Regulatory Focus™ > News Articles > 2019 > 2 > Recon: Sanofi and Regeneron Cut Price of Praluent by 60%

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

Posted 11 February 2019 | By Michael Mezher 

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

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • 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)
In Focus: International
  • 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-$)
  • Aurobindo acquires Apotex's operations in 5 European countries (Economic Times)
Pharmaceuticals & Biotechnology
  • Pharmaceutical market growth set to slow? (Nature)
  • CureVac walks away from Arcturus’ urea cycle disorder drug, but partnership remains intact (Endpoints) (Fierce)
  • Digital Therapeutics Need Quality Standards (Forbes)
  • TimesUS drugs pricing: jagged little pill (Financial Times)
  • How To Demand A Medical Breakthrough: Lessons From The AIDS Fight (NPR)
  • Seattle Genetics Down On Light 2019 Adcetris Sales Guidance (BioCentury)
  • Opioid prescriptions for pets surge, mirroring human crisis (Reuters)
  • Tailored Cancer Drugs from New Cell Receptor Insights (GEN)
  • Uncoupling resistance to cancer immunotherapy (Nature)
  • A ‘Fountain Of Youth’ Pill? Sure, If You’re A Mouse. (KHN)
  • Giving Medicine To Young Children? Getting The Dose Right Is Tricky (NPR)
  • Immunomedics, still searching for first approval, discloses forthcoming FDA re-inspection (BioPharmaDive)
  • FDA's Real World Study on Adoption of PD-1 Dosing Change Aims to Inform Reviewers (Pink Sheet-$)
  • 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)
Pharmaceuticals & Biotechnology: Study Results, Filings & Designations
  • 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)
Medical Devices
  • Report: Smith & Nephew eyeing $3B NuVasive acquisition (MassDevice)
  • Nuvaira raises $79m to support COPD device (MassDevice)
  • Exemptions for Unclassified Devices: CDRH Updates Guidance (Focus)
  • Synopsys Launches Simpleware ScanIP Medical with CE Marking and FDA 510(k) Clearance (Press)
US: Assorted & Government
  • AAM to Congress: Reject 2019 Hatch-Waxman bill (DSN)
  • Failing to Disclose Foreign Influence: NIH Seeks OIG Help (Focus)
  • False Lead: Senator’s Offer To Help Patient Import Cheap Insulin Goes Nowhere (KHN)
  • Hospital Mergers Improve Health? Evidence Shows the Opposite (NYTimes)
  • Medicare patients face surging costs for some life-saving drugs (CBS)
  • Washington lawmakers weigh vaccine bill amid outbreak (NBC)
  • In Medicare For All Battle, Insurers Tout Democratic Allies (Forbes)
  • J&J Unit Dodges Suit Over Gastric Band Device Death (Law360-$)
  • 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)
Upcoming Meetings & Events Europe
  • 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)
India
  • 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
  • Australia Updates GMP Guidance On Product Release (Pink Sheet-$)
  • Australia Wants to Improve Generic Drug Authorizations (FDANews-$)
General Health & Other Interesting Articles
  • 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)
Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe. Each weekday morning, we aim to bring you the latest highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the latest trends with the potential to impact regulatory affairs professionals and the industry in which they work.
 
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