Culmination Bio has secured $10m in investment from the Merck Global Health Innovation Fund (venture capital arm of MSD) and Amgen Ventures to develop an intelligence platform to facilitate diagnostic and therapeutic development. The US-based company has a library of multimodal and longitudinal data along with the accompanying biospecimens, Culmination Bio’s CEO Lincoln Nadauld told Pharmaceutical Technology. The data for Culmination’s library consists of de-identified HIPPA-compliant data from Intermountain Health. This allows the company to “identify specific patient cohorts and proactively or prospective rapidly recruit them”, which can accelerate drug discovery and clinical trial recruitment. Nadauld said that having biospecimens is instrumental in validating diagnostic devices, adding: “An example would be a liquid biopsy company validating their novel technology in the liquid biopsy space, for cancer. They often need fresh samples from patients with defined diseases, and we can deliver not only the biospecimens but the accompanying multimodal data that ...
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 ...
Nicholas Saraceno IQVIA report explores why these shortages are increasing, and how they can be mitigated. Image Credit: Adobe Stock Images/Julia Drug shortages are an issue that continue to grow in news coverage, due to their impact on patient care and public health. Data suggests that the amount of drug shortages in the US is increasing as more shortages continue to be reported than resolved. As a report by IQVIA titled Drug Shortages in the US 2023: A Closer Look at Volume and Price Dynamics1suggests, stakeholders have suggested various tactics to mitigate shortages, including prioritizing essential medicines, stockpiling, and making changes to reimbursement or statutory rebates. Shortages appear to be driven by a variety of causes that need to be better understood, as they may impact which solutions will best address them. This aforementioned report assesses shortages reported by the FDA, alongside sales and volume data of these medicines in ...
By Tristan Manalac Pictured: NASDAQ Stock Exchange headquarters Carmot Therapeutics on Friday filed for an initial public offering (IPO), banking on its pipeline of GLP-1 agonists and the multibillion-dollar potential of the obesity market. Carmot did not disclose how many shares of its common stock will be put up for sale or its projected earnings from the planned offering. The company expects to wrap up its IPO before the year closes, after which it will trade on Nasdaq under the proposed ticker CRMO, according to a Nov. 17 SEC filing. The California-based biotech is advancing a pipeline of “life-changing therapeutics for people living with metabolic diseases,” particularly obesity and diabetes, per the SEC filing. One of its most mature candidates is CT-868, a dual agonist of both the GLP-1 and GIP receptors, both of which play crucial roles in the regulation of insulin secretion, appetite and weight. CT-868 is being ...
By Tristan Manalac Data from an early-stage study showed that Eli Lilly’s investigational RNA silencing therapeutic lepodisiran can induce sharp and durable reductions in serum lipoprotein(a) levels, the company revealed in a read-out presented over the weekend at the 2023 Scientific Sessions of the American Heart Association. These findings come nearly three months after the Indianapolis-based pharma notched another Phase I victory, this time for its oral drug candidate muvalaplin, which strongly decreased lipoprotein(a) levels in healthy participants within 24 hours. Lipoprotein(a), also known as Lp(a), is a form of cholesterol that can cause plaques to form in arteries and block blood flow and is often tied to the risk of developing cardiovascular diseases. The first-in-human trial of lepodisiran enrolled 48 patients who were given ascending doses of the investigational therapy—from 4 mg up to 608 mg—or a placebo. At the highest dose level, lepodisiran was able to elicit a ...
Adzynma is the first approved genetically engineered protein product for the treatment of patients with congenital thrombotic thrombocytopenic purpura. The FDA has approved Takeda’s Adzynma as the first genetically engineered protein medication for the preventative treatment or for on-demand enzyme replacement therapy in patients with congenital thrombotic thrombocytopenic purpura (cTTP). Image credit: olegganko | stock.adobe.com The FDA granted the application for Adzynma with a Rare Pediatric Disease Priority Review Voucher, as well as Priority Review, Fast Track, and Orphan designations. cTTP affects fewer than 1,000 individuals in the United States. “The FDA remains deeply committed in our efforts to help facilitate the development and approval of safe and effective therapies for patients with rare diseases,” said FDA Director of the Center for Biologics Evaluation and Research Peter Marks, MD, PhD, in a press release.1 “Without treatment, cTTP is ultimately fatal. Today’s approval reflects important progress in the development of ...
Novo Nordisk has agreed to acquire ocedurenone, a drug for uncontrolled hypertension, from KBP Biosciences in a deal worth up to $1.3bn. Ocedurenone, an orally administered, small molecule, non-steroidal mineralocorticoid receptor antagonist, is currently being evaluated in the late-stage CLARION-CKD trial as a treatment option for patients with uncontrolled hypertension as well as for those with advanced chronic kidney disease (CKD). Uncontrolled hypertension is when a person’s blood pressure remains high despite taking two or more blood pressure-lowering treatments. An estimated 1.28 billion adults aged 30 to 79 years worldwide have hypertension and only about 21% have it under control, marking a significant unmet need in the treatment of the condition. Martin Holst Lange, executive vice president and head of development at Novo, said: “Hypertension is a leading risk factor for cardiovascular events, heart failure, CKD and premature death. “With its expected benefit-risk profile, ocedurenone has best-in-class potential in treating ...
By Gerard Platenburg Pictured: RNA/iStock, Artur Plawgo Based on the significant progress made over the last few decades with RNA therapeutics, RNA editing is widely considered the next generation of promising medicines in this field. RNA therapies have made significant progress over the last few years, with an increasing number of FDA approvals beginning in 1998 with Vitravene for CMV retinitis, followed by Macugen for macular degeneration in 2004 and Spinraza for spinal muscular atrophy in 2016. There have also been multiple siRNA-based drugs, including Onpattro for polyneuropathy of hereditary transthyretin-mediated amyloidosis in 2018. And finally, in 2020, perhaps the most well-known products in the RNA space were introduced: the mRNA-based COVID-19 vaccines. All of these demonstrate the strength of RNA therapies and their potential impact on diseases with high unmet need. RNA therapeutics are indeed elegant approaches to altering RNA and thus protein expression, opening the potential to target ...
In a recent study published in the journal Nutrients, researchers investigated whether a meticulously crafted meal plan for children in kindergarten aged five to six years could effectively increase their regular intake of vegetables, whole grains, and nuts. The preschool years are a time of rapid growth and development and a vital age for forming lifelong food habits. In pre-primary schools, students receive at least three meals (breakfast, lunch, and snack), which are frequently complemented by an additional snack. The relationships between foods, nutrients, and dietary patterns have significant health consequences, particularly for preventing and developing noncommunicable diseases (NCDs) such as diabetes, cardiovascular disease, and cancer. According to studies, preschoolers do not eat enough nutritional foods such as fruits, vegetables, nuts, and whole grains. About the study In the present cross-sectional study, researchers evaluated the impact of carefully designed kindergarten meals on the regular consumption of healthy foods among kindergarteners. ...
Non-alcoholic fatty liver disease (NAFLD) is a common condition that affects up to 30% of adults in the general population. It is characterized by the accumulation of fat in the liver. It is often associated with other conditions, such as obesity, type 2 diabetes, and metabolic syndrome. The new definition of metabolic dysfunction-associated fatty liver disease (MAFLD) was proposed in 2020. MAFLD is diagnosed based on hepatic steatosis (fatty liver) and at least one of three metabolic risk abnormalities: overweight/obesity, type 2 diabetes, or evidence of metabolic dysregulation. A recent meta-analysis led by Ming-Hua Zheng from the First Affiliated Hospital of Wenzhou Medical University has reported a global prevalence of MAFLD of 38.8% in adults. MAFLD can progress to cirrhosis and promote the development of some critical extrahepatic diseases, such as cardiovascular disease and chronic kidney disease. MAFLD is a severe condition that can lead to cirrhosis and other health ...
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