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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
Most Medicaid Enrollees Are Unaware About the Return to Eligibility Renewals

About 65% of Medicaid enrollees are unsure if states are allowed to now disenroll people from Medicaid if they aren’t eligible anymore or didn’t renew coverage, and 7% incorrectly believe that states can’t do this, a new analysis showed. During the Covid-19 pandemic and under the continuous enrollment provision, states were barred from disenrolling people on Medicaid. However, this provision ended March 31, meaning the normal renewal process for Medicaid has resumed and states will disenroll those who are no longer eligible or don’t renew coverage (many states are completing this process over the course of a year). As many as 18 million people could lose Medicaid coverage during this period. The new analysis, published Wednesday by the Kaiser Family Foundation, was based on the organizations’ Survey of Health Insurance Consumers. The survey was conducted prior to the end of the continuous enrollment provision between February 21 and ...
- Source: https://medcitynews.com/2023/05/medicaid-eligibility-renewal-redetermination/
- 133
- 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
- 154
- May 27, 2023
Celadon secures medicinal cannabis contract

Celadon will sell a minimum of £3m worth of the high-THC product over the next three years Celadon Pharmaceuticals – a company focused on researching cannabis-based medicines – has announced that it has secured a contract for the commercial supply of its pharmaceutical-grade cannabis product with a UK medicinal cannabis company. As part of the agreement, Celadon will sell a minimum of £3m worth of the high-THC product over the next three years. The initial shipment is expected to be made towards the end of 2023, while the contract could be extended for a further two years with the mutual agreement of the parties. The milestone contract follows the company’s Good Manufacturing Practices registration in January and the update to its Home Office licence, also from earlier this year. Directors at Celadon believe that it is one of a limited number of companies globally with the approvals in place to ...
- Source: drugdu
- 125
- May 27, 2023
Mirati’s long wait for next lung cancer med ends in phase 3 failure

After a five and a half month wait, Mirati Therapeutics finally has the answer it’s been waiting for on a lung cancer med called sitravatinib: The therapy did not improve survival in a phase 3 study. Back in December 2022, Mirati said that the SAPPHIRE trial would continue to its final analysis instead of getting an interim readout as planned. The company had hoped to use the early data to support an FDA application for approval in second- and third-line non-small cell lung cancer (NSCLC). Mirati was looking for a 3.5-month overall survival benefit, but, according to a brief update Wednesday afternoon, that measure was not successful at the final analysis. The company is not releasing the data set at this time but promised to do so “at a future date.” Patients who are experiencing clinical benefit may continue on treatment at the discretion of the principal investigators. The failure ...
- Source: drugdu
- 111
- May 27, 2023
First UK death linked to ‘zombie’ drug xylazine

The death of a 43-year-old man is the first in the UK to be linked to the “zombie” drug xylazine, which is prompting overdose warnings in the US. Normally used as a large-animal tranquiliser but now being found in heroin, it can cause a dangerously low heart rate and large open skin wounds. UK experts are calling it “a really concerning drug”. They say drug users should be warned it is now present in the UK but there is no safe dose in humans. ‘Bought heroin’ Karl Warburton, form Solihull, West Midlands, died in May 2022 at home and had a history of illicit drug use, according to the coroner’s report. He had been referred to addiction services on a number of occasions. An examination of his body detected heroin, fentanyl and cocaine in his system, as well as xylazine. A report on his death in the Journal of Forensic and ...
- Source: BBC news
- 113
- May 27, 2023
With Novartis circling, Lilly touts Verzenio’s ability to help cancer patients make memories in TV ad

Eli Lilly is throwing more money behind breast cancer drug Verzenio as it prepares to fend off a challenge from Novartis. Having seen growth hit 100% late last year, the Big Pharma has released a TV spot to push the message that Verzenio can help patients make new memories every day. Ads for Verzenio are a frequent sight on TV screens, with the estimated $111.8 million that Lilly spent on spots last year landing the drug in the 10 top most promoted products. Lilly has continued the promotional push in 2023. The “School Play” Verzenio spot was the second most seen pharma TV ad at the 65th Annual Grammy Awards early this year, and Lilly rolled out a fresh video earlier this month. The latest ad opens with a gray-haired Black woman sitting on a sofa looking at a photo album. As the camera zooms in and flips to an over-the-shoulder shot, a voice-over by the woman says ...
- Source: drugdu
- 127
- May 27, 2023
Medtronic agrees to buy Korean insulin patch pump maker for $738m to boost diabetes business

Dive Brief: Medtronic agreed to buy EOFlow, a company based in South Korea that makes a tubeless, disposable insulin pump on a patch. The company will make a public tender offer to acquire all of EOFlow’s outstanding public shares for 971 billion South Korean won ($738 million). The purchase will allow Medtronic to compete with Insulet, which has gained market share with its tubeless insulin pumps, and Tandem Diabetes Care, which agreed last year to buy patch pump-maker AMF Medical. Dive Insight: Medtronic, with a warning letter recently lifted from its U.S. diabetes business, aims to bring new products to market. The company plans to integrate its new insulin dosing algorithm, which is used in the 780G pump, with EOFlow’s pump. “We’ve never lost faith in our technology,” Medtronic CEO Geoff Martha said on a Thursday earnings call, adding that “the patch segment is a good segment and we ...
- Source: https://www.medtechdive.com/news/medtronic-acquire-eoflow-patch-pump-insulin-MDT/651278/
- 116
- 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
Common diabetes drug could be repurposed as a treatment for autoimmune disorders

Swansea University researchers have found that a drug commonly used to treat type 2 diabetes can potentially be used in the treatment of autoimmune disorders. Academics at the University’s Faculty of Medicine, Health and Life Science have found that the drug, canagliflozin (also known as Invokana), could be used to treat autoimmune disorders such as rheumatoid arthritis and systemic lupus erythematosus as it targets T-cells, which form an essential component of the immune system. Canagliflozin is a drug that controls blood sugar levels in people with type 2 diabetes, however researchers have found an unexpected role for the drug involving the human immune system. Existing research has reported that targeting T-cell metabolism in autoimmunity can lead to therapeutic benefits. T-cells are a type of white blood cell that help the body fight infections and diseases, but in autoimmune diseases they have been observed to attack healthy tissues. The new study, ...
- Source: drugdu
- 136
- May 26, 2023

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