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

• 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)

• 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)

• 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• Gottlieb Takes Aim At CROs’ ‘Outdated Processes’ In Push For Clinical Trial Digitization (Pink Sheet-$)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)

• 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)

• 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)

• 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)

• FDA Advisory Committee Calendar

• 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)

• 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)

• 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)

• Reclassification of surgical mesh medical devices (TGA)