XTalks

AUGUST 15, 2023

Akeega is a dual-action tablet (DAT) that contains the company’s androgen receptor-targeting hormone therapy Zytiga (abiraterone acetate) and PARP inhibitor (poly [ADP-ribose] polymerase inhibitor) niraparib. Niraparib is also sold by GSK under the name Zejula in other indications. In April 2016, Janssen Biotech, Inc.

FDA Approval 52

FDA Approval Gene Hormones Drugs 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

The Pharma Data

NOVEMBER 25, 2020

technology platform simultaneously identifies both targets and the antibodies that bind to them, generating many promising new drug candidates to fuel the Company’s own clinical development pipeline or for additional licensing and partnering. The Company’s validated, proprietary F.I.R.S.T

Antibody 52

Antibody Manufacturing Clinical Trials Clinical Trials 52

The Pharma Data

JANUARY 24, 2021

Sairiyo is a biotechnology company focused on repurposing and developing improved formulations of naturally derived compounds for serious, rare, and life-threatening diseases with the aim to obtain European Medicines Evaluation Agency and U.S. Food and Drug Administration (“FDA”) approval. PharmaDrug Inc.

Drugs 52

Drugs Containment Development Clinical Development 52

The Pharma Data

JANUARY 19, 2021

technology platform simultaneously identifies both targets and the antibodies that bind to them, generating many promising new drug candidates to fuel the Company’s own clinical development pipeline or for additional licensing and partnering. The Company’s validated, proprietary F.I.R.S.T

Antibody 40

Antibody Clinical Trials Clinical Trials Licensing 40

XTalks

APRIL 24, 2023

For rare disease studies where there is little or no clinical trial experience, outcome assessments would have to be validated within a clinical development program. Early and ongoing engagement with regulators greatly helps clinical development planning.

Gene Therapy 71

Gene Therapy Gene Trials Clinical Trials 71

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

DECEMBER 20, 2020

BT-001 is being co-developed through a 50/50 collaboration between BioInvent and Transgene. “This clinical trial approval sets the stage to further broaden BioInvent’s promising clinical pipeline. BT-001 is our fourth program in clinical development. The Company’s validated, proprietary F.I.R.S.T

Trials 52

Trials Antibody Clinical Trials Clinical Trials 52

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

We are pleased to be advancing our second therapy into clinical development in our quest to bring transformative medicines to patients who need them,” said Bruce Goldsmith, Ph.D., We are excited to investigate the potential of PBFT02 as a treatment for FTD-GRN as we initiate our clinical development program in the coming months.”.

Gene Therapy 52

Gene Therapy Gene Clinical Trials Clinical Trials 52

The Pharma Data

JANUARY 12, 2021

Dr Graham is a medicines development expert and Infectious Diseases Epidemiologist with global Biotech and Pharma R&D experience in Phase I-IV therapeutics as well as in-vivo & in-vitro diagnostics, across many modalities. He has in depth Global Development Expertise (e.g. About Tiziana Life Sciences.

Life Science 52

Life Science Antibody In-Vivo In-Vitro 52

The Pharma Data

DECEMBER 2, 2020

ERS Genomics – Ireland’s ERS Genomics Limited, and Germany’s Vivlion GmbH, announced a non-exclusive license agreement granting Vivlion access to ERS Genomics’ CRISPR/Cas9 patent portfolio, to enhance Vivlion’s gene editing reagents and screening services. Horizon Discovery Group – U.K.-based for its cGMP-compliant CHOSOURCE platform.

Drugs 52

Drugs Gene Editing Genome Genomics 52

The Pharma Data

JANUARY 3, 2021

The Phase 1/2 clinical trial will primarily investigate the safety and tolerability of INZ-701 and characterize its pharmacokinetic and pharmacodynamic profile, including plasma pyrophosphate (PPi) and other biomarker levels, to establish a recommended dosing regimen for further clinical development. About INZ-701.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Containment 52

Pfizer

FEBRUARY 16, 2023

The clinical trial remains ongoing with other sites not operated by the third party, and Pfizer continues to enroll new participants at those sites. The companies intend to work with regulatory authorities, and as previously announced, 1,2 aim for Pfizer to potentially submit a Biologics License Application (BLA) to the U.S.

Clinical Trials 76

Clinical Trials Clinical Trials Vaccination Vaccine 76

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

OCTOBER 14, 2020

ELX-02 is in the early stages of clinical development focusing on cystic fibrosis. This press release contains forward-looking statements, which are generally statements that are not historical facts. ELX-02 is an investigational drug that has not been approved by any global regulatory body. Forward-Looking Statements.

Protein 52

Protein RNA Production Genetics 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

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 Development Production 52

The Pharma Data

OCTOBER 26, 2020

Fast Track designation allows for early and frequent communication with the FDA throughout the entire drug development and review process. It may also allow for priority or rolling review of a company’s Biologics License Application (BLA).

Gene Therapy 40

Gene Therapy Gene Containment Development 40

pharmaphorum

SEPTEMBER 8, 2022

Last year, the company signed two deals in quick succession, which saw it form a licensing deal worth $1.3 The diagnostic products containing Cu-64 have a shelf-life of several days, allowing central manufacture and regional distribution, potentially reaching more treatment centres and patients,” Taylor outlined.

Manufacturing 105

Manufacturing Development Antibody Drugs 105

The Pharma Data

JANUARY 14, 2021

Bemarituzumab is being developed in gastric and GEJ cancer as a targeted therapy for tumors that overexpress FGFR2b. Five Prime granted an exclusive license to Zai Lab to develop and commercialize bemarituzumab in Greater China, and Zai Lab collaborated with Five Prime on the Phase 2 FIGHT trial in Greater China. References.

Trials 52

Trials HR Containment Development 52

Pfizer

NOVEMBER 2, 2022

The vaccine candidate combines Pfizer’s quadrivalent modRNA-based influenza vaccine candidate, qIRV (22/23), which is currently in Phase 3 clinical development , and Pfizer and BioNTech’s authorized Omicron-adapted bivalent COVID-19 BNT162b2 (Original/Omicron BA.4/BA.5) COMIRNATY® (COVID-19 Vaccine, mRNA). INDICATION.

Vaccination 85

Vaccination Vaccine Clinical Trials Clinical Trials 85

The Pharma Data

JANUARY 27, 2021

The Company is in late-stage clinical development and has been working toward establishing commercial readiness. This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. About MultiStem ®. Forward-Looking Statements.

Clinical Trials 52

Clinical Trials Clinical Trials Production Trials 52

The Pharma Data

DECEMBER 16, 2020

“Since becoming a public company, our clear focus has been on advancing the clinical development of Berubicin. CNS holds a worldwide exclusive license to the Berubicin chemical compound and has acquired all data and know-how from Reata Pharmaceuticals, Inc. . .

FDA Approval 52

FDA Approval Drugs Clinical Trials Clinical Trials 52

The Pharma Data

JANUARY 31, 2021

Gilead will be responsible for conducting a Phase 1 study for the HIV-specific therapeutic vaccine and holds an exclusive option under the collaboration to obtain an exclusive license to develop and commercialize the HIV-specific therapeutic vaccine beyond Phase 1. This press release features multimedia.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

Pfizer

DECEMBER 8, 2022

The vaccine candidate is based on BioNTech’s proprietary mRNA platform technology and contains mRNA strands encoding the wild-type spike protein of SARS-CoV-2 and the spike protein of the Omicron sublineages BA.4/BA.5, The information contained in this release is as of December 9, 2022. COMIRNATY® (COVID-19 Vaccine, mRNA). INDICATION.

Vaccination 81

Vaccination Vaccine Clinical Trials Clinical Trials 81

The Pharma Data

JANUARY 18, 2021

In-licensed from Merck KGaA, Darmstadt, Germany , atacicept has been studied previously in autoimmune diseases and shown to reduce autoantibodies in a dose-dependent fashion with once-weekly subcutaneous dosing and has a well-established and acceptable clinical safety profile. For more info, please visit abingworth.com.

Development 52

Development Life Science Protein Clinical Development 52

The Pharma Data

DECEMBER 17, 2020

With experiences attained in licensing and business development functions from Amgen, Baxter and Johnson & Johnson, Mr. Bliss introduced himself in Mandarin Chinese. This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. SOUTH SAN FRANCISCO, Calif.

Clinical Trials 40

Clinical Trials Clinical Trials Trials Containment 40

The Pharma Data

JANUARY 13, 2021

Fast Track designation facilitates the development and expedites the review of drugs that are intended to treat serious and life-threatening conditions and show the potential to fill an unmet medical need. Brilacidin for UP/UPS was licensed to Alfasigma S.p.A. More information is available on the Company website at www.IPharmInc.com.

Clinical Trials 52

Clinical Trials Clinical Trials Trials In-Vitro 52

The Pharma Data

FEBRUARY 25, 2021

Food and Drug Administration (FDA) accepted for Priority Review the company’s Biologics License Application (BLA) for TicoVac , its tick-borne encephalitis (TBE) vaccine for active immunization to prevent TBE in individuals 1 year of age and older. DISCLOSURE NOTICE: The information contained in this release is as of February 23, 2021.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

The Pharma Data

JANUARY 10, 2021

“We expect 2021 will mark a number of key clinical and commercial milestones. By the end of the year, we expect to have five independent TransCon product candidates in clinical development leveraging TransCon technologies through our algorithm for product innovation. Pipeline Updates. •. ?.

Hormones 40

Hormones Clinical Development Clinical Trials Clinical Trials 40

The Pharma Data

JANUARY 13, 2021

Complete approval for these indications is contingent upon results from ongoing randomized, controlled confirmatory clinical trials. We also market or plan to market in China additional oncology products licensed from Amgen Inc., Celgene Logistics Sàrl, a Bristol Myers Squibb (BMS) company, and EUSA Pharma. Forward-Looking Statements.

Production 52

Production Trials Antibody Clinical Trials 52

The Pharma Data

MAY 7, 2021

population in just a few months, the BLA submission is an important cornerstone of achieving long-term herd immunity and containing COVID-19 in the future,” said Ugur Sahin, M.D., 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 7, 2021.

Licensing 52

Licensing Licensing Vaccination Vaccine 52

The Pharma Data

JANUARY 18, 2021

This press release and any statements made for and during any presentation or meeting contain forward-looking statements related to Sorrento Therapeutics, Inc. ZTlido ® was approved by the FDA on February 28, 2018. For more information visit www.sorrentotherapeutics.com. Forward-Looking Statements.

Antibody 40

Antibody Trials Production Clinical Trials 40

The Pharma Data

SEPTEMBER 9, 2020

The information contained in this release is as of September 7, 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 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

The Pharma Data

SEPTEMBER 9, 2020

The information contained in this release is as of September 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 52

Vaccination Vaccine RNA Clinical Trials 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.

Clinical Trials 52

Clinical Trials Clinical Trials Development Trials 52