The Pharma Data

DECEMBER 3, 2020

The Phase 1 trial was a randomized, observer-blind, placebo-controlled study to assess the safety, reactogenicity and immunogenicity of the adjuvanted COVID-19 S-Trimer vaccine candidates formulated with different antigen levels. No serious adverse events related to the vaccine candidates studied were reported.

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The Pharma Data

NOVEMBER 9, 2020

(Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for NVX-CoV2373, the Company’s COVID-19 vaccine candidate. Glenn, M.D., and globally.”.

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The Pharma Data

JANUARY 20, 2021

FDA Approves Verquvo (vericiguat) for Heart Failure with Reduced Ejection Fraction. This approval builds upon Merck’s proud history of developing therapies for the treatment of patients with cardiovascular disease.”. Related Articles: Verquvo (vericiguat) FDA Approval History. KENILWORTH, N.J.–(BUSINESS

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The Pharma Data

JANUARY 31, 2021

Adjuvanted S-Trimer COVID-19 vaccine candidates demonstrated favorable safety and tolerability profiles and strong neutralizing immune responses in a phase 1 trial. Clover plans to initiate a global phase 2/3 trial in the first half of 2021 with an interim analysis for vaccine efficacy potentially in the middle of 2021.

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The Pharma Data

DECEMBER 10, 2020

–( BUSINESS WIRE )– ImmunityBio , a privately-held immunotherapy company, today announced its COVID-19 vaccine candidate protected nasal and lung airways of non-human primates against coronavirus (SARS-CoV-2) in a challenge study. 11, 2020 02:48 UTC. CULVER CITY, Calif.–(

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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.

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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.

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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.,

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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.

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The Pharma Data

MAY 31, 2022

if approved Acceptance marks another important step in advancing Dupixent for a broad range of diseases with underlying type 2 inflammation. Both trials met the primary and key secondary endpoints, showing Dupixent significantly improved disease signs and symptoms compared to placebo, including reduction in itch and skin lesions.

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The Pharma Data

APRIL 4, 2022

The target action date for the FDA decision on this investigational use is August 3, 2022. The potential use of Dupixent in EoE is currently under clinical development, and the safety and efficacy have not been fully evaluated by any regulatory authority. Regulatory filings around the world are also planned in 2022. In the U.S.,

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The Pharma Data

NOVEMBER 12, 2020

The CALAVI trials were launched based on preclinical and early clinical evidence that Calquence could decrease the hyperinflammatory immune response and improve clinical outcomes in patients hospitalised with respiratory symptoms of COVID-19.1 Related Articles: Calquence (acalabrutinib) FDA Approval History.

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The Pharma Data

SEPTEMBER 1, 2020

“Alongside our industry-leading collaborators, we are investigating novel endpoints, brain volume and cognition, which may help to further our understanding of the safety and efficacy profile of Zeposia and can advance transformational science for multiple sclerosis patients experiencing this unpredictable, debilitating disease.”.

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The Pharma Data

JULY 21, 2021

Bayer also issued a news release earlier today announcing the EC approval. Food and Drug Administration (FDA) approved VERQUVO in the U.S. The approval of VERQUVO in the EU will provide doctors, health care professionals and patients with an important treatment option to complement currently available heart failure therapies.”.

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The Pharma Data

MARCH 23, 2023

Dupixent is the first and only biologic to demonstrate a clinically meaningful and highly significant reduction (30%) in moderate or severe acute exacerbations of COPD (rapid and acute worsening of respiratory symptoms), while also demonstrating significant improvements in lung function, quality of life and COPD respiratory symptoms.

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The Pharma Data

OCTOBER 29, 2020

30, 2020 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) and Incyte (NASDAQ: INCY) announced today new data for baricitinib (marketed as OLUMIANT ® ) will be presented at the annual Fall Clinical Dermatology meeting taking place virtually October 29-November 1, 2020. INDIANAPOLIS , Oct.

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The Pharma Data

JULY 29, 2021

Launch activities continue following the full FDA approval for second-line metastatic triple-negative breast cancer (“mTNBC”) and accelerated approval for metastatic urothelial cancer. Sales of Veklury are generally affected by COVID-19 related rates of infections, hospitalizations and vaccinations. Viral Diseases.

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Conversations in Drug Development Trends

MAY 30, 2024

This trend is on the rise despite recent disappointments with clinical trial outcomes, which have the potential to destabilize the industry in the short term regarding drug development strategy and optimal study designs.

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The Pharma Data

NOVEMBER 30, 2020

(Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced that the primary efficacy analysis of the Phase 3 study of mRNA-1273 conducted on 196 cases confirms the high efficacy observed at the first interim analysis.

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The Pharma Data

MARCH 15, 2022

“There remains a significant unmet need for patients diagnosed with advanced prostate cancer, who have a poor prognosis after not responding to initial therapy,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. Merck’s Focus on Cancer. About Merck.

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Codon

MARCH 24, 2024

MenAfriVac is a meningococcal vaccine that remains active, without refrigeration, for up to four days and has significantly boosted vaccine coverage in parts of sub-Saharan Africa. Mixing the extracts with a bit of water and genetic material then “reboots” the enzymes, which make conjugate vaccines at a cost of about $0.50

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The Pharma Data

APRIL 4, 2023

Patients were treated until disease progression or unacceptable toxicity. Thirty-seven percent of patients had upper tract disease. Patients in the dose escalation cohort (n=5), Cohort A (n=40), and Cohort K (n=76) received enfortumab vedotin 1.25 A total of 121 patients received KEYTRUDA in combination with enfortumab vedotin.

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The Pharma Data

MARCH 4, 2021

AA is an autoimmune disease that causes patchy hair loss on the scalp, face and sometimes on other areas of the body that can progress. 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.”

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The Pharma Data

OCTOBER 26, 2020

The results we have announced today demonstrate the potential of the combination of TG4001 with an immune checkpoint inhibitor in this particularly severe disease setting. Specific immune cell responses against oncogenic antigens are major determinants to achieve long-term disease control for HPV-related malignancies.

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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).

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The Pharma Data

OCTOBER 28, 2020

An adverse effect on revenue has been observed in some of our therapeutic areas, such as Neuroscience, for reasons such as patients visiting their medical care providers less frequently for non-life-threatening and chronic diseases. Rare Diseases The Rare Diseases franchise with JPY 295.4 EU, and Japan. Press release ).

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Agency IQ

SEPTEMBER 22, 2023

Since that time, the FDA’s use of single pivotal trials has become more common , especially due to FDA’s expanded reviews of products intended to treat, cure or prevent rare diseases or life-threatening conditions for which there is an unmet clinical need. When should this occur? at the end-of-phase 2 meeting).

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