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Regulatory Focus™ > News Articles > 2020 > 1 > Recon: Roche Reports Positive Results for SMA Drug in Infants; Amgen to Buy Astellas Out of JV in Ja

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

Posted 23 January 2020 | By Michael Mezher 

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

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • 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 $29 million on lobbying in 2019 (The Hill)
  • Coronavirus Infections—More Than Just the Common Cold (JAMA)
In Focus: International
  • Millions on virus lockdown in China as WHO weighs response (Reuters)
  • Chinese listed companies ramp up virus efforts after president's call (Reuters)
  • Discovery of a novel coronavirus associated with the recent pneumonia outbreak in humans and its potential bat origin (BioRxiv)
  • Amgen To Buy Out Japan JV With Astellas (Scrip-$) (Endpoints) (Fierce) (Press)
  • Roche's SMA drug trial win bolsters $2 billion sales prospects (Reuters) (Endpoints) (Press)
  • Vaccine prevents deadly meningitis B in infants (Reuters) (NEJM)
  • Roche cracks China's ADC market open as Kadcyla scores its first breast cancer OK in the country (Endpoints)
  • Coronavirus Vaccine Candidate Eyed for Human Trials by April (Bloomberg) (The Hill)
Pharmaceuticals & Biotechnology
  • Teva Scores Earliest Generic License For Allergan's Linzess (Law360-$) (PMLive)
  • FDA Commissioner Continues To Staff Up (Politico)
  • Sandoz Execs: Biosimilar Initiatives For A New Decade (Biosimilar Development)
  • The Price of Innovation (
  • 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)
Pharmaceutical & Biotechnology: Study Results, Filings & Designations
  • 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)
Medical Devices
  • 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)
US: Assorted & Government
  • 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)
Upcoming Meetings & Events Europe
  • 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)
Coronavirus Outbreak
  • 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)
Other International
  • Paraguay's President Abdo contracts dengue fever amid outbreak (Reuters)
Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
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