Search Results for “FDA” – Page 41 – media

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
- 206
- August 17, 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
- 112
- August 16, 2023
FDA Delays PDUFA Date for Valneva’s Chikungunya Shot

By Tristan Manalac Pictured: Sign in front of FDA building/iStock, JHVEPhoto The FDA has delayed its PDUFA action date for Valneva’s investigational chikungunya vaccine VLA1553 to the end of November, the company announced Monday. The original decision was due by the end of August. The regulator extended the review period “to allow sufficient time to align and agree on a phase 4 program,” as required under the agency’s accelerated approval pathway, according to Valneva’s announcement. The FDA did not request additional clinical data to support the application. VLA1553, a live-attenuated investigational shot, could be “the first vaccine candidate to be approved under the accelerated approval pathway in an outbreak disease,” Valneva Chief Medical Officer Juan Carlos Jaramillo said in a statement. This makes its Phase IV plan all the more important as it will set a “future standard” for the industry. Despite the PDUFA delay, Valneva still expects to launch ...
- Source: drugdu
- 107
- August 16, 2023
FDA Approves J&J’s Akeega for BRCA-Positive Prostate Cancer

By Tristan Manalac Pictured: Janssen headquarters in California/iStock, Sundry Photography The FDA on Friday signed off on Janssen Pharmaceutical’s niraparib and abiraterone acetate tablets, now to be marketed as Akeega, for the treatment of metastatic castration-resistant prostate cancer in patients carrying the BRCA mutation. According to Janssen’s announcement, Akeega is the first dual-action tablet that combines the activity of a PARP inhibitor with abiraterone acetate, an androgen biosynthesis inhibitor sold by the company under the brand name Zytiga. Janssen is a subsidiary of Johnson & Johnson. The approval covers a combination regimen of Akeega with prednisone and is based on data from the Phase III MAGNITUDE study, a randomized, double-blinded and placebo-controlled trial with 765 participants. Compared with Zytiga plus prednisone, the Akeega-based regimen significantly improved radiographic progression-free survival by 47% in BRCA-positive patients. Akeega also led to a trend toward better overall survival, though this effect fell short of ...
- Source: drugdu
- 184
- August 16, 2023
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
【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
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
Boston Scientific receives FDA approval for cryoablation system

Dive Brief Boston Scientific on Thursday received approval from the Food and Drug Administration for a new heart ablation device to treat atrial fibrillation, according to a company announcement. The POLARx Cryoablation System can accommodate two balloon sizes in one catheter, which Boston Scientific said allows physicians to tailor care to individual patients. The device has been selling well in Europe and Japan, where it is cleared for use, CEO Mike Mahoney said in an earnings call last month. Boston Scientific has been competing with companies like Johnson & Johnson and Medtronic, which are also bringing new cardiac ablation devices to market. Dive Insight Cryoablation is a minimally invasive procedure that uses a balloon catheter to freeze tissue near the pulmonary vein. Scars then block irregular electric signals that can cause atrial fibrillation. Switching between two balloon sizes, clinicians can adjust the device to a patient’s anatomy during a procedure, ...
- Source: drugdu
- 143
- August 12, 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
Potential treatment for inherited blindness wins FDA fast-track

The US Food and Drug Administration (FDA) is addressing inherited blindness in children after it granted HuidaGene Therapeutics a rare paediatric disease designation (RPDD) to expedite the development and review times of the company’s gene therapy candidate. China-headquartered HuidaGene’s HG004, which received an orphan drug designation in March, is a one-time gene replacement drug intended to treat patients who are affected by inherited retinal diseases (IRDs) caused by mutations in the RPE65 gene. The therapy delivers a functional version of the gene to the retinal pigment epithelium via an adeno-associated virus (AAV) vector. RPE65-induced IRDs include Leber’s congenital amaurosis (LCA), severe early childhood-onset retinal dystrophy (SECORD), early-onset severe retinal dystrophy (EOSRD), and retinitis pigmentosa (RP). The diseases are often present in toddlers and can cause night blindness and a loss of visual field and central vision. The impairment of vision at such an early age likely affects other areas of ...
- Source: drugdu
- 122
- August 9, 2023

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