The Pharma Data

NOVEMBER 18, 2021

KEYTRUDA Is Now Approved for the Adjuvant Treatment of Patients With RCC at Intermediate-High or High Risk of Recurrence Following Nephrectomy, or Following Nephrectomy and Resection of Metastatic Lesions. KEYTRUDA Is the First Immunotherapy Approved for the Adjuvant Treatment of These Patients With RCC.

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The Pharma Data

DECEMBER 9, 2020

Together with our immune cell-targeting assets, this could enable new powerful combinations that will allow for efficacious and durable treatments for patients,” said Michel Pairet, member of Boehringer Ingelheim’s Board of Managing Directors with responsibility for the company’s Innovation Unit. .

FDA Approval 52

FDA Approval Clinical Development Vaccine Therapies 52

The Pharma Data

DECEMBER 11, 2020

FDA authorizes COVID-19 mRNA vaccine for emergency use; companies are prepared to deliver first doses in the U.S. In collaboration with Operation Warp Speed, Pfizer and BioNTech, as well as other vaccine companies are expected to deliver hundreds of millions of vaccine doses to Americans by the end of 2021.

Vaccine 52

Vaccine Clinical Trials Licensing Licensing 52

The Pharma Data

NOVEMBER 20, 2020

billion doses by the end of 2021; the companies will be ready to distribute the vaccine within hours after authorization. BNT162b2 demonstrated a vaccine efficacy rate of 95%, with no serious safety concerns observed to date. by the middle to end of December 2020. participants are 56-85 years of age.

Vaccine 52

Vaccine FDA Clinical Trials Trials 52

The Pharma Data

DECEMBER 10, 2020

. Data from 43,448 participants, half of whom received BNT162b2 and half of whom received placebo, showed that the vaccine candidate was well tolerated and demonstrated 95% efficacy in preventing COVID-19 in those without prior infection 7 days or more after the second dose. Jansen, Ph.D.,

Vaccine 52

Vaccine Trials Clinical Trials Therapies 52

The Pharma Data

NOVEMBER 9, 2020

Vaccine candidate was found to be more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis. This means that protection is achieved 28 days after the initiation of the vaccination, which consists of a 2-dose schedule.

Vaccine 40

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The Pharma Data

APRIL 4, 2022

If approved, Dupixent would be the first medicine available in the U.S. living with eosinophilic esophagitis who are currently treated, of whom approximately 48,000 have failed multiple treatments. FDA granted Breakthrough Therapy designation to Dupixent for the treatment of patients aged 12 years and older with EoE.

FDA 52

FDA Treatment FDA Approval Disease 52

The Pharma Data

NOVEMBER 12, 2020

José Baselga, Executive Vice President, Oncology R&D, said: “Since the beginning of the year, AstraZeneca has been committed to doing everything we can to respond to COVID-19, including investigating existing medicines as potential treatments. Related Articles: Calquence (acalabrutinib) FDA Approval History. J Hematol Oncol.

Trials 52

Trials Clinical Trials Immune Response FDA Approval 52

The Pharma Data

MAY 31, 2022

The FDA grants priority review to therapies that have the potential to provide significant improvements in the treatment, diagnosis or prevention of serious conditions. who are unable to control their disease with systemic therapy and are most in need of a treatment option. There are approximately 75,000 people in the U.S.

FDA 52

FDA Disease Trials FDA Approval 52

The Pharma Data

JULY 21, 2021

mg, 5 mg, and 10 mg) is indicated for the treatment of symptomatic chronic heart failure in adult patients with reduced ejection fraction who are stabilized after a recent decompensation event requiring intravenous (IV) therapy. Bayer also issued a news release earlier today announcing the EC approval. In the EU, VERQUVO (2.5

Treatment 52

Treatment Production Hospitals FDA Approval 52

The Pharma Data

SEPTEMBER 1, 2020

The trial included 2,494 patients who had previously completed a Phase 1, 2 or 3 Zeposia clinical trial and who had an average treatment time of 35.4 Gaining insight into long-term therapeutic outcomes can enable clinicians to identify the most appropriate treatment approach for their multiple sclerosis patients. Author: Selmaj.

Clinical Trials 52

Clinical Trials Treatment Trials Disease 52

Conversations in Drug Development Trends

MAY 30, 2024

Since marketing authorization for the first breakthrough treatment in 1994, the steady increase in clinical trials reflects the community’s commitment to finding effective ALS treatments despite the numerous hurdles associated with clinical trial design, from proof-of-concept to pivotal trials.

Treatment 81

Treatment Small Molecule Clinical Trials Therapies 81

The Pharma Data

OCTOBER 29, 2020

Interim analyses were conducted after patients completed 12 and 36 weeks of treatment, the latter for the primary endpoint of the Phase 2 part of the study. ” In March, the FDA granted Breakthrough Therapy designation to baricitinib for the treatment of AA based on positive Phase 2 results from BRAVE-AA1.

Therapies 52

Therapies Treatment Disease Clinical Trials 52

The Pharma Data

MARCH 23, 2023

Head of Global R&D ad interim and Chief Medical Officer at Sanofi “Change cannot come quick enough for people living with uncontrolled COPD but , unfortunately , many investigational treatments have failed to demonstrate significant clinical outcomes leaving these vulnerable patients with limited treatment options.

Trials 40

Trials Disease Treatment Therapies 40

The Pharma Data

JULY 29, 2021

The series of promising pipeline updates included the data from the landmark ZUMA-7 study for the treatment of second-line large B-cell lymphoma. Launch activities continue following the full FDA approval for second-line metastatic triple-negative breast cancer (“mTNBC”) and accelerated approval for metastatic urothelial cancer.

Science 52

Science Production Treatment FDA 52

Drug Discovery World

SEPTEMBER 16, 2022

Globally, the pipeline for therapies in this sector has continued to grow over the years, and in 2021, there were just under 2,500 cell and gene therapies in some stage of clinical development. . The UK stands as one of the key markets for cell and gene therapies. billion in funding. .

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Therapies Clinical Trials Production Trials 130

The Pharma Data

MARCH 15, 2022

Merck will inform study investigators of the recommendation from the DMC and advise patients in the study to speak to their physician regarding treatment. Merck has an extensive clinical development program in prostate cancer evaluating KEYTRUDA as monotherapy and in combination with LYNPARZA and other anti-cancer therapies.

DNA 52

DNA Clinical Trials Trials Therapies 52

The Pharma Data

APRIL 4, 2023

First approved therapeutic regimen that combines an anti-PD-1 and an antibody-drug conjugate in the US in these patients Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. This indication is approved under accelerated approval based on tumor response rate and durability of response.

Treatment 40

Treatment FDA Approval FDA Therapies 40

The Pharma Data

MARCH 4, 2021

Food and Drug Administration (FDA) for the treatment of AA. There are currently no FDA-approved treatments for AA. “This level of high-quality research is needed to advance our understanding and the treatment of this frequently devastating disease.”

Trials 52

Trials Treatment Therapies Clinical Trials 52

The Pharma Data

OCTOBER 26, 2020

The treatment induced HPV-specific T-cell responses and was associated with increased levels of immune cell infiltration in the tumors and expression of genes associated with activation of the immune system. We developed TG4001, a viral based vaccine against the HPV E6 and E7 antigens. and a median PFS of 5.6

Vaccine 52

Vaccine Virus Trials Treatment 52

The Pharma Data

AUGUST 22, 2021

today that the European Commission (EC) has approved XELJANZ ® (tofacitinib) for the treatment of active polyarticular juvenile idiopathic arthritis (JIA) and juvenile psoriatic arthritis (PsA) in patients two years of age and older who have responded inadequately to previous therapy with disease modifying antirheumatic drugs (DMARDs).

Marketing 52

Marketing Clinical Trials Treatment Therapies 52

The Pharma Data

OCTOBER 28, 2020

Wave 1 Q2 highlights include: TAK-721 completed the rolling NDA submission and remains on track to be the first FDA-approved agent to treat eosinophilic esophagitis. TAK-003 is on track for a regulatory filing for Dengue vaccine in endemic countries in Asia and Latin America, and in the EU in Q4 FY2020.

Pharmaceutical Companies 40

Pharmaceutical Companies Engineering Therapies Clinical Trials 40