Search Results for “mental health” – Page 35 – media

Gilead-backed Lyndra Therapeutics cuts nearly a quarter of staff as ph. 3 data nears

Lyndra Therapeutics is laying off roughly 23% of its staff, two months after the company swapped out longtime CEO Patricia Hurter, Ph.D., and as a pivotal trial for a long-acting, oral schizophrenia drug nears an interim readout. The cuts come after the company’s recent decisions to outsource commercial manufacturing and partner on both the development and commercialization of “all future products,” a spokesperson said Friday. The company is also leaving its headquarters in Watertown, Massachusetts, and is consolidating at a nearby location in Lexington. “With our topline data readout from our pivotal trial of oral weekly risperidone expected in the next few weeks, we feel these changes will set us up to successfully navigate the regulatory pathway ahead and ultimately bring oral weekly medications to patients,” the spokesperson said. The company plans to partner up on lead asset LYN-005, though a collaborator has not been disclosed or named, the spokesperson ...
- Source: drugdu
- 156
- September 19, 2023
Bausch + Lomb seeks funding for $1.75B eye drop acquisition from Novartis

Dive Brief Bausch + Lomb is seeking to raise almost $2 billion to fund the planned acquisition of Xiidra eye drops from Novartis. The eye health company struck a deal in June to buy the dry eye disease treatment Xiidra and other assets for $1.75 billion upfront, and followed up by agreeing to pay Johnson & Johnson $107 million for a line of eye and contact lens drops. It has the cash to fund the J&J deal but needs to arrange financing to close the larger acquisition of the Novartis assets. Fitch Ratings, in a note to investors, said the Xiidra deal will boost Bausch + Lomb’s ophthalmic pharmaceutical market presence while the company’s R&D efforts help drive revenue growth and support margins longer term. Dive Insight Bausch + Lomb, which split from parent company Bausch Health last year, has identified two ways to strengthen its balance sheet ahead of ...
- Source: drugdu
- 125
- September 14, 2023
Seagen, Nurix Team to Create New Class of Antibody Conjugates for Cancer

By Tristan Manalac Pictured: Illustration of an antibody molecule/iStock, Dr_Microbe Seagen on Thursday inked a strategic collaboration agreement with San Francisco-based Nurix Therapeutics to develop a potentially new class of therapies—called degrader-antibody conjugates—that selectively kill cancer cells. Under the terms of the agreement, Seagen will make an upfront payment of $60 million and pledge up to $3.4 billion in research, development, regulatory and commercial milestone payments. Nurix will also be entitled to receive mid-single to low-double digit tiered royalties on future sales. The California biotech will also have the option for profit-sharing and co-promotion in the U.S., applicable to two products that emerge from the partnership. Seagen and Nurix will combine their respective expertise and produce degrader-antibody conjugates (DACs), which combine the “tissue and tumor specificity of antibodies with highly potent and catalytic targeted degradation of cancer driver proteins,” Nurix CEO Arthur Sands said in a statement. To achieve this, ...
- Source: drugdu
- 223
- September 12, 2023
Guardant abandons cancer blood test trial early, restates confidence in product line

Dive Brief Guardant Health has stopped a trial of a minimum residual disease (MRD) test early after seeing the results of an interim analysis. The study, called COBRA, was evaluating the ability of Guardant’s MRD blood test to improve outcomes in patients with stage II colon cancer after surgery. Patients underwent circulating tumor deoxyribonucleic acid testing to inform further treatment. Guardant, which collaborated with NRG Oncology on the study, has yet to share data from the trial but confirmed it stopped early after the news leaked on social media. Shares in Guardant fell around 13% to below $35 on Friday. Dive Insight Guardant and NRG Oncology, a clinical trial group funded by the National Cancer Institute, began the trial in 2020 on the strength of evidence that the LUNAR-1 blood test may help identify patients who are likely to benefit from chemotherapy after surgery. The test, the product of a ...
- Source: drugdu
- 127
- September 8, 2023
Delaware’s Marlex Pharmaceuticals recalls 2 batches of heart failure drug after labeling mix-up

When it comes to heart failure medication, a labeling mix-up can have dire consequences. That’s why Marlex Pharmaceuticals of New Castle, Delaware, is recalling two lots of digoxin tablets at the 0.125-mg and 0.25-mg doses. The company is pulling the batches of the heart failure medication because certain bottles of 0.125-mg digoxin tablets are mislabeled with the 0.25-mg dose and vice versa. The labeling snafu could cause either overdosing of underdosing in patients who unknowingly take the wrong strength of medication, Marlex warned in a notice posted on the FDA’s website. Patients on 0.125-mg strength digoxin who take the higher dose could experience “significant drug toxicity” such as mental disorientation, dizziness, blurred vision, memory loss and fainting, the company added. Meanwhile, patients who take a subpotent dose may experience loss of control of heart rate and potential heart failure exacerbation, Marlex said. As of Thursday, Marlex said it hadn’t received ...
- Source: drugdu
- 223
- September 6, 2023
【EXPERT Q&A】What are the regulations and requirements for exporting medical devices to the European Union?

Drugdu.com expert’s response: Entering the European Union market requires medical device products to adhere to a series of stringent regulations and quality standards. Firstly, products must obtain CE certification, a mark that signifies compliance with EU requirements for safety, health, and environmental protection. Before submitting an application, make sure that all relevant application forms are completed in detail, including key data such as product specifications and manufacturer information. Upon passing preliminary review, the product will be sent to an EU-designated third-party certification body for comprehensive and accurate testing and evaluation. This body will assess the product’s compliance with the EU Medical Device Directive (MDD) or Medical Device Regulation (MDR), depending on the case. After successfully completing the certification process, you will receive EU export product certification, an indispensable credential proving that your product can be legally sold in the EU market. It should be noted that due to the wide variety ...
- Source: drugdu
- 320
- September 5, 2023
European Union medical device regulations
The past, present, and future of cancer drug development

A new editorial paper was published in Oncoscience (Volume 10) on August 17, 2023, entitled, “Cancer drug development yesterday, today and tomorrow.” In this new editorial, researchers Elzbieta Izbicka and Robert T. Streeper from New Frontier Labs discuss the history of cancer drug development and how it has evolved over time. The editorial also highlights the current state of cancer drug development and what the future may hold. Editorial Introduction: The “war on cancer” began with the National Cancer Act, a United States federal law intended “to amend the Public Health Service Act so as to strengthen the National Cancer Institute in order to more effectively carry out the national effort against cancer” that was signed by President Richard Nixon on December 23, 1971. As the 50th anniversary is now two years gone, the war has not been necessarily a blitzkrieg. To paraphrase Charles Dickens, today “it is the best ...
- Source: drugdu
- 109
- August 28, 2023
Inherent Biosciences, Inc. Advances Fertility Solutions with Transformative Grant Funding from the NIH

A Leap Forward for Patients, A Promising Opportunity for Investors, and a Revolutionary Tool for Physicians Salt Lake City, Utah – Inherent Biosciences, Inc., a commercial-stage life science company, is at the forefront of innovation with its epigenetic diagnostic tools designed to enhance and support the reproductive journey. The company has secured a $1.9M Fast-Track SBIR grant from the National Institutes of Health (NIH) to further its mission of raising the standard of care in reproductive health. Inherent Biosciences is driven by a vision to transform trial and error medicine and restore hope for patients. The company’s Sperm Quality Test (SpermQT), marketed under the brand Path Fertility (pathfertility.com), offers a cutting-edge assessment of male fertility. This grant will bolster the development of the company’s second test, targeting the needs of approximately 40 million men worldwide affected by azoospermia, a condition where there is an absence of sperm in the ejaculate, ...
- Source: drugdu
- 157
- August 19, 2023
Genentech to pay $158K fine after EPA flagged mishandling of hazardous waste at San Francisco plant

After settling with the U.S. Environmental Protection Agency (EPA) over environmental violations at one of its former plants, Genentech is on the hook for a fine of $158,208.The findings came out of a 2021 inspection of the company’s now-closed plant in South San Francisco. During the visit, EPA inspectors found several instances of the company skirting requirements related to the disposal of hazardous materials, the agency said. For one, the company stored waste without a permit and didn’t correctly monitor air emissions from the materials, according to the EPA. Plus, the overfill protection controls for a hazardous waste tank weren’t maintained at all, the agency said. Inspectors also found manifests for the waste that didn’t include all necessary federal waste codes. “When a company fails to comply with hazardous waste storage and monitoring requirements, that company puts workers and communities at risk of harmful exposures,” EPA pacific southwest regional administrator ...
- Source: drugdu
- 137
- August 14, 2023
Thermo Fisher Scientific Selected as the Transplantation Statistical and Clinical Coordinating Center (T-SCCC) for the U.S. National Institute of Allergy and Infectious Diseases

T-SCCC will support initiatives seeking to ensure success of organ transplants for patients WILMINGTON, N.C.–(BUSINESS WIRE)– The PPD clinical research business of Thermo Fisher Scientific Inc., the world leader in serving science, has been granted a five-year award to provide a Transplantation Statistical and Clinical Coordinating Center for the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health in the United States. This center will offer a broad range of support services critical to the design, development, execution and analysis of NIAID transplantation clinical trials and research. According to the United Network for Organ Sharing, the non-profit serving as the nation’s transplant system under contract with the federal government, more than 40,000 organ transplants were performed in 2022, setting an annual record, with total kidney transplants exceeding 25,000 for the first time ever. Meanwhile, the Health Resources & Services Administration within the U.S. Department ...
- Source: drugdu
- 116
- August 14, 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.