Recon: Roche Reports Positive Results for SMA Drug in Infants; Amgen to Buy Astellas Out of JV in Japan

• Civica Rx teams with Blue Cross Blue Shield to widen its alternative market for generics (STAT) (Reuters) (NYTimes)
• Many patient groups have deep ties to pharma but fail to disclose backing (STAT)
• Eli Lilly’s $1.6B cancer drug failed to spark even the slightest positive gain for patients in its 1st PhIII (Endpoints)
• Insys founder faces stiff prison sentence, $100 million-plus in forfeiture (Reuters)
• The FDA continues to struggle with the implications of approving Sarepta’s drugs (STAT) (Reuters)
• Despite an industry crackdown, compounded drugs could still be dangerous (CNBC)
• White House prepared short list to shake up HHS leadership (Politico)
• PhRMA spent record-high $29 million on lobbying in 2019 (The Hill)
• Coronavirus Infections—More Than Just the Common Cold (JAMA)

• Millions on virus lockdown in China as WHO weighs response (Reuters)
• Chinese listed companies ramp up virus efforts after president's call (Reuters)
• Discovery of a novel coronavirus associated with the recent pneumonia outbreak in humans and its potential bat origin (BioRxiv)
• Amgen To Buy Out Japan JV With Astellas (Scrip-$) (Endpoints) (Fierce) (Press)
• Roche's SMA drug trial win bolsters $2 billion sales prospects (Reuters) (Endpoints) (Press)
• Vaccine prevents deadly meningitis B in infants (Reuters) (NEJM)
• Roche cracks China's ADC market open as Kadcyla scores its first breast cancer OK in the country (Endpoints)
• Coronavirus Vaccine Candidate Eyed for Human Trials by April (Bloomberg) (The Hill)

• Teva Scores Earliest Generic License For Allergan's Linzess (Law360-$) (PMLive)
• FDA Commissioner Continues To Staff Up (Politico)
• Sandoz Execs: Biosimilar Initiatives For A New Decade (Biosimilar Development)
• The Price of Innovation (Tradeoffs.org)
• The FDA has devalued the gold standard on R&D. And that threatens everyone in drug development (Endpoints)
• Pascal Soriot and AstraZeneca commit to zero-carbon by 2025, carbon-neutral by 2030. Where's the rest of Pharma? (Endpoints)
• With Vascepa nod in the bag, Amarin rolls CV risk campaign targeting passé prescription meds (Fierce)
• Sorting it Out – FDA AdComm Review for 2019 (Eye on FDA)
• After AstraZeneca, Osbourn Reflects on Roles at CAT & MedImmune (Xconomy)
• Postmarketing Trial For Horizon Thyroid Eye Drug Tepezza To Be Larger Than Expected (Pink Sheet-$)
• ‘Real World’ Opioid Abuse Data On OxyContin Again Under Review At US FDA (Pink Sheet-$)
• US FDA ‘Public Health’ Approach To Opioids May Open Up Pricing Debates (Pink Sheet-$)
• Vaccines Boost Priority Profile Of US FDA’s Biologic Center 2019 Approvals (Pink Sheet-$)
• Merck KGaA spinout gets first funding to bring dual-acting cancer molecules into the clinic (Endpoints)
• PureTech bags $200M from sale of Karuna shares — still sizzling from promising schizophrenia data (Endpoints)
• Pfizer’s Greenstone and Digital Men’s Health Clinic Roman Collaborate to Offer Patients Remote Access to the Only FDA-Approved Authorized Generic Version of Viagra® (sildenafil citrate) (Press)
• Pfizer Vaccines Launches Global Centers of Excellence Network to Conduct Real-World Research on Vaccine-Preventable Diseases Affecting Adults (Press)
• Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act Guidance for Industry (FDA)
• Determination That CARDENE (Nicardipine Hydrochloride) Injection, 25 Milligrams/10 Milliliters, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness (FDA)

• Endometriosis drug reduces bleeding in women with fibroids (Reuters) (NEJM)
• Cadent Therapeutics Announces FDA Acceptance of IND Application for CAD-1883 for Spinocerebellar Ataxia (SCA) (Press)
• Biohaven's Verdiperstat Receives FDA May Proceed Letter To Initiate Trial In Amyotrophic Lateral Sclerosis Conducted By The Healey Center For ALS At Mass General (Press)
• The New England Journal of Medicine Publishes Comprehensive Data from Phase 3 Clinical Trial (OPTIC) of TEPEZZA™ (teprotumumab-trbw) for Thyroid Eye Disease (Press)
• Celularity Announces FDA Clearance of Landmark IND for CYNK-001, an Allogeneic, Off-the-Shelf Cryopreserved NK Cell Therapy (Press)
• LB Pharmaceuticals Announces the Initiation of Patient Dosing in a First-in-Human Phase 1 Study of LB-102, a Novel Benzamide for the Treatment of Schizophrenia (Press)
• BlackThorn Therapeutics Advances Phase 2 Clinical Development for Selective KOR Antagonist, BTRX-140, in Neuropsychiatric Disorders (Press)
• Ascletis Received Approval of Clinical Trials in HBV Patients for ASC22, a Subcutaneously Administered PD-L1 Antibody (Press)

• Cardinal begins recall of 9.1M surgical gowns amid sterility concerns (MedtechDive)
• Johnson & Johnson planning a robotic surgery reveal in May (MassDevice)
• Boston Sci wins CE Mark for disposable duodenoscope Exalt Model D (MassDevice)
• Quest buys Helsinki-based Blueprint Genetics to expand reach (MedtechDive)
• Abbott ups 2020 growth targets, downplays Libre 2 delay (MedtechDive)
• FDA OKs latest Medtronic leadless pacemaker, potentially tripling market (MedtechDive)

• Health Subcommittee To Hold Legislative Hearing On Policies Related To Food And Drugs (House E&C)
• Epic’s CEO is urging hospital customers to oppose rules that would make it easier to share medical info (CNBC)
• Fourth Foundation Resolves Allegations that it Conspired with Pharmaceutical Companies to Pay Kickbacks to Medicare Patients (DOJ)
• Letter to FDA Commissioner Hahn on Flavored Vaping Pods (House Oversight Committee)
• White Paper: Sidelined: How Seniors Miss Out On Savings Available Through Generic Substitution (AAM)
• Senators Unveil Bill Requiring Vape Cos. To Pay FDA (Law360-$)
• Bristol-Myers Wants $1.5B From Gilead After Cancer IP Trial (Law360-$)
• General Causation Experts Excluded In Viagra/Cialis MDL (Drug & Device Law)
• St. Louis County Drug Monitoring Program Continues To Grow Across Missouri (St. Louis Public Radio)

• FDA Advisory Committee Calendar
• Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket – 26 February 2020

• Clinical trial publications: A sufficient basis for healthcare decisions? (European Journal of Internal Medicine)
• MDR Watch: Is Switzerland becoming a Third Country? (Emergo)
• What will the medtech sector look like under EU MDR Law? (MedCity)
• Medical devices: information for users and patients (MHRA)
• MHRA gender pay gap report (MHRA)
• Confidential government documents reveal names of 209 medicine shortages in 2019 (Pharmaceutical Journal)

• Gene And Cell Therapies In Asia: Pricing, Manufacturing Stand-Out Issues in Supportive Japan Ecosystem (Pink Sheet-$)
• Double haul of Japanese approvals for Eisai (PharmaLetter-$)
• Ferring’s Propess® is the first pharmacological treatment for cervical ripening to be approved in Japan for over 20 years (Press)
• Sysmex Wins Chinese Approval for Breast Cancer IVD Reagent (GenomeWeb)

• DoP rejects Emcure Pharma's review application against NPPA's price notification on emtricitabine+tenofovir tablets (Pharmabiz)

• Submissions received and TGA response: Increased online access to ingredient information (TGA)

• Maps: Where the Wuhan Coronavirus Has Spread (NYTimes)
• China Silences Critics Over Deadly Virus Outbreak (NYTimes)
• Wuhan lockdown 'unprecedented', shows commitment to contain virus: WHO representative in China (Reuters)
• Coronavirus Deaths Are So Far Mostly Older Men, Many With Previous Health Issues (NYTimes)
• China's mask makers cancel holidays, jack up wages as new virus spurs frenzied demand (Reuters)
• Total number of coronavirus cases in China at 634: State TV (Reuters)
• Wuhan to build designated hospital to treat coronavirus patients: Beijing News (Reuters)
• Singapore confirms first case of new China virus, another likely (Reuters)
• Abu Dhabi screen China flights as virus spreads (Reuters)
• Saudi Arabia to screen travelers from China after virus outbreak (Reuters)
• Egypt starts screening travelers from China for new coronavirus (Reuters)
• Vietnam says two Chinese citizens in Vietnam confirmed to have coronavirus (Reuters)
• UAE to screen passengers on China flights after virus outbreak (Reuters)
• Oxford Immunotec to supply TB diagnostic tests to china to aid in coronavirus crisis (Pharmafile)

• Paraguay's President Abdo contracts dengue fever amid outbreak (Reuters)