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

• US Sues Gilead Over HIV Drug Patents (Focus) (NYTimes) (STAT) (Endpoints) (Law360-$)
• George Church startup eGenesis rakes $100M for CRISPR pig organ transplants (Endpoints) (Press)
• Purdue Opioid Suits Put On Hold Until April (Law360-$) (Reuters)
• Teva puts further $468m aside for opioid-related settlements (Financial Times)
• How the FDA & EPA’s failure to communicate could put patients in danger (Politico) (MedtechDive)
• First New HIV Strain in 19 Years Identified (Scientific American) (Chicago Tribune) (WSJ)
• Medicare overpays for certain orthotic devices, OIG finds (MedtechDive)
• First Rituximab Biosimilar, Truxima, Launches in the United States  (Center for Biosimilars) (Press)

• 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)

• 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)

• 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)

• 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)

• 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)

• FDA Advisory Committee Calendar

• EU Regulatory Roundup: Swissmedic Details Plans to Align Combination Product Rules With EU (Focus)

• China sentences fentanyl drug ring in rare public trial amid US trade talks (CNN)

• 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)

• Injured soldier has functional penis one year after first-of-its-kind transplant (Reuters)