Centene Commits $100M To Personalized Medicine Research (Forbes)
Alkermes says long-acting drugs could help schizophrenics stay on medication longer (Reuters)
New Target for Cancer Immunotherapy: Exosomes (NIH)
Bayer cuts with one hand, adds cancer R&D jobs in Kendall Square with the other (Fierce) (Endpoints)
Drugs Are Keeping Seniors Healthy, And Hurting Them (Forbes)
Creating new antimicrobial drugs will require governments working with industry (STAT)
PhaseBio touts ‘breakthrough’ badge for bloodthinner reversal agent licensed from AstraZeneca, shares leap (Endpoints)
Finance Watch: Q1 Biopharma Venture Capital Dips From All-Time High, But Numbers Still Impress (Scrip-$)
Peter Hecht recruits Bayer/Shire vet Andreas Busch for a top R&D post at his $175M biotech spinout (Endpoints)
Drugmakers Push Back Against Proposed Exclusion Criteria for Rare Esophageal Disease Trial (FDANews-$)
Patient Engagement In Clinical Trials Needs More FDA Guidance, Stakeholders Say (Pink Sheet-$)
Rebate Reshuffle: Could Pharma Foot The Bill To Offset Higher Premiums? (Pink Sheet-$)
Pharmaceuticals & Biotechnology: Study Results, Filings & Designations
Roivant-backed Merck Serono spinout hits phase 3 diabetes goal; NDA on the horizon (Fierce) (Press)
PIXUVRI® (pixantrone) Receives Positive CHMP Opinion to Convert Conditional Approval into Standard Marketing Authorization in Patients with Aggressive non-Hodgkin B-cell Lymphoma (Press)
Rakuten Medical's ASP-1929 photoimmunotherapy for head and neck cancers to be designated under the Sakigake Designation System for its potential innovativeness and effectiveness (Press)
LSK BioPharma and Jiangsu Hengrui Medicine Announce FDA Clearance to Initiate a Phase 3 Clinical Trial in Advanced Hepatocellular Carcinoma (HCC) (Press)
MaaT Pharma Announces Second Positive DSMB Safety Assessment of Phase II HERACLES Study in Acute GvHD (Press)
NanOlogy announces First Patient Enrolled in a Phase 1/2 Clinical Trial of NanoDoce® for Treatment of Bladder Cancer (Press)
Frequency Therapeutics Announces Positive Phase 1/2 Data for Drug Candidate for Hearing Restoration (Press)
Ra Pharmaceuticals Announces Completion of End-of-Phase 2 Interactions with FDA and Design of Pivotal Phase 3 gMG Study (Press)
Peloton Therapeutics Announces Completion of Enrollment in Phase 2 Trial of PT2977 for Treatment of Von Hippel-Lindau Disease-Associated Renal Cell Carcinoma (Press)
Cerevel Therapeutics Announces Publication of Phase 2a Study Results in Neurology on Its Most Advanced Investigational Epilepsy Treatment (Press)
Galmed Pharmaceuticals Announces Successful Completion of End of Phase 2 Meeting With FDA and Plan for Start of Phase 3 (Press)
Medical Devices
FDA Warns Patients Against Using Pre-Owned and Unauthorized Diagnostic Test Strips (Focus)
WHO Drafts Global Strategy on Digital Health (Focus)
Novartis completes spinout of Alcon eye biz (MassDevice)
Bain, Piramal-led fund offers Panacea a Rs 992 crore bail-out deal (Economic Times)
J&J agrees to pay only Rs 25 lakh compensation for faulty hip implants (Economic Times)
Australia
International Work-sharing Initiative - Abemaciclib (Verzenio) (TGA)
Canada
Consultation of Draft Guidance Documents: Identifying and Labelling Medicinal Ingredients, Generic Drug Equivalence: Medicinal Ingredients (Canada)
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.
Need to contact the editor of Regulatory Reconnaissance? Email us at [email protected].
A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.
We have completed our migration to a new platform and are pleased to introduce the updated site.
What to expect: If you have an existing login, please RESET YOUR PASSWORD before signing in. After you log in for the first time, you will be prompted to confirm your profile preferences, which will be used to personalize content.
We encourage you to explore the new website and visit your updated My RAPS page. If you need assistance, please review our FAQ page.