PharmaFocus Today – Page 299 – media

3M reaches $6B settlement to resolve combat earplug lawsuits

Dive Brief 3M has agreed to pay $6 billion to settle more than 250,000 lawsuits brought by U.S. military service members who allegedly suffered hearing loss after using its combat earplugs, the company announced on Tuesday. The settlement could avoid a larger liability related to Dual-Ended Combat Arms earplugs, products that 3M acquired in its 2008 takeover of Aearo Technologies and sold through 2015. Bloomberg and Reuters reported earlier this week that the company was nearing an agreement, based on anonymous sources. Shares in 3M rose in the wake of the reports as investors digested news of a settlement that could see the company pay much less than the $10 billion forecast by analysts. Dive Insight 3M and Aearo have maintained that the earplugs were safe and effective when used properly, but have faced lawsuits from hundreds of thousands of claimants. The company has lost 10 of the16 cases that ...
- Source: drugdu
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- August 31, 2023
ARAMIS trial finds no benefit of anakinra in acute myocarditis

The largest randomized controlled trial of patients with acute myocarditis has found that anakinra is safe but does not reduce complications. The late breaking research presented in a Hot Line session today at ESC Congress 2023. Acute myocarditis is an inflammation of the myocardium that can cause permanent damage to the heart muscle and lead to myocardial infarction, stroke, heart failure, arrhythmias and death. The disease can occur in individuals of all ages, but is most frequent in the young. There are no specific therapies, and patients are generally treated with beta-blockers, ACE inhibitors and sometimes steroids, in accordance with an ESC expert consensus. Anakinra is an interleukin-1 receptor antagonist that works by targeting the interleukin-1β innate immune pathway. While anakinra is effective in pericarditis, there are only case reports of successfully treated acute myocarditis. ARAMIS was the largest randomized controlled trial of acute myocarditis and the first to evaluate ...
- Source: drugdu
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- August 31, 2023
Pfizer telegraphs 4th-quarter production restart at North Carolina plant damaged by tornado

With many medicines from Pfizer’s Rocky Mount, North Carolina, production plant relegated to an emergency ordering list following a devastating tornado last month, hospitals and government health officials are likely eager for the massive injectables facility to restart production. Now, Pfizer has clarified the timeline by which it expects manufacturing to resume. “There are many sequential steps and variables to restart operations and Pfizer is making significant progress,” the company said Monday. The company signaled (PDF) its intention to restart manufacturing at Rocky Mount by the fourth quarter of 2023. After the tornado struck the plant July 19, Pfizer says it reopened parts of the facility Aug. 7. Current efforts to resume production remain “on track,” the company said, with several functions—such as packaging and quality laboratories—now operational. To help with product storage, Pfizer has also locked down a temporary warehouse location and received a certificate of occupancy. The tornado ...
- Source: drugdu
- 132
- August 30, 2023
FTC pulls back on legal challenge to Amgen’s $28B bid for Horizon

By objecting to Amgen’s deal for Horizon, the FTC put to the test new ideas about how drugmaker mergers can harm consumers. Typically, regulators have maintained that overlaps between competing products can give combining companies a more powerful market position, and have sought divestments as a resolution. However, in this case, the FTC argued that Amgen could use rebates and discounts on established drugs like Enbrel to secure favorable insurance coverage for Horizon drugs like Tepezza and Krystexxa. The FTC claimed Amgen has a history of using such “cross-market bundling” practices. The Horizon acquisition was one of the first major opportunities for the FTC to apply the new framework for reviewing pharmaceutical mergers, which agency leadership laid out early in the Biden administration. A pre-trial settlement could reveal the evidence regulators have compiled to support their case, and indicate whether they believe they can prevail in court. In a statement ...
- Source: drugdu
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- August 30, 2023
Pfizer’s RSV vaccine granted EC approval to protect infants and older adults

Pfizer’s respiratory syncytial virus (RSV) vaccine has been approved by the European Commission (EC) to protect both infants and older adults against RSV-caused lower respiratory tract disease (LRTD). The EC’s decision allows Abrysvo to be given as a single dose to adults aged 60 years and older, and those who are 24 to 36 weeks into their pregnancy to protect their babies from birth until they are six months old. RSV is a common contagious virus characterised by several mild, cold-like symptoms. Although most people recover within a week or two, the virus can cause severe illness in young infants and older adults. In the EU, about 245,000 yearly hospital admissions have been associated with RSV in children aged under five years, while the virus is estimated to cause more than 270,000 hospitalisations in older adults each year. The EC’s decision, which follows a recent recommendation from the European Medicines ...
- Source: drugdu
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- August 30, 2023
Sandoz’s Tyruko approved by FDA as first biosimilar for relapsing multiple sclerosis

Sandoz, a Novartis division, has announced that its biosimilar Tyruko (natalizumab-sztn) has been approved by the US Food and Drug Administration (FDA) to treat adults with relapsing forms of multiple sclerosis (MS). The disease-modifying therapy, developed by Polpharma Biologics, is a version of Tysabri (natalizumab) and is now the first FDA-approved biosimilar for this patient population. A biosimilar, according to the FDA, is a biological product that is highly similar to one already approved in the US. This means patients can expect the same safety and effectiveness from the biosimilar as they would from the reference product, but may potentially benefit from lower healthcare costs. “Biosimilar medications offer additional effective treatment options that have the potential to increase access for people living with relapsing forms of MS,” said Paul Lee, director of the Division of Neurology 2 in the FDA’s Center for Drug Evaluation and Research. Tyruko, which is administered ...
- Source: drugdu
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- August 30, 2023
Danaher to buy antibody supplier Abcam for $5.7B

Dive Brief Danaher plans to buy Cambridge, England-based Abcam for about $5.7 billion in cash, the companies announced on Monday. The acquisition would bring together two firms that make equipment and supplies for life sciences companies. Abcam, with a market capitalization of $5.2 billion, would operate as a standalone company under Washington, D.C.-based Danaher, which has a market cap of $191.7 billion. Danaher reportedly outbid other companies including Agilent Technologies, Reuters wrote on Friday, citing people familiar with the matter. Dive Insight Abcam, a maker of antibodies, reagents, biomarkers and assays for life science companies, began a review of strategic alternatives in June. A proxy battle waged this summer between the company’s founder and its CEO attracted “strategic inquiries from multiple parties,” Abcam said in a June statement. The company evaluated more than 20 potential acquirers, Abcam said on Monday. The agreement values Abcam at about $24 per share. The ...
- Source: drugdu
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- August 30, 2023
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
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- 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
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- August 30, 2023
BridgeBio Builds ATTR-CM Case for Acoramidis with Promising Phase III Data

By Tristan Manalac Pictured: Ultrasound machine used to obtain images of the heart/iStock, sudok1 Detailed results from the Phase III ATTRibute-CM study showed that BridgeBio Pharma’s acoramidis met its primary endpoint, inducing significant improvements in patients with transthyretin amyloid cardiomyopathy (ATTR-CM), the company announced Sunday. ATTRibute-CM is a randomized and double-blinded study with over 630 patients enrolled. Its primary endpoint is a combination of all-cause mortality, frequency of cardiovascular-related hospitalizations and changes from baseline in NT-proBNP levels and six-minute walk distance (6MWD) performance. Acoramidis achieved a “highly statistically significant result” compared with placebo, BridgeBio wrote in its announcement, touting a Win Ratio of 1.8 with a p-value less than 0.0001. This effect was consistent across NYHA functional classes and between wild-type and variant transthyretin amyloid cardiomyopathy (ATTR-CM) patient subgroups. BridgeBio presented the findings at the 2023 Congress of the European Society of Cardiology, held in Amsterdam over the weekend. The ...
- Source: drugdu
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- August 30, 2023

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