Search Results for “EC” – Page 109 – media

reports

The costs for Roche to decommission and demolish its former API manufacturing plant in County Clare, Ireland, continue to climb, with the bill now reaching 57.3 million euros ($62.7 million) over a three-year period, according to local reports. In documents filed with the Companies Registration Office of Ireland, the Swiss pharma giant said it spent 11.53 million euros ($12.6 million) on winding down the facility in 2022. That’s in addition to the 23.4 million euros ($25.6 million) it shelled out dismantling the facility in the previous two years, The Irish Times reports. Roche also spent 13.18 million euros ($14.4 million) in related environmental costs last year, plus 9.1 million euros in that category through 2020 and 2021, according to the publication. “The company is continuing with its plan to decommission and demolish its assets,” Roche said in the filing, as quoted by The Irish Times. “It has successfully transitioned from a manufacturer ...
- Source: drugdu
- 124
- May 15, 2023
Chiesi, Protalix’s PRX-102 secure FDA nod to treat Fabry disease

Chiesi Global Rare Diseases and Protalix BioTherapeutics have received approval from the US Food and Drug Administration (FDA) for PRX-102 (pegunigalsidase alfa) to treat Fabry disease in adult patients. The latest move follows the receipt of marketing authorisation for PRX-102 from the European Commission (EC) for the same indication. The PEGylated enzyme replacement therapy (ERT), PRX-102 is a recombinant human α‑Galactosidase‑A enzyme expressed in plant-cell culture that is designed for providing a long half-life. The therapy was found to have an initial half-life of 78.9 ± 10.3 hours, in clinical trials. Chiesi Global Rare Diseases head Giacomo Chiesi said: “While much progress has been made in the treatment of Fabry disease, there is still a need for new treatment options. “We established Chiesi Global Rare Diseases to deliver innovative therapies and solutions for people affected by rare diseases. “With the FDA approval of PRX-102, we can now offer people ...
- Source: drugdu
- 139
- May 15, 2023
WHO declares global emergency over

IMAGE SOURCE,GETTY IMAGES Image caption, Monkeypox is caused by the monkeypox virus, a member of the same family of viruses as smallpox BBC By Michelle Roberts Digital health editor Monkeypox is no longer a global public health emergency, the World Health Organization (WHO) has said, almost a year after the threat was raised. The virus is still around and further waves and outbreaks could continue, but the highest level of alert is over, the WHO added. The global health body’s chief Tedros Adhanom Ghebreyesus called on countries to “remain vigilant”. It can be passed on by close contact with someone who is infected. What is monkeypox? Its official name is Mpox and it is caused by the monkeypox virus, a member of the same family of viruses as smallpox, although it is much less severe. Initial symptoms include fever, headaches, swellings, back pain, aching muscles. Once the fever breaks ...
- Source: drugdu
- 92
- May 15, 2023
Amylyx’s ALS drug again surpasses Wall Street expectations

Amylyx Pharmaceuticals has again impressed Wall Street, disclosing Thursday a new earnings report in which product revenue was significantly higher than many analyst forecasts. The Cambridge, Massachusetts-based biotechnology company said product revenue from January through the end of March totaled $71.4 million, up from the nearly $22 million generated during the final three months of last year. Amylyx has one product, an ALS medicine sold as Relyvrio in the U.S. and Albrioza in Canada. The company is now profitable less than a year into the drug’s launch, having posted nearly $1.6 million in net income during its latest quarter. In March, Amylyx executives told investors Relyvrio’s launch was going better than expected. They estimated that more than 1,300 U.S. patients with ALS, or amyotrophic lateral sclerosis, were taking the drug at the end of last year, and that the company was on pace to double this ...
- Source: https://www.biopharmadive.com/news/amylyx-als-relyvrio-sales-first-quarter/650139/
- 111
- May 14, 2023
Otsuka, Lundbeck’s Rexulti nabs new use in Alzheimer’s disease agitation

After Lundbeck and Otsuka’s Rexulti cleared a key advisory committee hurdle, the FDA has given the drug the go-ahead to treat dementia-associated agitation in Alzheimer’s disease patients With the approval, Rexulti becomes the first drug approved for this use in the United States. The FDA granted the nod based on data from two 12-week studies in which patients showered statistically significant and clinically meaningful improvements on the Cohen-Mansfield Agitation Inventory scale, according to the FDA. The metric looks at the frequency and intensity of dementia-related agitation. In the studies, Rexulti demonstrated a 31% improvement from baseline agitation symptoms compared with placebo. Agitation symptoms cover a wide group of behaviors including pacing, gesturing, profanity, shouting, and physical outbursts, Otsuka said in a release. The symptoms are the leading causes of assisted living or nursing room placement and have been known to be associated with accelerated disease progression, Tiffany Farchione, director ...
- Source: drugdu
- 108
- May 13, 2023
Cancer drugs among top 5 most affected by shortages in the US

By Deidre McPhillips, CNN CNN — As the US faces a near-record number of drug shortages, cancer treatments are among the hardest hit. There is an active shortage of about two dozen chemotherapy drugs, the fifth most of any drug category, according to data from the end of March from the University of Utah Drug Information Service. “The fact that we have this many chemo drugs in shortage is really concerning,” said Michael Ganio, senior director of pharmacy practice and quality at the American Society of Health-System Pharmacists. Unlike some other drugs that also rank among the top five categories for shortages, such as antimicrobials, there aren’t often alternatives for chemotherapy drugs, he said. And the shortages are affecting treatment for a broad range of cancers. “One of the key predictors of how well a patient will respond to treatment is getting a full dose on the right schedule,” Ganio said. “So when ...
- Source: drugdu
- 110
- May 13, 2023
New drug delivery system delivers antioxidant directly to mitochondria in the liver

A new drug delivery system delivers an antioxidant directly to mitochondria in the liver, mitigating the effects of oxidative stress. Mitochondria are microscopic organelles found within cells, and are well-known as the “powerhouse of the cell.” They are by far the largest producer of the molecule adenosine triphosphate (ATP), which provides energy to many processes in living cells. The process by which mitochondria synthesize ATP generates a large amount of reactive oxygen species (ROS), chemical groups that are highly reactive. In a healthy cell, the ROS are controlled by the mitochondria; however, when this balance is lost, the excess ROS damages the mitochondria and subsequently cells and tissues. This phenomenon, known as oxidative stress, can cause premature aging and disease. The ROS that cause oxidative stress can be controlled by antioxidants. A research team led by Professor Yuma Yamada, Distinguished Professor Hideyoshi Harashima and Assistant Professor Mitsue Hibino at ...
- Source: drugdu
- 132
- May 12, 2023
AstraZeneca’s heart failure treatment approved for expanded use in US

AstraZeneca’s (AZ) Farixga (dapagliflozin) has been approved for extended use in the US, meaning adult patients with heart failure (HF) can benefit from the treatment regardless of their left ventricular ejection fraction status (LVEF). Farxiga, sold as Forxiga in certain markets, was previously approved in the US for HF patients with reduced ejection fraction (HFrEF) which is equal to or less than 40%. HF affects approximately seven million people in the US and is associated with substantial morbidity and mortality, with chronic HF the leading cause of hospitalisation for those over the age of 65. Roughly half of all HF patients have mildly reduced ejection fraction (HFmrEF) or preserved ejection fraction (HFpEF), with few therapeutic options available. As well as the greater risk of death and hospitalisations, patients with HFmrEF or HFpEF experience an especially high burden of symptoms and physical limitations. The US Food and Drug Administration’s (FDA) ...
- Source: drugdu
- 130
- May 12, 2023
First Of Its Kind Urine Biomarker Methylation Test Predicts Bladder Cancer Recurrence

By LabMedica International staff writers Bladder EpiCheck is the first urine biomarker methylation test of its kind to be FDA cleared for NMIBC surveillance (Photo courtesy of Nucleix) Bladder cancer ranks as the sixth most common cancer in the U.S., with around 700,000 individuals living with the disease and over 80,000 new cases detected each year. The majority of these cases are classified as non-muscle invasive bladder cancer (NMIBC). Although NMIBC can be treated surgically and therapeutically, it has a high recurrence rate (up to 70% over five years), necessitating frequent monitoring to detect high-grade recurrence and treat it promptly. The standard of care involves regular and invasive cystoscopies, which patients undergo up to four times annually for a minimum of five years or, in some cases, for their entire lives. Now, a simple, objective urine test for recurrent bladder cancer is set to become commercially available in the ...
- Source: drugdu
- 116
- May 11, 2023
Novavax surges after biotech company unveils job cuts, positive vaccine data

Novavax’s stock jumped around 30% on Tuesday after the biotech company unveiled promising new vaccine data and a broad cost-cutting push that includes major layoffs. The announcements are a sign of hope for investors after last quarter, when the company raised doubts about its ability to stay in business and decided not to provide full-year guidance. Novavax’s stock closed Tuesday at $9.52. The company’s share price is down more than 7% so far this year, giving it a market value of nearly $821 million. Novavax is now betting on its cost controls and new vaccines to help it stay afloat, forecasting 2023 sales of $1.4 billion to $1.6 billion, according to its first-quarter earnings report. The Gaithersburg, Maryland-based company said its combination vaccine targeting Covid and the flu produced a strong immune response against the viruses and was well tolerated in a phase two trial. Novavax shared similar trial results ...
- Source: drugdu
- 134
- May 11, 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.