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

• 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)

• At BSI's full-day EU Medical Device Roadshow, learn the challenges in meeting European CE-marking regulatory and compliance expectations for the new MDR/IVDR requirements. BSI will be sharing our current experiences, best practice and expectations from the perspective of the first notified body designated under the MDR (EU 2017/745).

• 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)

• 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)

• 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)

• 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)

• 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)

• FDA Advisory Committee Calendar
• Regulatory Education for Industry: 2019 Complex Generic Drug Product Development Workshop –  25-26 September 2019
• Webinar - Marketing Clearance of Diagnostic Ultrasound Systems and Transducers: Final Guidance - 22 August 2019

• 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)

• Pharma wants a booster fund to push innovation (Economic Times)

• Advertising directions notices (TGA)

• AI Algorithms Need FDA-Style Drug Trials (Wired)
• Virtual reality experiences can help ease severe pain (Reuters)