MAA

Mirati Therapeutics Reports Third Quarter 2023 Financial Results and Recent Corporate Updates

Retrieved on: 
Monday, November 6, 2023
Bristol Myers Squibb, Research, National Comprehensive Cancer Network, PD-L1, Colorectal cancer, Trial of the century, NSCLC, ESMO, MAA, CHMP, Therapy, Life, Committee, Pembrolizumab, European Directive on Traditional Herbal Medicinal Products, Docetaxel, Contingent value rights, Acquisition, Committee for Medicinal Products for Human Use, Conditional, Journal of the National Comprehensive Cancer Network, Cetuximab, MHRA, Marketing, EMA, NCCN, European Medicines Agency, Immunotherapy, Colon, Lung cancer, Medicines and Healthcare products Regulatory Agency, European Society for Medical Oncology, Cancer, Investment, CVR, Patient, Mirati Therapeutics, SAN, Pharmaceutical industry, Nursing, Mirati

SAN DIEGO, Nov. 6, 2023 /PRNewswire/ -- Mirati Therapeutics, Inc. ® (NASDAQ: MRTX), a commercial stage biotechnology company, today announced financial results for the third quarter 2023 along with recent pipeline and corporate updates.

Key Points: 
  • SAN DIEGO, Nov. 6, 2023 /PRNewswire/ -- Mirati Therapeutics, Inc. ® (NASDAQ: MRTX), a commercial stage biotechnology company, today announced financial results for the third quarter 2023 along with recent pipeline and corporate updates.
  • We look forward to continuing our work to improve the lives of people with cancer through Mirati discovered and developed therapeutics."
  • Excluding the August 2023 financing, net decrease in cash, cash equivalents and short-term investments for the third quarter of 2023 was $135.5 million.
  • Net KRAZATI product revenue for the three and nine months ended September 30, 2023 was $16.4 million and $36.1 million, respectively.

MAA Sauces Use Cryogenic Spices to Amp Up the Flavor in Indian Cuisine

Retrieved on: 
Tuesday, October 31, 2023
Knowledge, MSG, Learning, Nutrient, Nut, MAA, Spice, Food, Cooking

FORT LAUDERDALE, Fla., Oct. 31, 2023 /PRNewswire/ -- Indian foods are known for their spicy flavor profile. While they may universally utilize spices like cumin, coriander, and garam masala, MAA is taking the Indian food experience to all-new levels. The ambitious sauce brand is doing so by using cryogenic spices to amp up the flavor profile of traditional Indian cuisine, specifically in the form of easy-to-use, pre-prepared sauces.

Key Points: 
  • While they may universally utilize spices like cumin, coriander, and garam masala, MAA is taking the Indian food experience to all-new levels.
  • The ambitious sauce brand is doing so by using cryogenic spices to amp up the flavor profile of traditional Indian cuisine, specifically in the form of easy-to-use, pre-prepared sauces.
  • "Our sauces are quick and easy to make while remaining faithful to the authentic Indian culinary experience," says company founder and all-around sauce aficionado Harry "Guru" Khanna.
  • The MAA website describes this approach to grinding spices thusly, "Cryogenic spices are powdered herbs and spices that are ground at sub-zero temperatures using liquid nitrogen.

The Top-Allergen-Safe Indian Sauce Brand Preparing to Take America by Storm

Retrieved on: 
Tuesday, October 31, 2023
Diet, MSG, Food, Nut, Spice, MAA, Cholesterol, Allergen, Flour, Fast food, Himalayas

FORT LAUDERDALE, Fla., Oct. 31, 2023 /PRNewswire/ -- Indian cuisine, and especially the sauces that smother so many authentic Indian dishes, are a staple favorite of many Americans. However, those with dietary allergies, as well as food intolerances and sensitivities, must often be wary of Indian dishes. Often, both pre-packaged recipes and restaurant dishes contain rich creams, high concentrations of salt, unhealthy fats, meats, gluten, and nuts.

Key Points: 
  • However, those with dietary allergies, as well as food intolerances and sensitivities, must often be wary of Indian dishes.
  • Often, both pre-packaged recipes and restaurant dishes contain rich creams, high concentrations of salt, unhealthy fats, meats, gluten, and nuts.
  • "Indian food is delicious, but it can also be dangerous for your diet if you aren't careful," says Khanna.
  • This was one of the motivating factors that inspired him to launch his own sauce brand, MAA.

ImmunoGen Announces European Medicines Agency Acceptance of Marketing Authorization Application for Mirvetuximab Soravtansine in Platinum-Resistant Ovarian Cancer

Retrieved on: 
Friday, October 27, 2023
Oncology, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, Survival, Medical Affairs Bureau, IMGN, Food, MAA, Progression-free survival, ImmunoGen, MD, US Foods, European Medicines Agency, Mirvetuximab soravtansine, Society, Yissum Research Development Company of the Hebrew University, ADC, Medicine, Spacecraft, EMA, Cancer, Patient, Marketing, Vaccine, Pharmaceutical industry, Research

ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for mirvetuximab soravtansine (ELAHERE®) for the treatment of patients with folate receptor alpha (FRα)-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer.

Key Points: 
  • ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for mirvetuximab soravtansine (ELAHERE®) for the treatment of patients with folate receptor alpha (FRα)-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer.
  • We look forward to working closely with the EMA throughout the review process and to potentially bring this novel ADC to Europe as early as 2024."
  • In the MIRASOL trial, ELAHERE demonstrated statistically significant and clinically meaningful improvements in progression-free survival, objective response rate, and overall survival compared to investigator's choice (IC) of single-agent chemotherapy.
  • ELAHERE demonstrated a tolerable safety profile compared to IC chemotherapy consisting predominantly of low-grade ocular and gastrointestinal events.

Nymox Reports New NYMOZARFEX Marketing Application is Accepted For Review

Retrieved on: 
Thursday, October 26, 2023
Health care, MAA, TM, MHRA, BPH, Pharmaceutical industry, Nursing

The formal review process has now started.

Key Points: 
  • The formal review process has now started.
  • The trademarked name for the new product is NYMOZARFEX (TM).
  • The Marketing Authorization Application (MAA) was submitted September 25, 2023.
  • Paul Averback MD, CEO of Nymox said, "We are extremely pleased that the Nymozarfex (TM) MAA submission was accepted for review by the UK authorities.

Cetera's My Advice Architect ® Manager Program Wins Money Management Institute/Barron's Industry Award for Wealth Manager Platform of the Year

Retrieved on: 
Thursday, October 19, 2023
Morgan Stanley, MAA, Wealth, Conference, Automotive Executive of the Year Award, MMI, West Australian Music Industry Awards, Cetera Financial Group, Financial adviser, Cetara

LOS ANGELES, Oct. 19, 2023 /PRNewswire/ -- Cetera Financial Group (Cetera), the premier financial advisor Wealth Hub, announced today that it won the 2023 Money Management Institute (MMI)/Barron's Wealth Manager Platform of the Year Award for its innovative My Advice Architect ® (MAA) Manager Program. The Wealth Manager Platform of the Year award honors a platform that exemplifies innovation in delivering better outcomes for investors and financial advisors. This year, finalists for the award included J.P. Morgan Wealth Management, Merrill Lynch Wealth Management and Morgan Stanley.

Key Points: 
  • LOS ANGELES, Oct. 19, 2023 /PRNewswire/ -- Cetera Financial Group (Cetera), the premier financial advisor Wealth Hub, announced today that it won the 2023 Money Management Institute (MMI)/Barron's Wealth Manager Platform of the Year Award for its innovative My Advice Architect ® (MAA) Manager Program.
  • The Wealth Manager Platform of the Year award honors a platform that exemplifies innovation in delivering better outcomes for investors and financial advisors.
  • This year, finalists for the award included J.P. Morgan Wealth Management, Merrill Lynch Wealth Management and Morgan Stanley.
  • Home to five distinct programs and more than $110 billion under management, MAA is Cetera's fastest growing advisory platform.

Cosmo announces submission of Winlevi® to the European Medicines Agency (EMA)

Retrieved on: 
Tuesday, October 17, 2023
III, European, Prescription, IQVIA, Cosmo, Ageing, Safety, Sun Pharma, EMA, FDA, Marketing Authorisation Application, European Medicines Agency, Marketing, IGA, Acne, XETRA, Dermatology, Patient, C43, MAA, Pharmaceutical industry, Medical device, EU

This filing marks a significant milestone in pipeline progression, as approval will open the substantial EU market to already selected, high-standing partners.

Key Points: 
  • This filing marks a significant milestone in pipeline progression, as approval will open the substantial EU market to already selected, high-standing partners.
  • Cosmo has officially submitted the Marketing Authorisation Application (MAA) for its innovative acne treatment clascoterone 1% cream (Winlevi®) to the European Medicine Agency (EMA) through the centralized procedure, aimed at obtaining a single Marketing Authorization for the product in the European Union.
  • The EMA's rigorous evaluation process will assess the product's safety, quality, and efficacy, ultimately determining its suitability for approval within the European market.
  • This submission to the EMA is a pivotal step forward in our mission as well as a testament to our ongoing commitment to innovation.

Amylyx Pharmaceuticals Receives Negative CHMP Opinion on its Marketing Authorisation Application for AMX0035 for the Treatment of ALS in the European Union Following Re-Examination Process

Retrieved on: 
Friday, October 13, 2023
Biotechnology, Neurology, Health, Pharmaceutical, Clinical Trials, European, ALS, EudraCT, Food, European Directive on Traditional Herbal Medicinal Products, CHMP, Eupales, Frustration, European Organization for Quality, Committee for Medicinal Products for Human Use, Health Canada, European Commission, Safety, European Medicines Agency, Survival, EMA, Marketing Authorisation Application, FDA, AMX0035, Marketing, Clinical trial, Committee, Patient, Medication, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Civil service commission, MAA, Pharmaceutical industry, Amylyx Pharmaceuticals, PHOENIX, EU

The decision follows the conclusion of the CHMP’s formal re-examination procedure of an initial negative opinion adopted in June 2023.

Key Points: 
  • The decision follows the conclusion of the CHMP’s formal re-examination procedure of an initial negative opinion adopted in June 2023.
  • Since the medication’s approval with conditions in Canada and full approval in the U.S., thousands of people have been prescribed AMX0035 in North America.
  • PHOENIX is a 48-week, randomized placebo-controlled global Phase 3 clinical trial further evaluating the safety and efficacy of AMX0035 for the treatment of ALS.
  • The CHMP opinion will be forwarded to the European Commission, who will adopt the final decision on this application.

Northwest Biotherapeutics Provides Update On Near Term Plans For Submission of Marketing Authorization Application

Retrieved on: 
Friday, October 13, 2023
MHRA, Medicines and Healthcare products Regulatory Agency, OTCQB, Northwest Biotherapeutics, Glioblastoma, Marketing, Consultant, Medication, Biotechnology, MAA, Pharmaceutical industry

The publisher is an independent party who does the final step of the preparation for the submission: formatting, checking references and the like.

Key Points: 
  • The publisher is an independent party who does the final step of the preparation for the submission: formatting, checking references and the like.
  • The Company and its consultants are working intensively to finalize this last key section of the MAA, after overcoming an unexpected delay in that regard.
  • With this timeline, the submission of the MAA to the MHRA would take place between mid and late November.
  • The Company plans to provide updates when the delivery is made to the publisher and when the MAA is submitted.

Northwest Biotherapeutics Provides Update On Near Term Plans For Submission of Marketing Authorization Application

Retrieved on: 
Friday, October 13, 2023
MHRA, Medicines and Healthcare products Regulatory Agency, OTCQB, Northwest Biotherapeutics, Glioblastoma, Marketing, Consultant, Medication, Biotechnology, MAA, Pharmaceutical industry

The publisher is an independent party who does the final step of the preparation for the submission: formatting, checking references and the like.

Key Points: 
  • The publisher is an independent party who does the final step of the preparation for the submission: formatting, checking references and the like.
  • The Company and its consultants are working intensively to finalize this last key section of the MAA, after overcoming an unexpected delay in that regard.
  • With this timeline, the submission of the MAA to the MHRA would take place between mid and late November.
  • The Company plans to provide updates when the delivery is made to the publisher and when the MAA is submitted.