Drug Discovery

Black Diamond Therapeutics (Nasdaq: BDTX) has announced that it has dosed the first patient in the Phase 1 study focused on BDTX-1535. BDTX-1535 is a MasterKey inhibitor of epidermal growth factor receptor (EGFR) to potentially treat non-small cell lung cancer (NSCLC) and glioblastoma (GBM). Cambridge, Massachusetts–based Black Diamond believes BDTX-1535 holds significant potential for EGFR-mutant…

Sanofi (Nasdaq:SNY) has announced that the New England Journal of Medicine (NEJM) has published positive data from the Phase 1/2 dose-finding study testing the safety, pharmacokinetics and clinical activity of rilzabrutinib for immune thrombocytopenia. Immune thrombocytopenia is associated with bruising and bleeding. Fewer than 200,000 Americans are diagnosed with the condition each year. Rilzabrutinib is…

Pfizer (NYSE:PFE) and BioNTech SE (Nasdaq:BNTX) have shared positive data from a Phase 2/3 clinical study testing a third 10-µg dose of the Pfizer-BioNTech COVID-19 vaccine in healthy children aged 5 through 11. The most recent data show that a booster dose of the BNT162b2 vaccine led to increased neutralizing titers for the omicron variant…

The FDA today issued a new draft guidance outlining plans for increased diversity in clinical trials in the U.S. Expanding upon previous guidances for improving clinical trial diversity, this latest draft guidance — “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Subgroups in Clinical Trials” — recommends that sponsors of medical…

Olympus (TYO: 7733) announced today that it has completed the separation of its Scientific Solutions Division into a wholly-owned subsidiary called Evident. The creation of Evident — which encompasses life science research and industrial equipment — enables Olympus management to better focus on the continued growth of the company’s Medical Business, which made up 86%…

Moderna (Nasdaq:MRNA) announced today that it appointed Jorge Gomez as its new chief financial officer. Gomez resigned as CFO of Dentsply Sirona (Nasdaq:XRAY), effective May 6, to assume the same role at Cambridge, Massachusetts-based Moderna. He will join effective May 9. Dentsply Sirona said in a news release that it is initiating a search process…

The National Institute of Allergy and Infectious Diseases (NIAID) this week announced four new grants to establish tuberculosis research centers in the U.S. The NIAID, which is part of the National Institutes of Health (NIH), issued four new grant awards to establish Tuberculosis Research Advancement Centers (TRAC) to support the development of the next generation…

Pfizer (NYSE:PFE) announced today that it entered into an agreement to acquire biopharmaceutical company ReViral. ReViral discovers, develops and commercializes novel antiviral therapeutics designed to target respiratory syncytial virus (RSV). “At Pfizer, we have a strong heritage in, and commitment to, fighting infectious diseases, most recently evidenced by our delivery of the first authorized vaccine…

Johnson & Johnson’s (NYSE:JNJ) Janssen Pharmaceutical Companies recently announced analysis data on the benefits of Xarelto. The Phase 3 Voyager PAD clinical trial evaluated the Xarelto (rivaroxaban) vascular dose (2.5 mg twice daily plus aspirin 100 mg once daily) in reducing severe vascular events in patients with peripheral artery disease (PAD) after lower-extremity revascularization (LER).…

The biopharma Akebia Therapeutics (Nasdaq:AKBA) has received a dreaded complete response letter from FDA for vadadustat, the experimental oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor proposed as a treatment for anemia associated with chronic kidney disease (CKD). A complete response letter communicates the agency’s rejection of an application in its present form. In the case…

CureVac N.V. (Nasdaq:CVAC) and its partner GSK (NYSE:GSK) have launched a Phase 1 dose-escalation study to test the performance of CV2CoV, a COVID-19 vaccine candidate based on CureVac’s second-generation mRNA backbone. In late morning trading, CureVac’s stock ticked up 0.10% to $19.22. CVAC shares were trading above $100 before announcing in mid-June 2021 that the…

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…

Drug sales in 2021 hit record heights, with a handful of pharmaceutical companies handsomely rewarded for creating COVID-19 vaccines and treatments. Pfizer alone raked in $36.9 billion in sales from the Comirnaty vaccine it developed jointly with BioNTech. Demand for the COVID-19 vaccine helped catapult Pfizer to be 2021’s top pharmaceutical company. Continued demand for…

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…

The clinical-stage biopharma Acelyrin has appointed Bruce C. Cozadd, co-founder and CEO of Jazz Pharmaceuticals (Nasdaq:JAZZ), to its board of directors. Cozadd co-founded Jazz Pharmaceuticals in 2003. Last year, the company brought in $3 billion in revenue. Cozadd continues to serve as the company’s chairperson and CEO. Before taking the helm of Jazz Pharmaceuticals, Cozadd…

Moderna’s mRNA Access program (Nasdaq: MRNA) enables researchers to use its mRNA technology platform for research projects related to emerging and neglected infectious diseases. “It takes a community of scientists and disease experts to develop novel vaccines to tackle our greatest public health threats,” said Hamilton Bennett, Moderna’s senior director, vaccine access and partnerships. “mRNA Access was…

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…

[Check out Part 1 of this feature on what constitutes a true cloud laboratory.] The term “cloud lab” was first coined by Stephen Wolfram and Brian Frezza in 2012 to describe the lab being built by Emerald Therapeutics. The term came into public use in 2014, with the introduction of Emerald Cloud Lab. “Cloud lab”…

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…

Researchers from the NIH’s National Institute of Allergy and Infectious Diseases (NIAID) are conducting a clinical trial on allergic reactions to mRNA-based COVID-19 vaccines. The single-site trial will enroll up to 100 people between 16 and 69 years old who had an allergic reaction to a first dose of COVID-19 mRNA vaccines. NIAID seeks participants…

Midatech Pharma (Nasdaq:MTP) announced today that it extended its R&D collaboration with Johnson & Johnson’s (NYSE:JNJ) Janssen Pharmaceuticals. Cardiff, United Kingdom-based Midatech, a drug delivery technology company focused on the biodelivery and biodistribution of medicines, initially entered into the R&D collaboration with Janssen on July 21, 2020. Get the full story at our sister site, Drug Delivery Business News.