Alvotech announced that it has reached settlement agreements with Johnson & Johnson in Japan, Canada and in the European Economic Area (EEA) for AVT 04, a biosimilar to… read more.
Genentech, a member of the Roche Group, announced data from Stage 1 of the National Institutes of Health (NIH)-sponsored pivotal Phase III OUtMATCH study evaluating the efficacy and… read more.
Vertex Pharmaceuticals announced that the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for the label expansion of Kalydeco (ivacaftor)… read more.
Rigel Pharmaceuticals, Inc. announced that it has entered into a definitive agreement to acquire the U.S. rights to Gavreto (pralsetinib) from Blueprint Medicines Corporation. Gavreto is a once… read more.
MHLW (Japan) approved on February 9 Nippon Boehringer Ingelheim’s SGLT2 inhibitor Jardiance (empagliflozin) for the treatment of chronic kidney disease (CKD) </p. Jardiance has been available in Japan… read more.
Regeneron Pharmaceuticals, Inc. announced that the Ministry of Health, Labor and Welfare (MHLW) in Japan has granted marketing and manufacturing authorization for Dupixent (dupilumab) for the treatment of… read more.
Eisai Co., Ltd. and nippon medac Co., Ltd., a subsidiary of medac Gesellschaft für klinische Spezialpräparate mbH announced that they have obtained manufacturing and marketing approval from the… read more.
Positive high-level results from the LAURA Phase III trial showed AstraZeneca’s Tagrisso (osimertinib) demonstrated a statistically significant and highly clinically meaningful improvement in progression-free survival (PFS) for patients… read more.
The biologics license application (BLA) for the interleukin (IL)-2–based immunotherapy denileukin diftitox (Lymphir) in patients with relapsed or refractory cutaneous T-cell lymphoma (CTCL) following at least 1 prior… read more.
The FDA has accepted a biologics license application (BLA) for Alvotech’s ustekinumab biosimilar candidate (AVT 04) referencing Stelara, which will be used to treat several autoimmune disorders. Alvotech… read more.
Roche announced that the FDA has approved Xolair (omalizumab) for the reduction of allergic reactions, including anaphylaxis, that may occur with accidental exposure to one or more foods… read more.
Insulet Corporation ,the global leader in tubeless insulin pump technology with its Omnipod brand of products, announced it has received CE mark approval under the European Medical Device… read more.