Recon: Novartis Plans Lottery for Free Zolgensma Treatments; FDA Approves Astellas, Seattle Genetics' Padcev for Advanced Urothelial Cancer

• FDA grants accelerated approval to Astellas, Seattle Genetics' Padcev (Reuters) (Endpoints) (Press)
• Grassley says McConnell sabotaged support for his drug pricing bill (CNBC)
• 4 reasons why Trump’s drug importation bill won’t work (Politico)
• North America trade pact deals rare setback to Big Pharma (AP)
• National Academies outlines opioid guidelines, aiming to make approach to prescribing more consistent (STAT) (FDA) (NASEM)
• Epizyme's sarcoma drug sails through FDA panel with unanimous vote (Fierce) (Endpoints) (Press)
• Jazz rolls the dice on a billion-dollar gamble on a SCLC drug, shooting for 2020 launch (Endpoints) (BioPharmaDive)
• Boston Scientific Can't Nix $275M Merger With Device Maker (Law360-$) (MedtechDive)
• Ra Pharma's $2.1B Sale Hits Merger Review Snag At FTC (Law360-$)

• Novartis plans to give away world's costliest therapy to some patients (Reuters) (STAT) (WSJ)
• Ultragenyx sells European royalty stake in rare disease drug for $320M (BioPharmaDive)
• Takeda puts $120M in near-term cash on the table to complete a new oncology platform deal (Endpoints) (Fierce) (Press)
• Fujifilm to acquire Hitachi's diagnostic imaging arm for $1.63B (MedtechDive) (Nikkei)
• Scotland gives Roche’s haemophilia A drug the go-ahead (PharmaTimes)
• AbbVie’s JAK inhibitor Rinvoq approved in EU for rheumatoid arthritis (PMLive)
• Roche’s Kadcyla cleared in Europe for certain breast cancers (PharmaTimes) (Press)
• EMA backs adjuvant use of Roche’s breast cancer ADC Kadcyla (PMLive)
• EU Clears Danaher $21B GE Biopharma Buy With Divestitures (Law360-$)

• FDA warns about serious breathing problems with seizure and nerve pain medicines gabapentin (Neurontin, Gralise, Horizant) and pregabalin (Lyrica, Lyrica CR) (FDA)
• Ring Therapeutics is developing a new way to deliver gene therapy (STAT) (Endpoints)
• Biogen, Novartis go different ways on Ionis therapies (BioPharmaDive) (Endpoints)
• AstraZeneca lupus drug shows potential, but it may not be enough for FDA (BioPharmaDive)
• Stephen Hahn Should Focus On Stability In First Days As US FDA Commissioner, Stakeholders Say (Pink Sheet-$)
• Waning treatment for immune deficiency is a warning for all ‘one-and-done’ therapies (STAT)
• Manufacturing: the next breakthrough in gene therapy (STAT)
• HP&M Attorney Co-Authors Nature Reviews Article with NIH, FDA, and EMA on the Progress and Challenges of Drug Development for Rare Diseases (FDA Law Blog) (Nature)
• Don’t Let Trade Issues Interfere With Drug Inspection Coordination, Experts Say (Pink Sheet-$)
• Pharma's gene and cell therapy ambitions will kick into high gear in 2020—despite some major hurdles (Fierce)
• Rheos pens Roche collab for next-gen immunometabolism research (Fierce)
• Generics Modernization Effort At US FDA Receives Full Funding Over Two Years (Pink Sheet-$)
• Considerations for the Development of Dried Plasma Products Intended for Transfusion; Guidance for Industry (FDA)
• Research pact between Syros Pharma, Global Blood seeks new drugs to treat sickle cell disease (STAT)
• Experimental vaccine patch embeds invisible dots under the skin, leaving record of immunization (STAT)
• Oxford Biomedica extends lentiviral deal with Swiss giant (PharmaLetter-$)
• Deerfield adds Duke to its roster of college partners, kicking off a $130M discovery alliance (Endpoints)
• Harvard taps Tishman Speyer to manage first phase of its new 36-acre research campus — and biotechs can't wait (Endpoints)
• Another depression trial goes bust, as Minerva drug fails PhII study (Endpoints)
• Joinn Biologics nabs $60M to use for biologics capacity (Fierce)
• How Alexion's FcRn inhibitor attacks autoimmune diseases from 2 sides (Fierce)
• Forma Therapeutics bounces back from Celgene fallout with $100 million Series D (Endpoints)
• Ionis licenses investigational Alzheimer's therapy (Press)
• Achillion Shareholders Approve Agreement to be Acquired by Alexion (Press)

• UroGen Pharma Announces FDA Filing Acceptance and Priority Review of U.S. New Drug Application (NDA) for UGN-101 (Press)
• Biosimilar Clinical Trial Updates (Big Molecule Watch)
• Epizyme Submits New Drug Application to the U.S. FDA for Tazemetostat for the Treatment of Patients with Follicular Lymphoma  (Press)
• Bristol-Myers Squibb Announces Submission of Biologics License Application for CAR T-Cell Therapy Lisocabtagene Maraleucel (liso-cel) to FDA (Press)
• Minerva Neurosciences shares crushed under depression flop, development halted (Fierce) (Press)
• U.S. FDA Accepts and Grants Priority Review to sNDA for BRAFTOVI® (encorafenib) in Combination with ERBITUX® (cetuximab) (BRAFTOVI Doublet) for the Treatment of BRAFV600E-Mutant Metastatic Colorectal Cancer After Prior Therapy (Press)
• Embera NeuroTherapeutics Completes Series B Financing and Receives Grants to Advance EMB-001 into Phase 2 Clinical Studies in Cocaine Use Disorder and Smoking Cessation (Press)
• Exelixis Enters into a Clinical Collaboration for Three Phase 3 Combination Trials for Patients with Advanced Solid Tumors (Press)
• Aldeyra Therapeutics Announces First Patient Enrolled in the Phase 3 GUARD Trial for Prevention of Proliferative Vitreoretinopathy (Press)

• AI-based heart failure screening from Eko, Mayo Clinic earns FDA breakthrough nod (MedtechDive)
• Georgia cites BD for warehouse ethylene oxide emissions (MassDevice)
• GE warns on ApexPro telemetry server (MassDevice)
• Neurological Devices: Reclassification of Cranial Electrotherapy Stimulator Devices Intended to Treat Anxiety and/or Insomnia (FDA)
• Interscope announces new FDA Clearance of the EndoRotor®, for use in Airway procedures including in Interventional Pulmonology (Press)

• U.S. appeals court sidesteps major Obamacare ruling (Reuters)
• What the ACA ruling does and doesn't do (Politico)
• Orphan Drug Act’s ‘nonprofitability’ loophole needs to be closed (STAT)
• ONC data reveal safety issues in some EHRs (MedtechDive)
• NIH-directed purge of researchers with China ties sweeps up Moffitt CEO Alan List, colleagues (Endpoints)
• Amgen Inc. v. Hospira, Inc. (Fed. Cir. 2019) (Patent Docs)
• Like Day and Night (Drug & Device Law)
• Feds Want 15 Years For Convicted Insys Founder (Law360-$)
• The Biggest Patent Rulings Of 2019 (Law360-$)
• Allergan Breast Implant Risk MDL Heading To NJ (Law360-$)
• Valeant Urges Fed. Circ. To Revive Lawsuit Over Jublia (Law360-$)
• Medtronic wins dismissal of Pennsylvania couple’s DBS lawsuit (MassDevice)
• Opening Statement of Amanda Liskamm, Director of Opioid Enforcement and Prevention Efforts, Before the Senate Judiciary Committee (DOJ)

• FDA Advisory Committee Calendar

• European Medicines Agency closed 21 December 2019 to 5 January 2020 (EMA)
• Medicines: marketing authorisation holders submission of Nitrosamine risk evaluation (MHRA)
• Valproate use by women and girls (MHRA)
• Arrow EZ-IO intraosseous vascular access needle sets – risk of needle stick injury (MHRA)
• Company led drug alert – Paclitaxel 6 mg/ml concentrate for solution for infusion (25ml vials) (MHRA)
• Police raid German doctors suspected of taking pharma cash (DW)
• E-Cigarette Posts on Instagram Struck Down by U.K. Watchdog (NYTimes)
• New guidance on medical device sampling criteria, Notified Body coding for European MDR, IVDR (Emergo)

• Daiichi Sankyo launches Avastin biosimilar in Japan (PharmaLetter-$)
• AstraZeneca Vietnam obtains license to import pharmaceuticals (Pharmafile)

• Panacea Biotec bags orders worth USD 24 mn from UN agencies (Economic Times)

• Notice: Guidance Document: Software as a Medical Device (SaMD): Definition and Classification (Health Canada)

• TGA operations over the holiday period 2019-20 (TGA)
• Opioid reforms: Information for sponsors (TGA)
• Launch of international pilot programme on inspection of manufacturers of sterile medicines (TGA)
• Therapeutic Goods (Materials or Articles that are Not Medical Devices) Order 2019 (TGA)
• EpiPen investigation outcomes (TGA)

• Some Push To Change State Laws Requiring HIV Disclosure To Sexual Partners (NPR)
• Breast cancer survivors face other health risks after treatment (Reuters)