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BD Gains FDA Clearance to Relaunch Alaris Infusion Pump After Recalls

Dive Brief The Food and Drug Administration has granted Becton Dickinson 510(k) clearance for its updated Alaris infusion pump, paving the way for the company to begin distributing the system again and to remediate or replace all older versions of the device in the field, BD said Friday. The FDA’s green light comes two years after the company filed a new submission for modifications to the pump, which delivers medications and other fluids intravenously to patients, following a series of recalls due to system malfunctions. A large installed base of Alaris systems remains in hospitals. BD said it will address all recall requirements still open to bring those devices into compliance with the FDA clearance, including hardware, software and cybersecurity updates. Dive Insight Widely used in healthcare, infusion pumps from a number of manufacturers have been among the devices that frequently appear on the ...
- Source: drugdu
- 254
- July 27, 2023
Study Sheds Light on the Susceptibility of Chinese Men to 60 Diseases Related to Alcohol Consumption

Recently, a study conducted by researchers from Peking University and Oxford Population Health shed light on the susceptibility of Chinese men to 60 diseases related to alcohol consumption. The study, titled “Alcohol consumption and risks of more than 200 diseases in Chinese men,” was published in the prestigious journal Nature Medicine. Alcohol consumption poses a significant global health threat, with previous research highlighting its strong association with diseases such as liver cirrhosis, stroke, and various types of cancer. However, there has been a lack of systematic investigation into the overall medical impact of drinking within a specific population, which prompted the researchers to undertake this study. To conduct their research, the team utilized data from the China Kadoorie Biobank (CKB), a comprehensive database comprising information from over 512,000 adults recruited across China between 2004 and 2008. The database not only contained crucial health information but also included ...
- Source: drugdu
- 119
- July 27, 2023
Elevar Touts First-line Potential of Rivoceranib in Phase III Liver Cancer Trial

Pictured: Illustration of a liver with tumors/iStock, libre de droit A pre-specified primary analysis of the Phase III CARES 310 trial showed that Elevar Therapeutics’ cancer candidate rivoceranib, when combined with fellow investigational drug camrelizumab, significantly improved survival in patients with unresectable hepatocellular carcinoma, the company announced Monday. Patients who received the drug combination saw a 48% reduction in the risk of death or disease progression, an effect that was significantly better as compared with Bayer’s Nexavar (sorafenib), the standard first-line treatment for unresectable hepatocellular carcinoma (uHCC). At the interim analysis, overall survival was also significantly longer in the rivoceranib-camrelizumab group versus Nexavar. Results of CARES 310 showed that “camrelizumab plus rivoceranib demonstrate significant promise as a potentially improved therapy for advanced hepatocellular carcinoma,” Elevar CEO Saeho Chong said in a statement. The study’s findings were published Monday in the medical journal The Lancet. CARES 310 is a randomized, ...
- Source: drugdu
- 131
- July 27, 2023
Biogen to Cut 1,000 Jobs as Part of $1B Cost Savings Plan

Pictured: Biogen/The Boston Globe via Getty, John Tlumacki With full FDA approval and CMS coverage for Leqembi in hand, Biogen is ramping up its launch efforts for the Alzheimer’s drug and executing a massive cost reduction program. The biotech company announced second-quarter earnings and its new cost-savings plan on Tuesday. The “Fit for Growth” program is expected to generate around $1 billion in operating expense savings by 2025, which includes a headcount reduction of approximately 1,000 jobs, or about 11% of Biogen’s workforce. Around $300 million will be reinvested into product launches and R&D programs for a net savings of $700 million. The staff reduction will be completed by 2025. The company had more than 8,700 employees in 2022, according to Statista. Biogen CFO Michael McDonnell told investors on Tuesday’s earnings call that a “substantial portion” of the $700 million in net operating expense savings are expected to come from cutting ...
- Source: drugdu
- 143
- July 27, 2023
One Simple Brain Hack Might Boost Learning and Improve Mental Health

New research from Duke found that people who imagined being a thief scouting a virtual art museum in preparation for a heist were better at remembering the paintings they saw, compared to people who played the same computer game while imagining that they were executing the heist in-the-moment. These subtle differences in motivation—urgent, immediate goal-seeking versus curious exploration for a future goal—have big potential for framing real-world challenges such as encouraging people to get a vaccine, prompting climate change action, and even treating psychiatric disorders. The findings appeared online July 25 in the Proceedings of the National Academy of Sciences. Alyssa Sinclair, Ph.D. ’23, a postdoctoral researcher working in the lab of Duke Institute for Brain Sciences director Alison Adcock, Ph.D., M.D., recruited 420 adults to pretend to be art thieves for a day. The participants were then randomly assigned to one of two groups and received ...
- Source: drugdu
- 102
- July 27, 2023
Astellas Strikes Another Deal to Expand in Cancer, Partnering With PeptiDream

Photo: Kiyoshi Ota/Bloomberg, via Getty Images Astellas Pharma is far from alone in viewing cancer as a major growth area, but the Japanese drugmaker has specifically identified a type of therapy called targeted protein degradation as one of the key areas for increasing revenue. It just struck its second deal in the past two months to help it execute on that strategy and perhaps stand apart from others pursuing the same type of drugs. Under a partnership announced Tuesday, Astellas will work with PeptiDream to discover new protein degraders using the technology of that company. Specific targets were not disclosed, but they will be selected by Astellas. The deal also grants Tokyo-based Astellas the option to select up to three additional targets for inclusion in the collaboration. Astellas will pay PeptiDream 3 billion yen (about $21 million) up front. PeptiDream, based in Kawasaki, Japan, is eligible to receive up to ...
- Source: drugdu
- 115
- July 27, 2023
Kodiak Sciences Scraps Late-Stage Vision Loss Biologic

Pictured: Person undergoing an eye exam/iStock, Jacob Wackerhausen Kodiak Sciences shares fell over 50% on Monday after the company announced that its late-stage biologic failed to sufficiently improve the vision of patients with diabetes macular edema and that it would not be pursuing this program any further. The California-based company was testing tarcocimab tedromer, a novel antibody-polymer conjugate developed by the company for the treatment of vision loss. Kodiak had three Phase III trials: DAYLIGHT, GLEAM, and GLIMMER. The DAYLIGHT trial investigated the safety and efficacy of tarcocimab tedromer in a high-intensity dosing regimen for patients with wet age-related amcular degeneration (AMD). Not only was the drug “safe and well tolerated,” but it met the clinical target of “non-inferior visual acuity gains” relative to aflibercept, sold commercially as Eylea and Zaltrap. But the next two Phase III trials, GLEAM and GLIMMER, were far less promising. These were identical studies investigating ...
- Source: drugdu
- 120
- July 26, 2023
Bavarian Nordic Drops Out of RSV Vaccine Race with Phase III Flop

Pictured: Respiratory syncytial virus vial and syringe/iStock, Manjurul Bavarian Nordic’s portfolio has taken a hit as the company announced Saturday its respiratory syncytial virus vaccine candidate did not meet all primary endpoints in a Phase III study in older adults. While the vaccine candidate showed 59% efficacy in preventing at least two pre-defined lower respiratory tract disease (LRTD) symptoms from RSV, that number dropped to below the co-primary endpoint for severe LRTD in patients 60 and older. With the miss, Bavarian Nordic is discontinuing its RSV program. The decision also terminates its partnership with Nuance Pharma and chance for the coupled milestone payments of 195 million Danish kroner for developing and launching in select Asian markets. Bavarian Nordic CEO Paul Chaplin said in the release that the outcome was “unexpected” and will impact short-term growth expectations. However, the company said there is no impact on the financial guidance ...
- Source: drugdu
- 119
- July 26, 2023
Bavarian Nordic Falls by RSV Vaccine Wayside After Phase III Failure

The respiratory syncytial virus (RSV) vaccine arena lost a competitor on Saturday 21 July after Danish company Bavarian Nordic shelved its programme following missed endpoints in a Phase III trial. The candidate, named MVA-BN RSV, failed to meet the co-primary endpoint of severe lower respiratory tract disease (LRTD) based on at least three pre-defined symptoms, only demonstrating a 42.9% efficacy. The vaccine did, however, have a 59% efficacy in preventing at least two pre-defined LRTD symptoms. The randomised, double-blind Phase III trial (NCT05238025) involved 20,000 older adults across centres in the US and Germany. As a result of the programme termination, Bavarian Nordic has also ended its partnership with Nuance Pharma, a Chinese pharma company brought in to develop and launch the vaccine for Asian markets. Although Bavarian Nordic’s president and CEO Paul Chaplin said in a statement that the blow would impact short-term growth, ...
- Source: drugdu
- 115
- July 26, 2023
Johnson & Johnson to Reduce Its Kenvue Stake by at Least 80% Through Exchange Offer

Johnson & Johnson on Monday said it plans to reduce by at least 80% its stake in Kenvue, the consumer health business it spun out as an independent company earlier this year, via a stock exchange offer. J&J owns 89.6% of Kenvue’s common stock, which amounts to more than 1.72 billion shares. The exchange offer, also known as a split-off, will allow J&J shareholders to swap all or a portion of their shares for Kenvue’s common stock at a 7% discount. The offer is expected to be tax-free, J&J said in a release. The company noted that the split-off is voluntary for investors and is slated to close on Aug. 18, which is far earlier than expected. J&J said it received a waiver that dismisses the share lockup period associated with Kenvue’s initial public offering in May. That lockup agreement would have required J&J to ...
- Source: drugdu
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- July 26, 2023

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