Recon: Drugmakers Kick Off 2019 With Hundreds of Price Increases

• Drugmakers Raise Prices on Hundreds of Medicines (WSJ) (NBC)
• Upcoming market catalysts in Q1 2019 (Nature)
• How PhRMA finally lost: the inside story of the group’s biggest lobbying failure in years (STAT)
• On the cusp of the ‘JPM,’ here’s a cheat sheet for what to watch in biotech in 2019 (STAT)
• What's ahead in health policy in 2019 (Politico)
• The 2018 breakdown on a chart-topping set of new drug approvals — and the 5 big things we learned from it (Endpoints)
• Pharma's 2019 Prognosis Hinges on These Key Themes (Bloomberg)
• How Sen. Orrin Hatch Changed America’s Health Care (KHN)
• House Democrats set up framework to intervene in federal court case striking down Obamacare (CNBC)
• Portola boosted by FDA nod for new Andexxa manufacturing (BioPharmaDive)
• BioWorld’s Top 10: Biggest newsmakers and trending stories of 2018 (BioWorld)
• Memorial Sloan Kettering’s Season of Turmoil (NYTimes)
• Pfizer, Merck shares smoking hot in 2018 despite doldrums for overall biopharma sector (Fierce)
• Pharma finds its feet in fight against climate change (Financial Times)
• At the end of a bumper year for approvals, FDA hit by government shutdown (Fierce)
• Sanofi's pediatric hexavalent vaccine approved by U.S. FDA (Reuters) (Press)
• U.S. medic quarantined in Nebraska for possible Ebola exposure (Reuters)

• Selling Drugs Is No Longer a Free Lunch in China (Bloomberg)
• Pharma firms face shake-up with China’s plan to bulk-buy drugs (SCMP)
• Celgene invests in Chinese biotech Antengene again (Fierce)
• Chinese Gene-Editing Experiment Loses Track of Patients, Alarming Technology’s Inventors (WSJ)
• China's Innovent Biologics Emerges As Immuno-Oncology Competitor With Sintilimab Approval (Scrip-$)
• After 4 years, it’s a no from Sanofi as it punts MyoKardia drug program deal (Fierce)
• Falling vaccination rates pose a global health risk (Financial Times)
• Longevity drugs: about time (Financial Times)
• Pharma’s confidence in Brexit deal falls as vote looms (PMLive)
• NHS to fund Afinitor for TSC-related epilepsy (PharmaTimes)
• NHS England to fund Actelion's Uptravi (PharmaTimes)
• Ebola outbreak in Congo surpasses 600 cases amid more violence (CNN) (Reuters)

• Did Moderna break the biotech IPO market? (Endpoints)
• Biomedical Research Highlighted in Science’s 2018 Breakthroughs (NIH)
• Orphan drugs dominate FDA's record-breaking year (PMLive)
• U.S. drug developer Capricor places Duchenne drug trial on hold (Reuters)
• Atlas Venture raises $250M for later-stage investments (Fierce)
• Boom: 2018's biotech IPOs (Nature)
• Targeting transcription factors (Nature)
• Harpoon files $86M IPO to help fund its T-cell engager platform (Fierce)
• Deciphera expands cancer trial after seeing early data (Fierce)
• The Luxturna Debate: Why Ethics Needs a Seat at the Drug Pricing Table (Harvard Bill of Health)
• Rapidly taking patients off opioids might not be a good idea, experts say (Reuters)
• FDA: Immune Tx Monotherapy in Bladder Ca May Worsen Survival (Medpage)
• Impact of FDA's Warning on Immunotherapy in Urothelial Ca (Medpage)
• Cipla recalls 4,800 bottles of anti-HIV tablets from US (Economic Times)
• Doctors still prescribing testosterone to men with heart disease, despite risks (Reuters)
• Federal proposal to force drug prices in TV ads draws big response from pharma, others (Fierce)
• Battered Acorda pulls off delayed Parkinson’s approval for Inbrija (Fierce)
• Pfizer, Merck KGaA's Bavencio takes a hit with second ovarian cancer failure (Fierce)
• FDA gifts Alexion quick OK for Soliris follow-up Ultomiris (Fierce)
• Product-Specific Guidance for Linaclotide; Draft Guidance for Industry; Availability (FDA)
• FDA accepts acer, kala ndas before funding lapse (BioCentury)
• Aurobindo Pharma USA recalls 80 lots of blood pressure drug from America (Economic Times) (FDA)
• Determination of Regulatory Review Period for Purposes of Patent Extension; PARSABIV (FDA)
• Determination of Regulatory Review Period for Purposes of Patent Extension; RYDAPT (FDA)
• International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Stability Testing of New Veterinary Drug Substances and Medicinal Products in Climatic Zones III and IV; Draft Guidance for Industry; Availability (FDA)

• Banner Receives FDA Tentative Approval for BAFIERTAM for the Treatment of Relapsing Forms of Multiple Sclerosis (Press)
• FDA Grants Priority Review Designation for Heron Therapeutics' NDA for HTX-011, a Non-Opioid for Postoperative Pain Management (Press)
• Myonexus Therapeutics Receives Orphan Drug Designation for MYO-102, an Investigational Gene Therapy for Alpha-sarcoglycanopathy (LGMD2D) (Press)
• Harpoon Therapeutics Announces Preliminary Safety and Pharmacology Data from its HPN424 Phase 1 Trial in Prostate Cancer (Press)
• Deciphera Pharmaceuticals Announces Positive, Preliminary, Top-Line Clinical Data for the Ongoing Phase 1 Clinical Study with DCC-3014 and an Update on Future Development Plans (Press)
• Intec Pharma Advances Medical Cannabinoid Development Program With Dosing of First Patient in a Phase 1 Pharmacokinetic Study of Accordion Pill-THC (Press)
• Innovent Announces First Patient Dosed in a Phase III Clinical Trial of Anti-PD-1 Antibody Tyvyt® (Sintilimab injection) as First-line Treatment for Patients with Advanced Esophageal Cancer (Press)

• FDA's Changes to Essure Postmarket Study: Too Little, Too Late? (Medpage)
• FDA Approves Next-Gen TAVR Device (Medpage)
• Class 1 Device Recall StealthStationTM Cranial and SynergyTM Cranial Depth Gauge (FDA)
• Personalized Medicine 2018: More Drugs, Greater NGS Adoption, Growing Appreciation of Dx Value (GenomeWeb)
• GenMark Fungal Blood Culture Test Clears FDA (GenomeWeb)
• FDA approves Teva’s digital COPD, asthma inhaler (DrugDelivery)
• BrainScope Receives FDA Clearance for Multi-Modal, Multi-Parameter Concussion Assessment (Press)

• Life Sciences Cases To Watch In 2019 (Law360-$)
• Patent Cases To Watch In 2019 (Law360-$)
• Health Care Cases To Watch In 2019 (Law360-$)
• Opioid-Makers Face Wave of Lawsuits in 2019 (NPR)
• Ex-CEO of Insys to plead guilty in major opioid case (NBC)
• Sun Pharma arm gets relief from US court in patent infringement case (Economic Times)
• Hoosier Daddy, Part 510(k): FDA Clearance is Admissible (Drug & Device Law)
• The DOJ Lashes Out at Qui Tam Abuse (Drug & Device Law)
• Federal Court Invalidates CMS’ Reduction of Medicare Hospital Outpatient Payment Rates for 340B Drugs (FDA Law Blog)

• FDA Advisory Committee Calendar

• Early access to Tecentriq combination granted through EAMS (PharmaTimes) (MHRA)
• Conversion of existing approved Community Marketing Authorisations to UK Marketing Authorisations (MAs) – letter to industry and guidance (MHRA)

• Foundation Medicine Cancer CDx Approved in Japan (GenomeWeb)
• China regulator probes TCM firm after cancer case sparks online furor (Reuters)

• Government may revise compensation formula for 'faulty' Johnson & Johnson hip implant patients (Economic Times)
• Suven Life gets product patents from Brazil, Eurasia (Economic Times)
• Shilpa Medicare gets USFDA nod for cancer treatment injection (Economic Times)
• Dr Reddy's launches oral suspension drug in the US market (Economic Times)
• French inspectors find issues at Indian plant cited earlier by Italy (Fierce)
• CDSCO to introduce rigorous quality control measures to boost quality of generic drugs (PharmaBiz)

• Advertising: Questions and answers on the Advertising Code (TGA)
• Medicine shortages guidance and resources (TGA)