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Pharmaceutical industry

Regulatory Reconnaissance: Daily Regulatory News and Intelligence Briefing

Strategic Insights

— 5 min read

The US FDA has approved Daiichi's breast cancer drug for broader use in the US, while President Biden maintains Dr. Francis Collins as the National Institutes of Health director. The administration is also renaming "Operation Warp Speed" due to perceived failures under the Trump administration. Meanwhile, the WHO is pushing for Pfizer's vaccine to be accessible to poorer nations, and scientists are discussing vaccine safety, efficacy, and access at the global R&D forum.

Key Takeaways:

  • The FDA has approved Daiichi's breast cancer drug for broader use in the US, expanding treatment options for patients.
  • President Biden will maintain Dr. Francis Collins as the National Institutes of Health director, ensuring continuity in healthcare leadership.
  • The Biden administration has renamed "Operation Warp Speed" due to perceived failures under the Trump administration, reflecting a shift in priorities and approach.
  • The WHO is advocating for Pfizer's vaccine to be accessible to poorer nations, highlighting the importance of global vaccine distribution and equitable access.
  • Scientists are discussing vaccine safety, efficacy, and access at the global R&D forum, focusing on optimizing testing and screening for COVID-19.
  • Health data firm Target RWE has acquired NoviSci in an Amgen-backed deal, highlighting the growing importance of health data analytics in the healthcare industry.
  • Janssen has filed Imbruvica for post-transplant GVHD in Japan, demonstrating ongoing efforts to secure regulatory approvals for innovative treatments.
  • The FDA has approved Janssen's AL amyloidosis drug, expanding treatment options for patients suffering from this rare condition.
  • The EU Notified Body Association has taken steps to address EC's virtual audit fears, ensuring regulatory compliance and oversight in the medical device industry.
  • Health officials propose waiving regulatory review of medical AI tools, sparking concerns about the risks of undue influence on regulatory bodies.

Statistics:

  • The US FDA has approved Daiichi's breast cancer drug for broader use in the US, expanding treatment options for patients.
  • President Biden has maintained Dr. Francis Collins as the National Institutes of Health director, ensuring continuity in healthcare leadership.
  • The WHO is advocating for Pfizer's vaccine to be accessible to poorer nations, highlighting the importance of global vaccine distribution and equitable access.
  • Scientists are discussing vaccine safety, efficacy, and access at the global R&D forum, focusing on optimizing testing and screening for COVID-19.
  • Health data firm Target RWE has acquired NoviSci in an Amgen-backed deal, highlighting the growing importance of health data analytics in the healthcare industry.
  • Janssen has filed Imbruvica for post-transplant GVHD in Japan, demonstrating ongoing efforts to secure regulatory approvals for innovative treatments.
  • The FDA has approved Janssen's AL amyloidosis drug, expanding treatment options for patients suffering from this rare condition.
  • The EU Notified Body Association has taken steps to address EC's virtual audit fears, ensuring regulatory compliance and oversight in the medical device industry.
  • Health officials propose waiving regulatory review of medical AI tools, sparking concerns about the risks of undue influence on regulatory bodies.

Sources:

  • "AstraZeneca's breast cancer drug gets broader US approval, Reuters, 2 February 2020"
  • "Biden will keep Dr. Francis Collins as National Institutes of Health director: statement," Reuters, 2 February 2020
  • "Biden warns of challenges ahead as he rolls out new vaccine plan," Politico, 2 February 2020
  • "Biden Administration Will Rename 'Operation Warp Speed,' Citing Trump 'Failures'," NPR, 2 February 2020
  • "COVID-19 Supply Deal Lets Vaccine Maker Earmark Doses For Employees And Their Families," NPR, 2 February 2020
  • "Biden to Elevate Science Adviser to His Cabinet," NYTimes, 2 February 2020
  • "Trump admin enlists private firm to review some Covid-19 tests," Politico, 2 February 2020
  • "Health officials confident Biden will deliver on promise of 100 million vaccines in 100 days," Politico, 2 February 2020
  • "The Trump administration bailed out prominent anti-vaccine groups during a pandemic," Washington Post, 2 February 2020
  • "WHO hopes poorer nations can access Pfizer vaccine 'very soon'," Reuters, 2 February 2020
  • "Chinese and Russian vaccines in high demand as world scrambles for doses," FT, 2 February 2020
  • "Norway says advice on use of Pfizer vaccine is unchanged," Reuters, 2 February 2020
  • "Israel sharing COVID-19 data with Pfizer to help fine-tune vaccine rollout," Reuters, 2 February 2020
  • "UK says vaccine manufacturing is 'lumpy' but still on course for targets," Reuters, 2 February 2020
  • "Sinovac says its COVID-19 vaccine more effective with longer dosing interval," Reuters, 2 February 2020
  • "A Mix of Pride and Doubts as Modi Launches India's Covid-19 Vaccine Drive," NYTimes, 2 February 2020
  • "Scientists tackle vaccine safety, efficacy and access at global RandD forum," WHO, 2 February 2020
  • "Emergency Committee on COVID-19 advises on variants, vaccines," WHO, 2 February 2020
  • "Vaccine nationalism puts world on brink of 'catastrophic moral failure' - WHO chief," Reuters, 2 February 2020
  • "Coronavirus Pandemic Black Americans Are Getting Vaccinated at Lower Rates Than White Americans," KHN, 2 February 2020
  • "US and China clash at WHO over scientific mission in Wuhan," Reuters, 2 February 2020
  • "EU works to plug large gap in virus sequencing as COVID variants spread," Reuters, 2 February 2020
  • "Swiss to get Moderna vaccine in tranches until mid-year: Blick," Reuters, 2 February 2020
  • "Swiss set to approve AstraZeneca COVID vaccine this month: NZZ," Reuters, 2 February 2020
  • "Pakistan approves AstraZeneca COVID-19 vaccine for emergency use," Reuters, 2 February 2020
  • "Pfizer delays Jan. vaccine delivery to Bahrain - health ministry," Reuters, 2 February 2020
  • "Valneva says UK rollout of COVID-19 vaccine could start in July-Sept -- report," Reuters, 2 February 2020
  • "Bayer aims to help CureVac with COVID-19 vaccine output, says CEO," Reuters, 2 February 2020
  • "Lebanon inks final deal for 2.1 million doses of Pfizer-BioNTech vaccine," Reuters, 2 February 2020
  • "Brazil clears emergency use of Sinovac, AstraZeneca vaccines, shots begin," Reuters, 2 February 2020
  • "Priority strategies to optimize testing and screening for COVID-19 in Canada: Report," Health Canada, 2 February 2020
  • "The limits of acceptable political influence over the FDA," Nature, 2 February 2020
  • "Accelerating the Adoption of Advanced Manufacturing Technologies to Strengthen Our Public Health Infrastructure," FDA, 2 February 2020
  • "Thermo Fisher Shells Out $876M For Viral Vector Maker," Law360, 2 February 2020
  • "Health data firm Target RWE buys NoviSci in Amgen-backed deal," Reuters, 2 February 2020
  • "Janssen Files Imbruvica for Post-Transplant GVHD in Japan," PharmaJapan, 2 February 2020
  • "Xalkori bags FDA green light for rare paediatric non-Hodgkin lymphomac," PharmaTimes, 2 February 2020
  • "FDA approves Janssen's AL amyloidosis drug," Pharmafile, 2 February 2020
  • "EU Notified Body Association Takes Steps To Allay EC's Virtual Audit Fears," MedtechInsight, 2 February 2020
  • "'Slippery slope territory': Health officials propose waiving regulatory review of medical AI tools," STAT, 2 February 2020
  • "Consultation on proposed changes to the Medical Devices Directorate's Draft Guidance Document - List of Recognized Standards for Medical Devices," Health Canada, 2 February 2020
  • "Neuromod portfolios advance at Medtronic, Boston Scientific, Abbott," MedtechDive, 2 February 2020
  • "NANS 2021: Boston Scientific Advances New Personalized Pain Therapy," MedtechInsight, 2 February 2020
  • "Liquid Biopsy Company Delfi Diagnostics Raised $100M For New Class of Early Cancer Detection Test," MedtechInsight, 2 February 2020
  • "Pear Therapeutics inks deal with digital pill company etectRx," mobihealthnews, 2 February 2020
  • "EU Rule Presents New Medical Device Compliance Hurdles," Law360, 2 February 2020
  • "Government Report Outlines Costs, Savings Of Major Regs," MedtechInsight, 2 February 2020
  • "Supporting a Budget Increase for FDA for FY 22," Alliance for a Stronger FDA, 2 February 2020
  • "Maryland Senate overrides governor's veto of prescription drug affordability board," STAT, 2 February 2020
  • "Compounding Pharmacy Mogul Sentenced for Multimillion-Dollar Health Care Fraud Scheme," DOJ, 2 February 2020
  • "Rite Aid Must Face Trial For Inflated Drug Price Claims," Law360, 2 February 2020
  • "Sanofi Prevails Over Mylan At Fed. Circ. On Jevtana Patent," Law360, 2 February 2020
  • "Novo Joins Challenge To HHS Pharma Discount Opinion," Law360, 2 February 2020
  • "Fed. Circ. Sticks With Ruling In Bard's $68M Patent Fight," Law360, 2 February 2020

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