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Merck Foundation Strengthens Its Commitment to Expanding Access to Care in Asia-Pacific Region
3/26/2024
The Merck Foundation, a private charitable organization funded by Merck (NYSE:MRK), known as MSD outside of the United States and Canada, has made an $11 million, six-year (2023 - 2028) commitment to University of New Mexico Health (UNM Health) in support of its new initiative to bring high-quality care to an estimated 11 million people living with cancer in underserved communities throughout India, Indonesia, Malaysia and Vietnam.
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Emergent BioSolutions Receives NAI Status for Baltimore Bayview Manufacturing Facility
3/25/2024
Emergent BioSolutions Inc. announced that the U.S. Food and Drug Administration has listed “No Action Indicated” or NAI status classification for the company's Baltimore Bayview manufacturing facility.
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AbbVie to Acquire Landos Biopharma, Further Strengthening its Portfolio in Inflammatory and Autoimmune Diseases
3/25/2024
AbbVie Inc. (NYSE: ABBV) ("AbbVie") and Landos Biopharma, Inc. (NASDAQ: LABP) ("Landos") today announced a definitive agreement under which AbbVie will acquire Landos, a clinical stage biopharmaceutical company focused on the development of novel, oral therapeutics for patients with autoimmune diseases.
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Andelyn Biosciences and Grace Science, LLC Partner to Tech Transfer Phase I/II/III Manufacturing of a Suspension Process Adeno-Associated Virus (AAV) Gene Therapy for NGLY1 Deficiency
3/25/2024
Andelyn Biosciences has partnered with Grace Science, LLC, to tech transfer and manufacture GS-100, a suspension process AAV NGLY1 gene therapy for Phase I/II/III clinical trial material for the treatment of NGLY1 Deficiency.
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Bristol Myers Squibb to Present Data at the American College of Cardiology Annual Scientific Session 2024 Reinforcing Extensive Body of Evidence in Clinical and Real-World Settings Across Cardiovascular Portfolio
3/25/2024
Bristol Myers Squibb (NYSE: BMY) today announced the presentation of data at the American College of Cardiology (ACC) Annual Scientific Session & Expo, taking place April 6-8, 2024 in Atlanta, Georgia.
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U.S. FDA Approves OPSYNVI® (macitentan and tadalafil) as the First and Only Once-Daily Single-Tablet Combination Therapy for Patients with Pulmonary Arterial Hypertension (PAH)
3/22/2024
Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) has approved OPSYNVI® – a single-tablet combination of macitentan, an endothelin receptor antagonist (ERA), and tadalafil, a phosphodiesterase 5 (PDE5) inhibitor – for the chronic treatment of adults with pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group I) and WHO functional class (FC) II-III.
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Gilead Sciences Announces Completion of Acquisition of CymaBay
3/22/2024
Gilead Sciences, Inc. (Nasdaq: GILD) today announced the completion of the previously announced transaction to acquire CymaBay Therapeutics, Inc. (Nasdaq: CBAY) for approximately $4.3 billion in total equity value.
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U.S. Food and Drug Administration (FDA) Grants Full Approval for ELAHERE® (mirvetuximab soravtansine-gynx) for Certain Ovarian Cancer Patients
3/22/2024
AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has granted full approval for ELAHERE® (mirvetuximab soravtansine-gynx) for the treatment of folate receptor alpha (FRα)-positive, platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal adult cancer patients treated with up to three prior therapies.
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MorphoSys Announces U.S. Antitrust Clearance of Proposed Acquisition by Novartis Under HSR Act
3/22/2024
MorphoSys AG announced the receipt of U.S. antitrust clearance under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 in connection with the proposed acquisition of MorphoSys by Novartis AG, following the expiration of the HSR Act waiting period.
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Vertex Announces FDA Clearance of Investigational New Drug Application for VX-407 for the Treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD)
3/21/2024
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug Application (IND) for VX-407, an investigational first-in-class small molecule corrector that targets the underlying cause of autosomal dominant polycystic kidney disease (ADPKD) in patients with a subset of PKD1 genetic variants.
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Merck Provides Update on Phase 3 KEYLYNK-006 Trial Evaluating KEYTRUDA® (pembrolizumab) Plus Maintenance LYNPARZA® (olaparib) for Certain Patients With Metastatic Nonsquamous Non-Small Cell Lung Cancer
3/21/2024
Merck, known as MSD outside of the United States and Canada, announced that the Phase 3 KEYLYNK-006 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with maintenance LYNPARZA, a PARP inhibitor, did not meet its dual primary endpoints of overall survival and progression-free survival for the first-line treatment of certain patients with metastatic nonsquamous non-small cell lung cancer.
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Bristol Myers Squibb’s Abecma (idecabtagene vicleucel) Becomes First CAR T Cell Therapy Approved in the European Union in Earlier Lines for Triple-Class Exposed Relapsed and Refractory Multiple Myeloma
3/20/2024
Bristol Myers Squibb (NYSE: BMY) today announced that the European Commission (EC) has granted approval to Abecma® (idecabtagene vicleucel; ide-cel) for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies, including an immunomodulatory agent (IMiD), a proteasome inhibitor (PI), and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.
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Koneksa Announces Merck Joins Data Syndication Partnership Program Around Parkinson’s Digital Biomarkers Observational Study
3/20/2024
Koneksa announced that Merck has joined its Data Syndication Partnership program for the LEARNS observational study, which seeks to develop digital biomarkers in neurodegenerative disorders from smart phone-based assessments and wearable technologies.
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Pfizer Invites Public to View and Listen to Webcast of May 1, 2024 Conference Call with Analysts
3/20/2024
Pfizer Inc. invites investors and the general public to view and listen to a webcast of a conference call with investment analysts at 10 a.m. EDT on Wednesday, May 1, 2024.
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Alnylam to Webcast Investor Event to Discuss Results from KARDIA-2 Phase 2 Study of Zilebesiran at American College of Cardiology Scientific Session
3/20/2024
Alnylam Pharmaceuticals, Inc. announced today that it will host a webcast event to discuss results from the KARDIA-2 Phase 2 study of zilebesiran, an investigational RNAi therapeutic targeting liver-expressed angiotensinogen (AGT) in development for the treatment of hypertension, at the American College of Cardiology (ACC) Scientific Session on Sunday, April 7, 2024 at 7:00 pm ET.
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Forge Biologics’ Novel AAV Gene Therapy FBX-101 for Patients with Krabbe Disease is Granted UK’s Innovation Passport Designation
3/19/2024
Forge Biologics today announced that the Medicines and Healthcare Products Regulatory Agency (MHRA), the healthcare regulatory body of the United Kingdom (UK), granted Innovation Passport designation to the Company’s novel AAV gene therapy program, FBX-101.
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Ferinject® approved by Health Canada for the treatment of iron deficiency anemia in adult and pediatric patients and iron deficiency in adult patients with heart failure
3/19/2024
CSL Vifor announced that Health Canada has authorized Ferinject for the intravenous treatment of iron deficiency anemia in adult and pediatric patients one year of age and older when oral iron preparations are not tolerated or are ineffective, as well as for the treatment of iron deficiency in adult patients with heart failure and New York Heart Association class II/III* to improve exercise capacity.
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AstraZeneca to acquire Fusion to accelerate the development of next-generation radioconjugates to treat cancer
3/19/2024
AstraZeneca has entered into a definitive agreement to acquire Fusion Pharmaceuticals Inc., a clinical-stage biopharmaceutical company developing next-generation radioconjugates.
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ATCC Announces Award from the National Cancer Institute to Provide Biospecimen Processing Services and Assays for Cancer Research
3/19/2024
ATCC will continue to support the National Cancer Institute's (NCI) mission to prevent cancer and the Division of Cancer Epidemiology and Genetics (DCEG) Biospecimen Activity and Assay Support (BAAS) program.
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Fusion Pharmaceuticals to be Acquired by AstraZeneca, Accelerating Development of Next-Generation Radioconjugates to Treat Cancer
3/19/2024
Fusion Pharmaceuticals Inc., a clinical-stage oncology company focused on developing next-generation radioconjugates as precision medicines, announced the Company has entered into a definitive agreement to be acquired by AstraZeneca.