FDA charts path forward for biosimilars — but drug makers aren’t all on board (STAT-$)
Sage Therapeutics CEO: Have to weigh investor returns but will price postpartum drug ‘fairly’ (CNBC)
Two Harvard Biotech Entrepreneurs Are Creating The "Trojan Horse" Of Cancer Treatment (Forbes)
Lilly seeks to quickly advance—and if needed kill—novel drugs to avoid ‘pile-on effect’ in hot targets (Fierce)
Students push UCLA to improve access to a cancer drug developed by its scientists (STAT-$) (The Wire)
Novartis and GSK CEOs set out diverging strategies (Financial Times-$)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
Gene therapy could promote healing in brain, spinal cord injuries (Fierce)
Sunovion Submits New Drug Application to the FDA for Apomorphine Sublingual Film (APL-130277) for the Treatment of OFF Episodes Associated with Parkinson’s Disease (Press)
NIH study may help explain why iron can worsen malaria infection (NIH)
Study in pregnant women hints at pertussis protection from flu vaccination (CIDRAP)
Targeting stress proteins on cells to help treat cancer (BioCentury)
Mallinckrodt Inc. et al.; Withdrawal of Approval of Five New Drug Applications (FDA)
Medical Devices
Study shows promise for detecting mental health problems using smartphone app (Fierce)
US FDA Panel To Tackle Hospital Glucose Meter Accuracy Issue (Medtech Insight)
These medical devices offer hope for treating chronic pain without opioids (CNBC)
T2 Biosystems touts results from 4 studies of its T2Dx diagnostics system (MassDevice)
Quest Beats Out-Of-Pocket Overcharge Suit, For Now (Law360-$)
A medical-grade smartwatch is helping people live with epilepsy (Wired)
Salmonella outbreak from raw chicken products leads to 30 cases in Canada (CBC News)
Canada's largest health research platform teams up with University of Toronto to accelerate cancer and chronic disease research (Press)
General Health & Other Interesting Articles
Starbucks coffee in California must have cancer warning, judge says (Reuters)
Hawaii lawmakers approve bill to legalize physician-assisted suicide (The Hill) (Reuters)
Customer Service In Assisted Living, Homecare And Healthcare: The 'Required Hospitality' Difference (Forbes)
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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