The Pharma Data

AUGUST 5, 2021

The platform already has potentially ground-breaking medical innovations in clinical development, such as a therapy for the treatment of Parkinson’s. Bayer recently formed its own cell and gene therapy platform as part of its transformation strategy for Pharmaceuticals. Group sales in the second quarter increased by 12.9

Sales 52

Sales Production Gene Therapy Allergies 52

XTalks

JANUARY 19, 2024

Regulatory bodies have demonstrated preparedness for the surge in radiopharmaceuticals as evidenced by inaugural Chemistry, Manufacturing and Controls (CMC) Development and Readiness Pilot (CDRP) programs to expedite commercial manufacturing, US Food and Drug Administration (FDA) approvals and marketing authorizations.

DNA 66

DNA Radiology FDA Approval Development 66

The Pharma Data

DECEMBER 8, 2020

Orphan drug designation is the first step in receiving orphan drug exclusivity following approval, which confers seven years of market exclusivity for the relevant indication. The granting of an orphan drug designation request does not alter the standard regulatory requirements and process for obtaining marketing approval.

Drugs 40

Drugs FDA Approval Marketing Containment 40

The Pharma Data

MARCH 17, 2021

Across clinical trials (MONARCH 1, MONARCH 2, MONARCH 3), 3.3% Additional cases of ILD/pneumonitis have been observed in the post-marketing setting, with fatalities reported. Symptoms may include hypoxia, cough, dyspnea, or interstitial infiltrates on radiologic exams. had Grade 3 or 4, and 0.4% had fatal outcomes.

HR 52

HR Trials In-Vitro Manufacturing 52

XTalks

SEPTEMBER 11, 2024

Jansen recently moderated a webinar in which her colleagues at Medpace discussed the evolving women’s health sector, including the historical challenges and emerging trends in clinical development. This surge reflects a growing recognition of the market potential in addressing women’s health.

Clinical Trials 103

Clinical Trials Clinical Trials Trials Hormones 103

The Pharma Data

MARCH 29, 2022

AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab), a long-acting antibody combination, has been granted marketing authorisation in the European Union (EU) for the pre-exposure prophylaxis (prevention) of COVID-19 in a broad population of adults and adolescents aged 12 years and older weighing at least 40 kg.

Antibody 52

Antibody In-Vivo Vaccination Vaccine 52

The Pharma Data

MAY 3, 2021

Alnylam provides long-term look at Oxlumo, aiming to further carve out stake in PH1 market ( Endpoints ). ICH plots major overhaul of good clinical practice guideline ( Endpoints ). Radiology Partners, Aidoc talk AI adoption, handling bias, FDA actions ( MedtechDive ). Medtech.

Gene Therapy 52

Gene Therapy Vaccination Vaccine Bioequivalency 52

XTalks

SEPTEMBER 14, 2020

All this cannot begin to explain the weird reality that the stock markets in the US (and elsewhere) are doing just fine. In fact, financial markets have almost regained most of the losses caused by COVID-19. Here again, the stock markets are functioning in a parallel universe. billion in June. ECONOMIC IMPACT: Canada.

Vaccination 92

Vaccination Vaccine Antibody Life Science 92