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Amgen's (AMGN) KRAS inhibitor, Lumakras, gets approval in Japan for the treatment of KRAS G12C-mutated positive advanced/recurrent non-small-cell lung cancer.

THOUSAND OAKS, Calif. , Jan. 20, 2022 /PRNewswire/ -- Amgen (NASDAQ: AMGN ) today announced that LUMAKRAS ® (sotorasib) has been approved in Japan for the treatment of KRAS G12C-mutated positive, unresectable, advanced and/or recurrent non-small cell lung cancer (NSCLC) that has progressed after systemic anticancer therapy. "Today''s approval of LUMAKRAS as the first and only KRAS G12C inhibitor marks a paradigm shift in the treatment of patients with non-small cell lung cancer in Japan ," said David M. Reese , M.D., executive vice president of Research and Development at Amgen. "In just over three years since the first patient was dosed in the pivotal CodeBreaK 100 trial, LUMAKRAS is now approved in nearly 40 countries, illustrating our commitment to accelerating transformative medicines for patients living with cancers that have yet to be fully addressed." The approval by the Japan Ministry of Health, Labour and Welfare (MHLW) is based on positive results from the Phase 2 CodeBreaK 100 clinical trial in NSCLC, the largest trial conducted to date for patients with the KRAS G12C mutation.

Amgen Inc's (NASDAQ: AMGN) Lumakras (sotorasib) has been approved in Japan for KRAS G12C-mutated positive, unresectable, advanced and/or recurrent non-small cell lung cancer (NSCLC) progressed afte

SOUTH SAN FRANCISCO, Calif., Jan. 19, 2022 (GLOBE NEWSWIRE) -- CytomX Therapeutics, Inc. (NASDAQ: CTMX ), a leader in the field of conditionally activated therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has cleared the company''s Investigational New Drug (IND) application for CX-904, an EGFRxCD3 T-cell-engaging bispecific antibody being co-developed by CytomX and Amgen. "The impressive innovation of CX-904''s design and its advancement into the clinical setting underscores our commitment to destroying cancer differently. The CX-904 IND also marks the sixth therapeutic candidate and the third treatment modality overall to enter the clinic from our versatile and tunable Probody platform, reinforcing our leadership in the field of conditional activation of biologic therapeutics," said Sean McCarthy, D.Phil., president, chief executive officer and chairman of CytomX Therapeutics. "Our masked Probody T-cell engagers are designed to harness the power of this highly potent modality.

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BridgeBio (BBIO) forges an alliance with Amgen to evaluate their respective cancer drugs for the treatment of advanced solid tumors with KRAS G12C mutations.

Amgen (AMGN) and AstraZeneca (AZN) announce TEZSPIRE (tezepelumab-ekko) is now available for shipment to wholesalers in the U.S.TEZSPIRE was approved by the FDA on Dec

DUBLIN , Jan. 12, 2022 /PRNewswire/ -- The "Global Clinical Stage Partnering Terms and Agreements in Pharma and Biotech 2014-2021" report has been added to ResearchAndMarkets.com''s offering. The Global Clinical Stage Partnering Terms and Agreements in Pharma and Biotech 2014- 2021 report provides comprehensive access to available deals and contract documents for over 2,900 clinical stage deals. The report provides a detailed understanding and analysis of how and why companies enter clinical stage partnering deals and provides details of the latest clinical agreements announced in the healthcare sector. Understanding the flexibility of a prospective partner''s negotiated deals terms provides critical insight into the negotiation process in terms of what you can expect to achieve during the negotiation of terms. Whilst many smaller companies will be seeking details of the payments clauses, the devil is in the detail in terms of how payments are triggered - contract documents provide this insight where press releases and databases do not.