Recon: FDA Approves AZ's Asthma Drug Fasenra for Self-Administration

• FDA green lights AstraZeneca's asthma drug Fasenra for self-administration (Reuters)
• FDA approves Gilead's Descovy for HIV prevention (Reuters) (Endpoints) (FDA)
• An unconventional health care speech: Trump wishes pharma stocks would drop, and implies drug industry is behind impeachment (STAT) (Endpoints) (KHN)
• Trump's Medicare executive order (Politico) (CNBC) (NPR) (Reuters)
• Trump: Drug Importation Coming Soon (Focus)
• White House insists drug prices are falling, but critics say its report is flawed (STAT)
• After Brain Cancer Drug Fails, Tocagen to Cut More Than Half of Staff (Xconomy)
• Why Lifesaving Drugs May Be Missing on Your Next Flight (NYTimes)
• NIH funding bolsters rare diseases research collaborations (NIH)
• CVS drug coverage plan based on outside pricing review is off to a slow start (Reuters)
• US vaping-related deaths rise to 18, illnesses surpass 1,000: CDC (Reuters)

• UK pharma sector welcomes export curbs on selected medicines (Financial Times)
• With Drug Shortages in Mind, UK Looks to Block Some Parallel Exports (Focus)
• Brexit: recent UK proposals do not offer the safeguards the EU and Ireland need (European Parliament)
• Drug firms colluded to raise price of essential NHS medicine by 1,800%, watchdog finds (Independent) (Fierce)
• Tanzania denies hiding information on suspected Ebola cases (Reuters)
• Servier acquires Pixuvri from CTI BioPharma (PharmaTimes)
• Sanofi to add 350 jobs at shared services site in Hungary (Fierce)
• ABPI details Brexit plans at PIPA conference (PharmaTimes)

• Icosavax nabs $51M as synthetic virus heads toward clinic (Endpoints)
• Gene therapy stocks have taken a beating. Their recovery may be slow (BioPharmaDive)
• Gene therapy coming of age: Opportunities and challenges to getting ahead (McKinsey)
• Update on FDA Approvals for 2019 (Eye on FDA)
• In the Pancreas, Common Fungi May Drive Cancer (NYTimes)
• Head and neck melanomas increasing, especially among boys and young men (Reuters)
• Woodcock Bemoans Lack Of 'Biobetter' Provision In BPCIA (Pink Sheet-$)
• GlaxoSmithKline unveils $139M US plant for Benlysta production (Fierce)
• Third Rock's Goldfinch bags rights to Takeda kidney disease drug (Fierce)
• It May Be Time For Standard Breast Cancer Treatment To Change (Forbes)
• Eli Lilly's Taltz tops J&J's Tremfya with 41% skin clearance in head-to-head tussle (Fierce)
• PDUFA Spending Trends: Fee Revenue Jumps As Percentage Of Funding As Staffing Grows (Pink Sheet-$)
• Pivotal failure triggers job cuts at San Diego-based Tocagen (Endpoints)
• Regeneron doubles down on partner Adicet's gamma delta T cell tech in $80M financing (Endpoints)
• Aeovian Pharmaceuticals brings in $37 million in mTOR play (Endpoints)

• Janssen Announces US FDA Breakthrough Therapy Designation Granted for Niraparib for the Treatment of Metastatic Castration-Resistant Prostate Cancer (Press)
• Verastem Oncology Receives Orphan Drug Designation from FDA for COPIKTRA for the Treatment of T-Cell Lymphoma (Press)
• Oncternal Therapeutics Announces Opening of Phase 1b Expansion Cohort of Clinical Trial of Cirmtuzumab in Combination with Ibrutinib in Patients with Mantle Cell Lymphoma (Press)
• ACADIA Pharmaceuticals Announces Late-Breaking Oral Presentation of the Phase 3 HARMONY Study of Pimavanserin in Dementia-Related Psychosis at the Clinical Trials on Alzheimer’s Disease (CTAD) 2019 Meeting (Press)
• New Data from Enanta’s Phase 2a Human Challenge Study of EDP-938 for RSV Demonstrates Highly Statistically Significant Reductions (p<0.001) in Total Symptom Score, Mucus Weight and RSV Viral Load as Measured by RT-PCR Assay and by Plaque Assay (Press)
• MEI Pharma Announces Updated Clinical Data from ME-401 Phase 1b Study in Patients with Indolent B-cell Malignancies (Press)

• Paralyzed man walks again with brain-controlled exoskeleton (Reuters)
• Brain Stimulation Shows Promise in Treating Severe Depression (NYTimes)
• CSA Medical touts one-year feasibility data for RejuvenAir bronchitis device (MassDevice)
• FDA clears Exogenesis nano-modified hernia mesh (MassDevice)

• House Bill Aims to Cut Insulin List Prices to 2006 Levels (Focus)
• Top colleges took in at least $60 million from family that owns Purdue Pharma as opioid lawsuits piled up (STAT)
• Legislators on the road in southern Minnesota hear about skyrocketing drug prices (Star Tribune)
• Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act (FDA Law Blog)
• FTC opens inquiry into e-cigarette industry’s marketing practices (CNBC)
• Altria launches Iqos tobacco device in US, and the timing couldn’t be better (CNBC)

• FDA Advisory Committee Calendar
• 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 – 4 November 2019

• EU Guide Aims To Help Manufacturers Avoid Setting Off 'False Alarms' Under FMD (Pink Sheet-$)
• EU Regulatory Roundup: EMA Expands Nitrosamines Investigation to All Chemically Synthesized APIs (Focus)
• Variations to Marketing Authorisations (MAs) after Brexit (MHRA)
• Emerade pens – patients reminded to carry 2 pens at all times (MHRA)
• Class 4 Medicines Defect Information: Emerade 150, 300 and 500 microgram solution for injection in pre-filled syringe (MDR 57-08/19) (MHRA)
• Breathing circuit swivel elbow – recall due to risk of cracks forming before or during use (MDA/2019/032) (MHRA)

• Higher court rules in Chugai’s favor in Baxalta patent row (PharmaLetter-$)

• Lupin appoints Johnny Mikell as Global Head of Quality (Economic Times)

• Brazil’s ANVISA approves formal regulations for custom-made medical devices (Emergo)
• Quality of care and health of ethnic groups in the Americas are the focus of two new PAHO action plans (PAHO)

• Drinking within recommended limits not tied to dementia (Reuters)