Drug Discovery

The U.S. government is planning to establish the Advanced Research Projects Agency for Health (ARPA-H) to accelerate biomedical research. The new federal research agency will not be based alongside its NIH parent in Bethesda, Maryland. After winning authorization to create the agency, Sen. Edward J. Markey (D-Mass.) and several colleagues in Massachusetts are asking the…

Blockchain may be arguably one of the most hyped technologies in recent memory, but the distributed ledger technology better known for its role in cryptocurrency may have significant potential in the pharma supply chain, clinical trials and beyond. A blockchain-based initiative known as PharmaLedger has won support from prominent companies like Pfizer, Novartis, Merck &…

On the heels of announcing a restructuring plan that reduces its workforce by 30%, Black Diamond Therapeutics (Nasdaq:BDTX) has announced that its discovery engine was featured in the peer-reviewed Cancer Research journal. The journal is published by American Association for Cancer Research (AACR). A paper highlighted in the journal explained how the company’s Mutation-Allostery-Pharmacology (MAP) discovery…

The Biden-Harris administration has announced that the NIH has licensed COVID-19 research technologies and vaccine candidates to the Medicines Patent Pool (MPP). Working with the WHO’s COVID-19 Technology Access Pool (C-TAP), the NIH will provide licenses to enable manufacturers to use the technologies to develop COVID-19 vaccines, treatments and diagnostics. In total, NIH is providing…

Seagen (Nasdaq:SGEN) has tapped a law firm to lead an investigation into its CEO Clay Siegall, who was charged with misdemeanor assault against his wife on April 23. Siegall maintains his innocence. A police report related to the incident reported that Siegall’s wife called 911 after he allegedly forced her to the ground. Siegall was…

In 2021, Johnson & Johnson’s (NYSE:JNJ) pharmaceutical segment Janssen reported revenue of more than $50 billion in fiscal 2021 and operational growth of 13.1%. Janssen exec Tom Cavanaugh’s next big goal for Janssen is ensure Janssen is a $60 billion pharmaceutical company by 2025. Heavy reliance on R&D will get them there, said Cavanaugh — Janssen’s…

Decentralized clinical trial specialist Curebase said today that it has secured $40 million in Series B funding. The lead investor in the round was Industry Ventures. Other investors contributing to the round include Acrew Capital, World Innovation Lab, Positive Sum, Gilead Sciences (Nasdaq:GILD) and existing investors GGV Capital, Bold Capital and Xfund. The San Francisco–based…

Pfizer (NYSE:PFE) shares rose today on first-quarter financial results that came in ahead of the consensus forecast. The New York-based pharmaceutical company posted profits of $7.9 billion, or $1.37 per share, on sales of $25.7 billion for the three months ended April 3, 2022, for a 61.2% bottom-line gain on sales growth of 76.8%. Adjusted…

Sage Therapeutics (Nasdaq:SAGE) and Biogen (Nasdaq: BIIB) have begun a rolling submission of a New Drug Application (NDA) to FDA for zuranolone to treat major depressive disorder (MDD). The two companies plan on submitting additional clinical data for the NDA in the second half of the year. Biogen entered into a $1.5 billion licensing agreement…

At the heart of Johnson & Johnson’s (NYSE:JNJ) $6.5 billion acquisition of Momenta Pharmaceuticals in 2020 is a portfolio of drug candidates for immune-mediated diseases. One of the promising compounds in the acquisition is nipocalimab, which Janssen sees as a potential “pipeline in a pathway.” Nipocalimab holds promise for an array of diseases, ranging from…

SK Bioscience (KRX:302440) and GSK (NYSE:GSK) have filed a biologics license application with the Korean Ministry of Food and Drug Safety for their SKYCovione, a recombinant protein-based COVID-19 vaccine candidate. The self-assembled nanoparticle vaccine candidate is adjuvanted with GSK’s pandemic adjuvant. SKYCovione fared well in a Phase 3 study involving more than 4,000 adults in…

The contract research organization (CRO) Syneos Health has promoted Michelle Keefe to be its CEO and a member of its board. Keefe was previously the president, medical affairs and commercial solutions at Morrisville, North Carolina-based Syneos. The company’s departing CEO, Alistair Macdonald, is retiring after working at the company for two decades. Macdonald will serve…

The Swiss Big Pharma Novartis (NYSE:NVS) announced that the anti-PD-1 immune checkpoint inhibitor tislelizumab with chemotherapy improved overall survival in patients with advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) in a Phase 3 study. The RATIONALE 306 trial of tislelizumab and chemotherapy met its primary endpoint at interim analysis. The study pitted the…

While a portion of the public is now eligible to receive a second booster dose of COVID-19 vaccine, the FDA has not yet authorized a vaccine for children aged 6 months to 5 years old. Moderna (Nasdaq:MRNA) is vying to be the first. The company announced today that it is filing a request for emergency…

Precision oncology firm Black Diamond Therapeutics (Nasdaq:BDTX) has announced a restructuring plan to free up cash to prioritize the development of BDTX-1535 and BDTX-4933. The company plans on trimming nearly one-third of its workforce. BDTX shares ticked up about 1% to $2.75 after announcing the news yesterday but fell 4% today to $2.64. According to…

Retinoic acid receptor-related orphan receptor gamma t (RORγt) inhibitors are currently in development for various indications. RORγt plays a crucial role in driving T helper 17 (Th17) differentiation and interleukin 17 (IL-17) expression. In homeostasis, these cells play a vital role in the defense against bacteria and fungi. However, this cell type seems to be…

FDA has announced that it has signed off on the use of COVID-19 therapy Veklury (remdesivir) from Gilead Sciences (Nasdaq:GILD) to include children at least 28 days old who weigh at least 3 kg (roughly 7 lb) and test positive results for COVID-19. The indication is limited to children who are either hospitalized or have…

The lack of appropriate representation in clinical trials, particularly in terms of ethnicity and race, has been a long-standing issue that directly impacts health equity and treatment efficacy. In a 2020 analysis of the global participation in clinical trials, the Food and Drug Administration (FDA) highlighted the vast difference between enrolled participants and the global population.…

Tübingen, Germany–based CureVac N.V. (Nasdaq:CVAC) and its partner GSK (NYSE:GSK) have announced positive preclinical data about their second-generation COVID-19 vaccine candidate that combines mRNAs for the beta and delta variants. The companies conducted the preclinical research in conjunction with the Friedrich-Loeffler-Institut, Germany. The research pitted the bivalent candidate against monovalent COVID-19 vaccine candidates. The bivalent…

In the Phase 3 Provent trial, Evusheld (AZD442) cut the risk of developing symptomatic COVID-19 by 77% in the primary analysis focused on patients at high risk for severe COVID-19. The monoclonal antibody cocktail, including tixagevimab and cilgavimab cut the risk by 83% in the six-month follow-up analysis compared to placebo.  The drug is currently authorized…

The neurotology biopharma Otonomy (Nasdaq:OTIC) has announced that the brain-derived neurotrophic factor agonist OTO-413 resulted in clinically meaningful improvement in a Phase 2a trial focused on subjects with hearing loss. In the randomized, double-blind, placebo-controlled study, subjects received a single intratympanic injection of 0.3 mg of OTO-413. Subjects in the study had 30 evaluable subjects…

It doesn’t get any bigger than Amazon in the world of cloud computing. The Amazon Web Services cloud computing business at Seattle-based Amazon.com (Nasdaq: AMZN) is the largest player in the industry, with control of about a third of the market and a significant lead over cloud competitors Microsoft and Google. Dr. Taha Kass-Hout, the…

Takeda (NYSE:TAK) has announced that it has won manufacturing and marketing approval from the Japan Ministry of Health, Labour and Welfare (MHLW) for Nuvaxovid, a novel COVID-19 vaccine. Nuvaxovid (NVX-CoV2373) was initially developed by Novavax (Nasdaq:NVAX). The approval covers the use of the vaccine as both a primary and booster immunization in adults at least…

Introduction The study of genetics dates to the mid-19th century, from the works of Gregor Mendel, but it wasn’t until the completion of the Human Genome Project and other significant technological advances in the second half of the 20th century that great strides were made in the field of genetics. In light of these advances,…

Moderna (Nasdaq:MRNA) announced that its first bivalent booster vaccine candidate, mRNA-1273.211, offered superior protection against SARS-CoV-2 variants of concern compared with its first-gen mRNA-1273 vaccine. A 50-µg booster of the mRNA-1273.211 vaccine offered protection against the beta, delta and omicron variants for six months and appeared to provide similar tolerability to the FDA-approved mRNA-1273 vaccine.…