Pharmaceutical Technology

JUNE 15, 2023

Eloxx has revealed its lead candidate ELX-02 improved predicted forced expiratory volume (ppFEV1) in patients with Class 1 cystic fibrosis (CF) in a new analysis of a Phase II trial that missed its efficacy endpoints. The regimen in the trial was a one-week monotherapy period (1.5

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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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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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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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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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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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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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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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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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Pharmaceutical Technology

DECEMBER 16, 2022

Spearheaded by collaborations between non-profit groups and pharma players, new treatments are edging closer to late-stage trials in malaria and neglected tropical diseases such as sleeping sickness. However, Mosquirix’s efficacy is limited, while results from a Phase III licensure trial of R21 are expected this year.

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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

JULY 21, 2022

The company received fast-track designation from the US Food and Drug Administration (FDA) for the eltanexor development programme as a single agent to treat relapsed or refractory intermediate, high or very high-risk MDS patients. Eltanexor is a new oral selective inhibitor of nuclear export (SINE) compound.

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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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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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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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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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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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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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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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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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Worldwide Clinical Trials

APRIL 7, 2025

Have you optimized your trial designs to employ precision medicine approaches for your novel solid tumor intervention? The tumor microenvironment can also impact drug efficacy, while strict eligibility criteria can limit the pool of potential participants, affecting the generalizability of study findings.

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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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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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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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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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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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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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XTalks

OCTOBER 24, 2024

In August 2024, Artax Biopharma completed patient recruitment for its Phase IIa trial of AX-158, exploring a new immune-modulating therapy for psoriasis. Meanwhile, Innovent Biologics recently saw its New Drug Application (NDA) for picankibart, an IL-23p19 inhibitor, accepted by the Chinese National Medical Products Administration (NMPA).

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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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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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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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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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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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Pharmaceutical Technology

DECEMBER 23, 2022

The US Food and Drug Administration (FDA) has granted approval for Gilead Sciences ’ Sunlenca (lenacapavir) plus other antiretroviral(s) (ARV) to treat human immunodeficiency virus type 1 (HIV-1) infection. Subcutaneous lenacapavir’s antiviral activity administered every six months was analysed in the trial.

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