The Pharma Data

JANUARY 19, 2021

Dr. Mats Jerkeman is Professor in Clinical Oncology at Lund University, Sweden. His research focus is all possible aspects of malignant lymphomas, aiming for the improvement of the quality of life and survival of these patients. To register for the call, please click here. The Company’s validated, proprietary F.I.R.S.T

Antibody 40

Antibody Clinical Trials Clinical Trials Licensing 40

The Pharma Data

JANUARY 24, 2021

Sairiyo is advancing the clinical development of its lead drug candidate, Cepharanthine, a repurposed and reformulated naturally derived compound for the potential treatment of cancer, neurological, inflammatory and infectious diseases. Research and development efforts will be led by Dr. Paul Van Slyke.

Drugs 52

Drugs Containment Development Sales 52

Drug Discovery World

FEBRUARY 12, 2024

After all, these failures come on top of decades and decades of research into these diseases. Animal research Unfortunately, most of the research into these diseases has been conducted on animals. In this sort of research, scientists try to reproduce the disease in animals and then test new drugs on these animals.

Medicine 59

Medicine Genome Genomics Drugs 59

The Pharma Data

NOVEMBER 3, 2020

According to the FDA, the purpose of Fast Track designation is to get important new drugs to patients earlier by facilitating the development, and expediting the review, of drugs to treat serious conditions and fill an unmet medical need. It may also allow for priority or rolling review of a company’s Biologics License Application (BLA).

Clinical Trials 52

Clinical Trials Clinical Trials Gene Editing Genome 52

The Pharma Data

JANUARY 27, 2021

. A total of 15 patients have been recruited to date in the Phase I dose escalation part of the study, all of whom were late stage and have failed conventional treatments, including several lines of rituximab-containing therapies. ET ) to discuss the results and next steps in clinical development of BI-1206.

Antibody 52

Antibody Containment Development Trials 52

Pfizer

FEBRUARY 16, 2023

GCP is the international ethical and scientific quality standard for clinical trials that all clinical researchers need to follow. The clinical trial remains ongoing with other sites not operated by the third party, and Pfizer continues to enroll new participants at those sites.

Clinical Trials 76

Clinical Trials Clinical Trials Vaccination Vaccine 76

The Pharma Data

JANUARY 4, 2021

The program was licensed to Allergan in April 2016 , and Allergan was acquired by AbbVie in May 2020. Sosei Heptares will now conduct a full internal review to determine a strategy for the further development and re-partnering of the program. . ” About the License Agreement. TOKYO and CAMBRIDGE, England , Jan.

Licensing 40

Licensing Licensing Development Production 40

The Pharma Data

JANUARY 3, 2021

With these important regulatory clearances for our first-in-human clinical trial for INZ-701 in subjects with ENPP1 deficiency, we have transitioned from a research-stage to a clinical-stage company. and Axel Bolte, MSc, MBA, with technology developed by Dr. Braddock and licensed from Yale University.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Containment 52

The Pharma Data

JANUARY 14, 2021

Associate Professor of Medicine at UCLA, Co-director of the Gastrointestinal Oncology Program and Director of Early Phase Clinical Research at the Jonsson Comprehensive Cancer Center. Bemarituzumab is being developed in gastric and GEJ cancer as a targeted therapy for tumors that overexpress FGFR2b. Wainberg, M.D.,

Trials 52

Trials HR Containment Development 52

The Pharma Data

OCTOBER 19, 2020

“Pneumococcal disease in adults is on the rise globally, in part driven by disease-causing serotypes not targeted by the currently available pneumococcal conjugate vaccine,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories.

Vaccination 52

Vaccination Vaccine Immune Response Containment 52

The Pharma Data

APRIL 27, 2021

The information contained in this release is as of April 19, 2021. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. Pfizer Disclosure Notice. For more information, please visit www.BioNTech.de.

Vaccination 52

Vaccination Vaccine Manufacturing Clinical Trials 52

The Pharma Data

DECEMBER 23, 2020

The Company has Now Resumed the Clinical Development of its Proposed Anti-Nausea Pharmaceutical Grade Version of Tauri-Gum. With this funding now complete, the Company is excited about its prospects for 2021 – as it pertains to its pharmaceutical development efforts. . NEW YORK, NY, Dec.

Life Science 52

Life Science Manufacturing Production Development 52

The Pharma Data

DECEMBER 14, 2020

The Company anticipates using net proceeds from the offering to fund the continued development of ublituximab and umbralisib, the potential in-license, acquisition, development and commercialization of other pharmaceutical products, and for general corporate purposes. Morgan Securities LLC, Goldman Sachs & Co.

Clinical Trials 40

Clinical Trials Clinical Trials Clinical Development Antibody 40

The Pharma Data

JANUARY 25, 2021

“ This marks our second strategic agreement with Asieris, a well-run and well-capitalized company that is executing ahead of plan on the clinical development of Cevira ®, which we licensed to them in July 2019. but with a healthcare system that is still developing.

Production 40

Production Clinical Development Licensing Licensing 40

Drug Discovery World

MARCH 29, 2023

Peter O’Donnell, Applied Clinical Trials’ Brussels Correspondent, summarises this as the EMA being tasked with creating a European network of patient representatives, academics, drug developers, investigators, and centres with expertise in the performance of studies in the paediatric population.

Clinical Trials 52

Clinical Trials Clinical Trials Production Medicine 52

The Pharma Data

NOVEMBER 22, 2020

We believe we are well prepared to press forward given our strong balance sheet and pioneering leadership in the development of muscle-directed therapies.”. The company will be conducting market research to gain additional feedback from physicians and payors to inform the potential path forward. Terms of Termination.

Development 52

Development Clinical Trials Clinical Trials Trials 52

The Pharma Data

SEPTEMBER 8, 2020

Together, these nine companies have collectively developed more than 70 novel vaccines that have helped to eradicate some of the world’s most complex and deadly public health threats, underscoring their experience in clinical development and regulatory rigor, as well as their longstanding commitments to patient safety and public health.

Vaccination 52

Vaccination Vaccine Containment Clinical Trials 52

The Pharma Data

DECEMBER 11, 2020

Pfizer and BioNTech expect to file a Biologics License Application for possible full regulatory approval in 2021. Pfizer has a 171-year track record of researching, developing, manufacturing and delivering innovative medicines and vaccines to patients in need. Pfizer Disclosure Notice.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

The Pharma Data

JANUARY 18, 2021

a clinical-stage biotechnology company focused on developing treatments for immunological and inflammatory diseases, today announced its launch backed by $80 million Series C financing led by Abingworth LLP. . SOUTH SAN FRANCISCO, Calif. , 19, 2021 /PRNewswire/ — Vera Therapeutics, Inc. ,

Development 52

Development Life Science Protein Clinical Development 52

The Pharma Data

JANUARY 13, 2021

.” MindMed Chief Development Officer Rob Barrow said, “Psychedelic therapies offer a once in a lifetime opportunity to revolutionize the delivery of mental healthcare. About MindMed.

Clinical Trials 52

Clinical Trials Clinical Trials Development Trials 52

The Pharma Data

SEPTEMBER 8, 2020

Together, these nine companies have collectively developed more than 70 novel vaccines that have helped to eradicate some of the world’s most complex and deadly public health threats, underscoring their experience in clinical development and regulatory rigor, as well as their longstanding commitments to patient safety and public health.

Vaccination 52

Vaccination Vaccine Containment Clinical Trials 52

The Pharma Data

MAY 6, 2021

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. The information contained in this release is as of May 6, 2021. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

The Pharma Data

JULY 21, 2021

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. The information contained in this release is as of July 21, 2021. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

Manufacturing 52

Manufacturing Vaccination Vaccine Clinical Trials 52

The Pharma Data

JANUARY 4, 2021

We believe our allogenic CAR-T platform is significantly stronger with chPD1 target licensed from Longwood University. Barber’s work will give Kiromic a significant acceleration in the clinical development of its therapy platform and an even more significant advantage over its competitors. “We believe Prof.

In-Vivo 40

In-Vivo Development Big Data Immune Response 40

The Pharma Data

NOVEMBER 20, 2020

Zokinvy-naïve patients originated from a separate natural history study (n=81) conducted by The Progeria Research Foundation. The Rare Pediatric Disease Priority Review Voucher program is designed to encourage development of new drugs and biologics for the prevention or treatment of rare pediatric diseases.

FDA Approval 52

FDA Approval Genetics Clinical Trials Clinical Trials 52

The Pharma Data

JANUARY 18, 2021

OKYO has been developing the chemerin molecule as a promising anti-inflammatory treatment for dry-eye disease (“DED”) licensed from researchers at On Target Therapeutics LLC. THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES OF ARTICLE 7 OF REGULATION (EU) NO 596/2014. LONDON and BOSTON, Jan. Gary S.

Life Science 40

Life Science Development Sales Drugs 40

The Pharma Data

SEPTEMBER 9, 2020

On July 27, Pfizer and BioNTech announced that following extensive review of preclinical and clinical data from Phase 1/2 clinical trials, and in consultation with the FDA’s Center for Biologics Evaluation and Research (CBER) and other global regulators, the companies selected the BNT162b2 vaccine candidate to move forward into a Phase 2/3 study.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

The Pharma Data

NOVEMBER 20, 2020

The company has developed specially designed, temperature-controlled shippers for the BNT162b2 vaccine candidate, which can maintain recommended storage conditions (-70°C ±10°C) up to 15 days. Each shipper contains a GPS-enabled thermal sensor to track the location and temperature of each vaccine shipment. Pfizer Disclosure Notice.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

The Pharma Data

OCTOBER 30, 2020

REGN-COV2’s development and manufacturing has been funded in part with federal funds from the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services under OT number: HHSO100201700020C.

Production 52

Production Antibody Manufacturing Trials 52

The Pharma Data

AUGUST 20, 2020

The totality of the clinical and preclinical data informed Pfizer and BioNTech’s decision to select BNT162b2 as the lead candidate to advance into pivotal trials. Senior Vice President and Head of Vaccine Research & Development, Pfizer. “We The information contained in this release is as of August 20, 2020.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

The Pharma Data

DECEMBER 1, 2020

The data submitted to regulatory agencies around the world are the result of a scientifically rigorous and highly ethical research and development program.”. Pfizer has a 171-year track record of researching, developing, manufacturing and delivering innovative medicines and vaccines to patients in need.

Vaccination 40

Vaccination Vaccine Manufacturing Clinical Trials 40

The Pharma Data

NOVEMBER 11, 2020

Under the FDA’s Rare Pediatric Disease Priority Review Voucher program, a sponsor who receives approval of a biologics license application (BLA) for a rare pediatric disease product application may be eligible for a voucher which can be redeemed to obtain priority review for a subsequent marketing application for a different product.

Clinical Trials 40

Clinical Trials Clinical Trials Trials Development 40

The Pharma Data

DECEMBER 10, 2020

Senior Vice President and Head of Vaccine Research & Development, Pfizer. “As The information contained in this release is as of December 10, 2020. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

Vaccination 52

Vaccination Vaccine Trials Medicine 52

FDA Law Blog

SEPTEMBER 20, 2021

Perhaps the most welcome commitment, both the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER) plan to hire significantly more drug review staff under PDUFA VII than we had seen under PDUFA VI. Notable Dates and Timelines – Applications open, Q4 of FY 2023.

Development 52

Development Gene Therapy Production Drugs 52

The Pharma Data

DECEMBER 12, 2020

AstraZeneca has developed a broad range of technologies, initially focused on small molecules and biologics and with a growing focus in precision medicine, genomics, oligonucleotides and epigenetics. More recently, AstraZeneca has increased its efforts in immunology research and the development of medicines for immune-mediated diseases.

Development 75

Development Regulation Medicine Containment 75

The Pharma Data

DECEMBER 20, 2020

Weber, MD, PhD, Deputy Director of the Perlmutter Cancer Center at New York University (NYU)-Langone Health, co-Director of its Melanoma Research Program Center and Chair of SELLAS’ Scientific Advisory Board. SELLAS’ lead product candidate, GPS, is licensed from MSK and targets the WT1 protein, which is present in an array of tumor types.

Life Science 52

Life Science Immune Response Trials Clinical Trials 52

The Pharma Data

NOVEMBER 9, 2020

The information contained in this release is as of November 9, 2020. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. Pfizer Disclosure Notice. For more information, please visit www.BioNTech.de.

Vaccination 40

Vaccination Vaccine Clinical Trials Clinical Trials 40