Recon: FDA Panel Backs Shionogi Antibiotic for Complicated UTIs; J&J to Settle Surgical Mesh Probe for $117M

• AstraZeneca breast cancer treatment gets FDA priority review (Reuters) (Endpoints) (Press)
• Johnson & Johnson agrees to pay about $117 million to settle US states' mesh probe (Reuters)
• Drug Giants Close In on a $50 Billion Settlement of Opioid Cases  (NYTimes) (Reuters)
• Judge summons drug company CEOs to court to discuss opioid settlement: source (Reuters)
• Fitbit, Bristol-Myers, Pfizer partner to speed earlier diagnosis of AFib  (MedtechDive) (Fierce) (Press)
• FDA Panel Backs Cefiderocol for Complicated UTI  (Medscape) (Medpage) (Endpoints) (Press)
• J&J, Amarin cardiovascular drugs are cost-effective, ICER says—but there's a catch (Fierce) (ICER)
• Give up board chairmanship? No thanks, US big pharma CEOs say (BioPharmaDive)
• Most state Medicaid programs continue to restrict access to hepatitis C medicines (STAT)
• Forecasting Alzheimer’s: With a tsunami of new diagnoses expected, experts calculate the best ways to shift the tide (STAT)

• Time is of the essence for patients who have serious and life-threatening conditions. Fast Track designation is one of four programs that can help expedite the development and review of drugs intended to address unmet medical need in the treatment of serious conditions. If you’re interested in pursuing a Fast Track designation for your therapy, here are some of the basics you’ll need to know.

• European VC Sofinnova raises €333M for early-stage biotech, medtech firms (Fierce) (Endpoints)
• Brexit: EU and UK reach deal but DUP refuses support (BBC) (CNBC) (NYTimes) (Pink Sheet-$)
• Brexit healthcare fears fuel expatriate insurance interest in Europe (Reuters)
• Roche CEO does not expect U.S. to slap tariffs on European drugs (Reuters)
• All Or Nothing: Paratek Withdraws EU Filing For Nuzyra (Pink Sheet-$)
• Courier groups hired to keep medicine flowing after no-deal Brexit (Financial Times)
• Italy: Added Benefit Will Be Key To Reimbursement (Pink Sheet-$)

• Sean Parker-Backed ArsenalBio Wants To Create Better Weapons Against Cancer (Forbes) (STAT) (Endpoints)
• As Biosimilars Emerge in Oncology and Rare Disease, Innovator Companies Look to New Drugs to Maintain Sales (Center for Biosimilars)
• PhI fizzle forces Syros to spike its lead drug, triggering another rout on shares  (Endpoints) (Fierce)
• Starting Chemotherapy, When You’re Ready (NYTimes)
• What Drug Development Sponsors, Contract Research Organizations, and Investigators Can Do to Increase Diversity in Clinical Trials (ACCP)
• Health Canada and United States Food and Drug Administration Joint Regional Consultation on the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (FDA)
• FDA: Deliveries Of Scarce Childhood Cancer Drug Due To Resume Later In October, But Shortages May Continue For Months (Forbes)
• After 13% discount Innate Pharma raises $69M; AZTherapies bags $26.3M from Series C financing round (Endpoints)
• San Diego upstart debuts discovery engine that puts a twist to protein degradation (Endpoints)
• Mirati preps its first look at their KRAS G12C contender, and they have to clear a high bar for success (Endpoints)
• Understanding Precision Medicine And AI Within The Life Cycle Of Technology Revolutions (Forbes)
• Early GMP Compliance Seen As A Key To Avoiding Complete Responses (Pink Sheet-$)
• New Study Adds Concern That Medication To Treat Painful Bladder Condition Linked To Vision-Threatening Eye Condition (Forbes)
• Sanofi investing in gene therapy as R&D focus turns toward rare disease (BioPharmaDive)
• Gedeon Richter acquires rights to Mycovia’s for VT-1161 (PharmaLetter-$)
• Submitting Study Datasets for Vaccines to the Office of Vaccines Research and Review (FDA)
• Viatrexx Bio Incorporated Issues Voluntary Nationwide Recall of Sterile Injectables due to a Lack of Sterility Assurance (FDA)
• Important Drug Information - Humate-P [Antihemophilic Factor/von Willebrand Factor Complex (Human)] (FDA)

• Kiadis Pharma provides regulatory update on ATIR101 (Press)
• UCB's bimekizumab meets primary and secondary endpoints, beating Janssen's Stelara in chronic plaque psoriasis (Pharmafile)
• FDA Grants Orphan Drug Designation for Neuren's NNZ-2591 to Treat Angelman, Phelan-McDermid and Pitt Hopkins Syndromes (Press)
• Genentech Announces FDA Approval of Xofluza (Baloxavir Marboxil) for People at High Risk of Developing Influenza-Related Complications (Press)
• Sensorion Announces the Last Patient’s Last Visit in SENS-111 Phase 2 Clinical Trial (Press)
• Protalix BioTherapeutics Announces Positive 12-Month Interim Data From the BRIDGE Phase III Open Label Switch-over Study of Pegunigalsidase Alfa for the Treatment of Fabry Disease (Press)
• Aristea Therapeutics Announces the Completion of Enrollment in RIST4721-201, a Phase 2a Proof-of-Concept Study of RIST4721 for the treatment of Palmoplantar Pustulosis (PPP) (Press)
• SurgiMab Recruits First US Patient in Pivotal Phase 3 Trial Evaluating SGM-101, a Novel Fluorescent Tumor-specific Antibody, for the Improvement of Surgical Outcomes in Colorectal Cancer Patients (Press)
• NeuClone Announces First Human Dose of Stelara® (Ustekinumab) Biosimilar Candidate in Phase I Clinical Trial (Press)

• Artificial pancreas system better controls blood glucose levels than current technology (NIH)
• NIH scientists develop test for uncommon brain diseases (NIH)
• Scientists work toward a rapid point-of-care diagnostic test for Lyme disease (NIH)
• IUDs associated with lower ovarian cancer risk (Reuters)
• Titan Medical Delays Timeline for Surgical Robot Again (MDDI)

• Pelosi: Democrats will name marquee drug pricing bill for late Rep. Cummings (STAT) (Pink Sheet-$)
• Patient advocates launch drug pricing ad campaign (The Hill)
• CSL sues a former employee and rival over alleged theft of trade secrets (STAT)
• US vaping-related deaths rise to 31, Minnesota confirms two more deaths (Reuters)
• Seema Verma to face House Democrats (Politico)
• PTAB Won't Rehear Challenge To Prostate Cancer Drug Patent (Law360-$)
• Insys Judge Unsure If Execs' Bribes Equal Drug Dealing (Law360-$)
• Sandoz Revealed Trade Secrets In Antitrust Suit, Court Told (Law360-$)
• Toss 3-Way Zetia Conspiracy Claim, Judge Says (Law360-$)
• Shkreli Asks Justices To School 2nd Circ. On Securities Fraud (Law360-$)
• HZNP Medicines LLC v. Actavis Laboratories UT, Inc. (Fed. Cir. 2019) (Patent Docs)
• Eleventh Circuit Allows Trial by Ambush and Bad Science (Drug & Device Law)
• Aloe Vera Supplement Seller Barred from Making Misleading Health Claims (FTC)

• FDA Advisory Committee Calendar

• EMVO Provides Guidance on Batch Recalls (EMVOv)

• MHLW Taking Public Comments on Rx-to-OTC for Mosapride (PharmaJapan)
• Sumitomo Dainippon drops pursuit of Cynata (PharmaLetter-$)

• Multinationals and domestic drugmakers upping R&D investment in India (PharmaLetter-$)
• CDSCO mandates licensing authorities to get PERs of 19 specified IVD tests for grant of import and manufacturing licenses (Pharmabiz)
• DoP tweaks composition of scheme steering committee to implement scheme for development of APIs (Pharmabiz)

• As 'Cannabis 2.0' kicks off in Canada, industry strangled by limited retail outlets (Reuters)

• TGA presentation: TERMIS-AP + ABMC7 2019 Congress, 14-17 October 2019 (TGA)
• Current status of breast implant products in Australia (TGA)
• Therapeutic Goods (TGA Assessed Claim) Authorisation 2019 (TGA)
• Consultation: Proposed clarification of the regulatory requirements for medical device systems and procedure packs (TGA)