Search Results for “FDA” – Page 49 – media

FDA’s cancer chief weighs in on common chemo shortages — report

Tyler Patchen Richard Pazdur, director of the FDA’s Oncology Center of Excellence, attributes the current shortage of two cancer drugs to drug companies that haven’t invested in building out their production capacity. In an interview with The Cancer Letter, a weekly cancer publication, Pazdur said that the current shortages of cisplatin and carboplatin, a pair of drugs used to treat a wide range of cancer patients, are the result of two problems: manufacturers not investing in enhancing production capacity, and drug companies being dependent on one supplier of raw ingredients. The cisplatin shortage followed an inspection that revealed quality issues at a manufacturing facility, which then led to the shutdown of production. This led to a surge in carboplatin demand, creating a secondary shortage. The shortages are causing oncologists across the US to ration platinum-based drugs, according to The Cancer Letter. To restore the supply of cisplatin, the FDA is ...
- Source: drugdu
- 120
- June 2, 2023
FDA decisions that could be delayed if the U.S. defaults on its debt

As lawmakers trudge through debt ceiling negotiations, the possibility that the U.S. will default on its loan obligations in the coming days looms like a dark cloud over Washington. Should government coffers run dry on June 1, as Treasury Secretary Janet Yellen has warned they could, federal workers will go unpaid and agencies like the FDA could see operations come to a screeching halt. Just last week, FDA Commissioner Robert Califf said that without a bipartisan bill to raise the debt limit by June, the regulator wouldn’t have the money to pay staff and scientific reviewers, potentially delaying upcoming drug approval decisions, advisory committee meetings and regulations. And with President Joe Biden and House Speaker Kevin McCarthy scrambling to finish negotiations — while haggling over where to cut federal spending in future budget packages — it’s unclear when a deal might be struck, or how long a potential default could ...
- Source: drugdu
- 124
- May 31, 2023
What is the process for obtaining FDA certification in the United States?

Drugdu.com expert’s response: 1.Pre-Submission Consultation: This initial step often involves a formal or informal consultation with the FDA to discuss the product’s classification, the type of application needed, and data requirements. 2.Preparing Documentation: Following consultation, you’ll need to prepare all necessary documentation, which usually includes preclinical and clinical data, product information, manufacturing details, labeling, and more. The exact documentation needed will depend on the product classification and type of application. 3.Submission of Application: The next step is to submit your application or registration to the FDA. The type of application may include a Premarket Notification (510(k)), Premarket Approval (PMA), Investigational Device Exemption (IDE), or others, based on the product classification. 4.FDA Review: Once the FDA receives your application, they will conduct a review. This involves an assessment of all submitted materials and may include inspections, additional data requests, and more. 5.FDA Decision: After the review process, ...
- Source: drugdu
- 297
- May 30, 2023
Pfizer’s Paxlovid approved by FDA and Gilead’s Veklury recommended by CHMP

Pfizer’s Paxlovid (nirmatrelvir and ritonavir tablets) has been approved by the US Food and Drug Administration (FDA), and Gilead Science’s Veklury (remdesivir) recommended by the European Medicines Agency’s human medicines committee to treat certain COVID-19 patients. Pfizer’s oral antiviral, which has now been granted full approval to treat mild-to-moderate COVID-19 in adults at a high risk for progression to severe disease, has been available in the US since December 2021 under the FDA’s accelerated approval pathway. The agency’s latest decision is supported by the totality of evidence submitted by Pfizer, the company said, including efficacy data from the phase 2/3 EPIC-HR study showing an 86% reduction in risk of COVID-19-related hospitalisation or death from any cause in patients who took Paxlovid within five days of symptom onset. The drugmaker said in a statement that at this time, the US government will continue to oversee the distribution of Paxlovid, and eligible ...
- Source: drugdu
- 102
- May 30, 2023
FDA approves Lexicon’s heart-failure drug after defeat in diabetes

Nicole DeFeudis Editor The FDA on Friday approved Lexicon’s heart failure drug sotagliflozin following a string of setbacks for the pharma company, including an FDA rejection in diabetes and the loss of a development deal with Sanofi. The dual SGLT1 and SGLT2 inhibitor will be marketed as Inpefa and is a once-daily tablet. It’s been approved to reduce the risk of cardiovascular death and heart failure-related hospitalization or urgent visits in adults with heart failure or type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors. The label spans the range of left ventricular ejection fraction, including preserved ejection fraction and reduced ejection fraction, as well as patients with or without diabetes, Lexicon said Friday. The company did not release Inpefa’s price but said it will be “comparable to existing branded heart failure medications.” Lexicon CEO Lonnel Coats expects the drug to hit the market by the end ...
- Source: drugdu
- 106
- May 30, 2023
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
- 110
- 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/
- 119
- 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
- 149
- 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
- 111
- 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
- 107
- May 26, 2023

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