Danielle Kirsh

CardiaCare recently announced it signed a strategic licensing agreement with Dr. Reddy’s Laboratories to further develop CardiaCare’s wearable atrial fibrillation treatment device. Through the agreement, Dr. Reddy’s Laboratories will lead necessary clinical studies for CardiaCare to receive regulatory clearance in India. CardiaCare is developing a non-invasive, personalized neuromodulation wearable for atrial fibrillation treatment. It will…

Sanofi today announced a collaboration with Howard University College of Pharmacy for a two-year post-professional Doctorate in Pharmacy fellowship program. The collaboration is a part of the Cambridge, Massachusetts-based company’s ongoing efforts to address disparities in underrepresented communities. The goal is to hire fellows into permanent full-time positions at Sanofi. The program will begin in…

Pfizer and BioNTech today announced they submitted to the European Medicines Agency (EMA) for an omicron-adapted bivalent COVID-19 vaccine candidate based on the BA.1 sub-lineage. The application follows guidance from the EMA and International Coalition of Medicines Regulatory Authorities (ICMRA) to develop an omicron-adapted bivalent vaccine candidate to address the spread of SARS-CoV-2. Pfizer recently…

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…

Element Materials Technology recently announced that with the completed acquisition of JMI Laboratories in 2021, it has built out its life sciences testing capabilities for the pharmaceutical and biopharmaceutical industries. The acquisition added more than 1,000 experts in 23 facilities in North America and Europe and marked a strategic shift for the London-based company to…

Thermo Fisher Scientific (NYSE:TMO) today posted third-quarter results that beat the overall consensus on Wall Street. The Waltham, Massachusetts–based laboratory supply company reported profits of $1.9 billion, or $4.79 per share, on sales of $9.3 billion for the three months ended October 2, for a bottom-line loss of -1.6% on sales growth of 9.49% compared with…

A former Celgene scientist took the stand on Wednesday in the Elizabeth Holmes federal fraud trial to testify to a partnership the company had with Theranos on certain projects. Victoria Sung testified about speaking to Theranos in 2009 about helping the biopharmaceutical company in a drug trial for a medication in development to treat anemia.…

Moderna today said it has dosed its first patients in the Phase 1/2 study of the mRNA-1010 seasonal flu mRNA vaccine candidate. The Phase 1/2 randomized, stratified, observer-blind, dose-ranging study will evaluate the safety, reactogenicity and immunogenicity of mRNA-1010 seasonal influenza vaccine candidate. The study will enroll healthy adults 18 years and older in the…

By Stewart Eisenhart, Emergo Group As governments, industry and other entities begin COVID-19 vaccine distribution efforts worldwide, cold chain management has emerged as a crucial factor for ensuring vaccine safety and effectiveness. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do…

By Timothy Herr, Emergo Group Participating regulatory bodies in the Medical Device Single Audit Program (MDSAP) published a new consolidated guidance document, MDSAP AU P0002.005 Audit Approach, which combines the former MDSAP Audit Model and Process Companion Document​ into a single source of information detailing the process for auditing the quality management systems of medical […]

For the past 18 years, the Cleveland Clinic has predicted what the top 10 medical disruptors will be for the following year. The list of technologies, cultivated by a panel of physicians and scientists at the clinic, was led by Dr. Will Morris, executive medical director of Cleveland Clinic Innovations, and Dr. Akhil Saklecha, managing…

The Galien Foundation recently announced nominees for most innovative pharmaceutical agents for its 14th Annual Prix Galien USA Awards. The foundation bestows the Prix Galien Award annually to examples of outstanding biomedical, pharmaceutical drugs and medical technology products that are designed to improve the human condition. “As we celebrate 50 years of the Prix Galien…

PerkinElmer recently launched an online, open-access COVID-19 data dashboard for the global scientific community. The dashboards are powered by the company’s data analytics and data visualization solutions to help researchers quickly and easily leverage large amounts of drug compounds and clinical trial data. The COVID-19 dashboards are supported by PerkinsElmer’s Signals Lead Discovery and the…

Mydecine Innovations today announced it entered a definitive share exchange agreement to acquire 100% of NeuroPharm. Mydecine Innovations will acquire all issued and outstanding shares in the capital of NeuroPharm for $6 million, which will be payable in common shares in the capital of the company. NeuroPharm is currently developing evidence-based medicine of psychedelic based…

Sherlock Biosciences and Binx Health recently signed a strategic partnership to develop a point-of-care diagnostic test for COVID-19 that uses CRISPR technology. Through the collaboration, Binx’s IO diagnostic platform will be combined with the Sherlock CRISPR technology to develop a test that is simple to use. The test is designed to provide rapid and accurate…

Bio-Rad Laboratories (NYSE:BIO) this week said it acquired Celsee for an undisclosed amount. Celsee develops instruments and consumables for the isolation, detection and analysis of single cells. The company’s Genesis System allows scientists to isolate, analyze and interpret cellular behavior and collect cell-based information for improved results in single-cell cytometry, single-cell transcriptomics, single-cell multiomics, rare-cell enrichment…

A Phase 1 clinical trial for an investigational COVID-19 vaccine is underway at Kaiser Permanente Washington Health Research Institute in Seattle. The open-label trial plans to enroll 45 healthy adults aged 18 to 55 years over a six week period. The first study participant received the vaccine yesterday. Researchers at Kaiser Permanente Washington Health Research…

Retrogenix and Resonant Therapeutics recently announced a non-exclusive strategic partnership that will help identify the targets of Resonant antibodies that are targeting tumor microenvironment. Resonant uses its IMPaCT tumor microenvironment models and data platform to discover targets and functionally active anti-tumor antibodies to treat more difficult tumors. Through the agreement, Retrogenix will perform targeted screening…

Owlstone Medical last week announced that it has forged a partnership with Thermo Fisher Scientific‘s (NYSE:TMO) to advance non-invasive breath sampling in disease detection. Through the agreement, both companies will integrate the Thermo Scientific Q Exactive GC Hybrid Quadrupole-Orbitrap MassSpectrometer into Owlstone Medical’s Breath Biopsy platform. The collaboration will hopefully qualify the mass analyzer for…

Mesa Labs this week announced it is acquiring Sweden-based Gyros Protein Technologies for a cash consideration of $180 million. The acquisition is expected to add between $37 million to $40 million in revenue during the first 12 months, according to Mesa Laboratories. The company also adjusted its operating income as a percentage of revenues to…