- LumiraDx Receives WHO Emergency Use Listing for SARS-CoV-2 Ag Test
admin Mon, 05/23/2022 - 15:35
LumiraDx Limited a next-generation point of care diagnostics company, announced today that its rapid COVID-19 antigen assay, LumiraDx SARS-CoV-2 Ag Test has successfully received the Emergency Use Listing (EUL) by the World Health Organization (WHO) in their latest response effort to combat COVID-19.
- CTI BioPharma announces FDA Accelerated Approval of VONJO
admin Tue, 03/01/2022 - 16:11
CTI BioPharma Corp announced the U.S. Food and Drug Administration (FDA) has approved VONJO (pacritinib) for the treatment of adults with intermediate or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis with a platelet count below 50 × 109/L. VONJO is a novel oral kinase inhibitor with specificity for JAK2 and IRAK1, without inhibiting JAK. The recommended dosage of VONJO is 200 mg orally twice daily.
- Biocon Biologics to Acquire Viatris Biosimilars Assets for up to USD 3.335 billion in Stock and Cash
admin Mon, 02/28/2022 - 16:13
Biocon Biologics Ltd., a subsidiary of Biocon Ltd announced today that it has entered into a definitive agreement with its partner Viatris Inc. . Accordingly, Biocon Biologics Ltd will acquire Viatris’ biosimilars business to create a unique fully integrated global biosimilars enterprise. Viatris will receive consideration of up to USD 3.335 billion, including cash up to USD 2.335 billion and Compulsorily Convertible Preference Shares in BBL, valued at USD 1 billion.
- After FDA recommendation, Pfizer and BioNTech preparing regulatory submission of their COVID-19 vaccine for below 5 years children
admin Thu, 02/03/2022 - 15:46
Pfizer Inc and BioNTech SE announced that following a request from the U.S. Food and Drug Administration the companies have initiated a rolling submission seeking to amend the Emergency Use Authorization of the Pfizer-BioNTech COVID-19 Vaccine to include children 6 months through 4 years of age 6 months to <5 years of age, in response to the urgent public health need in this population. The companies expect to complete the EUA submission in the coming days.
- EU approves Lumykras on conditional basis for lung cancer
admin Tue, 01/11/2022 - 16:06
Amgen announced that the European Commission has granted conditional marketing authorization for LUMYKRAS® (sotorasib), a first-in-class KRASG12C inhibitor, for the treatment of adults with advanced non-small cell lung cancer (NSCLC) with KRAS G12C mutation and who have progressed after at least one prior line of systemic therapy. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
- Carisma engineered macrophage technology with Modernas mRNA and LNP technologies to generate and develop in vivo CAR-M therapeutics
admin Tue, 01/11/2022 - 16:02
Moderna Inc a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, and Carisma Therapeutics Inc., a biopharmaceutical pioneer in engineered macrophage-based therapeutics, announced that the two companies have entered into a strategic collaboration agreement to discover, develop and commercialize in vivo engineered chimeric antigen receptor monocyte (CAR-M) therapeutics for the treatment of cancer.
- Vifor Pharma and Angion report topline results from phase-II GUARD trial of ANG-3777 in cardiac surgery associated acute kidney injury
admin Mon, 12/13/2021 - 16:13
Vifor Pharma and Angion Biomedica Corp announced results from the exploratory phase-II GUARD trial of Angion’s ANG-3777 in patients undergoing cardiac surgery involving cardiopulmonary bypass at risk for developing acute kidney injury (CSA-AKI). The trial did not meet its primary endpoint of percentage increase in serum creatinine based upon the area under the curve (AUC). However, Angion and Vifor Pharma continue to review the data, based on the signal demonstrated in the clinically-relevant MAKE90 secondary endpoint.
- FDA approves New KYPROLIS Combination Regimen With DARZALEX FASPRO and dexamethasone
admin Fri, 12/03/2021 - 16:03
Amgen announced that the U.S. Food and Drug Administration (FDA) has approved the expansion of the KYPROLIS® (carfilzomib) U.S. prescribing information to include its use in combination with DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.
- Gilead and AWS Collaborate on Development and Delivery of New Medicines for Patients
admin Tue, 11/30/2021 - 15:23
Amazon Web Services, Inc an Amazon.com, Inc. company announced that Gilead Sciences, Inc. a biopharmaceutical company advancing innovative medicines to prevent and treat life-threatening diseases, has selected AWS as its preferred cloud provider. Innovating on AWS and with the help of AWS experts and partners in healthcare and life sciences, Gilead provides its data scientists with the latest advances in machine learning and analytics.
- BioNTech Receives FDA Fast Track Designation for its FixVac Candidate BNT111 in Advanced Melanoma
admin Mon, 11/22/2021 - 15:32
BioNTech SE announced that the U.S. Food and Drug Administration (FDA) granted Fast Track Designation for BNT111, an investigational cancer immunotherapy for the potential treatment of advanced melanoma. BNT111 is the lead product candidate from BioNTech’s fully owned FixVac platform that utilizes a fixed combination of mRNA-encoded, tumor-associated antigens aiming to trigger a strong and precise immune response against cancer.