Recon: Drug Suppliers Say Brexit Freight Plans Urgently Needed; Philippines Prepares Vaccination Campaign After Polio Reemerges

• Pelosi Unveils Plan to Lower Prescription Drug Prices (Focus)
• US House speaker: Drug pricing plan should be priority for White House (Reuters)
• Democrats' drug pricing proposal 'dead on arrival' in Senate: leading Republican (Reuters) (Politico)
• Trump says he likes a Republican drug bill after Democratic alternative unveiled (Reuters)
• How An 'International Price Index' Might Help Reduce Drug Prices (NPR)
• New data reveals that Big Pharma is raking in almost half of all the profits in healthcare (Business Insider)
• Opioid-maker Purdue Pharma is allowed bonus payout in bankruptcy case (CNN)
• Purdue Pharma Warns That Sackler Family May Walk From Opioid Deal (NYTimes)
• As Drugmakers Face Opioid Lawsuits, Some Ask: Why Not Criminal Charges Too? (NPR)
• Trump signs order aimed at development of better flu vaccines (Reuters)
• Insys gets bankruptcy court okay for Subsys sale (PMLive) (Law360-$)
• US awards $3 million to fill gaps in medical marijuana research (AP) (NIH)
• Vaping-related illnesses surge as FDA discloses criminal probe (Washington Post) (Forbes) (CNBC)

• Drug and medical suppliers say urgently need Brexit freight plans (Reuters) (Pink Sheet-$)
• Philippines to vaccinate millions as polio virus resurfaces in 2 children (Reuters) (NYTimes)
• French weight-loss pill scandal set for landmark trial (Reuters)
• Emmaus rescinds EU marketing application, following negative review (Endpoints)
• Roche to close Irish site by next year, plans 132 layoffs: report (Fierce) (Irish Times)
• Lundbeck and Takeda's depression drug approved in Japan (Pharmafile)
• FibroGen and Astellas’ Evrenzo approved in Japan (PharmaLetter-$) (Press)
• First MDR Certificate Issued for Class III Device (Focus)

• Should You Keep Taking Zantac for Your Heartburn? (NYTimes)
• Patients, doctors may not share priorities for chronic diseases (Reuters)
• As Nasdaq enrolls the final batch of 2019 IPOs, how have the numbers compared to past years? (Endpoints)
• Product Hopping: E&C Hearing Addresses Restrictions to Generic Competition (Focus) (Pink Sheet-$)
• IPO take 2: Kindler's Centrexion restarts bid to fund pain trial (Fierce)
• FDA Calls on Compounders to be More Diligent About Their Bulk Suppliers (Focus)
• Tampa cancer centre’s expertise draws biotech start-ups (Financial Times)
• Pfizer amps up gene therapy manufacturing with another North Carolina facility (Fierce)
• FDA Develops Tool to Simulate Immune Response to Biologics (Focus)
• Reference Listed Drug (RLD) Access Inquiries – Updated (FDA)
• FDA’s Comprehensive Response to HIV — Part II (FDA)
• "Abbreviated Approval Pathways for Drug Product: 505(b)(2) or ANDA?" September 19, 2019 Issue (FDA)
• How an arthritis drug from Roche's library could repair damaged hearts (Fierce)
• After swinging the ax on staffers, Five Prime Therapeutics loses CEO (Fierce)
• While Novartis banishes Zolgensma scandal scars — Biogen goes on a Spinraza 'offensive' (Endpoints)
• Polypill for Cardiovascular Disease Prevention in an Underserved Population (NEJM)
• Abortions in Clinics Decline, but Abortions With Black-Market Pills Are Rising (NYTimes)
• Breath test could predict response to immunotherapy (PMLive)
• Updated: Torrent Pharmaceuticals Limited Expands Voluntary Nationwide Recall of Losartan Potassium Tablets, USP and Losartan Potassium / Hydrochlorothiazide Tablets, USP (FDA)

• Merck’s PIFELTRO™ (doravirine) and DELSTRIGO™ (doravirine/lamivudine/tenofovir disoproxil fumarate) Receive US FDA Approval for Use in Appropriate Adults Living with HIV-1 Who Are Virologically Suppressed (Press)
• The Lancet Publishes Results from Two Positive Phase 3 Trials of Dupixent® (dupilumab) in Severe Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) (Press)
• Eisai to Present New 12-month Safety & Effectiveness Data from Phase 3 Lemborexant SUNRISE 2 Study and New Patient and Cohabitant Insights about Insomnia and Toll on Next-Day Functioning at World Sleep Congress (Press)
• Cerevel Therapeutics to Present Results from a Phase 2 Study of Tavapadon in Patients with Early-stage Parkinson’s Disease (Press)
• Tetra Therapeutics Sees Rapid Patient Recruitment and Representative Patient Diversity in its PICASSO Phase 2 Alzheimer’s Disease Trial (Press)
• FDA Grants Orphan Drug Designation to Reneo Pharmaceuticals for REN001 for Treatment of Fatty Acid Oxidation Disorders (Press)
• Elysium Health™ Announces FDA Acceptance of Investigational New Drug Application to Evaluate BASIS™ for Prevention of Acute Kidney Injury in Surgical Cardiac Patients (Press)

• CDRH Takes First Step to Operationalize New Safety and Performance Based Pathway (Focus)
• FDA approves cobas Babesia, Roche’s first whole blood test for donor screening (Press)
• Active Implants wins breakthrough nod for NUsurface knee implant (MassDevice)
• Tandem Diabetes Care touts real-world t:slim X2 insulin pump data (MassDevice)
• FDA clears Viseon’s Voyant spine surgery imaging device (MassDevice)
• ACLA Urges FDA to Reconsider Recent PGx Enforcement Moves (GenomeWeb)
• Where are the world’s medtech headquarters? (MassDevice)
• LimFlow Receives FDA Approval for U.S. Pivotal Study of Minimally-Invasive Technology Designed to Prevent Amputations in Chronic Limb-Threatening Ischemia Patients (Press)

• Board of Regents of the University of Texas System v. Boston Scientific Corp. (Fed. Cir. 2019) (Patent Docs)
• Don’t Forget About OTC Express Preemption (Drug & Device Law)
• Purdue Loses Bid To Toss Mass. Suit Amid Ch. 11 Stay Fight (Law360-$)
• Searching For A Legal Pathway For CBD Products (Law360-$)
• Walgreens And Alphabet’s Wing To Test Drone Delivery (Forbes)

• FDA Advisory Committee Calendar

• EU Regulatory Roundup: Ireland Details Efforts to Mitigate Impact of No-Deal Brexit on Device Supply (Focus)
• Keep It Simple: EU Consults On Future Design Of EMA’s Fee System (Pink Sheet-$)
• EuroBiotech Report—Lundbeck to buy Alder, Euro biotechs reel in cash and Russian lab blast (Fierce)
• Medicines: reclassify your product (MHRA)
• Clinical trials for medicines: authorisation assessment performance (MHRA)
• Update on the licensing status of Avastin when intended for intravitreal administration (MHRA)

• Inspection of Unichem's Kolhapur facility by USFDA completed without observations (Economic Times)
• FDA knocks Lupin plant with warning letter after drugmaker failed to remedy operational woes (Fierce)
• Strides Pharma board approves addnl USD 40 mn investment in Stelis Biopharma (Economic Times)

• Invasive Mosquitoes Plunge Deeper Into California (KHN)
• Scientists Identify Neurons That Help the Brain Forget (NYTimes)
• Neurotoxin may have caused diplomats’ illness in Cuba: study (Reuters)