Recon: FDA Approves J&J’s Antidepressant Nasal Spray; Vertex’s Second Triple-Drug CF Combo Hits Phase III Goals

• Gottlieb to Resign as FDA Commissioner (Focus) (Washington Post) (NYTimes) (Politico)
• Scott Gottlieb’s sudden resignation will give biotech a panic attack (STAT)
• Side effects of Alnylam's gene-silencing drug raise concerns, shares slip (Reuters) (STAT) (Endpoints) (Press)
• J&J nasal spray gets US approval as first new type of anti-depressant in decades (Reuters) (Endpoints) (NYTimes) (FDA) (Press)
• Vertex's cystic fibrosis therapy meets goal of late-stage studies (Reuters) (Endpoints) (Xconomy) (Press)
• Bristol-Myers urges shareholders in open letter to support $74 billion Celgene deal amid resistance (CNBC) (Endpoints)
• Pacira Pharmaceuticals acquires med device company MyoScience in deal worth up to $220M (MedCity)
• US Cities Skeptical Of FDA Warnings Against Medicine Imports From Canadian Firm (NPR)
• Two Maryland bills are the state’s latest attempt to rein in drug prices (Washington Post)
• Novartis Can't Halt Janssen's Promo Comparing Their Psoriasis Drugs (Pink Sheet-$)
• Americans want lower prescription prices, but not if it means fewer drugs, survey finds (CNBC)

• WHO unveils sweeping reforms in drive towards 'triple billion targets (WHO)
• Patient advocacy groups in Canada with ties to pharma are big boosters for government coverage (STAT)
• French VC Seventure focuses second fund on fertile microbiome field — targets €200M-plus (Endpoints)
• Bayer launches combination insecticide to fight resistance malaria (Reuters)
• Passengers, crew on Virgin Atlantic flight quarantined in UK (NBC)
• Canada pharma council calls for new national agency (Reuters)
• Brexit - Implications for therapeutic goods in Australia (TGA)
• NICE evidence request for Blincyto for acute lymphoblastic leukaemia (PharmaTimes               )
• Firm in NHS row over cystic fibrosis drug paid almost no UK tax (The Guardian)
• Médecins Sans Frontières calls on CEPI to revise 'toothless' access policy (Pharmafile)
• Brazil's ANVISA publishes regulation for Notification pathway for low-risk medical devices and IVDs (Emergo)

• ‘Ten Drugs’ Review: Better Living Through Chemistry (WSJ)
• What Really Makes a Difference in Vaccination Rates? (NYTimes)
• Patients Experiment With Prescription Drugs To Fight Aging (KHN)
• Treat Medicines Like Netflix Treats Shows (NYTimes)
• CDER Guidance Agenda for 2019: What’s Coming (Focus)
• Astellas taps ReForm to improve clinical-phase biologics (Fierce)
• After November rollout, GW Pharma says Epidiolex positioned for strong growth (Fierce)
• Tufts CSDD report reveals use of CROs increasing (PharmaLetter-$)
• Nonefficacy Benefits: Research Evaluates What Companies and FDA Say (Focus)
• Oncology pipeline chief Alessandro Riva joins the exodus at Gilead, heading to helm a biotech spinoff 4 days after O’Day’s arrival as CEO (Endpoints) (Fierce)
• FDA Warns Pennsylvania Drugmaker Over GMP Violations (Focus)
• AbbVie and Pfizer return to the top of pharma's TV spending list for February (Fierce)
• DBV loses regulatory, R&D executives ahead of peanut drug refile (Fierce)
• Gene editing upstart backed by Broad star Feng Zhang nabs $135M, blueprinting a platform biotech for the long haul (Endpoints) (Fierce)
• Following key late-stage advances, BeiGene puts down $10M to get some discovery projects rolling at Ambrx (Endpoints)
• PhRMA, BIO On Board With NIH's Heal Committee (BioCentury)
• Roche Broadens Its BD Scope (BioCentury)

• FDA Accepts Genentech’s Supplemental New Drug Application for XOFLUZA (baloxavir marboxil) for the Treatment of Influenza in People at High Risk of Complications (Press)
• Baxter Announces FDA Approval and Launch of Ready-to-Use Cardiovascular Medicine Eptifibatide (Press)
• Verrica’s Full Phase III Dataset In Molluscum Shows Greater Separation From Placebo (Scrip-$)
• NKMax America Announces FDA Approval of IND for Phase 1 Trial of SNK01 in Patients with Refractory Cancer (Press)

• CDRH Seeks to Exempt Certain Flow Cytometers from 510(k) Reviews (Focus)
• Class 1 Device Recall Raindrop Near Vision Inlay (FDA)
• Valeritas posts mixed Q4 results (MassDevice)
• Steris wins $48m DoD hospital equipment contract (MassDevice)
• Eargo raises another $52 million for ‘invisible’ hearing aid (MassDevice)

• Illumina Tells PTAB To Invalidate Columbia Univ. DNA Patent (Law360-$)
• Mental Health Treatment Denied to Customers by Giant Insurer’s Policies, Judge Rules (NYTimes)
• FDA finds asbestos in three Claire's cosmetics products (Reuters)
• Federal opioid task force visits Johns Hopkins to learn about stemming epidemic (Baltimore Sun)

• FDA Advisory Committee Calendar

• Webinars related to making submissions to the MHRA if the UK leaves the EU with no deal (MHRA)

• India requires pragmatic compulsive licensing system: Cipla (Economic Times)
• Biocon gets 6 observations from USFDA after inspection of its Bengaluru plant (Economic Times)
• Industry asks govt to stand firm on price cap on medical devices as revocation of GSP status by US to have only limited impact (PharmaBiz)

• Consultation: Proposed new classification rule for medical devices that administer medicines or biologicals by inhalation (TGA)
• Consultation: Proposed changes to the classification of active implantable medical devices and their accessories (TGA)
• Consultation: Proposed medical device classification for human cells, tissues and organs storage solutions and IVF media (TGA)
• Consultation: Proposed changes to the classification of medical devices used in direct contact with the heart, central circulatory or central nervous systems (TGA)
• Consultation: Proposed new medical device classification for substances introduced into the body via a body orifice or applied to the skin (TGA)