Regulatory Focus™ > News Articles > 11 > Recon: Teva Launches Generic EpiPen at Same Price as Mylan’s Generic

Recon: Teva Launches Generic EpiPen at Same Price as Mylan’s Generic

Posted 27 November 2018 | By Michael Mezher 

Recon: Teva Launches Generic EpiPen at Same Price as Mylan’s Generic

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Teva prices EpiPen generic at $300, same price as Mylan generic (CNBC) (WSJ) (Press)
  • How can a medical device deemed unsafe in another country still be sold in the US? (NBC)
  • CVS, Aetna Draw Closer to Closing $69B Combination (NYTimes) (WSJ)
  • Gene drive should be a nonprofit technology (STAT)
  • Breast implants reveal problems in tracking device safety (AP) (NBC)
  • Novartis CEO says four factors can help with pricing and payment of lifesaving cell and gene therapies (CNBC)
  • Trump Moves to Lower Medicare Drug Costs by Relaxing Some Patient Protections (NYTimes) (Bloomberg) (Endpoints) (STAT)
  • Medicare Part D rule aims to lower drug costs (Politico) (Law360-$)
  • Not With A Bang, But A Whimper . . . FDA Capitulates On Off-Label Regulation (Forbes)
  • Loxo, Bayer drug for cancers driven by rare mutation gets US nod (Reuters) (Endpoints) (Press) (FDA)
  • Bristol-Myers Squibb says cancer drug combination fails late-stage trial (Reuters) (Endpoints) (Press)
  • CDC now confirms 116 cases of polio-like paralysis (NBC)
In Focus: International
  • He took a crash course in bioethics. Then he created CRISPR babies (STAT)
  • Rogue Chinese CRISPR scientist cited US report as his green light (MIT Technology Review)
  • Scientists, officials in China abhor gene editing that geneticist claims (Reuters)
  • China orders investigation after scientist claims first gene-edited babies (Reuters) (MIT Technology Review)
  • China Expands Research Funding, Luring U.S. Scientists And Students (NPR)
  • South Africa's Aspen launches three-in-one HIV drug (Reuters)
  • Democratic Republic of the Congo begins first-ever multi-drug Ebola trial (WHO)
  • UNICEF, WHO launch polio vaccination campaign in Yemen (Reuters)
  • Israeli Company Set To Begin Testing New Radiation Cancer Therapy (Forbes)
  • NHS to save £300 million by switching to Humira biosimilars (Pharmafile)
  • Sun gets dermatology portfolio, two plants in Japan with Pola Pharma deal (Fierce)
  • Countries in the Americas commit to continuing to collaborate in strengthening regulatory systems to ensure safe, effective and quality medicines (PAHO)
  • Industry Probes Regulators On Speeding Up CMC For Early Access Pathways (BioCentury)
  • Medicines, vaccines and health products: Cancer medicines - Report by the Director-General (WHO)
Pharmaceuticals & Biotechnology
  • CDER Recruitment Wins Begin Outnumbering Losses (Pink Sheet-$)
  • Gottlieb Takes Aim At CROs’ ‘Outdated Processes’ In Push For Clinical Trial Digitization (Pink Sheet-$)
  • AbbVie, Roche aim to face down Pfizer with Venclexta’s move into AML arena (Fierce)
  • Doctors want ‘big data’ insights to improve health care. But America’s scattershot medical records make it hard to go big (STAT)
  • Smallest patients have highest risk from radiation accidents, doctors warn (Reuters)
  • The unique challenges of global clinical trial transparency (MedCity)
  • UK-based CRO Sygnature puts down roots in US, its largest market (Outsourcing Pharma)
  • Global syndicate backs $400M genomics R&D play in Ireland as WuXi NextCODE extends its reach into Europe (Endpoints)
  • Wellington, HBM lead €24M round as Adrenomed preps septic shock treatment for human testing (Endpoints)
  • Novo Nordisk May Use Priority Review Voucher To Speed Oral Semaglutide To Market (Scrip-$)
  • Vivek Ramaswamy ramps up biotech startup #14 — this time working on a gene therapy for sickle cell disease and β-thalassemia (Endpoints)
  • Real-Time Oncology Review Has Sponsors Rethinking What Data To Share With US FDA And When (Pink Sheet-$)
  • US FDA’s Assessment Aid May Spell The End Of Dueling Advisory Committee Briefing Packages (Pink Sheet-$)
  • Halozyme drops PFS co-primary endpoint from PEGPH20 phase 3 (Fierce)
  • Probiotics Do Not Ease Stomach Flu (NYTimes) (Editorial) (NEJM)
  • Janssen discovery head joins Incyte as its CSO jumps to Third Rock (Fierce)
  • In the latest reverse merger, Vienna’s Arsanis serves as vehicle for X4 Pharma’s Nasdaq listing (Endpoints)
  • Cannabinoid executive switcheroo: FSD Pharma grabs GW’s ex-marketing chief for CEO job (Fierce)
  • Abeona ejects CEO Carsten Thiel for ‘personal misconduct’ (Fierce)
  • BeiGene bags Asian rights to Zymeworks’ HER2 bispecifics (Fierce)
  • Pfizer Inc. Issues A Voluntary Nationwide Consumer Level Recall of Six Lots of Thermacare® Heatwraps Due to Leaking Wraps With The Potential For Skin Injuries (FDA)
  • FDA warns consumers to avoid Rhino male enhancement products found at retailers because of undeclared and potentially dangerous drug ingredients (FDA)
Pharmaceuticals & Biotechnology: Study Results, Filings & Designations
  • Vertex cystic fibrosis drug combination shows strong results in pivotal clinical trials (STAT) (Endpoints) (Press)
  • Rocket Pharmaceuticals Receives FDA Regenerative Medicine Advanced Therapy (RMAT) and Fast Track Designations for RP-L102 Gene Therapy for Fanconi Anemia (Press)
  • US grants AZ’ Fasenra orphan drug status for rare autoimmune disease (PharmaTimes)
  • Catabasis Pharmaceuticals Announces Publication of Phase 1 Clinical Results of Edasalonexent (CAT-1004) in Duchenne Muscular Dystrophy (Press)
  • Encore Dermatology, Inc. Announces Phase 2 Safety Data Demonstrating Lower Systemic Drug Exposure With Impoyz™ (clobetasol propionate) Cream, 0.025% Compared to Temovate® (clobetasol propionate) Cream, 0.05% (Press)
  • Spirita Oncology, LLC Initiates a Phase 1 Clinical Trial of the Anti-Cancer Agent E6201 in Patients with Central Nervous System Metastases from BRAF+ or MEK-Mutated Metastatic Melanoma (Press)
  • Vedanta Biosciences Announces Initiation of Phase 1 Clinical Study with Janssen of Microbiome-Derived Product Candidate for Inflammatory Bowel Disease (Press)
  • Antibe Therapeutics Announces Successful Completion of Part One of Phase 2B Dose-Ranging, Efficacy Study for ATB-346 (Press)
  • Precision BioSciences Receives FDA Authorization to Initiate Clinical Study of Gene Edited Cancer Immunotherapy (Press)
Medical Devices
  • Possible Major Changes to 510(k) Program Ahead (FDA Law Blog)
  • Is the medical device industry endangering people? (MassDevice)
  • Aethlon Medical's Cancer Therapy Receives "Breakthrough Device" Designation from the U.S. Food and Drug Administration Press)
  • Group B Strep Test From DiaSorin Molecular Cleared by FDA (GenomeWeb)
  • PerkinElmer Vanadis NIPT Receives CE-IVD Mark (GenomeWeb)
  • FDA approves Genentech’s prefilled autoinjector for Actemra (Drug Delivery)
  • Zimmer Biomet Recalls 1,300 Bone Growth and Spinal Fusion Stimulators (MDDI)
  • Class 1 Device Recall BrightMatter Guide (FDA)
  • The Promises (and Problems) of Real World Data (MassDevice)
US: Assorted & Government
  • AbbVie Files Claim Construction Brief in BI Adalimumab Litigation (BigMoleculeWatch)
  • 32 States Back Ark. In Potential High Court Drug-Price Fight (Law360-$)
  • Collins, Shaheen Press Insurers for Insulin Pricing Details (FDA News-$)
  • Pa. Mesh Judge Won't Recuse Over Mom's Case Against J&J (Law360-$)
  • Tris Pharma, Inc. v. Actavis Laboratories FL, Inc. (Fed. Cir. 2018) (Patent Docs)
  • Audit: Iowa Medicaid savings barely half what was projected (Lexington Herald)
  • Discovery Rule Rules the Day on Statute of Limitations Motion to Dismiss (Drug & Device Law)
Upcoming Meetings & Events Europe
  • European MDR Transition: Update at the Halfway Point (Emergo)
  • Breast implants and Anaplastic Large Cell Lymphoma (ALCL) (MHRA)
  • European Commission Approves ALUNBRIG® (brigatinib) for ALK+ Non-Small Cell Lung Cancer in Patients Previously Treated with Crizotinib, Advancing Treatment Paradigm in Europe (Press)
Asia
  • New therapy for spinal cord injuries gets fast-tracked (Asahi)
  • ViiV wins Japanese approval for Juluca (PharmaLetter-$)
  • WuXi Biologics announces new discovery, development and manufacturing site in China (BioPharmaReporter)
India
  • Alembic Pharma gets USFDA nod for insomnia treatment drug (Economic Times)
  • Maha FDA serves notices to retailers in Ahmednagar, Aurangabad & Nashik for selling polio vaccines meant for govt supply (PharmaBiz)
  • World Bank-funded programme to help Indian R&D firms develop affordable tech, devices to combat heart ailments, COPD (PharmaBiz)
Australia
  • Reclassification of surgical mesh medical devices (TGA)
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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