Search Results for “EC” – Page 89 – media

ECLS does not improve survival in patients with acute myocardial infarction complicated by cardiogenic shock

Early extracorporeal life support (ECLS) does not improve survival in patients with acute myocardial infarction complicated by cardiogenic shock who are scheduled for early revascularization, according to late breaking research presented in a Hot Line session today at ESC Congress 2023. Cardiogenic shock is the leading cause of death in hospitalized patients with acute myocardial infarction. Evidence-based treatment is limited to immediate revascularisation of the culprit lesion. However, mortality remains high, reaching 40-50% within 30 days. Ongoing efforts to improve outcomes have led to an increase in the use of active mechanical circulatory support devices to achieve hemodynamic stabilization in severe shock. In particular, the use of venoarterial extracorporeal membrane oxygenation (VA-ECMO), also called ECLS, has risen by more than 10 times in recent years. ECLS enables full circulatory and respiratory support, which differentiates it from other devices. However, evidence for ECLS in patients with cardiogenic shock and acute myocardial ...
- Source: drugdu
- 113
- August 30, 2023
AstraZeneca Latest to Sue Biden Administration Over IRA’s Drug Price Negotiations

By Nadia Bey Pictured: AstraZeneca’s San Francisco office/iStock, hapabapa AstraZeneca has joined a growing list of drugmakers suing the Biden administration over a provision in the Inflation Reduction Act that allows the federal government to negotiate Medicare drug prices, the company announced Friday. The British drugmaker is the latest pharma company to file a legal complaint. Boehringer Ingelheim filed a lawsuit Aug. 18, arguing that Medicare price negotiations under the IRA violate the company’s constitutional rights to due process, protection against excessive fines and free speech. Other companies—including Merck, Bristol Myers Squibb, Johnson & Johnson and Astellas—that have sued the U.S. government over the IRA have focused on constitutional arguments. Similarly, the lobbying group Pharmaceutical Research and Manufacturers of America filed a suit challenging the constitutionality of the law. However, AstraZeneca has taken a different approach in its legal complaint filed Aug. 25 in the U.S. District Court for the ...
- Source: drugdu
- 103
- August 30, 2023
Merck, Eisai Drop Phase III Keytruda-Lenvima Trial for Head and Neck Cancer

By Connor Lynch Pictured: Merck logo on building/iStock, Sundry Photography Merck and Eisai have dropped another joint drug trial after disappointing Phase III results. The companies announced Friday that they would be ending their combination treatment of Keytruda and Lenvima, respectively, after a second interim analysis found no improvement in overall survival. The LEAP-010 trial was evaluating the safety and effectiveness of Merck’s anti-PD-1 therapy in combination with Eisai’s multiple receptor tyrosine kinase inhibitor for metastatic or unresectable head and neck squamous cell carcinoma (HNSCC). An independent monitoring committee conducted two interim analyses over the course of 11 months. Initial results from the first analysis were promising: the therapy combo met two of the trial’s three primary endpoints of progression-free survival and objective response (OS) rate. However, the treatment failed to show evidence of meeting the third endpoint, overall survival, in the second analysis. The companies in Friday’s announcement said ...
- Source: drugdu
- 106
- August 29, 2023
VC funding in medtech ticks up, raising hopes that slump has bottomed

Dive Brief Venture capital investment in medtech startups increased sequentially in the second quarter, in both volume and value, according to the financial database PitchBook. Activity remains down from last year, and well down from the highs hit in 2021, but the PitchBook analysts think funding bottomed out in the first quarter and will “inch upwards over the rest of the year.” The analysts also speculated that M&A activity could pick up now that large companies “have worked through their numerous spinoff and spinout plans.” On Wednesday, wound care device maker Sanuwave Health announced it plans to go public through a $127.5 million merger agreement with SEP Acquisition, a special purpose acquisition company, or SPAC. Dive Insight VC investment in medtech fell across 2022, and the downward trend in deal value continued in the first quarter of 2023. The second quarter brought potential signs that a recovery is starting. Deal ...
- Source: drugdu
- 95
- August 28, 2023
Regeneron wins FDA approval for rare immune disease med Veopoz, expects high-dose Eylea decision in the coming weeks

Along with resolving site inspection issues that cost Regeneron a high-dose Eylea launch in June, the company has scored an FDA nod for Veopoz as the first treatment for the ultra-rare inherited immune condition Chaple disease. The disease, which is also known as CD55-deficient protein-losing enteropathy, has a global patient population of fewer than 100 people. In just the U.S., fewer than 10 patients have been diagnosed, Regeneron said in its Friday release. Chaple disease is caused by mutations of the complement regulator CD55 gene, which can lead the compliment system to attack the body’s own cells. Enter Veopoz, a fully human monoclonal antibody that targets a protein involved in complement system activation called compliment factor C5. It’s approved for patients 1 year of age and older and comes with a $34,615 price tag per single-use vial, a Regeneron spokesperson said in an emailed statement. The injection was tested in ...
- Source: drugdu
- 117
- August 22, 2023
Moderna says new Covid vaccine was effective against Eris variant in early trial

Moderna’s new Covid vaccine generated a robust immune response against the now-dominant Eris variant and another rapidly spreading strain of the virus in an early clinical trial, the biotech company said Thursday. The updated shot is designed to target omicron subvariant XBB.1.5, but the results suggest that the jab may still be effective against newer variants of the virus that are gaining ground nationwide. That includes Eris and another variant nicknamed Fornax, both of which are also descendants of the omicron virus variant. Moderna’s vaccine and new shots from Pfizer and Novavax are slated to roll out within weeks, pending potential approvals from the U.S. Food and Drug Administration. Meanwhile, Covid-related hospitalizations fueled by Eris and other variants continue to accelerate but remain below the summer peak that strained hospitals this time last year. Eris, also known as EG.5, accounted for 17.3% of all cases as of earlier this month, ...
- Source: drugdu
- 104
- August 20, 2023
MSF, trying to secure supplies of ViiV’s Apretude, calls out new clauses in purchasing contract

As GSK’s ViiV Healthcare looks to widen the reach of its HIV franchise, Médecins Sans Frontières (MSF) has been working to secure access to the company’s long-acting HIV prevention drug, Apretude, for more than a year. Now, the organization is airing grievances about the negotiation process with an open letter to ViiV’s executive team. MSF is calling on the company to take out what it says are problematic new amendments to the proposed purchase agreement. Since last June, MSF has been stuck in contract negotiations with ViiV for Apretude, according the letter from Sidney Wong, executive co-director of MSF’s access campaign, and Philip Aruna, team leader for MSF’s southern Africa region. The sides almost reached a deal in December, but ViiV subsequently changed the terms because of supply limitations, Wong and Aruna wrote. Thanks to last-minute edits that deviate from standard MSF purchase agreements, the new contract more closely resembles ...
- Source: drugdu
- 125
- August 19, 2023
GSK stays a step ahead in RSV vaccine battle as Arexvy becomes available at US pharmacies

As companies have flocked to compete in the new respiratory syncytial virus (RSV) vaccine market, GSK has had the best timing. In May, the U.K. company was first to secure FDA approval for its shot Arexvy for adults 60 and older, beating out rivals from Pfizer and Moderna. And now—well in advance of the fall and winter RSV season—Arexvy is available in major U.S. retail pharmacies, GSK said Thursday. Under the Inflation Reduction Act, Medicare Part D patients will pay no out-of-pocket expenses for the shot, GSK said. Additionally, under the Affordable Care Act, patients with commercial insurance may be covered when Arexvy is administered in-network, GSK said. In June, the Advisory Committee on Immunization Practices (ACIP) recommended that people 60 and older decide in consultation with their healthcare provider whether to receive the RSV vaccine. As people age, their immune systems can become compromised, making them more vulnerable to ...
- Source: drugdu
- 170
- August 19, 2023
Medtronic’s dialysis device recall assigned to Class I by the FDA

Dive Brief Medtronic’s recall of hemodialysis catheters was categorized by the U.S. Food and Drug Administration as a Class I event, according to a Friday entry in the FDA’s database. The company contacted customers in June after routine manufacturing testing identified a blockage that could obstruct the catheter, potentially delaying treatment and leading to outcomes such as blood clots and the destruction of red blood cells. Healthcare providers with devices covered by the recall should immediately quarantine and stop use of the catheters. Medtronic has received no confirmed complaints related to the problem, and no reports of adverse events or deaths. Dive Insight The Medtronic recall affects specific lots of Mahurkar Acute Triple Lumen Catheters and Mahurkar Acute High Pressure Triple Lumen Catheters. Medtronic’s Mahurkar Elite Catheters are unaffected by the recall. “Medtronic initiated a voluntary recall related to Mahurkar Acute Triple Lumen Catheters and Mahurkar Acute High Pressure Triple ...
- Source: drugdu
- 143
- August 18, 2023
Delcath Gets FDA Approval for Cancer Drug-Device Combo 10 Years After Rejection

By Tristan Manalac Pictured: Cancer cells growing on the liver/iStock, Rasi Bhadramani The FDA on Monday approved Delcath Systems’ Hepzato Kit for the liver-directed treatment of adult patients with metastatic uveal melanoma, capping a nearly decade-long effort to secure regulatory approval. Hepzato’s label covers metastatic uveal melanoma (mUM) patients with unresectable hepatic metastases that afflicts less than 50% of their liver and who do not show signs of extra-hepatic disease. Hepzato can also be used in cases of extra-hepatic spread, provided it is limited to the bone, lymph nodes, subcutaneous tissues or lungs. Monday’s approval makes Hepzato “the only liver-directed therapy that can treat the whole liver,” Delcath Chief Medical Officer Vojislav Vukovic said in a statement. The approved product comes with a boxed warning for severe peri-procedural complications, such as hemorrhage and hepatocellular injury, as well as myelosuppression. To manage these risks, the company will implement a Risk Evaluation ...
- Source: drugdu
- 109
- August 18, 2023

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