Search Results for “vaccine” – Page 41 – media

Takeda to Pull Lung Cancer Drug from Market After Failed Confirmatory Study

Takeda Pharmaceutical drug Exkivity failed the confirmatory study required of its 2021 accelerated approval. Our recap of other recent regulatory developments includes a partial clinical hold on a cancer drug, a Covid-19 vaccine authorization, and several drug approvals in the U.S. and beyond. By FRANK VINLUAN Accelerated approval offers a way to more quickly bring patients drugs for diseases that have few treatment options. But that speedy path to the market comes with the understanding that the FDA can take its regulatory blessing away—unless the company takes its drug away first. That is what Takeda Pharmaceutical has decided to do with its cancer drug, Exkivity. Following discussions with the FDA, the Japanese pharmaceutical giant is voluntarily withdrawing Exkivity from the market. Exkivity treats non-small cell lung cancer by targeting epidermal growth factor (EGFR). That cancer protein must have exon 20 mutations—the same genetic signature addressed by Johnson & Johnson’s Rybrevant. ...
- Source: drugdu
- 199
- October 10, 2023
Emergex and VIC to develop infectious disease therapies in the Gulf

Emergex Vaccines has signed a Memorandum of Understanding (MoU) with the Vaccine Industrial Company (VIC) to develop and commercialise T cell-priming immune set-point candidates against infectious disease therapies. The territories included in the agreement were Saudi Arabia and other specified territories, such as GCC member states (Bahrain, Kuwait, Oman, Qatar, Saudi Arabia and UAE), other Middle Eastern territories and specified regions. As per the deal, VIC will have an equity share in Emergex, contingent on the Saudi Arabian government’s support for Phase II/III clinical trials of Emergex’s T cell-priming candidates. These are beings studied for dengue, Covid-19, and others, including the add-on therapies related to these indications. In June, Emergex reported positive data from the Phase I trial of its T cell-priming immune set-point candidate, DengueTcP, for treating dengue. The results showed that the therapy was well tolerated in healthy volunteers. The company also reported positive data for CoronaTcP, a ...
- Source: drugdu
- 96
- October 9, 2023
Lumicell co-founder wins Nobel Prize in Chemistry

The co-founder of a fluorescence-guided imaging technology firm has been awarded part of the Nobel Prize in Chemistry in acknowledgement of his research into quantum dots. The Nobel Prize Committee said that Moungi Bawendi revolutionised the chemical production of quantum dots, resulting in almost perfect particles. Quantum dots are nanoparticles so tiny that their size determines their properties. They have frequently been employed in the use of medical imaging devices such as those provided by the company Bawendi co-founded, Lumicell. The Nobel Prize Committee said: “Quantum dots now illuminate computer monitors and television screens based on QLED technology. They also add nuance to the light of some LED lamps, and biochemists and doctors use them to map biological tissue.” The Royal Swedish Academy of Sciences additionally awarded the prize to two other researchers, Louis E. Brus and Alexei I. Ekimov. Both of whom were pivotal in the development of quantum ...
- Source: drugdu
- 136
- October 7, 2023
FDA Authorizes Novavax’s Covid-19 Vax, Set to Join Fall Rollout of Updated Shots

A Novavax Covid-19 vaccine developed for the fall vaccination season now has the FDA green light, bringing an alternative to the messenger RNA shots that are already rolling out to pharmacies, doctor’s offices, and other locations throughout the country. The FDA decision announced Tuesday afternoon is not an approval. Last year’s emergency authorization for the Novavax vaccine is now amended to include an updated formula, which reflects currently circulating variants. The initial Novavax vaccine was authorized for those 18 and older. For the updated shot, the FDA expanded the age range to 12 and older. The regulatory decision for the latest version of the Novavax vaccine means the company’s initial vaccine, developed for the original SARS-CoV-2 strain, is no longer authorized for use in the U.S. Gaithersburg, Maryland-based Novavax makes its protein-based vaccines with nanoparticle technology that engineers proteins that mimic antigens found on natural pathogens. For its Covid-19 vaccine, ...
- Source: drugdu
- 130
- October 4, 2023
Pharmacists can play key role in boosting HPV vaccination rates

HPV, or human papillomavirus, is the most common sexually transmitted infection. It is also the leading cause of cervical cancer. Over 1,400 Canadian women are affected yearly, with almost 400 deaths, according to the Canadian Cancer Society. It is completely preventable with the HPV vaccine, and yet, unfortunately, many people are unvaccinated. University of Waterloo researchers have found a possible solution to this on-going issues. Using an electronic questionnaire at the time of appointment scheduling for seasonal influenza or COVID-19 vaccines, researchers have found, is a quick and efficient way to identify people in Ontario willing to receive additional life-saving vaccines. Dr. Wasem Alsabbagh, associate professor, University of Waterloo School of Pharmacy, said, “This is a massive opportunity for policymakers to focus on vaccine campaigns to reach more patients.” Questions were embedded into MedEssist, a platform many pharmacists use for scheduling vaccination appointments, to reveal if individuals booking for their ...
- Source: drugdu
- 200
- October 4, 2023
Liquid, Oral Reformulation of Antibiotic Metronidazole

By Matt Olszewski Pictured: FDA signage at its office in Washington, D.C./iStock, JHVEPhoto Appili Therapeutics announced on Monday that the FDA has approved its liquid oral reformulation of the antibiotic metronidazole, ATI-1501, for the treatment of antimicrobial infections in patients with difficulty swallowing pills or who are unable to get injections. The drug is a prominent oral treatment with more than 10 million U.S. prescriptions annually. The injectable form of the drug, commonly used for treating parasitic and anaerobic bacterial infections, has been in shortage in the U.S. since last year due to extreme demand and regulatory delays, according to the American Society of Health-System Pharmacists “The current tablet form of metronidazole is the only other approved oral form on the U.S. market, but its bitter taste and lack of appropriate dosage forms for patients with difficulty swallowing often presents treatment compliance challenges,” according to Appili. Before the FDA’s approval ...
- Source: drugdu
- 113
- September 28, 2023
Merck KGaA’s MilliporeSigma pumps €28M into 2 new mRNA production plants

On a €1 billion quest to build a global mRNA network, Merck KGaA’s MilliporeSigma has rounded out its service offerings to include all key stages of mRNA development, manufacturing and commercialization.Tuesday, MilliporeSigma christened two new mRNA drug substance manufacturing sites in Darmstadt and Hamburg, Germany. The company has invested €28 million in the sites, where it plans to hire 75 new staffers, MilliporeSigma said in a release. The new facilities will be able to tackle a full range of mRNA services, from pre-clinical to commercial-scale projects, MilliporeSigma said. Those offerings will include analytical development and biosafety testing specifically designed for mRNA technologies, the company added. The facilities fall under the umbrella of MilliporeSigma’s €1 billion investment to advance mRNA technologies and build its global mRNA network. Employing 27,000 worldwide, MilliporeSigma sells life sciences companies the tools and tech needed for testing and manufacturing. It also operates a contract testing, development ...
- Source: drugdu
- 194
- September 28, 2023
CDMOs SK pharmteco, Oxford Biomedica make cell and gene therapy manufacturing M&A plays

It’s a boom time in the cell and gene therapy market, with manufacturers making moves to secure a larger piece of the pie. Wednesday, two CDMOs revealed acquisitions that will bolster their production capabilities and increase their global presence. Korean manufacturer SK pharmteco has taken a controlling stake in the Philadelphia-based Center for Breakthrough Medicines (CBM) for an undisclosed sum. Meanwhile, England’s Oxford Biomedica said it is in talks with Institut Mérieux to buy out its subsidiary, ABL Europe, for 15 million euros ($16 million). SK’s move comes after it invested $350 million in CBM in January of last year. As part of the agreement, SK had an option to increase its stake, which it exercised, becoming its largest stockholder. CBM was established in 2019 at a former GSK site. The prior funding allowed CBM to begin building end-to-end manufacturing capabilities. SK boasted that the site will be the world’s ...
- Source: drugdu
- 105
- September 22, 2023
New NIH plan outlines HSV research framework with four strategic priorities

In response to the persistent health challenges of herpes simplex virus 1 (HSV-1) and HSV-2, today the National Institutes of Health released the Strategic Plan for Herpes Simplex Virus Research. An NIH-wide HSV Working Group developed the plan, informed by feedback from more than 100 representatives of the research and advocacy communities and interested public stakeholders. The plan outlines an HSV research framework with four strategic priorities: improving fundamental knowledge of HSV biology, pathogenesis, and epidemiology; accelerating research to improve HSV diagnosis; improving strategies to treat HSV while seeking a curative therapeutic; and, advancing research to prevent HSV infection. HSV-1 and HSV-2 are among the most common viral infections in the United States. HSV can cause recurring blisters or sores. In severe cases HSV may lead to life-threatening or long-term complications, typically in the central nervous system. There are no licensed preventive HSV vaccines, and there is no cure. Up ...
- Source: drugdu
- 237
- September 21, 2023
As Lonza CEO departs, Catalent scoops up rival CDMO’s bioscience business head to lead biologics

Mere hours after it surfaced that Lonza’s CEO, Pierre-Alain Ruffieux, will step down, the Swiss CDMO has lost another major executive. And this time, the exec is jumping ship to U.S. contract manufacturing rival Catalent. Monday, Catalent named Lonza’s David McErlane group president of its biologics segment. McErlane, who most recently served as Lonza’s senior vice president and head of the bioscience business, will take up his post at Catalent on Sept. 25, a source familiar with the matter told Fierce Pharma. McErlane’s hiring represents one of the first major strategic grabs since Catalent caved in to activist investor Elliott Management last August. The New Jersey CDMO is now working to rejuvenate its business after a difficult stretch of manufacturing snares, executive turnover and dwindling revenues. Before joining Catalent, McErlane led a Lonza department that provides specialty raw materials and technology solutions for cell and gene therapies, injectable drugs, vaccines ...
- Source: drugdu
- 100
- September 20, 2023

your submission has already been received.

OK

Subscribe

Please enter a valid Email address！

Submit

The most relevant industry news & insight will be sent to you every two weeks.

more

more

Customer Services
Contact Us
Help Center

Buy on Drugdu.com
Browse Product Categories

Free APP

Follow Us

Terms & Conditions | Privacy Policy

粤ICP备16008861号

Copyright © 2016-2018 Drugdu.com. All Rights Reserved.