Blue-blooded crabs at heart of pharma dispute on drug testing (Reuters)
FDA-EMA Workshop Discusses Quality Challenges for PRIME, Breakthrough Therapies (Focus)
OPDP Issues Untitled Letter Over Birth Control Device TV Ad (Focus)
New FDA Guidances Target Women’s Health, Neonatal Care (Focus)
Why health companies are branding themselves as tech companies (STAT)
'Huge Need' For Neurotoxicity Biomarkers In Drug Development, FDA's Woodcock Says (Pink Sheet-$)
Saving the Endangered Physician-Scientist — A Plan for Accelerating Medical Breakthroughs (NEJM)
Lilly boosted by survival data for key growth drug Verzenio (PMLive)
Novo, e-therapeutics extend Type 2 diabetes research pact to include new genomics tech (Fierce)
National Immunization Awareness Month Faces Uphill Battle In Wealthy Areas Of US (Forbes)
The Patient As Customer: How Biotech And Medicine Are Being Driven By Advocacy Groups (Forbes)
Pathology Peer Review in Toxicology Studies: FDA Offers Q&A (Focus)
Adrian Hayday refutes challenge on influential autoantibody paper by Karolinska scientists (Endpoints)
Amicus touts latest set of gene therapy data; Novo Nordisk expands discovery deal for diabetes (Endpoints) (Fierce)
Adaptimmune R&D chief Amado is out amid a top-level shakeup as new CEO tries to revive ebbing enthusiasm (Endpoints)
Jumping into growing queue of buyers, Vertex chief targets a slate of new and 'larger' deals ahead (Endpoints)
PD-L1, CD47 and now CD24? Star Stanford I/O scientist Irv Weissman points to a ‘major’ new cancer target (Endpoints)
Specialty Pharmacies and PBMs Hop On the 340B Money Train (Drug Channels)
Sanofi in manufacturing deal for cannabinoid overdose treatment (InPharmaTechnologist)
Pharmaceuticals & Biotechnology: Study Results, Filings & Designations
Nektar Therapeutics and Bristol-Myers Squibb Announce U.S. FDA Breakthrough Therapy Designation for Bempegaldesleukin (NKTR-214) in Combination with Opdivo® (nivolumab) for the Treatment of Patients with Untreated Advanced Melanoma (Press)
Modra Pharmaceuticals Announces First Patients Treated in Phase IIb Metastatic Prostate Cancer Trial (Press)
Medical Devices
Integra Lifesciences picks up Arkis Biosciences (MassDevice)
Names of liposomal medicines to be changed to avoid medication errors (EMA)
Sussex criminal sentenced for laundering proceeds from the sale of black-market medicines (MHRA)
Proposal to make Colourstart Test 65mcg Cutaneous Patch available from general sales outlets without prescription (MHRA)
First allergy test for hair dye to go on general sale (MHRA)
Asia
Thailand set to deliver first batch of medical marijuana (Reuters)
India
Dr Reddy's expects US FDA re-inspection of Srikakulam plant (Pharmabiz) (Fierce)
Reddys seek funds: ADIA, Mitsui, Itochu eye stake in Apollo Holdco (Economic Times)
Australia
Advertising therapeutic goods: Natural claims on medicines and medical devices: naturally compelling? (TGA)
Advertising health products: Understanding what ‘natural’ means on your medicine (TGA)
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