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

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• FDA Advisory Committee Calendar

• 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)