PharmaFocus Today – Page 338 – media

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
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- 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
- 108
- 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
- 121
- 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/
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- 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
- 113
- 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
- 131
- 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
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- May 26, 2023
ElevateBio Takes Title of Largest 2023 Funding with $401M Series D

By Tristan Manalac Pictured: Hundred dollar bills/courtesy of Nomad_Soul/Adobe Stock On Wednesday, ElevateBio closed a $401 million Series D financing round, making it biotech’s largest private fundraising haul this year. The Massachusetts-based company will use the money to improve further the company’s gene editing, RNA, cell, vector engineering, protein and induced pluripotent stem cell technologies. ElevateBio will funnel these funds into BaseCamp, the company’s end-to-end genetic medicine cGMP manufacturing and process development business. Beyond advancing its platforms, ElevateBio will also use its Series D raise to broaden its geographic reach and increase its manufacturing capacity to satisfy the needs of its industry and academic partners. Wednesday’s funding round follows ElevateBio’s $525 million Series C in May 2021, one of biotech’s largest fundraises of that year. Since then, the company has further solidified its presence in the gene therapy space. In October 2021, ElevateBio bought biotech start-up Life Edit Therapeutics, whose ...
- 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
- 117
- May 26, 2023
New vaccine boosts hopes of eliminating meningitis across Africa

A trial of a new vaccine against meningococcal disease, a cause of meningitis and blood poisoning, has found that it is safe and induces a strong immune response across five strains of meningococcal bacteria: A, C, W, Y and X. The phase 3 trial compared the immune response generated by the new pentavalent vaccine NmCV-5 against that of the licensed quadrivalent MenACWY-D vaccine in 1,800 healthy participants aged 2–29 in Mali and The Gambia. After 28 days, across all ages, the immune responses generated by a single dose of NmCV-5 were generally higher than those generated by MenACWY-D. In addition, NmCV-5 induced a strong immune response to the emerging meningococcal X strain for which there is currently no licensed vaccine. The trial found no safety concerns with NmCV-5. The study, led by a team including researchers from the Medical Research Council (MRC) Unit, The Gambia, at the London School of ...
- Source: drugdu
- 112
- May 26, 2023

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