Search Results for “FDA” – Page 50 – media

FDA approves Blueprint Medicines’ Ayvakit for indolent systemic mastocytosis

The US Food and Drug Administration (FDA) has approved Blueprint Medicines’ Ayvakit (avapritinib) as the first and only medicine designed to treat indolent systemic mastocytosis (ISM). Systemic mastocytosis (SM) is a rare haematologic disorder that can lead to a range of debilitating symptoms across multiple organ systems. ISM accounts for the vast majority of SM cases and, despite the availability of multiple supportive care treatments, a number of ISM patients continue to experience a substantial disease burden. Ayvakit, which has been approved in the US to treat advanced SM since June 2021, works by targeting the primary underlying cause of the disease – a mutation known as KIT D816V. Blueprint’s chief medical officer, Becker Hewes, said the approval marked “a shift in the treatment paradigm from supportive care to disease modifying therapy” for ISM patients. “With a broad indication for ISM and a strong label, we are now engaging healthcare ...
- Source: drugdu
- 114
- May 29, 2023
Bipartisan lawmakers pressure FDA on common chemotherapies now in shortage

The US House of Representatives has turned a sharp eye to drug shortages over the past few months, with hearings and new caucuses to try and dampen the situation, but another bipartisan letter sent yesterday to FDA aims to keep the pressure up on cancer drug shortages. Reps. Debbie Dingell (D-MI) and Tim Walberg (R-MI) penned the letter to FDA Commissioner Rob Califf, expressing concerns around the shortages of two commonly used chemotherapies used to treat cancer, known as cisplatin and carboplatin, which are used for lung, gynecologic and breast cancers, as well as methotrexate, which is used in treating other forms of cancer. “These chemotherapy drug shortages come amid a shortage of other critical cancer medications. Taken together, they are straining the ability of doctors to provide the best course of treatment for their patients. We are hearing directly from impacted hospitals urging immediate action to address ...
- Source: https://endpts.com/
- 123
- May 27, 2023
BMS pitches Breyanzi as the first CAR-T for CLL. But will a single-arm trial persuade the FDA?

CAR-T therapies have been around for six years, but it was only in January that Bristol Myers Squibb unveiled the first positive readout for such a personalized immunotherapy in chronic lymphocytic leukemia (CLL), the most common form of leukemia, from a pivotal multicenter study. In new data released Thursday, Bristol Myers Squibb said that Breyanzi eradicated signs of cancer in 18.4% of patients with heavily pretreated CLL or small lymphocytic lymphoma (SLL). The phase 1/2 trial coded TRANSCEND CLL 004 has therefore met its primary endpoint. Among those who achieved a complete response, the median duration of response wasn’t reached after a median follow-up of 21.1 months. No patients in that group experienced disease progression or deaths by the data cutoff. The results will be presented during the 2023 American Society of Clinical Oncology annual meeting on June 6. Bristol released the findings ahead of the meeting Thursday. Breyanzi’s complete response data “are remarkable and ...
- Source: drugdu
- 151
- May 27, 2023
FDA clears Braeburn’s long-acting Brixadi to treat opioid use disorder

As the United States’ opioid epidemic rages on, health officials are busy looking for ways to help with the response. Now, right on the heels of the FDA’s approval for a new overdose rescue medication, the agency has cleared Braeburn’s Brixadi (buprenorphine) for use in patients with moderate to severe opioid use disorder. The long-acting injectable features weekly and monthly dosing options for patients who are already being treated with a transmucosal (administered in the mouth) buprenorphine-containing product. Brixadi’s active ingredient is buprenorphine, an old medicine used to treat pain and opioid dependence, according to the National Institutes of Health. Braeburn’s CEO and president Mike Derkacz called the approval “a significant step forward” in the fight against opioid use disorder. “Over the last three years the U.S. experienced a significant increase in opioid overdoses in part related to the economic and social upheaval that negatively impacted all of us, especially ...
- Source: drugdu
- 116
- May 26, 2023
FDA teams with Veterans Health Administration to make medtech supply chains more resilient

Dive Brief The U.S. Food and Drug Administration and the Veterans Health Administration have signed an agreement to increase medical product manufacturing capacity and flexibility in times of crisis. The agencies will create “digital stockpiles” to improve the resilience of domestic supply chains during emergencies, shortages and pandemics. The digital stockpiles will store electronic plans, instructions and methods to make and test medical products to enable trusted suppliers to quickly scale up production when needed, according to the agencies. Dive Insight The COVID-19 pandemic exposed the shortcomings of existing supply chains. When the crisis struck, the U.S. and other countries struggled to meet demand for personal protective equipment and other medical devices used in the response to the coronavirus. The experience led officials to consider how to make supply chains more resilient and able to cope with crises. Now, the FDA has signed a memorandum of understanding with the VHA. ...
- Source: drugdu
- 112
- May 26, 2023
FDA Delays Decision on Sarepta’s DMD Gene Therapy

By Heather McKenzie https://www.biospace.com/ Pictured: Sarepta logo on a building/courtesy of Sarepta Therapeutics Those in the Duchenne muscular dystrophy and gene therapy spaces hoping for a milestone decision by May 29 will have to wait approximately three more weeks as the FDA set a new action date of June 22 for Sarepta’s gene therapy for the neuromuscular disease. The FDA told the company Wednesday “it requires modest additional time to complete the review, including final label negotiations and postmarketing commitment discussions,” according to Sarepta’s announcement. The company went on to say that the FDA indicated it is “working toward potentially granting an accelerated approval for SRP-9001” for DMD patients aged 4-5 years. If approved, SRP-900 would be the first FDA-authorized gene therapy for DMD. Sarepta’s shares were down 14% in pre-market trading Wednesday.
- Source: drugdu
- 121
- May 26, 2023
FDA warns Sure-BioChem over quality and data issues

By Tyler Patchen News Reporter https://endpts.com/fda-warns-sure-biochem-over-quality-and-data-issues/ A warning letter has been given to a company that tests finished drug products over several quality issues. The FDA issued the warning letter to Sure-BioChem Laboratories, a Camden, NJ-based contract test laboratory that does microbial testing on products including finished drugs. Sure-BioChem was inspected late last year, but the regulator has advised the company that it still needs to make some corrections. The letter said that inspectors found that the company had failed to establish and follow procedures for some of its tests and it had not validated its use of “alternative microbial methods” used to test drug products to ensure that its methods were “Specifically, you failed to adequately establish that your microbiological testing methods can reliably detect objectionable microorganisms,” the letter said. Sure-BioChem’s methods also failed to detect Burkholderia cepacia complex (Bcc) bacteria and reported “not detected” to a client. The ...
- Source: drugdu
- 120
- May 25, 2023
Indivior’s Opvee crosses FDA finish line, adding new overdose rescue option amid raging opioid epidemic

Just two months after Emergent BioSolutions made history by winning the FDA’s blessing to sell its opioid reversal medicine over the counter, a new treatment option has arrived in Indivior’s Opvee. The nod, which covers Opvee’s use in people 12 years of age and older, marks the first approval for the medicine’s active ingredient in nasal spray form. The molecule, nalmefene hydrochloride, was first approved in the 1990s in an injectable format but was later pulled from the market in 2008. This time around, the FDA endorsed the drug based on new evidence that it can help combat rising overdose rates in the U.S. Indivior, which closed its purchase of Opiant in March and picked up the medicine in that buyout, plans to launch Opvee in the fourth quarter of 2023. The FDA’s approval comes as overdoses attributable to synthetic opioids such as fentanyl are on the rise, with more ...
- Source: drugdu
- 122
- May 25, 2023
Beta Bionics wins FDA nod to challenge Medtronic for automated insulin pump market

Dive Brief: Beta Bionics said it received 510(k) clearance from the Food and Drug Administration for its automated insulin dosing (AID) system, teeing it up to challenge Insulet, Medtronic and Tandem Diabetes Care for the Type 1 diabetes market. The system, iLet Bionic Pancreas, features an insulin pump and dosing software that combine with the Dexcom G6 continuous glucose monitor to automate the calculation and delivery of insulin doses. Beta Bionics, which showed the AID system beat standard of care last year, has differentiated its device through simplification and automation, limiting the information users need to input and preventing them from modifying their insulin doses. Dive Insight: The launch of iLet Bionic Pancreas may serve as a test of whether people with Type 1 diabetes are willing to almost totally cede control of their insulin dosing to an algorithm. Users of existing hybrid closed-loop systems enter information such as basal ...
- Source: drugdu
- 115
- May 24, 2023
AbbVie and Genmab’s blood cancer therapy granted FDA accelerated approval

AbbVie and Genmab’s blood cancer therapy, Epkinly (epcoritamab-bysp), has been granted accelerated approval by the US Food and Drug Administration (FDA). The authorisation specifically applies to adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who have received at least two prior lines of treatment. DLBCL is the most common type of aggressive lymphoma, with approximately 150,000 cases of the disease diagnosed globally each year. For R/R patients, several targeted therapies including T-cell mediated treatments have recently emerged, the companies said. However, single agent and ready-available or off-the-shelf treatment options are limited. Epkinly, which is being co-developed by AbbVie and Genmab as part of the companies’ oncology collaboration, is now the first and only T-cell engaging bispecific antibody for this indication. The FDA’s decision was supported by positive results from a phase 1/2 trial, in which Epkinly delivered an overall response rate of 61%, a complete response rate ...
- Source: drugdu
- 117
- May 24, 2023

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