Recon: Sanofi and Regeneron Cut Price of Praluent by 60%

• Sanofi and Regeneron cut list price of cholesterol drug by 60 percent (Reuters) (STAT) (Endpoints) (Press)
• J&J’s nasal antidepressant heads for FDA panel (Fierce) (BioPharmaDive)
• PhRMA asks the US trade rep to place added pressure on four countries over patent and pricing policies (STAT) (PhRMA)
• An early study ‘infuses hope’ back into attempts to use immunotherapy to treat brain cancer (STAT)
• 24-Hour Flu Pill May Not Be Miracle Drug Doctors Thought (WSJ)
• An ambassador to the Vatican. A GOP megadonor. And now, a rare Republican joining Democrats to take on pharma (STAT)
• University of California to be granted long-sought CRISPR patent, possibly reviving dispute with the Broad Institute (STAT)
• AstraZeneca CEO Soriot is overseeing a top exec team overhaul in move to integrate MedImmune in a sweeping restructuring (Endpoints)
• Top 20 biotech deals: 2019 dealmaking gets off to a roaring start, building on a record amount for ’18 (Endpoints)
• Prepare for grilling: 7 questions for 7 pharma execs who’ll testify before Congress about prices (STAT)
• Humana executives say Trump's drug rebate proposal would raise premiums, restrict consumer choice (CNBC)
• American Travelers Seek Cheaper Prescription Drugs In Mexico And Beyond (NPR)
• $62B Bayer-Monsanto Deal Gets Final DoJ OK Despite Pushback (Law360-$)
• How HHS is navigating the minefield facing HIV plan (Politico)
• FDA Targets Products Falsely Claiming to Treat Alzheimer’s Disease (Focus)

• French authorities call for ban of Allergan textured breast implants (NBC)
• Canaan leaps into UK biotech by co-leading $14M Series A for immuno-oncology upstart Grey Wolf (Endpoints)
• UK Could Be Kicked Out Of Newly Launched Pharma Tech Security System Because Of Brexit (Forbes)
• ABPI warns of greater exposure to fake meds under no-deal Brexit (PharmaTimes) (ABPI)
• EC OKs expanded use for Bristol-Myers' Sprycel (Seeking Alpha) (Press)
• Seattle Genetics Achieves $30 Million Milestone Payment for European Commission Approval of Adcetris (Press)
• Outrage as cystic fibrosis drug firm posts big profit (The Guardian)
• UCB teams up with charity to beat treatment-resistant epilepsy in $2.5m partnership (Pharmafile)
• Patent Rebuff For Roche’s Valcyte In India, Again (SCRIP-$)
• Samsung Bioepis links up on next-generation biosimilars in China (PharmaLetter-$)
• Aurobindo acquires Apotex's operations in 5 European countries (Economic Times)

• Pharmaceutical market growth set to slow? (Nature)
• CureVac walks away from Arcturus’ urea cycle disorder drug, but partnership remains intact (Endpoints) (Fierce)
• Digital Therapeutics Need Quality Standards (Forbes)
• TimesUS drugs pricing: jagged little pill (Financial Times)
• How To Demand A Medical Breakthrough: Lessons From The AIDS Fight (NPR)
• Seattle Genetics Down On Light 2019 Adcetris Sales Guidance (BioCentury)
• Opioid prescriptions for pets surge, mirroring human crisis (Reuters)
• Tailored Cancer Drugs from New Cell Receptor Insights (GEN)
• Uncoupling resistance to cancer immunotherapy (Nature)
• A ‘Fountain Of Youth’ Pill? Sure, If You’re A Mouse. (KHN)
• Giving Medicine To Young Children? Getting The Dose Right Is Tricky (NPR)
• Immunomedics, still searching for first approval, discloses forthcoming FDA re-inspection (BioPharmaDive)
• FDA's Real World Study on Adoption of PD-1 Dosing Change Aims to Inform Reviewers (Pink Sheet-$)
• Lyme Disease Vaccine Pushes Valneva To US Listing (SCRIP-$)
• A New Treatment for a Painful Penis Curvature (NYTimes)
• An Audience With Hal Barron (Nature)
• ‘One-and-done’ for new drugs could cut patent thickets and boost generic competition (STAT)
• A Man On A Mission: How One Patient Journey Can Change The Course Of A Hereditary Cancer (Forbes)
• AbbVie jumps into the frenzied race for a BCMA/CD3 bispecific targeting multiple myeloma. Teneobio who? (Endpoints)
• David Schenkein gets his third act in biotech, joining Google’s GV to co-lead life sciences group (Endpoints)
• Solidifying a new corporate structure, IFM launches second unit focused on cGAS-STING (Endpoints)
• Helping Patients Navigate Cancer With The Power And Simplicity of Waze (Forbes)
• The rise of virtual pharma (PharmaTimes)
• HDA Makes A Strong Case For ‘Reframing’ Of FDA’s Draft Guidance On DSCSA Verification Systems (RxTrace)
• FDA Recruiting for Director, Division of Epidemiology - Title 38(F) Supervisory Physician (FDA)
• Quantitation of AAV-Based Gene Therapy Products (FDA)

• FDA promises speedy review on moving Merck’s Keytruda up as first-line head and neck cancer therapy (Endpoints) (Press)
• Regeneron touts one-year diabetic retinopathy data for Eylea (Drug Delivery) (Press)
• Bridge Biotherapeutics Presented Preclinical and Phase I Study Results for BBT-401 at the Crohn's & Colitis Congress (Press)
• Novus Therapeutics Doses First Subjects in Phase 1 Pharmacodynamics Study of OP0201 (Press)
• Alpine Immune Sciences Announces First Subjects Dosed in Phase I Clinical Trial for Lead Autoimmune/Inflammatory Disease Program ALPN-101 (Press)
• Precigen Announces Clearance of IND to Initiate Phase 1 Study for First-in-Class PRGN-3005 UltraCAR-T™ to Treat Advanced Stage Platinum Resistant Ovarian Cancer Patients (Press)
• Concert Pharmaceuticals Selected for Late-Breaking Oral Presentation of CTP-543 Phase 2 Data in Alopecia Areata at 2019 AAD Annual Meeting (Press)
• NuvOx Pharma’s NVX-208 Shows Positive Results in Phase Ib/II Stroke Trial (Press)

• Report: Smith & Nephew eyeing $3B NuVasive acquisition (MassDevice)
• Nuvaira raises $79m to support COPD device (MassDevice)
• Exemptions for Unclassified Devices: CDRH Updates Guidance (Focus)
• Synopsys Launches Simpleware ScanIP Medical with CE Marking and FDA 510(k) Clearance (Press)

• AAM to Congress: Reject 2019 Hatch-Waxman bill (DSN)
• Failing to Disclose Foreign Influence: NIH Seeks OIG Help (Focus)
• False Lead: Senator’s Offer To Help Patient Import Cheap Insulin Goes Nowhere (KHN)
• Hospital Mergers Improve Health? Evidence Shows the Opposite (NYTimes)
• Medicare patients face surging costs for some life-saving drugs (CBS)
• Washington lawmakers weigh vaccine bill amid outbreak (NBC)
• In Medicare For All Battle, Insurers Tout Democratic Allies (Forbes)
• J&J Unit Dodges Suit Over Gastric Band Device Death (Law360-$)
• USPTO's Take On Reused PTAB Positions May Upend Strategy (Law360-$)
• Drugmaker Avadel Gets Boost From Parent In Del. Ch. 11 (Law360-$)
• Mumps In Houston ICE Facility: Another Vaccine Preventable Disease To Worry About (Forbes)
• House Bill Would Allow HHS Secretary to Authorize Competitive Licenses for Drug Patents (Patent Docs)
• Innovator Liability – Pandemonium Or Paper Tiger? (Drug & Device Law)
• FDA chief accuses Juul, Altria of reneging on promise to combat 'epidemic' teen vaping use (CNBC)

• FDA Advisory Committee Calendar
• 22nd US-Japan Cellular and Gene Therapy Conference – 7 March 2019
• Hearing: Managing Pain During the Opioid Crisis – 12 February 2019
• Hearing: The Cost Of Rising Prescription Drug Prices – 12 February 2019

• Medical devices: information for users and patients (MHRA)
• Professor Dame Sally Davies to step down as chief medical officer (PharmaTimes)
• 33% of antibiotics prescribed by NHS are given without associated diagnosis, England's Chief Medical Officer warns (Phamafile)
• Medicines and Healthcare products Regulatory Agency Privacy Notice (MHRA)
• Following FMD rulings using a ‘pragmatic’ approach (EPR)

• Two TB survivors fight Johnson & Johnson monopoly bid (Economic Times)
• Glenmark Pharma gets USFDA nod for drug for patients on dialysis (Economic Times)
• CDSCO reaches consensus to roll out medical devices regulations in phased manner (PharmaBiz)
• Pharma SMEs seek rollback of mandatory submission of stability test for drug approval (PharmaBiz)

• Australia Updates GMP Guidance On Product Release (Pink Sheet-$)
• Australia Wants to Improve Generic Drug Authorizations (FDANews-$)

• More than 26 million people have taken an at-home ancestry test (MIT Technology Review)
• Fitbit has a new health tracker, but you can only get it through your employer or insurer (CNBC)
• Former Rep. John Dingell Left An Enduring Health Care Legacy (NPR)