pharmaphorum

DECEMBER 15, 2022

Woxström, a 26-year veteran of AstraZeneca, will lead sales, marketing, and commercial operations for 30 European countries plus Canada. Prior to 2022, she did sales and marketing at Pfizer, Allergan, DuPont Pharma, and Johnson & Johnson. The month of November saw a number of notable hires and personnel moves in biotech and pharma.

Sales 52

Sales In-Vitro Antibody Drug Delivery 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

XTalks

JUNE 30, 2023

Sartorius is a globally recognized player in the diagnostics industry, providing a variety of solutions for in vitro diagnostics kit (IVD) manufacturers. In this Xtalks Spotlight feature, Xtalks spoke with two diagnostics experts from Sartoris: Wiktoria Banczyk, Strategy Analyst LPS, and Marvin (Ming) Xu, Manager of OEM DM Sales Asia.

In-Vitro 52

In-Vitro Manufacturing Production Antibody 52

The Pharma Data

SEPTEMBER 1, 2020

with whom Roche has a global distribution agreement and had also launched a Rapid Antibody Test in July. Antigen test reliably and quickly triages people suspected of SARS-CoV-2, with results ready in 15 minutes, allowing informed treatment decisions. Roche also intends to file for Emergency Use Authorisation (EUA) to the U.S.

In-Vitro 52

In-Vitro Antibody Medicine Clinical Trials 52

The Pharma Data

AUGUST 22, 2021

AZD7442 is the first antibody combination (non-vaccine) modified to potentially provide long-lasting protection that has demonstrated prevention of COVID-19 in a clinical trial. In the placebo arm, there were three cases of severe COVID-19, which included two deaths. About PROVENT.

Trials 52

Trials Antibody Vaccination Vaccine 52

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

AUGUST 31, 2020

Current serology-based testing methods rely on the ability to detect an antibody or antigen response. As a result, they can fail to identify an infection if the person is tested prior to having a detectable antibody or antigen response, which can take several weeks to generate.

FDA Approval 52

FDA Approval In-Vitro Antibody Medicine 52

The Pharma Data

JANUARY 19, 2021

Ortho Clinical Diagnostics is a leader in in vitro diagnostics. On January 12, its VITROS SARS-CoV-2 Antigen Test for mass-scale COVID-19 testing received FDA Emergency Use Authorization. The year is starting off with a number of biopharma and life sciences initial public offerings (IPOs). TCR2 Therapeutics – The Cambridge, Mass.

In-Vitro 52

In-Vitro Production Trials Manufacturing 52

XTalks

JUNE 12, 2023

As technology continues to revolutionize every sector of our lives, the medical device industry stands at the forefront of this innovation, playing a pivotal role in enhancing patient care, improving diagnostic accuracy and transforming treatment modalities. Note: When it comes to companies that report in foreign currencies, the conversion to U.S.

FDA Approval 98

FDA Approval Production Sales In-Vitro 98

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 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

MAY 18, 2021

If approved, ENSPRYNG will be the first and only treatment available to both adults and adolescents from 12 years of age with anti-aquaporin-4 antibody (AQP4-IgG) seropositive NMOSD in the EU. ENSPRYNG is the only subcutaneous treatment option for NMOSD that can be administered at home every four weeks.

Antibody 40

Antibody Medicine In-Vitro Development 40

The Pharma Data

SEPTEMBER 9, 2020

Food and Drug Administration (FDA) for adults with anti-aquaporin-4 (AQP4) antibody positive NMOSD. Food and Drug Administration (FDA) for adults with anti-aquaporin-4 (AQP4) antibody positive NMOSD. ENSPRYNG lowered relapse severity in double-blind periods of SAkura Phase III studies. ENSPRYNG was recently approved by the U.S.

Antibody 52

Antibody Medicine In-Vitro HR 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

AUGUST 6, 2020

Safety for the Tecentriq combination appeared to be consistent with the known safety profile of the individual medicines, and no new safety signals were identified. Roche’s Chief Medical Officer and Head of Global Product Development. This includes studies evaluating Tecentriq both alone and in combination with other medicines.

Medicine 52

Medicine In-Vitro Protein Antibody 52

The Pharma Data

SEPTEMBER 2, 2020

New Phase III data from SAkuraStar and SAkuraSky studies demonstrate reduced severity of relapses with ENSPRYNG (satralizumab), recently FDA-approved as the first and only subcutaneous treatment for adults living with anti-aquaporin-4 (AQP4) antibody positive neuromyelitis optica spectrum disorder (NMOSD).

Clinical Trials 52

Clinical Trials Clinical Trials Antibody Medicine 52

The Pharma Data

SEPTEMBER 18, 2020

Recommendation is based on the results of the IMbrave150 study, in which the Tecentriq combination improved overall survival and progression-free survival compared with the previous standard of care. Chief Medical Officer and Head of Global Product Development. Chief Medical Officer and Head of Global Product Development.

Medicine 52

Medicine HR In-Vitro Protein 52

The Pharma Data

MAY 4, 2021

Tecentriq significantly improved overall survival in people with high PD-L1 expression, compared with chemotherapy in a Phase III study. Tecentriq approval offers an alternative to chemotherapy for all eligible patients. We are delighted to bring Tecentriq to people in the EU with this specific type of lung cancer,” said Levi Garraway, M.D.,

Protein 52

Protein HR In-Vitro Medicine 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 Development 40

The Pharma Data

AUGUST 9, 2020

Etrolizumab met its primary endpoint of inducing remission versus placebo for people with ulcerative colitis in only two of three studies. Etrolizumab failed to meet its primary endpoint versus placebo as maintenance therapy in people with ulcerative colitis. Analyses of these data are ongoing to better understand the results.

Medicine 52

Medicine In-Vitro Clinical Trials Clinical Trials 52

The Pharma Data

SEPTEMBER 10, 2020

75% of patients with relapsing-remitting multiple sclerosis (RRMS) and suboptimal response to prior treatment had no evidence of disease activity two years after switching to OCREVUS in open-label Phase IIIb CASTING study. 97% persistence and strong adherence to OCREVUS treatment and twice-yearly dosing schedule from real-world data.

In-Vitro 52

In-Vitro Medicine FDA Approval Clinical Trials 52

The Pharma Data

SEPTEMBER 19, 2020

Data from the Phase III IMpassion031 study demonstrated that Tecentriq in combination with chemotherapy improved pathological complete response for patients with early triple-negative breast cancer (TNBC), when compared to placebo plus chemotherapy. Roche’s Chief Medical Officer and Head of Global Product Development. from 41.1% (95% CI: 33.6–48.9)

HR 52

HR Medicine In-Vitro Development 52

The Pharma Data

JUNE 26, 2021

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. Roche’s Chief Medical Officer and Head of Global Product Development. FDA in this setting, but the U.S.

Clinical Trials 40

Clinical Trials Clinical Trials In-Vitro Antibody 40

The Pharma Data

MAY 18, 2021

The advisory committee provides the FDA with independent opinions and recommendations from outside medical experts though the recommendations are not binding. The FDA has not announced when it will make its final decision for Tecentriq in this indication. Roche’s Chief Medical Officer and Head of Global Product Development.

Medicine 40

Medicine In-Vitro Containment Development 40

The Pharma Data

APRIL 27, 2021

The advisory committee provides the FDA with independent opinions and recommendations from outside medical experts, though the recommendations are not binding. The FDA has not announced when it will make its final decision for Tecentriq in this indication. Roche’s Chief Medical Officer and Head of Global Product Development.

Medicine 40

Medicine In-Vitro Antibody Development 40

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

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

The Pharma Data

SEPTEMBER 16, 2020

New and updated data from across our broad cancer portfolio including phase III results in breast, lung and prostate cancers. New integrated analyses from our tumour agnostic Rozlytrek ® (entrectinib) clinical development programme. Join this event on Roche’s LinkedIn page here. Roche highlights featured at ESMO Virtual Congress 2020.

HR 52

HR Medicine Hormones Trials 52

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

Moderna, for one, recently reported positive results in older adults between 56 and 71, as well as those 71 years of age and older, who reportedly mounted levels of neutralizing antibodies against the SARS-CoV-2 virus after two doses of its vaccine that were comparable to those seen in younger adults. The price of that prize is incalculable.

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Vaccine Vaccination Antibody Life Science 92