Drug Discovery and Development Archives - Page 73 of 158

UK regulators approve Valneva’s COVID-19 vaccine

A COVID-19 vaccine from the French vaccine company Valneva SE (Nasdaq:VALN; Euronext Paris:VLA) has become the sixth to win regulatory approval in the United Kingdom.

Valneva also anticipated that it would receive the regulatory nod from the European Medicines Agency (EMA) for its COVID-19 vaccine in April.

Officials at the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK have already approved COVID-19 vaccines from Moderna, AstraZeneca, Janssen and Novavax vaccines. The latter two are, however, not currently in use in the UK.

Valneva vaccine vials

MHRA is the first regulatory agency to approve the Valneva vaccine, an inactivated whole-virus vaccine.

MHRA indicated that the vaccine design may spur a more comprehensive immune response than vaccines solely targeting the SARS-CoV-2 spike protein.

The Valneva vaccine is also stable when stored at standard refrige…

Tackling the DMPK challenges of developing PROTAC drugs

PROTACs, or PROteolysis TArgeting Chimera, emerged as novel therapeutic modalities in 2001 but have only begun emerging from clinical trials (PROTAC® is a registered trademark of Arvinas. In this article, PROTAC specifically refers to the abbreviation of PROteolysis TArgeting Chimera as therapeutic modalities). PROTACs’ unique structures and modes of action (MOA) differentiate them from conventional small molecules and present exciting and unprecedented therapeutic opportunities. But questions remain about PROTACs’ broad-scale utility, given some of the pharmacological challenges scientists have uncovered during preclinical and clinical research.

In the first of a two-part series, we will showcase PROTACs’ unique structure and function, and highlight the challenges and strategies that PROTAC drug sponsors and developers should anticipate from the perspective of DMPK (drug metabolism and pharmacokinetics) studies. The second article in this series wil…

15 of the best pharma companies to work for

The pharmaceutical industry is on the upswing and is poised to have a compound annual growth rate of 13.7% from 2020 to 2027, according to projections from Grand View Research.

R&D-focused pharma and biotech companies tend to offer lucrative salaries and strong job security.

Slated to have a compound annual growth rate (CAGR) of 11.34% from 2021 to 2028, according to projections from Grand View Research, the industry has entered a solid growth phase.

The growing adoption of Pharma 4.0 technologies and artificial intelligence is driving new opportunities for workers.

To understand which pharmaceutical companies in the sector were the best employers, we analyzed data on company review sites Glassdoor, Indeed.com, Comparably and other sources.

Below are the 15 companies that came in on top. (And browse data on all the Pharma 50 companies here.)

1. Sage Therapeutics

Glassdoor rating: 4.5/5 Indeed.com rating: 4.4/5 82% would recommend…

Pfizer-BioNTech COVID-19 vaccine booster spurs strong immune response in kids 5–11

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 and wild-type strain of SARS-CoV-2 compared to two doses. In particular, a sub-analysis of 30 sera from the Phase 2/3 study indicated that a third dose resulted in a 36-fold increase in neutralizing antibody titers for the omicron variant compared to two doses.

The Phase 2/3 clinical trial analysis included data from 140 children aged 5 through 11 years old who received three 10-µg doses of vaccine. In addition, participants received a booster dose approximately six months after a two-dose primary series.

Pfizer and BioNTech intend to seek emergency use authorization (EUA) for a booster dose in the near future and sha…

FDA issues draft guidance for increasing racial and ethnic diversity in clinical trials

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 products develop and submit a “Race and Ethnicity Diversity Plan” to the agency in the early stages of clinical development, based on a framework outlined in the guidance.

Get the full story at our sister site, MassDevice.

Mustang Bio launches clinical study combining CAR T cells and oncolytic virus to treat glioblastoma

The cell and gene therapy company Mustang Bio (Nasdaq:MBIO) will initiate a Phase 1 clinical trial combining CAR T cells and oncolytic virus as a potential therapy for recurrent glioblastoma.

The prognosis for glioblastoma is generally poor with approximately 40% survival in the first year following diagnosis, according to the American Association of Neurological Surgeons.

The Worcester, Massachusetts–based company made the announcement after reviewing interim data from two ongoing investigator-sponsored Phase 1 clinical studies testing MB-108 (C134 oncolytic virus) and MB‐101 (City of Hope’s IL13Rα2‐targeted CAR T cell therapy).

Mustang Bio recently shared data supporting the safety of administering MB-108 and MB-101 sequentially in a regimen designated as MB-109 at the American Association for Cancer Research (AACR) Annual Meeting 2022.

“The data presented at the AACR Annual Meeting support the initiation of a Phase 1 clinical trial to evaluate …

GSK to purchase biopharma Sierra Oncology for $1.9 billion

GlaxoSmithKline plc (LSE/NYSE:GSK) has reached a deal to acquire Sierra Oncology (Nasdaq:SRRA) to bolster its oncology pipeline.

Under the terms of the proposed deal, GSK would pay $44 per share for a total value of approximately $1.9 billion.

GSK shares were mostly flat in mid-day trading, dipping 0.032% to $46.52. SRRA shares surged 38.31% to $54.66.

Sierra Oncology’s differentiated momelotinib, which inhibits JAK1 and JAK2, offers potential for patients with myelofibrosis, a rare bone marrow cancer. Myelofibrosis can lead to scarring in the bone marrow, thus causing severe anemia.

GSK expects to benefit from sales of momelotinib starting in 2023, with growth ramping up after that.

There is a significant unmet need for patients with myelofibrosis. Roughly 40% of patients diagnosed with myelofibrosis are already anemic, with the majority developing anemia eventually.

Momelotinib has been the subject of 22 clinical trials to date. Read more

How federated learning can enable faster, more accurate pharmaceutical-grade AI

Image via www.vpnsrus.com

It’s been said that data is the new oil, something pharma researchers understand well. The phrase hits especially close to home for artificial intelligence (AI) researchers who work heavily with medical images. Medical imaging is a powerful diagnostic tool in the drug development process, as it can provide the efficacy and safety monitoring required in clinical trials for regulatory submission. And notably, medical images provide valuable insights into the drug mechanism of action and effects that can guide researchers during their design process.

Machine learning and AI researchers can leverage this rich medical imaging data to dramatically accelerate the drug discovery process. However, to realize this potential, AI models must be exposed to vast amounts of training data. Acquiring and curating imaging data in the volumes necessary to build accurate, non-biased models is a challen…

AbbVie shares positive investigational navitoclax combination data in Phase 2 Refine trial in patients with rare blood cancer

AbbVie (NYSE:ABBV) has announced new data from a Phase 2 study of navitoclax with ruxolitinib in patients with myelofibrosis, a rare bone marrow cancer.

The data indicate that the combination therapy induces cell death, potentially leading to the reversal of bone marrow fibrosis and improving survival for patients who respond to the therapy.

The study found that 12 out of 32 patients had improvements in bone marrow fibrosis. To date, however, the study did not reach the median overall survival for the overall survival.

The company presented the results at the American Association for Cancer Research annual meeting (AACR 2022, abstract #LB108).

Navitoclax is a small-molecule-based, experimental, novel oral BCL-XL/BCL-2 inhibitor designed to activate programmed cell death (apoptosis) in cancer cells.

Overall, Navitoclax has been the subject of 39 trials to date.

North Chicago, Illinois–based AbbVie presented the results at AACR 2022 fr…

Neuron23 names chief medical officer

The early-stage biotech Neuron23 has appointed Dr. Sam Jackson as its first chief medical officer.

South San Francisco, California–based Neuron23 specializes in developing precision medicines for genetically-defined neurological and immunological diseases.

Jackson is a board-certified emergency physician with fellowship training in medical toxicology.

“I am thrilled to welcome Dr. Jackson to our growing Neuron23 leadership team,” said Nancy Stagliano, CEO of Neuron23, in a statement.

Neuron23 is working to advance NEU-723, a brain-penetrant LRRK2 inhibitor for Parkinson’s disease, into clinical trials.

Previously, Jackson worked as the senior vice president and chief medical officer of Alector (NASDAQ:ALEC), a biopharma developing therapies for neurodegeneration diseases.

Neuron23 was founded in 2018 to focus on neurodegenerative diseases, neuroinflammatory diseases and systemic autoimmune and inflammatory diseases.…

Q-VANT Biosciences signs master agreement with the Kansas State University College of Veterinary Medicine

Quillaja saponin-based adjuvant specialist Q-VANT Biosciences announced that Kansas University College of Veterinary Medicine will test its adjuvants in several of its veterinary vaccines.

The project’s first focus will test Q-VANT’s sustainable saponin-based adjuvants against other adjuvants using K-State’s subunit classic swine fever (CSF) vaccine.

The Kansas University researchers will also validate the safety and efficacy of other Quillaja saponin-based adjuvants from Q-VANT.

[Related: Q-VANT aims to rewrite the narrative for Quillaja saponin-based adjuvants.]

Kansas University is also home to the Biosecurity Research Institute, a comprehensive infectious disease high-security research facility.

The CSF vaccine that will be the initial focus of the research was developed by professor Jishu Shi, a professor within the school’s College of Veterinary Medicine who focuses on developing strategies to protect against s…

Olympus splits scientific solutions from medtech to create Evident subsidiary

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% of revenue in the company’s 2020–21 fiscal year.

Get the full story on our sister site Massdevice.