Recon: Amgen to Buy Celgene’s Otezla for $13.4B; Companies Sue Over Canada Drug Pricing Rules

• J&J ordered to pay $572 million in Oklahoma opioids case (WSJ) (NY Times)
• Amgen to buy Celgene’s Otezla in $13.4bn deal (Financial Times) (WSJ) (Endpoints) (STAT) (Press)
• Price hikes for multiple sclerosis drugs helped Medicare Part D out-of-pocket costs to skyrocket (STAT)
• Oklahoma judge to deliver judgment in state’s opioid lawsuit (AP) (Reuters)
• New Details Emerge Over Mallinckrodt’s Role in Opioid Crisis (WSJ)
• STAT wins long legal fight as Kentucky Supreme Court clears way for release of Purdue OxyContin files (STAT 1, 2)
• The $6 Million Drug Claim (NYTimes)
• Medicines Co.'s PCSK9 drug succeeds in first Phase 3 test (BioPharmaDive) (Endpoints) (Press)
• Lilly's Taltz wins third approval, this time in patients with active ankylosing spondylitis (Endpoints)
• Top 20 by revenue: New analysis highlights huge impact of tax reform on many — but not all — of the top pharma giants (Endpoints)
• Zogenix buys Modis for $250M, building out rare disease pipeline (BioPharmaDive) (Fierce)
• Measles-stricken New Zealand girl visited Disneyland, other California destinations (Reuters) (AP)
• US records 12 new cases of measles, raising year's total to 1,215 (Reuters)

• Companies file suit in Canada challenging new rules to lower drug prices (Reuters)
• Commission confirms deadline extension for more medical devices (Politico)
• EU announces record €550 million contribution to save 16 million lives from AIDS, tuberculosis and malaria (EC)
• Japan to Set Up Dedicated Team to Expedite Review of Sakigake-Designated Cell/Gene Therapies (PharmaJapan)
• China loosens curbs on small, unapproved drug imports (Reuters)
• China says US can do more to reduce fentanyl demand (Reuters)
• Lupin's South African arm inks commercial pact with Creso Pharma (Economic Times)
• Biotech in Europe: A strong foundation for growth and innovation (McKinsey)
• Iran Under Sanctions: A Scramble For Cancer Care And Blame To Go Around (NPR)
• Congo has given over 200,000 people Merck Ebola vaccine: government (Reuters)
• Ebola appears contained in Goma, but flares in other parts of Congo: WHO (Reuters)

• Don’t Give Up on Biosimilars—Congress Can Give Them a Boost (WSJ)
• Why Doctors Still Offer Treatments That May Not Help (NYTimes)
• US FDA Urged To Stop Slowing Approvals By Seeking Metals Data From Suppliers (Pink Sheet-$)
• Unlocking market access for gene therapies in the United States (McKinsey)
• MIT scientists say new skin patch to deliver cancer medication in 60 seconds shows promise in mice (CNBC)
• Study Questions Mainstay Treatment For Mild Asthma (NPR)
• BeiGene's first U.S. NDA tests global development strategy (BioCentury)
• There were no guidelines for fecal transplants. Then, a patient died. (NBC)
• ADC Therapeutics signs pact with Freenome; Shanghai Henlius Biotech eyes $600M for Hong Kong IPO (Endpoints)
• For GW Pharma CEO Justin Gover, The CBD Trend Started 20 Years Ago (Xconomy)
• Older Heart, Lung Surgery Patients at High Risk for Opioid Dependence (Medpage)
• FibroGen founder and CEO Thomas Neff dies unexpectedly as lead drug nears commercial threshold (Endpoints)
• From $30M launch round to $400M buyout deal — with $250M upfront — in 10 short months (Endpoints)
• Olumiant from Lilly, Incyte clears third eczema study, but who will use it? (Endpoints)
• ‘Absolute standout’ biopharma analyst Mark Schoenebaum has died (Endpoints)
• Aerie adds Vargas, once of Abbott, to medical affairs team (Fierce)
• Altaire Pharmaceuticals, Inc. Issues Voluntary Recall Of Veterinary Ophthalmic Products (FDA)

• Lilly Announces Top-Line Phase 3 Results for Oral JAK Inhibitor Baricitinib, in Combination with Topical Corticosteroids in Adult Patients with Moderate to Severe Atopic Dermatitis (Press)
• Evofem Biosciences Completes Phase 2b 'AMPREVENCE' Trial of Amphora for Prevention of Chlamydia and Gonorrhea in Women (Press)
• Long-acting Injectable Antipsychotic Using Medincell’s Technology Receives FDA IND Clearance to Initiate Clinical Activities (Press)
• FDA Approves US WorldMeds' MYOBLOC® (rimabotulinumtoxinB) Injection for Chronic Sialorrhea (Press)
• DiscGenics Receives FDA Fast Track Designation for Cell Therapy for Disc Degeneration (Press)

• Allergan Beats Patient Suits Over Implant Warranty Program (Law360-$)
• Titan Medical delays timeline on Sport robot-assisted surgery device (MassDevice)
• FDA clears Biobeat’s cuffless BP wearable (MassDevice)
• Minimally Invasive Deformity Correction (MID-C) System - H170001 (FDA)
• FDA adds AAMI/UL 2800 standards for medical device interoperability (MassDevice)
• Class 1 Device Recall Quantum Pump Console (FDA)
• Study Finds New Blood Test Could Help Detect Brain Injury In Minutes (Forbes)
• Nucleic Acid Extraction System From Systaaq Diagnostic CE Marked (GenomeWeb)

• CDC flags one death and nearly 200 cases of lung illnesses in U.S., possibly tied to vaping (Reuters)
• University of California/Berkeley Granted Yet Another CRISPR Patent (Patent Docs)
• Trump calls on UPS, FedEx and Amazon to ‘search for & refuse’ fentanyl deliveries from China (CNBC)
• DEA Announces Steps Necessary to Improve Access to Marijuana Research (DoJ)
• The CBD Market Is Red Hot, But Buyer Beware When It Comes To Product Safety And Efficacy, Experts Argue (Forbes)
• Sometimes Things Just Don’t Go as Planned (or Hoped) (Alliance for a Stronger FDA)
• Coalition forms to push changes in antimicrobial payment system (BioCentury)
• The FTC Loses Big in the Seventh Circuit (FDA Law Blog)
• Awaiting Answers On A Post-Bristol-Myers Class Question (Law360-$)
• Opioid Litigation Pushes American Pain Society Into Bankruptcy (Pink Sheet-$)
• Prescription Medical Product Causation – Expert Required − Part Three (Drug & Device Law)
• VA facilities offering cochlear implants to vets are few and far between (Reuters)
• J&J’s Ethicon loses pelvic mesh appeal in Pennsylvania (MassDevice)
• Dexcom claims win in patent war with AgaMatrix unit Waveform Technologies (MassDevice)

• FDA Advisory Committee Calendar
• Regulatory Education for Industry (REdI): Pharmaceutical Quality Symposium – Oct. 16-17, 2019
• Vaccines and Related Biological Products Advisory Committee; Notice of Meeting – 9 October 2019

• We need to be told which medicines are at risk in no-deal Brexit (The Guardian)
• UK patient groups demand action on trial data nondisclosure as politicians ramp up pressure (Fierce)
• UK’s No-Deal Brexit Plans For SPC Waiver Could Reduce IP Rights, Warns BIA (Pink Sheet-$)
• Exporting active substance manufactured in the UK in a no-deal Brexit (MHRA)
• SME Office NEWSLETTER – August 2019 (EMA)
• Competent Authorities on Substances of Human Origin Expert Group (CASoHO E01718) Meeting of the Competent Authorities for Tissues and Cells (EC)

• Pfizer Launches Herceptin Biosimilar in Japan (PharmaJapan)

• Sixteen injured in blast at Indian manufacturer (InPharmaTechnologist)
• Glenmark recalls products from US market (Economic Times)
• Chennai startup Eywa enters US pharma market (Economic Times)
• Central drug regulator preparing list of dual-use APIs imported from unregistered firms (Economic Times)
• Hygiene products like sanitary napkins, disinfectants and adult diapers could soon come under price control (Economic Times)
• Health ministry to mandate medical device import licence holders towards SUSAR reporting (PharmaBiz)
• Regulators need to curb unethical practices in human clinical trials: Prof Gagandeep Kang (PharmaBiz)
• PNB Vesper receives DCGI nod for 2 molecules to conduct phase 1/2a human studies (PharmaBiz)

• Consultation forecast (TGA)
• Direct acting oral anticoagulants and risk of recurrent thrombotic events (TGA)

• Consumer DNA testing has hit a lull — here’s how it could capture the next wave of users (CNCB)