Recon: Gilead to Challenge US Patents on Truvada; NICE Chief to Step Down

• Gilead to challenge US patents on HIV drug Truvada (Financial Times) (STAT) (Bloomberg)
• Trump administration appeals drug price disclosure ruling (The Hill) (Reuters)
• Retrophin scraps nervous system disorder study, shares dive (Reuters) (Endpoints)
• Biotech leaders rally behind Chinese scientists in US, calls for 'measured' policies in wake of purges (Endpoints) (BioCentury)
• Customers Handed Over Their DNA. The Company Let the FBI Take a Look. (WSJ)
• Johnson & Johnson opioid trial judge expected to issue landmark verdict Monday (CNBC)
• To patients, Sarepta repeats message on surprise rejection of Duchenne drug (BioPharmaDive)
• Scientists Attempt Controversial Experiment To Edit DNA In Human Sperm Using CRISPR (NPR)
• Shopping Abroad For Cheaper Medication? Here’s What You Need To Know (KHN)
• Feds Pave The Way To Expand Home Dialysis — But Patients Hit Roadblocks (KHN)

• Vienna-based vaccine developer Themis signs pact with Merck for 'blockbuster indication' (Endpoints) (Fierce) (Press)
• Sir Andrew Dillon, NICE's first and only CEO to step down next year (Endpoints) (PMLIve) (NICE)
• GSK's long acting HIV injection gets boost from study (Reuters) (Endpoints) (Press)
• As Brexit nears, Britain's drugs, devices and pricing regulators seek the exit (Fierce)
• Fitbit targets 1 million new users with Singapore government tie-up (Reuters)
• Japan approves Genmab's Darzalex in newly diagnosed multiple myeloma (Pharmafile)
• Fiasp approved for children in Europe (PharmaTimes)
• Skyrizi bags NICE fast-track (PharmaTimes)
• Technical Report On Terminology Maintenance For Medicinal Products Just Published (ISO)

• Scientists routinely cure brain disorders in mice but not us. A new study helps explain why (STAT) (NPR)
• Accelerating the Development of a Universal Influenza Vaccine (Influenzer)
• Former FDA Commissioners Seek to Expand Use of RWE in Regulatory, Payment Decisions (Focus)
• FDA review finds no increased risk of prostate cancer with Parkinson's disease medicines containing entacapone (Comtan, Stalevo) (FDA)
• Opinion: Time to Throw In the Towel on Biosimilars (WSJ)
• New Age Thinking: US FDA’s Temple Sees Third Era Of Drug Development (Pink Sheet-$)
• Patient Perspectives About Decisions to Share Medical Data and Biospecimens for Research (JAMA)
• AI startups are racing into drug development. Here’s 5 burning questions about which will survive (STAT)
• Finch grabs a $53M round designed to take their ‘breakthrough’ microbiome treatment through a potentially pivotal trial (Endpoints) (Fierce)
• Roche's effort to stop cancer metastasis unexpectedly leads to a Merck drug (Fierce)
• IQVIA launches new online patient portal (PMLive)
• Versant-backed Chinook gets a $65M launch round for its discovery quest in a resurgent kidney field (Endpoints)
• Patent “March-In” As Price Control Draw Little Support At US National Academies Meeting (Pink Sheet-$)
• Gene editing to stop Lyme disease: caution is warranted (STAT)
• A community-guided genome editing project can fight Lyme disease (STAT)
• Can a new Lyme disease vaccine overcome a history of distrust and failure? (STAT)
• Topical Cocaine Provides US FDA With First Case Of ‘Dueling’ 505(b)(2) NDAs (Pink Sheet-$)

• U.S. FDA Grants XTANDI® (enzalutamide) Application Priority Review for the Treatment of Men with Metastatic Hormone-Sensitive Prostate Cancer (Press)
• BeiGene gets speedy US review for lymphoma drug zanubrutinib (PMLive)
• Rocket Pharmaceuticals Announces Clearance from the Spanish Agency for Medicines and Health Products for the Phase 2 Registration-enabling FANCOLEN-II Study of RP-L102 for Fanconi Anemia (Press)
• Amgen, Allergan biosimilar of Roche's blockbuster Rituxan clears another US pivotal study  (Endpoints)
• Mundipharma Announces the Licence Extension Submission for Invokana® (canagliflozin) and Vokanamet® (canagliflozin and metformin) to the European Medicines Agency (Endpoints)

• Edwards Recalls Part of Transcatheter Heart System After One Death (Focus) (FDA)
• Varian closes $90m microspheres buy from Boston Scientific (MassDevice)
• Orexo, GAIA to develop digital therapeutic for opioid use disorder (BioCentury)
• FDA wants more on new manufacturing process from Clearside Biomedical (MassDevice)
• FDA grants breakthrough nod to Miracor Medical’s PiCSO device (MassDevice) (Press)
• SurGenTec® Announces FDA Clearance for Neurostimulation with ALARA™ Access Needle Kit (Press)

• Deepening mystery of lung illness linked to vaping (Politico)
• JAMA Forum: Price Transparency in Health Care Has Been Disappointing, but It Doesn’t Have To Be (JAMA)
• Opioid Treatment Is Used Vastly More in States That Expanded Medicaid (NYTimes)
• Oregon’s 25 most-expensive prescription drugs (The Oregonian)
• Explainer: What are the obstacles to Bayer settling Roundup lawsuits? (Reuters)
• Biotech Cos. Say Cancer-Killing Cell IP Fight Can Be Litigated (Law360-$)
• PTAB Will Review 2 Guardant Diagnostic Patents (Law360-$)
• Pharmacy Retailers Fight Glenmark's Bid To Exit Zetia MDL (Law360-$)
• New Hampshire Court Applies New Hampshire Product Liability Law and Denies Motion to Dismiss Plaintiff’s Product Liability Claims (Drug & Device Law)
• Petition to Allow Generic Label Approval for Labels on Products from Exotic Species that Received Voluntary Inspection (FDA Law Blog)
• Enzo Life Sciences, Inc. v. Becton, Dickinson and Co. (Fed. Cir. 2019) (Patent Docs)
• Research Misconduct Finding: Rahul Agrawal (HHS ORI)

• FDA Advisory Committee Calendar
• Vaccines and Related Biological Products Advisory Committee; Notice of Meeting – 8 November 2019

• Industry Criticizes EC’s Specifications for Reprocessing Single-use Devices under EU MDR (Focus)
• EU Regulatory Roundup: MHRA Expands Guidance on Assistive Technology to Help Device Industry (Focus)
• Analytical Quality by Design (AQbD): questions and answers (MHRA)
• Danish Regulators Seek to Help Smaller Companies With EU MDR Compliance (Focus)

• Alvogen cleared to market Qsymia in South Korea (PharmaLetter-$)
• Biocon's Malaysian arm gets EU GMP certification for insulin manufacturing facility (Economic Times)

• Pharma traders want DCGI to introduce digital system in place of hard copies of invoices as office records (Pharmabiz)
• Union health ministry to notify GDP norms under D&C Rules to ensure quality of drugs (Pharmabiz)
• NPPA fixes ceiling prices of 2 formulations under DPCO 2013 (Pharmabiz)

• Help us promote adverse event reporting: promotional resources kit (TGA)
• Opioids: Upcoming changes to reduce harm (TGA)
• Notice of a final decision to amend (or not amend) the current Poisons Standard, August 2019 (TGA)

• A doctor and medical ethicist argues life after 75 is not worth living (MIT Technology Review)
• Plastic particles in drinking water present 'low' risk: WHO (Reuters) (NPR)
• Poll: Nearly 1 in 5 Americans Says Pain Often Interferes With Daily Life (NPR)
• With cancer risk timeline, middle-aged women recognize need for cervix screening (Reuters)