Recon: GSK Nabs Priority Review for Myeloma Drug; BeiGene Lung Cancer Treatment Hits Goals in Phase III Study

• GSK advances blood cancer drug to FDA, but rivals threaten (BioPharmaDive) (Endpoints) (Press)
• Scientists find unexpected anti-cancer activity in range of non-oncology drugs (Endpoints) (Scientific American) (Broad)
• Pfizer’s big data exec on pharma’s ‘arms race’ to partner with companies like Fitbit, 23AndMe, and others (STAT)
• Will the FDA give the go-ahead to a prescription video game? (STAT)
• Trump blowup could mean more drug pricing action (Politico)
• US Supreme Court declines to fast-track Obamacare appeal (Reuters) (Politico)

• Pharma firms not making enough progress against superbugs: report (Reuters) (AMF) (Report)
• BeiGene lung cancer treatment meets main goal in late-stage study (Reuters) (Endpoints) (Press)
• Celltrion blueprints $514M China plant, beefing up biosimilar, contract manufacturing (Endpoints)
• Chi-Med stops pivotal pancreatic cancer trial upon early success (Fierce) (Press)
• Pfizer Rolls Out Japan’s Second Rituxan Biosimilar (PharmaJapan)
• Novartis gets EU approval for multiple sclerosis therapy Mayzent (PMLive) (Press)
• EU clears Roche’s Polivy for certain lymphomas (PharmaTimes) (Press)
• J&J wins another label expansion for Darzalex in Europe (PMLive) (Press)
• Janssen’s ulcerative colitis medicine not recommended by NICE for use in adults (Pharmafile)
• Jazz Pharma's Sunosi becomes first EU-approved drug of its kind in narcolepsy and sleep apnoea (Pharmafile)
• War in the Blood: A Cure for Cancer? (BBC)

• The FDA Just Expanded Access to MDMA as a Therapy for PTSD (Vice)
• Scientists in race to protect humanity from future pandemics (Financial Times)
• Immune discovery 'may treat all cancer' (BBC) (Nature Immunology)
• A Year Ago, An Israeli Research Group Said They Would Cure Cancer Within A Year. Did They Do It? (Forbes)
• The wizard men curing breast cancer (For Better Science)
• LabCorp's CRO unit Covance doubles down on cell, gene therapy offerings (Fierce)
• GlaxoSmithKline halts Excedrin production over manufacturing stumble (Fierce)
• Excipients: Compliance with Compendial and GMP Requirements (IPEC)
• Are survival benefits keeping up with rising cancer drug costs? (Healthcare Economist)
• Pharma Says Price Regulation Will Take Life-Saving Drugs Away From Us, But Here’s The Truth (Forbes)
• Mapping the path to gene therapy 2.0 (BioCentury)
• Boehringer, Novo-backed German biotech banks €11M in liver regeneration push (Endpoints)
• Immuno-oncology, personalised medicine continues to drive pharma sector (PMLive)
• Neuroscience Challenges Oncology For Top Spot In CDER’s 2019 Novel Approvals (Pink Sheet-$)
• Novo Executive Calls For ‘Real AMR Action’ In Davos (Scrip-$)
• Aerie Pharmaceuticals Announces FDA Approval of its Athlone, Ireland Facility for Production of Rocklatan (Press)

• Genprex Receives FDA Fast Track Designation for Gene Therapy that Targets Lung Cancer (Press)
• OBI Pharma Granted FDA Orphan Drug Designation for the Treatment of Gastric Cancer for Its Antibody-Drug Conjugate (ADC) Targeted Cancer Therapy, OBI-999 (Press)
• FDA Accepts Evoke Pharma’s NDA Resubmission for Gimoti™ (Press)
• FDA Accepts Regulatory Submission of Supplemental New Drug Application for LYNPARZA® (olaparib) in HRR-Mutated Metastatic Castration-Resistant Prostate Cancer and Grants Priority Review (Press)
• Cyclerion drug's 4-pronged cracking of neurodegenerative diseases passes early test (Fierce)
• Aldeyra Therapeutics Announces First Patient Enrolled in the Phase 3 INVIGORATE Trial in Allergic Conjunctivitis (Press)
• First human clinical trial to study cannabinol initiated (EPR)
• Anokion Announces FDA Clearance of IND Application for its Lead Program in Celiac Disease (Press)

• Dexcom talks up Type 2 market, Medtronic says it has 'work to do' in diabetes at JPM (MedtechDive)
• UK health authority 'proactively' monitoring breast implant illness reports (MedtechDive)
• Getinge issues urgent field safety notice for 88-series (MassDevice)
• Axonics® Announces FDA Approval of Enhanced Neurostimulator Programmer (Press)
• AIROS Medical Granted FDA 510k Clearance to Market Compression Device for Lymphedema Treatment (Press)
• Ra Medical Systems Receives FDA IDE Approval to Begin Pivotal Atherectomy Clinical Study (Press)

• How much is Trump to blame for Trump's bad health care polling? (Politico)
• Bernie Sanders goes after BioMarin CEO JJ Bienaimé on his shot at a record drug price, threatening to break his patent (Endpoints)
• The US Health Care System Is Ill and Needs a Bold New Prescription (Annals of Internal Medicine)
• The Supreme Court's Latest Ruling on Drug Liability and its Implications for Future Failure-to-Warn Litigation (The Journal of Law, Medicine & Ethics)
• New Jersey Gives PMA Medical Device Case the Cold Shoulder (Drug & Device Law)
• Final reg reduces numbers of biopharma companies subject to CFIUS reviews (BioCentury)
• Francis Collins’ 2020 vision for NIH (BioCentury)
• Feds allow use of opioid funds to stem meth, cocaine surge (CBS)

• FDA Advisory Committee Calendar

• Will MDR Delays Create Roadblocks for Companion Diagnostics Regulation? (Medtech Insight-$)
• Shutdown of European Pharmacopoeia 9th Edition (Council of Europe)
• Letter of Announcement - Retirement of the OBP Interface 2016 schema (EMVO)
• MEB Citrix systems switched off (MEB)
• EU Countries Test Offering Simultaneous Scientific Advice (Pink Sheet-$)
• Export drugs and medicines: special rules (MHRA)
• EU-Vietnam free trade deal gets green light in trade committee (Europarl)

• India Rare Disease Policy Proposes Crowdfunding But Patients Feel Let Down (Pink Sheet-$)
• India’s Hilleman Plans ‘Affordable’ Vaccine Against Group B Strep (Scrip-$)
• DoP to create Pharma Bureau to facilitate ease of doing business in India through single window clearance (Pharmabiz)
• CDSCO declares 49 samples as NSQ and 1,286 samples as SQ in random sampling for December 2019 (Pharmabiz)

• Australian Fees To Rise As Drug Registrations Decline (Pink Sheet-$)

• WHO Emergency Committee on coronavirus to meet on Wednesday (Reuters)
• WHO expects further spread of new coronavirus in China (Reuters)
• China's national health commission to hold briefing on coronavirus Wednesday (Reuters)
• China mystery virus claims sixth victim as holiday travel stokes risk (Reuters)
• China's Chongqing city confirms five cases of new coronavirus (Reuters)
• Australia to screen some China flights, warns new virus difficult to stop (Reuters)
• Russia steps up airport screening of Chinese travelers over coronavirus fears (Reuters)
• North Korea to suspend foreign tourism over coronavirus fears: tour company (Reuters)
• Philippines investigates suspected case of Chinese virus (Reuters)

• ICU death rate higher in hospitals primarily serving minorities (Reuters)