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Terumo receives FDA clearance for automated whole blood processing system

Dive Brief Terumo Blood and Cell Technologies received clearance from the Food and Drug Administration for what it claims is the first whole blood automation device available in the U.S. The Reveos Automated Whole Blood System processes blood into platelets and other components in a single centrifugation cycle, eliminating some manual steps to separate platelets from the rest of the blood. The device can help blood centers make the process of collecting platelets from blood donations more efficient, increasing availability for people who need them for treatment, Chetan Makam, general manager of Terumo’s global blood solutions business, said in an interview. Dive Insight Platelets are used to treat trauma patients, for procedures like heart surgeries, and for patients who are undergoing chemotherapy. Demand for platelets continues to increase, Makam said. Currently, the majority of platelets available for transfusion in the U.S. come from a process called apheresis, where a donor’s ...
- Source: drugdu
- 114
- August 3, 2023
Non-profit receives FDA approval to supply cheaper OTC naloxone

The US Food and Drug Administration (FDA) approved the second over-the-counter (OTC) naloxone nasal spray product, RiVive (3mg) by non-profit pharmaceutical company Harm Reduction Therapeutics, for the emergency treatment of known or suspected opioid overdose. This approval follows the agency’s approval of Emergent BioSolutions’ Narcan in March 2023, as the agency has recently increased efforts to address the opioid crisis. The FDA also approved the first generic non-prescription naloxone drug in July 2023. Naloxone reverses opioid overdoses by blocking opioid receptors, thus preventing the drugs’ addictive effects. Harm Reduction Therapeutics has announced that the drug will be available by early 2024 and be primarily supplied to state governments and US harm organisations at “costs lower than other opioid antagonist nasal sprays”. The US-based non-profit organisation has said that the first 200,000 doses (10% of projected initial annual product production) of RiVive will be available free of charge. ...
- Source: drugdu
- 128
- August 2, 2023
Apellis Eye Injection Treatment Flagged for Safety Issues

Pictured: Healthcare worker checking the eye of an elderly woman patient/iStock, peakSTOCK Apellis’ recently approved eye injection Syfovre (pegcetacoplan injection) has been linked to several cases of retinal vasculitis, a rare complication involving eye inflammation, according to the American Society of Retina Specialists’ Research and Safety in Therapeutics Committee, as reported by several media outlets. In a press statement posted Saturday, Apellis confirmed seven retinal vasculitis cases, two of which arose in April 2023 following Syfovre injections, while two others were detected in May and three in June. The company has also received a report of one other retinal vasculitis event, but has yet to confirm this. Apellis has carried out a comprehensive investigation of these complications, including a review of Phase III safety data from Syfovre’s development program, as well as of its manufacturing process. However, “there is no indication that the drug product or manufacturing issues contributed to these events,” the ...
- Source: drugdu
- 109
- August 2, 2023
FDA approves second over-the-counter naloxone nasal spray for opioid overdose

The US Food and Drug Administration (FDA) has approved the over-the-counter (OTC), non-prescription use of Harm Reduction Therapeutics’s RiVive, a 3mg naloxone hydrochloride nasal spray, for the emergency treatment of known or suspected opioid overdose. The FDA’s decision means that RiVive stands as the second non-prescription, OTC naloxone nasal spray product that the agency has approved. FDA commissioner, Robert Califf, said: “We know naloxone is a powerful tool to help quickly reverse the effects of opioids during an overdose. “Ensuring naloxone is widely available, especially as an approved OTC product, makes a critical tool available to help protect public health.” Prescription opioids, such as morphine, codeine and fentanyl, are used as treatments to relax the body and relieve pain. However, misuse of opioids can lead to several harmful effects, including slowed breathing, and hypoxia, which can ultimately lead to death. In the US, drug ...
- Source: drugdu
- 101
- August 2, 2023
Biogen, amid layoffs, ponies up $7.3B for rare disease specialist Reata and potential blockbuster Skyclarys

On Monday during a quarterly earnings call, when Biogen CEO Chris Viehbacher was asked about the company’s potential to execute M&A, he randomly offered “we’ve got, I think, about $7.3 billion in cash?” Four days later, Biogen has revealed a proposal to acquire Reata Pharmaceuticals. The Massachusetts biotech will pay $172.50 per share for the Plano, Texas-based rare disease specialist in a deal that comes to—you guessed it—$7.3 billion. With the purchase—which is a 59% markup on Reata’s shares from close of the market on Thursday—Biogen gains Skyclarys, the first treatment for the rare, inherited neurologic disorder Friedreich’s ataxia. It was approved by the FDA in February of this year and carries sales potential of $1.5 billion in 2030, according to analysts. On a conference call Friday to bookend the busy week, Viehbacher called Biogen “the natural owner for Skyclarys.” When the deal is done, Biogen will be able to ...
- Source: drugdu
- 129
- August 1, 2023
UKHSA data reveals a 45% decline in hepatitis C prevalence in England

The UK Health Security Agency (UKHSA) has published new data showing that there were an estimated 70,649 people living in England with hepatitis C in 2022, marking a 45% decrease from the number recorded in 2015. Since 2015, NHS England has treated over 80,000 people for the infection as part of its national elimination programme. Of those treated, more than 80% were from the most deprived areas in England, which the UKHSA says highlights “the role of eliminating hepatitis C as a key driver of reducing health inequalities”. Hepatitis C is a blood-borne virus that can cause life-threatening liver disease, including cancer. However, those infected often have no symptoms until years later when their liver has already been badly damaged. Spread through blood-to-blood contact, the virus is commonly contracted through sharing needles contaminated with the infection, but it can also be contracted through the sharing of razors or toothbrushes. Dr ...
- Source: drugdu
- 127
- August 1, 2023
Octapharma Secures FDA Nod for Warfarin Reversal Agent Balfaxar

More than 2.4 million people in the United States use warfarin to keep their blood from clotting after a heart attack, stroke or other serious thromboembolic complication. But using a blood thinner carries risks of its own as patients become prone to bleeding, particularly during urgent surgery or other invasive procedures. To combat the risk, Swiss plasma specialist Octapharma has developed a treatment that rapidly restores the blood’s ability to coagulate. On Wednesday, the FDA signed off on the company’s Balfaxar (prothrombin complex concentrate, human-lans). Already marketed as Octaplex in Europe and Canada, Balfaxar is for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonists such as warfarin. Balfaxar, which is a lyophilized powder for reconstitution, is provided with sterile water for injection by way of a new transfer device called Nextaro. The drug earned approval based on a phase 3 trial that ...
- Source: drugdu
- 136
- July 28, 2023
GSK Tamps Down Short-Term Expectations for RSV Shot Arexvy, but Still Boosts 2023 Guidance

Expectations are sky high for GSK’s entry this fall into the new respiratory syncytial virus (RSV) vaccine market. The company forecasts peak sales of £3 billion ($3.9 billion) for its shot Arexvy, while Global Data sees the vaccine as the market leader through 2029. But with Arexvy set to launch in the United States later this year, GSK is tamping down the anticipation. On Wednesday, CEO Emma Walmsley said that Arexvy will not hit the ground running as quickly as GSK’s shingles shot Shingrix, which generated £784 million ($1.05 billion) in its first full year on the market (2018). “It won’t be the same rate of build as Shingrix was,” Walmsley said as GSK presented its second-quarter earnings (PDF). “But we do think it is a really key pillar.” The competitive landscape was more favorable for Shingrix to thrive early on, Walmely said. She also noted that the newly established market for ...
- Source: drugdu
- 113
- July 28, 2023
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
- 244
- July 27, 2023
Daily Prune Consumption Has Promising Effects on Biomarkers Related to Cardiovascular Health

A pair of new studies presented as abstracts today at the American Society of Nutrition (ASN) annual meeting report that daily prune consumption has promising effects on several biomarkers related to cardiovascular health. Conducted in postmenopausal women and men 55 years and older, the studies reveal: In men, long-term prune consumption improved HDL cholesterol and the total cholesterol to HDL ratio, while decreasing oxidative stress and the inflammatory biomarker C-reactive protein (CRP). In older women, long-term prune consumption had no negative effect on various metabolic measures related to heart disease risk including total cholesterol, total triglycerides, fasting glucose, and insulin levels. The results of both studies were presented at the ASN annual flagship meeting in Boston, MA. The ASN convenes researchers, practitioners, global and public health professionals, policymakers and advocacy leaders, industry, media, and other related professionals to advance nutrition science and its practical application. “Currently, there ...
- Source: drugdu
- 243
- July 26, 2023

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