FDA extends approval of remdesivir to encompass non-hospitalized high-risk

Gilead Sciences’ (NSDQ:GILD) Veklury (remdesivir) became the first FDA-approved COVID-19 drug when it was approved in October 2020.

Now, the company has announced that the FDA has granted expedited approval of a supplemental new drug application (sNDA) for the drug to treat non-hospitalized adult and adolescent patients with a high risk of progression to severe COVID-19, including hospitalization or death.

The drug was formerly approved for hospitalized adults and children in a hospital or healthcare setting capable of offering similar care. Now, it can be administered in some outpatient settings.

FDA also expanded the emergency use authorization of the drug for non-hospitalized children younger than 12 with a high risk of disease progression.

Demand has surged for COVID-19 therapies, including remdesivir that retain efficacy against the omicron variant of SARS-CoV-2.

Gilead first discovered and developed remdesivir in 2009 as a investigati…

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FDA approves second indication of AbbVie’s Skyrizi for adults with active psoriatic arthritis

FDA first approved AbbVie’s (NYSE:ABBV) interleukin-23 inhibitor Skyrizi (risankizumab-rzaa) for moderate to severe plaque psoriasis in 2019. Now, the agency has extended the approval to include adults with active psoriatic arthritis (PsA), which affects almost one out of three people with psoriasis.

To win the new indication, AbbVie provided data from the KEEPsAKE-1 and KEEPsAKE-2 pivotal studies. Those studies tested Skyrizi in adults with active PsA, including refractory patients.

In the placebo-controlled KEEPsAKE trials, Skyrizi met the primary endpoint of ACR20 at week 24. ACR20 is a composite measure from the American College of Rheumatology that refers to 20% improvement across several variables, including swollen, tender and painful joints.

“In the pivotal KEEPsAKE trials, Skyrizi demonstrated improvements across a number of psoriatic arthritis symptoms, including joint pain, enthesitis and dactylitis,” said Dr. Alan J. Kivitz, KEEPsAKE clinical…

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Patient groups voice disapproval for CMS proposal to limit coverage of aducanumab 

Image by Gerd Altmann from Pixabay

Biogen’s (NSDQ:BIIB) Alzheimer’s drug Aduhelm (aducanumab) continues to be a source of contention. Advocates cite the need for a new therapy for the memory-robbing disease while skeptics remain unconvinced about the benefit-risk profile of the drug. 

Most recently, Alzheimer’s disease advocates have criticized Medicare’s proposal to constrain coverage for the drug to clinical trial participants. 

The patient groups the Alzheimer’s Association, UsAgainstAlzheimer’s and the Global Alzheimer’s Platform Foundation have vowed to help overturn that decision by reaching out to the U.S. Health Secretary, lawmakers and officials within the Biden administration. 

The proposal would also apply to similar monoclonal antibodies that target the peptide amyloid-β (Aβ) and the protein tau to target Alzheimer’s.  

The Centers for Medicare & Medicaid Services (CMS) p…

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BD boasts of a landmark advancement in flow cytometry

BD (NYSE:BDX) touted a study on innovation in flow cytometry that featured as the cover story of the journal Science.

Franklin Lakes, New Jersey-based BD’s study was conducted in collaboration with the European Molecular Biology Laboratory (EMBL). It evaluated BD’s flow cytometry efforts that add fluorescence imaging and image-based decision-making to sort individual cells at high speed based on the visual details of each cell and not solely on the type or quantity of the biomarkers that are.

The company said in a news release that the new technology — known as BD CellView image technology — has the potential to transform immunology, cell biology and genomics research while enabling new cell-based therapeutic discovery.

BD says CellView can capture multiple images of individual cells flowing through the system at a speed of 15,000 cells per second. It also adds a previously impossible capability of sorting cells based on detailed microscopic …

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IntelGenx doses first patient in Phase 2a Alzheimer’s study

IntelGenx Corp. (TSX:IGX/OTCQB:IGXT) has dosed the first patient in a resumed Phase 2a clinical trial involving an oral film of montelukast for Alzheimer’s disease (AD). 

The COVID-19 pandemic previously interrupted the study for more than one year. 

In 2019, the company initially announced that the study would enroll roughly 70 individuals with mild-to-moderate AD and test a montelukast buccal film.

The company issued a temporary recruitment hold in the second quarter of 2020 and resumed patient screening in October 2021.

Intelgenx produces oral, oral-topical and transmucosal films as well as transdermal patches. 

Previously covered by U.S. Patent No. 5,565,473 that expired in 2012, montelukast (Singulair) from Merck & Co. first won FDA approval in 1998. 

A 2017 article published in Open Neurology Journal found that the drug appeared to improve memory in a limited number of patients with cognitive impairment. In addition, …

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Element expands life sciences testing business with pharma, biotech capabilities

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 increase its global presence in life sciences and connected technologies.

Get the full story on our sister site, Medical Design & Outsourcing.

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Akoya Biosciences hires new chief people officer

The self-proclaimed “spatial biology company” Akoya Biosciences (NSDQ:AKYA) has appointed Marilee Moy as its chief people officer.

Moy has more than three decades of experience in human resources and has worked for several life science companies, including Questcor, Counsyl, Tails Biomedical, Genentech and Johnson & Johnson.

Akoya, which went public last year, had raised more than $83 million in funding.

The company was founded in 2015 to commercialize technology developed at Stanford University that enables ultra-high multiplexed analysis for biomarker discovery.

Marilee Moy

Akoya specializes in spatial phenotyping, which provides insights into cell-cell interactions within tissue.

The company says its PhenoCycler-Fusion system can map one million cells in 10 minutes.

“As a member of our senior leadership team, I am particularly interested in the development of the com…

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Zymeworks to cut headcount at least 25% by end of 2022

Soon after taking the reins of Zymeworks (NYSE:ZYME), new chair and CEO Kenneth Galbraith has decided to sharpen the company’s focus and reduce the firm’s headcount.

To free up cash, the company plans to lay off at least one-quarter of its staff, including 10 members (50%) of its senior management team.

The Vancouver–headquartered company also intends to focus on executing its clinical development programs for the HER2-targeted bispecific antibody zanidatamab and ZW49, a HER2-targeted antibody-drug conjugate.

Ken Galbraith

In December, Zymeworks and its partner BeiGene (NSDQ:BGNE) announced the dosing of the first patient with zanidatamab in a South Korean study.

In the organizational shift, the company also intends to streamline its R&D activities while hunting for new potential partnerships and collaborations.

“Upon assuming my new role effective January 15th, we have moved …

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Biotech Altos Labs emerges with $3B in funding to focus on ‘cellular rejuvenation programming’

The biotech Altos Labs has exited stealth mode with top-tier talent and $3 billion in funding with a broad mission of promoting homeostasis in cells to reverse disease, injury and disability.

In other words, the company aims to use biotechnology to fight aging and disease, as early media reports have suggested.

In a press release, Altos chief scientist and founder said the company sought to “decipher the pathways of cellular rejuvenation programming to create a completely new approach to medicine, one based on the emerging concepts of cellular health.”

Early investors in the company reportedly include the billionaires Yuri Milner and Jeff Bezos.

Altos Labs’ funding haul will likely free it from resorting to selling intellectual property to established biotech companies.

GSK’s current president of R&D and chief scientific officer, Dr. Hal Barron, will become the company’s CEO on August 1.

​​Barron also worked as the presiden…

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Beckman Coulter Life Sciences wins IVDR for flow cytometry reagents

Image courtesy of Beckman Coulter

Beckman Coulter Life Sciences (Indianapolis) has received an EU Quality Management System Certificate under the In Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR) for more than 200 flow cytometry reagents manufactured at its Marseille, France facility.

In May 2022, IVDR 2017/746 will replace the In Vitro Diagnostics Directive (98/79/EC) (IVDD), which has been in place since 1993.

Beckman Coulter Life Sciences notes that it has prepared for IVDR 2022 for more than four years, enlisting multiple teams in the effort.

“We have worked to ensure our existing CE-IVD portfolio, including reagents, kits, software and instruments remain compliant to meet the new regulation,” said Dr. Mario Koksch, vice president and general manager of the company’s flow cytometry business unit. “As IVDR compliance also requires significant effort from individual laboratories,…

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Valneva shares surge 30% after announcing its vaccine candidate neutralized omicron in neutralizing antibody study

Valneva vaccine vials

Valneva SE (NSDQ:VALN) announced promising preliminary lab results involving recipients of its inactivated VLA2001 COVID-19 vaccine.

In a pseudovirus neutralization assay involving sera from 30 volunteers in the Phase 1/2 trial VLA2001-201, all samples had neutralizing antibodies against the ancestral virus and the delta variant. In addition, 87% (26 samples) had neutralizing antibodies to omicron.

VALN shares jumped 30.41% to $42.74 in mid-afternoon trading.

“We continue to believe that VLA2001 could be an important component of the fight against COVID-19, and Valneva remains fully committed to bringing VLA2001 to people who need it as soon as we can,” said Dr. Juan Carlos Jaramillo, chief medical officer of Valneva, in a statement.

Valneva said it was sending data on an ongoing basis to several regulatory agencies, including the European Medicines Agency (EMA) and…

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3 ways to reduce implicit bias in predictive analytics for better health equity

Image courtesy of Arcadia

The COVID-19 pandemic has brought into sharp focus the racioethnic and socioeconomic disparities inherent in the U.S. healthcare system. These disparities take the form of increased adverse health outcomes and reduced quality of life for affected groups.

For example, a study of cities that reported COVID-19 deaths by race and ethnicity found that 34% of deaths were among non-Hispanic Black people. This group accounts for just 12% of the total U.S. population, according to the U.S. Centers for Disease Control and Prevention (CDC), citing “long-standing systemic health and social inequities” among the reasons for the racial and ethnic disparities in COVID-19 deaths.

This heightened awareness around inequities and disparities in healthcare has also resulted in some much-needed attention to similar bias-related problems in the growing sector of healthcare artificial intelligence …

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