The Pharma Data

AUGUST 7, 2020

Most importantly, we are continuing to see patients benefit from the profound therapeutic effects of both approved products and those currently in clinical development. The LY-CoV555 antibodies are infection fighting that can bind to the surface of viruses and prevent the virus infecting cells.

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PPD

OCTOBER 24, 2024

Hepatitis B virus (HBV) infection remains a significant public health challenge, particularly in low- and middle-income countries (LMIC) and in the Asia-Pacific region. Coordinated efforts are needed to combat this disease and improve the clinical status of persons with HBV infection.

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The Pharma Data

JUNE 1, 2022

Under her leadership, Pfizer advanced into clinical development or approval bacterial vaccine programs directed at the prevention of diseases due to Streptococcus pneumoniae, Group B Streptococcus, Neisseria meningitidis, Staphylococcus aureus, and Clostridium difficile. Dr. Anderson joined Pfizer via Wyeth in 2007.

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The Pharma Data

OCTOBER 30, 2020

About REGN-COV2 REGN-COV2 is a combination of two monoclonal antibodies (REGN10933 and REGN10987) and was designed specifically to block infectivity of SARS-CoV-2, the virus that causes COVID-19.

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The Pharma Data

JUNE 26, 2021

The extensive Actemra/RoActemra RA IV clinical development programme included five phase III clinical studies and enrolled more than 4,000 people with RA in 41 countries. We also continue to identify, develop and support potential therapies which can play a role in treating the disease.

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The Pharma Data

JANUARY 20, 2021

Dr. John Teerlink – Professor of Medicine, University of California, San Francisco and Director of Heart Failure and the Echocardiographic Laboratory at the San Francisco Veterans Affairs Center. Wells is the author or co-author of over 400 published articles. Cardiol Therapeutics Inc. (

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The Pharma Data

DECEMBER 17, 2020

Senior Vice President and Head of Global Clinical Development at Regeneron and lead author of the publication. patients under an Emergency Use Authorization, and we also continue a robust clinical development program.” “The investigational cocktail is now available to indicated high-risk U.S.

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The Pharma Data

JANUARY 13, 2021

said, “Nearly 30 years ago my laboratory at Columbia University generated the first anti-CD40-ligand mAb (5c8), discovered and characterized human CD40-ligand and elucidated the molecular basis of T cell helper function 1. If claims are granted, a patent issuing from a national stage of this application could potentially provide U.S.

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The Pharma Data

NOVEMBER 19, 2020

The program is being led by Sosei Heptares and progressed in collaboration with multiple companies including Syngene International, Domainex, Fidelta, o2h Discovery, Piramal, WuXi AppTec and the MRC Laboratory of Molecular Biology.

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The Pharma Data

JUNE 30, 2021

Today’s results show us the potential power of cell therapy for patients with lymphoma when used earlier, and instead of standard treatment options,” said Frank Neumann, MD, PhD, Kite’s Global Head of Clinical Development. The most common non-laboratory adverse reactions (incidence ?20%)

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The Pharma Data

DECEMBER 29, 2020

Senior Vice President and Head of Global Clinical Development at Regeneron. All patients entering the trial were hospitalized with laboratory-confirmed COVID-19 requiring low-flow oxygen, and all received other background standard-of-care as required.

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The Pharma Data

JANUARY 3, 2021

Preclinical data from our laboratory have shown that the nasal administration of anti-CD3 stimulates Tregs that can suppress inflammation and ameliorate inflammatory diseases. Foralumab is the only fully human anti-CD3 monoclonal antibody (mAb) in clinical development in the world.

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The Pharma Data

NOVEMBER 1, 2020

Thus, our clinical study is both timely and potentially a life changer for the COVID-19 patients. The scientific concept, to activate nasal mucosal immunity by nasally administered Foralumab, is to fight against the virus in the respiratory tract and lungs,” stated Dr. Shailubhai, CEO and CSO of Tiziana Life Sciences.

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The Pharma Data

MARCH 4, 2021

vice president of immunology development at Lilly. “We are looking forward to sharing the totality of data from the overall clinical development program for baricitinib as a potential first-in-disease treatment for alopecia areata.” herpes zoster), were reported in clinical studies with Olumiant.

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Agency IQ

AUGUST 18, 2023

regulators, and certain laboratories – had new roles that they needed to adapt into their updated quality management systems. Some of these systems included the registration and vigilance database, EUDAMED, expert panels, the clinical and performance evaluation consultation procedures, and the establishment of E.U. regulators.

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The Pharma Data

OCTOBER 29, 2020

vice president of immunology development at Lilly. “The results of this study underscore baricitinib’s potential in alopecia areata, and we look forward to continuing the clinical development program for baricitinib in hopes of becoming the first FDA approved treatment option for adults with AA.”

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The Pharma Data

DECEMBER 5, 2020

REGN5458 and odronextamab are currently under clinical development, and their safety and efficacy have not been evaluated by any regulatory authority. Additionally, Regeneron bispecifics are manufactured using similar approaches used for human monoclonal antibody medicines, yielding similar properties and pharmacokinetics.

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The Pharma Data

NOVEMBER 5, 2020

“Last week, Regeneron achieved an important milestone in the fight against COVID-19 with prospective Phase 2/3 results showing REGN-COV2 significantly reduced virus levels and the need for further medical attention in non-hospitalized patients; we have shared these important data with regulatory authorities,” said Leonard S.

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The Pharma Data

MARCH 8, 2021

The companies today reported findings on one secondary objective from the Phase 2a study, showing a reduction in time (days) to negativity of infectious virus isolation in nasopharyngeal swabs from participants with symptomatic SARS-CoV-2 infection, as determined by isolation in Vero cell line culture. About Molnupiravir.

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The Pharma Data

NOVEMBER 20, 2020

LABORATORY ABNORMALITIES. Some patients treated with ZOKINVY developed laboratory abnormalities. Eiger’s lead clinical programs target Hepatitis Delta Virus (HDV) infection, the most serious form of human viral hepatitis. Eiger is developing two complementary treatments for HDV. times the human dose.

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The Pharma Data

JULY 12, 2021

The data were presented during the late-breaking clinical trials session at the European Congress of Clinical Microbiology & Infectious Diseases (ECCMID). In addition, Merck plans to initiate a clinical program to evaluate molnupiravir for post-exposure prophylaxis in the second half of 2021. “It About Molnupiravir.

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The Pharma Data

OCTOBER 26, 2020

Based on these promising findings, Transgene intends to continue the clinical development of TG4001 in a larger, controlled confirmatory study as we look to provide a better treatment option for this patient population,” added Dr. Maud Brandely, MD, PhD, Chief Medical Officer of Transgene. 27, 2020 06:30 UTC.

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The Pharma Data

DECEMBER 27, 2020

Infections due to hepatitis B virus (HBV) reactivation have occurred. Consider prophylaxis for herpes simplex virus, pneumocystis jiroveci pneumonia and other infections according to standard of care in patients who are at increased risk for infections. The most common Grade 3 or higher infection was pneumonia. Cytopenias.

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The Pharma Data

OCTOBER 26, 2020

V590 — a SARS-CoV-2 vaccine candidate in development in collaboration with the International AIDS Vaccine Initiative (IAVI) that uses a recombinant vesicular stomatitis virus (rVSV) platform, the same platform used for Merck’s approved Ebola Zaire virus vaccine, will enter Phase 1 development shortly.

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The Pharma Data

NOVEMBER 30, 2020

“I want to thank the thousands of participants in our Phase 1, Phase 2 and Phase 3 studies, as well as the staff at clinical trial sites who have been on the front lines of the fight against the virus. on October 22, including those at high risk of severe complications of COVID-19 disease.

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PPD

NOVEMBER 8, 2022

In the third year of the COVID-19 pandemic, we also see the virus’s lingering effect on industry operations. Clinical laboratory diagnostic services were most likely to be outsourced (80%), with data management , clinical trial management and biostatistical analyses (74%, 63% and 58%, respectively) close behind.

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The Pharma Data

APRIL 7, 2021

XELJANZ has been studied in more than 50 clinical trials worldwide and prescribed to over 208,000 adult patients (the majority of whom were RA patients) worldwide in the last eight years. Viral reactivation including herpes virus and hepatitis B reactivation have been reported. LABORATORY ABNORMALITIES. INDICATIONS.

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The Pharma Data

AUGUST 22, 2021

XELJANZ has been studied in more than 50 clinical trials worldwide, including more than 20 trials in RA patients, and prescribed to over 300,000 adult patients (the majority of whom were RA patients) worldwide since 2012. Viral reactivation including herpes virus and hepatitis B reactivation have been reported. MALIGNANCIES.

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The Pharma Data

JUNE 16, 2021

To effectively combat the COVID-19 pandemic, there remains a critical need for multiple therapeutic options to treat patients who have contracted the virus,” said Tamas Koncz, M.D., Viral reactivation including herpes virus and hepatitis B reactivation have been reported. LABORATORY ABNORMALITIES. MALIGNANCIES.

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Agency IQ

AUGUST 16, 2024

The final version newly clarifies that oncolytic viruses also fall outside the scope of the document and includes a new disclaimer that the guidance is not intended to address unique considerations of pediatric drug development.

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The Pharma Data

NOVEMBER 22, 2020

Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. Islatravir is a promising antiviral candidate with evidence from ongoing clinical trials to support its development as a once-monthly oral PrEP agent.

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