Regulatory Focus™ > News Articles > 2019 > 8 > Recon: Affordability Questions Follow New TB Approval; Sanofi Handed Win in Jevtana Patent Suit

Recon: Affordability Questions Follow New TB Approval; Sanofi Handed Win in Jevtana Patent Suit

Posted 15 August 2019 | By Michael Mezher 

Recon: Affordability Questions Follow New TB Approval; Sanofi Handed Win in Jevtana Patent Suit

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • FDA approves TB pill that cures more hard-to-treat patients (AP) (Reuters) (NYTimes) (FDA)
  • Nonprofit under pressure to make new TB drug affordable (BioPharmaDive) (MSF)
  • The Creation Of Biotech Startups: Evolution Not Revolution (LifeSciVC)
  • Compass Therapeutics and these three other biotech startups got venture funding a year ago. Where are they now? (STAT)
  • Sanofi defends top oncology drug with Jevtana patent win (Fierce) (Law360-$)
  • As Sarepta awaits approval of new Duchenne drug, questions hang over Exondys 51 (STAT)
  • Regeneron puts finishing touches on $800M expansion project close to home (Endpoints)
  • Ultragenyx snags option on antisense startup GeneTx (Fierce) (Endpoints)
  • Hearing industry calls Bose self-fit hearing aid study flawed in complaint to FDA (MedtechDive)
  • The Challenges of Home Dialysis (NYTimes)
Sponsored Content: Hear from the first Notified Body designated to the new EU-MDR In Focus: International
  • Brexit's Disruptive Impact On UK And European Prescription Drug Market (Forbes)
  • Teva shares approach 20-year low amid Moody’s warning and other woes (Fierce)
  • A battle over verifying online Canadian pharmacies goes to court (STAT)
  • China has become a CEO-level priority for multinational pharmaceutical companies: the trend and the implications (Endpoints)
  • EC Designates Third Notified Body Under MDR (Focus)
  • Pharming deal shows there's still life in struggling cancer drug class (BioPharmaDive)
  • Burundi starts Ebola vaccines for health workers: WHO (Reuters)
  • Mexico's top court demands regulation on medical marijuana after long delays (Reuters)
  • Why Sun Pharma’s healthy Q1 results failed to impress investors (LiveMint)
Pharmaceuticals & Biotechnology
  • Temple Wants US FDA To Consider Including PK/PD In Labels To Inform Dosing (Pink Sheet-$)
  • Insulins as Drugs or Biologics in the USA: What Diference Does it Make and Why Does it Matter? (BioDrugs)
  • ‘Fraud in the Lab’ Review: Experiments in Doubt (WSJ)
  • Do You Need All Those Meds? How To Talk To Your Doctor About Cutting Back (NPR)
  • Purdue Pharma sought to divert online readers from critical L.A. Times series on opioid crisis, records show (LA Times)
  • Three Issues That Plague the Drug Pricing System — and the Evidence That Can Shape Solutions (Arnold Ventures)
  • FDA Adds New Q&As to Lab Controls Section of CGMP Guidance (Focus)
  • FDA’s OCE Taps Syapse for Research on RWE (Focus)
  • Cannabidiol confusion: lofty promises and barriers to research (STAT)
  • FDA cites solvent recovery firm as a player in the valsartan mess (Fierce)
  • Osteoporosis: FDA Finalizes Nonclinical Development Guidance (Focus)
  • Opioid Prescribing Guidelines Are Slowing The Flow Of Pills — But Progress Is Slow (NPR)
  • Columbia scientist-CEO accused of improperly using confidential info from unicorn Alector (Endpoints)
  • Harmony Biosciences Announces FDA Approval Of WAKIX® (Pitolisant), A First-In-Class Medication For The Treatment Of Excessive Daytime Sleepiness In Adult Patients With Narcolepsy (Press)
  • Ailing Mallinckrodt's drug for rare, life-threatening renal condition clears pivotal study (Endpoints)
  • A PARP successor? Michigan academic team touts potential of an aging — but still experimental — AstraZeneca drug in DNA damage repair (Endpoints)
  • MacroGenics vs Merck: An underdog plans a premier bout with the heavyweight champion of the PD-1 class (Endpoints)
  • Y-mAbs ramps up head count in post-IPO hiring spree (Fierce)
  • Treating glioblastoma with a Ziopharm drug and IL-12 gene therapy (Fierce)
  • Pfizer Inc. Issues a Voluntary Nationwide Recall for 2 Lots of RELPAX® (eletriptan hydrobromide) 40 mg Tablets Due to Potential Microbiological Contamination of Non-Sterile Products (FDA)
Pharmaceutical & Biotechnology: Study Results, Filings & Designations
  • AstraZeneca drug heads to phase 2 in pancreatic cancer after small trial extends survival (Fierce)
  • Trovagene to Present New Data from Onvansertib Phase 2 Study in Metastatic Castration-Resistant Prostate Cancer at Asia-Pacific Prostate Cancer Conference (Press)
Medical Devices
  • V-Wave wins breakthrough nod for heart failure device (MassDevice)
  • Medtronic readies device to rival Intuitive Surgical’s da Vinci SP (MassDevice)
  • Abiomed wins extended Medicare coverage for Impella (MassDevice)
  • Is Software the 'Weak Link' in Medical Device Safety? (MDDI)
US: Assorted & Government
  • FDA Issues New Images to Add to Warnings on Cigarette Packages (NYTimes) (FDA)
  • The Outlook On Drug Pricing And Surprise Billing In Congress (Law360-$)
  • Beyond The "Blueprint": The Next Stage For US HHS Drug Price Policy (Pink Sheet-$)
  • Senators Call for Closing “Loopholes” That Make Health Care Fraud Easy (ProPublica)
  • HHS pushes back on Planned Parenthood threat (Politico)
  • New York Subpoenas Banks, Financial Advisers for Sackler Records (NYTimes)
  • Maker Of Defibrillator Vest To Face Trial In Suit Over Death (Law360-$)
  • Dozens of Young People Hospitalized for Breathing and Lung Problems After Vaping (NYTimes)
  • Most Kids On Medicaid Who Are Prescribed ADHD Drugs Don't Get Proper Follow-Up (NPR)
  • Allegations of Using Medicaid Coding to Maximize Medicaid Reimbursement Do Not State a Claim for Violation of the False Claims Act (Drug & Device Law)
  • CMS Proposes Regulations to Expand Sunshine Reporting (FDA Law Blog)
Upcoming Meetings & Events Europe
  • Fears of public health emergency as drug deaths hit record levels (The Guardian)
  • Assistive technology: definitions, examples and safe use (MHRA)
  • Early access to medicines scheme: expired scientific opinions (MHRA)
India Australia
  • Advertising directions notices (TGA)
General Health & Other Interesting Articles
  • AI Algorithms Need FDA-Style Drug Trials (Wired)
  • Virtual reality experiences can help ease severe pain (Reuters)
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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