Despite the promise of cell therapies, manufacturing the personalized medicines at scale has been a limiting factor for many companies. Now, as BlueRock Therapeutics advances its lead prospect, its parent company Bayer is ready to kick production into high gear.Bayer on Tuesday opened its first Cell Therapy Launch Facility in Berkeley, California, which is expected to create capacity to bring cell therapies to patients worldwide. Bayer has invested $250 million to build the plant, which will initially crank out materials for late-stage clinical trials across 100,000 square feet of space, the drugmaker said in a release. The plant is also equipped to support the potential commercial launch of BlueRock’s experimental cell therapy for Parkinson’s disease, bemdaneprocel. At the moment, BlueRock says planning is underway for its phase 2 study of bemdaneprocel, which is expected to start enrolling patients in the first half of 2024. The plant features flexible, modular space ...
Iambic Therapeutics brings together software engineers and drug-hunting scientists, all sharing the goal of using artificial intelligence to optimize properties of small molecule drugs. The startup will apply its Series B financing to a cancer drug pipeline that includes two candidates on track for the clinic in 2024. By FRANK VINLUAN Drug discovery isn’t only about finding new targets. There’s still plenty of opportunity to find better ways to hit targets that are already drugged, according to Tom Miller, CEO of startup Iambic Therapeutics. Understanding how a molecule interacts with a known disease target enables drug hunters to design molecules that could be superior alternatives for patients. Miller notes that a molecule’s ability to bind to a target protein while leaving related proteins unaffected improves its safety. It’s also important to understand how the distribution of a molecule across tissues in the body affect efficacy. Iambic’s drug discovery research employs ...
By Jennifer Markarian Pictured: Illustration of students sitting at a table/iStock, undrey Although the biopharma industry tends to focus on high-skill workers with advanced science and engineering degrees, just over half of entry-level jobs in the U.S. life sciences require skills considered middle and lower level that could be filled by people with less than a four-year degree, according to a recent report on life sciences workforce trends by the Coalition of State Biosciences Institutes (CSBI), which promotes bioscience education and workforce development, and research group TEConomy Partners. “The share of middle-skills workers needed for entry-level positions in life sciences has held steady over the past decade,” Liisa Bozinovic, chair of CSBI, told BioSpace. Individuals with degrees from the U.S. network of two-year Advanced Technical Education biotechnology programs, which provide hands-on, industry-relevant training, have been successfully filling these positions, she added. Organizations Collaborate to Promote Biotech Education InnovATEBIO, a National ...
BeiGene will utilise Nona’s Harbour Mice platform as part of the agreement BeiGene and Nona Biosciences have announced an agreement to expand their strategic collaboration for antibody discovery. The collaboration will allow BeiGene to utilise Nona’s Harbour Mice platform – a fully human transgenic mouse platform – to further improve therapeutic antibody discovery efficiency and flexibility. BeiGene first obtained the rights to use the proprietary Harbour Mice H2L2 platform for multiple antibody programmes in 2018 as part of the now expanded collaboration. Harbour Mice works to generate fully human monoclonal antibodies in classical two light and two heavy chain (H2L) formats and heavy chain only (HCAb) formats. The H2L platform allows mice to bear fully human immunoglobulin genes with robust B cell development and antibody maturation. The HCAb platform is the world’s first human HCAb transgenic mouse platform that works to generate fully human heavy chain-only antibodies. It allows the ...
The legal kerfuffle over the FDA’s 2000 approval of Danco Laboratories’ abortion pill mifepristone, also known as Mifeprex, is heading to the Supreme Court. Friday, Danco asked the Supreme Court to overturn a recent U.S. Court of Appeals for the Fifth Circuit ruling that would severely limit access to the abortion pill mifepristone. “The risks and confusion that result from the Fifth Circuit’s decision are not ones that women, teenage girls, and the public health system should be forced to bear without this Court’s review,” Danco’s lawyers wrote in a legal filing. “Denying review of the Fifth Circuit’s opinion would eviscerate the sovereign authority of states that have chosen to expand and protect access to medication abortion in their jurisdictions,” Danco’s legal team continued, adding that the case is of “indisputable importance.” Mifepristone remains unrestricted until the Supreme Court weighs in on the case. Medication abortion makes up the majority ...
Pictured: Flu vaccine vials and syringe/iStock, vchal Topline data from the Phase II PENINSULA study showed that Vir Biotechnology’s investigational flu shot VIR-2482 fell short of its primary and all secondary efficacy endpoints, the biotech announced Thursday. Patients inoculated with the highest 1,200-mg dose of the vaccine candidate saw a 16% drop in influenza A-like illness as compared with placebo, an effect that did not satisfy statistical significance, according to Vir’s news release. PENINSULA defined this primary endpoint as PCR-confirmed influenza A infection with at least one respiratory and one systemic symptom. Phil Pang, Vir’s chief medical officer, called these findings “disappointing” in a statement, but nevertheless said that the company needs to conduct further analysis to “better understand these outcomes.” Vir plans to present these analyses at a future major medical congress. PENINSULA is double-blinded, randomized and placebo-controlled study with approximately 3,000 adult patients enrolled. VIR-2482 was given as a ...
Pfizer is looking to enrich its pipeline with up to 10 new innovative medicines by partnering with startup creator Flagship Pioneering, the companies announced Tuesday. Under the terms of the agreement, Pfizer and Flagship will each contribute an upfront investment of $50 million. The collaboration will leverage Flagship’s rich ecosystem of biotechnology platforms and more than 40 human health companies. Pfizer and Flagship will explore up to 10 single-asset programs, which Pfizer will fund and have the option to acquire. Flagship and its companies will be eligible to receive up to $700 million in milestones and royalties for each program that hits the market, giving Tuesday’s deal a maximum potential value of $7 billion. This partnership will bring together expertise from Pfizer and Flagship “to maximize discovery and development potential from inception to impact,” Paul Biondi, executive partner at Flagship and president of Pioneering Medicines, said in a statement. ...
Antimicrobial resistance (AMR) happens when microbes such as bacteria, viruses and fungi change over time and stop responding to medicine. Their failure to respond makes it harder to treat infections, potentially resulting in spread, serious illness or death. In today’s AMR drug discovery sector, pharmaceutical companies find it challenging to profit from new innovative drugs because, rightfully, hospitals reserve these drugs for only advanced cases. As a result, the current approach reduces the financial incentive to make these drugs, contributing to global concern about AMR infections and their impact. Legal guidance on AMR returns On 27 April, the Pasteur Act, which deals with AMR and is sold as a bipartisan legislation to combat superbugs, was reintroduced into the US Senate. A core focus, this time around, is to jumpstart antibiotic development with a new payment model for novel treatments alongside improving how existing antibiotics are prescribed. ...
Biopharma companies, including Sanofi, AbbVie and Virax Biolabs, are finding significant business opportunities in the Middle East, particularly in the United Arab Emirates and Saudi Arabia. These countries have emerged as attractive markets for novel therapies, driven by growing populations with increasing incidences of chronic diseases such as diabetes and cardiovascular diseases. The Middle East is emerging as a key healthcare market, with an increasing demand for innovative healthcare solutions, particularly after the region struggled to meet the challenges brought on by the pandemic, said Cameron Shaw, chief operating officer for Virax Biolabs, which recently made a deal to set up a regional headquarters in the Dubai Science Park in the UAE. “The UAE was hit very hard by the COVID pandemic, similarly to how everyone in the world was affected,” Shaw told BioSpace. This is partly due to the high prevalence of diabetes and obesity in Dubai and Saudi Arabia, he ...
Labcorp, the laboratory service supplier based in the US, has completed the spin-off of Fortrea, to create the newly formed contract research organisation that will give pharmaceutical and biotechnology organisations access to global Phase I-IV clinical trial management, patient access and technology solutions. Fortrea made a cash distribution of around $1.6bn as partial consideration for the assets that Labcorp contributed to Fortrea in connection with the spin-off. Labcorp will use the distribution toward a $1bn accelerated share repurchase program and pay down $300m of debt maturing this year. Whatever is left of the funds will be distributed among shareholders. The spin-off distribution was completed on 30 June 2023 to stockholders of record as of the close of business on 20 June 2023. Labcorp’s stockholders each received one share of Fortrea common stock for every share of Labcorp common stock they held as of the record date. The spin-off will pass ...
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