Recon: FDA Expands Use of Seattle Genetics’ Adcetris Under Real-Time Review Pilot

• A newcomer rises to the defense of pharma — and tries to salvage its bruised reputation (STAT)
• FDA approves Seattle Genetics’ Adcetris for first-line treatment of peripheral T-cell lymphoma under new review pilot (FDA) (Press)
• Key AstraZeneca lung cancer treatment misses study goal (Reuters) (Financial Times) (Endpoints) (Fierce) (Press)
• AbbVie touts promising PhIII data for Orilissa as execs line up their second pitch and rivals lay in wait (Endpoints)
• Trump Administration Plots Costly Private-Care Expansion for Veterans (ProPublica)
• Medicaid expansion advocates eye 2020 targets (Politico)
• An Age-Old Sexually Transmitted Disease Faces a New Foe (Bloomberg)
• As new therapies arrive, pressure builds on the health care system to figure out how to pay for them (STAT)
• Sen. Enzi Questions FDA Over Leadership Succession Plans (Letter)
• ICER finalizes report finding asthma biologics too pricey (BioPharmaDive)
• A grandpa's hope for hemophilia cure leads him to gene therapy clinical trial (CNBC)
• A Spine-Surgery Robot Turned This Entrepreneur Into A Billionaire. But How Well Does His Robot Work? (Forbes)

• Novartis launches third-to-market Remicade copy in Germany (Reuters)
• EMA’s CHMP Recommends Four Medicines for Approval (EMA)
• With radiotherapy en vogue, Belgian startup nabs nearly $42M in Series A funding (Endpoints)
• Takeda dissident investors make last push to block Shire deal (Financial Times)
• BHA, ABPI welcome UK’s EU withdrawal agreement (PharmaTimes)
• While controversy over Brexit reaches full boil, a pharma trade group sees the upside in a draft deal (Endpoints)
• Draft Brexit Agreement’s Implications for Medical Device Sector (Emergo)
• Pharma industry launches call for coalition of countries to pilot new incentives for antibiotic R&D (IFPMA)
• Sanofi teams with non-profit on a landmark new drug for sleeping sickness (Endpoints)
• Chi-Med sees shares tank as its newly approved cancer drug flunks PhIII lung cancer trial (Endpoints)
• NICE issues final draft guidelines for Novartis’ Kymriah (PharmaTimes) (BioCentury)
• There's Growing Fear The Ebola Outbreak In Congo Could Get Much Worse (NPR)
• Pharma Wants Clarity On Use of EMA’s New Myeloma Endpoint (Pink Sheet-$)

• EpiPen may have a lot of value … but only if it costs $24 (STAT)
• CDER Conversation: Monitoring Social Media to Better Understand Drug Use Trends (FDA)
• A pharma veteran best known for biotech reflects on leading a startup, pricing a drug, and investing in politics (STAT)
• Shire’s lanadelumab shown to significantly cut HAE attacks (PharmaTimes)
• Request for Nominations for Individuals and Consumer Organizations for Advisory Committees (FDA)
• A big Indian generics maker failed an FDA inspection, but how bad was it? (STAT)
• Why You Should Care About Big Data This Flu Season (Forbes)
• Orphan drugs from Biogen and Amicus win UK Prix Galien (PMlive)
• The Amazing Ways Artificial Intelligence Is Transforming Genomics and Gene Editing (Forbes)
• Could a combo of cancer drugs for adults also treat neuroblastoma in children? (Fierce)
• Lori Kunkel takes acting CMO role at gene therapy firm Tocagen (Fierce)
• Centrexion Therapeutics changes its mind on initial public offering (MedCity)
• FDA reconsiders cardiovascular outcomes trials for diabetes drugs, 10 years on (Nature)

• Deciphera Pharmaceuticals Completes Enrollment in the INVICTUS Pivotal Phase 3 Clinical Study of DCC-2618 in Patients with Advanced Gastrointestinal Stromal Tumors (Press)
• First-in-human randomized controlled trial of an oral, replicating adenovirus 26 vector vaccine for HIV-1 (PLOS)
• 4D Molecular Therapeutics Announces FDA Orphan Drug Designation Granted to 4D-110 for the Treatment of Choroideremia (Press)
• Vyera Pharmaceuticals Receives FDA Clearance To Initiate A Phase 1 Study Of A New Chemical Entity Designed As A Potential Treatment For Toxoplasmosis (Press)
• First-in-Human Trial Launched for Super-Enhancer Inhibitor GZ17-6.02 (Press)
• Nexus Pharmaceuticals Receives FDA Approval for Arsenic Trioxide Injection in 10mg per 10mL Vial (Press)
• Promentis Pharmaceuticals Announces Successful Completion of Phase 1 Studies for SXC-2023 Targeting Novel Glutamatergic Mechanism (Press)
• Oragenics, Inc. Receives Clearance to Enroll Patients in Germany and the United Kingdom into Its Phase 2 Clinical Trial of AG013 for Oral Mucositis (Press)

• Boston Scientific plans $200m restructuring (MassDevice)
• FDA Publishes Draft Updated Guidance on Medical Device Cybersecurity (Drug & Device Law)
• Medtech pins tax repeal hopes on a lame duck (MassDevice)
• Medtronic touts 3-year Heli-FX EndoAnchor registry study data (MassDevice) (Press)
• Roundup: 12 healthcare algorithms cleared by the FDA (mobihealthnews)
• Edwards Lifesciences wins CE Mark for Sapien 3 Ultra TAVR (MassDevice)
• Abbott wins CE Mark, FDA nod for DRG Invisible Trial neuromod system (MassDevice)
• Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications (FDA)

• Pharma Cos. Must Hand Over Generic Restasis Plans In MDL (Law360-$)
• Judge Won't Quash AGs' Subpoenas In Generic Pricing MDL (Law360-$))
• Expansion of the Medicare 340B Payment Program (JAMA)
• FDA chief Gottlieb threatens to pull e-cigarettes off market if 'astonishing' surge in teen use doesn't slow (CNBC)
• California judge orders next Monsanto weed-killer cancer trial for March (Reuters)
• New jury fails to reach verdict in J&J South Carolina talc cancer trial (Reuters)

• FDA Advisory Committee Calendar

• Amgen Receives CHMP Positive Opinion To Expand Use Of BLINCYTO® (Blinatumomab) In Patients With Minimal Residual Disease-Positive B-Cell Precursor Acute Lymphoblastic Leukemia (Press)
• Janssen receives positive CHMP opinion for ERLEADA™ (apalutamide) for patients with non-metastatic castration-resistant prostate cancer who are at high risk of developing metastatic disease (Press)
• Vertex Receives European CHMP Positive Opinion for ORKAMBI® (lumacaftor/ivacaftor) for Treatment of Children with Cystic Fibrosis Aged 2 to 5 Years Old with Most Common Form of the Disease (Press)

• Govt set to finalise New Drugs and Clinical Trials Rules 2018; CDSCO to meet stakeholders next week (PharmaBiz)
• AFDLHF to send notices to FDC manufacturers including Sun Pharma & Glaxo for price control violation (PharmaBiz)
• Glenmark gets USFDA nod for multiple sclerosis medication (Economic Times)
• Shilpa Medicare gets tentative USFDA nod for multiple sclerosis drug (Economic Times)
• Zydus Cadila gets USFDA nod to market generic HIV treatment tablets (Economic Times)

• Medicine shortages reporting reforms: What you need to know (webinar) (TGA)

• Blacks Are Twice as Likely as Whites to Experience Sudden Cardiac Death (NYTimes)
• Batkid five years later: Miles Scott is cancer free, Make-A-Wish Foundation says (NBC)