Recon: NICE Backs Novartis’ Tafinlar/Mekinist Combo for Skin Cancer

• FDA approves Teva migraine drug, shares rise (Reuters) (Endpoints) (Press)
• DOJ grants clearance to Cigna's acquisition of Express Scripts (Press)
• US senators query pharma chief over drug price rise (Financial Times) (Letter)
• Allergan says revenue from aesthetics unit may double by 2025 (Reuters)
• FDA May Start Missing ANDA User Fee Goals – In Order To Speed Approvals (Pink Sheet-$)
• 2nd Ex-GSK Scientist Pleads Guilty In Chinese IP Theft Case (Law360-$)
• Prominent Cancer Researcher Resigns from Dartmouth Amid Plagiarism Charges (NYTimes)
• NEJM doubles down on refusal to retract article Dartmouth says is plagiarized (STAT)
• Medicine’s Financial Contamination (NYTimes)
• Transparency Hasn’t Stopped Drug Companies From Corrupting Medical Research (NYTimes)
• NIH and Children’s National partner to advance pediatric clinical research (NIH)
• Hurricane Maria’s lessons for the drug industry (C&EN)
• FDA clears 1st acute coronary artery perforation stent in 17 years (MassDevice) (FDA)
• CVS To Restrict Patient Access Using Cost-Effectiveness: Too Much, Too Soon (Health Affairs)
• Why CVS Is Giving Plans A New Tool To Target High Launch Prices (Health Affairs)
• New Medicare Advantage Tool To Lower Drug Prices Puts Crimp In Patients’ Choices (KHN)
• Final Judgment Entered Against Hospira for Infringing Amgen’s Epoetin Patent (Big Molecule Watch)

• NICE nod for Novartis’ targeted skin cancer combo (PharmaTimes)
• Closing NICE’s Orphan Gap (BioCentury)
• France suspends blood collection using Haemonetics devices (MassDevice)
• Turmoil erupts over expulsion of member from leading evidence-based medicine group (STAT)
• AZ to file triple combination therapy for COPD (PharmaTimes) (Endpoints)
• Takeda’s £46B Shire Buy Gets Nod From Chinese Regulator (Law360-$)
• Australia to start powerful public inquiry into aged-care sector (Reuters)
• Two new medicines added to Australia's Pharmaceutical Benefits Scheme (PharmaLetter-$)
• Sanofi looks to China in business restructure (BioPharmaDive)
• Cancer Research UK launches new London Centre, infusing £14M into biotherapeutics work from leading institutes (Endpoints)
• The Case for China BioPharma, by Brad Loncar (Loncar)
• Multi-stakeholder workshop on biosimilar medicines a crucial milestone in achieving increased patient access to biological therapies (Medicines For Europe)

• She’s been helping Republicans on Capitol Hill oversee the FDA for years. Now, she’ll be its top lawyer (STAT)
• How an Unsolved Mystery Changed the Way We Take Pills (NYTimes)
• Launch a new company, steer a $150M IPO and ink a big data collaboration — they call it Monday at Vivek Ramaswamy’s Roivant (Endpoints)
• FDA Clears Mersana to Restart Cancer Drug Trial With New Safeguards (Xconomy) (Endpoints) (Fierce)
• Baby-aspirin risks overwhelm benefits in healthy elderly (Reuters) (NYTimes)
• CRISPR pays to partner with ViaCyte on an off-the-shelf gene-editing approach to curing diabetes (Endpoints)
• FDA Is Eliminating Regulations? Here’s One that Makes Sense! (Lachman Consultants)
• Making Real World Evidence Less "Messy" To Help With Drug Pricing (Pink Sheet-$)
• US FDA Reviews IBS-C Candidates Both New (Tenapanor) And Old (Tegaserod) (Pink Sheet-$)
• ASCO Addresses Financial Barriers To Participation In Cancer Trials (BioCentury)
• Bristol-Myers Squibb Statement on Resignation of Dr. José Baselga (Press)
• Why we need bolder action to combat the opioid epidemic (McKinsey)
• Post-op opioids used far more in US than Hong Kong (Reuters)
• Realm surrenders after back-to-back clinical defeats (Fierce) (Endpoints)
• Illuminating Chiari malformation, an orphan disease (PharmaLetter-$)
• Ex-GSK R&D head joins OxStem as CSO (Pharmafile)
• Gene variations linked to severity of Zika-related birth defects, small NIH study suggests (NIH)
• Post-Marketing Pediatric-Focused Product Safety Reviews – Establishment of Public Docket (FDA)

• Pfizer Presents Positive Phase 2 Data in Alopecia Areata During Late-Breaker Session at the 27th European Academy of Dermatology and Venereology (EADV) Congress (Press)
• Positive Phase 3 Results Presented for Dupixent® (dupilumab) Show Significant Improvement on Multiple Measures of Disease Severity in Adolescents with Moderate-to-Severe Atopic Dermatitis (Press)
• AmpliPhi Biosciences Announces Positive FDA Feedback for its Clinical Stage Bacteriophage Product Candidate AB-SA01 (Press)
• Lyra Therapeutics to Present Clinical Data from Phase 1 Study of LYR-210 for the Treatment of Chronic Rhinosinusitis (Press)

• FDA comes under fire for rapid Apple Watch approvals (HealthDataManagement)
• Just Where Does Apple’s New ECG Fit into the Market? (MDDI)
• FDA hopes new disruptive wearables will lead to ‘universal digital future in healthcare’ (MassDevice)
• Staar Surgical wins FDA nod for Visian Toric ICL (MassDevice)
• FDA clears Olympus’ latest biopsy needle (Medical Design & Outsourcing)
• Debate Over Diagnostics Regulation In Washington Suggests Agreement Could Be In Sight (Biocentury)
• SpineVision Receives FDA Clearance and CE Mark for Next-Gen Titanium 3D-Printed HEXANIUM TLIF Cage (Press)
• Venture Heat Announces FDA Clearance for New Infrared Heat Therapy Pain Relief (Press)
• Remote heart monitoring, management device maker Endotronix lands $45 million (mobihealthnews)
• ConforMIS claims $11m win in patent infringement case against Smith & Nephew (MassDevice)

• Sexual assault allegation may freeze Kavanaugh (Politico)
• FTC Told Impax Can't Justify Opana Reverse Payment (Law360-$)
• FDA Focus: What Axinn's Practice Chair Is Watching (Law360-$)
• It’s a Trap – Or Is It? PMRS’ Abuse-Deterrent Opioid NDA (FDA Law Blog)
• So-Called “Death Panel” Affirmance Explores Off-Label Use Boundary (Drug & Device Law)
• Orexo AB v. Actavis Elizabeth LLC (Fed. Cir. 2018) (Patent Docs)

• FDA Advisory Committee Calendar
• Pathogen Reduction Technologies for Blood Safety; Public Workshop – 29 November 2018
• Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting – 24-25 October 2018
• FDA & MHRA Good Clinical Practice Workshop: Data Integrity in Global Clinical Trials – Are We There Yet? – 23-24 October 2018

• How Will They Delay The FMD? (RxTrace)
• Committee for medicinal products for human use (CHMP) - Draft agenda for the meeting on 17-20 September 2018 (EMA)
• Concept paper on the need for revision of the guideline on the investigation of medicinal products in the term and preterm neonate - Revision 1 (EMA)
• New application forms for operating licences available from November 2018 (Swissmedic)
• Meeting between Medtech Europe and DG SANTE B4 – Summary Minutes (EC)
• 15th Senior Officials Meeting between WHO and the European Commission (EC)

• Hua’s Institutional Advantage (Biocentury)

• Pharma industry hit by double whammy of FDC ban and API price hike (PharmaBiz)
• Supreme Court directs Centre to quickly finalise regulatory framework for clinical trials on humans (PharmaBiz)

• TGA international engagement strategy: operations plan 2018-19 (TGA)

• Coke, Aurora in talks to make cannabis-infused drinks: BNN Bloomberg (Reuters)