Biotech News

The approval gives Rigel, a biotech that’s been around since the mid-1990s, its second marketed medicine and a competitor to Servier’s Tibsovo.

The board reshuffling will consolidate Duato’s leadership of J&J as the company absorbs a big medtech acquisition and nears a planned spin out of its consumer health division.

The FDA’s decision is a step forward for a type of drugmaking known as “multiplex editing,” which involves editing several genes simultaneously.

Tris Pharma, Inc announced today (December 2) that they have expanded their partnership allowing Pediatrix Therapeutics to receive exclusive rights to commercialize its entire FDA-approved ADHD portfolio as well as ADHD pipeline products in China. Tris says it has a robust portfolio of FDA-approached products for the treatment of attention deficit/hyperactivity disorder (ADHD) and a pipeline of treatments for pain, addiction, spasticity and narcolepsy. Ketan Mehta, Tris’s founder and CEO, said: “China has a large population with limited treatment options for ADHD. With this partnership we hope to bring the first long-acting liquid and chewable products to treat ADHD to China, and arm physicians with new tools for the treatment of young patients. Treatment options for ADHD “The Pediatrix team has a wealth of experience developing products within the Chinese market. Because of this, we believe they are an excellent partner to facilitate access to these needed medicines in China and maximize the value our products can provide to both our companies, The post Tris Pharma and Pediatrix Therapeutics extend partnership for ADHD portfolio appeared first on Labiotech.eu. © Labiotech UG and Labiotech.eu. Unauthorized use and/or duplication of this material without express and written permission from this site’s author and/or owner is strictly prohibited. Excerpts and links may be used, provided that full and clear credit is given to Labiotech UG and Labiotech.eu with appropriate and specific direction to the original content.

A BC Platforms (BCP) partnership that includes Finland’s Euformatics and Hungary’s Oncompass Medicine has been awarded a contract for the second phase of developing standardized oncology workflows for a buyer consortium of seven European hospitals, represented by the Medical University Graz.  The consortium is formed by hospitals from the Medical University of Graz in Austria, University of Florence and University of Milano-Bicocca in Italy, Erasmus University Medical Center in the Netherlands, Christian-Albrecht University of Kiel and St. Anna Children’s Cancer Research Institute in Germany, and the Centre Léon Bérard in France. This follows on from the announcement in May 2022 about the three companies forming a partnership to deliver phase 1 of this Instand-NGS4P project. Instand-NGS4P is a Horizon 2020 funded project that shares BCP’s vision for improving cancer patients’ diagnostics. This is achieved by developing and providing integrated and standardized workflows for next generation sequencing (NGS) and integrating information from cancer gene testing, pharmacogenetics testing and e-medication, to support medical decision making. The program will run, with three phases, The post Partnership to deliver oncology workflow for 7 European hospitals appeared first on Labiotech.eu. © Labiotech UG and Labiotech.eu. Unauthorized use and/or duplication of this material without express and written permission from this site’s author and/or owner is strictly prohibited. Excerpts and links may be used, provided that full and clear credit is given to Labiotech UG and Labiotech.eu with appropriate and specific direction to the original content.

To prevent testing on animals and create more precise ways of testing therapeutics, the pharmaceutical industry is turning to human immune cells. However, the availability of cells has been limited to date.  Now, researchers at the Fraunhofer Institute for Toxicology and Experimental Medicine (ITEM) and Hannover Medical School (MHH) in Germany have succeeded in scaling the production of customized immune cells from laboratory up to industrial level. Human immune cells and immune cell preparations are gaining an increasingly prominent role in modern medicine, in new cancer treatments and in the development and testing of new drugs, for instance. To obtain these cells for health research purposes, the industry has long relied on human donors or used cell lines from different types of cancer.  Given that every human being and every cancer cell is unique, however, it was not possible to standardize the processes involved. This was proving a major problem until two stem cell researchers from Japan and the U.K. discovered a game changer in 2006, The post Creating designer immune cells at scale appeared first on Labiotech.eu. © Labiotech UG and Labiotech.eu. Unauthorized use and/or duplication of this material without express and written permission from this site’s author and/or owner is strictly prohibited. Excerpts and links may be used, provided that full and clear credit is given to Labiotech UG and Labiotech.eu with appropriate and specific direction to the original content.

Full-Life Technologies, a global radiotherapeutics company, is acquiring New Jersey-based Focus-X Therapeutics, a company developing targeted radiopharmaceuticals to treat cancer based on peptide engineering technology.  The acquisition expands Full-Life’s pipeline, including two compounds nearing clinical trials, provides a second innovative peptide focused discovery platform, and leverages its radiotechnology manufacturing and logistics platforms to advance compounds into clinical development. Under the terms of the acquisition, Focus-X shareholders are eligible to receive from Full-Life an upfront payment, potential development, regulatory and sales-based milestones of up to $245 million and royalties on any commercial sales. The acquisition is expected to close in the first quarter of 2023. “The Focus-X acquisition perfectly leverages Full-Life’s radiotechnology and development platform by adding two development ready compounds, including a lead with initial human data, a robust pipeline and world class peptide discovery capabilities,” said Lanny Sun, co-founder, chairman and CEO of Full-Life. Fa Liu, Focus-X’s co-founder and CEO, said: “Full-Life’s integrated platforms will provide the manufacturing technology, logistics and clinical development expertise to accelerate development of our compounds as well as expand our discovery efforts. The post Full-Life Technologies acquiring Focus-X Therapeutics appeared first on Labiotech.eu. © Labiotech UG and Labiotech.eu. Unauthorized use and/or duplication of this material without express and written permission from this site’s author and/or owner is strictly prohibited. Excerpts and links may be used, provided that full and clear credit is given to Labiotech UG and Labiotech.eu with appropriate and specific direction to the original content.

Biopharma company, Khondrion, has marked announced improvements from patients with MELAS spectrum disorders taking its lead asset, sonlicromanol. Updates were provided by the company from a 28-day double-blind, randomized placebo-controlled, three-way cross-over phase 2b study called KHNERGYZE in which 27 took part. It also reported updates on the ongoing, open-label extension KHEREREXT phase 2b study in seven patients for up to 52 weeks. Both studies are jointly called the phase 2b program. Sonlicormanol for MELAS syndrome People with MELAS syndrome have an accumulation of lactic acid in the blood (lactic acidosis), that can lead to vomiting, abdominal pain, fatigue, muscle weakness and difficulty breathing. This accumulation of lactic acid has also been observed in the spinal fluid and in the brain. In line with previous studies, sonlicromanol was found to be safe and well tolerated in the phase 2b program, with no serious adverse effects. The overall evaluation of the shorter and longer term data from the program shows patient benefits in several domains (cognition and mood, The post Khondrion’s sonlicromanol produces encouraging results for next stage of study appeared first on Labiotech.eu. © Labiotech UG and Labiotech.eu. Unauthorized use and/or duplication of this material without express and written permission from this site’s author and/or owner is strictly prohibited. Excerpts and links may be used, provided that full and clear credit is given to Labiotech UG and Labiotech.eu with appropriate and specific direction to the original content.

​​​​​​​GSK intends to file for approval of Jemperli in endometrial cancer after the checkpoint inhibitor met its primary endpoint in the Phase III RUBY trial.

The FDA has lifted its clinical hold on Beam Therapeutics’ BEAM-201 and cleared the way for an Investigational New Drug Application, the company announced Friday.

Athira Pharma’s experimental Alzheimer’s therapy, fosgonimeton, continues to show signs of being able to improve cognition and function in patients.

Amid rampant buyout speculation, Mirati Therapeutics reported that it will continue its final analysis of the Phase III SAPPHIRE trial following an interim survival analysis.

The FDA has approved Rigel's Rezlidhia for the treatment of adults with relapsed or refractory AML with a susceptible isocitrate dehydrogenase-1 mutation.

Home to many of the world's leading life science companies, the Genetown hotbed is a hub of activity. To help you in your job search, here are 10 Massachusetts biopharma companies hiring now.

Detailed clinical trial data for Roche's gantenerumab showed treatment cleared far less toxic protein from patients' brains than expected, potentially explaining its divergent result from Eisai’s lecanemab.

The first fecal microbiota product, Rebyota, approved by the U.S. Food and Drug Administration (FDA) today has been hailed ‘fantastic news’ by those in the microbiome field. Ferring Pharmaceutical’s product is approved to stop Clostridiodes difficile infection (CDI) in people over 18 and to be given after they have completed an antibiotic treatment for the infection. Brent Ragans, president, Ferring Pharmaceuticals U.S said: “Rebyota is a much-needed new treatment that offers hope to the thousands of people who suffer from recurrent C. difficile infection each year. It has the potential to impact not only patients and caregivers, but also the healthcare system.” James McIroy is CEO of EnteroBiotix,  a company he founded with the vision of building one of the world’s leading microbiome therapeutics businesses. He believes ‘everyone on the planet’ would benefit from enhancing their microbiome. He said: “The FDA approval of Rebyota is fantastic news for the microbiome therapeutics field. It shows recognition by regulators of how it can really make a difference in hard-to-treat, The post FDA’s approval of first fecal microbiota product, Rebyota, hailed an ‘enormous step forward’ for the field appeared first on Labiotech.eu. © Labiotech UG and Labiotech.eu. Unauthorized use and/or duplication of this material without express and written permission from this site’s author and/or owner is strictly prohibited. Excerpts and links may be used, provided that full and clear credit is given to Labiotech UG and Labiotech.eu with appropriate and specific direction to the original content.

The drug is currently in mid-stage testing as a treatment for ulcerative colitis. If it continues to advance, it could be the first approved therapy aimed at a protein known as TL1A, a target multiple other companies are pursuing. 

SparingVision today announces that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug application (IND) for SPVN06. The genomic medicine company has had its developing vision-saving treatments for ocular diseases, lead gene independent therapy for the treatment of retinitis pigmentosa (RP), a form of rod-cone dystrophy (RCD) and the most prevalent inherited retinal disease (IRD). SparingVision has also submitted a  clinical trial authorization (CTA) application to the French regulator (ANSM), which is currently under review. This approval paves the way for the initiation of promising RCD gene therapy (PRODYGY), a first-in-human (FIH) phase 1/2 clinical trial. First safety data are anticipated in 2023 and the primary endpoint is expected to be reached in 2025. SparingVision trial to ‘assess quality of life’ The trial is to assess the safety, tolerability, efficacy and quality of life following a single subretinal injection of SPVN06 in the worst-seeing eye of adult patients with RP due to a mutation in the RHO, The post FDA clears SparingVision’s investigational new drug application to treat ocular diseases appeared first on Labiotech.eu. © Labiotech UG and Labiotech.eu. Unauthorized use and/or duplication of this material without express and written permission from this site’s author and/or owner is strictly prohibited. Excerpts and links may be used, provided that full and clear credit is given to Labiotech UG and Labiotech.eu with appropriate and specific direction to the original content.

The biotech will lay off 60% of its staff and reprioritize its research to focus on a "second-generation" approach to the cell therapies it’s been developing. 

The regulatory OK, a milestone for microbiome-based drug research, is for a medicine from Ferring Pharma that treats a recurrent type of gut infection.

The company's experimental treatment donanemab reduced amyloid levels in the brain by more than Biogen's approved medicine, but the data’s significance is unclear until Lilly reveals results from a larger study next year. 

The smartphone revolution is providing a promising tool to combat the human immunodeficiency virus (HIV) epidemic. We’ve listed five HIV test apps in development that could help people carry out at-home HIV tests and prevent the spread of the infection. The COVID-19 pandemic in the last two years has demonstrated how vital rapid diagnostic tests are for containing outbreaks. A wide array of home testing kits for COVID-19 and smartphone apps sprouted to help people test themselves and report results to health authorities. The growing interest in testing kits and mobile health (mHealth) apps could have a big impact on other infections. For example, HIV continues to lurk in the population, particularly in low- and middle-income countries (LMICs) in sub-Saharan Africa. The potential of mHealth in fighting HIV HIV infections are currently incurable for the vast majority of cases. They cause people to lose the ability to fight off infections in the lethal condition acquired immunodeficiency syndrome (AIDS). Ways to fight the epidemic include lifelong antiretroviral drug regimes, The post Five apps powering the future of at-home HIV tests appeared first on Labiotech.eu. © Labiotech UG and Labiotech.eu. Unauthorized use and/or duplication of this material without express and written permission from this site’s author and/or owner is strictly prohibited. Excerpts and links may be used, provided that full and clear credit is given to Labiotech UG and Labiotech.eu with appropriate and specific direction to the original content.

This article was originally published in April 2020 and has since been updated to reflect the latest developments in HIV research. HIV research has come a long way since the virus was discovered in the 1980s. Antiretroviral therapy was a major milestone that has changed the lives of millions; the goal now is to find an HIV cure.  Back in 2008, Timothy Ray Brown was the first person to be cured of HIV. Known as the “Berlin patient”, Brown received two bone marrow transplants from a donor who was naturally resistant to HIV to treat his leukemia. He remained off antiretroviral therapy until his death in 2020. When the case was announced, the medical world went nuts. Had we finally achieved an HIV cure? Unfortunately, the answer remains not yet. Since then only four other people have been reported to remain off antiretroviral therapy thanks to a similar transplant. However, bone marrow transplants carry very high risks for HIV-positive patients, The post Is an HIV Cure Possible? The Future of HIV Therapy appeared first on Labiotech.eu. © Labiotech UG and Labiotech.eu. Unauthorized use and/or duplication of this material without express and written permission from this site’s author and/or owner is strictly prohibited. Excerpts and links may be used, provided that full and clear credit is given to Labiotech UG and Labiotech.eu with appropriate and specific direction to the original content.

Netherlands-based ISA Pharmaceuticals B.V., has announced that it has completed enrolment in its phase 2 clinical trial. Named OpcemISA. The trial aims to checkpoint inhibitor therapy in patients with metastatic/advanced 1st and 2nd line HPV16 positive oropharyngeal cancer (OPC). The clinical stage biotech company is developing immunotherapies to treat cancers and infectious diseases, and has enrolled 194 patients on its trial which is a large randomized, double blind, placebo-controlled phase 2 clinical trial. The trial will evaluate the efficacy and safety of the addition of ISA101b to checkpoint inhibitor therapy in patients with metastatic/advanced 1st and 2nd line HPV16 positive OPC. Extensive clinical development program Primary endpoints will demonstrate overall response rate (ORR) and safety. Secondary endpoints include duration of response (DOR) and overall survival (OS). This trial is part of an extensive clinical development program of ISA101b in collaboration with US biotechnology company Regeneron. Leon Hooftman, chief medical officer of ISA Pharmaceuticals, said: “This large proof of concept trial of ISA101b has the potential to demonstrate for the first time that the combination of an HPV16-directed therapeutic vaccine with checkpoint inhibitor immunotherapy improves the short-term outcome and longer-term survival of difficult to treat head and neck cancer patients. The post Trial for HPV16 positive oropharyngeal cancer completes enrolment for phase 2 appeared first on Labiotech.eu. © Labiotech UG and Labiotech.eu. Unauthorized use and/or duplication of this material without express and written permission from this site’s author and/or owner is strictly prohibited. Excerpts and links may be used, provided that full and clear credit is given to Labiotech UG and Labiotech.eu with appropriate and specific direction to the original content.

The richly funded drugmaker will cut 15% of its workforce, or about 75 employees, as well as stop work on one of its preclinical research programs.