Recon: Vertex Prices Newly Approved CF Combo at $331K Per Year; Biogen to Seek Approval for Alzheimer’s Candidate

• Biogen resurrects Alzheimer's drug; shares jump 37%  (Reuters) (WSJ) (STAT) (Endpoints)
• Biogen’s Alzheimer’s Revelation Isn’t So Simple (WSJ)
• Drug companies and US states propose $48bn opioid settlement (Financial Times) (Reuters)
• How Joe Grogan shaped 5 key drug pricing policy proposals (STAT)
• Vertex CF triplet approved for 90% of patients (STAT) (Endpoints) (Evaluate) (Press) (FDA)
• Vertex prices cystic fibrosis combo treatment at $311,000-per-year (Reuters)
• BMS immunotherapies show promise in lung cancer trial; shares rise (Reuters) (Endpoints) (Press)
• FDA rejects Assertio Therapeutics' long-acting ACTH formulation, shares sink (Endpoints) (Press)
• Drugstore drones: UPS will fly CVS prescriptions to US customers (Reuters)
• Intraparty tension could emerge as Ways and Means marks up Pelosi drug pricing plan (Politico)
• Trump urges quicker action to allow imported drugs from Canada (Reuters)

• Takeda tees up $420M deal for celiac antidote, continuing R&D refocus (Endpoints) (Press)
• Novartis grows in Q3 thanks to stellar performance of key drugs (PMLive)
• Novartis Lauds Launch of World’s Most Expensive Drug (WSJ) (STAT) (Evaluate)
• UK’s Johnson Urges Support Ahead of Make-or-Break Brexit Vote  (WSJ) (BBC)
• That $335M JV Bayer set up on CRISPR/Cas9? They’re letting the biotech partner carry on (Endpoints)
• Idorsia's Clozel says recruitment delay won't dent Fabry drug prospects (Reuters)
• French To Press On With Rapid Trial Approval System (Pink Sheet-$)
• Novo Nordisk opens first Pharmatech branch office in Singapore (Pharmafile)
• MDCG Updates Q&As on Requirements for Notified Bodies (Focus)

• Drugs Inside Cells: How Hard Can It Be, Right? (In the Pipeline)
• Biopharma’s Innovation Defense Is Crumbling (Pink Sheet-$)
• Where are the Interchangeable Biosimilars? (Focus)
• US FDA Moves To Fix Hiring Process Threatened By Personnel Agency (Pink Sheet-$)
• Pfizer’s growth hormone falls short (Evaluate)
• This is awkward: Genome editing startup Beam has competition — from one of its own cofounders (STAT) (Endpoints)
• A new company enters the Tecfidera fight, offering to kill two birds (Endpoints)
• Researchers Estimate Costs of Exclusivity Extensions to Encourage Antibiotic Development (Focus)
• ProPublica Is Way Off Base With Its Analysis Of Pharma Payments To Doctors (Forbes)
• The Ethical Conundrums of Ultra-personalized Drugs (Harvard Bill of Health)
• Alphabet CFO Ruth Porat opens up about her bouts with cancer and Google’s work in early disease detection (CNBC)
• SeaGen to Seek FDA Nod After Breast Cancer Drug Hits Goals of Key Study (Xconomy)
• Porton Biopharma signs potential $24m deal to push its intranasal anthrax vaccine into Phase 1 trials (Pharmafile)
• CD47 player Trillium chops discovery efforts and 40% of staff; Brii Bio inks deal to bring antibiotics to China (Endpoints)
• Frazier Healthcare Partners' dermatology upstart attracts a marquee syndicate, $94M+ for 'in-between' topical drug (Endpoints)
• Failed PhIII fevipiprant trials pour more cold water on Novartis' blockbuster R&D engine — and spread the chill to a high-profile biotech (Endpoints) (Fierce)

• Cyclo Therapeutics Announces Completion of Enrollment in its Phase I Trial to Evaluate Trappsol® Cyclo™ for the Treatment of Niemann-Pick Disease Type C (Press)
• Cerevel Therapeutics Initiates Phase 1b Clinical Trial of CVL-231, a M4 Selective Positive Allosteric Modulator in Development for the Treatment of Schizophrenia (Press)

• A Million-Dollar Marketing Juggernaut Pushes 3D Mammograms (KHN)
• BioGx Gets CE-IVD Mark for Respiratory Infection Assay (GenomeWeb)

• How Warren could pay for 'Medicare for All' (Politico) (Reuters)
• FDA grants first-ever modified risk orders to eight smokeless tobacco products (FDA)
• Obamacare Premiums to Fall and Number of Insurers to Rise Next Year (NYTimes)
• Clinical Data Fraud Involving CROs Attracting US Justice Department Attention (Pink Sheet-$)
• White House Advances War On 'Guidance'; FDA Not Target, But May Feel Ripple Effects (Pink Sheet-$)
• Consumers sue Sanofi and other drug makers over Zantac link to a possible carcinogen (STAT)
• This small biotech is suing the Trump administration to get its drug covered (STAT)
• High Court Passes On Lilly's $20M Cialis Patent Loss (Law360-$)
• 3rd Circ. Declines To Reconsider J&J Remicade Antitrust Case (Law360-$)
• Briefing completed in trastuzumab IPR appeals (Big Molecule Watch)
• Consulting an Attorney Triggers Statute of Limitations (Drug & Device Law)
• CMS and OIG Propose Changes to the Stark Law, Anti-Kickback Statute and Civil Monetary Penalty Rule (FDA Law Blog)

• FDA Advisory Committee Calendar
• Repurposing Off-Patent Drugs: Research & Regulatory Challenges – 5 December 2019

• EMA Issues Guide on Consistency of Indication Wording (Focus)
• European Medicines Agency Approves Refined Commercial Manufacturing Specifications for ZYNTEGLO™ (Press)
• Company led drug alert – Docetaxel Injection 80mg /8ml (MHRA)

• Asia Regulatory Roundup: Hong Kong Proposes Regulatory Framework for Cell and Gene Therapies (Focus)
• India-China Pharma Park in south China to open ample opportunities for Indian pharma companies to market their products (Pharmabiz)

• Consultation: Proposed clarification that certain sports supplements are therapeutic goods (TGA)
• TGA Laboratories testing of ranitidine medicines (TGA)