Search Results for “EC” – Page 83 – media

WHO experts recommend the use of Takeda’s dengue vaccine QDENGA

Takeda today announced that the World Health Organization’s (WHO) Strategic Advisory Group of Experts (SAGE) on Immunization shared recommendations for use of QDENGA® (Dengue Tetravalent Vaccine [Live, Attenuated]) (TAK-003). In the coming months, the WHO will consider the SAGE recommendation and update its position paper on dengue vaccines to include final guidance on the use of QDENGA in public vaccination programs. SAGE made the following recommendations: The vaccine to be considered for introduction in settings with high dengue disease burden and high transmission intensity to maximize the public health impact and minimize any potential risk in seronegative persons. The vaccine to be introduced to children aged 6 to 16 years of age. Within this age range, the vaccine should be introduced about 1-2 years prior to the age-specific peak incidence of dengue-related hospitalizations. The vaccine should be administered in a 2-dose schedule with a 3-month interval between doses. The vaccine ...
- Source: drugdu
- 117
- October 10, 2023
FDA wants more testing in Philips recall

BY SEAN WHOOLEY The FDA has issued a communication stating its desire for more testing in the massive respiratory device recall at Philips (NYSE: PHG)+.The morning after the FDA’s evening announcement, PHG shares were down more than 7% on the NYSE to $18.31 apiece. PHIA shares in Amsterdam closed the day down more than 8%. (MassDevice’s MedTech 100 Index was up slightly.) Philips has been handling a Class I recall of certain respiratory devices since mid-2021. Respironics recalled millions of ventilators, bi-level positive airway pressure (BiPAP) and continuous positive airway pressure (CPAP) machines. Here’s a timeline of the events of the ongoing saga. FDA’s statement follows a scathing investigational report from ProPublica and the Pittsburgh Post-Gazette. The report outlined the alleged withholding of information around the issues with the devices even as they became more alarming. “The FDA remains unsatisfied with the status of this recall, and we continue to ...
- Source: drugdu
- 109
- October 10, 2023
Catheter ablation beats drugs in J&J retrospective study of AFib heart failure risk

Dive Brief Catheter ablation is better than antiarrhythmic drugs at cutting heart failure risk as a second-line treatment for atrial fibrillation patients, according to a retrospective study funded by Johnson & Johnson. The study, which was published in Heart Rhythm O2, compared the incidence of heart failure in a claims database to evaluate whether patients who have previously tried an antiarrhythmic drug should receive catheter ablation or a different medicine. Across a dataset of more than 18,000 patients, people who received catheter ablation had a 57% lower risk of developing heart failure than their counterparts on antiarrhythmic drugs. Dive Insight In 2019, a randomized clinical trial funded by the National Institutes of Health and medtech companies including J&J’s Biosense Webster found catheter ablation is no better at reducing the composite risk of death and major cardiovascular events than antiarrhythmic drugs. However, the trial linked ablation to a lower risk of ...
- Source: drugdu
- 140
- October 9, 2023
Amgen Fails to Secure FDA Adcomm Support for Full Lumakras Approval

By Tristan Manalac Pictured: Amgen’s office in Massachusetts/iStock, hapabapa The FDA’s Oncologic Drugs Advisory Committee on Thursday voted against Amgen, which is seeking to convert the accelerated approval of its oral G12C KRAS inhibitor Lumakras (sotorasib) to full approval in non-small cell lung cancer. In a 10-2 vote, the panel of external experts found that Amgen’s progression-free survival (PFS) data from the Phase III confirmatory CodeBreaK 200 study could not be reliably interpreted. In particular, the adcomm noted the high number of study dropouts, the small sample size and potentially biased behavior of the trial’s investigators. “No one expects a perfect [randomized controlled trial] but what we hope for is a small number of issues in trial conduct and an effect large enough to withstand the uncertainties caused by those issues,” committee member Mark Conaway, professor at the Division of Translational Research and Applied Statistics at the University of Virginia ...
- Source: drugdu
- 120
- October 9, 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
- 93
- October 9, 2023
FDA says Philips’ testing of recalled devices is inadequate

Dive Brief The Food and Drug Administration called for further testing by Philips to evaluate the risks of soundproofing foam used in its recalled sleep apnea machines and ventilators. “We do not believe that the testing and analysis Philips has shared to date are adequate to fully evaluate the risks posed to users from the recalled devices,” Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a Thursday statement that included more details on the recall and the agency’s actions. Philips has claimed use of the devices is “not expected to result in appreciable harm to health in patients,” but agreed with the FDA’s recommendations to run additional testing. Dive Insight Philips’ recall of sleep apnea devices and ventilators has continued since June 2021, when the company began an effort to repair or replace millions of devices that used polyester-based polyurethane (PE-PUR) foam for soundproofing. ...
- Source: drugdu
- 113
- October 8, 2023
Lokavant receives $8 million from investment giant, Mitsui to expand AI platform

Clinical trial platform company, Lokavant, has received an $8 million strategic investment from global trading and investment giant, Mitsui & Co. Ltd. The investment will be used to expand its AI-optimized platform across the Asia-Pacific (APAC) region. Lokavant entered Japan’s established clinical research market through one of its earliest customers, CMIC Group, the country’s largest contract research organization (CRO). Now with the backing from Mitsui, the company is poised to open a new APAC headquarters in Tokyo. The investment has come about following a year of efforts between the two companies which saw Mitsui’s extensive due diligence of the clinical trials landscape. Encouraged by Lokavant’s clinical trial intelligence technology and proven track record in Japan with current customers, Mitsui has vowed to offer operational support, including business development, staffing, and product localization to help expand Lokavant further in APAC after an initial focus on Japan. The regional headquarters will serve ...
- Source: drugdu
- 117
- October 8, 2023
AstraZeneca’s Forxiga meets primary endpoint for T2D

AstraZeneca has announced positive results from the T2NOW Phase III trial for paediatric patients treated with forxiga (dapagliflozin) for the treatment of type 2 diabetes (T2D). Forxiga is an oral sodium-glucose co-transporter-2 (SGLT2) inhibitor that lowers blood glucose levels. The drug is approved in 122 countries to improve glycaemic control in T2D patients in conjunction with diet and exercise. In the EU, paediatric patients above the age of 10 can be administered the drug after positive results from the T2GO study. Forxiga has not yet been approved for paediatric patients in the US. The T2NOW trial results showed a significant reduction in A1C, an average blood sugar marker in patients taking forxiga and metformin, insulin, or both, compared with patients receiving the placebo. Safety results in 10–17-year-olds are consistent with adult patients who take the drug. Forxiga is not the only SGLT2 inhibitor on the market. Invokana (canagliflozin) by J&J ...
- Source: drugdu
- 226
- October 7, 2023
Pfizer restarts production at tornado-hit plant—but supply squeezes are expected to persist

In the aftermath of a devastating summer tornado at Pfizer’s Rocky Mount injectables plant in North Carolina, manufacturing has largely resumed. Still, the company expects supply shortfalls for some drugs produced at the plant to stretch into next year.The “majority” of the Rocky Mount facility’s manufacturing lines have restarted, Pfizer said in a Monday release. What’s more, Pfizer has launched an additional line in the site’s new sterile injectable manufacturing area, dubbed R3, the company added. The “expedited restart” comes ahead of Pfizer’s previously stated timeline. Late last month, Pfizer said it intended to restart manufacturing at the plant the fourth quarter of 2023. Pfizer is restarting production in phases, with full production across the site’s three manufacturing suites expected to come back online by the end of the year. The company has planned its production restarts based on patient need and inventory levels. There are roughly a dozen medicines ...
- Source: drugdu
- 193
- October 6, 2023
FDA clears Krystal Biotech’s IND for Type 1 AATD treatment KB408

The US Food and Drug Administration has approved Krystal Biotech’s Investigational New Drug (IND) for a Phase I clinical trial of the investigational alpha-1 antitrypsin deficiency (AATD) treatment KB408. Earlier this month, the FDA granted orphan-drug status for KB408 in AATD. The first patient in the planned Phase I trial is expected to receive treatment in Q1 2024. The Phase I trial, involving adult patients with AATD and the PI*ZZ genotype, will assess the safety, tolerability, and efficacy at three planned dose levels. AATD is a rare genetic disorder that occurs when there is insufficient production or impaired functionality of the alpha-1 antitrypsin (AAT) protein. Low AAT levels result in damage to lung tissue, leading to chronic obstructive pulmonary disorder (COPD). KB408 is a gene therapy consisting of a modified herpes simplex virus 1 (HSV-1) derived vector, which delivers two full-length copies of the SERPINA1 gene to enable AAT expression. ...
- Source: drugdu
- 139
- October 4, 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.