Search Results for “FDA” – Page 31 – media

FDA grants second orphan drug designation to Priothera’s mocravimod

The US Food and Drug Administration (FDA) has granted an orphan drug designation to Priothera’s mocravimod for leukaemia patients undergoing a stem cell transplant. The drug is indicated to help improve the outcome of patients with haematologic malignancies following a haematopoietic stem cell transplantation, according to a 27 November press release. Following the designation, the Dublin, Ireland-headquartered biotech will now be in line for tax credits for US-based clinical trials and, if the therapy is approved, have seven years of market exclusivity in the designated indication. Haematopoietic stem cell transplantation, also known as blood and bone marrow transplantation, is used to treat a wide range of blood cancers. There are nearly 60,000 new cases of leukaemia in the US each year. This is the second orphan drug designation for Priothera’s mocravimod. The first, granted in March 2022, was for the treatment of acute myeloid leukaemia (AML) in patients undergoing hematopoietic ...
- Source: drugdu
- 206
- November 29, 2023
FDA fast tracks Alladapt’s multi-food allergy immunotherapy

The US Food and Drug Administration (FDA) has granted a fast track designation to Alladapt Immunotherapeutics’ IgE-mediated multi-food oral immunotherapy ADP101. The FDA’s decision was based on the results from the Phase I/II Harmony trial, which investigated the immunotherapy’s use in inducing desensitisation in patients with single or multiple food allergies, including nuts, dairy, seafood and more. Fast track designations enable earlier interactions with the FDA for the pursuit of accelerated approval. The status also opens chances of rolling and priority reviews. In this instance the designation allows Alladapt to seek accelerated approval for oral immunotherapy in paediatric patients, aged between four and 17 years, with one or more of the 15 food allergies covered by ADP101, as per a 22 November press release. Phase I/II data The double-blind, placebo-controlled Phase I/II Harmony trial (NCT04856865) enrolled 61 paediatric patients (aged four-17 years) and 12 adult patients (aged 18-55 years). The ...
- Source: drugdu
- 209
- November 26, 2023
FDA concerned Cardinal Health failed to mitigate risk of incompatible syringes

Dive Brief The Food and Drug Administration voiced concerns in a Monday letter that Cardinal Health failed to sufficiently mitigate the risk of incompatibility between its syringes and certain pumps in its communication to healthcare providers. Cardinal wrote to its customers in September to explain that some lots of Monoject Luer-lock tip syringes are incompatible with certain infusion pumps, leading to a Class I recall notice covering the device correction. The recall affects more than 32 million syringes. Days after posting the Class 1 notice, the FDA revised recommendations for healthcare providers. It said the dimensional changes made to Cardinal Health’s Monoject syringes, when used with syringe pumps or patient-controlled analgesia (PCA) pumps, may result in issues that include overdose, underdose, or delays in therapy or occlusion alarms. Dive Insight On Monday, the FDA moved to clarify the advice for healthcare providers in a notice titled “Do Not Use Cardinal ...
- Source: drugdu
- 99
- November 24, 2023
FDA pushes back decision date on BMS, 2seventy bio’s Abecma in earlier line of treatment

It appears Bristol Myers Squibb’s multiple myeloma cell therapy Abecma will not end the year on a happy note. The company’s effort to gain approval for the CAR-T in an earlier line of treatment—previously set for an FDA decision on Dec. 16—will have to be pushed back pending an advisory committee meeting. BMS revealed on Monday that the FDA’s Oncologic Drug Advisory Committee (ODAC) will meet to discuss data from the KarMMa-3 study. The United States regulator has not identified a date for the meeting, BMS said. BMS and its partner on the drug, 2seventy bio, said in the release that they expect the meeting has been called to review overall survival (OS) data, which is a secondary endpoint of the phase 3 study. The companies added that the meeting will not impact Abecma’s approval for multiple myeloma as a fifth-line treatment. This is another blow to the CAR-T medicine, ...
- Source: drugdu
- 88
- November 22, 2023
AstraZeneca’s AKT Inhibitor Wins FDA Approval for Combo Breast Cancer Treatment

By Tyler Patchen Pictured: AstraZeneca office in Gothenburg, Sweden AstraZeneca announced Friday that its adenosine triphosphate (ATP)-competitive inhibitor Truqap (capivasertib), in combination with its endocrine therapy Faslodex (fulvestrant), has been approved by the FDA to treat adults with hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer. According to AstraZeneca, the first-in-class inhibitor of all three AKT isoforms (AKT1/2/3) “has potential to reshape treatment for breast cancer patients” with specific biomarker alterations (PIK3CA, AKT1 or PTEN). The company also announced that the FDA has approved a “companion” diagnostic test meant to detect the “relevant” alterations. The FDA approval was based on the CAPItello-291 Phase III trial, which showed that the combination of Faslodex and Truqap reduced the risk of disease progression or death by 50%, compared to Faslodex alone, in patients with tumors having PI3K/AKT pathway biomarker alterations. “The combination of capivasertib and fulvestrant, a first-of-its-kind combination, provides a much-needed ...
- Source: drugdu
- 121
- November 21, 2023
AstraZeneca’s Truqap plus Faslodex receives FDA approval for advanced breast cancer

AstraZeneca’s (AZ) AKT inhibitor Truqap (capivasertib) in combination with its endocrine therapy Faslodex (fulvestrant) has been approved by the US Food and Drug Administration (FDA) to treat a subset of advanced breast cancer patients. The FDA’s decision specifically applies to adults with HR-positive, HER2-negative locally advanced or metastatic breast cancer with at least one of three biomarker alterations: PIK3CA, AKT1 or PTEN. The US regulator has also approved the use of a companion diagnostic test to detect the relevant alterations. Eligible patients will have progressed on at least one endocrine-based regimen in the metastatic setting or experienced recurrence on or within 12 months of completing adjuvant therapy. Breast cancer is the most common cancer worldwide and more than 290,000 people in the US are expected to be diagnosed with breast cancer in 2023. HR-positive breast cancer is the most common subtype, with over 65% of tumours considered HR-positive and HER2-low ...
- Source: drugdu
- 112
- November 21, 2023
FDA signs off on new uses for Astellas and Pfizer’s Xtandi, Merck’s Keytruda

The FDA has signed off on label expansions for two of the world’s most important cancer medicines—Merck’s Keytruda and Pfizer and Astellas’ Xtandi. Keytruda’s expansion is in stomach cancer, allowing its use alongside chemotherapy to treat first-line patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma. Xtandi’s new indication expands its already deep portfolio in the treatment of prostate cancer. It now becomes the only androgen receptor inhibitor approved by the FDA for patients with nonmetastatic castration-sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis (high-risk BCR). These patients can be treated with Xtandi with or without GnRH analog therapy. Of men who have had prostate cancer treatment, 20% to 40% will have BCR within 10 years. Of those with high-risk BCR, 90% will develop metastatic disease, with one in three dying. The nod was backed up by the phase 3 EMBARK ...
- Source: drugdu
- 111
- November 21, 2023
AstraZeneca Cancer Drug Is First in Class, But FDA Nod Is Narrower Than Expected

The most common type of breast cancer now has a new targeted treatment: an AstraZeneca drug that’s first in a new class of therapies addressing a certain genetic signature. But the new approval is narrower than expected, which limits the total addressable market for the therapy. The FDA approved the new drug, capivastertib, for use in combination with fulvestrant, an older AstraZeneca breast cancer therapy. The new drug will be marketed under the brand name Truqap. Approval of Truqap covers the treatment of adults with advanced cases of breast cancer classified as HR positive and HER2 negative. Those patients must also have disease that has either progressed after treatment with a hormone therapy or has come back after adjuvant therapy. Truqap joins a group of therapies already available for HR positive, HER2 negative breast cancer, including products from AstraZeneca. Truqap stands apart from them as the first AKT inhibitor. AKT ...
- Source: drugdu
- 112
- November 20, 2023
FDA approves study of Versameb’s mRNA therapy in urinary incontinence

Swiss company Versameb will initiate a clinical trial investigating a messenger ribonucleic acid (mRNA) to treat stress urinary incontinence, after receiving clearance from the US Food and Drug Administration (FDA). The FDA approved the company’s investigational new drug (IND) application for a Phase IIa trial of VMB-100 – an intramuscularly locally delivered, sequence-engineered mRNA. The study is scheduled to start in the first half of 2024. Versameb’s candidate encodes human insulin-like growth factor-1 (IGF-1). According to Versameb, preclinical studies have shown that VMB-100 can induce the expression of IGF-1 in human muscle cells, and the candidate accelerated the regeneration of the urinary sphincter muscle and restored urinary sphincter function in animal models of stress urinary incontinence, after a single dose of treatment. Stress urinary incontinence is a condition where there is an involuntary leakage of urine due to a weakened urinary sphincter muscle. It is a condition that particularly affects ...
- Source: drugdu
- 170
- November 20, 2023
LetsGetChecked secures first FDA authorization for at-home chlamydia and gonorrhea test

Dive Brief The Food and Drug Administration has authorized the first chlamydia and gonorrhea test with at-home sample collection. LetsGetChecked received de novo authorization for the Simple 2 Test, an over-the-counter kit that uses vaginal swabs or urine specimens to detect the bacteria that cause the two sexually transmitted diseases (STDs). The authorization will move sample collection from the doctor’s office to the home — potentially increasing testing of STDs, which are on the rise — and create a 510(k) pathway for rival diagnostics. Dive Insight Until this week, the FDA had only authorized at-home sample collection for one STD, HIV. Sample collection for all other STDs occurred at the point of care, for example, in a doctor’s office. People may be less likely to get tested at the point of care, particularly for frequently asymptomatic infections such as chlamydia and gonorrhea, because of concerns about confidentiality and convenience. The ...
- Source: drugdu
- 129
- November 18, 2023

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