Boston-based start-up Pepper Bio has raised $6.5m in oversubscribed seed funding to develop its Compass drug discovery platform. The financiers included venture capital companies such as NFX, Silverton Partners, Mana Ventures and others. Pepper’s CEO Jon Hu told Pharmaceutical Technology that the Compass platform provides biological maps for insight into different “-omics”- genomics, transcriptomics, proteomics and phosphoproteomics. The success rate of drug development from pre-clinical studies to regulatory approval is 3%-10%, says Hu. If one can improve this success rate, it can bring down the cost of drug approval, he adds. According to Hu, the high cost of development is driven by the cost of failed iterations of the therapy. Pepper sources its database consists of publicly and commercially available data in addition to its proprietary data, which was either generated in-house or acquired through partnerships. Hu added that public and commercial data undergoes a series of transformations including an ...
In a bid to expand its oncology pipeline AbbVie has announced it will acquire ImmunoGen under a definitive agreement. The proposed $10.1bn acquisition will see AbbVie purchase ImmunoGen’s outstanding shares at $31.26 per share. The acquisition is expected to be completed in mid-2024. On an investor call following the announcement this morning (30 November), AbbVie’s executive vice president and chief financial officer Scott Reents, said the funding of the transaction will be driven by a combination of cash and debt. The exact split of cash and debt has not been indicated, but Reents anticipates that AbbVie will spend at least $2bn in cash in the acquisition. Through the transaction, AbbVie will gain an asset in Elahere (mirvetuximab soravtansine-gynx), ImmunoGen’s lead antibody-drug candidate (ADC), which received an accelerated approval to treat folate receptor alpha (FRα)-positive, platinum resistant ovarian, fallopian tube, or primary peritoneal cancer, in November 2022. As per AbbVie’s executive ...
By Kate Goodwin Pictured: Boehringer Ingelheim building/iStock, Sundry Photography Boehringer Ingelheim is striking a deal to leverage artificial intelligence for some of the hardest to treat cancers. Phenomic AI announced a collaboration agreement with the pharma giant Wednesday. The Toronto and Boston-based biopharma is getting a $9 million upfront payment with another potential $500 million on the line in milestones and royalties to discover targets for stroma-rich cancers. The stroma-rich cancer category is among the most difficult to treat. Including types like colorectal and pancreatic, the tumor stroma in these cancers provides a hard-to-penetrate barrier around the tumor that both protects the cancer and helps feed it. Phenomic’s platform is focused on targets that can break through the stroma to ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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