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Legend exec

Johnson & Johnson and Legend Biotech’s Carvykti continues to grow in multiple myeloma despite the introduction of a more convenient option. Carvykti generated $117 million in the second-quarter sales, up from $72 million in the first three months of the year. The increase suggests the two companies’ efforts to ramp up supply are working. Manufacturing capacity has been a limiting factor for Carvykti’s performance since its launch last Spring, and expansion is key as the partners angle for earlier lines of treatment. Under a regular review timeline, the FDA has set April 5, 2024, as the target decision date for Carvykti’s application as a second- to fourth-line myeloma treatment, Legend said Tuesday. The standard review is somewhat disappointing given that industry watchers were expecting a priority review, which might’ve enabled a launch in December. But the longer timeline shouldn’t be much of a problem because J&J and Legend don’t have ...
- Source: drugdu
- 117
- August 18, 2023
Galecto Drops Idiopathic Pulmonary Fibrosis Hopeful After Phase II Flop

By Tristan Manalac Pictured: Air sacs inside the lungs/iStock, Ozgu Arslan Galecto’s investigational drug GB0139 fell short of its primary efficacy endpoint in the Phase IIb GALACTIC-1 trial, failing to slow the decline of forced vital capacity in patients with idiopathic pulmonary fibrosis, the company announced Tuesday. Following the failure, Galecto will discontinue the clinical development of GB0139 in idiopathic pulmonary fibrosis (IPF) and instead focus its resources on advancing assets for severe liver diseases, the company said in the announcement. Galecto CEO Hans Schambye said in a statement that results from GALACTIC-1 “do not support the continued development of GB0139 as a new treatment for IPF” and that the company is currently re-evaluating its options and resource allocation plans “with the goal of extending our cash runway into 2025.” Previously granted the FDA’s Orphan Drug Designation, GB0139 was an inhaled small-molecule inhibitor of the galectin-3 protein, which is a ...
- Source: drugdu
- 211
- August 17, 2023
Pfizer Bispecific Drug Wins FDA Accelerated Approval for Multiple Myeloma

By Tristan Manalac Pictured: Pfizer office at its South San Francisco campus/iStock, hapabapa The FDA on Monday granted accelerated approval to Pfizer’s bispecific antibody elranatamab, to be marketed as Elrexfio, for the treatment of relapsed or refractory multiple myeloma. Elrexfio’s label covers patients who had been treated with at least four prior lines of therapy, including an anti-CD38 antibody, an immunodulatory agent and a proteasome inhibitor. According to Pfizer’s announcement, Monday’s approval makes Elrexfio the first off-the-shelf, ready-to-use fixed-dose subcutaneous therapeutic that targets the BCMA protein. “With significant responses in a patient population with highly refractory disease, we believe Elrexfio is poised to potentially become the new standard of care for multiple myeloma,” Pfizer Chief Commercial Officer Angela Hwang said in a statement, adding that the company will continue the treatment’s clinical development through its broad MagnetisMM program. The FDA’s approval was supported by data from the Phase II MagnetisMM-3 ...
- Source: drugdu
- 208
- August 17, 2023
Study reveals coping mechanisms used by South African healthcare workers during the pandemic

A new study by UC Berkeley Anthropology Professor Andrew Wooyoung Kim reveals resilient coping mechanisms used by healthcare workers during the COVID-19 pandemic in metro Johannesburg, South Africa. Titled “Coping strategies employed by public psychiatric healthcare workers during the COVID-19 pandemic in southern Gauteng, South Africa,” Kim’s paper was published in PLOS ONE in August. It explores the diverse coping strategies employed by public psychiatric healthcare workers during the pandemic in the metropolitan Johannesburg area. Andrew Wooyoung Kim, Anthropology Professor, UC Berkeley, said, “This research illuminates the adaptability and creativity of individuals facing unprecedented healthcare challenges. The psychiatric healthcare workers’ ability to innovate in the face of extreme adversity is particularly inspiring. Understanding these coping strategies is vital for building short-term support systems for healthcare workers, providing a roadmap for bolstering psychiatric service delivery while also improving patient outcomes in times of healthcare emergencies.” The study identified seven major coping ...
- Source: drugdu
- 112
- August 16, 2023
Chasing AstraZeneca and Pfizer, Johnson & Johnson snags FDA nod for prostate cancer combo Akeega

Following FDA approvals for fellow PAPR inhibitors made by AstraZeneca/Merck and Pfizer, Johnson & Johnson has got its own combo approval in prostate cancer. The tablet treatment, known commercially as Akeega, combines J&J’s androgen-directed Zytiga (abiraterone acetate) and the PARP inhibitor niraparib, which is sold by GSK as Zejula in other indications. The FDA has signed off on its use along with the corticosteroid prednisone, but only in a subset of mCRPC patients—those with BRCA mutations. Akeega will compete with AstraZeneca and Merck’s Lynparza as well as Pfizer’s Talzenna in the indication. Eleven weeks ago, the FDA gave Lynparza the same narrow label for those with the BRCA-positive tumors. Talzenna’s approval covers a broader population, including other mutations in the homologous recombination deficiency family. Under a 2016 deal with Zejula’s developer Tesaro, J&J carved out rights to the drug in prostate cancer. GSK then bought out Tesaro in 2019. The ...
- Source: drugdu
- 114
- August 16, 2023
Biotech Financings Fall, M&A Activity Expected to Pick Up

Venture capital is available, but the trending numbers do not favor startups. Deal counts have plateaued and deal sizes are down from the recent peak in 2021. These market conditions are leading startups to change their strategies in order to make the money they have last longer, according to the second quarter Venture Monitor report from Pitchbook and the National Venture Capital Association (NVCA). Breaking out biotech investments specifically, the report tallied $2.6 billion invested in 199 biotech deals globally in the second quarter, down significantly compared to the same period in 2022, when $4.8 billion was invested in 245 deals. In the U.S., Pitchbook and NVCA calculated $1.9 billion invested across 81 biotech deals in the second quarter compared to $3.3 billion invested in 93 deals in the same period last year. The report counts more than 50,000 U.S.-based venture capital-backed companies—double the number in 2016. This group now ...
- Source: drugdu
- 137
- August 15, 2023
Genentech to pay $158K fine after EPA flagged mishandling of hazardous waste at San Francisco plant

After settling with the U.S. Environmental Protection Agency (EPA) over environmental violations at one of its former plants, Genentech is on the hook for a fine of $158,208.The findings came out of a 2021 inspection of the company’s now-closed plant in South San Francisco. During the visit, EPA inspectors found several instances of the company skirting requirements related to the disposal of hazardous materials, the agency said. For one, the company stored waste without a permit and didn’t correctly monitor air emissions from the materials, according to the EPA. Plus, the overfill protection controls for a hazardous waste tank weren’t maintained at all, the agency said. Inspectors also found manifests for the waste that didn’t include all necessary federal waste codes. “When a company fails to comply with hazardous waste storage and monitoring requirements, that company puts workers and communities at risk of harmful exposures,” EPA pacific southwest regional administrator ...
- Source: drugdu
- 134
- August 14, 2023
Regeneron to acquire Decibel Therapeutics in deal worth up to $213m

Regeneron Pharmaceuticals has entered into a definitive agreement to acquire hearing loss specialist Decibel Therapeutics in a deal worth as much as $213m. The transaction gives Regeneron access to investigational gene therapy, DB-OTO, which is designed to provide hearing to people with otoferlin-related hearing loss. The candidate is currently in phase 1/2 clinical development. Under the terms of the agreement, Regeneron will pay $4 per share of Decibel common stock, with an additional non-tradeable contingent value right (CVR) for $3.50 apiece, upon achievement of certain clinical development and regulatory milestones for DB-OTO. The deal gives Decibel a total equity value of about $109m, based on the amount payable at closing, though that valuation increases to $213m if the CVR milestones are met. The agreement builds on the existing gene therapy collaboration between Regeneron and Decibel aimed at developing three programmes targeting different forms of congenital, monogenic hearing loss. There are ...
- Source: drugdu
- 120
- August 14, 2023
Galera Lays Off 70% of Staff After FDA Rejection in Severe Oral Mucositis

Pictured: FDA sign in its headquarters/iStock, Grandbrothers The FDA rejected on Wednesday Galera Therapeutics’ avasopasem manganese, which the company was proposing as a treatment for radiotherapy-induced severe oral mucositis in patients with head and neck cancer. Galera shares fell 83% in after-hours trading in response to the FDA’s rejection. In its Complete Response Letter, the regulator said that Galera’s data were “not sufficiently persuasive to establish substantial evidence of avasopasem’s effectiveness and safety for reducing severe oral mucositis in patients with head and neck cancer.” The FDA noted that it will need results from an additional trial if the company wants to file a resubmission. The New Drug Application for avasopasem manganese included data from the Phase III ROMAN study, topline data from which showed that treatment with Galera’s candidate significantly reduced the incidence of radiotherapy-induced severe oral mucositis (SOM). The company supported these findings with results from the Phase ...
- Source: drugdu
- 120
- August 14, 2023
Thermo Fisher Scientific Selected as the Transplantation Statistical and Clinical Coordinating Center (T-SCCC) for the U.S. National Institute of Allergy and Infectious Diseases

T-SCCC will support initiatives seeking to ensure success of organ transplants for patients WILMINGTON, N.C.–(BUSINESS WIRE)– The PPD clinical research business of Thermo Fisher Scientific Inc., the world leader in serving science, has been granted a five-year award to provide a Transplantation Statistical and Clinical Coordinating Center for the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health in the United States. This center will offer a broad range of support services critical to the design, development, execution and analysis of NIAID transplantation clinical trials and research. According to the United Network for Organ Sharing, the non-profit serving as the nation’s transplant system under contract with the federal government, more than 40,000 organ transplants were performed in 2022, setting an annual record, with total kidney transplants exceeding 25,000 for the first time ever. Meanwhile, the Health Resources & Services Administration within the U.S. Department ...
- Source: drugdu
- 112
- August 14, 2023

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