Recon: EU, UK Agree to Brexit Extension; Allergan Settles Alzheimer’s Suit for $750M

• Allergan settles Alzheimer's therapy lawsuit for $750 million (Reuters) (Endpoints)
• AstraZeneca aims to carve into Merck’s immunotherapy dominance (STAT) (Endpoints) (Press)
• Seniors clamor for high-dose flu shot, but it’s not always easy to find (STAT)
• Patient Assistance Groups Settle Kickback Claims For $6M  (Law360-$) (STAT)
• What to make of Gilead's latest NASH deal (BioPharmaDive)
• A deal-hungry Vertex ushers in three more gene editing programs as it closes out harbinger CRISPR deal (Endpoints)
• Intraparty Disputes Dim Outlook for Drug-Price Legislation (WSJ)
• Pelosi's office working to kill progressive change to drug pricing bill (Politico)
• Vulnerable Republicans balk at Trump-backed drug pricing bill (The Hill)
• Trade Unions Join Pharma To Attack Democrats Over Bill To Lower Drug Prices (The Intercept)
• Mylan Chief Executive to Get $30.8 Million Payout After Pfizer Deal (Bloomberg)
• The Full Cost of the Opioid Crisis: $2.5 Trillion Over Four Years (White House)
• Google owner Alphabet in bid to buy Fitbit (Reuters)

• Brexit: Johnson agrees to Brexit extension, urges election (BBC) (Reuters) (PMLive) (Pink Sheet-$)
• Ascentage soars during its first day on the Hong Kong exchange, following $53M debut (Endpoints)
• GlaxoSmithKline starts late-stage trial for experimental antibiotic (Reuters) (Endpoints)
• Verseon faces painful reversal after Woodford biotech bubble bursts (Financial Times)
• New tuberculosis treatment for developing countries to cost $1,040 (Reuters)
• As Sanofi preps to leave Bangladesh, workers there plan a hunger strike: report (Fierce)
• Advent’s Zentiva grabs Romanian drugmaker Labormed from Alvogen (Fierce)
• Provention Bio wins PRIME designation for type 1 diabetes prevention drug (PMLive)
• Australia To Use Japanese Reports For Faster Drug Approvals (Pink Sheet-$)

• FDA accepts Heron's painkiller re-submission; splits Blueprint Medicines' NDA for avapritinib (Endpoints)
• Here’s a new way to raise money for your biotech. This trailblazer came out $61M ahead with a place on the NYSE (Endpoints)
• Why People With MS Need Permission from Insurers To Take Life-Saving Drugs. It’s Not The Reason You Think. (Forbes)
• Ovarian cancer market set to smash $6.7 billion by 2025 (Pharmafile)
• Older Patients (Still) Left Out of Cancer Clinical Trials (JAMA)
• Do Expert Panelists Herd? Evidence from FDA Committees (SSRN)
• Oversight of 'Right to Try' stem cell market raises concerns, bioethicists say (SPGlobal)
• Former Axovant CEO David Hung is back — leading a cancer biotech with hefty funding (STAT) (Endpoints)
• Merus makes case for bispecific antibody in specific cancer gene fusion (PMLive)
• USP Views Early Broad Stakeholder Engagement as Essential in Developing Performance-Based Standards for Biologics (IPQ)
• I used to work on Biogen’s Alzheimer’s drug. Is the company spinning bad data? (STAT)
• Google’s venture arm recruits a Harvard/Tesaro vet to help plant the seeds for a second oncology R&D revolution (Endpoints)
• US FDA Details Facilities That NDAs, ANDAs Should Note (Pink Sheet-$)
• The human element: A biotech upstart hopes to carve a path around faulty animal models (Endpoints)
• Sanofi's Dengvaxia: ACIP Decision On Use Will Hinge On Screening Test (Pink Sheet-$)
• Lilly Isn't (Immediately) Worried About US Drug Pricing Legislation (Pink Sheet-$)
• Macleods Pharma USA Inc recalls 31,968 bottles of diabetes drug in US (Economic Times)
• Mylan Pharmaceuticals Initiates Voluntary Nationwide Recall of One Lot of Alprazolam Tablets, USP C-IV 0.5 mg, Due to the Potential of Foreign Substance (FDA)
• Former FDA Reviewer Iftekhar Mahmood, Ph.D., Joins Nuventra Pharma Sciences as Senior Consultant, Clinical Pharmacology and Pharmacometrics (Press)

• CARsgen Announces Investigational CAR-T Therapy CT053 Granted RMAT Designation by the U.S. FDA for R/R Multiple Myeloma (Press)
• Mixed early data on Agios' AG-270 suggest combo therapy could be way forward (Endpoints)
• FDA backs Mike Grey's bet on a comeback drug play with breakthrough status for maralixibat (Endpoints) (Press)
• Omeros Corporation Initiates BLA Submission for Narsoplimab for the Treatment of HSCT-TMA (Press)
• U.S. FDA Grants Fast Track Designation to Astellas for the Development of ASP1128 for Patients at Risk for Acute Kidney Injury (Press)
• IVERIC bio’s Zimura®, a Novel Complement C5 Inhibitor, Met its Primary Endpoint and Reached Statistical Significance in a Phase 2b Randomized, Controlled Clinical Trial in Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration (Press)
• First-Ever U.S. Pivotal Phase 3 Clinical Study in Eosinophilic Esophagitis (EoE) Completes: Takeda's Investigational Therapy Meets Co-Primary & Key Secondary Efficacy Endpoints (Press)
• Deciphera Pharmaceuticals Presents Data from Rebastinib and DCC-3116 Programs at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics (Press)
• SFA Therapeutics, Inc. Receives an FDA Orphan Drug Designation (ODD) for SFA001 in the Treatment of Hepatocellular Carcinoma (HCC) (Press)
• Biohaven Completes Enrollment In Phase 3 Generalized Anxiety Disorder (GAD) Trial Of Troriluzole (Press)
• Zymeworks Announces Phase 1 Data for ZW25 in Combination with Chemotherapy in Advanced Gastroesophageal Adenocarcinoma at AACR-NCI-EORTC International Conference (Press)

• State Medical Technology Association Statement on EtO (AdvaMed)
• Medical Device Innovation Consortium (MDIC) Awarded Funding for Expansion of Case for Quality and Cybersecurity Threat Modeling (Press)
• FDA In Brief: FDA provides new information on risks for patients with endovascular grafts based on real-world data as the agency continues to monitor postmarket safety of these devices (FDA)
• Direct-to-consumer genetic test results may be unreliable (Reuters)
• The Accreditation Scheme For Conformity Assessment (Asca) Pilot Program: Draft Guidance (FDA)
• Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Continuous Glucose Monitor Data Management System (FDA)

• Vaping case numbers tapering off, but U.S. outbreak may not have peaked -CDC (Reuters)
• Novartis Sues Indian Generic Cos. Over Heart Failure Drug IP (Law360-$)
• Ethicon Can't Escape Damages Claims In Pelvic Mesh Suit (Law360-$)
• Lilly Says It Didn't Give Up Alternatives By Narrowing Patent (Law360-$)
• Recent Antitrust Lessons For The Life Sciences Industry (Law360-$)
• Redistribute This! (Drug & Device Law)
• The Privatization of Opioid Litigation (Harvard Bill of Health)
• Walgreens cuts jobs at its US headquarters as drugstore chain slashes costs (CNBC)
• Former FDA chief: ‘I don’t see how’ regulators keep Juul, other e-cigarettes, on the market (CNBC)
• Democrats’ new logic on drug pricing: Developing slightly fewer medicines is OK if it means lower prices (STAT)

• FDA Advisory Committee Calendar

• UKRI and BBSRC award £170m to 3 UK universities for biotech and biology PhD studentships (Pharmafile)
• Metrics For Measuring UK Pricing Scheme Success: Good Start But More Work Needed (Pink Sheet-$)
• EFPIA position on clinical trial transparency (PharmaLetter-$)
• Preparatory discussions between the Commission and Member States for future decisions on health data exchange in Europe (EC)
• New product information wording – Extracts from PRAC recommendations on signals (EMA)
• PRAC recommendations on signals (EMA)

• Biocon number six in top 10 Global Biotech Employers ranking for 2019 (Economic Times)
• Mumbai pharma company gets licence for breakthrough TB drug (Economic Times)
• Dr Reddy's gets 4 observations from USFDA for Srikakulam plant (Economic Times)

• It’s time for Canada to embrace universal pharmacare and protect drug coverage from corporate erosion (STAT)

• TGA-led IMDRF Personalised Medical Devices working group meets in Canberra (TGA)

• Novartis partners with Brazil’s Fiocruz on neglected diseases (PharmaLetter-$)
• Almost 400 Nigerian medical dispensaries shut down for sub-standard practice (Pharmafile)