pharmaphorum

JANUARY 15, 2021

South Korea’s Celltrion has announced encouraging top-line results for its potential antibody therapy for COVID-19, with the first part of a phase 2/3 trial showing it could cut recovery times and chances of progression from moderate to more severe disease. days shorter than placebo, the company said. reported with placebo.

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Pharmaceutical Technology

FEBRUARY 17, 2023

The agency proposes that pharma move away from the common maximum tolerated dose (MTD) to trial designs that prioritise drug dosage optimisation at different stages. In clinical trials, dose-ranging is testing different drug doses against each other to establish which works best.

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Clinical Trials Clinical Trials Trials Drugs 289

XTalks

APRIL 11, 2025

Jobevne, like Avastin, is a humanized monoclonal antibody that blocks vascular endothelial growth factor (VEGF). In 2024 its first year operating as a standalone global biosimilars enterprise BioconBiologics launched more than 60 products across emerging and established markets. CAGR through 2033.

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Antibody Marketing Clinical Trials Clinical Trials 109

pharmaphorum

DECEMBER 16, 2020

AbbVie is to begin clinical development of an antibody designed to neutralise the SARS-CoV-2 coronavirus after licensing the therapy in from Harbour BioMed and Utrecht University. AbbVie has begun a phase 1 clinical trial of the antibody, with clinical development beginning in the US and expanding into Europe.

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Antibody Trials Licensing Licensing 98

Worldwide Clinical Trials

OCTOBER 14, 2024

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. One of the biggest hurdles in developing new therapies is recruiting diverse patients for clinical trials.

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Research Clinical Trials Clinical Trials Immune Response 147

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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Marketing Trials Antibody Clinical Trials 105

Worldwide Clinical Trials

OCTOBER 14, 2024

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. One of the biggest hurdles in developing new therapies is recruiting diverse patients for clinical trials.

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Research Clinical Trials Clinical Trials Immune Response 130

pharmaphorum

OCTOBER 25, 2021

Expectations for Novartis’ canakinumab as a therapy for cancer have taken another dive, after a second phase 3 trial in non-small cell lung cancer (NSCLC) failed to meet its primary objectives. The post Strike two for Novartis’ lung cancer antibody canakinumab appeared first on.

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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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Antibody FDA Approval Clinical Trials Clinical Trials 246

Bio Pharma Dive

FEBRUARY 14, 2023

The British drugmaker will retain an interest in COVID antibody drug sotrovimab, which was withdrawn from the U.S. market, and a second treatment still in early-stage trials.

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Antibody Trials Marketing Drugs 176

Pharmaceutical Technology

FEBRUARY 14, 2023

Precision oncology firm Corbus Pharmaceuticals and CSPC Megalith Biopharmaceutical have entered an exclusive licensing agreement for the latter’s new clinical stage antibody drug conjugate (ADC), CRB-701 (SYS6002). Currently, CSPC is investigating CRB-701 in a Phase I dose escalation clinical trial to treat advanced solid tumours in China.

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Antibody Drugs Clinical Development Licensing 130

Pharmaceutical Technology

MARCH 16, 2023

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for argenx’s Vyvgart (efgartigimod alfa-fcab) to treat generalised myasthenia gravis (gMG). The regulatory approval was based on the data obtained from the international Phase III ADAPT trial.

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Marketing Antibody Medicine Trials 130

XTalks

JANUARY 22, 2025

seroresponse rate indicating the proportion of participants achieving antibody levels above a predefined protective threshold sustained one year after vaccination. The VLA1553-321 trial, conducted in Brazil, was the first to assess the vaccine in an endemic region. The findings reveal a remarkable 98.3%

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Immune Response Vaccine Vaccination Trials 59

pharmaphorum

NOVEMBER 6, 2022

The potential of monoclonal antibodies (mAbs) as therapies is indisputable. The current mAbs market is expected to be around ~USD 150 billion. Naturally, the pharma industry has seen an explosion of mAbs in the pipeline, which has led to the evolution of new methods for improving and refining the antibody pipeline.

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Antibody Drugs Protein Life Science 123

pharmaphorum

OCTOBER 8, 2024

The stock rocketed 362% after the announcement, taking Scholar Rock's market cap above $2.7 Shares in Scholar Rock have gone into overdrive after the biotech reported positive phase 3 results with apitegromab in patients with spinal muscular atrophy (SMA), setting up regulatory filings in early 2025.The

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Pharmaceutical Technology

MAY 22, 2023

Biogen and Eisai have submitted a marketing authorisation application (MAA) to the UK’s medicines and healthcare products regulatory agency (MHRA) for lecanemab to treat early Alzheimer’s disease (AD). The submission of MAA is based on the findings from the Phase III Clarity AD trial and Phase IIb clinical study (Study 201).

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Marketing Antibody Licensing Licensing 130

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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Marketing Drugs Clinical Trials Clinical Trials 130

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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Gene Therapy Gene Clinical Trials Clinical Trials 264

Pharmaceutical Technology

APRIL 6, 2023

The designation, under the regulator’s Innovative Licensing and Access Pathway (ILAP), will fast-track a potential route to market for AD04 by providing collaborative opportunities with UK institutes like the National Institute for Health and Care Excellence (NICE).

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FDA Approval Licensing Licensing Antibody 264

pharmaphorum

OCTOBER 28, 2020

Our goal is to ensure that Lilly antibody treatments are available to patients who need them, no matter where they live. “As As long as supply of neutralising antibodies is constrained, we believe the only way to ensure equitable access is for Lilly to contract directly with governments and pan-national philanthropic organisations. “As

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Antibody Trials Allergies Nurses 104

pharmaphorum

JULY 19, 2024

Less than two years after pulling multiple myeloma therapy Blenrep off most markets around the world, GSK has filed for approval of the drug in the EU once again, hoping to restore its blockbuster credentials.The remarkable renaissance for the BCMA-directed antibody-drug conjugate is supported by a pair of phase 3 trials that could not only support (..)

Marketing 104

Marketing Antibody Trials Drugs 104

Pharmaceutical Technology

SEPTEMBER 13, 2022

Gilead’s Trodelvy (sacituzumab govitecan-hziy) is a first-in-class Trop-2 directed antibody-drug conjugate (ADC), with a potent topoisomerase I inhibitor payload. month OS benefit compared to SOC chemotherapy in the DESTINY-Breast04 trial.

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HR Marketing Hormones FDA Approval 162

Pharma Times

MAY 31, 2022

Antibody addresses high unmet medical need in rapidly growing kidney transplant market

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Antibody Trials Marketing 123

BioPharma Reporter

JULY 11, 2024

Amid a period of clinical holds and legal tangles, the US antibody specialist CytoDyn has reached a settlement to resolve legal disputes with its former contract research organization (CRO) Amarex Clinical Research.

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Antibody Drug Trials Clinical Research Trials 98

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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Development Engineer Clinical Trials Clinical Trials 264

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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Marketing Clinical Trials Clinical Trials Trials 130

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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Antibody Insulin Trials Production 98

Pharmaceutical Technology

APRIL 17, 2023

Pharmaceutical company Genmab is entering a partnership with argenx to develop antibody therapies for oncology and immunology. This collaboration is being made to combine the companies’ capabilities to develop novel therapeutic antibodies with applications in the two disease areas. Please check your email to download the Report.

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Antibody Engineer FDA Approval Development 130

pharmaphorum

JUNE 24, 2021

Armed with a positive mid-stage trial readout in lung cancer, Arcus Biosciences will expand a phase 3 programme for domvanalimab, its anti-TIGIT antibody. Zimberelimab “showed activity similar to that of marketed anti-PD-1 antibodies studied in this setting,” said Arcus’ chief medical officer Bill Grossman.

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Antibody Trials Licensing Licensing 84

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% In the trial, 1.9% According to the interim efficacy data from a pre-specified patient cohort, a 5.4

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FDA Approval Clinical Trials Clinical Trials Engineer 264

Pharmaceutical Technology

MARCH 9, 2023

Global biopharmaceutical firm UCB and Cancer Research UK have entered a multi-project partnership to advance two of the former’s oncology antibody candidates through clinical trials. The clinical development partnership will focus on the development of UCB6114 and UCB4594 investigational antibody candidates.

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Antibody Research Clinical Trials Clinical Trials 130

Pharmaceutical Technology

JUNE 29, 2022

The European Commission (EC) has granted marketing authorisation for Gilead Sciences’ subsidiary Kite’s CAR T-cell therapy, Yescarta (axicabtagene ciloleucel), to treat adults with relapsed or refractory follicular lymphoma (FL). . In the trial, 6% of the subjects had Grade ?3

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Gene Therapy Clinical Trials Clinical Trials Genetics 278

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. However, it is possible to target CD33 in the clinic, as evidenced by the FDA approval of Pfizer’s anti-CD33 antibody-drug conjugate Mylotarg (gemtuzumab ozogamicin) in 2000.

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Marketing Gene Editing Production Sales 130

pharmaphorum

FEBRUARY 25, 2021

The company announced a phase 1 trial is beginning of its nasal spray vaccine just as scientists in the UK said they are considering a similar approach. AZ already markets a nasal flu vaccine called FluMist, so the precedent is there, and the Oxford team is thinking of going down this route with its own research.

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Vaccine Vaccination Immune Response Trials 111

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.

Marketing 130

Marketing Antibody Clinical Trials Clinical Trials 130

pharmaphorum

MARCH 8, 2021

The EMA’s human medicines committee has said two Eli Lilly antibodies are effective in people with COVID-19 who are at risk of developing severe disease, clearing the way for use in EU member states. The post EMA backs emergency use of Lilly’s COVID antibodies appeared first on.

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Antibody Licensing Licensing Protein 105

XTalks

MARCH 10, 2025

Omalizumab is an anti-IgE antibody that works by blocking the effects of IgE, a key driver in many allergic reactions. In a global Phase III clinical trial, 619 adult patients were enrolled and received either 150 mg or 300 mg of omalizumab-igec every four weeks. The trial also noted some significant side effects.

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Allergies FDA Approval Antibody Trials 66