Recon: BMS to Divest Celgene Psoriasis Drug Otezla to Appease FTC in Merger – Regulatory Focus

Posted 24 June 2019 | By Michael Mezher 

Recon: BMS to Divest Celgene Psoriasis Drug Otezla to Appease FTC in Merger
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US

  • At Least Three People in Running to Head FDA (WSJ)
  • Bristol-Myers to Shed Psoriasis Drug to Win Approval for Celgene Deal (WSJ) (STAT) (Endpoints) (Pharmafile) (Press)
  • FDA spurns hay fever drug from India’s Glenmark (Endpoints) (Fierce) (Economic Times)
  • Bristol-Myers star Opdivo fails survival test in a matchup with Nexavar aimed at shaking up the big HCC market (Endpoints) (Fierce) (Press)
  • FDA approves controversial women’s libido drug (STAT) (Reuters) (Endpoints) (NYTimes) (FDA)
  • Alarmed by new ‘CRISPR babies’ plan, top science figures say they’re powerless to stop it (STAT)
  • VA declines broad coverage for new J&J depression drug touted by Trump (STAT) (NYTimes)
  • FDA lifts hold on AbbVie multiple myeloma study (BioPharmaDive) (Endpoints)
  • US records 33 new measles cases, mostly in New York State (Reuters)
  • US Supreme Court takes up insurers’ $12 billion Obamacare dispute (Reuters)
  • How Big Pharma Suppresses ‘Biosimilars’ (WSJ)
  • Cheaper insulin ‘nowhere to be found’ in Arizona, pharmacies and advocates say (AZCentral)
  • A voter’s guide to Drug Costs: Compare where all the 2020 candidates stand (Politico)
  • Drug costs should be a ‘prominent issue’ in Trump trade talks: Mount Sinai Health CEO (CNBC)

In Focus: International

  • LifeArc steers new-found financial clout into expanded drugs research (Financial Times) (Fierce)
  • EMA clears Novo Nordisk’s long-acting haemophilia A drug (PMLive)
  • Pfizer’s Talzenna cleared for breast cancer in Europe (PMLive)
  • Glenmark signs deal with Novartis over distribution in Brazil (Pharmafile)
  • Global Inspection Scheme Increases Burden On Pre-Accession Applicants (Pink Sheet-$)
  • China drafts guidelines for use of real-world data (BioCentury)
  • Why China’s 4 + 7 policy is good news for innovative drug developers (BioCentury)
  • Shionogi out-licenses assets in China (PharmaLetter-$)
  • They Thought This HIV Strategy Couldn’t Work. But It Did (NPR)
  • A rapid TB test for people living with HIV (MSF)

Pharmaceuticals & Biotechnology

  • A male contraceptive pill may still prove too hard to swallow (Financial Times)
  • For Vitiligo Patients, New Treatments Offer Hope (NYTimes)
  • The top 10 drug launches of 2019 (Fierce)
  • Locana, Fueled With $55M, Looks to Develop Fixes for Faulty RNA (Xconomy)
  • It’s Pioneer Institute vs. ICER: Drug-pricing watchdog comes under fire for a ‘one-size-fits-all’ approach (STAT)
  • ICER says pricing for Novartis MS drug ‘far out of line,’ but more groups push back (STAT)
  • FDA Finalizes Guidance on Advertising and Promotional Material Submissions (Focus)
  • In $86M IPO pitch, Mirum spells out plans to turn Shire discards into orphan liver drug successes (Endpoints)
  • Oxford, Evotec ramp up LAB10x with AI experts at Sensyne — focused on biotech spinouts (Endpoints) (Fierce)
  • Woodcock: Eric Stone Will Serve As Director Of CDER Management Office (IHP)
  • How inhibiting both HDAC and PD-1 could improve immuno-oncology treatments (Fierce)
  • Issuance of Priority Review Voucher; Rare Pediatric Disease Product (FDA)

Pharmaceuticals & Biotechnology: Study Results, Filings & Designations

  • Alexion wins priority review for Ultomiris’ aHUS indication; FDA expands approval of Vertex’s Symdeko (Endpoints)
  • NantKwest Launches First-in-class, First-in-human Phase I Clinical Trial With a Targeted PD-L1 t-haNK Cell Therapy in Patients With Solid Tumors (Press)
  • FDA Grants Orphan Drug Designation to XW Laboratories’ XWL-008 for the Treatment of Patients with Narcolepsy (Press)
  • Epygenix Therapeutics Submits Investigational New Drug Application for EPX-100 to the U.S. FDA for the Treatment of Patients With Dravet Syndrome (Press)
  • Correvio Resubmits Brinavess (Vernakalant) New Drug Application to U.S. FDA for the Treatment of Patients with Recent Onset Atrial Fibrillation (Press)
  • Asieris Announces Completion of Enrollment for its US APL-1202 Phase Ib Clinical Trial (Press)
  • Better than Ambien? Minerva soars on PhIIb update on seltorexant for insomnia (Endpoints) (Press)
  • Gene therapy biotech sees its stock rocket higher on promising results for rare cases of butterfly disease (Endpoints)

Medical Devices

  • Medtronic put up $316m for Epix Therapeutics (MassDevice)
  • Doctors Learn The Nuts And Bolts Of Robotic Surgery (NPR)
  • Allergan Receives FDA Clearance For CoolTone™ Device (Press)
  • CMS expands TAVR coverage (MassDevice) (Medtronic)
  • Liquid Biopsy Assay From MSKCC Approved by New York State (GenomeWeb)

US: Assorted & Government

  • Trump to order hospitals to be transparent about healthcare costs (Reuters)
  • House bill seeks 5-year biologics exclusivity period (BioCentury)
  • Azar, White House work to publicly mend fences (Politico)
  • Biggest Health And Life Sci Rulings Of 2019: Midyear Report (Law360-$)
  • Louisiana’s Experiment Paying For Hepatitis C Drugs: Lessons For Other States, Other Treatments? (Forbes)
  • Johnson & Johnson faces multibillion opioids lawsuit that could upend big pharma (The Guardian)
  • Generic Drug Cos. Still Trying To Rein In AG Disclosures (Law360-$)
  • Hauled from the Deep End? New (and One Old) Developments in Pennsylvania Personal Jurisdiction (Drug & Device Law)
  • Consumers Encouraged to “Make Smart Choices” About CBD Products (FDA Law Blog)
  • Heraeus can pursue trade secret suit against Zimmer Biomet supplier (MassDevice)

Upcoming Meetings & Events Europe

  • Notified Body Survey Offers New Data on EU Medical Device Certificates (Focus)
  • EC Previews Call to Set up Expert Panels for EU MDR/IVDR (Focus)
  • UK Government pledges to fight ‘deadly’ antimicrobial resistance (PharmaTimes)
  • Clinical trials for medicines: authorisation assessment performance (MHRA)
  • EAMS opinion: Atezolizumab as 1st line treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumours have PD-L1 expression ≥ 1% (MHRA)
  • EAMS opinion: Dupilumab as a treatment of adolescent patients between 12 and 18 years of age with severe atopic dermatitis for whom the available systemic therapies are not suitable (MHRA)
  • Company led drug alert – Docetaxel Injection 160mg /16ml and Docetaxel Injection 20mg / 2ml (MHRA)


  • IPA’s ‘Vision 2030’ report stresses on 7 strategic interventions by govt to take Indian pharma industry to US$ 120-130 billion by 2030 (PharmaBiz)


  • Notice: Regulatory Enrolment Process (REP) implementation and expansion of the scope for the Common Electronic Submissions Gateway (CESG) (Health Canada)


  • Changes to ingredient names: End of transition period – are you ready? (TGA)
  • IMDRF consultation: Personalised Medical Devices – Regulatory Pathways (TGA)

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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