Pharmaceuticals and Medical Devices Agency

Athersys Reports Fourth Quarter and Full Year 2021 Financial Results and Business Highlights

Retrieved on: 
Tuesday, March 15, 2022
Biotechnology, General Health, Health, Stem Cells, Pharmaceutical, Intensive care medicine, Therapy, CMO, Commercial, Research, Patient, Review, European Medicines Agency, Pharmaceuticals and Medical Devices Agency, FDA, EMA, Medication, Senior, Learning, Regenerative medicine, Safety, COVID, Stroke, Clinical trial, Stem cell, Company, Scientific Reports, Technology transfer, CEO, Medicines and Healthcare products Regulatory Agency, EU–UK Trade and Cooperation Agreement, Trauma, Horizon Therapeutics, PMDA, Frontiers, Online gambling, Pharmaceutical industry, Management, Animal, Regeneration, Immunology

Athersys, Inc. (Nasdaq: ATHX) announced today its financial results for the three months and full year ended December 31, 2021, along with a corporate update.

Key Points: 
  • Athersys, Inc. (Nasdaq: ATHX) announced today its financial results for the three months and full year ended December 31, 2021, along with a corporate update.
  • Net loss for the fourth quarter was $21.7 million in 2021 compared to a net loss of $22.2 million in the fourth quarter of 2020.
  • At December 31, 2021, we had $37.4 million in cash and cash equivalents, compared to $51.5 million at December 31, 2020.
  • Management will host a conference call today to review Athersys fourth quarter and full year 2021 financial results and provide a general business update:

Eisai to Present New Lecanemab Data Exploring Distinct Mechanism of Action and Clinical Outcomes, Disease State (DSE) Symposium, and Other Pipeline Assets at the AD/PD 2022 Annual Meeting

Retrieved on: 
Friday, March 11, 2022
Safety, Clinical trial, Senior, PMDA, Medication, Research, Autumn, FDA, International Conference on Population and Development, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Alzheimer's disease, Conference, Amyloid beta, Biologics license application, ARIA, Amyloid, Medicines and Healthcare products Regulatory Agency, African Americans, Pharmaceuticals and Medical Devices Agency, Neurodegeneration, Disease, Food, AD, Pharmaceutical industry, Clarity, Eisai

The lecanemab data and additional research findings from Eisai's clinical development programs will be featured in 13 presentations.

Key Points: 
  • The lecanemab data and additional research findings from Eisai's clinical development programs will be featured in 13 presentations.
  • Lecanemab was granted Breakthrough Therapy and Fast Track designations by the U.S. Food and Drug Administration (FDA) in June and December 2021, respectively.
  • Additionally, the readout of the Phase 3 confirmatory Clarity AD clinical trial will occur in the Fall of 2022.
  • There is no guarantee that such investigational agent will successfully complete clinical development or gain health authority approval.

Eisai Initiates Submission of Application Data Under the Prior Assessment Consultation System in Japan with the Aim of Obtaining Early Approval for Investigational Anti-Amyloid Beta Protofibril Antibody Lecanemab

Retrieved on: 
Friday, March 4, 2022
Accelerated approval (FDA), Regulation of food and dietary supplements by the U.S. Food and Drug Administration, BLA, MHLW, Research, MCI, AD, Food, Biologics license application, PMDA, Ministry, BAN2401, Medicines and Healthcare products Regulatory Agency, FDA, Person, Ministry of Health, Labour and Welfare, Alzheimer's disease, Disease, Trial of the century, Marketing, Medication, Clarity, Amyloid beta, Review, Ministry of Health (Saudi Arabia), Pharmaceuticals and Medical Devices Agency, Pharmaceutical industry, Biogen, Eisai, Health

By identifying and resolving any potential issues prior to submission, the aim is to shorten application review time.

Key Points: 
  • By identifying and resolving any potential issues prior to submission, the aim is to shorten application review time.
  • The prior assessment consultation is conducted at the development stage before new drug application submission based on available quality, non-clinical and clinical data.
  • By identifying and resolving any potential issues prior to submission, the aim is to shorten application review time.
  • Lecanemab is an investigational humanized monoclonal antibody for Alzheimer's disease (AD) that is the result of a strategic research alliance between Eisai and BioArctic.

Eisai initiates submission of application data of lecanemab under the prior assessment consultation system in Japan with the aim of an earlier regulatory approval

Retrieved on: 
Friday, March 4, 2022
Accelerated approval (FDA), Ageing, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, BLA, MHLW, Clinical trial, Research, Biomarker, National, MCI, AD, Biogen, Food, Neurodegeneration, Biologics license application, PMDA, Ministry, Safety, BAN2401, Medicines and Healthcare products Regulatory Agency, AbbVie, FDA, Parkinson's disease, Person, Ministry of Health, Labour and Welfare, US, EU, Disease, Development, Eisai, Trial of the century, Marketing, Medication, University, Clarity, CET, National Institute, National Institute on Aging, Review, Ministry of Health (Saudi Arabia), Partnership, Commercialization, Nasdaq, Pharmaceuticals and Medical Devices Agency, Pharmaceutical industry, Medical device, Alzheimer's disease, Health, Uppsala University

The PMDA's process, known as "prior assessment consultation", is conducted at the development stage before the new drug application submission, which is based on available quality, non-clinical and clinical data.

Key Points: 
  • The PMDA's process, known as "prior assessment consultation", is conducted at the development stage before the new drug application submission, which is based on available quality, non-clinical and clinical data.
  • By identifying and resolving any potential issues prior to submission, the aim is to shorten application review time.
  • The agency approved Eisai's request and Eisai has submitted the non-clinical lecanemab data to PMDA.
  • Eisai is responsible for the clinical development, application for market approval and commercialization of the products for Alzheimer's disease.

Eisai initiates submission of application data of lecanemab under the prior assessment consultation system in Japan with the aim of an earlier regulatory approval

Retrieved on: 
Friday, March 4, 2022
Accelerated approval (FDA), Ageing, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, BLA, MHLW, Clinical trial, Research, Biomarker, National, MCI, AD, Biogen, Food, Neurodegeneration, Biologics license application, PMDA, Ministry, Safety, BAN2401, Medicines and Healthcare products Regulatory Agency, AbbVie, FDA, Parkinson's disease, Person, Ministry of Health, Labour and Welfare, US, EU, Disease, Development, Eisai, Trial of the century, Marketing, Medication, University, Clarity, CET, National Institute, National Institute on Aging, Review, Ministry of Health (Saudi Arabia), Partnership, Commercialization, Nasdaq, Pharmaceuticals and Medical Devices Agency, Pharmaceutical industry, Medical device, Alzheimer's disease, Health, Uppsala University

The PMDA's process, known as "prior assessment consultation", is conducted at the development stage before the new drug application submission, which is based on available quality, non-clinical and clinical data.

Key Points: 
  • The PMDA's process, known as "prior assessment consultation", is conducted at the development stage before the new drug application submission, which is based on available quality, non-clinical and clinical data.
  • By identifying and resolving any potential issues prior to submission, the aim is to shorten application review time.
  • The agency approved Eisai's request and Eisai has submitted the non-clinical lecanemab data to PMDA.
  • Eisai is responsible for the clinical development, application for market approval and commercialization of the products for Alzheimer's disease.

Apple Rush Company, Inc. updates its partners with a letter to shareholders

Retrieved on: 
Friday, December 31, 2021
Securities Exchange Act of 1934, Growth, APRU, Pharmaceuticals and Medical Devices Agency, Small business, Communication, FDA, LLC, Goal, Medicines and Healthcare products Regulatory Agency, Family, Cannabinoid, Medication, Edible, Nation, CEO, OTC, Transport, RTD, Research, Drug Quality and Security Act, Program, Kava, FDACS, Radio, PMDA, Delta, ABV, CPG, Judgement, Time, Friends, Acquisition, Sale, Environment, Beer, Drink, Industry, Securities Act of 1933, Cryptocurrency, Retail, Music, Georgia Southern Eagles football

However, shortly after, the capacity tightened up quickly through the fall due to shortages of equipment with our manufacturing partners.

Key Points: 
  • However, shortly after, the capacity tightened up quickly through the fall due to shortages of equipment with our manufacturing partners.
  • This frivolous lawsuit hindered and limited our communication to shareholders over the past year, due to recommendations by council.
  • We are close to the approval of the Apple Rush label, and detailed updates will be given when paperwork has been permitted.
  • The Apple Rush Company, Inc., through its subsidiary APRU, LLC, is a distributor of cpg products under the trademarked Apple Rush brand and other labels.

LINEPHARMA INTERNATIONAL FILES FOR MANUFACTURING, MARKETING APPROVAL OF THE ABORTION PILL IN JAPAN

Retrieved on: 
Wednesday, December 22, 2021
Mifepristone, Reproductive health, Income, Marketing, Medication, Pharmacist, WHO, Pregnancy, MS, Doctor of Philosophy, Misoprostol, RN, World Health Organization, Abortion, General manager, Barrier, Master of Science, Medicines and Healthcare products Regulatory Agency, Health, Pharmaceuticals and Medical Devices Agency, Ageing, Solution, PMDA, Implementation, Safety, World, Woman, The Lancet, Birth control, MD

If the drug is approved, the 156,430 Japanese women who had surgical abortion procedures in 2019 alone will have another therapeutic option based on their individual need.

Key Points: 
  • If the drug is approved, the 156,430 Japanese women who had surgical abortion procedures in 2019 alone will have another therapeutic option based on their individual need.
  • "Linepharma is a global pioneer in abortion medicine and is dedicated to improving sexual and reproductive health including the discovery, development and distribution of innovative health solutions including a combination abortion medication.
  • "Our drug application for MEFEEGO in Japan is a very significant milestone for Japanese women who, for the very first time, will have an entirely new option for abortion."
  • Unintended pregnancy and abortion by income, region, and the legal status of abortion estimates from a comprehensive model for 19902019.

LINEPHARMA INTERNATIONAL FILES FOR MANUFACTURING, MARKETING APPROVAL OF THE ABORTION PILL IN JAPAN

Retrieved on: 
Wednesday, December 22, 2021
Mifepristone, Reproductive health, Income, Marketing, Medication, Pharmacist, WHO, Pregnancy, MS, Doctor of Philosophy, Misoprostol, RN, World Health Organization, Abortion, General manager, Barrier, Master of Science, Medicines and Healthcare products Regulatory Agency, Health, Pharmaceuticals and Medical Devices Agency, Ageing, Solution, PMDA, Implementation, Safety, World, Woman, The Lancet, Birth control, MD

If the drug is approved, the 156,430 Japanese women who had surgical abortion procedures in 2019 alone will have another therapeutic option based on their individual need.

Key Points: 
  • If the drug is approved, the 156,430 Japanese women who had surgical abortion procedures in 2019 alone will have another therapeutic option based on their individual need.
  • "Linepharma is a global pioneer in abortion medicine and is dedicated to improving sexual and reproductive health including the discovery, development and distribution of innovative health solutions including a combination abortion medication.
  • "Our drug application for MEFEEGO in Japan is a very significant milestone for Japanese women who, for the very first time, will have an entirely new option for abortion."
  • Unintended pregnancy and abortion by income, region, and the legal status of abortion estimates from a comprehensive model for 19902019.

SanBio Joins the Newly Formed National TBI Registry Coalition (NTRC) as a Founding Member Organization

Retrieved on: 
Wednesday, December 15, 2021
Data Management, Medical Supplies, Health, Medical Devices, Technology, Stem Cells, Biotechnology, Organization, TBI, Tissue (biology), Government, Death, Company, Prevalence, Stroke, Awareness, Adult, Pharmaceuticals and Medical Devices Agency, Brain, Global Burden of Disease Study, Incidence, Caregiver, Head, Veni, vidi, vici, Medication, Research, SL, Hospital, Quality of life, Traumatic brain injury, Disease, Disability, National, Medicines and Healthcare products Regulatory Agency, Biologics license application, Person, Microsoft, Stem cell, Health insurance, Meat, Traumatic Brain Injury, SB623, SanBio Group (SanBio Co., Ltd., SanBio, Inc. and SanBio Asia Pte. Ltd.), TRAUMATIC BRAIN INJURY, SB623, SANBIO GROUP (SANBIO CO., LTD., SANBIO, INC. AND SANBIO ASIA PTE. LTD.)

The SanBio Group (SanBio Co., Ltd. of Tokyo, Japan, SanBio, Inc. of Mountain View, California, US, and SanBio Asia Pte.

Key Points: 
  • The SanBio Group (SanBio Co., Ltd. of Tokyo, Japan, SanBio, Inc. of Mountain View, California, US, and SanBio Asia Pte.
  • Ltd. of Singapore) (TSE:4592), today announced it is one of the founding member organizations of the National TBI Registry Coalition (NTRC) in the United States.
  • Additionally, NTRC member organizations are working together to promote public awareness about individuals and caregivers impacted by TBI.
  • About SanBio Group (SanBio Co., Ltd., SanBio, Inc. and SanBio Asia Pte.

Pharmaceutical API Manufacturing Global Market Research Report 2021: Focus on Chemical API, Biological API, Innovative Drugs, Generics, OTC - ResearchAndMarkets.com

Retrieved on: 
Wednesday, December 8, 2021
Health, Pharmaceutical, Zero, Degenerative disease, Pharmaceuticals and Medical Devices Agency, Ageing, Sun Pharma, Population, API, Lists of diseases, Buffer, Pfizer, Drug Master File, Disease, ICC, Cancer, Hygiene, Aurobindo Pharma, Excipient, DMF, ILC Dover, Medication, Medicines and Healthcare products Regulatory Agency, Powder, COVID-19, PMDA, Boehringer Ingelheim, Growth, Infection, Freezing, Fine chemical, Pharmaceutical industry

The "Pharmaceutical API Manufacturing Global Market Report 2021: COVID-19 Growth and Change to 2030" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Pharmaceutical API Manufacturing Global Market Report 2021: COVID-19 Growth and Change to 2030" report has been added to ResearchAndMarkets.com's offering.
  • Major players in the pharmaceutical active pharmaceutical ingredients (API) manufacturing market are Teva Pharmaceutical Industries Ltd., Sun Pharmaceutical Industries Ltd., Boehringer Ingelheim), Pfizer, Inc. and Aurobindo Pharma.
  • The pharmaceutical active pharmaceutical ingredients (API) manufacturing market consists of sales of pharmaceutical active pharmaceutical ingredients and related services.
  • Stringent regulations for approval of pharmaceutical drugs acts as a restraint on the pharmaceutical API manufacturing market.