clinical trials

FDA has approved a 2 mg injectable dose of Novo Nordisk’s (NYSE:NVO) Ozempic (semaglutide), a once-weekly glucagon-like peptide-1 (GLP-1) analog. The indication covers improving blood sugar control and reducing the risk of cardiovascular complications in adults with type 2 diabetes when used in conjunction with diet and exercise changes. To win the new indication, the…

Organ-on-a-chip technology, which simulates the function of an organ or an organ system, has steadily evolved over the past decade.  The promise of the technology has evolved as well, said Timothy Petrie, head of strategy and business development, pharmaceutical R&D technologies at Draper (Cambridge, Mass).  In the beginning, it seemed like the central appeal of…

Icosavax (Nasdaq:ICVX) saw its stock skid 65.5% to $4.26 in mid-day trading after announcing interim results from an ongoing Phase 1/2 trial of IVX-411, a virus-like particle vaccine candidate against SARS-CoV-2. After going public last July, the company’s stock hit a peak of $39.73 on September 3. Initial data from IVX-411 was comparable or below…

In 2019, clinically-studied probiotic specialist Seed Health launched a partner company known as LUCA Biologics focused on women’s health. Based on 15 years of academic vaginal microbiome research, LUCA’s pipeline targets urinary tract infections (UTI), bacterial vaginosis and preterm birth. The company’s first drug candidate targets UTIs and will enter a Phase 1b trial this…

PhysIQ announced today that it will collaborate with CellCarta to undertake a study using AI in vaccine development. Enrollment is now complete in the VIII (Vaccine-induced inflammation investigation), which will monitor individual differences in physiologic changes associated with immune system activation in patients receiving vaccinations, including those developed to combat diseases like COVID-19. According to…

The National Institute of Allergy and Infectious Diseases (NIAID) has announced a Phase 1 clinical study of HIV vaccines using mRNA sequences. The study will test the safety and immunogenicity of three investigational HIV mRNA vaccines known as BG505 MD39.3 mRNA, BG505 MD39.3 gp151 mRNA and BG505 MD39.3 gp151 CD4KO mRNA. The three HIV vaccine…

Gepants have gained ground in recent years as a migraine treatment following the FDA’s approval of Allergan’s Ubrelvy (ubrogepant) in 2019. Now, AbbVie (NYSE:ABBV) has announced that a Phase 3 study testing Qulipta (atogepant) met its primary endpoint of reducing mean monthly migraine days over placebo. FDA approved atogepant as a preventive treatment of episodic…

The COVID-19 pandemic has elevated the importance of clinical trial diversity while also asserting remote clinical trials as a valid approach for a growing number of drug studies, as a recent JAMA study concluded. At the same time, the pandemic highlighted the need for continued progress, according to Otis Johnson, chief diversity, inclusion and sustainability officer…

Pfizer (NYSE:PFE) is looking to expand the use of the  antiviral Paxlovid, which FDA has authorized to treat mild-to-moderate COVID-19 in individuals who are at least 12 years of age who weigh at least 40 kg. The authorization covers individuals with a risk of developing severe disease. A recently launched Phase 2/3 study will test…

Tens of millions of Americans have immune-mediated inflammatory diseases (IMIDs), including conditions as diverse as rheumatoid arthritis, psoriasis, multiple sclerosis and inflammatory bowel disease. Because such diseases have an inflammatory component, a single biologic could treat multiple IMIDs. “We are committed to investigating inflammatory pathways to develop therapies that can potentially address the immense unmet…

Lack of diversity in clinical trials has long been an issue, driven by challenges with recruitment and participation. In recent years, pharmaceutical companies have prioritized recruiting more diverse patient groups for their trials. And in some areas, it is working. In the past ten years, the representation of Black and African American patients in U.S.-based…

Automata (London) announced today that it has raised $50 million in Series B funding to support its automation systems for life science research. Octopus Ventures led the round, with participation from returning investors Hummingbird, Latitude Ventures, ABB Technology Ventures and Isomer Capital, and strategic investors such as In-Q-Tel. Company officials plan to use the money…

Agios Pharmaceuticals Inc. (NASDAQ:AGIO) has announced that Pyrukynd (mitapivat) has won FDA approval to treat hemolytic anemia in adults with pyruvate kinase (PK) deficiency. A first-in-class oral PK activator, mitapivat is the first disease-modifying therapy for hemolytic anemia to win FDA approval. FDA based its decision on data from the Phase 3 ACTIVATE and ACTIVATE-T…

A controversial SARS-CoV-2 challenge study involving 36 volunteers found that 47% of individuals did not develop COVID-19. The volunteers were unvaccinated and had no evidence of prior infection with SARS-CoV-2. The study, whose results were recently published in a pre-print, could potentially point to new vaccine targets or inspire future COVID-19 drug research. “This study has…

Pardes Biosciences (NSDQ:PRDS) said its PBI-0451 twice-daily COVID-19 pill candidate had favorable tolerability and good oral bioavailability, based on interim data from an ongoing Phase 1 trial. The company also said the drug candidate lacked clinically significant drug-drug interactions. “We’re very encouraged by the safety profile and bioavailability profile we’re seeing to date,” Brian Kearney,…

PharmaJet announced today that its partner, Technovalia, reported positive interim safety results from a needle-free COVID-19 vaccine trial. Golden, Colorado-based PharmaJet’s needle-free injection systems are being studied with Covigen, a DNA-based vaccine developed by French-Thai pharmaceutical company BioNet-Asia in collaboration with Melbourne, Australia-based Technovalia. Enrollment for the trial began in June 2021. Get the full story at…

The U.S. Senate confirmed Dr. Robert Califf as FDA commissioner in a 50-46 vote today. The vote capped a months-long campaign to secure Califf’s confirmation after President Joe Biden nominated him to return to the post he held near the end of the Obama administration. The Senate voted 49-45 yesterday on a cloture vote to…

Bayer spin-off AiCuris (Wuppertal, Germany) has acquired exclusive rights to develop and commercialize RNA-based therapies for individuals with acute and chronic kidney diseases. AiCuris will acquire the developmental therapies from the startup Hybridize Therapeutics (Leiden, Netherlands), which will get €100 million in upfront and milestone payments in addition to tiered royalties on net sales. Sitting…

Sanofi (NSDQ:SNY) has announced that olipudase alfa offered a sustained improvement in patients with acid sphingomyelinase deficiency (ASMD) in investigational long-term follow-up studies. ASDM is a rare progressive and potentially life-threatening disease with no authorized treatments. Patients in the trial had improvements in terms of lung function and reduced spleen and liver volumes. The research…

Cambridge, Massachusetts–based biotech QurAlis Corp., has appointed Bryan Boggs as head of regulatory affairs. In addition, Christopher Gerry Lohan will join as head of clinical operations, and Guzide Adhikari will take on the role of head of global supply chain management. The company is focused on developing novel treatments for amyotrophic lateral sclerosis (ALS) and…

Demand is heating up for Quillaja saponin-based adjuvants, which owe their existence to the soap bark tree (Quillaja saponaria) found primarily in Chile. In particular, the QS-21 saponin adjuvant is popular. It is found in GSK’s (NYSE:GSK) Shingrix shingles vaccine, GSK’s Mosquirix malaria vaccine and Novavax’s (NSDQ:NVAX) COVID-19 vaccine. QS-21 is uniquely capable of enhancing…

Medable and CVS Health (NYSE:CVS) announced yesterday that they will collaborate to expand clinical trial access and engagement. Under the collaboration, Medable’s software platform will be combined with CVS Health’s community reach and experienced MinuteClinic providers to deliver clinical trials in a manner that improves patient access, engagement and retention. According to a news release,…

A network meta-analysis (NMA), a method for comparing multiple therapies within a single analysis, uses direct and indirect evidence within a network of randomized controlled studies. An NMA is a type of meta-analysis, which itself is a research technique used to statistically analyze the findings of independent studies. An NMA is thus a meta-analysis comparing…

Because of the way they provide protection, nasal vaccines could be the best long-term way to prevent COVID-19 infection, according to experts cited in The New York Times. The Times reported that India-based Bharat Biotech, which has the Covaxin COVID-19 vaccine authorized in India and elsewhere, has an experimental COVID-19 nasal vaccine that may offer…

Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) have begun a rolling submission for the BNT162b2 vaccine for children ages 6 months to 4 years. The FDA requested that Pfizer apply for emergency authorization for that age group, according to media reports. The agency is awaiting data from a third dose of the vaccine in the age group,…