XTalks

JANUARY 21, 2025

The approval makes Datroway AstraZenecas eighth new medicine since 2020, the first US approval for Daiichi Sankyo and AstraZenecas TROP2-directed ADC and the second based on their proprietary DXd technology. The approval was based on the TROPION-Breast01 trial, which enrolled 732 patients with advanced disease. months for chemotherapy.

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Antibody FDA Approval HR Trials 105

Pharmaceutical Technology

APRIL 13, 2023

Clinical-stage biopharmaceutical firm Alentis Therapeutics has raised $105m in a Series C financing round for advancing transformational medicines targeting the CLAUDIN-1 protein. The latest financing round comes after the company received $67m in Series B funding in June 2021.

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pharmaphorum

SEPTEMBER 14, 2020

Here he gives us a deeper look at how genomic medicine is evolving and the barriers that are preventing it from reaching its full potential. At that time, we thought this would be the holy grail for medicine. Now, however, the field is changing with respect to genomic medicine.

Genome 119

Genome Genomics Medicine Gene 119

Pharmaceutical Technology

AUGUST 17, 2022

The Phase III trial announcement comes at a notable time, as the number of Lyme disease cases is growing over the long term in several countries, including the UK and the US. However, advances in research allowed for the identification of outer surface protein A (OspA) of the bacteria as a target for vaccines. of Valneva.

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Vaccine Vaccination Bacteria Protein 299

XTalks

DECEMBER 12, 2023

Plasma medicine is a critical and specialized field within healthcare, centering on the use of human plasma for the development and administration of life-saving treatments. Human plasma, the clear, liquid portion of blood, is composed of water, electrolytes, nutrients and crucial proteins such as antibodies, clotting factors and albumin.

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Medicine Recombinant Antibody Protein Antibody 111

Pharmaceutical Technology

OCTOBER 18, 2022

Last week, Nature magazine published a paper detailing an in-situ study of Parkinson’s disease (PD), showing protein structural changes in cerebrospinal fluid (CSF) between healthy individuals and Parkinson’s patients. Genetic biomarkers are being investigated to aid in the development of precision medicine for PD.

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Protein Genetics Gene Clinical Research 264

Pharmaceutical Technology

JUNE 29, 2022

The next wave of medicine is well on course to be cell and gene-based. In September 2021, GlobalData figures revealed there to be 1,320 industry-sponsored regenerative medicine and advanced therapy trials ongoing worldwide. Meanwhile, the pharma industry is undergoing somewhat of a transformation itself.

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pharmaphorum

SEPTEMBER 14, 2020

AstraZeneca has resumed UK trials for its coronavirus vaccine, after the country’s medicines regulator gave the all-clear following a safety scare. A UK safety committee has concluded its investigations and recommended to the country’s Medicines and Healthcare products Regulatory Agency (MHRA) that trials are safe to resume.

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Vaccine Vaccination Trials Protein 104

Pharmaceutical Technology

SEPTEMBER 14, 2022

The protein-based vaccine is indicated as a two-dose initial regimen for active immunisation for the prevention of Covid-19 in adults aged 18 years and above. The latest development was based on the totality of manufacturing, preclinical and clinical trial findings filed for assessment.

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Vaccine Vaccination Clinical Trials Clinical Trials 147

Pharmaceutical Technology

MAY 29, 2023

Novavax has received positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for full marketing authorisation (MA) of its Covid vaccine, Nuvaxovid (NVX-CoV2373) , in the European Union (EU).

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Pharmaceutical Technology

MARCH 10, 2023

Personalised medicines will also be developed at the centre. In an email to Pharmaceutical Technology , an NHSBT spokesperson said the centre will “support early phase clinical trials and preclinical work, providing a route to eventual commercial scale production”.

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XTalks

JANUARY 7, 2025

Symvess is a one-time, single-use, acellular tissue-engineered vessel (ATEV) composed of human extracellular matrix proteins. Secondary endpoints, such as infection rates, amputation and limb salvage, also favored Symvess, with the trial covering traumatic injuries from car accidents, gunshot wounds and industrial accidents.

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FDA Approval Engineer Clinical Trials Clinical Trials 105

pharmaphorum

MAY 13, 2021

The first UK patient has enrolled on Pfizer’s phase 3 trial for its Duchenne muscular dystrophy (DMD) gene therapy. The first patient was recruited in The Newcastle upon Tyne Hospitals NHS Foundation Trust, one of three UK sites for the clinical trial and part of 55 globally, across 15 countries.

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Gene Therapy Gene Trials Protein 102

Pharmaceutical Technology

AUGUST 24, 2022

Patients provide blood samples for clinical trial sponsors to develop and deliver these emerging immunotherapies. Flow cytometry (FCM) is the primary method scientists use to monitor immune responses in clinical trials, primarily because of its power, speed, and ability to provide a comprehensive view of a disease’s macro-environment.

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Clinical Trials Clinical Trials Trials Development 130

Worldwide Clinical Trials

AUGUST 14, 2024

They play a crucial role in tailoring hematology oncology therapeutic strategies to individual patients and have transformed personalized medicine in oncology. Protein-based Biomarkers : Include proteins found in blood, tissues, or other bodily fluids that can indicate disease presence or progression.

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Genetics Protein Gene Genotype 195

pharmaphorum

JUNE 28, 2021

Preliminary results from a phase 1 trial run by Regeneron and CRISPR specialist Intellia Therapeutics – co-founded by Nobel Prize winner Jennifer Doudna – showed steep reductions in a biomarker of ATTR amyloidosis disease activity with a single dose of the NTLA-2001 drug. — Eric Topol (@EricTopol) June 26, 2021.

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In-Vivo Gene Editing Trials Drugs 105

STAT News

NOVEMBER 29, 2022

SAN FRANCISCO — A closely watched new treatment for Alzheimer’s disease held up to scrutiny in a detailed scientific presentation Tuesday, as its developers, partners Eisai and Biogen, begin the lengthy process of turning this medicine into what they hope could be a groundbreaking therapy.

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Clinical Trials Clinical Trials Protein Medicine 144

Pharmaceutical Technology

SEPTEMBER 2, 2022

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting expanded conditional marketing authorization (CMA) for Novavax ’s Covid-19 vaccine, Nuvaxovid (NVX-CoV2373), as a booster in adults aged 18 years and above.

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Vaccine Vaccination Trials Clinical Trials 147

pharmaphorum

SEPTEMBER 16, 2020

Regeneron’s COVID-19 antibody cocktail has been added to the UK’s RECOVERY trial, one of the largest of its kind in the world that is testing several potential coronavirus therapies at the same time. RECOVERY is conducted by the Nuffield Department of Population Health in partnership with the Nuffield Department of Medicine.

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Pharmaceutical Technology

MAY 26, 2023

HanAll Biopharma and Daewoong Pharmaceutical will combine their resources and knowledge to develop NurrOn’s ATH-399A and other compounds targeting Nurr1 [nuclear receptor-related 1 protein] to treat neurodegenerative disorders. They will help to progress ATH-399A towards a Phase I trial.

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Development Clinical Trials Clinical Trials Protein 130

Pharmaceutical Technology

JANUARY 22, 2023

In 2022, the FDA approved only 37 new medicines, an underwhelming number compared to 98 in 2018. While in the US, the therapy is already being prescribed under an expanded access program , the FDA has requested additional data from a randomised, placebo-controlled trial before it will allow Egetis to schedule a PDUFA date.

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Drugs Gene Hormones Clinical Trials 317

Pharmaceutical Technology

JUNE 21, 2023

In the past year, Hemgenix has been granted approval by the US Food and Drug Administration (FDA) and has received conditional marketing authorisation from the European Commission (EC) and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). This followed positive results from CSL’s Phase III HOPE-B trial (NCT03569891).

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Gene Therapy Gene Protein Sales 246

Pharmaceutical Technology

MAY 11, 2023

It inhibits the C5 protein in the terminal complement cascade, part of the body’s immune system. The EC’s approval follows a positive opinion from the committee for medicinal products for human use. Ultomiris met the primary endpoint of time to first on-trial relapse, confirmed by an independent adjudication committee.

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Trials Clinical Trials Clinical Trials Medicine 130

Pharma Mirror

SEPTEMBER 11, 2022

Honesti Baasyir, the President Director of PT Bio Farma, said the company collaborated with Baylor College of Medicine, a private, independent health sciences centre in Houston, Texas to develop IndoVac, a recombinant protein subunit vaccine produced from yeast.

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Pharmaceutical Technology

APRIL 4, 2023

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorisation for AstraZeneca ’s Ultomiris (ravulizumab) to treat neuromyelitis optica spectrum disorder (NMOSD) in adult patients.

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XTalks

DECEMBER 12, 2023

The world of neuroscience trials is rapidly evolving, presenting new challenges and opportunities for researchers and clinicians. The worldwide market for neurology clinical trials stood at a valuation of $5.24 There is currently a heightened emphasis on imaging and liquid biomarkers in neuroscience clinical trials.

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Trials Clinical Trials Clinical Trials Genetics 111

Pharmaceutical Technology

NOVEMBER 13, 2022

The approval was based on the findings from the randomised, multicentre, open-label, international Phase III POSEIDON trial. In the trial, the safety profile of Imjudo plus Imfinzi and chemotherapy combination treatment was in line with each medicine’s known profiles without any new safety signals detected.

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Protein FDA Approval Antibody Trials 130

Pfizer

JULY 26, 2022

Pfizer and BioNTech Advance COVID-19 Vaccine Strategy With Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design. Pfizer and BioNTech Advance COVID-19 Vaccine Strategy With Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design. deliesschef. Tue, 07/26/2022 - 17:41.

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Vaccine Vaccination Protein Immune Response 111

Pharmaceutical Technology

JULY 5, 2022

Researchers at the UNC School of Medicine have discovered that hepatitis A virus (HAV) replication needs particular interactions between the human protein ZCCHC14 and TENT4 poly(A) polymerases, a group of enzymes. In addition, the scientists later found that the HAV needs TENT4A/B for its replication.

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Protein RNA Genomics Genome 130

pharmaphorum

NOVEMBER 16, 2021

MK-0616 has been shown to reduce LDL cholesterol by a similar margin to injectables sold by Amgen and Sanofi/Regeneron – as well as Novartis’ longer-lasting RNAi therapy Leqvio – in two clinical trials reported at the American Heart Association (AHA) meeting. For now though, any threat from Merck’s drug is speculative.

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Trials Drugs Sales Clinical Trials 98

Pharmaceutical Technology

JANUARY 13, 2023

The single-dose oral medicine, Xofluza has been approved to treat uncomplicated influenza and post-exposure prophylaxis of influenza. It has been designed to inhibit the cap-dependent endonuclease protein, which is said to be essential for viral replication. It was also well tolerated, with no new safety signals identified.

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Medicine Clinical Trials Clinical Trials Protein 130

Pharmaceutical Technology

APRIL 28, 2023

Generate Biomedicines has signed a co-development and commercialisation agreement with the University of Texas MD Anderson Cancer Center to expedite the development of new protein therapeutics for oncology using generative AI.

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Development Clinical Trials Clinical Trials Protein 130

Bioengineer

JANUARY 22, 2025

The research, led by Dr. Daniel McIsaac, an anesthesiologist and senior scientist at The Ottawa Hospital, compiles data from over 15,000 patients involved in 186 randomized clinical trials internationally. These trials are vital as they not only expand the patient pool but also enhance the generalizability of findings.

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Trials Clinical Trials Clinical Trials Research 59

Pharmaceutical Technology

JANUARY 20, 2023

BeiGene has received marketing authorisations for Brukinsa (zanubrutinib) in Great Britain from the Medicines and Healthcare products Regulatory Agency (MHRA) to treat chronic lymphocytic leukemia (CLL) and marginal zone lymphoma (MZL).

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Marketing Bioavailability Trials Clinical Trials 130

Pharmaceutical Technology

FEBRUARY 7, 2023

The BLA covers all indications which are covered by Prolia (denosumab) and Xgeva (denosumab) reference medicines. The human monoclonal antibody denosumab has been designed to bind to osteoclasts activator, RANKL protein. It decreases the osteoclast’s production and activity by attaching to and inhibiting RANKL.

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Packaging Packaging Medicine Licensing 130

Pharmaceutical Technology

DECEMBER 23, 2022

This approval is backed by findings from the multicentre, double-blinded, placebo-controlled, international Phase II/III CAPELLA clinical trial of lenacapavir plus an optimised background regimen. Subcutaneous lenacapavir’s antiviral activity administered every six months was analysed in the trial.

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Drugs FDA Approval Clinical Trials Clinical Trials 147

Scienmag

MARCH 15, 2021

The first vaccine has been administered in a comparative adjuvant trial of DNA prime/protein boost HIV vaccine regimens in Kericho, Kenya Credit: U.S. Military HIV Research Program SILVER SPRING, Md.

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Vaccine Vaccination Trials DNA 68