Recon: Eli Lilly Raises Guidance on New Drug Sales; Alkermes to Lay Off 160

• Novartis data suggest payers getting breaks on gene therapy Zolgensma (Reuters)
• Seema Verma faces first oversight hearing with House Democrats (Politico)
• Eli Lilly raises earnings guidance as new drugs boost sales (Financial Times) (Reuters)
• Eli Lilly CEO Says Drugmaker Won’t Rehash Old Alzheimer’s Data (Bloomberg)
• Nancy Pelosi’s drug pricing plan passes to House floor for full vote this month (CNBC) (The Hill)
• Drug companies spend millions on lobbying as Congress tries to rein in high drug prices (The Hill)
• That New Alzheimer’s Drug? Don’t Get Your Hopes Up Yet (NYTimes)
• Biogen CEO ‘reasonably confident’ once-doomed Alzheimer’s drug will be granted FDA approval (CNBC)

• Canadian election clears path for universal drug plan (Reuters)
• Disease fighters to mark partial victory in polio eradication battle (Reuters)
• NIH and Gates Foundation launch effort to bring genetic cures for HIV, sickle cell disease to world’s poor (STAT)
• Alkermes to lay off 160 in cost-cutting restructure (BioPharmaDive) (Endpoints)
• UK rations AZ’s paediatric flu vaccine after delivery delays (PMLive)
• Janssen files Tremfya for psoriatic arthritis in Europe (PMLive)
• Vertex Strikes Spanish Payment-For-Results CF Deal (Pink Sheet-$)
• Novartis' Zolgensma faces EU, Japan delays after regulators raise 'manufacturing questions' (Fierce)
• Zealand takes on Takeda's IBD drug with tiny buyout (Endpoints)
• Novartis bets $80M on Pliant's preclinical NASH prospect (Fierce) (Endpoints)
• NICE amends depression guideline highlighting 'severe' and long-lasting withdrawal symptoms (Pharmaceutical Journal)

• Making Drug Companies Pay for the Opioid Epidemic (NYTimes)
• FDA's Pazdur Advocates Platform Trials For Cancer Drug Development (Pink Sheet-$)
• US FDA 'Uni-Review' Rolls Out: Psychiatric Division Is Among Early Adopters (Pink Sheet-$)
• Accelerated Approval For Medicare Coverage? FDA Model Could Be Useful For Value-Based Agreements (Pink Sheet-$)
• ‘We conquered a disease’: How Vertex delivered a transformative medicine for cystic fibrosis (STAT)
• Expanding the gene editing landscape (Nature)
• Sheriffs’ Ads Slammed Drug Imports, and Big Pharma Helped Pay the Tab (Bloomberg)
• Biogen’s good news on aducanumab could ‘open the floodgates’ for Alzheimer’s drugs (STAT)
• Biologic Drug Price Updates and Biosimilar Market Competition (Big Molecule Watch)
• Success for early MLD gene therapy (PharmaTimes)
• New Breed Of Biotech Investors Show Their Hand With $10 Million Investment In London Startup LabGenius (Forbes)
• Is there a recipe for M&A success? The best and worst buyout deals in the past decade offer some keys to success — and failure (Endpoints)
• Soriot, Schleifer, Perreault named top global CEOs — but gone are pharma's golden years (Endpoints)
• A livestock-poison-turned-drug might save her from endless cancer surgeries. But if she helps test it, could she afford to keep taking it? (STAT)
• Eli Lilly’s USA, diabetes chief Enrique Conterno is heading out after 27 years, and he’s being replaced by a company insider (Endpoints)
• Evotec brings early stage accelerator model to Israel (Fierce)
• EY vet set to replace retiring Amgen CFO Meline (Endpoints)
• NeuroRx secures $95M to fund PhIII for NMDA depression drug; Trump revives science advisory council (Endpoints)
• RAPT Therapeutics returns to Wall Street to revive IPO bid (Endpoints)
• Regulatory Pharmaceutical Fellowship (FDA)

• Provention Bio's J&J-licensed Crohn's drug stumbles in mid-stage study (Endpoints)
• HKBU Drug the First in Hong Kong to be Granted Orphan Drug Designation by the US FDA (Press)
• Moderna Receives FDA Fast Track Designation for Propionic Acidemia Program (mRNA-3927) (Press)
• Talaris Therapeutics Announces Initiation of Phase 3 Clinical Trial of FCR001 in Living Donor Kidney Transplant Recipients (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)
• 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)
• RAPT Therapeutics Announces Initiation of First-in-Human Phase 1 Study of RPT193 (Press)

• BioGx Gets CE-IVD Mark for Respiratory Infection Assay (GenomeWeb)

• Johnson & Johnson CEO testified Baby Powder was safe 13 days before FDA bombshell (Reuters)
• Clinical Trials And Specific Jurisdiction After Bristol-Myers (Law360-$)
• The FDA Regulatory Landscape For Tobacco And Cannabis (Law360-$)
• Plaintiff Cannot Defeat Diversity by Suing Local Hospital without Complying with Louisiana Med-Mal Requirements (Drug & Device Law)
• California Chamber of Commerce Files Lawsuit to End Prop. 65 Warnings for Acrylamide on Foods (FDA Law Blog)

• FDA Advisory Committee Calendar

• Loud And Clear: EMA Gets Message On Advancing Reg Science (Pink Sheet-$)
• Electronic prescriptions could save NHS £300m (PharmaTimes)
• Comparator products in Bioequivalence/Therapeutic Equivalence studies after Brexit (MHRA)
• Class 2 Medicines recall: Sayana Press 104mg/0.65ml (MDR 055-06/19) (MHRA)
• Damage control: How will pharma manage the health economic impacts of Brexit? (Pharmafile)
• Global drugmakers may reduce prices in Russia in exchange for guaranteed demand (PharmaLetter-$)

• South Korea warns of 'serious risk' from vaping, considers sales ban (Reuters)
• Gene And Cell Therapies In Asia: New Korean Law To Change Landscape Of Cutting Edge Biologics (Scrip-$)

• Union health ministry releases draft notification to notify all medical devices under D&C Act for effective regulation (Pharmabiz)
• Dr Reddy's recalls all its ranitidine products in US (Economic Times)

• Summary Safety Review - Xarelto (rivaroxaban) – (Health Canada)

• Microbiological quality of prescription and over-the-counter medicines (TGA)
• Submissions received: Proposed reclassification of spinal implantable medical devices (TGA)