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. More information is available at www.bioinvent.com. SOURCE BioInvent.

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The Pharma Data

JANUARY 25, 2021

26, 2021 /PRNewswire/ — Asieris Pharmaceuticals announced today that the company has entered into a license agreement with Photocure ASA (Photocure, PHO: OSE) to exclusively register and commercialize Hexvix® in Mainland China and Taiwan. For more information, please visit us at www.photocure.com , www.hexvix.com or www.cysview.com.

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The Pharma Data

NOVEMBER 23, 2020

For more information, please visit Synthetic Biologics’ website at www.syntheticbiologics.com. . This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. . View original content to download multimedia: [link].

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The Pharma Data

JANUARY 21, 2021

Spectrum Pharmaceuticals is a biopharmaceutical company focused on acquiring, developing, and commercializing novel and targeted oncology therapies. For additional information on Spectrum Pharmaceuticals please visit www.sppirx.com. Spectrum has a late-stage pipeline with novel assets that serve areas of unmet need.

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The Pharma Data

JANUARY 10, 2021

Based on its leading expertise in antibody, protein and peptide technologies, MorphoSys, together with its partners, has developed and contributed to the development of more than 100 product candidates, of which 27 are currently in clinical development. More information at www.morphosys.com or www.morphosys-us.com.

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The Pharma Data

DECEMBER 8, 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. More information is available at www.bioinvent.com. 46 (0)46 286 85 50.

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The Pharma Data

NOVEMBER 23, 2020

At Ultimovacs, he will lead all business and corporate development efforts and continue to maintain and foster connections with leading biotechnology and pharmaceutical companies. “In Mr. Berkien is currently a board member of the Nordic Pharma Licensing Group. For further information, please see www.ultimovacs.com.

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FDA Law Blog: Drug Discovery

JANUARY 4, 2023

The purpose of these town halls are to discuss topics related to OTAT-regulated products, engage with product development stakeholders, and to provide information to help stakeholders to help advance drug development. Manufacturers who hold a biological license should report manufacturing deviations to the FDA per 21 CFR 600.14.

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The Pharma Data

OCTOBER 18, 2020

Dr. Berk, commented “I am excited to join the Board of Inflection Biosciences as it advances its novel PIM/PI3K inhibitor, IBL-202, towards clinical development for unmet needs in B-cell malignancies and other cancers.”. Dr. Berk most recently has served as a consultant to several companies developing oncology therapies.

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The Pharma Data

OCTOBER 14, 2020

Conference Call Information : Date : Thursday, November 5, 2020. ELX-02 is in the early stages of clinical development focusing on cystic fibrosis. For more information, please visit www.eloxxpharma.com. Time : 4:30 p.m. Domestic Dial-in Number : (866) 913-8546. International Dial-in Number: (210) 874-7715.

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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.”.

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The Pharma Data

MARCH 16, 2021

The potential of centrally acting COMT inhibitors has not yet been evaluated in the clinic due to the unavailability of such compounds. In partnering with the Lieber Institute, Boehringer Ingelheim has in-licensed preclinical pipeline candidates, representing a first-in-class approach for targets in neuropsychiatric disorders.

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The Pharma Data

OCTOBER 6, 2021

Janssen is now moving its dengue program into clinical development. We look forward to working with our collaborators to accelerate clinical development.”. “As Global Head of Global Public Health R&D at Janssen Research & Development, LLC. Janssen Pharmaceutica, N.V.

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The Pharma Data

MARCH 2, 2021

Boehringer Ingelheim and Gubra today announced a new research and licensing agreement focused on the identification and validation of targets and innovative peptide compounds for the treatment of obesity. Boehringer Ingelheim will advance the programs further and bring promising candidates into non-clinical and clinical development.

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The Pharma Data

JANUARY 27, 2021

ET ) to discuss the results and next steps in clinical development of BI-1206. 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.

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The Pharma Data

JANUARY 12, 2021

Biond Biologics announced today that it has entered into a potentially $1 billion global licensing agreement with Sanofi to take a joint stab at defeating advanced forms of cancer with a more comprehensive and expedited approach to immuno-oncology. . Keitma/Shutterstock.

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The Pharma Data

NOVEMBER 18, 2021

Gilead has been encouraged by early clinical data generated for each of the three programs. By concluding in early to all three programs now, Gilead and Arcus are suitable to accelerate the clinical development and advancement of these clinical- stage motes and grease the disquisition of treatment combinations across the portfolios.

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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. More information is available at www.bioinvent.com. SOURCE BioInvent.

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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. Enters into Master Services Agreement with CSTI to Resume the Clinical Development of its Anti-Nausea Pharmaceutical Grade Version of Tauri-Gum ”. NEW YORK, NY, Dec.

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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. For more information, please visit gritstoneoncology.com.

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The Pharma Data

NOVEMBER 26, 2020

The intention is to carry out the reverse share split during December 2020 and more detailed information about the timetable is expected to be announced no later than the second week in December. More information is available at www.bioinvent.com. This information was brought to you by Cision [link].

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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. For more information, please visit [link].

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The Pharma Data

MARCH 11, 2021

Preclinical studies are ongoing and will continue over the next several months to evaluate whether MRT5500, as well as additional mRNA vaccine candidates, will induce neutralizing antibodies against the emerging SARS-CoV-2 variants, with the potential to inform current and future clinical development.

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The Pharma Data

NOVEMBER 11, 2020

These data provide further evidence of efficacy and high potency of SLV213 against SARS-CoV-2 and support the clinical development of SLV213 as a potential oral treatment for COVID-19,” said Ted Daley, President and CEO, Selva Therapeutics. “As For more information, visit www.selvarx.com. About Selva Therapeutics.

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The Pharma Data

OCTOBER 26, 2020

AR-301 is a fully human IgG1 mAb currently in Phase 3 clinical development targeting gram-positive Staphylococcus aureus ( S. AR-101 is a fully human immunoglobulin M, or IgM, mAb in Phase 2 clinical development targeting Pseudomonas aeruginosa ( P. AR-301 (VAP). aureus) alpha-toxin in VAP patients. AR-101 (HAP).

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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. More information is available at www.bioinvent.com.

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Agency IQ

JULY 26, 2024

Postapproval manufacturing changes for biological products During clinical development or following a product’s approval , sponsors and/or manufacturers may identify the need for a change in the product, production process, quality controls, equipment, facilities, responsible personnel, or labeling.

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The Pharma Data

MARCH 1, 2022

It has been a pleasure to partner with our investors to investigate the potential of SDI-118 in early clinical studies. Now, as part of AbbVie, the program is well positioned to move into later stages of clinical development.” For more information about AbbVie, please visit us at www.abbvie.com.

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PPD

MAY 7, 2024

By prioritizing PICOs based on their impact rather than developing a lengthy list, HTDs can ensure they meet critical timelines. Early scientific advice, either formal or informal, can shape pivotal study design early in the development process.

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The Pharma Data

JANUARY 3, 2021

our ability to sustain and enhance an effective commercial infrastructure and enter into and maintain commercial agreements for YUTIQ and DEXYCU; the development of our YUTIQ line extension shorter-duration treatment for non-infectious uveitis affecting the posterior segment of the eye; potential off-label sales in the U.S.

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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).

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The Pharma Data

APRIL 4, 2022

About the Actemra®/RoActemra® (tocilizumab) COVID-19 Clinical Trial Programme Roche’s clinical trial programme evaluated the safety and efficacy of Actemra/RoActemra in hospitalised patients with COVID-19. today announced that the U.S. Actemra/RoActemra is not U.S.

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The Pharma Data

JANUARY 27, 2021

This Breakthrough Therapy designation will enable the accelerated development of Batoclimab for MG thereby bringing this life-changing innovative drugs to patients in China sooner.” Harbour BioMed also licenses the platforms to companies and academic institutions. For more information, please visit: www.harbourbiomed.com.

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The Pharma Data

JANUARY 19, 2021

(NASDAQ/TASE: BLRX) is a late clinical-stage biopharmaceutical company focused on oncology. The Company’s business model is to in-license novel compounds, develop them through clinical stages, and then partner with pharmaceutical companies for further clinical development and/or commercialization.

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The Pharma Data

AUGUST 15, 2021

Fast Track designation includes opportunities for more frequent meetings with the FDA to discuss trial design, development plans, data needed to support drug approval, submission of a New Drug Application (NDA) on a rolling basis, and eligibility for accelerated approval and priority review, if relevant criteria are met. About VTX-801.

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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.

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The Pharma Data

JANUARY 27, 2021

The Company is in late-stage clinical development and has been working toward establishing commercial readiness. More information is available at www.athersys.com. Access to a replay of the presentation will be available on the Company’s website shortly after the meeting under the archived events. About MultiStem ®.

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