Recon: Lilly, AC Immune Partner on Alzheimer’s Treatment; FDA Rejects Mallinckrodt’s Abuse-Deterrent Opioid

• FDA declines to approve Mallinckrodt's abuse-deterrent opioid painkiller (Reuters) (Endpoints)
• Lilly partners with AC Immune for Alzheimer's treatment (Reuters) (BioCentury) (Fierce) (Endpoints)
• Kaleo, maker of $4,100 overdose antidote, authorizes a generic version for just $178 (STAT) (The Hill)
• This Killer Opioid Could Become a Weapon of Mass Destruction (Bloomberg)
• Fentanyl now America's deadliest drug, federal health officials say (USA Today)
• Lawmaker chastises Pfizer for reverting to price hikes next month (STAT)
• CVS-Aetna deal will save money by cutting supply chain negotiations (STAT)
• Physician assistant faces US trial over Insys opioid kickbacks (Reuters)
• Indivior wins fresh hold on Dr. Reddy's Suboxone copy (Reuters)
• J&J says its psoriasis drug superior to Novartis' in study (Reuters) (Endpoints)
• FDA clears first xenotransplantation trial of skin cells derived from genetically engineered pigs (Fierce)
• Before He Died, Paul Allen Gifted $125 Million To A New Institute To Study The Immune System (Forbes) (STAT)
• Large coalition joins drug lobby in denouncing Trump proposal to import drug prices for Medicare (Endpoints)
• New documents shed light on secretive ElevateBio, next step for former Alexion execs (STAT)

• Samsung BioLogics Vows Improved Management Transparency As Stock Resumes Trade (SCRIP-$)
• China’s global reputation shapes its citizens’ reaction to ‘CRISPR babies’ (STAT)
• Scientists Skeptical About Gene-Edited Baby Experiment (WSJ)
• Oxford BioTherapeutics, WuXi Biologics team up to create cancer antibodies (PharmaTimes)
• EMA Set For More Staff Losses & Activity Cuts Next Year (Pink Sheet-$)
• NICE says no to rival Alnylam and Akcea amyliodsis drugs – but deal could be done (PMLive)
• Launch of largest ever UK lung cancer screening study (PharmaTimes)
• Revamped Cancer Drugs Fund Means More Positive Recommendations, Says NICE (Pink Sheet-$)
• Scottish Medicines Consortium approves Verkazia for severe eye condition in children and adolescents (Pharmafile)
• CHMP Delays Review of Portola's Ondexxya; Who Will Pass Muster? (Pink Sheet-$)
• Brexit Delays Key ATMP Guideline Update – EMA Says Perhaps Not So Bad (Pink Sheet-$)
• Merck and Instituto Butantan Announce Collaboration Agreement to Develop Vaccines to Protect Against Dengue Infections (Press)

• CDER New Drugs Program: 2018 Update (FDA)
• Remarks by Dr. Gottlieb to the FDLI Enforcement, Litigation, and Compliance Conference (FDA)
• Scramble For Shingles Vaccine: How To Cope With Shingrix Shortage (NPR)
• AstraZeneca kicks off second blood cancer launch, this time for orphan drug Lumoxiti (Fierce)
• As competition heats up, US prices for Remicade and biosims slip: analyst (Fierce)
• Pfizer to add 100 oncology R&D jobs, cut others amid restructure (BioPharmaDive)
• Allergan strengthens Finance Leadership Team with two appointments (Pharmafile)
• Emergency allergy shots less effective after heat exposure (Reuters)
• Bausch is keen on Synergy, after troubled constipation drug maker files for Chapter 11 (Endpoints)
• Upstart Akero continues its swoosh into NASH space with $70M windfall round (Endpoints)
• In a repeat setback, Neurocrine flags a failure for Tourette syndrome study — shares sink (Endpoints)
• Merck promotes oncology, vaccine executives to replace Adam Schechter in commercial rejig (Fierce)
• Circassia takes on full US rights to AZ’ Tudorza (PharmaTimes)
• Shinichi Tamura reclaims the helm at Sosei as CEO Peter Bains hits the exit (Endpoints)
• China's Zhejiang Huahai lambasted in FDA warning letter for putting profits ahead of safety (Fierce)
• Many older adults don't take prescribed antidepressants (Reuters)
• Casma names Third Rock venture partner as COO (Fierce)
• AbbVie's Humira still leads pharma’s TV ad spending, but new ads for Aimovig, Mavyret and Truvada pop in November (Fierce)

• New Phase 3 data demonstrate superiority of TREMFYA® (guselkumab) vs Cosentyx® (secukinumab) in delivering PASI 90 responses in the treatment of moderate to severe plaque psoriasis at week 48 (Press)
• Generex Biotechnology Receives IND Approval from FDA for Phase II Combination Study using AE37 plus Keytruda® (pembrolizumab) for the Treatment of Triple Negative Breast Cancer (Press)
• Gibson’s Novel Anti-cancer Drug, LMP-400, Receives FDA Rare Pediatric Disease Designation for the Treatment of Ewing Sarcoma (Press)
• Levo Therapeutics Announces Initiation of the CARE-PWS Phase 3 Study of Intranasal Carbetocin for the Treatment of Prader-Willi Syndrome (Press)
• GenSight rebuilds its case for LHON gene therapy, eyeing filing next year (Fierce) (Press)
• Rodin Therapeutics Announces Initiation of Phase 1 Clinical Trial of a Selective CoREST Inhibitor to Treat Neurologic Diseases (Press)
• Altasciences Contributes to Positive Top-Line Phase 1 Results for Chronic Cough Drug Candidate (Press)

• NuVasive wins expanded FDA nod for Monolith corpectomy system (MassDevice)
• BioCardia submits bid for FDA clearance of Avance transseptal introducer (MassDevice)
• Boston Scientific touts win in continued TAVR patent spat with Edwards Lifesciences (MassDevice)

• Improve Act passes House (Politico)
• Target to pay $3M to resolve Massachusetts Medicaid claim (AP)
• NIH to fund HIV care and prevention research in vulnerable southern US communities (NIH)
• Feds drop insider trading, perjury charges against ex-AMO chief Mazzo (MassDevice)              
• McDonald's to curb antibiotic use in its beef supply (Reuters)
• Amgen's Biosimilar IP Win Was Wrong, Hospira Tells Fed. Circ. (Law360-$)
• Full Fed. Circ. Urged To Review Venue In Cialis Patent Fight (Law360-$)
• Hoffman La-Roche Can't Keep Malaria Drug Suit In Fed. Court (Law360-$)
• Fed. Circ. OKs Stryker's $248M IP Win After High Court Trip (Law360-$)
• 3rd Circ. Questions 'Imminent' Shire Antitrust Actions (Law360-$)
• Failure to File Adverse Event Reports Results in Criminal Pleas for Medical Device Company and Quality Manager (FDA Law Blog)
• Novartis Pharmaceuticals Corp. v. Breckenridge Pharmaceutical Inc. (Fed. Cir. 2018) (Patent Docs)
• N.D. Cal. Dismisses IVC Filter Claims (Drug & Device Law)

• FDA Advisory Committee Calendar

• Pilots Between NHS And Pharma Finally Take Off (SCRIP-$)
• New NICE standards to improve digital health tech uptake (PharmaTimes)

• Infectious Diseases Proposed As Focus Of Inter-Korea Health Cooperation (Pink Sheet-$)
• Chinese firm plans ‘first-in-class’ biologics after $325m manufacturing investment (BioPharmaReporter)

• Johnson & Johnson moves Delhi High Court against government orders to compensate faulty hip implant patients (Economic Times)
• Report: India still lacks solid medical device regulation (MassDevice)

• TGA operations over the holiday period 2018-19 (TGA)
• Therapeutic Goods (Microbiological Standards for Medicines) (TGO 100) Order 2018 (TGA)
• Final scheduling decisions and reasons: NCEs and Appendix H (TGA)