Recon: Eli Lilly Profit Boosted by Trulicity Demand; Roche Posts 2019 Growth Despite Biosimilar Competition

• Eli Lilly beats profit estimates on strong demand for diabetes drug Trulicity (Reuters) (Endpoints)
• Biogen's multiple sclerosis drug powers quarterly profit beat (Reuters)
• As Biogen gets squishy on timing for an aducanumab filing, the clock is ticking (STAT)
• GSK, Pfizer and more sign on for Accenture, Google's new data platform (Fierce)
• Health-Records Company Pushed Opioids to Doctors in Secret Deal With Drugmaker (Bloomberg)
• Abiomed device controversy revived in Circulation editorial (MedtechDive)
• CVS offers option for diabetes drugs with no out-of-pocket cost (Reuters)
• Life expectancy went up while drug overdoses fell (Politico)
• Trump launches coronavirus task force as US readies more Wuhan evacuations (Reuters)
• CDC confirms first known case of person-to-person spread of new coronavirus in US (STAT)

• WHO panel to reconvene on Thursday to decide if virus global emergency (Reuters)
• China virus outbreak death toll rises to 170 as infections rise (Reuters)
• On eve of Brexit, Britain faces critical test to defend drug trial crown (Reuters)
• EU court sets criteria for GSK case on 'pay-for-delay' drug deals (Reuters)
• Roche Posts Growth as Diversification Efforts Pay Off (WSJ) (Bloomberg) (Endpoints) (PMLive)
• Roche says closed Chinese cities hinder virus diagnostics test deliveries (Reuters)
• Most innovative cancer drugs take too long to reach patients in the UK (STAT) (Study)
• MHLW to Incentivize Physicians to Use Biosimilars with New Premium (PharmaJapan)
• Vas Narasimhan wants Novartis to have a big focus on China. Here’s what that looks like (Endpoints)
• Record Funding For Global Health Research, But Neglected Tropical Diseases Remain Neglected (Forbes)
• Brexit: Council adopts decision to conclude the withdrawal agreement (Council of the EU)
• Brexit deal approved by the European Parliament (EP) (BBC)

• AI-designed drug to enter human clinical trial for first time (Financial Times)
• Big pharma backed away from brain drugs. Is a return in sight? (BioPharmaDive)
• Makers of novel cell/gene therapy say off-the-shelf approach only way to solve pricing woes (MedCity)
• US FDA's Yim Hopes To See European-Like Robustness For US Biosimilars Market In 10 Years (Pink Sheet-$)
• Novartis gives up on Advair generic, leaving Mylan as sole competitor (BioPharmaDive) (Fierce)
• Antibiotic therapy cuts stomach cancer rate by more than half in high-risk population (Reuters)
• Go or no go? Esperion's double whammy and a look to priority reviews (Evaluate)
• Managing Uncertainty In Drug Value: Outcomes-Based Contracting Supports Value-Based Pricing (Health Affairs)
• A National Survey of the Frequency of Drug Company Detailing Visits and Free Sample Closets in Practices Delivering Primary Care (JAMA)
• Drug price inflation slows, but problems persist (Modern Healthcare)
• Amgen’s R&D Group Focuses On Efficiency As Drug Cost Concerns Continue (Scrip-$)
• Cancer-focused Black Diamond vaults on to Nasdaq in $200M+ public debut, marking biggest biotech IPO in 2020 so far (Endpoints)
• Companies must responsibly manufacture the antimicrobials society needs (STAT)
• Rani Therapeutics eyes potential IPO as robotic pill technology takes shape (Endpoints)
• Recommendations to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Components; Draft Guidance for Industry (FDA)

• Sanofi polishes rare disease profile as Niemann-Pick drug scores promising PhII/III data — there's just one question (Endpoints)
• Lilly and Incyte Announce Positive Top-Line Results from the North American (BREEZE-AD5) Phase 3 Study of Oral Selective JAK Inhibitor Baricitinib in Patients with Moderate to Severe Atopic Dermatitis (Press)
• Astellas Submits Supplemental New Drug Application for Approval of Evrenzo® (roxadustat) for the Treatment of Anemia Associated with Chronic Kidney Disease in Non-Dialysis Dependent Patients in Japan (Press)
• Positive topline results demonstrated by olipudase alfa, first and only investigational therapy in late-stage development for acid sphingomyelinase deficiency (Press)
• Bayer application for nifurtimox to treat pediatric patients with Chagas disease submitted for approval in US (Press)
• F-star Therapeutics Announces FDA Acceptance of IND Application for FS120 (Press)
• Merakris Therapeutics, LLC Files Request With FDA for Pre-IND Meeting for Dermacyte® Amniotic Wound Care Liquid (Press)
• Cerevel Therapeutics Initiates Phase 1 Clinical Trial of CVL-936, an Investigational Medicine in Development to Treat Substance Use Disorder (Press)

• How We Used FDA MAUDE Data on NovaSure (Medpage)
• Patients, Physicians, And Industry Leaders Hold Briefing On Role Of Amyloid Pet Scans In Alzheimer’s Research (MITA)
• Robot sales spike to new high as Stryker eyes growth in Japan (MedtechDive) (MassDevice)
• Major conglomerates 3M, GE, Philips bet on healthcare (MedtechDive)
• Hologic Q1 results are a mixed bag (MassDevice)
• Dräger Medical cited in FDA warning letter (MassDevice)

• New FDA chief vows tougher action on youth vaping if needed (Washington Post)
• Actions Needed to Ensure Usefulness of Data on Suspicious Opioid Orders  (GAO)
• Trump admin to try letting states limit Medicaid benefits (Reuters)
• Meanwhile, Back at the Broad-CVC Interference . . . (Patent Docs)
• Congress Adopts Biosimilar Related Provisions in the 2020 Appropriations Act (Big Molecule Watch)
• Takeda Gets Go-Ahead To Appeal Actos Rulings At 2nd Circ. (Law360-$)
• Pharma CEO Asks Judge To Toss Opioid Trafficking Charge (Law360-$)
• Novartis, Armed With New IP, Again Sues Over $3B MS Drug (Law360-$)
• State AGs Diss Pfizer's Effort To Flee Price-Fixing MDL (Law360-$)
• Facebook to Pay $550 Million in Biometric Privacy Accord (Bloomberg Law)
• CSPI Letter Asking that FDA Act Against Misleading and Unauthorized Sugar Claims Is Followed by Class Action Complaint (FDA Law Blog)
• A Couple of Interesting Duty Cases (Drug & Device Law)

• FDA Advisory Committee Calendar
• European Medicines Agency EORTC workshop on novel PRO and QoL approaches in cancer clinical research – 12-13 March 2020

• UK: NICE’s Rare Disease Gatekeeping Comes Under The Microscope (Pink Sheet-$)
• Guidance for applicants on a pilot for Simultaneous National Scientific Advice (SNSA) (HMA)
• CT screening cuts lung cancer deaths in European men and women (Reuters)
• Innovation: Clonal neoantigen specific tumour-infiltrating lymphocytes for cancer treatment (MHRA)
• Class 2 Medicines Recall: Wockhardt UK Ltd, Levothyroxine 100micrograms/5ml Oral Solution EL(20)A/04 (MHRA)
• Opinion Of Advocate General in Generics (UK) Ltd and Others v Competition and Markets Authority (EUR-Lex)

• CDSCO notifies import of oxytocin reference standards exclusively for test and analysis (Pharmabiz)
• USFDA cautions Aurobindo Pharma's oral solids formulation facility of regulatory action (Economic Times)

• WHO lauds Chinese response to virus, says world 'at important juncture' (Reuters)
• Novel Coronavirus(2019-nCoV) Situation Report – 10 (WHO)
• Top Chinese, US diplomats discuss coronavirus situation (Reuters)
• China tells firms to resume production of medical goods for virus control (Reuters)
• China virus triggers global rush for protective masks (Reuters)
• China says Chinese nationals who are family members of foreigners can fly out of Wuhan (Reuters)
• Morgan Stanley warns coronavirus could drag on global, Chinese GDP growth (Reuters)
• India reports its first case of coronavirus (Reuters)
• BGI Sequencer, Coronavirus Molecular Assays Granted Emergency Use Approval in China (GenomeWeb)
• Thousands kept on board Italian liner amid coronavirus scare (Reuters)
• Finland confirms its first coronavirus case (Reuters)
• Philippines confirms first case of new coronavirus: health minister (Reuters)
• Canada to evacuate Canadians from flu-hit Chinese region: foreign minister (Reuters)
• US evacuees from China placed on 72-hour 'hold' at California military base for medical evaluation (Reuters)
• Spain to repatriate nationals from Wuhan in cooperation with UK (Reuters)
• US military won't be in contact with Wuhan evacuees -Pentagon (Reuters)
• South Korean officials face eggs, invective as quarantine plane takes off (Reuters)
• UK to evacuate around 200 of its citizens from China on Thursday (Reuters)
• Indonesia says preparing to evacuate citizens from Wuhan as virus spreads (Reuters)
• Three Japanese evacuees from Wuhan test positive for virus, two had no symptoms (Reuters)
• Coronavirus pandemic threatens to cut pharmaceutical industry’s lifeline (Economic Times)
• Why we panic about coronavirus, but not the flu (Axios)

• WHO Refines Approach For Listing Products In Health Emergencies (Pink Sheet-$)
• 146th session of the Executive Board (WHO)
• Global vaccines community must urgently support rollout of new more affordable pneumonia vaccine (MSF)