Drug Discovery and Development Archives - Page 74 of 158

Takeda’s Takhzyro hit primary endpoints in pediatric hereditary angioedema trial

The plasma kallikrein inhibitor Takhzyro (lanadelumab) from Takeda (TSE:4502/NYSE:TAK) met its objectives in a Phase 3 study focused on hereditary angioedema (HAE) in children aged 2 to 12 in an open-label Phase 3 study.

In the SHP643-301 multicenter, open-label study, Takhzyro also had a safety profile similar to that observed in clinical trials focused on patients 12 years old and older.

HAE involves recurring episodes of severe (angioedema) in various body parts, including the abdomen, limbs, face, intestinal tract, genitals, hands and throat.

HAE attacks involving the airways can be potentially life-threatening.

Takhzyro recently won approval in Japan as a prophylaxis against acute attacks of HAE.

“We are encouraged by these results, as each objective met instills further confidence in the potential to bring a treatment option to this vulnerable population,” said Ashley Yegin, global medical unit head, HAE, global medical affairs at Tak…

Psilocybin lit up the brains of people with severe depression in small study

Psilocybin image courtesy of Wikimedia Commons

A British study enrolling 43 people with severe depression found that the magic mushroom compound psilocybin bested the antidepressant Lexapro (escitalopram).

The blinded study published in Nature tracked patients’ symptoms and used functional magnetic resonance imaging (fMRI) to measure the brain’s metabolic function.

Those who received psilocybin weeks showed significant and sustained reductions in depressive symptoms, while fMRI scans showed prominent neural activity throughout the brain that lasted three weeks. In addition, the brain activity of psilocybin recipients was similar to that of a healthy brain.

Conversely, those who received Lexapro had a slight improvement in symptoms and neural activity that continued to be limited to defined brain regions.

Last year, a small Phase 2 study published in NEJM found that psilocybin…

Lilly’s lebrikizumab with topical corticosteroids improved atopic dermatitis in the study

Eli Lilly (NYSE:LLY) has announced promising results from a Phase 3 study of patients with moderate-to-severe atopic dermatitis (AD).

At 16 weeks, 70% of patients with moderate-to-severe atopic dermatitis (AD) taking both lebrikizumab and standard-of-care topical corticosteroids (TCS) achieved at least 75% improvement in overall disease severity (EASI-75*) in the ADhere trial.

The company made the announcement at the fourth annual Revolutionizing Atopic Dermatitis (RAD) Conference.

The combination of lebrikizumab, an experimental investigational interleukin (IL)-13 inhibitor, and topical corticosteroids also resulted in itch symptoms, sleep and quality of life compared with placebo and topical steroids.

“Today’s ADhere data, together with results from the ADvocate monotherapy studies, demonstrate the potential for lebrikizumab to reduce disease burden and provide relief for people with uncontrolled atopic dermatitis when used either al…

Bio-Rad debuts anti-cemiplimab antibodies

Bio-Rad Laboratories, Inc. (NYSE:BIO) has launched a line of antibodies specific to cemiplimab (Libtayo).

The antibodies inhibit the binding of the drug to its target, human programmed death receptor-1 (PD-1).

Hercules, California–based Bio-Rad Lab, said the ready-made antibodies could be used to develop selective and sensitive assays for bioanalysis and drug monitoring of cemiplimab.

Cemiplimab, developed by Regeneron and Sanofi-Aventis U.S., acts as a checkpoint inhibitor by binding to PD-1 on T cells.

It blocks the interaction with its ligands, PD-L1 and PD-L2, to activate T cells to attack cancer cells.

Bio-Rad reports that the anti-cemiplimab antibodies with varying degrees of affinity provide flexibility for bioanalytical ligand binding assays.

“These critical antibody reagents support researchers developing bioanalytical assays for checkpoint inhibitor drugs by providing sequence-defined, well-characterized reagents with stabl…

Veru’s COVID-19 drug candidate cuts deaths by 55% in hospitalized patients in study

The oncology biopharma Veru Inc. (Nasdaq:VERU) revealed positive efficacy and safety data from an interim analysis of a Phase 3 trial testing oral sabizabulin 9 mg against placebo.

The trial enrolled 210 hospitalized COVID-19 patients with an elevated risk of acute respiratory distress syndrome (ARDS). The interim analysis focused on data collected from 150 of those patients.

The primary endpoint of the study was death at or before day 60.

The independent data safety monitoring committee overseeing the trial unanimously concluded that the study should be stopped early, given the apparent efficacy and the lack of identifiable safety concerns.

In the study, patients were randomized in a 2:1 ratio to the sabizabulin treatment group versus placebo.

The mortality rate of the placebo group was 45%, while the rate was 20% for the treatment group.

Both treatment arms were also permitted to receive standard of care treatments, including remde…

Bruker unveils tissue imaging tools for multiplexed spatial proteomics and multiomic imaging

Bruker Corp. (Nasdaq:BRKR) has debuted new technologies for spatial multiomics, single-cell proteomics and cell-line, tissue and plasma proteomics cancer research.

The company announced the new offerings at the American Association for Cancer Research (AACR) Annual Meeting 2022.

Bruker is also building on its strategic investment in AmberGen Inc., a Boston-based life science technology focused on photonic technology. In particular, the companies are exploring new applications of the Ambergen Miralys peptide-code antibody kits used with the Bruker timsTOF flex novel MALDI HiPLEX-IHC workflow for targeted protein expression profiling in tissue.

According to the companies, using the two technologies in tandem can yield highly multiplexed images of target proteins in a wide field of view.

“Spatial protein expression mapping can elucidate processes in immuno-oncology and in TME and metastasis research,” said Dr. Michael L. Easterling, Bruker Director o…

Dentsply CFO Jorge Gomez leaves to assume same role at Moderna

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 to identify its next CFO.

“We thank Jorge for his many contributions since joining Dentsply Sirona in 2019, including strengthening the Finance and IT organizations and enhancing our ESG initiative,” Dentsply Sirona CEO Don Casey said in the release.

Gomez, who served as EVP and CFO at Dentsply since August 2019, spent 13 years at Cardinal Health with his most recent role there also being CFO.

“I am pleased to welcome Jorge to Moderna as our Chief Financial Officer and as a member of the Executive Committee,” Moderna CEO Stéphane Bancel said in a release. “As we grow and scale …

BioNTech and Matinas BioPharma forge mRNA-based research alliance

BioNTech SE (Nasdaq:BNTX) will partner with Matinas BioPharma (NYSE AMER:MTNB) to develop mRNA formats that use Matinas’ proprietary lipid nanocrystal (LNC) platform technology that could enable oral delivery.

The two companies will partner on formulation, optimization and in vitro testing.

BioNTech CEO Dr. Ugur Sahin said that the partnership could lead to the development of mRNA-based vaccines that facilitate intracellular delivery and the potential for oral delivery.

“This collaboration with BioNTech is an important validation from a leading global biotech company with demonstrated expertise in the design, formulation and delivery of mRNA,” said Matinas CEO Jerome D. Jabbour.

BioNTech will pay Matinas an upfront exclusive access fee and provide additional research funding.

NIH announces funding for new tuberculosis research centers

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 of researchers. The centers will provide focused mentoring and funding support for new investigators, opportunities for multidisciplinary and collaborative research and training in laboratory and clinical settings.

Total funding in the first year of the five-year grants is approximately $4.3 million, according to the NIH.

Awards were made to four research institutions, including: Texas Biomedical Research Institute in San Antonio, Texas; Johns Hopkins University in Baltimore; Emory University in Atlanta and the University of Washington School of Medicine in Seattle.

Pfizer to Acquire ReViral and Its Respiratory Syncytial Virus Therapeutic Candidates

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 and oral therapy to combat COVID-19,” Pfizer Chairperson and CEO Albert Bourla said in a news release. “We’re continuing to grow our pipeline – through our own research-and-development efforts, such as our investigational RSV vaccine programs, as well as strategic investments in companies like ReViral – with a focus on end-to-end capabilities to help protect patients from severe illness, hospitalization, and death.”

ReViral’s portfolio includes the sisunatovir oral inhibitor for blocking the fusion of the RSV virus to the host cell. Sisunatovir has …

Janssen reports positive clinical trial data for its Xarelto to treat PAD effects

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).

Data from two analyses reinforced the benefit of Xarelto by demonstrating positive effects delivered by the vascular dose in PAD patients with and without chronic kidney disease (CKD) and in PAD patients with and without a history of statin therapy. Xarelto significantly reduced hospitalizations due to thrombotic events in patients who underwent LER compared to patients who took aspirin alone, Janssen said in a news release.

Voyager PAD, a study of 6,564 patients across 542 sites in 34 countries, randomized patients at a 1:1 ratio for receiving the Xarelt…

Johnson & Johnson faces another ballot battle on racial justice audit

Johnson & Johnson is fighting another shareholder proposal for an independent racial justice audit of the company.

New Brunswick, New Jersey–based J&J (NYSE:JNJ) defeated a similar measure at last year’s annual meeting of shareholders, though the vote was far from a landslide. The company also unsuccessfully petitioned the U.S. Securities and Exchange Commission to keep it off the ballot.

Now, an independent audit is again up for consideration at the April 28 annual meeting after surviving another J&J appeal to the SEC.

Proponents of the audit cite ongoing controversies over talcum powder allegedly marketed to minorities. They also point to the J&J Political Action Committee’s financial support of Republican members of Congress who voted to overturn President Joe Biden’s election after insurrectionists stormed the U.S. Capitol.

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