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Lilly Puts Potential $660M on the Line for Protein-Protein Interaction Blockers

By Tristan Manalac Pictured: Eli Lilly’s Biotechnology Center in California Eli Lilly on Tuesday signed a license and collaboration agreement with Tokyo-based biotech PRISM BioLab to discover and develop small molecule inhibitors of protein-protein interactions. Under the terms of the deal, Lilly will make an upfront payment and pledges up to $660 million in preclinical, clinical and commercial development milestones. The Japanese biotech will also be eligible for royalties on future sales of any pharmaceutical product that emerges from the partnership. In return, Lilly will gain access to PRISM’s proprietary PepMetics platform, which synthesizes small molecule drug candidates that can behave like peptides, according to the biotech’s ...
- Source: drugdu
- 173
- December 1, 2023
FDA Accepts New Drug Application for Karuna Therapeutics’ Novel Schizophrenia Drug

Pharmaceutical Executive Editorial Staff KarXT (xanomeline-trospium) is currently in development to treat schizophrenia and psychosis related to Alzheimer disease. The FDA has accepted a New Drug Application (NDA) for Karuna Therapeutics, Inc’s KarXT (xanomeline-trospium) treatment for schizophrenia in adult patients. The novel muscarinic antipsychotic is currently in development to treat schizophrenia and psychosis related to Alzheimer disease. “There is a significant need for new treatment options for serious mental illness. If approved, KarXT could be one of the more important new product introductions in neuropsychiatry by providing a novel pharmacological approach for the treatment of schizophrenia,” said Bill Meury, Karuna Therapeutics president and chief executive officer, said in a press release.1 Schizophrenia can be a disabling condition, potentially causing a combination of hallucinations, delusions, and extremely disordered thinking and behavior that has a negative impact on the ability to function in daily life. As such, patients with schizophrenia require lifelong ...
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- 113
- December 1, 2023
4.6M Choose ACA Marketplace Coverage

Of those who have chosen ACA Marketplace coverage so far in the 2024 Open Enrollment Period, 20% are new consumers and 80% are returning consumers, according to CMS. By MARISSA PLESCIA Nearly 4.6 million people have chosen an Affordable Care Act (ACA) Health Insurance Marketplace plan so far during the 2024 Marketplace Open Enrollment period, CMS reported last week. The Marketplace Open Enrollment Period began November 1. CMS’ report shows data through November 18 for the 32 states using HealthCare.gov and November 11 for the 17 states and the District of Columbia with State-based Marketplaces. The open enrollment period ends January 15 with HealthCare.gov, while State-based Marketplaces have different deadlines. Those who enroll by December 15 can get coverage starting January 1. CMS said that 20% of the plan selections are from people who are new to the Marketplaces, representing 920,000 people. The remaining 80%, or 3.7 million consumers, have ...
- Source: drugdu
- 216
- December 1, 2023
【EXPERT Q&A】What are the processes involved in exporting pharmaceuticals to Japan?

Drugdu.com expert’s response: Exporting pharmaceuticals to Japan involves a complex process with multiple steps, due to the stringent regulatory system of the Japanese pharmaceutical market. Here are the key steps summarized by Dide Medical Trade Network: 1.Understanding Japanese Pharmaceutical Market Regulations Before starting the export process, it is crucial to have an in-depth understanding of Japan’s pharmaceutical regulatory laws. The Ministry of Health, Labour and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA) are the main regulatory bodies responsible for the approval and supervision of pharmaceuticals. 2.Product Registration and Approval All pharmaceuticals intended for sale in the Japanese market must be registered and approved by the MHLW. This usually involves submitting detailed information about the pharmaceutical, such as clinical trial data, evidence of safety and efficacy, etc. 3.Japanese GMP Certification Japan has strict quality control standards for pharmaceutical production, and pharmaceuticals exported to Japan must be produced in ...
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- 303
- December 1, 2023
New blood test to reduce heart attacks and death rates in A&E heart patients

A new trial led by researchers at the University of Edinburgh has revealed that a new blood test in emergency departments can spot more patients with injuries to their heart muscle, producing lower rates of future heart attacks and deaths. Funded by the British Heart Foundation (BHF) and published in the BMJ journal, the new blood test could improve diagnosis for one in five patients who have a heart muscle injury. In the UK, heart attacks are responsible for around 100,000 hospital admissions every year. During a heart attack or heart injury stemming from other heart conditions, a protein known as troponin is released into the blood. The new test detects very low levels of troponin more accurately than older versions of the tests, which have been used by doctors for years to help diagnose these conditions in people with chest pains and related symptoms. Researchers analysed the results of ...
- Source: drugdu
- 122
- December 1, 2023
Intas on import alert as FDA flags data manipulation, management failures in warning letter

Drug manufacturer Intas Pharmaceuticals is no stranger to FDA scrutiny. Now, one of its plants has been placed on an import alert after a series of interactions with the agency. After a May inspection of Intas’ plant in Gujarat, India, the FDA published a warning letter that points a finger at management and labels products made at the site “adulterated” because of the company’s manufacturing deficiencies. Before this development, the FDA earlier this year slapped the site with a Form 483 filing outlining problems at the plant. Shortly after that, the company provided a response that proved to be “inadequate,” as the FDA described it. In the warning letter, the FDA blasted Intas for an “egregious pattern” of shortfalls that shows the company’s failure to carry out “basic responsibilities.” The agency tracked multiple instances of data manipulation going back to 2021. In these cases, visual inspectors manipulated particle and other ...
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- 113
- December 1, 2023
Eli Lilly advances small molecule drug portfolio with Prism Biolab partnership

Eli Lilly is building on its small drug molecule portfolio with a partnership with Prism Biolab to develop and commercialise small molecules that modulate targets picked by Lilly. As part of the agreement, Prism will receive upfront payments and up to $660m based on preclinical, clinical, and commercial development milestone payments, along with royalty payments. This alliance will utilise Prism’s PepMetics technology platform to discover oral protein-protein interaction (PPI) targets. Lilly has made several moves in the last couple of years to develop small-drug molecules. Earlier this month, the company was one of the investors in Alto Neuroscience’s $45m Series C financing round, which will support Alto’s clinical programme of four small-molecule CNS candidates to treat psychiatric disorders including depression and post-traumatic stress disorder. Alto is expecting positive topline data from Phase II studies investigating two of the molecules, ALTO-100 and ALTO-300, in H2 2024 and H1 2025, respectively. In ...
- Source: drugdu
- 114
- December 1, 2023
FDA opens investigation into secondary cancer risk with CAR-T therapies

The US Food and Drug Administration (FDA) has started an investigation to review the safety of chimeric antigen receptor (CAR)-T cell immunotherapies following reports of T cell malignancies in patients who received these immunotherapies. The therapies under investigation include six approved B cell maturation antigen (BCMA)- or CD19-directed CAR-T cell therapies. The investigation follows reports collected from clinical trials and post-marketing adverse event surveillance. The FDA had required companies to conduct 15-year long term follow-up observational safety studies to assess the long-term safety and the risk of secondary malignancies as part of the respective therapy’s approval. The risk of post-therapy malignancies applies to all FDA-approved BCMA- or CD19-directed CAR-T cell therapies, as per a 28 November press release. The agency added that although the therapy benefits “continue to outweigh their potential risks for their approved uses”, the FDA is evaluating the need for regulatory action regarding the risk of T-cell ...
- Source: drugdu
- 107
- December 1, 2023
MS Expands Cardio Partnership with Avidity in Potential $2.3B Deal

By Kate Goodwin Pictured: Bristol Myers Squibb building in Munich/iStock, Tati Campelo Bristol Myers Squibb is upping the ante in its partnership with Avidity Biosciences. The San Diego-based biopharma announced Tuesday an expansion of its previous collaboration with BMS, with the latter paying $100 million upfront and adding up to five cardiovascular targets. With potential cumulative payments of up to $2.3 billion plus low double-digit royalties, the partnership could be a lucrative one for the RNA biopharma. The deal expansion sent Avidity’s suffering stock soaring around 35% in premarket trading. A welcome reprieve to the 72% tumble it took earlier this year. Avidity will get a $60 million upfront cash payment in addition to BMS scooping up $40 million of its stock to deliver new cardiovascular treatments utilizing the former’s antibody oligonucleotide conjugates (AOCs). Avidity’s AOCs combine the targeting specificity of monoclonal antibodies with the precision of oligonucleotide therapies to ...
- Source: drugdu
- 115
- November 30, 2023
FDA Launches Probe of Malignancies Linked to CAR-T Therapies

By Tyler Patchen Pictured: Exterior of an FDA building/iStock, Grandbrothers The FDA announced Tuesday that it is investigating the “serious risk” of malignancies in patients who received treatment with BCMA- or CD19-directed autologous CAR-T cell immunotherapies. The regulator said it has determined that the risk of T-cell malignancies “is applicable to all currently approved BCMA-directed and CD19-directed genetically modified autologous CAR T cell immunotherapies” including Bristol Myers Squibb’s Abcema and Breyanzi, Johnson & Johnson’s Carvykti, Novartis’ Kymriah and Gilead’s Tecartus and Yescarta. “T-cell malignancies have occurred in patients treated with several products in the class,” according to the FDA, which said it received reports from clinical trials and postmarketing adverse event data. While the agency said that the overall benefits of these products continue to outweigh their potential risks, it “is investigating the identified risk of T cell malignancy with serious outcomes, including hospitalization and death, and is evaluating the ...
- Source: drugdu
- 121
- November 30, 2023

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