Recon: GSK Sells Two Vaccines to Bavarian Nordic for $1.1B; Drug Companies Reach Last-Minute Settlement in Ohio Opioid Trial

• Drug companies reach $260 million settlement, averting first federal opioid trial (Reuters) (WSJ) (NYTimes)
• Seattle Genetics to seek approval for new breast cancer pill after positive clinical trial results (STAT) (BioPharmaDive) (Evaluate)
• Smith+Nephew CEO steps down, ex-Roche Diagnostics chief to take over (Reuters) (Evaluate)
• J&J's blockbuster Stelara wins US approval for ulcerative colitis (Endpoints)
• FDA approves AstraZeneca diabetes drug for treating heart failure risk (Reuters) (Endpoints)
• FDA approves Alexion's Ultomiris for another rare blood disease (Reuters) (Endpoints)
• The newest gene editor radically improves on CRISPR  (MIT Technology Review) (STAT)
• Opioid Epidemic Cost US More Than $600B Over 4 Years (CBS)
• The US opioid epidemic by the numbers (Reuters)

• GSK agrees €1bn sale of two vaccines  (Financial Times) (Reuters) (Endpoints) (Evaluate)
• Roche pushes late-comer Tecentriq as new liver cancer option  (Reuters) (Endpoints) (Press)
• China Is Striving for the World’s Best, Cheapest Healthcare (Bloomberg)
• Cancer Research UK among partners in new international research alliance (PMLive)
• Scotland Explains How To Tackle No-Deal Drug Shortages (Pink Sheet-$)
• Ebola concentrated in Congo mining area, still an emergency: WHO (Reuters) (NYTimes)
• See A Controversial Swarm Of Genetically Modified Mosquitoes In A Lab In Italy (NPR)

• Risk-Based Approach To Protecting Data Integrity Outlined In Forthcoming PDA Report (Pink Sheet-$)
• Real-World Evidence Study Registration May Help Drive FDA Acceptance (Pink Sheet-$)
• Human Immunodeficiency Virus-1 Infection: Developing Systemic Drug Products for Pre-Exposure Prophylaxis (FDA)
• Candidate Ebola Vaccine Still Effective when Highly Diluted, Macaque Study Finds (NIH)
• International pricing index ‘accomplishes nothing it sets out to do’ (STAT)
• New ACRO Report Quantifies Benefits of RBM for Quality Reviews (ACRO)
• Sofinnova-backed Abivax touts longer term mid-stage data in ulcerative colitis (Endpoints)
• 60% of online searches lead to counterfeit meds (PharmaTimes)
• Clay Siegall’s $614M wager on tucatinib pays off with solidly positive pivotal data and a date with the FDA (Endpoints)
• Armed with Langer tech and $50M, Verseau hails new checkpoint drugs unleashing macrophages against cancer (Endpoints)
• FDA approval lets Foamix set its maiden acne therapy on course for US market launch (Endpoints)
• Aerpio may hang the 'for sale' sign up, axes CEO after eye drug flop (Fierce)
• Determination That PROAMATINE (Midodrine Hydrochloride) Tablets, 2.5 Milligrams, 5 Milligrams, and 10 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness (FDA)

• Pfizer gets some encouraging PhIII news on a franchise savior, but is a dosing advantage worth the $295M upfront? (Endpoints)
• IND Application Submission To FDA For Phase 1 Trial Of Genetically Modified Autologous Cell Therapy For HIV Announced by American Gene Technologies (Press)
• Bayer Submits Supplemental New Drug Application to FDA for Intrauterine Device (IUD) Mirena® (levonorgestrel-releasing intrauterine system) 52 mg (Press)
• United Therapeutics Announces FDA Approval Of Updated Label For Orenitram Reflecting Results Of FREEDOM-EV Study (Press)
• Mallinckrodt to Present Results from its Pivotal Phase 3 CONFIRM Study of Terlipressin in Patients with Hepatorenal Syndrome Type 1 (HRS-1) at The Liver Meeting® 2019 (Press)
• Innovent Biologics Announces Positive Updated Result from the Incyte-sponsored Phase II Trial of Pemigatinib in Patients with Previously Treated, Advanced Cholangiocarcinoma (Press)
• Urovant Sciences Initiates Part 2 of Phase 3 COURAGE Study of Vibegron for Overactive Bladder in Men with Benign Prostatic Hyperplasia (Press)
• Amygdala Neurosciences Awarded $1.35 million NIH Grant to Conduct Long Term, Phase 3 Enabling, Toxicology Studies (Press)
• New subcutaneous formulation of Celltrion Healthcare’s CT-P13 (biosimilar infliximab) shows positive Phase 1 results for the treatment of IBD in data presented at UEG Week Barcelona 2019 (Press)
• Odonate Therapeutics Announces Completion of Enrollment in CONTESSA, a Phase 3 Study of Tesetaxel in Patients with Metastatic Breast Cancer (Press)
• DURECT Announces DUR-928 Phase 2a Alcoholic Hepatitis Study Results Selected for Late-Breaking Oral Presentation at The Liver Meeting® 2019 (Press)

• US Manufacturing Faces Further Headwinds from Return of Medical Device Tax (AdvaMed)
• Perflow Medical wins CE Mark for Cascade Agile neurovascular net (MassDevice)
• Shape Memory Medical wins CE Mark for Trellix embolic coil (MassDevice)
• Concept Medical wins CE Mark for MagicTouch DCBs (MassDdevice)
• Vygon acquires ECG guidance device maker Pilot (MassDevice)
• Canon Medical’s Ultra-High Resolution CT Receives FDA Clearance for Artificial Intelligence-Based Image Reconstruction Technology (Press)

• Warren vows to share plan to pay for 'Medicare for All' (Politico)
• Regulation of Laboratory Developed Tests by FDA: Time for the Agency to Cease and Desist Until Congress Enacts Legislation (FDA Law Blog)
• The Latest on Personal Jurisdiction and Class Actions (Drug & Device Law)
• PTAB Told To Weigh Invalid Claim Language In Ethicon Patent (Law360-$)
• J&J Pans Judge's 'Partisan Glee' After $8B Risperdal Verdict (Law360-$)
• NECC Pharmacists Lose Bid For New Trial In Meningitis Case (Law360-$)
• AstraZeneca's IP Suit Sent To W.Va. On TC Heartland Grounds (Law360-$)
• PTAB Gives Sanofi First-Ever Early Feedback On Amendments (Law360-$)
• Humana Slaps Generic-Drug Makers With New Price-Fix Suit (Law360-$)
• La. Insurer Sues Pharma Cos. Over Opioid Crisis (Law360-$)

• FDA Advisory Committee Calendar
• Focusing Innovation on the Individual Patient – 25 October 2019

• Welcome new MHRA senior appointments (MHRA)
• Graeme Tunbridge appointed interim Director of Devices (MHRA)
• EMA Identifies Potential Sources Of Nitrosamine Contamination (Pink Sheet-$)
• “No deal” Brexit and life sciences: What happens? (Pharmafile)

• China Inches Closer To Another Pharma Serialization Mandate (RxTrace)

• Granules India gets USFDA nod for allergy treatment drug (Economic Times)

• Annual performance statistics report: July 2018 to June 2019 (TGA)

• What Causes a Mysterious Paralysis in Children? Researchers Find Viral Clues (NYTimes)