Pharmaceuticals policy

Mycovia Pharmaceuticals Announces U.S. FDA Acceptance and Priority Review of New Drug Application for Oteseconazole for the Treatment of Recurrent Vulvovaginal Candidiasis  

Retrieved on: 
Wednesday, July 28, 2021

Under the Prescription Drug User Fee Act (PDUFA), the FDA set a six-month period with a target action date of January 27, 2022.

Key Points: 
  • Under the Prescription Drug User Fee Act (PDUFA), the FDA set a six-month period with a target action date of January 27, 2022.
  • Combined Phase 3 data showed that oteseconazole protected more than 90% of participants from having a recurrence for nearly a year.
  • With this timeline and pending full FDA review and approval, Mycovia is preparing for a U.S. launch of oteseconazole in early 2022.
  • Oteseconazole (VT-1161) is a novel, investigational oral therapy for the treatment of recurrent vulvovaginal candidiasis (RVVC).

Novita Pharmaceuticals and China Resources Double Crane Pharmaceutical Enter into an Exclusive License Agreement to Develop and Commercialize Fascin Inhibitor in China

Retrieved on: 
Wednesday, July 28, 2021

CRDC will receive the rights to research, develop, manufacture, and exclusively commercialize Novita's fascin inhibitor in oncology applications in the Greater China region.

Key Points: 
  • CRDC will receive the rights to research, develop, manufacture, and exclusively commercialize Novita's fascin inhibitor in oncology applications in the Greater China region.
  • In addition to excellent safety and pharmacokinetic profiles, NP-G2-044 has shown preliminary and exciting signals of efficacy in late-stage cancer patients.
  • "Novita is delighted to license our first-in-class fascin inhibitor to one of the largest pharmaceutical companies in China," said Jillian Zhang, Ph.D., President and Chief Scientific Officer of Novita.
  • About China Resources Double Crane Pharmaceutical Co., Ltd.
    China Resources Double Crane Pharmaceutical Co., Ltd. ("CRDC"), established in 1939 and headquartered in Beijing, China, has 21 subsidiaries and more than 11,000 employees throughout the country.

Worldwide Pharmaceutical Logistics Industry to 2026 - Strong Cooperation Among the Cold Chain Partners Presents Opportunities - ResearchAndMarkets.com

Retrieved on: 
Wednesday, July 28, 2021

What are the inhibiting factors and impact of COVID-19 shaping the Global Pharmaceutical Logistics Market during the forecast period?

Key Points: 
  • What are the inhibiting factors and impact of COVID-19 shaping the Global Pharmaceutical Logistics Market during the forecast period?
  • Which are the products/segments/applications/areas to invest in over the forecast period in the Global Pharmaceutical Logistics Market?
  • What is the competitive strategic window for opportunities in the Global Pharmaceutical Logistics Market?
  • What modes and strategic moves are considered suitable for entering the Global Pharmaceutical Logistics Market?

U.S. OTC Drugs Market Outlook & Forecasts 2021-2026 - COVID-19 has Considerably Influenced the Sales of OTC Drugs with the Increased Focus on Personal Health - ResearchAndMarkets.com

Retrieved on: 
Tuesday, July 27, 2021

In 2020, online pharmacies and hospital pharmacies segments accounted for the most significant U.S. OTC drugs market shares of 20.60% and 18.50%, respectively.

Key Points: 
  • In 2020, online pharmacies and hospital pharmacies segments accounted for the most significant U.S. OTC drugs market shares of 20.60% and 18.50%, respectively.
  • Online retail giants like Amazon, which recently launched a private label line called Basic Care, contribute to the US OTC drugs market trend.
  • In the past 30 years, the FDA has converted more than 700 prescription (Rx) products to OTC status.
  • What is the impact of COVID-19 on the U.S. OTC drugs market?

Xihua Scientific Selects LifeSphere MultiVigilance to Advance Pharmacovigilance Services

Retrieved on: 
Tuesday, July 27, 2021

Xihua Scientific, a CRO providing a one-stop set of cost-effective services to the global pharmaceutical industry, was searching for best-in-class cloud software that would enable them to expand their breadth of services to include pharmacovigilance.

Key Points: 
  • Xihua Scientific, a CRO providing a one-stop set of cost-effective services to the global pharmaceutical industry, was searching for best-in-class cloud software that would enable them to expand their breadth of services to include pharmacovigilance.
  • "LifeSphere MultiVigilance was the best choice to align with our core tenets of high quality and efficiency," said Dr. Jinsong Xing, Founder and Chairman, Xihua Scientific.
  • LifeSphere MultiVigilance was developed in partnership with the world's best life sciences companies and is the core of ArisGlobal's end-to-end automated safety platform, LifeSphere Safety.
  • "We are pleased that LifeSphere MultiVigilance will further Xihua Scientific's rapid growth and commitment to the highest quality standards for their clients.

Xihua Scientific Selects LifeSphere MultiVigilance to Advance Pharmacovigilance Services

Retrieved on: 
Tuesday, July 27, 2021

MIAMI, July 27, 2021 /PRNewswire/ -- ArisGlobal, the leading provider of life sciences software that automates core drug development functions for over 300 life sciences companies, today announced that Shanghai Xihua Scientific Co. Ltd., a fast-growing provider of late-phase drug research and development services for the global pharmaceutical industry, has selected ArisGlobal's LifeSphere MultiVigilance to deliver innovative pharmacovigilance services to their global client base.

Key Points: 
  • Xihua Scientific, a CRO providing a one-stop set of cost-effective services to the global pharmaceutical industry, was searching for best-in-class cloud software that would enable them to expand their breadth of services to include pharmacovigilance.
  • "LifeSphere MultiVigilance was the best choice to align with our core tenets of high quality and efficiency," said Dr. Jinsong Xing, Founder and Chairman, Xihua Scientific.
  • LifeSphere MultiVigilance was developed in partnership with the world's best life sciences companies and is the core of ArisGlobal's end-to-end automated safety platform, LifeSphere Safety.
  • "We are pleased that LifeSphere MultiVigilance will further Xihua Scientific's rapid growth and commitment to the highest quality standards for their clients.

California Family Physicians Support COVID-19 Vaccination Efforts for Health Care Workforce

Retrieved on: 
Tuesday, July 27, 2021

SAN FRANCISCO, July 27, 2021 /PRNewswire/ -- The California Academy of Family Physicians (CAFP) supports the efforts by Governor Newsom to require vaccination of state workers and health care workers across the state.

Key Points: 
  • SAN FRANCISCO, July 27, 2021 /PRNewswire/ -- The California Academy of Family Physicians (CAFP) supports the efforts by Governor Newsom to require vaccination of state workers and health care workers across the state.
  • CAFP supports universal vaccination and the concept of mandatory vaccination in a health care setting.
  • About the California Academy of Family Physicians:With more than 10,000 members, including active practicing family physicians, residents in family medicine, and medical students interested in the specialty, CAFP is the largest primary care medical society in California.
  • She did her medical residency in Family Medicine at the University of California Los Angeles and completed a fellowship in Primary Care Psychiatry at the University of California Irvine.

FDA Awards REI System $400M SIRCE IT Modernization Contract

Retrieved on: 
Tuesday, July 27, 2021

The FDA engaged REI Systems to address new legislative mandates, emerging health concerns, and leverage opportunities presented by evolving technologies through more efficient, reliable, and secure systems.

Key Points: 
  • The FDA engaged REI Systems to address new legislative mandates, emerging health concerns, and leverage opportunities presented by evolving technologies through more efficient, reliable, and secure systems.
  • The FDA selected REI Systems based on the company's success with complex application modernization throughout the federal government, unique Agile and DevSecOps capabilities, and a successful track record with previous technology transformations at FDA, including the Foreign Inspection Planning and Scheduling System.
  • REI Systems' CEO Shyam Salona said, "We are very pleased to expand our relationship with the FDA.
  • We take a Mindful Modernization approach in providing Application Modernization, Government Data Analytics, Grants Management Systems and Products, and Advisory Services.

Day One Receives FDA Rare Pediatric Disease Designation for DAY101 for the Treatment of Pediatric Low-Grade Glioma

Retrieved on: 
Tuesday, July 27, 2021

In addition to FDA Rare Pediatric Disease Designation, DAY101 has been granted Breakthrough Therapy designation by the FDA for the treatment of patients with pLGG harboring an activating RAF alteration who require systemic therapy and who have either progressed following prior treatment or who have no satisfactory alternative treatment options.

Key Points: 
  • In addition to FDA Rare Pediatric Disease Designation, DAY101 has been granted Breakthrough Therapy designation by the FDA for the treatment of patients with pLGG harboring an activating RAF alteration who require systemic therapy and who have either progressed following prior treatment or who have no satisfactory alternative treatment options.
  • In addition, DAY101 has received Orphan Drug designation from the FDA for the treatment of malignant glioma and orphan designation from the European Commission for the treatment of glioma.
  • The FDA has also granted Rare Pediatric Disease Designation to DAY101 for the treatment of low-grade gliomas harboring an activating RAF alteration that disproportionately affects children.
  • In addition, DAY101 has received Orphan Drug designation from the FDA for the treatment of malignant glioma and orphan designation from the European Commission for the treatment of glioma.

Canadian fast-food companies failing when it comes to chicken welfare says new global report

Retrieved on: 
Tuesday, July 27, 2021

Intensive farming methods also often rely on routine antibiotic use as a quick fix solution to keep stressed and sick animals alive.

Key Points: 
  • Intensive farming methods also often rely on routine antibiotic use as a quick fix solution to keep stressed and sick animals alive.
  • This over-use of antibiotics is fueling the deadly superbug crisis that kills over 700,000 people globally a year.
  • The latestreport called" Thepeckingorder 2021" ranksthesefast food restaurantsgloballyon how they are performing on their commitment, ambition, and transparency on chicken welfare in their supply chains.
  • Three companies received zero points for their Canadian policies - Starbucks, Subway and Domino's, although they have signed up to the BCC in other markets.