later, PEPFAR continues to save lives (NIH)
  • Professor Carole Longson MBE appointed Chief Scientific Officer at the ABPI (ABPI)
Pharmaceuticals & Biotechnology
  • Novartis move signals further gene therapy resurgence (EP Vantage) (PMLive)
  • Biotech’s next big IPO could unravel at the 11th hour (Stat-$)
  • Discounted Drugs for Needy Patients and Hospitals — Understanding the 340B Debate (NEJM)
  • Consequences of the 340B Drug Pricing Program (NEJM)
  • OECD Takes a Stab at Redefining Biotechnology and Nanotechnology (Focus)
  • Synergy Pharmaceuticals Announces FDA Approval of Trulance (Plecanatide) for the Treatment of Irritable Bowel Syndrome with Constipation (IBS-C) in Adults (Press)
  • Paragon expansion to address ‘deficit in gene therapy CDMO capacity’ (BioPharma-Reporter)
  • XtalPi secures $15m to boost AI drug development and design offering (Outsourcing-Pharma)
Pharmaceuticals and Biotechnology: Clinical Study Results, Filings & Designations
  • Takeda and Zinfandel write off yet another Alzheimer’s PhIII after Actos fails a key interim test (Endpoints) (Press)
  • Biogen earnings lack blockbuster acquisition pop, but executives pledge to keep looking (Stat-$) (Endpoints) (Fierce)
  • What can we learn from the latest Alzheimer’s drug failure? (Stat)
  • Going After Ebola (In the Pipeline)
  • Characteristics of Interim Publications of Randomized Clinical Trials and Comparison With Final Publications (JAMA)
  • Testimonials and Informational Videos on Branded Prescription Drug Websites: Experimental Study to Assess Influence on Consumer Knowledge and Perceptions (JMIR)
  • AZ enrolls first patient in Brilinta stroke trial (PharmaTimes)
  • Inclisiran’s First Pivotal Trial Achieves Target Enrollment Ahead of Schedule (Press)
  • Novan Announces First Patient Dosed in Phase 2 Molluscum Contagiosum Trial with SB206 (Press)
  • GE platform to be adopted at Clover facility in China (Biopharma-Reporter)
  • Advaxis’ Immunotherapy in Combination with Chemoradiation Highlighted as Potential Treatment for Anal Cancer in International Journal of Radiation Oncology (Press)
Medical Devices
  • 'We Survived MDSAP': Cynosure Aces Single-Audit Program Twice; Tells How Your Firm Can, Too (Medtech Insight)
  • Aptima HBV Quant Assay for Quantitation of Hepatitis B Viral Load Receives PMA Approval (Press)
  • Webinar - FDA Categorization of Investigational Device Exemption (IDE) Devices to Assist the Centers for Medicare and Medicaid Services (CMS) with Coverage Decisions - January 16, 2018 (FDA)
  • Reva implants first Fantom bioresorbable scaffold in Italy (Mass Device)
  • Ocular Therapeutix plans $32.5m public offering to fund NDA resubmission for Dextenza (Mass Device)
  • ConforMIS prices $20m offering, releases prelim 2017 earnings (Mass Device)
  • Hitachi receives FDA 510(k) for advanced motion management for its proton therapy system (Press)
US: Assorted & Government
  • FDA extending the comment period for draft guidance entitled "Recommendations for Dual 510(k) and Clinical Laboratory Improvement Amendments (CLIA) Waiver by Application Studies” (Federal Register)
  • Idaho to Allow New Insurance Plans Outside of Federal Health Law (WSJ-$)
Upcoming Meetings & Events General Health & Other Interesting Articles
  • An ultrasound on Instagram suggested the baby could be in danger. Does a physician have a duty to warn? (Stat)
  • Snapshots of Life: The Birth of New Neurons (NIH Director’s Blog)
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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