Regulatory Focus™ > News Articles > 2019 > 11 > Recon: J&J Submits Ebola Vaccine for EU Review; First Rituxan Biosimilar to Launch in US at 10% Disc

Recon: J&J Submits Ebola Vaccine for EU Review; First Rituxan Biosimilar to Launch in US at 10% Discount

Posted 07 November 2019 | By Michael Mezher 

Recon: J&J Submits Ebola Vaccine for EU Review; First Rituxan Biosimilar to Launch in US at 10% Discount

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US In Focus: International
  • J&J files for European approval of Ebola vaccine (Reuters) (Press)
  • J&J to supply 500,000 Ebola vaccines to fight DR Congo outbreak (Phamafile)
  • NICE International returns, will offer advisory services (PMLive) (PharmaTimes) (Pink Sheet-$) (NICE)
  • Takeda dengue vaccine effective overall in study but with major limitation (Reuters) (STAT)
  • New UK startup pursues off-the-shelf CAR-T, cancer vaccines through 'dark antigens' (Endpoints)
  • Novo bags rights to UBE's preclinical NASH prospect (Fierce)
  • ObsEva IVF nolasiban drug flops in key European trial (Reuters)
  • China's Bio-Thera gets NMPA approval for Humira biosimilar (Reuters)
  • GW's Epidiolex topped sales predictions, but investors bailed. What gives? (Fierce)
  • Evotec and Vifor announce joint venture for kidney disease treatments (PMLive)
Pharmaceuticals & Biotechnology
  • The FDA needs to set standards for using artificial intelligence in drug development (STAT)
  • Migraine hopefuls from Lilly, Allergan and Biohaven don't beat older drugs: ICER (Fierce) (ICER)
  • Teva spinout delays NASH IPO while Galera prices below range (Endpoints)
  • Problems With Drug Absorption Studies Still ‘Relatively Common’ In EU (Pink Sheet-$)
  • FDA Renames and Restructures Oncology Office (Focus)
  • FDA-EMA-PMDA Officials Discuss Convergence on Antibacterial Drugs (Focus)
  • Best Practices for Postmarket Drug Safety Surveillance: FDA Seeks Comments (Focus)
  • FDA Warns Chinese Drugmaker Over GMP, Data Integrity Violations (Focus)
  • Celgene posts pivotal CAR-T data ahead of FDA filing (Fierce) (ASH)
  • The U.S. Insulin Crisis — Rationing a Lifesaving Medication Discovered in the 1920s (NEJM)
  • Aurobindo is finding it difficult to satisfy the FDA, FTC (Fierce)
  • Double boost for mRNA cancer vaccines (Nature)
  • Affordable HIV and sickle cell disease gene therapies (Nature)
  • NIH launches open science Alzheimer initiative (Nature)
  • Arvinas’s PROTACs pass first safety and PK analysis (Nature)
  • Exclusive: Another Multi-Billion-Dollar Pharma Company Bets On Cannabis Technology For Smoking Cessation (Forbes)
  • Roche abandons anti-myostatin approach to Duchenne MD — one more nail in the class' coffin (Endpoints)
  • Some battle tested neuroscience vets are going all out on early onset dementia — with a $44M launch round to build the team (Endpoints)
  • Chikungunya Vaccine Development May Rely On Immunologic Biomarkers Instead Of Traditional Trials (Pink Sheet-$)
  • Alzheimer’s Drug Discovery Foundation still expects new treatments approved by 2025 (STAT)
Pharmaceutical & Biotechnology: Study Results, Filings & Designations
  • Declaring topline PhIII win, Takeda revives blockbuster hopes for its troubled multiple myeloma drug (Endpoints) (Press)
  • EIP Pharma Announces U.S. FDA Grants Fast-Track Designation to Neflamapimod as a Treatment for Dementia with Lewy Bodies (DLB) (Press)
  • CALQUENCE® Data To Show Improved Progression-Free Survival In Phase III Front-Line Chronic Lymphocytic Leukemia At ASH 2019 Annual Meeting (Press)
  • Bristol-Myers Squibb Underscores Precision-Focused Immunology Leadership with New Data on ORENCIA® (abatacept) in Early RA, ACPA-Positive Patients Presented at 2019 ACR/ARP Annual Meeting (Press)
  • TransThera Biosciences Lead Product TT-00420 Granted Orphan Drug Designation from FDA to Treat Cholangiocarcinoma (Press)
  • Triumvira Immunologics Announces Fast Track Designation for Its First TAC T-Cell Therapeutic Product Candidate: TAC01-CD19 (Press)
  • AVEO Oncology and Biodesix Announce Initiation of the CyFi-2 Study, a Phase 2 Randomized Study of Ficlatuzumab in Combination with High-Dose Cytarabine vs. High-Dose Cytarabine Alone in Patients with Relapsed and Refractory AML (Press)
  • Camallergy Provides Corporate Update and Prepares to Advance Lead Candidate CA002 Into Phase 3 Efficacy Trial for Peanut Allergy (Press)
  • The Medicines Company to Present Inclisiran Data from ORION-9 and ORION-10 Pivotal Phase 3 Clinical Studies at American Heart Association Scientific Sessions 2019 (Press)
  • Data From Intensity Therapeutics’ Phase 1/2 Study of INT230-6 Highlight Prolonged Disease Control, Abscopal Effects and Immune Response Activity in Patients With Advanced Solid Tumors (Press)
  • BerGenBio to Present Clinical Data From Phase II Combination Trial of Bemcentinib and LDAC Trial in Elderly AML Patients at ASH 2019 (Press)
  • Ocuphire Pharma Announces Results from Two Phase 2 Clinical Studies of Nyxol® Eye Drops (Press)
Medical Devices
  • CRADA report from UL and US VA: Procurement as driver of medical device cybersecurity (Emergo)
  • Medical Device Cybersecurity: What You Need to Know (FDA)
  • Cardinal Health posts Q1 results (MassDevice)
  • Dexcom posts 53% US revenue growth in 'blowout' Q3 (MedtechDive)
  • Hologic beats sales outlook on diagnostics, breast health (MedtechDive)
US: Assorted & Government
  • Trump health agenda continues to struggle in court (Politico)
  • US FDA's Budget Forecast: No Shutdown, But Funding Down From House Mark (Pink Sheet-$)
  • Drug Pricing Bill: Senate Sponsors ‘Not Backing Down’ From Inflation Rebates (Pink Sheet-$)
  • If Trump were to place tariffs on Swiss drugs, U.S. patients are most likely to get hurt (STAT)
  • Big Conversations: In-House Counsel Discuss the Past, Present, and Future of Biosimilars Market Entry In the EU and U.S. (Part 4) (BigMoleculeWatch)
  • Feds Ordered To Hand Over Docs To Ex-Theranos CEO (Law360-$)
  • Insys Creditors Say Liquidation Would Spark Chaos (Law360-$)
  • FTC Orders Prosthetic Maker To Unwind Merger (Law360-$)
  • Fed. Circ. Takes Issue With Hospira's 11th-Hour Arguments (Law360-$)
  • 23AndMe Urges Full Fed. Circ. To Rethink DNA Patent Ruling (Law360-$)
  • Another One for the A Fortiori File (Drug & Device Law)
  • Will USDA’s Rule Get Hemp Over the Hump? (Maybe Not Without Help from FDA) (FDA Law Blog)
Upcoming Meetings & Events Europe
  • EU Regulatory Roundup: Swissmedic Details Plans to Align Combination Product Rules With EU (Focus)
Asia
  • China sentences fentanyl drug ring in rare public trial amid US trade talks (CNN)
Australia
  • Australia Trials ‘More Transparent’ PBS Listing Procedure (Pink Sheet-$)
  • Therapeutic Goods Amendment (Declared Goods) Order 2019: Folate substances (TGA)
  • Webinar: Good Manufacturing Practice (GMP) Clearance Application - Common pitfalls (TGA)
General Health & Other Interesting Articles
  • Injured soldier has functional penis one year after first-of-its-kind transplant (Reuters)
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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