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Alvotech announces expected global market entry dates for AVT 04 biosimilar to Stelara (ustekinumab)

Written by | 1 Mar 2024

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.

New England Journal of Medicine publishes phase III data showing Xolair (omalizumab) significantly reduced allergic reactions across multiple foods in people With food allergies – Genentech/Roche

Written by | 29 Feb 2024

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.

CHMP positive opinion for Kalydeco for the treatment of infants with cystic fibrosis ages 1 month and older – Vertex Pharma

Written by | 28 Feb 2024

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 acquires U.S. rights to Gavreto (pralsetinib) from Blueprint Medicines Corporation

Written by | 27 Feb 2024

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) approves Jardiance (empagliflozin) for the treatment of chronic kidney disease (CKD) – Nippon Boehringer Ingelheim

Written by | 26 Feb 2024

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.

Japan first in the world to approve Dupixent (dupilumab) for chronic spontaneous urticaria (CSU) – Regeneron + Sanofi

Written by | 25 Feb 2024

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.

Metoject subcutaneous injection pen (methotrexate) pen – type autoinjector approved in Japan – Eisai

Written by | 24 Feb 2024

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.

Tagrisso (osimertinib) is the first EGFR inhibitor and targeted treatment to demonstrate progression-free survival benefit in Stage III setting of non-small cell lung cancer – AstraZeneca

Written by | 23 Feb 2024

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.

BLA resubmitted to FDA for denileukin diftitox in relapsed/refractory cutaneous T-cell lymphoma – Citius Pharmaceuticals

Written by | 22 Feb 2024

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.

FDA accepts BLA for Ustekinumab biosimilar – Alvotech

Written by | 21 Feb 2024

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.

FDA approves Xolair as first and only medicine for children and adults with one or more food allergies – Genentech/Roche + Novartis

Written by | 20 Feb 2024

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.

CE Mark approval of Omnipod 5 integration with Abbott FreeStyle Libre 2 plus sensor – Insulet

Written by | 19 Feb 2024

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.

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