PerkinElmer (NYSE:PKI) announced today that it launched its PKeye workflow monitor for remotely managing and monitoring workflows.
Waltham, Massachusetts–based PerkinElmer’s cloud-based PKeye workflow monitor enables laboratory personnel to remotely handle PerkinElmer instruments and workflows in real-time through 24/7 access and visibility into laboratory operations.
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FDA has informed Bristol Myers Squibb (NSDQ:GILD) that it has extended its review of mavacamten, an allosteric modulator of cardiac myosin.
Bristol Myers Squibb is aiming to win an FDA nod for the drug as a treatment for obstructive symptomatic hypertrophic cardiomyopathy (oHCM), a disease associated with heart muscle thickening.
Mavacamten addresses the molecular defect involved in oHCM.
FDA now expects to decide on whether to approve the drug for oHCM by April 28, 2022.
The agency requested extra time to review Bristol Myers Squibb’s proposed risk evaluation mitigation strategy.
“We are confident in the profile of mavacamten. This first-in-class cardiac myosin inhibitor demonstrated clinically meaningful improvements in symptoms, functional status, and quality of life in symptomatic oHCM patients in the pivotal EXPLORER-HCM trial,” said Dr. Samit Hirawat, executive vice president, chief medical officer, global drug development at Bristol …
CDC’s Advisory Committee on Immunization Practices voted unanimously to allow all fully vaccinated adults to receive a COVID-19 booster at least six months after receiving a primary series.
All 11 members of the panel also voted to recommend boosters for adults 50 and older.
Last week, FDA authorized the mRNA vaccines from Pfizer-BioNTech (NYSE:PFE/NSDQ:BNTX) and Moderna (NSDQ:MRNA) boosters for all adults at least six months after completion of a primary series.
Previously, government authorities had recommended boosters for people 65 and older, those who are moderately to severely immunocompromised, and those at high risk of exposure in occupational or residential settings.
Several states aimed to sidestep the federal government’s booster requirements by allowing all fully adults who received an mRNA-based COVID-19 vaccine to obtain a booster, provided at least six months had elapsed before receiving the second vaccine dose.
Guidance is m…
[Image from Breakthrough]
A life sciences real estate developer announced today that BD (NYSE:BDX) selected its property as a new facility for its biosciences business.Through a joint venture with Tishman Speyer and Bellco Capital, Breakthrough Properties confirmed that BD chose its Torrey View by Breakthrough property for an expanded San Diego reagent innovation center within its biosciences segment.
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The life sciences industry has just scratched the surface in terms of chimeric antigen receptor (CAR) T-cell therapy’s potential, according to a session at the Novartis Breakthrough Science media event held on November 10.
CAR-T therapy, which has emerged as one of the most promising new treatments for multiple myeloma, certain lymphomas and B-cell acute lymphoblastic leukemia, has found growing use in recent years. The treatment, however, is often expensive.
Manufacturing of CAR-Ts continues to improve, however. And in recent years, researchers have made progress in enhancing the fitness of CAR-T cells so that they have more potential for proliferation and “hopefully, overall, better benefit and higher response rates,” said Jennifer Brogdon, executive director, head of cell therapy research, department of exploratory immuno-oncology at the Novartis Institutes for BioMedical Research.
Manufacturing breakthroughs have enabled the therapy to be used …
GlaxoSmithKline (NYSE:GSK) will present 11 abstracts on Blenrep (belantamab mafodotin blmf) at the American Society of Hematology (ASH) Annual Meeting and Exposition on December 11–14. Presentations will include new data from the DREAMM (DRiving Excellence in Approaches to Multiple Myeloma) clinical trial program and two collaborative studies focused on Blenrep.
The drug won FDA approval on August 5, 2020, for adults with relapsed or refractory multiple myeloma who have received at least four prior therapies.
Featured presentations at ASH includes poster #2738, which will describe outcomes of regimen of belantamab mafodotin with the chemotherapies bortezomib and lenalidomide plus the steroid dexamethasone in transplant-ineligible patients with recently diagnosed multiple myeloma.
Another presentation will detail results from the BelaRd trial (poster #2736) from Hellenic Society of Hematology in collaboration with GSK exploring a similar cocktail mentione…
Molecubes’ benchtop Cubes NMI system. [Image from Molecubes/Bruker]
Bruker (NSDQ:BRKR) announced today that it acquired Molecubes, a maker of benchtop preclinical nuclear molecular imaging (NMI) systems.Ghent, Belgium-based Bruker said in a news release that the acquisition, for which financial terms were not disclosed, will strengthen its position as a leading NMI solutions provider in preclinical and translational imaging research.
The acquisitions will combine Bruker’s preclinical imaging products and global footprint with Molecubes’ modular benchtop Cubes systems, aiming to broaden the company’s NMI offering to further accelerate the worldwide adoption of preclinical NMI in academic medical centers and biopharma companies.
Molecubes develops and sells high-end PET, SPECT and CT Cubes systems, having installed more than 70 systems around the globe. Bruker believes the…
One of the first focuses of organ-chip specialist Emulate (Boston) was to reduce the need for animal testing over time. Its technology can simulate tissue-tissue interfaces within organs using human cells.
But the potential of the organ chips to yield mechanistic insights for drug discovery and understanding toxicities has become more evident over time.
The pandemic has underscored that promise, highlighting the potential of Emulate’s technology for drug discovery and vaccine testing.
A spinout of the Wyss Institute for Biologically Inspired Engineering at Harvard University, Emulate’s human airway chip culture was highlighted earlier this year in Nature Biomedical Engineering.
Created with microchip manufacturing techniques and microfluidic culture technology, Emulate’s organ chips contain living human cells that simulate organ-level functions. The organ chips can “recreate tissue-tissue interfaces, which is what defines an organ,” said Dr. D…
FDA has authorized booster shots of the Pfizer-BioNTech (NYSE:PFE/NSDQ:BNTX) and Moderna (NSDQ:MRNA) vaccines for everyone 18 and older.
Assuming CDC backs the decision, tens of millions of American adults who received two doses of the two mRNA COVID-19 vaccines at least six months ago will be eligible for boosters.
“Authorizing the use of a single booster dose of either the Moderna or Pfizer-BioNTech COVID-19 vaccine for individuals 18 years of age and older helps to provide continued protection against COVID-19, including the serious consequences that can occur, such as hospitalization and death,” said Acting FDA Commissioner Dr. Janet Woodcock, in a news release.
CDC is hosting a meeting of external advisors today to make recommendations concerning boosters for all adults.
The Biden administration has hoped federal officials would authorize boosters for months.
Some independent advisors to the FDA and CDC — and some employees of those ag…
Health insurers in the U.S. are seeking more data from Biogen regarding its $56,000-per-year Alzheimer’s treatment Aduhelm (aducanumab) before agreeing to pay for the treatment, according to Bloomberg. None of the 25 large insurers that took part in a Bloomberg News survey found that the drug was “medically necessary.”
Humana Inc. is, however, covering Aduhelm for patients who are similar to those in the drug’s clinical trials.
Having won conditional FDA approval in June, aducanumab has failed to gain traction as a popular therapy.
Biogen developed the drug in collaboration with Eisai Co., Ltd. (Tokyo, Japan).
The drug has received a flurry of negative headlines in recent months.
FDA called for an OIG investigation into its own dealings when reviewing the drug, and two House committees have launched investigations into its approval as well.
This week, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHM…
South San Francisco–based biopharma Fountain Therapeutics has pulled in $15 million in Series A-2 financing, bringing its total Series A funding to $26 million. The company focuses on drug development for chronic degenerative diseases.
Eli Lilly and Company (NYSE:LLY), Alexandria Venture Investments and R42 Group joined as new investors in the funding round. Prior investors Khosla Ventures and Nan Fung Life Sciences also contributed to the Series A-2 financing.
Like many other biopharma startups, Fountain Therapeutics aims to use computer vision, artificial intelligence and machine learning to enhance its drug discovery efforts.
The company’s specific focus is on treating age-related diseases by reversing cellular age.
“We have already identified novel biology around known targets and potential new insights into chronic disease states that may lead to new therapies,” said Dr. William Greene, CEO of Fountain Therapeutics, in a press release. “We lo…
Janssen (NYSE:JNJ) recently presented new data on Tremfya (guselkumab) related to active psoriatic arthritis (PsA) at the American College of Rheumatology (ACR) Convergence while also publishing data in Arthritis & Rheumatology. Notably, guselkumab provided durable joint symptom and disease activity improvement with a consistent safety profile through week 100 in adults with active psoriatic arthritis (PsA).
Guselkumab first won FDA approval in 2017 for treating moderate-to-severe plaque psoriasis. The drug became the first interleukin (IL)-23 inhibitor to win an FDA indication for active PsA in 2020.
“We at Janssen are committed to this IL-23 pathway and understanding how it is driving disease,” said Dr. Alyssa Johnsen, vice president, rheumatology and maternal-fetal immunology disease area leader at Janssen. The pathway is “very important for psoriatic arthritis and psoriasis, and we continue to investigate where it might be able to help patients and add…