Pharmaceutical Technology

MARCH 1, 2023

Orvacabtagene autoleucel is under clinical development by Bristol-Myers Squibb and currently in Phase II for Relapsed Multiple Myeloma. GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data.

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Pharmaceutical Technology

JANUARY 2, 2023

Danicamtiv is under clinical development by Bristol-Myers Squibb and currently in the Phase I and Phase II in clinical pathway. It is developed based on MyoKardia's drug discovery platform. Its primary focus is on cancer, cardiovascular, immunology and fibrotic therapeutic projects.

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The Pharma Data

MAY 7, 2021

Pfizer and BioNTech initiated the BLA by submitting the nonclinical and clinical data needed to support licensure of the COVID-19 vaccine for use in individuals 16 years of age and older. The companies will submit the required manufacturing and facility data for licensure in the coming weeks to complete the BLA.

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The Pharma Data

JULY 21, 2021

(NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the signing of a letter of intent with The Biovac Institute (Pty) Ltd, known as “Biovac,” a Cape Town-based, South African biopharmaceutical company, to manufacture the Pfizer-BioNTech COVID-19 Vaccine for distribution within the African Union. This press release features multimedia.

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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.

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Drug Discovery World

FEBRUARY 27, 2023

Under a new agreement, Destiny Pharma and Sebela Pharmaceuticals will co-develop NTCD-M3, Destiny’s lead asset for the prevention of Clostridioides difficile infection (CDI) recurrence.

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XTalks

APRIL 24, 2023

Melanie Blank, clinical team leader for General Medicine Branch 1 at the US Food and Drug Administration’s (FDA) Division of Clinical Evaluation and Pharmacology/Toxicology (DCEPT), the agency is seeing one or two new applications coming in every week for new gene therapies for different diseases. Reference: Chung DC, et al.

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pharmaphorum

FEBRUARY 19, 2021

The vaccine doses will be manufactured and distributed globally by Novavax and Serum Institute of India (SII), the latter under an existing agreement between Gavi and SII. NVX-CoV2373 is being studied in two ongoing pivotal phase 3 clinical trials: in the United States and Mexico, as well as in the UK for the prevention of COVID-19.

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pharmaphorum

DECEMBER 4, 2020

Exelixis has taken a $20 million option to license in an antibody-drug conjugate cancer (ADC) drug from Iconic, with clinical trials expected to start next year. After taking the option Exelixis now has responsibility for clinical development, marketing and manufacturing of the Tissue Factor (TF) targeting drug known as XB002.

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Drug Discovery World

JANUARY 15, 2024

Chiesi and Oak Hill Bio intend to continue a Phase IIb clinical trial in 2024 in the United States, Europe, and Japan. Clinical studies conducted to date have demonstrated OHB-607’s potential to significantly reduce the risk of severe BPD.

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The Pharma Data

NOVEMBER 30, 2020

1, 2020 /PRNewswire/ — Sosei Group Corporation (“the Company”) (TSE: 4565) announces it has entered into a global collaboration and license agreement with Biohaven Pharmaceutical Holding Company Ltd. (“Biohaven”, NYSE: BHVN). . TOKYO and CAMBRIDGE, England , Dec. GPCR – G protein-coupled receptors.

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pharmaphorum

DECEMBER 15, 2020

million (around $56 million) in a Series B funding round to take its novel group B streptococcus (GBS) vaccine into mid-stage clinical trials. Proceeds will advance the clinical development of MinervaX’s novel GBS vaccine through phase 2 clinical trials, as well as manufacturing and regulatory preparation for phase 3.

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The Pharma Data

DECEMBER 8, 2020

BioInvent International AB (OMXS: BINV) is a clinical stage company that discovers and develops novel and first-in-class immuno-modulatory antibodies for cancer therapies, with two ongoing programs in Phase l/ll clinical trials for the treatment of hematological cancer and solid tumors, respectively.

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The Pharma Data

NOVEMBER 22, 2020

Omecamtiv mecarbil is an investigational cardiac myosin activator, developed for the potential treatment of heart failure with reduced ejection fraction (HFrEF), and was recently studied in GALACTIC-HF, a positive Phase 3 cardiovascular outcomes clinical trial. Blum, Cytokinetics’ President and Chief Executive Officer.

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The Pharma Data

APRIL 27, 2022

We plan to discuss these data with health authorities, and we will continue to expand our tislelizumab clinical development program in pursuit of novel, synergistic combinations with the ultimate goal of extending survival for more patients.”. About Novartis Novartis is reimagining medicine to improve and extend people’s lives.

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The Pharma Data

JANUARY 19, 2021

Dr. Jerkeman is the coordinator of several ongoing clinical trials in diffuse large B-cell lymphoma and mantle cell lymphoma. An additional preclinical programs in solid tumors is expected to enter clinical trials in Q1 2021. The Company’s validated, proprietary F.I.R.S.T

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The Pharma Data

SEPTEMBER 9, 2020

The vaccine supply for the EU would be produced by BioNTech’s manufacturing sites in Germany and Pfizer’s manufacturing site in Belgium. Vaccine doses for Europe would be produced in BioNTech’s German manufacturing sites, as well as in Pfizer’s manufacturing site in Belgium. billion doses by the end of 2021.

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The Pharma Data

DECEMBER 11, 2020

Pfizer and BioNTech expect to file a Biologics License Application for possible full regulatory approval in 2021. The participants in our COVID-19 vaccine clinical trial are courageous volunteers who have made a personal and important choice to help make a difference during this pandemic. About the Phase 2/3 Study.

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The Pharma Data

JANUARY 21, 2021

.–( BUSINESS WIRE )– Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today announced an oral presentation on updated efficacy, safety, and dosing management of poziotinib from Cohorts 1 and 2 of the ZENITH20 clinical trial.

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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. Roche also partnered with Gilead Sciences, Inc.,

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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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pharmaphorum

SEPTEMBER 29, 2020

As summarised by The National Institutes of Health, this includes reducing the number of redundant clinical trials, enhancing the statistical strength of studies, reducing overall costs and risks, and improving study participant recruitment, all while triggering creativity and innovation between collaborators.

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The Pharma Data

NOVEMBER 20, 2020

Pfizer and BioNTech are extremely grateful to the study volunteers and investigative site staff in the clinical trial program, as their involvement was crucial to today’s important milestone in the companies’ efforts to address the COVID-19 global pandemic. Manufacturing and Delivery Capabilities. About the Study.

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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.

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XTalks

NOVEMBER 28, 2023

Ilsun Hong VP and Product Evaluation Team Leader, Samsung Bioepis To have a biologic product ready for launch, it takes years of commitment from planning, early-stage development, clinical development, regulatory approval to supply readiness.

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The Pharma Data

APRIL 27, 2021

COMIRNATY® will be produced in BioNTech’s and Pfizer’s manufacturing sites in Europe. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. AUTHORIZED USE IN THE EU: COMIRNATY® ?

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Drug Discovery World

JANUARY 31, 2024

Onward Therapeutics has announced the Phase I clinical trial of OT-A201, a first-in-class bispecific antibody targeting two immune checkpoints is in progress. With the drug development expertise and successful track records of the Onward Therapeutics team, we have moved forward from the cell line development, scale up, 1,000-litre?

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The Pharma Data

MAY 6, 2021

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Severe allergic reactions have been reported following the Pfizer-BioNTech COVID-19 Vaccine during mass vaccination outside of clinical trials.

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The Pharma Data

OCTOBER 27, 2020

Orphan Drug designation affords Passage Bio the potential for certain benefits, including up to seven years of market exclusivity, assistance in the drug development process, tax credits for clinical development, and exemptions from certain FDA fees.

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The Pharma Data

DECEMBER 1, 2020

In the trial, BNT162b2 was generally well tolerated with no serious safety concerns reported by the Data Monitoring Committee to date. Today’s decision also is based on a review of Pfizer’s and BioNTech’s Chemistry, Manufacturing and Control (CMC) data for BNT162b2. Manufacturing and Delivery Capabilities.

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Drug Discovery World

NOVEMBER 9, 2023

For patients with ‘cold’ tumours where there is a paucity of killer T-cells, or in ‘hot’ tumours that have become resistant to licensed checkpoint inhibitors, there are currently very few effective therapeutic options available. RA: What kind of cancers could benefit from this treatment approach?

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The Pharma Data

NOVEMBER 9, 2020

Clinical trial to continue through to final analysis at 164 confirmed cases in order to collect further data and characterize the vaccine candidate’s performance against other study endpoints. Pfizer Inc. The data will be discussed with regulatory authorities worldwide. “I billion doses in 2021.

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The Pharma Data

JANUARY 27, 2021

ET ) to discuss the results and next steps in clinical development of BI-1206. Two preclinical programs in solid tumors are expected to enter clinical trials by the end of 2020. .” BioInvent will hold a key opinion leader (KOL) call today, Thursday, January 28 at 5:30 p.m. CET ( 11:30 a.m.

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The Pharma Data

OCTOBER 26, 2020

PEX TM and MabIgX® technology platforms to rapidly identify rare, potent antibody-producing B-cells from patients who have successfully overcome an infection, and to rapidly manufacture monoclonal antibody (mAbs) for therapeutic treatment of critical infections. The Company’s pipeline is highlighted below: Aridis’ Pipeline.

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The Pharma Data

DECEMBER 10, 2020

The ongoing Phase 3 clinical trial of BNT162b2, which is based on BioNTech’s proprietary mRNA technology, has enrolled more than 44,000 participants, the vast majority of whom have received their second dose. About the Phase 2/3 Study. Germany, Turkey, South Africa, Brazil and Argentina.

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Drug Discovery World

MARCH 29, 2023

Moreover, an extra six months of RDP for drugs with full comparator clinical trials (rather than showing only that a drug is no worse than the standard of care). For rare disease drugs, a variable RDP period of five, nine, or ten years, depending on the novelty of the drug.

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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. and Roche will develop, manufacture and distribute it outside the U.S.

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