Recon: Roche, Lilly Alzheimer’s Drugs Fail in Phase II/III Study; WHO Coronavirus Advance Team Arrives in China

• Roche, Lilly drugs fail to halt gene-driven Alzheimer's disease (Reuters) (WSJ) (Roche) (Lilly)
• FDA hands Gilead a nice CAR-T boost as critics pounce on underwhelming Q4 call and Twitter buzzes with M&A chatter (Endpoints) (Press)
• FDA approves AI-based software that helps doctors take ultrasound pictures of the heart (STAT) (MedtechDive) (FDA)
• California scolds McKesson for supplying excessive controlled substances to children’s pharmacy (STAT)
• Biohaven anxiety treatment fails late-stage study, shares fall 16%  (Reuters) (Endpoints)
• FDA: No drug shortages reported because of coronavirus but situation 'fluid' (Politico)
• PhRMA 2020 Special 301 Report Urges USTR to Protect US Innovation (PhRMA)

• China allocates $10.26 billion to fight coronavirus (Reuters)
• Advance team of WHO experts arrives in China to probe coronavirus (Reuters)
• Coronavirus cases outside China 'could be spark' for bigger fire, says WHO (Reuters)
• Woodford's investors endure another blow as £550M deal to sell-off biotech holdings falters (Endpoints) (Fierce)
• WHO’s aggressive, three-part strategy aims to make cervical cancer a thing of the past (Washington Post)
• A Vending Machine in Canada Is Dispensing a Drug Twice as Strong as Heroin (Vice)
• WHO and FIND formalize strategic collaboration to drive universal access to essential diagnostics (WHO)

• The top 10 biopharma pipeline blowups, setbacks and snafus for H2 2019 (Endpoints)
• Double boost for cancer cell therapy (Nature)
• Are Novartis and Regeneron seeing the same thing? (BioPharmaDive)
• AbbVie's plan to replace Humira is ahead of schedule (BioPharmaDive)
• Exposure‐Response Assessment in Pediatric Drug Development Studies Submitted to the US FDA (ASCPT)
• Data Science Approaches for Effective Use of Mobile Device–Based Collection of Real‐World Data (ASCPT)
• FDA Expertise Advancing the Understanding of Intentional Genomic Alterations in Animals (FDA)
• FDA strengthens warning that untreated constipation caused by schizophrenia medicine clozapine (Clozaril) can lead to serious bowel problems (FDA)
• The Marketing of Stimulants for Children With A.D.H.D. (NYTimes)
• Investor impatience with Gilead reclamation project sparks acquisition chatter (STAT)
• Dr. Reddy’s Laboratories FDA Form 483 (FDA)
• Zealand acquires a struggling diabetes med-tech in push into US market (Endpoints)
• A crashing Wave takes out the budget ax to chop staff, abandoning work on Duchenne MD in restructuring (Endpoints)
• Major cancer institute sued by its own researchers over ‘tapering’ funding (Science Mag)
• Enterprise Therapeutics nabs Novartis VC exec as new CMO (Fierce)
• Vivek Ramaswamy's Arbutus kills another program over safety, stock takes another hit (Endpoints)
• The vodka trial: In search of a treatment for vocal disorders, a researcher puts patient anecdotes to the test (STAT)
• Science team designs a new CAR they say may work much better than BCMAs in fighting multiple myeloma (Endpoints)

• Eye drop developer Oculis showcases positive PhII data; Aquestive hunts for another FDA OK (Endpoints)
• Inovio Receives Authorization from the U.S. FDA To Begin Phase 1/2 Clinical Trial for INO-3107, a DNA Medicine To Treat a Rare Disease -- Recurrent Respiratory Papillomatosis (RRP) (Press)
• Successful meeting with USFDA to file an IND application to initiate phase III clinical trial of centhaquine in patients with hypovolemic shock (Press)
• Elorac to Present Naloxone Lotion Phase III Study Update at the 4th World Congress of Cutaneous Lymphomas in Barcelona (Press)
• Eagle Pharmaceuticals Receives Final FDA Approval for PEMFEXY™ (Pemetrexed for Injection) (Press)
• Kodiak Sciences Announces Additional Safety, Efficacy and Durability Data from Ongoing Phase 1b Study of KSI-301 in Patients with Wet Age-Related Macular Degeneration, Diabetic Macular Edema and Retinal Vein Occlusion at the Angiogenesis, Exudation, and Degeneration 2020 Meeting (Press)

• Shuren Fills Alliance in on Fast-Moving Science and CDRH Needs (Alliance for a Stronger FDA)
• Medtronic faces key test in establishing US market for renal denervation (MedtechDive)
• Aria CV wins breakthrough nod for pulmonary arterial hypertension device (MassDevice)
• AdvaMed and Biocom to produce Digital MedTech Conference together (MassDevice)
• GreenBone Ortho wins CE Mark for bone graft made of transformed wood (MassDevice)
• FDA Clears Paragonix Technologies’ LUNGguard for Donor Lung Preservation (Press)

• Amidst Coronavirus Outbreak, Peters, Leahy, Murray and Menendez Press Trump Administration to Fully Fund Pandemic Preparedness and Response Efforts (Senate HELP)
• House Passes Puerto Rico Earthquake Supplemental (House Appropriations)
• New FDA policy allows lab animals to be adopted after experiments (The Hill)
• DOJ 'Not Done' With Generic Drug Price-Fixing (Law360-$)
• Opioid MDL 'Negotiation Class' Gets Bombarded At 6th Circ. (Law360-$)
• Feinstein, Graham, Durbin Bill Keeping Fentanyl Schedule I Signed into Law (Fienstein)
• In their words: Warren, Buttigieg, Klobuchar, and other Democrats explain exactly how they’d lower drug prices (STAT)
• A closer look at Bernie Sanders’ plans to upend pharma and lower drug prices (STAT)
• Ninth Circuit Prohibits Plaintiff’s Bootstrap Class Action Discovery (Drug & Device Law)
• FDA Law Alert – February 2020 (FDA Law Blog)

• FDA Advisory Committee Calendar
• Regulatory Education for Industry (REdI): Generic Drugs Forum - April 15 & 16, 2020
• 3rd Meeting of the Strategic Advisory Group of Experts on IVDs – 23-27 March 2020

• UK To Cut Company Payments Under Statutory Pricing Scheme (Pink Sheet-$)
• Update on Plans for Ending Safety Features Use and Learn in Ireland on Phased Basis from 2 March 2020 (HPRA)
• European Pharmacopoeia welcomes its 39th member state, Albania (Council of Europe)

• Pacific Biosciences Targets China Clinical Market to Rebound After Illumina Deal Falls Through (GenomeWeb)

• Prolongation of coronavirus outbreak in China could hit Indian pharma sector (Economic Times)
• Panel mulls drug export curbs to avoid shortage (Economic Times)
• Medical devices trade margins likely to be capped at 30% (Economic Times)
• NGOs ask govt to reject US’ demand to adopt “TRIPS-plus” IP provisions and to do away with price caps on medical devices (Pharmabiz)
• Cadila Healthcare gets EIR from USFDA for its Ahmedabad facility (Economic Times)
• JB Chemicals Gujarat unit passes USFDA inspection with one observation (Economic Times)

• InSkin Cosmedics Group pays $37,800 in penalties for alleged supply and advertising of unapproved dermapen device (TGA)

• WHO Director-General's remarks at the media briefing on 2019-nCoV on 10 February 2020 (WHO) (Situation Report)
• Coronavirus sparks hectic trading in search of treatment (Financial Times)
• Fluctuating funding and flagging interest hurt coronavirus research, leaving crucial knowledge gaps (STAT)
• China health body warns against excessive use of protective suits (Reuters)
• US announces aid for China, other countries impacted by coronavirus (Reuters)
• US to spend up to $66M in efforts to counter coronavirus: health officials (The Hill)
• Therapeutic options for the 2019 novel coronavirus (2019-nCoV) (Nature)
• China to speed up the provision of medicines seen to be effective against coronavirus: state media (Reuters)
• Clinical characteristics of 2019 novel coronavirus infection in China (MedRxiv)
• ‘We’re definitely not prepared’: Africa braces for new coronavirus (STAT)
• UK coronavirus cases double to eight, government declares 'imminent threat' (Reuters)
• Britain says evacuation flight leaves Wuhan with over 200 on board (Reuters)
• NIHR, UKRI launch Coronavirus funding call (PharmaTimes)

• Journey to recovery: Yemeni patients get new lease on life in Jordan (WHO)