AstraZeneca has announced positive results from the T2NOW Phase III trial for paediatric patients treated with forxiga (dapagliflozin) for the treatment of type 2 diabetes (T2D). Forxiga is an oral sodium-glucose co-transporter-2 (SGLT2) inhibitor that lowers blood glucose levels. The drug is approved in 122 countries to improve glycaemic control in T2D patients in conjunction with diet and exercise. In the EU, paediatric patients above the age of 10 can be administered the drug after positive results from the T2GO study. Forxiga has not yet been approved for paediatric patients in the US. The T2NOW trial results showed a significant reduction in A1C, an average blood sugar marker in patients taking forxiga and metformin, insulin, or both, compared with patients receiving the placebo. Safety results in 10–17-year-olds are consistent with adult patients who take the drug. Forxiga is not the only SGLT2 inhibitor on the market. Invokana (canagliflozin) by J&J ...
The co-founder of a fluorescence-guided imaging technology firm has been awarded part of the Nobel Prize in Chemistry in acknowledgement of his research into quantum dots. The Nobel Prize Committee said that Moungi Bawendi revolutionised the chemical production of quantum dots, resulting in almost perfect particles. Quantum dots are nanoparticles so tiny that their size determines their properties. They have frequently been employed in the use of medical imaging devices such as those provided by the company Bawendi co-founded, Lumicell. The Nobel Prize Committee said: “Quantum dots now illuminate computer monitors and television screens based on QLED technology. They also add nuance to the light of some LED lamps, and biochemists and doctors use them to map biological tissue.” The Royal Swedish Academy of Sciences additionally awarded the prize to two other researchers, Louis E. Brus and Alexei I. Ekimov. Both of whom were pivotal in the development of quantum ...
Agomab Therapeutics has received the US Food and Drug Administration (FDA)’s fast track designation for AGMB-129 to treat fibrostenosing Crohn’s disease (FSCD). Designed to inhibit ALK5 in the gastrointestinal (GI) tract, AGMB-129 is an oral, small molecule GI-restricted ALK5 (TGF-βRI) inhibitor currently in clinical development. The single and multiple-dose AGMB-129 was well-tolerated at all doses in a Phase I study in healthy participants. The company has also announced the commencement of the STENOVA Phase IIa clinical study to assess AGMB-129 for patients with symptomatic FSCD. This global, placebo-controlled, multi-centre, double-blind study will assess 36 patients with symptomatic FSCD at investigational sites in Europe, Canada and the US. Subjects will be randomised to receive one of two doses of AGMB-129 or a placebo for a period of 12 weeks. Tolerability and safety of AGMB-129 in FSCD patients are the primary endpoints of the trial. The pharmacokinetics and target engagement at the ...
As artificial intelligence (AI) hovers between a “buzz phrase” and marveled reality, many point to the potential the technology has in the pharma industry. While some criticize the rate at which pharma uptakes new technologies and implements them into their processes, the industry must also strike a fine balance with moving cautiously when it comes to changes due to the nature of the industry and the potential impact on patients those changes can bring. But it can’t be denied that there is a plethora of data in every part of the process of drug creation and distribution that needs to be more efficiently managed and utilized—from preclinical and R&D to manufacturing to commercialization and distribution. But perhaps one of the greatest appeals of AI is the potential it has for innovation. Andrew Hopkins, founder and CEO of Exscientia, an AI-driven precision medicine company founded in 2012, shares in this Q&A ...
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 ...
Exec joins the organization with decades of biopharma experience. Image Credit: Adobe Stock Images/Mongkol Syneos Health, a biopharma clinical and commercial solutions organization has appointed Colin Shannon as CEO, effective immediately. He succeeds Michelle Keefe, who will continue her tenure with Syneos Health as a member of the executive leadership team. Shannon and Keefe will remain on the board of directors. Shannon brings decades of leadership experience driving growth at global biopharmaceutical solutions organizations. During his 14 years at PRA Health Sciences, he served in executive roles, most recently as chairman and CEO. During his tenure, he led the company through a successful IPO and subsequent sale to ICON plc., where he also served on its board of directors. “It is an honor to be tasked with leading Syneos Health at such an exciting time in its evolution,” comments Shannon. “I look forward to working with Michelle and the rest ...
A brand-new kind of drug, tested in mice, shows promising new results that could lead to the development of a new weight-loss drug that mimics exercise. The new compound, developed and tested by a University of Florida professor of pharmacy and his colleagues, leads obese mice to lose weight by convincing the body’s muscles that they are exercising more than they really are, boosting the animals’ metabolism. It also increases endurance, helping mice run nearly 50% further than they could before. All without the mice lifting a paw. The drug belongs to a class known as “exercise mimetics,” which provide some of the benefits of exercise without increasing physical activity. The new treatment is in the early stages of development but could one day be tested in people to treat diseases like obesity, diabetes, and age-related muscle loss. The research comes as drugs like Ozempic have provided a breakthrough in ...
Eisai and BioArctic have received approval for the Alzheimer’s disease drug Leqembi (lecanemab-irmb) in Japan, making it the second country to gain access to the treatment. Leqembi is a monoclonal antibody that targets and reduces insoluble amyloid-beta (Aβ) forms in the brain. It is the first and only approved treatment that has demonstrated a reduction in the rate of disease progression in patients with Alzheimer’s. The Japanese approval unlocked a milestone-based payment of EUR 17m ($18m) to BioArctic. The approval is based on Phase III data from the Clarity AD trial (NCT03887455) led by Eisai that showed that treatment with Leqembi reduced clinical decline in patients by 27% at 18 months compared to the placebo. The prescribing information for Leqembi includes a warning for amyloid-related imaging abnormalities (ARIAs), a concern for Alzheimer’s patients taking certain medication. Last week, BrainScope announced an investment from the Alzheimer’s Drug Discovery Foundation (ADDF) to ...
The Novo Nordisk Foundation has announced that it has committed up to €127m in funding to develop and manufacture a new cell therapy facility, Cellerator, in Denmark, to help fight chronic diseases. The new Novo Nordisk Foundation, Cellerator, will be used for the final development steps of animal research and upscaling new cell therapies for testing in humans. This will help to accelerate treatments for people with diseases including chronic heart failure, Parkinson’s disease, kidney disease, type 1 diabetes and several forms of cancer. Cell therapies work by transplanting living cells into patients to treat diseases. It’s estimated that one in three adults suffers from multiple chronic conditions. In the US alone, it’s been calculated that out of 58 million deaths in 2005, chronic disease was responsible for 35 million. The funding follows a report prepared for the European Federation of Pharmaceutical Industries and Associations, which came to the conclusion ...
In the aftermath of a devastating summer tornado at Pfizer’s Rocky Mount injectables plant in North Carolina, manufacturing has largely resumed. Still, the company expects supply shortfalls for some drugs produced at the plant to stretch into next year.The “majority” of the Rocky Mount facility’s manufacturing lines have restarted, Pfizer said in a Monday release. What’s more, Pfizer has launched an additional line in the site’s new sterile injectable manufacturing area, dubbed R3, the company added. The “expedited restart” comes ahead of Pfizer’s previously stated timeline. Late last month, Pfizer said it intended to restart manufacturing at the plant the fourth quarter of 2023. Pfizer is restarting production in phases, with full production across the site’s three manufacturing suites expected to come back online by the end of the year. The company has planned its production restarts based on patient need and inventory levels. There are roughly a dozen medicines ...
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