DrugBank

AUGUST 15, 2024

Drug development is challenging, including not only the complexities of biomolecular drug mechanisms but also the convolutions of regulatory pathways and commercialization strategies. UCSD, with its world-renowned Center for Microbiome Innovation , provides expertise in microbial genomics and drug discovery platforms.

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The Pharma Data

JANUARY 5, 2021

Durham, North Carolina-based Ribometrix announced a strategic collaboration deal with Genentech , a Roche company, to identify and advance novel RNA-targeted small molecule therapeutics. This is because many proteins do not have small-molecule binding sites. The first identifies the 3D RNA motifs.

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The Premier Consulting Blog

AUGUST 8, 2024

On July 31, 2024, the US Food and Drug Administration (FDA) announced Fiscal Year 2025 (FY2025) Prescription Drug User Fee Amendments of 2022 (PDUFA VII) fee rates for the review of human drug and biological product applications along with prescription drug program fees.

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The Pharma Data

OCTOBER 15, 2020

Vertex Pharmaceuticals has decided to give up on its experimental VX-814, a small molecule drug for the rare genetic disease Alpha-1 antitrypsin deficiency (AATD), canning the drug’s development after seeing lackluster results from an early phase 2 trial.

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The Pharma Data

DECEMBER 13, 2020

RLY-1971 is a potent small molecule inhibitor of Src homology region 2 domain-containing phosphatase-2 (SHP2). Relay Therapeutics (Nasdaq: RLAY) is a clinical-stage precision medicines company transforming the drug discovery process with the goal of bringing life-changing therapies to patients. . CAMBRIDGE, Mass.,

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The Pharma Data

MAY 7, 2021

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 16 years of age and older.

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LifeSciVC

JANUARY 16, 2024

Rise of the best-in-class biologics plays: Are you looking to in-license or invest in “de-risked” biology that is already in the clinic? Small molecule GLP1s? Whether trial design, execution, or otherwise, drug development even where there is precedent is a challenging road and should not be taken for granted.

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The Pharma Data

JUNE 28, 2021

Broadens company’s oncology platform of Targeted Alpha Therapies / Acquisition includes actinium-225 labeled differentiated PSMA small molecule for the treatment of prostate cancer. Bayer today announced that it has entered into an agreement to acquire Noria Therapeutics Inc. Noria) and PSMA Therapeutics Inc.

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The Pharma Data

NOVEMBER 29, 2020

The drug candidate is currently entering IND-enabling studies. “As a new strategy to induce protein degradation, PROTAC has emerged as a novel modality in drug discovery,” said Dr. Wang. ” “The emergence of the PROTAC technology represents another breakthrough in the identification of small molecule drugs.

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Sygnature Discovery

NOVEMBER 29, 2023

Patients at a clinical cancer center in Michigan, USA, have been dosed with the experimental drug QN-302, a potential first-in-class novel treatment for advanced or metastatic solid tumors. In January 2023, QN-302 received Orphan Drug Designation by the FDA for the potential treatment of pancreatic cancer.

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FDA Law Blog: Biosimilars

FEBRUARY 26, 2024

Relevant here, FDA interpreted in Guidance that a proposed injectable biosimilar must “demonstrate that its product has the same strength as the reference product by demonstrating that both products have the same total content of drug substance (in mass or units of activity) and the same concentration of drug substance.”

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Drug Target Review

NOVEMBER 22, 2023

Whilst TGF-β is an attractive target for cancer therapy because of its critical role in promoting tumor aggressiveness, immune escape and resistance to therapy, activation of alternative resistance pathways has hindered drug development attempts in the past.

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Sygnature Discovery

NOVEMBER 29, 2023

Patients at a clinical cancer center in Michigan, USA, have been dosed with the experimental drug QN-302, a potential first-in-class novel treatment for advanced or metastatic solid tumors. In January 2023, QN-302 received Orphan Drug Designation by the FDA for the potential treatment of pancreatic cancer.

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The Pharma Data

JANUARY 26, 2021

Food and Drug Administration’s Office of Orphan Products Development has granted Orphan Drug Designation to Uttroside-B , a small molecule chemotherapeutic for the treatment of hepatocellular carcinoma (HCC), the most common form of liver cancer. NEW YORK , Jan. 27, 2021 /PRNewswire/ — Q Biomed Inc.

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The Pharma Data

NOVEMBER 23, 2020

His most recent position was at Amgen as Director Global Business Development – Transactions, a position he assumed in August 2019 following the acquisition of Nuevolution, a Danish small molecule development company, at which he led the commercial and business activities as Chief Business Officer.

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The Pharma Data

DECEMBER 9, 2020

Atlas cofounded, seeded and incubated Vigil, with pre-clinical stage assets in-licensed from Amgen Inc., The company plans to do this by developing drugs that eliminate protein aggregation by either reducing the production of toxic proteins or removing them after the fact through autophagy. which will remain a key shareholder.

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The Pharma Data

OCTOBER 18, 2020

Dr. Berk, brings over 30 years of experience in medicine, industry and academia, with extensive expertise in oncology drug development and regulatory strategy. Inflection Biosciences Ltd is developing small molecule therapeutics for the treatment of cancer. Berk, MD, to its Board of Directors. biopharma companies.

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The Pharma Data

JANUARY 17, 2021

Food and Drug Administration (FDA) are starting to pick up. The drug is being developed for several indications, but the NDA is for lupus nephritis (LN), a serious inflammation of the kidneys the result of systemic lupus erythematosus (SLE). Sarah Silbiger/Getty Images. After a start-of-the-year lull, activities at the U.S.

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The Pharma Data

NOVEMBER 18, 2021

— Gilead Exercises Options to Arcus’s Anti-TIGIT Program (Domvanalimab and AB308), Etrumadenant (A2a/A2b Adenosine Receptor Antagonist) and Quemliclustat (Small Molecule CD73 Inhibitor) — — Arcus to Receive Option Payments Totaling $725 million — Gilead Lores,Inc. Nasdaq GILD) and Arcus Biosciences,Inc.

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The Pharma Data

FEBRUARY 25, 2022

Food and Drug Administration (FDA) has accepted for review the Prior Approval Supplement (PAS) to the Biologics License Application (BLA) for ABRILADA™ (adalimumab-afzb) as an interchangeable biosimilar to Humira® (adalimumab). Pfizer Inc. NYSE: PFE) today announced that the U.S.

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The Pharma Data

AUGUST 21, 2020

Fortunately, as a member of the Novartis Business Development & Licensing (BD&L) department, she was in a position to try to help. Jennifer Leeds , Head of West Coast Search and Evaluation, NIBR Business Development & Licensing. Knowing that a pandemic was likely coming made watching the crisis unfold no less heartbreaking.

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The Pharma Data

NOVEMBER 22, 2020

In one of the largest heart failure clinical trials ever conducted, our novel mechanism drug candidate demonstrated positive efficacy in a diverse patient population with high unmet need and without an imbalance in the overall incidence of adverse events. Blum, Cytokinetics’ President and Chief Executive Officer. “In

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The Pharma Data

NOVEMBER 15, 2020

R&D collaboration building on Lead Pharma’s expertise in the discovery, design and optimization of small molecule treatments. Lead Pharma may receive payments of up to €260 million plus royalties on sales. OSS, Netherlands , Nov. OSS, Netherlands , Nov.

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The Pharma Data

JANUARY 13, 2021

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions.

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The Pharma Data

JANUARY 18, 2021

Sorrento’s multimodal, multipronged approach to fighting cancer is made possible by its extensive immuno-oncology platforms, including key assets such as fully human antibodies (“G-MAB library”), clinical stage immuno-cellular therapies (“CAR-T”, “DAR-T”), antibody-drug conjugates (“ADC”), and clinical stage oncolytic virus (“Seprehvir ® ”).

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The Pharma Data

OCTOBER 26, 2020

Such deficiencies include, but are not limited to, increasing drug resistance, short duration of efficacy, disruption of the normal flora of the human microbiome and lack of differentiation among current treatments. AR-711 is an in-licensed mAb that is directed against the receptor binding domain of the SARS-Cov 2 virus.

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The Pharma Data

OCTOBER 25, 2020

Both those serotypes are associated with invasive pneumococcal disease globally and are not otherwise in currently licensed conjugate vaccines for use in adults. Six sponsored by Astellas focus on the drug in adults with anemia of chronic kidney diseases (CK) related to the Phase III DOLOMITES study and a Japanese Phase III CL-0310 study.

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The Pharma Data

APRIL 27, 2021

The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals.

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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. Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 16 years of age and older.

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The Pharma Data

SEPTEMBER 12, 2020

Food and Drug Administration to expand the enrollment of their Phase 3 pivotal COVID-19 vaccine trial to up to approximately 44,000 participants which also allows for the enrollment of new populations. NEW YORK & MAINZ, Germany–(BUSINESS WIRE)– Pfizer Inc.

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The Pharma Data

JULY 21, 2021

Biovac will obtain drug substance from facilities in Europe, and manufacturing of finished doses will commence in 2022. The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Pfizer and BioNTech expect that Biovac’s Cape Town facility will be incorporated into the vaccine supply chain by the end of 2021.

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The Pharma Data

AUGUST 16, 2021

Food and Drug Administration (FDA) has granted Fast Track designation to lebrikizumab for moderate-to-severe AD in adult and adolescent patients (aged 12 to less than 18 years of age and weighing at least 40 kg). .’s 1-4 The U.S. ’s Chief Scientific Officer. About Atopic Dermatitis. Source link: [link] nvestor.lilly.com/.

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The Pharma Data

NOVEMBER 5, 2020

Prior to that, Taveras was vice president of Small Molecule Drug Discovery and CMC Development at Biogen Idec, and Alantos Pharmaceuticals, which was acquired by Amgen in 2007. Prior to this, he held a position as a director of Analytical Chemistry in Drug Discovery at GlaxoSmithKline. from 1993 to 1995.

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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. Food and Drug Administration (FDA) has authorized the emergency use of the mRNA vaccine, BNT162b2, against COVID-19 in individuals 16 years of age or older.

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LifeSciVC

APRIL 24, 2024

Is a novel target at the inflection point where enough evidence is available to suggest it may prove to be a compelling drug? and whether a molecule’s pharmacology can help to mitigate safety risk. In order to start building a case for or against a target, I like to start with genetics – first human and then mouse. in liver, in CNS)?

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New Drug Approvals

SEPTEMBER 29, 2024

link] 01 Aug 2022 Cortexyme is now called Quince Therapeutics You need to be a logged in or subscribed to view this content This small molecule is an orally available protease inhibitor targeting the lysine proteases of the periodontal pathogen Porphyromonas gingivalis. All were deemed unrelated to drug. J Alzheimers Dis Rep.

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The Pharma Data

NOVEMBER 5, 2020

Merger completed with Rexahn Pharmaceuticals creating a Nasdaq-listed Biopharmaceutical Company Focused on Advancing Ocuphire’s Late-Stage Clinical Pipeline of Ophthalmic Drug Candidates. Ocuphire’s pipeline currently includes two small-molecule product candidates targeting front and back of the eye indications.

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