Recon: NICE Backs Clovis’ Rubraca After Increased Discount; EU, UK Extend Brexit Talks as Prospect of Deal Improves

• Trump's smoke-and-mirrors 2020 health care strategy (Axios)
• PhRMA CEO warns Pelosi bill to lower drug prices would be 'devastating' for industry (The Hill)
• PhRMA Willing To Contribute To Drug ‘Affordability’ – But Less Than $15bn A Year (Pink Sheet-$)
• Pharma industry is 'right in the crosshairs,' Merck CEO Kenneth Frazier says (Yahoo Finance) (Feirce)
• US appeals court will not disqualify judge in opioid cases or delay trial (Reuters)
• OxyContin maker Purdue begins showdown to halt opioid lawsuits (Reuters) (AP)
• US judge urges parties to wisely use Purdue opioid settlement funds (Reuters)
• Gilead builds case for Xeljanz rival filgotinib as it preps US filing (PMLive) (Endpoints) (Press)
• Biosimilars: US FDA Ends FY 2019 With Record Number Of Approvals, One Complete Response Letter (Pink Sheet-$)
• FDA too slow in assessing cancer link to blood pressure drugs, watchdog says (CBS) (US PIRG)
• US vaping-related deaths rise to 26, illnesses to 1,299 (Reuters) (CDC)

• Brexit Talks to Intensify as Prospect of Deal Improves (WSJ) (Axios) (BBC) (AP)
• Sanofi opens new HQ (PharmaTimes)
• Canada Opens the Door to Public Scrutiny of Clinical Drug Trials (UnDark)
• Doctors Without Borders demands drug makers lower their prices for TB treatments (STAT)
• Increased discount leads NICE to reverse position on Clovis cancer drug (PMLive) (Endpoints)
• Documents potentially misleading in Aurobindo Pharma's Unit-VII: USFDA (Economic Times)
• Report finds ‘startling’ lack of progress of antibiotic R&D agenda (PMLive)
• 'Alarming upsurge' in measles has devastating impact, WHO warns (Reuters)

• Resisting Protein Degradation: The Cells Fight Back (In the Pipeline)
• FDA new drug approvals in Q3 2019 (Nature)
• Wellness Brands Skirt FDA Rules to Push Shady UTI ‘Cures’ on Instagram (Vice)
• N-of-1 Trials: FDA Plots Path to Regulation (Focus)
• Researchers Find 15% of Trials Could be Replicated Using Real World Data (Focus)
• Gene therapy biotechs caught in manufacturing crunch (BioPharmaDive)
• Health Officials Urge Caution in Reducing Opioids for Pain Patients (NYTimes)
• Men account for a small fraction of breast cancer cases. Their mortality rate has soared over women’s (STAT)
• Roche vice-chair: Let's repair the damage that short-term profit drive has done to the planet (Endpoints)
• A road map for including Latinos and African Americans in Alzheimer’s research (STAT)
• Vir Bio’s IPO Brings In $143M for Tests of Hepatitis B Drug and More (Xconomy)
• The Placebo Effect Is Hobbling New Psychiatric Drugs. What Can Stop It? (Xconomy)
• Medicines in Development for Mental Illness 2019 Report (PhRMA)
• Parexel partners with Datavant on real-world data (BioPharmaDive)
• Premier joins forces with Amphastar on 7 drugs in short supply (BioPharmaDive)
• This teen had a disease so rare, it didn't have a name. His legacy could help countless others (NBC)
• PDA, ISPE Launch Quality Culture Effort With Root Cause Analysis Guide (Pink Sheet-$)
• Nitrosamine Episode Could Lead To Paradigm Shift In Quality (Pink Sheet-$)
• ‘Sticky’ gene may help Valium calm nerves (NIH)
• FDA’s Latest PFDD Guidance Puts What Is Important to Patients at the Center of Drug Development. How? By Asking Them. (FDA Law Blog)
• Aridis nabs pharma veteran as ex-CMO leaves for 'personal reasons' after drug flop (Fierce) (Endpoints)
• Northwest Bio still hanging on; Five Prime's latest round of layoffs claims 70 (Endpoints) (Fierce)
• Zosano Pharma CEO passes baton down to successor; James Sapirstein takes the helm at AzurRx (Endpoints)
• Innoveix Pharmaceuticals, Inc. Issues Voluntary Recall of all Sterile Compounded Drug Products Due to a Lack of Sterility Assurance (FDA)

• Ex-AbbVie partner Principia posts encouraging PhII results for its BTK-inhibitor (Endpoints)
• MGB Biopharma reveals positive mid-stage diarrhoea data (PharmaTimes)
• ProQR eye-disease data lend confidence that pivotal trial will succeed (BioPharmaDive)
• Eyevensys Presents Initial Data from Phase I/II Trial of Innovative, Non-Viral Gene Therapy for Ocular Diseases at 11th Annual Ophthalmology Innovation Summit (Press)
• Mezzion Pharma announces that it has conducted a Type C Meeting with the FDA Regarding the TOP Line Data from the FUEL Phase 3 Clinical Trial (Press)
• Immunic, Inc. Announces Completion of Enrollment for its Phase 2 EMPhASIS Trial of IMU-838 in Patients with Relapsing-Remitting Multiple Sclerosis (Press)
• Aerpio Pharmaceuticals Announces Interim Results from its Phase 1b Clinical Trial of Topical Ocular Formulation of AKB-9778 for Primary Open Angle Glaucoma (Press)
• Harbour BioMed Announces Completion of Phase 2 Study in China of HBM9036 In Patients With Moderate-to-Severe Dry Eye Disease (Press)
• Kangpu Biopharmaceuticals Successfully Completed Phase I Study of Novel CRL4-CRBN Modulator KPG-818 in the U.S. (Press)

• 2020 Guidance: CDRH Offers a Look at What’s Coming (Focus)
• FDA Clears First Rapid Diagnostic Test for Ebola (Focus)
• Medtronic’s Tiny New InterStim Micro Neurostimulator Submitted to FDA (MedGadget)
• Grail Stays at Forefront of Liquid Biopsy Conversation with New Results (MDDI)
• HHS hesitant to include implantable medical devices in Anti-Kickback safe harbor (MedtechDive)

• PhRMA’s talking points shouldn’t derail the Pelosi drug pricing bill (STAT)
• Medicaid work requirements back in court today (Politico)
• NIH strategic research plan addresses growing tickborne diseases threat (NIH)
• Gottlieb: Pot Legalization Makes Vaping Deadly (WSJ)
• Court green-lights Clovis case after detailing evidence the board ‘ignored red flags’ on false safety and efficacy data (Endpoints)
• GAO finds low uptake of disposable wound care devices (MedtechDive) (GAO)
• Ohio Trial In Opioid MDL Will Go Forward, 6th Circ. Says (Law360-$)
• J&J Beats Class Action Over Opioid Health Insurance Costs (Law360-$)
• 19 Abilify Claims Tossed As Lacking Proof In MDL Settlement (Law360-$)
• USPTO Seeks Comments on Patenting AI-based Inventions (Patent Docs)
• Idaho Breaks The Right Way on Innovator Liability (Drug & Device Law)

• FDA Advisory Committee Calendar

• Austria Works On Method To Improve Price Transparency (Pink Sheet-$)
• Roche Takes Orphan Satralizumab To EMA (Pink Sheet-$)
• PRIME eligibility requests (EMA)

• Shionogi expands deal with Hsiri Therapeutics in mycobacterial diseases (PharmaLetter-$)
• OncoSec Announces $30 Million USD Strategic Investment at a Premium to Market by China Grand Pharmaceutical and Healthcare Holdings (CGP) in Connection with Exclusive License to TAVO™ in Greater China and 35 Other Asian Countries (Press)

• US FDA finds failures at Goa plant of India’s Cipla (PharmaLetter-$)
• CDSCO soon to notify list of OTC drugs to prevent misuse of medicines (Pharmabiz)
• Health ministry launches WHO India Country Cooperation Strategy 2019–2023 (Pharmabiz)

• For the Most Vulnerable, California Blackouts ‘Can Be Life or Death’ (NYTimes)
• It’s Possible to Inherit More DNA From One Parent Than the Other (The Atlantic)
• A Virus in Koala DNA Shows Evolution in Action (NYTimes)
• New transplant research aims to salvage infected donated organs (Reuters)
• Men who conceive with assisted reproduction at increased prostate cancer risk (Reuters)