Search Results for “Clinical Trial” – Page 90 – media

Janssen’s Talvey granted FDA accelerated approval for difficult-to-treat blood cancer

Janssen, a Johnson & Johnson company, has announced that its bispecific antibody has been granted accelerated approval by the US Food and Drug Administration (FDA) for use in certain patients with relapsed or refractory multiple myeloma (RRMM). The authorisation for Talvey (talquetamab-tgvs) specifically applies to adult RRMM patients who have received at least four prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody. Multiple myeloma is a difficult-to-treat blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow. Despite recent advances, Janssen has reported that an unmet need remains for more therapeutic options with different modes of action, including for those treated with prior bispecific or CAR-T cell therapies, to better address the unique characteristics of every patient’s individual needs. Talvey, which is administered as a weekly or bi-weekly subcutaneous injection after an initial step-up phase, ...
- Source: drugdu
- 164
- August 15, 2023
Amylyx’s ALS drug Relyvrio gets off the ground as company eyes new brain disorder

Amylyx Pharmaceuticals’ amyotrophic lateral sclerosis (ALS) drug Relyvrio continues to wow Wall Street. Approved in the U.S. as Relyvrio and in Canada under a different brand name, the drug brought in $98.2 million in revenue during the second quarter, Amylyx said Thursday. The haul topped analysts’ consensus estimates of below $92 million, according to Mizuho Securities. Having annual revenue now tracking at $400 million after just four quarters of commercialization is no easy feat, Mizuho analyst Graig Suvannavejh, Ph.D., said in a Friday note. Besides, a strong balance sheet—Amylyx had $357 million cash as of June—means the company “faces no existential need to raise capital—an increasingly daunting challenge given a difficult equity capital markets environment,” he said. The beat was fueled by better-than-expected pricing discounts, according to Suvannavejh. New patient starts actually slowed. By the end of June, Relyvrio added 800 more patients compared with the end of March, bringing ...
- Source: drugdu
- 106
- August 15, 2023
【EXPERT Q&A】What is the FDA’s drug approval process?

Drugdu.com expert’s response: The FDA drug approval process is both standardized and rigorous. Here’s a detailed breakdown of the entire process: 1.Preclinical Research: This is the first step in the drug approval process. It includes pharmacological and toxicological studies to evaluate the safety and effectiveness of the drug. These studies are usually conducted in laboratories or on animal models. 2.Submission of Investigational New Drug (IND) Application: Once the data from preclinical studies suggest that the drug might be safe, the pharmaceutical company submits an Investigational New Drug (IND) application. The IND contains data from preclinical studies, manufacturing information, clinical trial protocols, and more. 3.Clinical Trials: This is the heart of the drug approval process and it typically encompasses three phases. Phase I primarily tests the drug’s safety and dosage in humans. Phase II focuses on its effectiveness and side effects. Phase III further verifies its effectiveness, monitors side effects, and compares ...
- Source: drugdu
- 208
- August 15, 2023
FDA drug approval
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
- 118
- 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
- 118
- August 14, 2023
BioNTech and Duality Biologics add third ADC candidate to oncology partnership

BioNTech and Duality Biologics have expanded their existing agreement to include a third antibody-drug conjugate (ADC) for solid tumours. The companies announced the first deal covering two ADCs in April this year. Under the terms of the agreement, DualityBio would receive upfront payments totalling $170m and be eligible to receive development, regulatory and commercial milestone payments of potentially more than $1.5bn. ADCs are a class of potent cancer therapies combining the selectivity of antibodies with the potent cell-killing properties of chemotherapy or other anti-cancer agents. Unlike chemotherapy, which works by attacking lots of different cells as well as the cancer, ADCs are designed to target and kill tumour cells while sparing healthy cells. Professor Ugur Sahin, chief executive officer and co-founder of BioNTech, said at the time of the first announcement: “Over the last years, the ADC field has made significant progress, overcoming several limitations and demonstrating its potential as ...
- Source: drugdu
- 103
- August 11, 2023
analysts

Dive Brief Analysts at Needham expect a U.S. Food and Drug Administration advisory panel to support the safety and efficacy of Medtronic’s renal denervation device at a meeting later this month. The meeting, which the FDA scheduled in June, will enable experts in circulatory system devices to discuss the evidence on Medtronic’s Symplicity Spyral and ReCor Medical’s rival renal denervation system. While the analysts expect Medtronic to face questions over the failure of its pivotal trial, they think the experts will vote in favor of the device, putting it on track to target a $1 billion-plus market. Dive Insight Medtronic’s multi-year effort to build confidence in renal denervation as a way to treat high blood pressure hit a snag late last year when a pivotal trial found it worked no better than drugs alone at reducing patients’ blood pressure at home. However, while the missed endpoint was an unwelcome development ...
- Source: drugdu
- 170
- August 9, 2023
Biogen, Sage’s postpartum depression approval overshadowed by larger rejection

While an FDA approval is typically cause for celebration, Sage Therapeutics and Biogen have a tough road ahead to market their new postpartum depression (PPD) drug.Friday, the U.S. FDA gave the green light to zuranolone. Now going by the commercial moniker Zurzuvae, the partners’ drug represents the first and only oral treatment for women with PPD, which affects some 500,000 patients in the U.S. each year, according to Biogen and Sage. But PPD represents just a fraction of the total market Biogen and Sage were hoping to tap into. Alongside Friday’s approval, the partners also received a rejection for Zurzuvae in adults with major depressive disorder (MDD). The FDA told the partners their application didn’t provide “substantial evidence of effectiveness” and that additional studies would be needed. Sage and Biogen said they are reviewing possible next steps. The dual approval and rejection was “more disappointing than good,” according to analysts ...
- Source: drugdu
- 112
- August 9, 2023
FDA Approves Biogen, Sage’s Zurzuvae as First Pill for Postpartum Depression

By Heather McKenzie Pictured: FDA Headquarters/iStock, Grandbrothers In a bittersweet decision for Biogen and Sage Therapeutics, the FDA approved the fast-acting therapy zuranolone Friday as the first pill for postpartum depression—but rejected the treatment for major depressive disorder. Zuranolone—to be marketed as Zurzuvae in postpartum depression (PPD) —is only the second treatment for this indication and the first pill that can be taken at home. Prior to Zurzuvae, there was only one FDA-approved treatment for PPD—Sage’s Zulresso (brexanolone)—but as it must be administered intravenously at a hospital, it is out of reach for many women, Fortune Well reported. Zurzuvae also marks a significant change from the current treatment paradigm, which consists of drugs that are longer acting, showing efficacy typically within six to eight weeks, Sage Chief Business Officer Chris Benecchi, told BioSpace in a previous interview. However, the fast-acting pill—jointly developed by Biogen and Sage—can improve symptoms in as ...
- Source: drugdu
- 101
- August 8, 2023
Quest Launches Alzheimer’s Beta-Amyloid Blood Test for Consumers

By Tristan Manalac Monday, Quest Diagnostics launched the AD-Detect Test, a direct-to-consumer blood test designed to catch abnormal levels of the beta-amyloid protein to assess a patient’s risk of developing Alzheimer’s disease. According to Quest, AD-Detect is the first direct-to-consumer blood-based biomarker test for Alzheimer’s disease, though the company is quick to point out that it is not a diagnostic test. “Only a physician or healthcare professional can provide an Alzheimer’s disease diagnosis,” the company said in its announcement. “The risk of having Alzheimer’s disease as the underlying cause for mild cognitive impairment (MCI) or dementia should be considered in conjunction with the findings from medical and family history, physicals, nutritional deficiency biomarkers, neurological and neuropsychological examinations, and neuroimaging,” according to Quest. AD-Detect works by measuring two types of beta-amyloid biomarkers in the blood and determining the beta-amyloid 42/40 ratio, a validated tool used to assess a patient’s risk of ...
- Source: drugdu
- 213
- August 3, 2023

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