Shares of Laval, Quebec-based ProMetic Life Sciences Inc. jumped more than 8.7 percent this morning after securing the U.S. Food and Drug Administration’s Rare Pediatric Disease Designation for its Inter-Alpha-Inhibitor-Proteins (IAIP) treatment for necrotizing enterocolitis (NEC).
AstraZeneca today announced that the European Medicines Agency has accepted the Marketing Authorisation Variation forForxiga (dapagliflozin), a selective SGLT-2 inhibitor, for use as an oral adjunct treatment to insulin in adults with type-1 diabetes (T1D).
One-fifth of patients in a phase 1 study responded to an investigational ERK inhibitor from Merck, bolstering hopes that this type of drug could be used effectively in combination with other cancer drugs. ERK is a cell signal that is believed to drive the growth of many cancers.
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today their entry into a worldwide collaboration with an affiliate of Theravance Biopharma, Inc. to develop TD-1473, a first-in-class oral, gastrointestinal (GI) restricted pan-Janus kinase (JAK) inhibitor for the treatment of inflammatory bowel disease (IBD), which includes Crohn's disease and ulcerative colitis (UC).
AstraZeneca AZN and partner Merck MRK announced that the Japanese Ministry of Health, Labour and Welfare has granted approval to its PARP inhibitor, Lynparza, as a maintenance therapy for relapsed ovarian cancer, irrespective of BRCA mutation status in patients who have responded to their last platinum-based chemotherapy.
AstraZeneca still enjoys the perks of being first to market with its PARP inhibitor. Lynparza (olaparib) sales were $81 million from July to September, whereas net revenues were $16.8 million and $39.4 million for Clovis Oncology Inc.'s Rubraca (rucaparib) and Tesaro Inc.'s Zejula (niraparib), respectively.
Pfizer Inc. today announced full results from the Phase 2 clinical trial of the investigational, next-generation tyrosine kinase inhibitor lorlatinib that exhibited clinically meaningful activity against lung tumors and brain metastases in a range of patients with ALK-positive and ROS1-positive advanced non-small cell lung cancer (NSCLC), including those who were heavily pretreated.
Amgen’s total revenues grew in Q1 2024 to $7.4bn, displaying a 22% increase from earnings reported in the first quarter of last year. The company reported an operating income of $3.1bn, on a non-GAAP [generally accepted accounting principles] basis. The non-GAAP earnings per share (EPS) dipped 1% to $3.96, with the decrease attributed to higher operating and interest expenses that resulted from the acquisition of Horizon Therapeutics. Amgen acquired Horizon for $27.8bn (£22.76bn) following approval from the US Federal Trade Commission (FTC) in October 2023. The revenue growth was driven by a 22% increase in product sales and a 25% volume growth, with ten products achieving double-digit volume growth. Key performers included hyperlipidemia immunotherapy Repatha (evolocumab) and osteoporosis treatment in postmenopausal women Evenity (romosozumab-aqqg), which grew 33% year-over-year (YoY) and 35% YoY respectively in Q1. Amgen also reported an 80% YoY growth for the severe asthma medication Tezspire (tezepelumab-ekko), and ...
Zydus Lifesciences announced that the New Drug Application (NDA) of Desidustat Tablets has been accepted by the National Medical Products Administration of China (NMPA). CMS International Development and Management, a wholly-owned subsidiary of China Medical System Holdings (CMS) obtained an exclusive license for the Product from Zydus in 2020. Desidustat, administered orally is a novel, oral Hypoxia-Inducible Factor-Prolyl Hydroxylase Inhibitor (HIF-PHI) for treating anaemia in Chronic Kidney Disease (CKD) patients. CKD involves the gradual loss of functioning of kidneys and eventually leads to kidney failure. Healthy kidneys naturally secrete a hormone called Erythropoietin (EPO), which stimulates red blood cell production also known as erythropoiesis. When kidneys are impaired as in patients suffering from Chronic Kidney Disease, EPO production is impaired, leading to development of anaemia. HIF-PHI promotes erythropoiesis through increasing endogenous erythropoietin, reducing hepcidin thereby improves iron availability. Discovered and developed by Zydus, Desidustat is being marketed by the group ...
Deciphera Pharmaceuticals is set to be acquired in a $2.4bn buyout, as the biopharma announced that it has commenced a definitive merger agreement with Ono Pharmaceutical. Under the terms of the offered transaction, Ono will make a cash purchase of all outstanding shares of Deciphera’s common stock at $25.60 per share and subsequently merge Deciphera with a wholly-owned subsidiary of Ono upon the deal’s completion. The deal has been unanimously approved by both companies’ boards of directors and is expected to close in Q3 2024. Following the announcement of acquisition, Deciphera’s stock has jumped 71.9%. Waltham, Massachusetts-based Deciphera brings to the table an extensive kinase inhibitor pipeline, kinase drug discovery expertise, and a strong commercial and sales platform in the US and European markets that is meant to advance Ono’s capabilities and presence in the oncology space. Upon the successful completion of the acquisition, Ono will gain access to Deciphera’s ...
Go to Page Go
your submission has already been received.
OK
Please enter a valid Email address!
Submit
The most relevant industry news & insight will be sent to you every two weeks.