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SCOTUS Blocks $6B Purdue Pharma Bankruptcy Settlement

By Tristan Manalac Pictured: Oxycontin bottles on a shelf/iStock, Pureradiancephoto The Supreme Court of the United States on Thursday granted the Department of Justice’s application for a stay on Purdue Pharma’s $6 billion bankruptcy settlement plan shielding the Sackler family from lawsuits related to the opioid epidemic. In the short order, SCOTUS also put any other bankruptcy proceedings against Purdue on hold. The court will schedule a hearing in December 2023 to discuss the legality of a bankruptcy settlement plan reached with state and local governments that traded the Sacklers’ immunity from civil lawsuits for a contribution of up to $6 billion. The issue at hand is whether U.S. bankruptcy laws provide protections for the Sackler family, even though they had not personally declared bankruptcy themselves. The Sacklers were previously the owners of Purdue who are alleged to have fueled the opioid-addiction crisis and required a release from liability as ...
- Source: drugdu
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- August 15, 2023
【EXPERT Q&A】What is the FDA’s drug approval process?

Drugdu.com expert’s response: The FDA drug approval process is both standardized and rigorous. Here’s a detailed breakdown of the entire process: 1.Preclinical Research: This is the first step in the drug approval process. It includes pharmacological and toxicological studies to evaluate the safety and effectiveness of the drug. These studies are usually conducted in laboratories or on animal models. 2.Submission of Investigational New Drug (IND) Application: Once the data from preclinical studies suggest that the drug might be safe, the pharmaceutical company submits an Investigational New Drug (IND) application. The IND contains data from preclinical studies, manufacturing information, clinical trial protocols, and more. 3.Clinical Trials: This is the heart of the drug approval process and it typically encompasses three phases. Phase I primarily tests the drug’s safety and dosage in humans. Phase II focuses on its effectiveness and side effects. Phase III further verifies its effectiveness, monitors side effects, and compares ...
- Source: drugdu
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- August 15, 2023
FDA drug approval
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
- 139
- August 14, 2023
World Health Organization classifies EG.5 as a COVID-19 ‘variant of interest’

The World Health Organization (WHO) has announced that the circulating COVID-19 strain, EG.5, has been designated as a “variant of interest”. The fast-spreading variant, which is another descendant of Omicron, has been detected in 51 countries, including the US, UK, China and Canada. In WHO’s risk evaluation, between 17 July and 23 July, EG.5 accounted for 17.4% of cases – a “notable rise” from the data reported four weeks prior, when the global prevalence of the variant was 7.6%. Despite this, the agency’s risk evaluation stated that the current “available evidence does not suggest that EG.5 has additional public health risks” and that a more comprehensive evaluation is needed. Globally, COVID-19 has caused over 6.9 million deaths, with more than 768 million cases confirmed since December 2019. In 2020, WHO declared the outbreak a pandemic and recently ended the global emergency status for COVID-19 in May this year. Despite its ...
- Source: drugdu
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- August 14, 2023
GenScript and T-MAXIMUM partner for CAR-T cell therapy development

Genscript Biotech has formed a strategic collaboration agreement with T-MAXIMUM Biotech to develop CAR-T cell therapy. Leveraging GenScript’s CRISPR nucleic acid re-agents, the partnership will focus on developing T-MAXIMUM’s CAR-T cell therapy. GenScript research and development (R&D) and manufacturing vice-president Dr Li Hong stated: “Our R&D-to-GMP-level sgRNA will support their UCAR-T products for solid tumours. While CAR-T cell therapies have made remarkable strides in haematological tumours, addressing the unmet need for solid tumours remains crucial.” T-MAXIMUM will receive a number of CRISPR re-agents from GenScript. These will support the development of T-MAXIMUM’s universal CAR-T products from discovery to commercialisation. GenScript’s partnership with T-MAXIMUM will drive the latter’s strategic development plan, advancing products into Phase II clinical research and enabling market delivery up to 2027. T-MAXIMUM is currently focused on the development of its universal CAR-T cell therapy product, MT027, to treat recurrent high-grade gliomas. T-MAXIMUM CEO Dr Shang Xiaoyun stated: ...
- Source: drugdu
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- August 14, 2023
Regeneron to acquire Decibel Therapeutics in deal worth up to $213m

Regeneron Pharmaceuticals has entered into a definitive agreement to acquire hearing loss specialist Decibel Therapeutics in a deal worth as much as $213m. The transaction gives Regeneron access to investigational gene therapy, DB-OTO, which is designed to provide hearing to people with otoferlin-related hearing loss. The candidate is currently in phase 1/2 clinical development. Under the terms of the agreement, Regeneron will pay $4 per share of Decibel common stock, with an additional non-tradeable contingent value right (CVR) for $3.50 apiece, upon achievement of certain clinical development and regulatory milestones for DB-OTO. The deal gives Decibel a total equity value of about $109m, based on the amount payable at closing, though that valuation increases to $213m if the CVR milestones are met. The agreement builds on the existing gene therapy collaboration between Regeneron and Decibel aimed at developing three programmes targeting different forms of congenital, monogenic hearing loss. There are ...
- Source: drugdu
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- August 14, 2023
Galera Lays Off 70% of Staff After FDA Rejection in Severe Oral Mucositis

Pictured: FDA sign in its headquarters/iStock, Grandbrothers The FDA rejected on Wednesday Galera Therapeutics’ avasopasem manganese, which the company was proposing as a treatment for radiotherapy-induced severe oral mucositis in patients with head and neck cancer. Galera shares fell 83% in after-hours trading in response to the FDA’s rejection. In its Complete Response Letter, the regulator said that Galera’s data were “not sufficiently persuasive to establish substantial evidence of avasopasem’s effectiveness and safety for reducing severe oral mucositis in patients with head and neck cancer.” The FDA noted that it will need results from an additional trial if the company wants to file a resubmission. The New Drug Application for avasopasem manganese included data from the Phase III ROMAN study, topline data from which showed that treatment with Galera’s candidate significantly reduced the incidence of radiotherapy-induced severe oral mucositis (SOM). The company supported these findings with results from the Phase ...
- Source: drugdu
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- 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
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- August 14, 2023
【EXPERT Q&A】What might be the reasons for not closing deals despite following up with many clients?

Drugdu.com expert’s response: For foreign trade salespeople, every inquiry received is hard-won and should be treasured. However, inevitably among these inquiries, there will be phishing emails, junk inquiries, and even more seriously, potential scammers. Therefore, upon receiving an email, the immediate response is not advisable. Instead, it’s essential first to discern and analyze. How to handle and reply to inquiries more effectively is the key to success. 1. Determine authenticity: 01 Check the IP: Check the sender’s IP by right-clicking the email, selecting properties-details to view the IP address of the email. Determine its geographical location. Also, cross-reference the IP records in the website counter to observe whether the visitor clicked a link to enter the website or typed in your URL directly. 02 Consider the sending time: Look at the email sending time and account for time zone differences. Generally, no one would send emails in the middle ...
- Source: drugdu
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- August 14, 2023
Foreign Trade Experience
Boston Scientific receives FDA approval for cryoablation system

Dive Brief Boston Scientific on Thursday received approval from the Food and Drug Administration for a new heart ablation device to treat atrial fibrillation, according to a company announcement. The POLARx Cryoablation System can accommodate two balloon sizes in one catheter, which Boston Scientific said allows physicians to tailor care to individual patients. The device has been selling well in Europe and Japan, where it is cleared for use, CEO Mike Mahoney said in an earnings call last month. Boston Scientific has been competing with companies like Johnson & Johnson and Medtronic, which are also bringing new cardiac ablation devices to market. Dive Insight Cryoablation is a minimally invasive procedure that uses a balloon catheter to freeze tissue near the pulmonary vein. Scars then block irregular electric signals that can cause atrial fibrillation. Switching between two balloon sizes, clinicians can adjust the device to a patient’s anatomy during a procedure, ...
- Source: drugdu
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- August 12, 2023

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