Search Results for “FDA” – Page 113 – media

Johnson & Johnson Seeks Approval for Darzalex Faspro Combo in Newly Diagnosed Multiple Myeloma

Pharmaceutical Executive Editorial Staff Darzalex Faspro has previously been approved by the FDA for eight indications in multiple myeloma. The FDA will evaluate Johnson & Johnson’s supplemental Biologics License Application (sBLA) for Darzalex Faspro (daratumumab and hyaluronidase-fihj) with bortezomib, lenalidomide, and dexamethasone (D-VRd) for induction and consolidation therapy and in combination with lenalidomide (D-R) for the maintenance treatment of adults newly diagnosed with multiple myeloma who are eligible for autologous stem cell transplant (ASCT).1 Darzalex Faspro, a CD38-directed antibody, has previously been approved by the FDA for eight indications in multiple myeloma, with three in the frontline treatment of newly diagnosed patients who are transplant eligible or ineligible. “We are committed to changing the course of multiple myeloma through building combination regimens such as D-VRd with complementary mechanisms of action. The Darzalex Faspro-based quadruplet therapy demonstrated a clinically significant reduction in the risk of progression or death for transplant-eligible, newly ...
- Source: drugdu
- 126
- February 2, 2024
Biogen abandons Aduhelm efforts, focuses on Eisai-partnered Leqembi and pipeline drugs

More than two years after Aduhelm’s controversial and ill-fated FDA accelerated approval, Biogen is discontinuing the Alzheimer’s disease therapy after walking a rocky path. Wednesday, Biogen said it’s pulling all efforts from the first-of-its-kind anti-amyloid beta therapy to focus on Leqembi, its Eisai-partnered newer medicine, and its pipeline candidates. The newer drug, Leqembi, won a full FDA approval early last year, making the partners’ marketing efforts on the therapy much simpler than was the case with Aduhelm. Biogen is taking a $60 million charge and is discontinuing all development and sales of Aduhelm, the company said. It’s terminating the ENVISION clinical study, which sought to confirm the benefit of the medicine as required under its 2021 accelerated approval. The decision follows Biogen’s move to launch a strategic review in early 2023 under new CEO Chris Viehbacher, the former Sanofi chief who joined the Massachusetts drugmaker in November 2022. During that ...
- Source: drugdu
- 185
- February 2, 2024
Daiichi Sankyo again dials up Enhertu sales forecast, advances 2nd AstraZeneca-partnered ADC

AstraZeneca-partnered Enhertu has become a bright spot in Daiichi Sankyo’s business, and the Japanese pharma has again increased its sales projection for the HER2-directed antibody-drug conjugate. But this time, the rosier outlook reflects developments outside the U.S. Daiichi now expects Enhertu sales to come in at 383.9 billion Japanese yen (about $2.6 billion) for the 12 months ending March 31. The number includes profits from regions where AstraZeneca books Enhertu sales. Daiichi had already once dialed up its Enhertu forecast for its current fiscal year. The drugmaker’s projection was originally 320 billion yen back in April 2023, then Daiichi raised it to 381.7 billion yen in October. Despite rolling out the higher global forecast, Daichii actually reduced Enhertu’s 12-month sales estimate in the U.S. by $30 million to $1.58 billion. For the first nine months of the company’s fiscal year, Enhertu generated $1.14 billion in the U.S., an increase of ...
- Source: drugdu
- 127
- February 2, 2024
Chip Monitors Cancer Cells in Blood Samples to Assess Treatment Effectiveness

Approximately only half of cancer patients see a positive response to treatments, with the remaining experiencing inadequate outcomes. The high costs and potential adverse reactions of treatments make it crucial for clinicians to quickly determine their effectiveness, or if an alternative therapy is more suitable. Presently, it can take weeks or months to fully gauge the success of cancer treatment, typically using CT scans to measure significant size changes in tumors. While tumor biopsies offer more precise data, their infrequency limits the ability to provide ongoing updates. As a solution, many clinicians are now resorting to liquid biopsies, which involve testing for cancer indicators in a patient’s blood, like tumor-shed cancer cells. However, these tests require sufficiently high cell levels for detection. This is particularly challenging in lung cancer, where some FDA-approved methods for detecting blood-borne cancer cells are ineffective, often due to targeting a single, less common protein in ...
- Source: drugdu
- 140
- February 1, 2024
HUTCHMED Receives ELUNATE® (fruquintinib) Marketing Approval in Hong Kong for Treatment of Metastatic Colorectal Cancer

Hong Kong, Shanghai & Florham Park, NJ — Tuesday, January 30, 2024: HUTCHMED (China) Limited (Nasdaq/AIM:HCM, HKEX:13) (“HUTCHMED”) today announces that the marketing approval of ELUNATE® (fruquintinib) by the Pharmacy and Poisons Board of Hong Kong for the treatment of adult patients with previously treated metastatic colorectal cancer (“CRC”). ELUNATE® is a selective oral inhibitor of vascular endothelial growth factor (“VEGF”) receptors -1, -2 and -3, which play a pivotal role in blocking tumor angiogenesis. This marks the first medicine to be approved under the new mechanism for registration of new drugs (“1+” mechanism) announced by the Government of the Hong Kong Special Administrative Region (“SAR”) in October last year. The mechanism officially commenced on November 1, 2023. It allows drugs which are beneficial for treatment of life-threatening or severely debilitating diseases to apply for registration for use in Hong Kong, if they have supporting local clinical data and recognition ...
- Source: drugdu
- 106
- February 1, 2024
Pfizer’s layoff campaign ramps back up with dozens of SF-area cuts expected next month

The start of the new year doesn’t seem to have dulled the zeal of Pfizer’s global cost-cutting campaign, which has already left hundreds of jobs in its wake.Come mid-February, Pfizer will lay off some 52 employees at a facility in South San Francisco, according to a recent Worker Adjustment and Retraining Notification Act (WARN) alert. That address matches the former headquarters of Global Blood Therapeutics, which Pfizer scooped up for $5.4 billion back in 2022. Along with the deal, Pfizer gained GBT’s marketed sickle cell disease drug Oxbryta. “As previously communicated, Pfizer has launched an enterprise-wide cost realignment program,” a Pfizer spokesperson said via email. The program will “result in some job loss across a number of our locations, including South San Francisco,” the spokesperson said.“Pfizer does not take these changes lightly,” she added. GBT’s Oxbryta won FDA approval in sickle cell disease back in 2019. When Pfizer closed its GBT buyout in October 2022, ...
- Source: drugdu
- 154
- January 31, 2024
Hengrui Medicine’s immunosuppressant tacrolimus sustained-release capsules were approved for marketing in the United States

Recently, Chengdu Shengdi Medical Company Co., Ltd.., a subsidiary of Jiangsu Hengrui Pharmaceuticals Co., Ltd., received notification from the U.S. Food and Drug Administration (FDA) that the company’s Abbreviated New Drug Application (ANDA, U.S. generic drug application) for tacrolimus extended-release capsules has been approved for marketing in the U.S.. This product is suitable for use in combination with other immunosuppressants to prevent graft rejection after adult kidney transplantation. The company’s tacrolimus sustained-release capsules are the first generic drug approved by the U.S. FDA for marketing, and are also the first domestic generic products. They have been approved for marketing in China in June 2022. Tacrolimus is the core basic immunosuppressant after transplantation [1]. It is a calcineurin inhibitor (CNI). Its mechanism is to inhibit the activity of calcineurin, thereby inhibiting the production of various cytokines. Expression and/or production, such as IL-1β, IL-2, IFN-γ, TNF-α, etc., ultimately inhibit T lymphocyte activation and ...
- Source: drugdu
- 112
- January 31, 2024
Hengrui Pharmaceuticals’ Immunosuppressant Tacrolimus Extended-Release Capsules Approved for U.S. Marketing

Recently, Hengrui Pharmaceuticals’ subsidiary Chengdu Shengdi Pharmaceuticals Co., Ltd. has received notification from the U.S. Food and Drug Administration (FDA) that the company’s abbreviated new drug application (ANDA, i.e., U.S. generic application) for the filing of tacrolimus extended-release capsule has been approved for production and marketing in the U.S. market. The product is indicated for use in combination with other immunosuppressive agents for the prevention of graft rejection following kidney transplantation in adults. The Company’s tacrolimus extended-release capsule is the first generic of this product approved for marketing by the U.S. FDA, and is also the first generic product approved for marketing in China. Tacrolimus is the core basic immunosuppressant after transplantation, which belongs to calmodulin neural phosphatase inhibitor (CNI), and its mechanism of action is to inhibit the expression and/or production of various cytokines, such as IL-1β, IL-2, IFN-γ, TNF-α, etc., by inhibiting the activity of calmodulin phosphatase, and ...
- Source: drugdu
- 81
- January 31, 2024
EMA Grants Bersiporocin Orphan Drug Designation

Mike Hollan The agency recognized the medication as a significant advancement for the treatment of IPF. Daewoong Pharmaceuticals The European Medicines Agency (EMA) granted its orphan drug designation to bersiporocin, a medication developed by Daewoong Pharmaceuticals. The drug earned the title for its treatment of idiopathic pulmonary fibrosis (IPF). Daewoong Pharmaceuticals describes the drug as the world’s first PRS inhibitor for IPF. In a press release, Daewoong Pharmaceutical CEO Seng-ho Jeon said, “With Bersiporocin’s global recognition and its clinical advancements, we are more committed than ever to delivering this promising treatment to IPF patients, potentially transforming the landscape of this challenging disease.” IPF is a rare disease and only has about 13 cases per 100,000 people across the entire planet. It is a serious condition and the 5-year survival rate is about 40%. Patients with the condition suffer from a reduction of lung function due to a build-up of ...
- Source: https://www.pharmexec.com/authors/mike-hollan
- 101
- January 31, 2024
Biosimilar Insulins Promise Patients New Choices, But Competition Is Still Lacking

Insulin prices have long been a pain point for diabetics. The big three insulin manufacturers have cut prices across their product lineups, but potential competition from other biosimilar insulins is still in earlier stages of development. By FRANK VINLUAN Inflation remains a top consumer gripe, but the higher cost of milk and eggs is negligible when compared to insulin. Spending on insulin has tripled in the past decade, topping $22 billion in 2022, according to research from the American Diabetes Association. While some of that increase is due to a growing patient pool, it’s also due to rising prices. The inflation-adjusted cost of insulin increased 24% from 2017 to 2022. Lower-cost insulin is becoming available to more Americans with diabetes. Implementation of the Inflation Reduction Act last year was a catalyst. One of the federal law’s provisions set a $35 cap on the monthly out-of-pocket cost for insulin. Though the ...
- Source: drugdu
- 83
- January 30, 2024

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