Pharmaceutical Technology

NOVEMBER 14, 2022

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for Oncopeptides’ Pepaxti (melphalan flufenamide; melflufen) along with dexamethasone to treat multiple myeloma patients. Currently, the company is analysing Pepaxti’s market access options in the country.

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Pharmaceutical Technology

JANUARY 27, 2023

All three treatments are monoclonal antibodies. While the occurrence and severity of side effects for Briumvi is comparable to other monoclonal antibodies available on the market, its approval still brings positive news for MS patients, due to its good efficacy in reducing disease progression.

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pharmaphorum

NOVEMBER 22, 2022

GSK confirmed this morning that the disappointing readout from the DREAMM-3 trial of multiple myeloma therapy Blenrep reported earlier this month means that it will take the drug off the US market. The post GSK will pull Blenrep from US market after failed trial appeared first on.

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Pharmaceutical Technology

SEPTEMBER 19, 2022

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting marketing authorisation for AstraZeneca ’s Evusheld (formerly AZD7442) for Covid-19 in the European Union (EU). Additionally, in the trial, the antibody cocktail was found to be well-tolerated.

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Pharmaceutical Technology

JUNE 20, 2023

In a Phase III clinical trial, SKYCovione showed neutralising antibody responses against the SARS-CoV-2 parental strain. The vaccine is based on recombinant protein vaccine technology and is suitable for storage between 2°C and 8°C.

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Worldwide Clinical Trials

OCTOBER 14, 2024

Fortunately, advances in clinical research are providing hope for better treatments and outcomes. With the support of global networks like ours at Worldwide Clinical Trials (Worldwide), autoimmune and bone health research is accelerating, providing new solutions to patients around the world.

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Pharmaceutical Technology

JANUARY 19, 2023

Acute myeloid leukemia (AML) is part of a market of blood malignancies that commercial cell therapies have not managed to penetrate yet. Antigens such as CD123 and CD33, despite being markers of myeloid cells, are shared with their healthy counterparts, and myeloablation following their depletion often leads to detrimental clinical outcomes.

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Advarra

MARCH 21, 2023

While drugs require Phase I-III clinical trials—and are also subject to post-approval tracking—digital therapeutics, devices, and IVDs may be able to leverage bench testing, animal studies, pilot studies, and training sets. The greater the risk, the more likely a series of trials for market clearance or approval will be required.

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Worldwide Clinical Trials

OCTOBER 14, 2024

Fortunately, advances in clinical research are providing hope for better treatments and outcomes. With the support of global networks like ours at Worldwide Clinical Trials (Worldwide), autoimmune and bone health research is accelerating, providing new solutions to patients around the world.

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pharmaphorum

APRIL 9, 2021

The FDA says it has uncovered “deficiencies” in the marketing application for Provention Bio’s much-anticipated drug teplizumab for the prevention of type 1 diabetes (T1D) that could delay its review. The post Provention faces delay in FDA review of diabetes prevention antibody appeared first on.

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XTalks

NOVEMBER 7, 2022

Gleich, MD, FACS, Senior Vice President, Medical Department, and Dr. Christopher Huth, PhD, Senior Clinical Trial Manager, Clinical Trial Management. Liquid Biopsy Use in Oncology Clinical Trials. percent show less reliability). Optimal methods for bioinformatic analysis are still needed.

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pharmaphorum

AUGUST 8, 2022

As we reported this morning, the deal gives Pfizer already-approved SCD therapy Oxbryta (voxelator) – which industry watchers reckon could see a dramatic uptick in sales with Pfizer’s marketing muscle – plus a phase 3 antibody candidate, a phase 1 follow-up to Oxbryta that could offer improved dosing.

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Pharmaceutical Technology

MAY 12, 2023

On 8 May 2023, China-based Bliss Biopharmaceutical (BlissBio) announced a clinical trial collaboration with Eisai to develop BB-1701, an antibody-drug conjugate (ADC) for multiple cancer types. Seagen has three marketed ADCs as well as two novel ones, one of which, disitamab vedotin, is HER2-directed.

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BioPharma Reporter

OCTOBER 14, 2020

Enrollment is temporarily on hold in the ACTIV-3 clinical trial, which is evaluating Lilly's investigational neutralizing antibody bamlanivimab (LY-CoV555) as a treatment for COVID-19 in hospitalized patients. The pause was recommended by the study's independent Data and Safety Monitoring Board (DSMB).

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Pharmaceutical Technology

MARCH 31, 2023

Available to people ages 16 years and above who have been vaccinated with a Covid-19 mRNA vaccine, EMA’s Human Medicines Committee concluded the vaccine is ready for marketing authorization in the EU, on 30 March. Bimervax is a recombinant protein subunit vaccine, marketed by the Girona, Spain-based Hipra.

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Pfizer

FEBRUARY 16, 2023

These study participants, representing approximately half of the total recruited participants in the trial, are being discontinued following violations of Good Clinical Practice (GCP) at certain clinical trial sites run by a third-party clinical trial site operator.

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Pharmaceutical Technology

NOVEMBER 14, 2022

The antibody-drug conjugate (ADC) treatment is indicated for such patients who have previously received one to three systemic therapy regimens, irrespective of the usage of Avastin priorly. Elahere obtained the approval based on the findings on objective response rate (ORR) and duration of response (DOR) reported in the SORAYA clinical trial.

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pharmaphorum

OCTOBER 18, 2022

Gilead Sciences has made yet another rush into the oncology category, licensing a bispecific antibody from MacroGenics in development as a treatment for CD123-positive blood cancers, including acute myeloid leukaemia (AML) and myelodysplastic syndromes (MDS). Along with the signing fee, there is another $1.7 It brought in $4.7

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Pharmaceutical Technology

DECEMBER 19, 2022

With the latest development, Sanofi will licence a NK cell engager programme that acts on B7H3 from the antibody-based NK cell engager therapeutics (ANKET) platform of Innate. On choosing the candidate, the company will oversee the complete development, production and marketing.

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pharmaphorum

MAY 10, 2021

The EMA has begun a rolling review of a COVID-19 antibody developed by GlaxoSmithKline and Vir BioTech which could become the fourth drug of its type cleared for early use in the EU. . Other data such as final clinical trial results will be assessed in due course. EMA_News starts evaluating the monoclonal antibody sotrovimab.

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Pharmaceutical Technology

AUGUST 12, 2022

The latest approval was based on the findings from the Phase II DESTINY-Lung02 clinical trial, which assessed the safety and efficacy of two doses of Enhertu in HER2 mutant metastatic NSCLC patients. . In the trial, 1.9% According to the interim efficacy data from a pre-specified patient cohort, a 5.4

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Pharmaceutical Technology

AUGUST 8, 2022

The approval was based on findings from the international, randomised, open-label Phase III DESTINY-Breast04 clinical trial. Furthermore, Enhertu’s safety profile was in line with prior clinical trials without any new safety concerns detected. Enhertu-treated subjects had a median overall survival (OS) of 23.4

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Pharmaceutical Technology

FEBRUARY 14, 2023

Cullinan Oncology has signed an exclusive licence with Harbour BioMed for clinical-stage B7H4 x 4-1BB bispecific immune activator HBM7008’s (CLN-418) development and marketing in the US. HBM7008 has been developed from HBICE, a next-generation heavy chain-only antibody (HCAb)-based multi-specific antibody discovery platform.

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The Pharma Data

AUGUST 20, 2020

Poor regulation of antibodies tests – that could indicate if someone has had coronavirus – could be putting the public at risk, doctors have warned. It is still not known whether having antibodies will protect people from a second infection. Coronavirus infection triggers the immune system to produce antibodies.

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Pharmaceutical Technology

JANUARY 13, 2023

Being co-developed and co-marketed by Daiichi Sankyo along with AstraZeneca , Enhertu is a specifically engineered HER2-directed antibody-drug conjugate (ADC). Enhertu’s safety profile was consistent with the previous clinical trials.

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Pharmaceutical Technology

OCTOBER 17, 2022

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicine Agency (EMA) has recommended granting conditional marketing authorization (CMA) for Boehringer Ingelheim’s spesolimab as a therapy option in adults with generalised pustular psoriasis (GPP) flares. It is marketed as Spevigo in Japan and the US.

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World of DTC Marketing

APRIL 11, 2021

The CDC says “neither the recently authorized and recommended vaccines nor the other COVID-19 vaccines currently in clinical trials in the United States can cause you to test positive on viral tests , which are used to see if you have a current infection.? But again 90% is not 100%.

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pharmaphorum

JANUARY 31, 2022

Daiichi Sankyo has stepped up its efforts to bring a Japanese COVID-19 vaccine to patients, starting a new clinical trial of its mRNA-based candidate DS-5670 that focuses on its use as a booster dose. The post Daiichi makes play for share of Japan’s COVID booster market appeared first on.

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Pharmaceutical Technology

MAY 19, 2023

Rinvoq is a major pillar in AbbVie’s plan to stem revenue drops once biosimilars to its behemoth Humira (adalimumab) enter the market on a sustained basis this year. AbbVie anticipates Rinvoq sales to exceed $7.5bn in 2025 and for the peak revenues from both drugs to exceed Humira’s peak sales by 2027.

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Delveinsight

JANUARY 22, 2021

The launch of a novel drug in the market is not less than a celebration in the pharmaceutical and healthcare market; however, it also brings the real challenge of sustenance in the market. Similar is the picture of the Thrombocytopenia Drugs Market. At present, there stands no treatment option that can cure the disease.

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Pharmaceutical Technology

DECEMBER 18, 2022

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended granting variation to the marketing authorization (MA) for Moderna ’s Spikevax bivalent Original/Omicron BA.1 Additionally, the application included findings from a Phase II/III clinical trial of mRNA-1273.214.

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Pharma Mirror

FEBRUARY 11, 2021

KS) announced another successful Investigational New Drug (IND) clearance from the FDA for its client to begin clinical trials on a cancer immunotherapy, furthering the company’s track record as a premiere CDO service provider in the global market. Samsung Biologics (KRX: 207940.KS) We are extremely glad to.

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Pharmaceutical Technology

AUGUST 25, 2022

The European Commission (EC) has granted conditional marketing authorisation (CMA) for BioMarin Pharmaceutical ’s gene therapy, Roctavian (valoctocogene roxaparvovec), to treat adults with severe haemophilia A (congenital Factor VIII deficiency).

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Pharmaceutical Technology

MAY 2, 2023

IO agents include the classes of immune checkpoint modulators, cell therapies, bispecific antibodies, oncolytic viruses, therapeutic vaccines, and cytokines. There are more than 20 marketed ICIs with approvals across a very wide spectrum of solid tumour indications.

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XTalks

AUGUST 23, 2021

This is not a debate on approval,” said Stacie Weninger, PhD, president of the F-Prime Biomedical Research Initiative, in a focused topic session on the impact of drug approval on future clinical trials held on Tuesday July 27. Now that [aducanumab] is approved, how will this affect clinical trials going forward?”.

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Roots Analysis

MARCH 16, 2022

Exosome Service Providers – Current Market Landscape. The market is characterized by a mix of well-established and small firms. Broad Clinical Trial Landscape. Future Evolution of Exosome Development and Manufacturing Services Market. Want additional details on the pipeline? Want additional details on the pipeline?

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The Pharma Data

SEPTEMBER 17, 2020

The new Elecsys Anti-SARS-CoV-2 S test can quantitatively measure the level of antibodies against SARS-CoV-2 in patients who have been exposed to the virus. The test targets antibodies against the spike protein. The majority of current candidate vaccines aim to induce an antibody response against the spike protein. “As

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