Data sourced from Our World in Data Cardiovascular disease and cancer remain the leading causes of death in the world, based on an analysis of data sources ranging from World Health Organization and Our World in Data. While respiratory illnesses were the third most common cause of death in 2019, deaths in this category…

Much of the world is grappling with a mental health crisis — with soaring rates of depression and anxiety. Last year, the startup Gate Neurosciences emerged with a novel approach. While the Carmel, Indiana–based company is focused on synaptic plasticity like many other contemporary CNS companies, it diverges in its strategy. Rather than using a…

Top pharmaceutical companies sponsor over a hundred clinical trials annually, generating vast amounts of data. Harnessing this deluge is a monumental task. eClinical Solutions, led by CEO Raj Indupuri, tackles this through advanced applications of data analytics and machine learning with a strong emphasis on AI in clinical trials optimization. Specifically, eClinical Solutions taps AI/ML…

Johns Hopkins researchers have made strides in a study focusing on multiple sclerosis. By applying microparticles to activate regulatory T cells, they were able to reverse MS-like symptoms in mice. There is no cure for multiple sclerosis (MS). But a recent study by Johns Hopkins Medicine shows encouraging progress towards: They have demonstrated the ability…

Drug development involves many rounds of regulatory approval and oversight, including multiple stages of regulatory submissions. In the U.S., these include the Investigational New Drug Application (IND) before clinical trials in humans, the New Drug Application (NDA) or Biologics License Application (BLA), prior to commercial sale and Annual Product Quality Reviews (APQR) to monitor ongoing…

In a recent conversation with Dr. Andy Beck, co-founder and CEO of PathAI, we had the opportunity to discuss PathExplore, an AI-driven platform that aims to transform the way tumor microenvironment (TME) analysis is conducted. Traditional methods such as manual pathology, multiplex immunofluorescence and single-cell omics often face limitations, including high costs or tissue consumption.…

During Nvidia’s (Nasdaq:NVDA) GTC event, the company introduced BioNeMo Cloud, a new component to their AI Foundations suite. This service, designed to streamline life sciences research, drug discovery and protein engineering, provides researchers with access to pretrained AI models, allowing for customization with proprietary data. Offered as a cloud service, BioNeMo Cloud enables accelerated drug…

Lucy Scientific Discovery Inc. (Nasdaq:LSDI), a Canadian firm that focuses on developing and manufacturing psychotropics-based medicines, had its initial public offering (IPO) today. The company had priced 1,875,000 common shares at a public offering price of $4.00 per share. On its first day of trading, however, the stock dropped by 25.25%, reaching a closing price…

South San Francisco–based Neuron23 has started the first-in-human Phase 1 trial of NEU-723 for the treatment of Parkinson’s disease. NEU-723 is a highly potent and selective leucine-rich repeat kinase 2 (LRRK2) inhibitor. This clinical trial will evaluate the safety, tolerability and pharmacokinetics of NEU-723 in healthy volunteers. A targeted approach The company has also collaborated…

In 2021, two scientists founded Parallel Bio to harness the human body’s ability to fight disease using the immune system. The Cambridge, Massachusetts–based company is developing a platform for drug discovery and development that replicates human immune systems at population scale. The company has grand ambitions. “Nearly 95% of drugs that make it to human trials fail…

At the American College of Rheumatology (ACR) meeting, Janssen Immunology presented a Tremfya (guselkumab) posthoc analysis demonstrating stringent disease activity control at two years in patients with psoriatic arthritis. In addition, the analysis of Phase 3 DISCOVER-2 data indicated that patients with active psoriatic arthritis with a response at week eight to the IL-23 inhibitor…

Pfizer (NYSE:PFE) and BioNTech (Nasdaq:BNTX) have announced that their omicron BA.4/BA.5-adapted bivalent booster fared well against novel omicron variants in neutralizing antibody detection tests. The company published the results from the bivalent booster tests against the BA.4.6, BA.2.75.2, BQ.1.1 and XBB.1 subvariants on the preprint server BioRxiv. One month after administering a fourth vaccine dose, the…

As part of its ongoing restructuring efforts, Novartis AG (NYSE:NVS) is reportedly considering selling its ophthalmology and respiratory businesses, according to Bloomberg. Private equity firms are reportedly sizing up the business units. According to the company’s website, its core therapeutic areas are cardiovascular, hematology, solid tumors, immunology and neuroscience. Novartis’s ophthalmology division focuses on various therapies…

Among psychedelic companies, Compass Pathways plc (Nasdaq: CMPS) is noteworthy for having received Breakthrough Therapy designation from FDA for psilocybin in treatment-resistant depression in 2018. Now, Compass has completed the design of a Phase 3 pivotal study to test its COMP360 psilocybin therapy in treatment-resistant depression (TRD). The Phase 3 study will be the first Phase 3…

Pfizer (NYSE:PFE) and BioNTech (Nasdaq:BNTX) have filed paperwork with the FDA requesting Emergency Use Authorization (EUA) for an updated COVID-19 vaccine booster. Specifically, the request relates to an omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine. In late June, FDA recommended including an omicron BA.4/5 component for COVID-19 vaccine boosters. Last week, the UK approved Moderna’s bivalent COVID-19 vaccine…

“Fail fast” is a philosophy many use in every industry worldwide. It’s the notion of freely experimenting and learning throughout the process to make necessary changes to reach the desired outcome. Failing along the way, businesses learn more and make changes that will improve the final product. While some industries, such as information technology, decide…

The concept of “locality” differentiates a business or company and conveys its value. Phrases like “shop local,” “locally sourced” or “local place” demonstrate the importance of something that doesn’t require significant time, travel or expense, offers convenience and is trustworthy. Locality breeds familiarity and comfort, particularly in healthcare, where it can heavily influence decisions. Patients…

Amylyx Pharmaceuticals (Nasdaq:AML) has received Health Canada approval for Albrioza (AMX0035). The FDA is anticipated to decide on Albrioza, which consists of sodium phenylbutyrate and ursodoxicoltaurine, by September 29, 2022. Amylyx is the first new therapy for ALS to win approval in Canada since 2018. The approval also is the first global regulatory approval for…

Novavax (Nasdaq:NVAX) has won unanimous backing from the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) for its NVX-CoV2373 COVID-19 vaccine. Voting 21 to 0 with one abstention, the VRBPAC recommended that FDA grant emergency use authorization (EUA) to the vaccine for adults 18 and older. The Novavax would be the fourth vaccine to…

Postpartum depression is one of the most common psychological conditions after childbirth, affecting roughly one in eight new mothers. “Postpartum depression is one of the most common — often underdiagnosed complications of childbirth,” said Dr. Samantha E. Meltzer-Brody, director of the University of North Carolina Center for Women’s Mood Disorders. The pandemic has likely only…

Vertex Pharmaceuticals Inc. (Nasdaq: VRTX) has won marketing authorization for the expanded use of Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) in children with cystic fibrosis who are between the ages of 6 and 11 years old. The latest approval covers children with at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. The…

Pfizer (NYSE:PFE) and BioNTech (Nasdaq:BNTX) recently asked FDA to allow individuals 65 and older to receive a second booster of their BNT162b2 COVID-19 vaccine. Now, Moderna (Nasdaq:MRNA) is filing for FDA authorization to permit a fourth dose of its Spikevax (mRNA-1273) COVID-19 vaccine for adults 18 and older. In its submission, Moderna included data gathered…

Novartis (NYSE:NVS) has inked a deal with the biopharma Carisma Therapeutics focused on the production of human epidermal growth factor receptor 2 (HER2)-targeted chimeric antigen receptor macrophages (CAR-M) to potentially treat solid tumors. Carisma is headquartered in Philadelphia. As part of the deal, Carisma will shift manufacturing to a Novartis cell therapy site in Morris…

GlaxoSmith Kline (NYSE:GSK) and Sanofi (NYSE:SNY) recently announced their intent to seek regulatory authorization for an adjuvanted recombinant protein-based COVID-19 vaccine. Now, GSK and its partner Medicago have received approval from Health Canada for another COVID-19 vaccine, which combines the former’s adjuvant technology with the latter’s plant-derived vaccine.  Known as Covifenz, the vaccine makes use of plant-based virus-like…

Having recently sold an equity stake in Samsung Bioepis for up to $2.3 billion, Biogen (NSDQ:BIIB) has announced a licensing deal with Xbrane Biopharma (STO:XBRANE), a Swedish biosimilar developer. The agreement relates to the development of Xcimzane, a preclinical monoclonal antibody referencing Cimzia (certolizumab pegol) from UCB. Having first won FDA approval in 2018 for moderate to…