RESEARCH TRIANGLE PARK, N.C., Aug. 31, 2022 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for BCX9250 for the treatment of fibrodysplasia ossificans progressiva (FOP).
The AstraZeneca-Daiichi Sankyo antibody-drug conjugate has passed another trial, this time a Phase III trial testing the cancer drug versus physician’s choice in patients with HER2-positive metastatic breast cancer.
Natco Pharma Ltd's Generic Lapatinib Ditosylate Receives Approval In US
The product information for Tyverb, a breast cancer medicine, will continue to state that no data are available on the effectiveness of Tyverb used together with an aromatase inhibitor compared with trastuzumab used with an aromatase inhibitor in patients previously treated with trastuzumab.
Puma Biotech has only retained commercial rights to its cancer drug Nerlynx in the U.S. and Japan after a series of licensing deals. But even the remaining U.S. launch doesn’t seem to be going well.
EMA is PDF iconupdating the prescribing information for Tyverb (lapatinib) following detection of errors in results of a study involving postmenopausal women who had ‘HR+/HER2+’ breast cancer and whose disease had worsened despite previous treatment with trastuzumab. The results had indicated a benefit of Tyverb over trastuzumab when each medicine was used together with an aromatase inhibitor.
Hetero, one of India’s leading generic pharmaceutical companies and world’s largest producer of anti-retroviral drugs, has announced the launch of generic version of Lapatinib (250 mg) tablets in India.
LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company, announced top line results from the Phase III NALA trial of the Company's lead drug candidate PB272 (neratinib) in patients with HER2-positive metastatic breast cancer who have failed two or more prior lines of HER2-directed treatments (third-line disease) in the setting of metastatic disease. The Phase III NALA trial is a randomized controlled trial of neratinib plus capecitabine versus Tykerb® (lapatinib) plus capecitabine in patients with third-line HER2-positive metastatic breast cancer.
The company said that it has also enrolled the first patient in Japan in another phase 1 study of the drug. The plan is to enroll up to 36 Japanese patients with biliary tract cancer, and study the safety and tolerability of varlitinib as a monotherapy and also in combination with capecitabine.
The first-in-class treatment was awarded Promising Innovative Medicine designation by the Medicines and Healthcare products Regulatory Agency (MHRA) in January last year, and shortly afterwards won FDA approval through its accelerated approval programme.