Pfizer is still hungry for ADC opportunities, including in the Far East. Astellas’ impressive phase 3 data for its gastric cancer candidate couldn’t garner an approval because of manufacturing issues. Takeda’s 2022 TYK2 buy from Nimbus was highly competitive, an exec said. And more. 1. JPM24: Even after Seagen buyout, Pfizer oncology chief still eyes ADC deals As Pfizer continues its prowl for antibody-drug conjugate (ADCs) deals, the company is keeping an eye on opportunities around the globe. In an interview, Pfizer’s new oncology chief Chris Boshoff, Ph.D., said the company is looking for opportunities in China, which he said “is important in this whole area, especially ADC development.” The company is “not currently looking for big acquisitions,” Boshoff added. 2. Astellas’ gastric cancer candidate rejected by FDA because of manufacturing issues After running two phase 3 trials, Astellas’ near-term approval ambitions for its zolbetuximab have been dashed because of ...
Astellas Pharma’s zolbetuximab was on track to become the first gastric cancer drug that targets claudin 18.1, a protein found on cancerous stomach cells. Others with clinical-stage programs addressing this this target include AstraZeneca and Bristol Myers Squibb. By FRANK VINLUAN Astellas Pharma’s path to winning the first drug approval for a particular promising gastrointestinal cancer target has hit a detour. The FDA turned down the drugmaker’s application, citing manufacturing issues for the therapy, zolbetuximab. Astellas announced the FDA action earlier this week. The company did not go into detail about the problems spotted by the regulator, but described them as “unresolved deficiencies following its pre-license inspection of a third-party manufacturing facility for zolbetuximab.” Astellas added that the agency did not raise any concerns about the safety or efficacy of the drug, nor is it asking for additional clinical data. Zolbetuximab was developed as a treatment for patients with locally ...
Pfizer knows it had a bad year in 2023. Speaking to reporters at the 2024 J.P. Morgan Healthcare Conference on Monday, the company’s CEO, Albert Bourla, spoke bluntly about the hits the company took, and he acknowledged the underperformance of certain key launches. But 2024 represents a fresh opportunity for the pharma giant, Bourla said. “In essence, you should expect 2024—after all the changes in the setup that we did in year ’23—to be a year of execution,” he told the JPM audience. Pfizer will attempt to execute, in part, by leveraging its recent $43 billion buyout of antibody-drug conjugate specialist Seagen, Bourla explained. Further, the company hopes to advance its presence in respiratory syncytial virus (RSV), where Pfizer recently launched its vaccine Abrysvo. Still, Bourla was frank about the challenges Pfizer faced in 2023. “The year for us, we missed our internal projections. And also we missed the expectations ...
Pharmaceutical Executive Editorial Staff Moderna’s vaccine revenue dropped from $18.4 billion in 2022 to $6.7 billion in 2023, however the company anticipates profitability this year powered by COVID-19 vaccine sales and the launch of its mRNA-based respiratory syncytial virus vaccine. Sales of Moderna’s COVID-19 vaccine dropped from $18.4 billion in 2022 to $6.7 billion in 2023, which was ultimately above projections, the company announced in a business update presented at the at 42nd annual JP Morgan Healthcare Conference. The significant decline in people seeking immunizations for COVID-19 products last year comes at a time when the virus is still surging worldwide. The decline resulted in shares of Moderna dropping by approximately 45% last year; however, the shares are up more than 60% following a drop to approximately $70 per share in November 2023. Moderna projected that it would reach the lower end of its forecast range of $6 billion to ...
COLUMBUS, Ohio, & SHANGHAI, Jan. 11, 2024 – Sermonix Pharmaceuticals Inc., a privately held biopharmaceutical company developing innovative therapeutics to specifically treat metastatic breast cancers harboring ESR1 mutations, and Shanghai Henlius Biotech, Inc. (2696.HK), today announced a strategic collaboration agreement in which Henlius will receive exclusive rights to develop, manufacture and commercialize Sermonix’s lead investigational drug, lasofoxifene, in China. Under the terms of the agreement, Henlius will receive exclusive rights and sublicenses to lasofoxifene for at least two estrogen receptor-positive (ER+)/HER2- breast cancer indications in the territory, with Sermonix retaining all other global rights. Sermonix received an upfront payment and is further eligible to receive up to $58 million in certain predetermined milestones, in addition to royalties upon Henlius commercialization in China. Breast cancer is the cancer with the highest incidence rate in the world, according to GLOBOCAN 2020. There were 2.26 million new cases of breast cancer in 2020 ...
While some Merck & Co. investors may still get the heebie-jeebies when thinking about Keytruda’s patent cliff in 2028, but the company’s CEO Rob Davis now thinks “it’s just another year.” Make no mistake, given Keytruda’s size, an overall business decline will likely still hit. But Merck is focused on making “the hill to dip as small as possible and the return to growth as fast as possible,” Davis said Monday at the 2024 annual J.P. Morgan Healthcare Conference. Davis and Merck Research Laboratories President Dean Li, M.D., Ph.D., pointed to the breadth of Merck’s portfolio across oncology, infectious disease, cardiometabolic, immunology and neuroscience to explain Merck’s potential for growth. “I know that the conversation continues to be about Keytruda and 2028,” Davis said. “But increasingly, we’re not focused on 2028. 2028, it’s just another year, it’s just another point. We’re focused on 2030 to 2040.” At last year’s J.P. ...
Johnson & Johnson’s acquisition of antibody drug conjugate developer Ambrx Biopharma comes as Novartis and Merck also unveiled M&A deals on the first day of the J.P. Morgan Healthcare conference. In a report, the investment bank said big pharmas are looking for deals involving de-risked assets. By FRANK VINLUAN Big pharmaceutical companies splashed out big bucks in 2023 to acquire or license antibody drug conjugates, or ADCs. The trend is continuing into the new year with Johnson & Johnson reaching a $2 billion deal to acquire clinical-stage Ambrx Biopharma. According to deal terms announced Monday, J&J will pay $28 cash for each Ambrx share, which is a 105% premium to the biotech’s closing stock price on Friday. In other biopharma deal announcements, Merck is paying $680 million to acquire Harpoon Therapeutics, a developer of targeted cancer therapies, and Novartis is buying autoimmune disease drug developer Calypso Biotech for $250 ...
San Francisco—Nearly all top cancer drugmakers have struck deals in the sizzling antibody-drug conjugate field—but not Novartis. On Monday, the Swiss pharma’s CEO Vas Narasimhan explained how he’s resisted the temptation. The answer is radioligand therapies, Narasimhan said Monday during the 2024 J.P. Morgan Healthcare Conference in response to a question from Fierce Pharma. “We have a long history within research of ADCs, but we have not been successful,” Narasimhan said. “To be clear, part of our focus strategy is looking at places where we think we can create long-term sustainable leadership. And we are investing in radioligand therapies.” ADCs and radioligand therapies are similar in that both technologies act as guided missiles. For ADCs, the guiding force is an antibody, and the cancer-killing payload is a chemotherapy. A radioligand therapy uses a ligand to target cancer cells and kills them with a therapeutic radioisotope. Radiotherapies may have a safety ...
On December 29, 2023, China’s National Drug Administration (NMPA) has formally accepted the New Drug Application (NDA) for Garsorasib tablets (D-1553 tablets, KRAS G12C inhibitor) for the treatment of locally advanced or metastatic non-small-cell lung cancer with disease progression or intolerable disease after prior first-line systemic therapy, and with the presence of a KRAS G12C mutation confirmed by testing. metastatic non-small cell lung cancer. This NDA acceptance is primarily based on the results of a Phase II single-arm registrational clinical study (Study D1553-102, CDE Registry No. CTR20220745) conducted in China with Professor Lu Shun of Shanghai Chest Hospital as the principal investigator. Previously, the results of the Phase I clinical study of D-1553 in KRAS G12C mutation-positive non-small cell lung cancer were selected for an oral presentation at the World Conference on Lung Cancer (WCLC) in August 2022 and published in April 2023 in the Journal of Thoracic Oncology1 . ...
Recently, the Chinese Breast Cancer Society Breast Cancer Diagnosis and Treatment Guidelines (2024 Edition) (hereinafter referred to as the CBCS Guidelines) has been updated and released. As one of the most important and authoritative Chinese diagnosis and treatment norms in the field of breast cancer, the CBCS Guidelines follow the international pace and cutting-edge progress, and comprehensively summarize and elaborate on breast cancer screening, examination, diagnosis and treatment, and reporting. In this guideline recommendation, two new indications for Hengrui Pharmaceuticals’ innovative drugs have been added, which are the first-line treatment regimen of piretinib combination for HER2-positive metastatic breast cancer, and the first- and second-line treatment regimen of dalsirib for HR-positive HER2-negative metastatic breast cancer (MBC). Thus, both innovative drugs have been recommended by the 2024 CBCS guidelines for the marketed breast cancer indications. Breast cancer has become the number one malignant tumor worldwide and is one of the most common ...
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