Scientist Invented A New Pathway To Approve Biosimilars - And The FDA Is Listening (Forbes)
AbbVie prices new endometriosis drug at $10,000 a year (Reuters)
U.S. to narrow opioid bribe case against Insys founder, others (Reuters)
Paying for therapies that cure: innovative solutions needed (STAT)
Prescription apps are gaining ground — and drug makers’ backing — as digital therapeutics (STAT-$)
Activists want the NIH to break patents on a Gilead drug for preventing HIV (STAT-$)
Illinois Law Expands Ban on Discharging Unused Medicines (Bloomberg-$)
Shareholder Accuses Acadia of Hiding Nuplazid Safety Issues (Bloomberg-$)
Zavante CEO sells his late-stage antibiotic biotech to Nabriva — grabbing the helm in the deal (Endpoints)
bluebird bio to raise $550 million through public offering (The Pharma Letter)
Valsartan products not recalled as of July 24, 2018 (FDA)
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Permanent Discontinuation or Interruption in Manufacturing of Certain Drug and Biological ProductS (FDA)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
Can gene therapy halt diseases in babies before they’re even born? (STAT)
Takeda R&D team rings the blockbuster bell with key PhIII success in frontline lung cancer (Endpoints)
Janssen Presents Switch Data for New HIV-1 Treatment SYMTUZA (D/C/F/TAF) and Second Study Supporting its Use in a Rapid Initiation Scenario (Press)
First Long-term Immune Response Data for Investigational HIV-1 Preventive Vaccine Announced by Johnson & Johnson (Press)
Corium Presents Additional Positive Clinical Results at Alzheimer's Association International Conference 2018 (Press)
Eisai and Biogen Present Detailed Results From Phase II Clinical Study of Elenbecestat in MCI and Mild to Moderate Alzheimer’s Disease at Alzheimer’s Association International Conference (AAIC) 2018 (Press)
Baxter Announces Health Canada Approval of Spectrum IQ Infusion System (Press)
General Health & Other Interesting Articles
Study: Lowering blood pressure helps prevent mental decline (AP News)
IBM’s Watson supercomputer recommended ‘unsafe and incorrect’ cancer treatments, internal documents show (STAT-$)
Mobile App Will Transform Data Entry And Collection In Clinical Studies, Company Says (Forbes)
Want to reach smartphone-happy doctors? Hint: Typical mobile marketing won't work (Fierce)
The Next Cancer Drug Might Start in Outer Space (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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