Regulatory Focus™ > News Articles > 2019 > 3 > Recon: EC Approves Roche’s MabThera for Rare Autoimmune Indication

Recon: EC Approves Roche’s MabThera for Rare Autoimmune Indication

Posted 15 March 2019 | By Michael Mezher 

Recon: EC Approves Roche’s MabThera for Rare Autoimmune Indication

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Senator asks two pharma CEOs to clarify discrepancies in recent testimony about drug samples (STAT)
  • The Family That Profited From the Opioid Crisis (NYTimes)
  • Alex Azar's confusing claim on Medicaid work requirements (Politico)
  • Grassley on the President's 2020 Budget W/ HHS Sec. Azar (Senate Finance)
  • An ICU staple has exponentially spiked in price. Can compounding solve that problem? Now the courts will decide (STAT)
  • FDA delays Karyopharm PDUFA to review extra information (Fierce)
  • Scott Gottlieb to biopharma: You wanted us to help modernize R&D, now go out and do it (Endpoints)
  • Spectrum yanks marketing application for Neulasta rival after FDA demands more data (Endpoints)
  • FDA allows marketing of new device to help treat carbon monoxide poisoning (FDA)
In Focus: International
  • WHO says Ebola area contained but Congo needs long-term support (Reuters)
  • Roche clinches EU approval for MabThera in rare autoimmune indication (Endpoints) (Pharmafile) (Press)
  • The world’s top 10 blockbusters — and what they tell us about R&D trends (Endpoints)
  • US Visa Concerns Led ICH To Choose Canadian Meeting Site (Pink Sheet-$)
  • More trouble for Samsung BioLogics: Prosecutors raid Korea Exchange in IPO probe (Fierce) (Endpoints)
  • Pharma Uncertainty Remains As UK Votes To Delay Brexit (Pink Sheet-$) (EPR)
  • MHLW to Draw Up Guidelines on Registry Data Use for Submissions: Clinical Innovation Network Initiative (PharmaJapan)
  • Analysts: Keytruda has a blockbuster market not factored into Merck’s forecasts—China (Fierce)
  • UK Closes Investigation Into Anti-Competitive Scheme With Remicade (Focus)
Pharmaceuticals & Biotechnology
  • Risk-Based Monitoring and Enrichment Strategies: FDA Offers More Clinical Trial Guidance (Focus)
  • FDA Finalizes Guidance on Nonclinical Drug Development for Serious Hematologic Disorders (Focus)
  • Ex-Pfizer CEO Ian Read sees 2018 pay slashed by a third as incentive package plummets (Fierce) (Endpoints)
  • Call For CRISPR Moratorium Echoes Early Days Of Gene Therapy (Forbes)
  • ​Health Care Chutzpah vs. Health Plan Literacy (CMPI)
  • New Study Says Breast Cancer Is 11 Different Diseases, Allowing Researchers To Predict Relapse (Forbes)
  • J&J chief Gorsky took a big pay hit in 2018 but still nabbed $20M (Fierce)
  • Surrozen banks $50M round to fuel its drive to the clinic with regenerative med platform (Endpoints)
  • Desperately seeking a turnaround, beleaguered veteran fund manager Woodford hits out at critics, fake news (Endpoints)
  • Transforming Medical Affairs: Tapping the alchemy of storytellers and digital start-ups (McKinsey)
  • Update on Valsartan “Priority” Review (Lachman Consultants)
Pharmaceuticals & Biotechnology: Study Results, Filings & Designations
  • Adamis Pharmaceuticals Announces FDA Acceptance for Review of the New Drug Application of Its Higher Dose Naloxone Injection Product Candidate (Press)
  • Bayer's Phase III Clinical Trial Of Nifurtimox In Pediatric Patients With Chagas Disease Meets Primary Endpoint (Press)
  • Sutro Biopharma Initiates Phase I Clinical Trial of STRO-002 for the Treatment of Ovarian and Endometrial Cancers (Press)
  • Soleno Therapeutics Announces Positive Outcome from Planned Data Safety Monitoring Board Review of Phase III DESTINY PWS Clinical Trial of DCCR in Prader-Willi Syndrome (Press)
  • Xeris Pharmaceuticals Doses First Patient in Phase 2 Trial Evaluating Its Ready-to-Use Glucagon to Address Exercise-Induced Hypoglycemia (Press)
  • ImmunogenX Initiates Phase 2 Trial for its Lead Therapeutic and Diagnostic Candidates Latiglutenase and CypCel (Press)
Medical Devices
  • Exactech wins FDA nod for Alteon Cup, XLE liner acetabular system (MassDevice)
  • FDA Grants Breakthrough Device Designation to Fresenius Medical Care North America's Software for Fluid Management During Hemodialysis (Press)
  • Abbott Receives FDA Approval for Expanded Indication for MitraClip™ Device (Press)
  • Biotronik wins FDA nod for Acticor, Rivacor high-voltage tachycardia devices (MassDevice)
  • Fresenius wins FDA breakthrough device nod for fluid management software (MassDevice)
  • Oberd launches AI-assisted tech for gathering outcome data (MassDevice)
  • Stryker Buys Israeli Med Tech Co. In Deal Worth Up To $220M (Law360-$)
  • CDRH Classifies Respiratory Infection IVD, System for Neurological and Psychiatric Disorders (Focus)
  • CDRH Tweaks Guidance on Medical Devices Containing Animal-Derived Materials (Focus)
US: Assorted & Government
  • Tobacco and E-Cigarette Lobbyists Circle as FDA Chief Exits (NYTimes)
  • Medtronic’s Covidien Agrees to $20M DOJ Settlement Over Kickback Allegations (Focus)
  • Three’s Finally a Crowd: DEA Proposes Replacing Triplicate DEA-222 Order Forms with Single-Sheet Form (FDA Law Blog)
  • Fate Of JHL Biotech's Biosimilars Uncertain As Judge Bars Use Of Genentech Trade Secrets (Pink Sheet-$)
  • Plaintiff Loses in a Game of “What If …” (Drug & Device Law)
  • Bayer Must Face Essure Stillbirth Suit, 4th Circ. Rules (Law360-$)
  • Attys In Opioid Suits Are Holding Big Pharma Accountable (Law360-$)
Upcoming Meetings & Events Europe
  • EU Regulatory Roundup: UK Industry and Lords Criticize No-Deal Preparations (Focus)
  • EMA Opens for Consult ICH M10 Guideline on Bioanalytical Method Validation (Focus)
  • Chi-Med in ‘prime position’ to take advantage of Chinese growth (InPharmaTechnologist)
  • Improper Handling of Personal Information of Blood Donors (HSA)
  • Nicox signs licensing deal for Zerviate in China (PharmaLetter-$)
  • Health Canada Begins Release of Clinical Data on Drugs and Devices (Focus)
General Health & Other Interesting Articles
  • Breast cancer risk tied to DDT varies by exposure timing (Reuters)
Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe. Each weekday morning, we aim to bring you the latest highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the latest trends with the potential to impact regulatory affairs professionals and the industry in which they work.
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