The Pharma Data

SEPTEMBER 8, 2021

today announced that data reinforcing the potential of immunotherapies to impact clinical outcomes for patients will be featured at the European Society for Medical Oncology (ESMO) 2021 Virtual Congress from September 16-21. To date, the Opdivo clinical development program has treated more than 35,000 patients.

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The Pharma Data

MAY 31, 2022

.” Evrysdi is approved in 81 countries and the dossier is under review in a further 27 countries. More than 5,000 patients have now been treated worldwide with Evrysdi in clinical trials, compassionate use or real-world settings. Food and Drug Administration in 2017.

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The Pharma Data

JULY 12, 2021

The clinical data from FIGARO-DKD are scheduled for presentation at the European Society of Cardiology (ESC) Congress 2021 on August 28th. The cardiology franchise at Bayer already includes a number of products and several other compounds in various stages of preclinical and clinical development.

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The Pharma Data

JULY 8, 2021

The update clarifies the indication by emphasizing information about the disease stages studied in the ADUHELM clinical trials. Information about the population studied has been previously communicated by Biogen and Eisai, including in the companies’ statement of June 23, 2021. Please see the full Prescribing Information. INDICATION.

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The Pharma Data

DECEMBER 9, 2020

Initial results for the open-label study are expected in 2021. It has shown remarkably high safety and tolerability measure during non-clinical development. . The total transaction value for the acquisition also includes contingent clinical and regulatory milestones and is set to close in early 2021. .

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Broad Institute

OCTOBER 11, 2023

As a first step, Manguso set his sights on treatments called PD-1 checkpoint inhibitors, which at the time had shown tremendous promise in clinical trials and would receive their first FDA approval in 2014. Along the way, TIDE is showing how careful, systematic science at scale can quickly home in on promising drug targets.

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The Pharma Data

APRIL 4, 2022

If approved, Actemra/RoActemra would be the first U.S. FDA approval is expected in the second half of this year. Chief Medical Officer and Head of Global Product Development, Roche. A decision on U.S. 7 Following the emergence of the SARS-CoV-2 variant of concern, Omicron (B.1.1.529), Actemra/RoActemra is not U.S.

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The Pharma Data

APRIL 11, 2021

The data were presented at the 2021 American Association for Cancer Research (AACR) Annual Meeting, held virtually April 10-15, 2021. Retevmo was approved based on the Phase 1/2 LIBRETTO-001 trial’s endpoints of ORR and DoR. was approved by the European Commission in February 2021. About LIBRETTO-001.

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PerkinElmer

JANUARY 7, 2022

The pharmaceutical industry is under huge pressure to address the high attrition rates in drug development. With around 90% of candidates failing during clinical development, 1 the process is not only long and risky, but also expensive for those involved. 2021 [cited 16 December 2021]. Sci Rep 9, 18911 (2019).

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The Pharma Data

JANUARY 13, 2021

13, 2021 (GLOBE NEWSWIRE) — Harpoon Therapeutics, Inc. NASDAQ: HARP), a clinical-stage immunotherapy company developing a novel class of T cell engagers, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for HPN217 for the treatment of multiple myeloma.

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The Pharma Data

JANUARY 7, 2021

07, 2021 (GLOBE NEWSWIRE) — Cerecor Inc. The offering is expected to close on or about January 12, 2021, subject to customary closing conditions. The company is also developing two monoclonal antibodies, CERC-002, and CERC-007. ROCKVILLE, Md. and CHESTERBROOK, Pa., per share (the “Public Offering Price”).

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The Pharma Data

AUGUST 19, 2021

Oral presentation at the International Association for the Study of Lung Cancer’s (IASLC) 2021 World Conference on Lung Cancer (WCLC) shows evidence that the bispecific mechanism of action for RYBREVANT TM can provide anti-tumor activity against either EGFR-mutated or MET-mutated non-small cell lung cancer. 4] , [5] , [6].

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The Pharma Data

JANUARY 17, 2021

Company Expects to Report Initial Clinical Data in 2021. 17, 2021 /PRNewswire/ — Sirnaomics, Inc. , ” The Company expects to report initial clinical data from the trial in 2021. Additional information about this clinical trial is available at clinicaltrials.gov using the identifier: NCT04669808.

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Advarra

JUNE 20, 2023

of new cancer drugs tested in Phase I were likely to receive Food and Drug Administration (FDA) approval. Additionally, in 2021, a literature review estimated the average capitalized research and development (R&D) costs per new cancer medicine at between $944 million and $4.54

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New Drug Approvals

JANUARY 3, 2023

Adagrasib Formula C32H35ClFN7O2 cas 2326521-71-3 Mol weight 604.1174 Antineoplastic Disease Non-small cell lung cancer 2022/12/12 FDA APPROVED, KRAZATI (Mirati Therapeutics) MRTX-849 MRTX849 KRAS G12C inhibitor MRTX849 Adagrasib , sold under the brand name Krazati , is an anticancer medication used to treat non-small cell lung cancer. [1]

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The Pharma Data

JANUARY 31, 2021

Clover plans to initiate a global phase 2/3 trial in the first half of 2021 with an interim analysis for vaccine efficacy potentially in the middle of 2021. These findings give confidence that Clover’s COVID-19 vaccine candidates are suitable for further clinical development.”

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The Pharma Data

DECEMBER 18, 2020

(FibroGen) are committed to working with the FDA and have agreed to submit the additional clarifying analyses as soon as possible to assist with the completion of labelling discussions. The NDA remains under regulatory review, with the FDA having set a new action date of 20 March 2021. The Lancet 2020; 395(10225):709–33.

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The Pharma Data

JANUARY 24, 2021

– January 25, 2021) – PharmaDrug Inc. Management of the Company believe that the proposed acquisition will strengthen PharmaDrug’s product pipeline, intellectual property portfolio and pharmaceutical development expertise. Food and Drug Administration (“FDA”) approval. About PharmaDrug Inc.

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The Pharma Data

DECEMBER 3, 2020

Based on the positive Phase 1 results reported and the unprecedented need for COVID-19 vaccines, Clover and its partners are confident to enter late-stage clinical development for both adjuvanted vaccines. The Phase 1 clinical trial was funded by the Coalition for Epidemic Preparedness Innovations (CEPI).

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The Pharma Data

NOVEMBER 9, 2020

(Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for NVX-CoV2373, the Company’s COVID-19 vaccine candidate. NVX-CoV2373 (SARS-CoV-2 vaccine) FDA Approval History.

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The Pharma Data

AUGUST 17, 2021

Results from CheckMate -648 were presented in an oral session during the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting and were selected for the official ASCO press program. To date, the Opdivo clinical development program has treated more than 35,000 patients. On March 25, 2011, the U.S.

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The Pharma Data

DECEMBER 8, 2020

Now poised to advance a robust therapeutics pipeline to clinical development, Nuance will use the funds for ongoing R&D of existing products and business development of potential new assets. BioAge is on the cusp of taking pilot therapies BGE-117 and BGE-175 into clinical trials, targeting the first half of 2021.

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The Pharma Data

APRIL 11, 2021

Data selected for an oral presentation in a Clinical Trials Plenary Session at the American Association for Cancer Research Annual Meeting 2021. To date, the Opdivo clinical development program has treated more than 35,000 patients.

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The Pharma Data

JANUARY 13, 2021

14, 2021 (GLOBE NEWSWIRE) — Innovation Pharma (Formerly known as Cellceutix) (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, is pleased to announce that the U.S. WAKEFIELD, Mass., Brilacidin for UP/UPS was licensed to Alfasigma S.p.A.

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Drug Target Review

JUNE 21, 2023

Strikingly, a strong genetic link between target and disease biology is emerging as a predictor for success in clinical trials. 2,3 This is exemplified by drugs that target disease-specific genes or genetically distinct patient subsets which are more likely to succeed in demonstrating efficacy in clinical development.

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The Pharma Data

DECEMBER 8, 2020

Phase 3 TETON study planned in 2021 for Tyvaso® in patients with idiopathic pulmonary fibrosis. FDA recently cleared United Therapeutics’ investigational new drug application (IND) for the TETON study, and the company expects to commence enrollment in 2021. SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C. ,

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The Pharma Data

SEPTEMBER 11, 2021

Results from EMPEROR-Preserved were presented at the European Society of Cardiology Congress 2021 on August 27 and published in The New England Journal of Medicine. No currently approved treatments have been clinically proven to significantly improve outcomes specifically for people with HFpEF. About EMPEROR-Preserved.

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The Pharma Data

JANUARY 15, 2021

–(BUSINESS WIRE) January 15, 2021 — Daiichi Sankyo Company, Ltd. hereafter, Daiichi Sankyo) and AstraZeneca’s Enhertu ( fam-trastuzumab deruxtecan -nxki) has been approved in the U.S. mg/kg) is also approved in the U.S. About the Enhertu Clinical Development Program. Accessed January 2021.

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Metabolite Tales Blog

JULY 5, 2023

Metabolism of de novo-designed macrocyclic drugs approved by the FDA By Julia Shanu-Wilson To date, only 4% (67) of FDA approved drugs are macrocycles [1]. Current macrocycles in clinical use generally focus on treatment of infectious diseases, cancer and auto-immune disorders. Gangl et al.,

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Metabolite Tales Blog

JULY 5, 2023

Metabolism of de novo-designed macrocyclic drugs approved by the FDA By Julia Shanu-Wilson To date, only 4% (67) of FDA approved drugs are macrocycles [1]. Current macrocycles in clinical use generally focus on treatment of infectious diseases, cancer and auto-immune disorders. Gangl et al.,

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The Pharma Data

DECEMBER 27, 2020

(NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today provided a year-end review and an outline of its plans for 2021.

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

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The Pharma Data

OCTOBER 27, 2020

Food and Drug Administration (FDA) has granted Orphan Drug and Rare Pediatric Disease (RPD) designations to PBKR03 for the treatment of Krabbe disease (Globoid Cell Leukodystrophy). Passage Bio expects to initiate a Phase 1/2 trial for PBKR03 in the first half of 2021.

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The Pharma Data

NOVEMBER 30, 2020

Biohaven launched NURTECä ODT (rimegepant), our lead CGRP receptor antagonist oral small molecule for the acute treatment of migraine in March of this year in the USA , and have submitted an sNDA for the preventive treatment of migraine with an expected PDUFA in the second quarter of 2021. GPCR – G protein-coupled receptors.

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The Pharma Data

DECEMBER 29, 2020

” The Phase III clinical development program consists of three studies, the BRIDGE study, the BALANCE study and the BRIGHT study. The FDA also indicated in the BLA filing communication letter that it is not currently planning to hold an advisory committee meeting to discuss the application.

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Codon

MARCH 24, 2024

million liters in 2021, according to an analysis by BioProcess International. Once approved, patent-protected drugs are the highest-margin physical products on the planet—even with the high price of bioreactors. The real cost is clinical development. The total global bioprocessing capacity was estimated at 17.4

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The Pharma Data

JANUARY 18, 2021

His research on understanding the role of angiogenesis and vascular endothelial growth factor (VEGF) in cancer development, led to the discovery that VEGF is a key mediator of angiogenesis associated with intraocular neovascular syndromes. LONDON and BOSTON, Jan.

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