MAA

Outlook Therapeutics® Reports Financial Results for First Quarter Fiscal Year 2024 and Provides Corporate Update

Retrieved on: 
Wednesday, February 14, 2024
AmerisourceBergen, EMA, Injection, Committee, Fiscal, CRL, Outlook, MAA, Ranibizumab, FDA, Calendar, Completion, Bevacizumab, Symantec Endpoint Protection, Chemistry, Therapy, CHMP, European Medicines Agency, AMD, Patient, SPA, Retina, CMC

ISELIN, N.J., Feb. 14, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve regulatory approval for the first ophthalmic formulation of bevacizumab for the treatment of retinal diseases, today announced financial results for first quarter fiscal year 2024 and provided a corporate update.

Key Points: 
  • ISELIN, N.J., Feb. 14, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve regulatory approval for the first ophthalmic formulation of bevacizumab for the treatment of retinal diseases, today announced financial results for first quarter fiscal year 2024 and provided a corporate update.
  • Importantly, the first subject was enrolled in NORSE EIGHT in January 2024,” commented Russell Trenary, President and Chief Executive Officer.
  • In January 2024, Outlook Therapeutics announced that it received written agreement on the NORSE EIGHT trial protocol from the FDA under a SPA for NORSE EIGHT.
  • Outlook Therapeutics expects NORSE EIGHT topline results and resubmission of the ONS-5010 BLA by the end of calendar year 2024.

Deciphera Pharmaceuticals Announces Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Tuesday, February 6, 2024
Biotechnology, Pharmaceutical, Health, Oncology, OS, KIT, European, Investigational New Drug, Trial of the century, DNA, Research, Patient, IND, Autophagy, ASCO, GIST, Public expenditure, FDA, EMA, MAA, Part, Food, Society, TGCT, Gastrointestinal stromal tumor, European Medicines Agency, Sunitinib, Neoplasm, Cancer, INSIGHT, Tenosynovial giant cell tumor, NDA, Nature Medicine, Pharmaceutical industry

Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH), a biopharmaceutical company focused on discovering, developing, and commercializing important new medicines to improve the lives of people with cancer, today announced financial results for the fourth quarter and year ended December 31, 2023 and provided a corporate update.

Key Points: 
  • Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH), a biopharmaceutical company focused on discovering, developing, and commercializing important new medicines to improve the lives of people with cancer, today announced financial results for the fourth quarter and year ended December 31, 2023 and provided a corporate update.
  • Expects to present updated results from the Phase 1/2 study of vimseltinib in TGCT in the second half of 2024.
  • Expects to initiate a Phase 2 proof-of-concept study of vimseltinib for the treatment of chronic graft versus host disease (cGVHD) in the fourth quarter of 2024.
  • Cost of Sales: Cost of sales were $1.8 million in the fourth quarter of 2023, which includes $0.9 million in cost of product sales, compared to cost of product sales of $0.7 million for the fourth quarter of 2022.

Linvoseltamab Receives EMA Filing Acceptance for Treatment of Relapsed/Refractory Multiple Myeloma

Retrieved on: 
Friday, February 2, 2024
Marketing, Regeneron Pharmaceuticals, Bone marrow, Patient, Safety, FDA, EMA, MAA, BCMA, B-cell maturation antigen, Biologics license application, Disease, Tissue, Cancer, BLA, Pharmaceutical industry

Linvoseltamab is an investigational bispecific antibody designed to bridge B-cell maturation antigen (BCMA) on multiple myeloma cells with CD3-expressing T cells to facilitate T-cell activation and cancer-cell killing.

Key Points: 
  • Linvoseltamab is an investigational bispecific antibody designed to bridge B-cell maturation antigen (BCMA) on multiple myeloma cells with CD3-expressing T cells to facilitate T-cell activation and cancer-cell killing.
  • The MAA is supported by data from a Phase 1/2 pivotal trial (LINKER-MM1) investigating linvoseltamab in R/R MM, which were last shared in December 2023.
  • A Phase 1 trial of linvoseltamab in combination with a CD38xCD28 costimulatory bispecific in MM is also planned.
  • Linvoseltamab is currently under clinical development, and its safety and efficacy have not been fully evaluated by any regulatory authority.

Tisotumab Vedotin Marketing Authorization Application Validated by European Medicines Agency for Treatment of Recurrent or Metastatic Cervical Cancer

Retrieved on: 
Friday, February 2, 2024
Oncology, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, OS, PFS, Patient, Progression-free survival, EMA, MAA, Marketing, Cervical cancer, ADC, European Medicines Agency, Woman, Pharmaceutical industry

Genmab A/S (Nasdaq: GMAB) and Pfizer, Inc. (NYSE PFE) today announced that the European Medicines Agency (EMA) has validated for review the marketing authorization application (MAA) of tisotumab vedotin, an antibody-drug conjugate (ADC), developed for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after systemic therapy.

Key Points: 
  • Genmab A/S (Nasdaq: GMAB) and Pfizer, Inc. (NYSE PFE) today announced that the European Medicines Agency (EMA) has validated for review the marketing authorization application (MAA) of tisotumab vedotin, an antibody-drug conjugate (ADC), developed for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after systemic therapy.
  • If approved, tisotumab vedotin would be the first ADC granted European Union (EU) marketing authorization for people living with cervical cancer.
  • Data from the innovaTV 204 pivotal Phase 2 single-arm clinical trial evaluating TIVDAK as monotherapy in patients with previously treated recurrent or metastatic cervical cancer was also included in the MAA.
  • The safety profile of tisotumab vedotin in innovaTV 301 was consistent with its known safety profile as presented in the U.S. prescribing information.

Apellis Announces Negative CHMP Opinion for Pegcetacoplan for GA in the European Union and Plans to Seek Re-Examination of Application

Retrieved on: 
Friday, January 26, 2024
CHMP, European Medicines Agency, OAKS, Geographic atrophy, Quality of life, APLS, Paratriathlon, AMD, Marketing, Committee, MAA, Pharmaceutical industry

As previously announced, this opinion was expected based on a negative trend vote following an oral explanation meeting in December 2023.

Key Points: 
  • As previously announced, this opinion was expected based on a negative trend vote following an oral explanation meeting in December 2023.
  • Apellis plans to seek immediate re-examination of its application.
  • Treatment with both every-other-month and monthly pegcetacoplan reduced GA lesion growth with increasing treatment effects over time and showed a well-demonstrated safety profile.
  • Additionally, pegcetacoplan preserved visual function longer in multiple post hoc Phase 3 analyses that have been presented at medical congresses.

MAA Announces Date of Fourth Quarter and Full-Year 2023 Earnings Release, Conference Call

Retrieved on: 
Thursday, January 18, 2024
International, Conference, MAA, Domestic, Central Time

GERMANTOWN, Tenn., Jan. 18, 2024 /PRNewswire/ -- MAA (NYSE: MAA) announced today that the Company expects to release its fourth quarter and full-year 2023 results on Wednesday, February 7, 2024, after market close and will hold a conference call on Thursday, February 8, 2024, at 9:00 a.m. Central Time.

Key Points: 
  • GERMANTOWN, Tenn., Jan. 18, 2024 /PRNewswire/ -- MAA (NYSE: MAA) announced today that the Company expects to release its fourth quarter and full-year 2023 results on Wednesday, February 7, 2024, after market close and will hold a conference call on Thursday, February 8, 2024, at 9:00 a.m. Central Time.
  • During the conference call, company officers will review fourth quarter and full-year performance and conduct a question-and-answer session.
  • The conference call-in number is (800) 343-4849 (Domestic) or +1 (203) 518-9856 (International).
  • The Conference ID is MAA.

Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 16-17 January 2024

Retrieved on: 
Friday, January 19, 2024
Classification, EMEA, Commission, Certification, Animal, Eukaryote, DNA, QWP, Decision-making, Meloxicam, AWP, Sheep, Dog, CEP, CVMP, IWP, Environment, Horse, Cat, The Committee, Cattle, MRL, Marketing, Committee, Guideline, Excipient, MAA, Medical device

CVMP opinions on veterinary medicinal productsThe Committee adopted by consensus a positive opinion for a grouping of variations requiring assessment for Metacam (meloxicam), from…

Key Points: 


CVMP opinions on veterinary medicinal productsThe Committee adopted by consensus a positive opinion for a grouping of variations requiring assessment for Metacam (meloxicam), from…

Baldrige Foundation Announces 2024 Leadership Award Recipients

Retrieved on: 
Tuesday, January 16, 2024
Magnet, Security engineering, Nonprofit organization, MAA, Community, Cisco, MSN, Congress, Small business, Medical Center, Senior, Student, NIST, Memorial Hospital, Schneider Electric, Mary Imogene Bassett Hospital, Charter school, Health care, Government, Associate, Faculty, RN, Strategic planning, Education, NWMO, SVP, Nursing

WASHINGTON, Jan. 16, 2024 /PRNewswire/ -- Al Faber, President and CEO of the Foundation for the Malcolm Baldrige National Quality Award, Inc., today announced the 2024 recipients of the Baldrige Foundation's Leadership Awards.

Key Points: 
  • Awardees Represent Large and Small Business, Health Care, Education, Nonprofit, Cybersecurity, Communities, and Government
    WASHINGTON, Jan. 16, 2024 /PRNewswire/ -- Al Faber, President and CEO of the Foundation for the Malcolm Baldrige National Quality Award, Inc., today announced the 2024 recipients of the Baldrige Foundation's Leadership Awards.
  • "We have four categories of leadership awards," said Faber, "that recognize outstanding individuals, leaders, and supporters who embody Baldrige leadership and management values and principles, and who have provided outstanding service to the Baldrige community and beyond."
  • The 2024 recipient of the Spong Award in Mary Bixby, Superintendent School Services and Founder, The Charter School of San Diego.
  • "The Hertz Leadership Award recognizes role-model leaders that challenge, encourage, and empower others to achieve performance excellence," said Faber.

Eisai: The Scientific Advisory Group (SAG) to Convene to Discuss the Marketing Authorization Application for lecanemab in the EU

Retrieved on: 
Thursday, January 11, 2024
CHMP, European Medicines Agency, SAG, European Commission, Scientific Advisory Group, EMA, Eisai, Biogen, Committee, MAA

TOKYO, Jan 11, 2024 - (JCN Newswire) - Eisai Co., Ltd. announced today that the Scientific Advisory Group (SAG) will convene to discuss the marketing authorization application (MAA) of lecanemab (generic name, brand name: LEQEMBI), which is currently under review by the European Medicines Agency (EMA).

Key Points: 
  • TOKYO, Jan 11, 2024 - (JCN Newswire) - Eisai Co., Ltd. announced today that the Scientific Advisory Group (SAG) will convene to discuss the marketing authorization application (MAA) of lecanemab (generic name, brand name: LEQEMBI), which is currently under review by the European Medicines Agency (EMA).
  • The meeting of the SAG is expected to take place during FY2023, which ends on March 31, 2024.
  • Eisai expects the European Commission's decision for the MAA of lecanemab in the first quarter of FY2024 ending June 30, 2024, if the opinion from the CHMP is received by March 31, 2024, following discussion by the SAG.
  • Eisai serves as the lead of lecanemab development and regulatory submissions globally with both Eisai and Biogen Inc. (U.S.) co-commercializing and co-promoting the product and Eisai having final decision-making authority.

The European Medicines Agency's Scientific Advisory Group (SAG) to discuss the Marketing Authorisation Application for lecanemab: BioArctic

Retrieved on: 
Thursday, January 11, 2024
CHMP, European Medicines Agency, SAG, European Commission, Scientific Advisory Group, EMA, Eisai, Committee, Marketing, MAA, Vaccine

STOCKHOLM, Jan. 11, 2024 /PRNewswire/ -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai announced today that the Scientific Advisory Group (SAG) will convene to discuss the Marketing Authorisation Application (MAA) of lecanemab (generic name, brand name: Leqembi®), which is currently under review by the European Medicines Agency (EMA).

Key Points: 
  • STOCKHOLM, Jan. 11, 2024 /PRNewswire/ -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai announced today that the Scientific Advisory Group (SAG) will convene to discuss the Marketing Authorisation Application (MAA) of lecanemab (generic name, brand name: Leqembi®), which is currently under review by the European Medicines Agency (EMA).
  • The meeting of the SAG is expected to take place during the first quarter of 2024.
  • BioArctic has the right to commercialize lecanemab in the Nordic region, pending European approval, and currently Eisai and BioArctic are preparing for a joint commercialization in the region.
  • This information is information that BioArctic AB (publ) is obliged to disclose pursuant to the EU Market Abuse Regulation.