XTalks

JANUARY 6, 2025

The US Food and Drug Administration (FDA) has approved Alyftrek (vanzacaftor/tezacaftor/deutivacaftor), a next-in-class triple combination cystic fibrosis transmembrane conductance regulator (CFTR) modulator, to treat cystic fibrosis (CF) in patients aged six years and older with at least one F508del mutation or another responsive CFTR mutation.

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Gene Therapy Protein Genetic Disease Gene 105

Bio Pharma Dive

JUNE 5, 2023

Results from a “basket” trial of the antibody-drug conjugate show it shrank tumors across a half dozen cancers, suggesting a broader role to targeting the protein HER2.

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Drugs Protein Antibody Trials 183

XTalks

MARCH 11, 2025

Vepdegestrant, an investigational oral therapy, utilizes PROteolysis TArgeting Chimera (PROTAC) technology a mechanism that harnesses the bodys natural protein disposal system to selectively target and degrade the estrogen receptor. From a business perspective, Arvinas fourth quarter financial highlights report that revenue surged to $263.4

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Trials Clinical Trials Clinical Trials Protein 59

Bio Pharma Dive

MARCH 22, 2023

Though the drug, called tofersen, missed the main goal of a key clinical trial, it showed an effect on a protein tied to ALS. Experts see that as a good sign, but some worry Biogen has not yet gathered enough supportive evidence.

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Drugs Clinical Trials Clinical Trials Protein 177

Bio Pharma Dive

MAY 15, 2024

Uniquity Bio emerged from stealth mode ready to begin Phase 2 trials of an antibody targeting the protein TSLP in asthma and COPD.

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Protein Antibody Drugs Trials 177

Pharmaceutical Technology

FEBRUARY 16, 2023

Aqilion and Merck have entered an exclusive licence and strategic research partnership for the discovery, development and commercialisation of the transforming growth factor-β-activated kinase 1 (TAK1) protein-small molecule inhibitors. Merck will be responsible for leading the preclinical pharmacology and biology trials.

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Protein Development Sales Business Development 147

Pharmaceutical Technology

JUNE 24, 2022

Novavax has obtained emergency use authorization (EUA) for its Covid-19 vaccine, Nuvaxovid (NVX-CoV2373), from the Taiwan Food and Drug Administration for use in people of the age 18 years and above. The protein-based vaccine is engineered from the genetic sequence of the SARS-CoV-2 virus’ initial strain.

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Vaccine Vaccination Clinical Trials Clinical Trials 263

AuroBlog - Aurous Healthcare Clinical Trials blog

JUNE 19, 2024

link] Checkpoint inhibitors are immunotherapy drugs that block crucial proteins from binding to cancerous tumors, meaning the immune system’s T cells can more easily […]

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Scientist Protein Drugs Research 246

Pharmaceutical Technology

JUNE 29, 2022

The pharmaceutical industry often relies on enzymes to perform a process known as biocatalysis, which facilitates the cost-effective and sustainable production of small molecule drugs at scale. The post Enabling the next wave of innovative drug therapies with speciality enzymes appeared first on Pharmaceutical Technology.

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Pharmaceutical Technology

NOVEMBER 11, 2022

The European Commission (EC) has granted approval for Sanofi and GSK ’s monovalent, recombinant-protein-based, adjuvanted Covid-19 vaccine, VidPrevtyn Beta, as a booster in adults aged 18 years and above. These trials comprised the Phase III VAT08 Stage 2 trial analysing initial efficacy and two other immunogenicity trials.

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Bio Pharma Dive

MARCH 11, 2025

Trial results show vepdegestrant, a protein-degrading drug Arvinas is developing with Pfizer, improved on fulvestrant in a subgroup of breast cancer patients, but not the overall study population.

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Protein Trials Development Drugs 152

Pharmaceutical Technology

FEBRUARY 20, 2023

Different approaches that are studied include antisense oligonucleotides (ASOs), and gene therapies, which are in early clinical trials. This includes Denali Therapeutics whose treatment TAK-594/DNL593 is in a Phase I/II trial. This protein promotes lysosomal function. The trial features four cohorts.

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Development Gene Therapy Protein Gene 246

Bio Pharma Dive

DECEMBER 1, 2022

Detailed clinical trial data for Roche's gantenerumab showed treatment cleared far less toxic protein from patients' brains than expected, potentially explaining its divergent result from Eisai’s lecanemab.

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Clinical Trials Clinical Trials Protein Research 161

Pharmaceutical Technology

DECEMBER 7, 2022

Health Canada has granted approval for a supplement to a New Drug Submission (sNDS) of Novavax ’s Covid-19 vaccine (Recombinant protein, Adjuvanted), Nuvaxovid (NVX-CoV2373), for use in adolescents aged 12 to 17 years. The trial is designed to analyse the safety and effectiveness of the vaccine.

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Vaccine Vaccination Protein Clinical Trials 264

Pharmaceutical Technology

JUNE 14, 2023

The US Food and Drug Administration (FDA) has granted fast track designation for CellCentric’s inobrodib (CCS1477) to treat relapsed or refractory multiple myeloma patients. It inhibits p300 and CBP by binding into the conserved bromodomain of the twin proteins.

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Protein Antibody Gene Trials 243

Pharmaceutical Technology

JANUARY 19, 2023

The US Food and Drug Administration (FDA) has granted Fast Track designation for Avidity Biosciences’ AOC 1020 to treat facioscapulohumeral muscular dystrophy (FSHD). This DUX4 protein abnormal expression leads to modifications in gene expression in muscle cells which are associated with progressive muscle function loss in FSHD patients.

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World of DTC Marketing

DECEMBER 29, 2020

Once introduced into the human body, the protein-making machinery uses this genetic material in our cells to churn out the coronavirus “spike protein,” triggering an immune response. Another consideration is that while in traditional vaccine development, clinical trials are carried out in sequence. Then there are the finances.

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Vaccine Vaccination Development Clinical Trials 307

XTalks

JANUARY 21, 2025

The FDA has approved Datroway (datopotamab deruxtecan-dlnk), a TROP2-directed antibody-drug conjugate (ADC) for adults with unresectable or metastatic HR-positive, HER2-negative breast cancer, developed through a global collaboration between Daiichi Sankyo and AstraZeneca. months for Datroway and 18.3 months for chemotherapy.

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Pharmaceutical Technology

JUNE 13, 2023

The US Food and Drug Administration (FDA) has accepted AstraZeneca’s new drug application (NDA) for the combination of capivasertib and FASLODEX (fulvestrant), and granted it priority review. The submission of the NDA was based on the findings of the CAPItello-291 Phase III trial.

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Pharmaceutical Technology

NOVEMBER 14, 2022

The US Food and Drug Administration (FDA) has granted accelerated approval for ImmunoGen’s Elahere (mirvetuximab soravtansine-gynx) to treat adults with folate receptor alpha (FR?)-positive, binding antibody, a cell-surface protein which is greatly expressed in ovarian cancer, as well as the maytansinoid payload DM4.

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XTalks

DECEMBER 26, 2024

Menarini Group has announced positive topline data from the Phase III BROADWAY and TANDEM clinical trials, evaluating obicetrapib and the fixed-dose combination of obicetrapib with ezetimibe. Meanwhile, the TANDEM trial evaluated a fixed-dose combination of obicetrapib with 10 mg ezetimibe in a similar patient population.

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Trials Life Science Clinical Trials Clinical Trials 52

Pharmaceutical Technology

JULY 29, 2022

The Food and Drug Administration (FDA) has acc epted to review ImmunityBio’s Biologics License Application (BLA) for N-803 to treat Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) carcinoma in situ (CIS) patients with or without Ta or T1 disease.

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Trials Clinical Trials Clinical Trials Licensing 264

Pharmaceutical Technology

SEPTEMBER 7, 2022

Indian company Bharat Biotech International has secured approval from Central Drugs Standard Control Organisation (CDSCO) under Restricted Use in Emergency Situation for its intranasal Covid-19 vaccine, iNCOVACC (BBV154), for usage in people aged 18 years and older.

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Vaccine Vaccination Clinical Trials Clinical Trials 263

pharmaphorum

APRIL 22, 2024

Ireland’s SynOx Therapeutics has completed a second-round financing, raising $75 million, as it prepares to take its drug for tenosynovial giant cell tumour (TGCT) into phase 3 trials.

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Trials Protein Drugs 105

Pharmaceutical Technology

FEBRUARY 22, 2023

The US Food and Drug Administration (FDA) has granted Fast Track designation for Biohaven ’s new anti-myostatin adnectin, taldefgrobep alfa, to treat spinal muscular atrophy (SMA). Taldefgrobep is a complete human anti-myostatin recombinant protein that is developed for lowering free myostatin.

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Clinical Trials Clinical Trials Genetics Protein 246

Pharmaceutical Technology

OCTOBER 18, 2022

A new study identifies a novel cerebrospinal fluid biomarker for Parkinson’s disease, expanding the scope of possible drug targets. In the Nature article, 76 CSF proteins were found to be structurally altered in individuals with PD relative to healthy individuals, identifying a new PD biomarker.

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Protein Genetics Gene Clinical Research 264

XTalks

FEBRUARY 19, 2025

Deciphera leverages its proprietary switch-control kinase inhibitor platform targeting kinase activation to develop orally administered drug candidates, reflecting its commitment to innovative treatments for conditions with limited therapeutic options. In 2024, Deciphera was acquired by ONO Pharmaceutical for $2.4

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FDA Approval Drugs Trials Clinical Trials 59

STAT News

NOVEMBER 28, 2022

Eisai’s announcement that lecanemab, its antibody drug for Alzheimer’s disease that targets the buildup of amyloid protein in the brain, modestly slowed cognitive decline in a Phase 3 trial offers hope to people with Alzheimer’s disease. ” Read the rest…

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Drugs Protein Antibody Trials 126

XTalks

NOVEMBER 26, 2024

The US Food and Drug Administration (FDA) has approved Attruby (acoramidis) , marking a significant advancement for patients with transthyretin-mediated amyloid cardiomyopathy (ATTR-CM). This progressive disease occurs when misfolded transthyretin (TTR) proteins form amyloid deposits in the heart, leading to cardiac dysfunction.

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Genetic Disease Genetics Protein Clinical Development 105

Pharmaceutical Technology

OCTOBER 20, 2022

PIC Therapeutics has raised $35m in a Series A funding round led by OrbiMed to develop therapies for drug-resistant breast cancer. The company will utilise the Series A funds to progress its small molecule drug presently in development into first-in-human clinical trials for advanced metastatic breast cancer.

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Development Drugs Protein Life Science 130

Pharmaceutical Technology

MAY 4, 2023

ARTHEx Biotech will use the funds to advance an antimiR oligonucleotide, ATX-01, to a Phase I/IIa clinical trial in the second half of 2023. It has a dual mechanism of action that targets toxic dystrophia myotonica protein kinase and MBNL protein.

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Clinical Trials Clinical Trials Trials Protein 130

STAT News

DECEMBER 10, 2022

NEW ORLEANS — Researchers had hoped in recent years that a protein called GPRC5D might offer a new way to get the immune system to hunt down and destroy multiple myeloma cells. Now, the results of a Phase 2 study on a bispecific antibody targeting this protein offers confirmation.

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Antibody Protein Trials Research 132

BioPharma Reporter

NOVEMBER 9, 2023

The proof-of-concept trial, dubbed IRIS-RA, is the first to investigate a treatment for rheumatoid arthritis that blocks a protein called neonatal Fc receptor (FcRn).

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Antibody Drugs Protein Trials 105

XTalks

JANUARY 7, 2025

In a major leap forward for trauma care, Humacyte has received full approval from the US Food and Drug Administration (FDA) for Symvess, a first-of-its-kind bioengineered human tissue designed to repair extremity arterial injuries. When an artery is damaged, restoring blood flow quickly is crucial.

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FDA Approval Engineer Clinical Trials Clinical Trials 105

XTalks

FEBRUARY 29, 2024

Dual-function fusion proteins represent a cutting-edge approach in biopharmaceutical research, offering a promising avenue for the development of novel therapeutics in the treatment of complex diseases such as cancer and autoimmune disorders. At the helm of this venture is Dr. Taylor H. How is your lead program differentiated?

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Protein Development Clinical Trials Clinical Trials 94

pharmaphorum

SEPTEMBER 16, 2022

Alphabet subsidiary and precision health company Verily recently announced a breakthrough in its AI drug discovery GPCR research collaboration with Sosei Heptares. It also bodes well for improving clinical trial success rates. What, then, is the solution?

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Development Research Drugs Clinical Trials 135

pharmaphorum

MARCH 24, 2021

PF-07321332 is a protease inhibitor, which has been able to block replication of the SARS-CoV-2 coronavirus in preclinical trials as well as other coronaviruses. The class is not associated with any particular toxicity, meaning the drug is likely to be well tolerated, Pfizer said.

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Clinical Trials Clinical Trials Trials Vaccination 119