Recon: Drug Suppliers Say Brexit Freight Plans Urgently Needed; Philippines Prepares Vaccination Cam

Posted 20 September 2019 | By Michael Mezher 

Recon: Drug Suppliers Say Brexit Freight Plans Urgently Needed; Philippines Prepares Vaccination Campaign After Polio Reemerges
Welcome to Regulatory Reconnaissance, your each day regulatory information and intelligence briefing.
In Focus: US

  • Pelosi Unveils Plan to Lower Prescription Drug Prices (Focus)
  • US House speaker: Drug pricing plan ought to be precedence for White House (Reuters)
  • Democrats’ drug pricing proposal ‘useless on arrival’ in Senate: main Republican (Reuters) (Politico)
  • Trump says he likes a Republican drug invoice after Democratic various unveiled (Reuters)
  • How An ‘International Price Index’ Might Help Reduce Drug Prices (NPR)
  • New information reveals that Big Pharma is raking in virtually half of all of the income in healthcare (Business Insider)
  • Opioid-maker Purdue Pharma is allowed bonus payout in chapter 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 indicators order geared toward improvement of higher flu vaccines (Reuters)
  • Insys will get chapter courtroom okay for Subsys sale (PMLive) (Law360-$)
  • US awards $three million to fill gaps in medical marijuana analysis (AP) (NIH)
  • Vaping-related diseases surge as FDA discloses prison probe (Washington Post) (Forbes) (CNBC)

In Focus: International

  • Drug and medical suppliers say urgently want Brexit freight plans (Reuters) (Pink Sheet-$)
  • Philippines to vaccinate thousands and thousands as polio virus resurfaces in 2 kids (Reuters) (NYTimes)
  • French weight-loss tablet scandal set for landmark trial (Reuters)
  • Emmaus rescinds EU advertising and marketing software, following detrimental evaluate (Endpoints)
  • Roche to shut Irish web site by subsequent yr, plans 132 layoffs: report (Fierce) (Irish Times)
  • Lundbeck and Takeda’s melancholy drug permitted in Japan (Pharmafile)
  • FibroGen and Astellas’ Evrenzo permitted in Japan (PharmaLetter-$) (Press)
  • First MDR Certificate Issued for Class III Device (Focus)

Pharmaceuticals & Biotechnology

  • Should You Keep Taking Zantac for Your Heartburn? (NYTimes)
  • Patients, docs could not share priorities for power illnesses (Reuters)
  • As Nasdaq enrolls the ultimate batch of 2019 IPOs, how have the numbers in comparison with previous 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 ache trial (Fierce)
  • FDA Calls on Compounders to be More Diligent About Their Bulk Suppliers (Focus)
  • Tampa most cancers centre’s experience attracts biotech start-ups (Financial Times)
  • Pfizer amps up gene remedy manufacturing with one other 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 may restore broken 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, however Abortions With Black-Market Pills Are Rising (NYTimes)
  • Breath take a look at may 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)

Pharmaceuticals & Biotechnology: Study Results, Filings & Designations

  • 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 three Trials of Dupixent® (dupilumab) in Severe Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) (Press)
  • Eisai to Present New 12-month Safety & Effectiveness Data from Phase three 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)

Medical Devices

  • CDRH Takes First Step to Operationalize New Safety and Performance Based Pathway (Focus)
  • FDA approves cobas Babesia, Roche’s first entire blood take a look at 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 information (MassDevice)
  • FDA clears Viseon’s Voyant backbone surgical procedure imaging machine (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)

US: Assorted & Government

  • 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)

Upcoming Meetings & Events


  • 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 purchase Alder, Euro biotechs reel in money and Russian lab blast (Fierce)
  • Medicines: reclassify your product (MHRA)
  • Clinical trials for medicines: authorisation evaluation efficiency (MHRA)
  • Update on the licensing standing of Avastin when supposed for intravitreal administration (MHRA)


  • Inspection of Unichem’s Kolhapur facility by USFDA accomplished with out observations (Economic Times)
  • FDA knocks Lupin plant with warning letter after drugmaker didn’t treatment operational woes (Fierce)
  • Strides Pharma board approves addnl USD 40 mn funding in Stelis Biopharma (Economic Times)

General Health & Other Interesting Articles

  • Invasive Mosquitoes Plunge Deeper Into California (KHN)
  • Scientists Identify Neurons That Help the Brain Forget (NYTimes)
  • Neurotoxin could have precipitated diplomats’ sickness in Cuba: research (Reuters)

Regulatory Reconnaissance is our each day intelligence briefing for the regulatory affairs house, bringing you the highest regulatory information tales from across the globe. Each weekday morning, we goal to convey you the most recent highlights of latest approvals, conferences, authorized and political developments, rules and steering, and the most recent developments with the potential to influence regulatory affairs professionals and the business wherein they work.
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