The Pharma Data

AUGUST 16, 2020

First and only FDA-approved subcutaneous treatment option for anti-aquaporin-4 antibody positive NMOSD that can be self-administered by a person with NMOSD or a caregiver every four weeks. First and only approved therapy for NMOSD designed to target and inhibit interleukin-6 receptor activity, using novel recycling antibody technology.

FDA Approval 52

FDA Approval Antibody Clinical Trials Clinical Trials 52

The Pharma Data

JULY 23, 2021

The antibody combination was granted a Special Approval Pathway under article 14-3 of the Pharmaceuticals and Medical Devices Act. Ronapreve is a combination of two monoclonal antibodies (also known as REGN10933 and REGN10987, respectively) and was designed to block infectivity of SARS-CoV-2, the virus that causes COVID-19.

Antibody 52

Antibody Medicine Production In-Vitro 52

The Pharma Data

JUNE 26, 2021

Roche-sponsored global trials included the placebo-controlled EMPACTA, COVACTA and REMDACTA studies. Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. The EUA is based on results from four randomised, controlled studies that evaluated Actemra/RoActemra for the treatment of COVID-19 in more than 5,500 hospitalised patients.

Clinical Trials 40

Clinical Trials Clinical Trials In-Vitro Antibody 40

The Pharma Data

MAY 18, 2021

Today’s ODAC meeting is part of an industry-wide review of accelerated approvals with confirmatory trials that have not met their primary endpoint(s) and have yet to gain regular approvals. This Phase III trial is the designated PMR for the first-line mUC indication and met its co-primary endpoint of progression-free survival.

Medicine 52

Medicine Containment In-Vitro Development 52

The Pharma Data

AUGUST 9, 2020

The safety profile of etrolizumab was consistent with previous studies and no major safety issues were identified in the four phase III clinical trials reported to date. The safety profile of etrolizumab was consistent with previous studies and no major safety issues were identified in the four phase III clinical trials reported to date. “We

Medicine 52

Medicine In-Vitro Clinical Trials Clinical Trials 52

The Pharma Data

DECEMBER 14, 2020

Harbour BioMed (HBM) announced with Utrecht University on Monday that they have licensed their fully human SARS-CoV-2 neutralizing antibody, 47D11, and its program to AbbVie. AbbVie has initiated a Phase I clinical trial of the antibody, and it will conduct the initial clinical program in the U.S.

Antibody 52

Antibody Licensing Licensing In-Vitro 52

The Pharma Data

APRIL 23, 2021

Roche announces positive CHMP opinion for Venclyxto-based combinations in certain patients with acute myeloid leukaemia. Venclyxto combinations significantly improved complete response rates in people with newly diagnosed acute myeloid leukaemia in two key studies (VIALE-A and M14-358). The median OS was 14.7 months (95% CI: 11.9, months (95% CI: 7.4,

Medicine 40

Medicine In-Vitro Antibody Branding 40

The Pharma Data

APRIL 27, 2021

Today’s ODAC meeting is part of an industry-wide review of accelerated approvals with confirmatory trials that have not met their primary endpoint(s) and have yet to gain regular approvals. The FDA has not announced when it will make its final decision for Tecentriq in this indication.

Medicine 40

Medicine In-Vitro Antibody Development 40

The Pharma Data

SEPTEMBER 16, 2020

Blueprint Medicines will present new data from the registrational phase I/II ARROW trial, investigating Gavreto TM (pralsetinib) for the treatment of people with RET-mutant medullary thyroid cancer. New and updated data from across our broad cancer portfolio including phase III results in breast, lung and prostate cancers.

HR 52

HR Medicine Hormones Trials 52

XTalks

NOVEMBER 15, 2023

Valneva recently reported that it has been experiencing an increase in sales of its other vaccines due to the “recovery of the travel industry.” It appears the company has already done so as its quarterly earnings report included $96 million and $117 million of additional revenue from the sale of the PRV in its 2023 revenue guidance.

FDA Approval 59

FDA Approval Vaccination Vaccine In-Vitro 59

The Pharma Data

AUGUST 22, 2021

The trial accrued 25 cases of symptomatic COVID-19 at the primary analysis.There were no cases of severe COVID-19 or COVID-19-related deaths in those treated with AZD7442. The trial included 5,197 participants in a 2:1 randomisation AZD7442 to placebo.

Trials 52

Trials Antibody Vaccination Vaccine 52

The Pharma Data

SEPTEMBER 8, 2020

Phase III clinical trial programme initiated for investigational medicine fenebrutinib, designed to be a highly selective and reversible Bruton’s tyrosine kinase (BTK) inhibitor, in relapsing multiple sclerosis (RMS) and primary progressive MS (PPMS). Roche’s Chief Medical Officer and Head of Global Product Development. “We

Clinical Trials 52

Clinical Trials Clinical Trials Trials Medicine 52

The Pharma Data

JUNE 25, 2021

AstraZeneca today announced results from the STORM CHASER trial assessing the safety and efficacy of AZD7442, a long-acting antibody (LAAB) combination, for the prevention of symptomatic COVID-19 in participants recently exposed to the SARS-CoV-2 virus. The PROVENT trial will give us more clarity in this patient population.

Trials 52

Trials Antibody In-Vitro Medicine 52

The Pharma Data

JULY 21, 2021

Group sales up 8% 1 at constant exchange rates (CER); 5% in Swiss francs. Pharmaceuticals Division sales decline 3%; sales grow 4% in the second quarter, following a first-quarter decrease of 9%; newly launched medicines (+30%) compensate for the continued impact from biosimilars. [Ad hoc announcement pursuant to Art.

Sales 52

Sales Medicine Antibody In-Vitro 52

XTalks

JUNE 12, 2023

Medtronic’s proactive stance towards R&D is evident from the over 230 clinical trials it conducted and the more than 200 regulatory approvals it received in the US, Europe, Japan and China in the 2022 fiscal year. Join us as we explore the inspiring journey and significant contributions of these top 10 medical device companies.

FDA Approval 98

FDA Approval Production Sales In-Vitro 98

The Pharma Data

SEPTEMBER 2, 2020

Initiation of Phase IIIb OCREVUS higher dose clinical trial programme and Phase IV study evaluating OCREVUS in minority populations. New data further reinforce OCREVUS (ocrelizumab) as a highly effective treatment option offering a favourable and consistent benefit:risk profile, with high treatment persistence and adherence.

Clinical Trials 52

Clinical Trials Clinical Trials Antibody Medicine 52

The Pharma Data

SEPTEMBER 3, 2020

As COVID-19 and influenza infections can hardly be differentiated based on symptoms, healthcare professionals can confidently provide the right diagnosis and best course of treatment for patients. Test for use on high-throughput cobas 6800/8800 Systems will continue to support high volume testing .

In-Vitro 40

In-Vitro Antibody Medicine Clinical Trials 40

The Pharma Data

SEPTEMBER 10, 2020

OCREVUS is the first and only treatment approved for both relapsing MS (RMS) and primary progressive MS (PPMS) and now more than 170,000 people have been treated with OCREVUS globally in clinical trial and real-world settings; favourable benefit-risk profile remains consistent over 7 years. Separate data from a U.S.

In-Vitro 52

In-Vitro FDA Approval Medicine Clinical Trials 52

The Pharma Data

MAY 4, 2021

Following the completion of the spin-off of the Upjohn Business (4) in the fourth quarter of 2020, Pfizer now operates as a focused innovative biopharmaceutical company engaged in the discovery, development, manufacturing, marketing, sales and distribution of biopharmaceutical products worldwide. per share amounts). Reported Diluted EPS (1).

Vaccination 40

Vaccination Vaccine Production Sales 40

Pharmaceutical Technology

FEBRUARY 28, 2023

Biocytogen Pharmaceuticals’ wholly owned subsidiary Eucure Biopharma and Shenzhen Chipscreen Biosciences’ holding subsidiary Chipscreen NewWay Biosciences have entered an exclusive licensing agreement for YH008, a bispecific antibody. It also activated tumour-infiltrating DCs and T cells in vivo pharmacodynamic studies.

In-Vivo 130

In-Vivo Antibody In-Vitro Licensing 130

XTalks

SEPTEMBER 14, 2020

By the end of August, the World Health Organization (WHO) counted 33 vaccine candidates in some stage of clinical trial evaluation. As of July, the company and its federal partner stated that it is on track to supply between 500 million to 1 billion doses a year at a dose of 100 µg now selected for their Phase III trial.

Vaccination 92

Vaccination Vaccine Antibody Life Science 92