Co-promotion

U.S. Veterans' Health Administration (VHA) Provides Coverage of LEQEMBI (lecanemab-Irmb) Two Months After LEQEMBI's FDA Accelerated Approval for Veterans Living with Early Stages of Alzheimer's Disease

Retrieved on: 
Tuesday, March 14, 2023
The New England Journal of Medicine, Tradition, Brain, Veteran, Pathology, Co-promotion, Priority review, VHA, Lecanemab, Patient, Clarity, FDA, Clinical trial, PDUFA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, AD, Plaque, Immunoglobulin G, Pharmaceutical industry, Alzheimer's disease, Biogen, Disease, Eisai

The VHA's careful consideration and timely action to make LEQEMBI available approximately two months after the FDA approved LEQEMBI under the accelerated approval pathway shows its continued commitment to veterans living with AD.

Key Points: 
  • The VHA's careful consideration and timely action to make LEQEMBI available approximately two months after the FDA approved LEQEMBI under the accelerated approval pathway shows its continued commitment to veterans living with AD.
  • If approved under the traditional pathway, the FDA will update the label for LEQEMBI, which will include new data that has been evaluated by the FDA.
  • The FDA has determined that the results of Clarity AD will serve as the confirmatory study to verify the clinical benefit of LEQEMBI.
  • On the same day that LEQEMBI received its Accelerated approval, Eisai submitted the supplemental Biologics License Application (sBLA) to the FDA for approval under the Traditional pathway.

FDA Accepts Eisai's Filing of a Supplemental Biologics License Application and Grants Priority Review for Traditional Approval of LEQEMBITM (lecanemab-irmb) for the Treatment of Alzheimer's Disease

Retrieved on: 
Monday, March 6, 2023
The New England Journal of Medicine, Brain, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Co-promotion, Pathology, Priority review, BIIB, Lecanemab, Patient, Clarity, FDA, Clinical trial, Oncology Drug Advisory Committee, PDUFA, Prescription Drug User Fee Act, Food, Advisory Committee, AD, Plaque, Immunoglobulin G, Pharmaceutical industry, Medical imaging, Alzheimer's disease, Biogen, Eisai

The LEQEMBI application has been granted Priority Review, with a Prescription Drug User Fee Act (PDUFA) action date of July 6, 2023.

Key Points: 
  • The LEQEMBI application has been granted Priority Review, with a Prescription Drug User Fee Act (PDUFA) action date of July 6, 2023.
  • The FDA is currently planning to hold an Advisory Committee to discuss this application but has not yet publicly announced the date of the meeting.
  • On the same day that LEQEMBI received its accelerated approval, Eisai submitted the sBLA to the FDA for approval under the traditional pathway.
  • The sBLA is based on the findings from Eisai's recently published large, global confirmatory Phase 3 clinical trial, Clarity AD.

Infodriver Capital Launches Fund for DeFi, GameFi, and AI Startups Across UK, UAE, EC, USA.

Retrieved on: 
Friday, March 3, 2023
Metaverse, Investment, Co-promotion, Internet, Digital, Web3, Decentralized finance, IPhone, AMI-audio, Cryptocurrency

The investment strategy charges only 5% investments and diversifies the total portfolio of the startups from Seed to A round with a working revenue model and user base.

Key Points: 
  • The investment strategy charges only 5% investments and diversifies the total portfolio of the startups from Seed to A round with a working revenue model and user base.
  • According to Kirill Mishanin, CEO and Founder of Infodriver Capital, investing in startups in the Web3 space is a wise decision, as it is the future of the internet.
  • Infodriver Capital is committed to shaping that future by supporting innovative startups in this field.
  • Mishanin stated, "We are thrilled to be able to support these innovative startups and help them reach their full potential.

Darolutamide receives EU approval for additional indication in prostate cancer

Retrieved on: 
Wednesday, March 1, 2023
Death, Prostate cancer, European, European Commission, Co-promotion, Disease, Ari, Risk, Darolutamide, Patient, ADT, Orion, Docetaxel, Incidence, Phase, Pharmaceutical industry, Bayer, EU

The European Commission has granted marketing authorisation in the European Union (EU) for darolutamide, an oral androgen receptor inhibitor (ARi), plus androgen deprivation therapy (ADT) in combination with docetaxel, for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC).

Key Points: 
  • The European Commission has granted marketing authorisation in the European Union (EU) for darolutamide, an oral androgen receptor inhibitor (ARi), plus androgen deprivation therapy (ADT) in combination with docetaxel, for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC).
  • Darolutamide is already approved under the brand name Nubeqa® for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC), who are at high risk of developing metastatic disease.
  • Additionally, the darolutamide combination showed consistent benefits across clinically relevant secondary endpoints, with the overall incidence of treatment-emergent adverse events being similar between treatment arms.
  • Darolutamide is being investigated in a broad development program with an additional three ongoing or planned large clinical studies, to investigate its potential across prostate cancer patients from the early- to the late-stage of this disease.

Biologics License Application for Lecanemab Designated for Priority Review by China National Medical Products Administration

Retrieved on: 
Tuesday, February 28, 2023
Amyloid beta, Ministry of Health, Labour and Welfare, Lecanemab, Alzheimer's disease, Ministry, Priority review, Ministry of Health (Saudi Arabia), Disease, Biologics license application, European Medicines Agency, BLA, Brain, Research, The New England Journal of Medicine, FDA, Neurotoxicity, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, National Medical Products Administration, Co-promotion, Medicines and Healthcare products Regulatory Agency, EMA, MAA, PMDA, AD, Pharmaceuticals and Medical Devices Agency, Clarity, Medication, MCI, Food, NMPA, Phase, MHLW, Procedure, Pharmaceutical industry, Medical device, Health, Eisai, Biogen

TOKYO, Feb 28, 2023 - (JCN Newswire) - Eisai Co., Ltd. and Biogen Inc. announced today that the Biologics License Application (BLA) for lecanemab (brand name in the U.S.: LEQEMBI), an investigational anti-amyloid beta (Abeta) protofibril antibody, has been designated for Priority Review by the National Medical Products Administration (NMPA) in China.

Key Points: 
  • TOKYO, Feb 28, 2023 - (JCN Newswire) - Eisai Co., Ltd. and Biogen Inc. announced today that the Biologics License Application (BLA) for lecanemab (brand name in the U.S.: LEQEMBI), an investigational anti-amyloid beta (Abeta) protofibril antibody, has been designated for Priority Review by the National Medical Products Administration (NMPA) in China.
  • In China, Eisai initiated submission of data for the BLA to the NMPA in December 2022.
  • In the U.S., lecanemab was granted accelerated approval by the U.S. Food and Drug Administration (FDA) on January 6, 2023.
  • On the same day, Eisai submitted a supplemental Biologics License Application (sBLA) to the FDA for approval under the traditional pathway.

Biologics License Application for Lecanemab Designated for Priority Review by China National Medical Products Administration

Retrieved on: 
Monday, February 27, 2023
Ministry of Health, Labour and Welfare, Lecanemab, Ministry, BIIB, Corporation, Priority review, Ministry of Health (Saudi Arabia), Disease, Biologics license application, European Medicines Agency, BLA, The New England Journal of Medicine, Brain, Research, FDA, Neurotoxicity, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Headquarters, National Medical Products Administration, Co-promotion, Medicines and Healthcare products Regulatory Agency, EMA, MAA, PMDA, AD, Pharmaceuticals and Medical Devices Agency, Clarity, Medication, MCI, Food, NMPA, Phase, MHLW, Procedure, Pharmaceutical industry, Medical device, Health, Eisai, Biogen

In China, Eisai initiated submission of data for the BLA to the NMPA in December 2022.

Key Points: 
  • In China, Eisai initiated submission of data for the BLA to the NMPA in December 2022.
  • Lecanemab selectively binds and eliminates soluble, toxic Aβ aggregates (protofibrils) that are thought to contribute to the neurotoxicity in AD.
  • In the U.S., lecanemab was granted accelerated approval by the U.S. Food and Drug Administration (FDA) on January 6, 2023.
  • On the same day, Eisai submitted a supplemental Biologics License Application (sBLA) to the FDA for approval under the traditional pathway.

MannKind Corporation Reports 2022 Fourth Quarter and Full Year Financial Results

Retrieved on: 
Thursday, February 23, 2023
Sale, Internet, Acquisition, R, Co-promotion, Investment, G&A, Levothyroxine, Professional corporation, UT, Cryptocurrency, Pharmaceutical industry, Inhalable insulin

As of December 31, 2022, $37.9 million of manufacturing revenue associated with Tyvaso DPI remains deferred and will be recognized as commercial product is sold to UT.

Key Points: 
  • As of December 31, 2022, $37.9 million of manufacturing revenue associated with Tyvaso DPI remains deferred and will be recognized as commercial product is sold to UT.
  • R&D expenses for 2022 were $19.7 million compared to $12.3 million for the prior year.
  • Selling expenses for 2022 were $53.8 million compared to $45.5 million for the prior year.
  • MannKind will host a conference call and presentation webcast to discuss these results today at 5:00 p.m. Eastern Time.

Michigan's Skinny Butcher, Launched by Former Garden Fresh Gourmet Partners, Debuts Its Breakthrough Plant-based Chick'n Products Statewide at Costco, Gordon Food Service and SpartanNash

Retrieved on: 
Wednesday, February 1, 2023
Nuggets, Patty, Stranger Things, Aronson, Taste, Water, Albertsons, Gordon Food Service, Gelson, Netflix, SpartanNash, Co-promotion, Walmart, Tender, Palm oil, Social media, Personality, Cancer, Grocery store, Poultry farming, Fast food, Costco, Safeway

BIRMINGHAM, Mich., Feb. 1, 2023 /PRNewswire/ -- Here's the skinny! Metro Detroit-based Skinny Butcher, a plant-based brand launched by the former Garden Fresh Gourmet executives behind America's #1 fresh salsa, has announced its' restaurant quality line of Crazy Crispy Chick'n Breasts, Tenders, Nuggets, and Patties is now available throughout Michigan at Costco Wholesale, all Gordon Food Service outlets, and SpartanNash corporate stores. Founded by Dave Zilko, Mike Griffin, and the late Jack Aronson (whose wife, Annette, remains active with the company), Skinny Butcher is also offered at independent markets via Lipari Foods' distribution network of more than 700 stores in 27 states.

Key Points: 
  • Unlike Garden Fresh's humble beginnings, at the Aronson's struggling Ferndale restaurant, Skinny Butcher debuted nationally in the competitive, plant-based frozen poultry alternatives category in May 2022 at Walmart.
  • Skinny Butcher then entered Midwest and Northern California Costco locations, and expanded regionally in thousands of Safeway, Albertsons, Gelson's, and H-E-B supermarkets.
  • Skinny Butcher is an equity partner with Los Angeles-based Golden West Food Group, which exclusively manufactures its products and shares sales responsibilities.
  • The suggested retail price for Skinny Butcher Crazy Crispy Chick'n Nuggets, Tenders, Patties, and Breasts packages in conventional retail stores is $5.99.

European Medicines Agency accepts Marketing Authorization Application for lecanemab as treatment for early Alzheimer's disease: BioArctic

Retrieved on: 
Friday, January 27, 2023
PMDA, Medication, Phase, EMA, CET, National Medical Products Administration, Eisai, European Medicines Agency, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Brand, NMPA, MAA, Medicines and Healthcare products Regulatory Agency, Pharmaceuticals and Medical Devices Agency, Co-promotion, EU, FDA, Alzheimer's disease, BLA, Food, AD, Pharmaceutical industry, Biogen, Nordic

In conjunction with EMA's acceptance of the file, BioArctic is entitled to a milestone of MEUR 5.

Key Points: 
  • In conjunction with EMA's acceptance of the file, BioArctic is entitled to a milestone of MEUR 5.
  • In the U.S., lecanemab was granted accelerated approval as a treatment for AD by the U.S. Food and Drug Administration (FDA) on January 6, 2023.
  • In Japan, Eisai submitted a marketing authorization application to the Pharmaceuticals and Medical Devices Agency (PMDA) on January 16, 2023.
  • BioArctic has right to commercialize lecanemab in the Nordic under certain conditions and is currently preparing for commercialization in the Nordics together with Eisai.

European Medicines Agency accepts Marketing Authorization Application for lecanemab as treatment for early Alzheimer's disease: BioArctic

Retrieved on: 
Friday, January 27, 2023
PMDA, Medication, Phase, EMA, CET, National Medical Products Administration, Eisai, European Medicines Agency, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Brand, NMPA, MAA, Medicines and Healthcare products Regulatory Agency, Pharmaceuticals and Medical Devices Agency, Co-promotion, EU, FDA, Alzheimer's disease, BLA, Food, AD, Pharmaceutical industry, Biogen, Nordic

In conjunction with EMA's acceptance of the file, BioArctic is entitled to a milestone of MEUR 5.

Key Points: 
  • In conjunction with EMA's acceptance of the file, BioArctic is entitled to a milestone of MEUR 5.
  • In the U.S., lecanemab was granted accelerated approval as a treatment for AD by the U.S. Food and Drug Administration (FDA) on January 6, 2023.
  • In Japan, Eisai submitted a marketing authorization application to the Pharmaceuticals and Medical Devices Agency (PMDA) on January 16, 2023.
  • BioArctic has right to commercialize lecanemab in the Nordic under certain conditions and is currently preparing for commercialization in the Nordics together with Eisai.