The Pharma Data

MAY 31, 2022

. “The priority review and subsequent approval of Evrysdi for babies under two months of age speaks to the urgent ongoing need for additional treatment options for babies with SMA,” said Levi Garraway, M.D., Roche’s Chief Medical Officer and Head of Global Product Development.

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The Pharma Data

JANUARY 6, 2021

As the compound was already approved by the FDA for its original indication, the companies are expecting significant savings in cost and time associated with its pre- or clinical development for the new indication. Jinhan Kim, co-founder and CEO of Standigm said, “Partnering with SK Group has been incredibly productive.

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The Pharma Data

JULY 8, 2021

With a global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to realize our hhc philosophy by delivering innovative products to target diseases with high unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology.

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The Pharma Data

DECEMBER 16, 2020

OS is a rigorous endpoint that the FDA has recognized as a basis for approval of oncology drugs when a statistically significant improvement can be shown relative to a randomized control arm. and 2 trials planned by our sublicensee WPD in Poland.

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The Pharma Data

JULY 12, 2021

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

OCTOBER 14, 2020

WAKIX is the first and only treatment approved by the FDA for people with excessive daytime sleepiness or cataplexy associated with narcolepsy that is not scheduled as a controlled substance by the U.S. WAKIX received FDA approval for the treatment of excessive daytime sleepiness in adult patients with narcolepsy in August 2019.

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The Pharma Data

APRIL 14, 2021

Food and Drug Administration (FDA) has approved the company’s supplemental Biologics License Application for Xolair® (omalizumab) prefilled syringe for self-injection across all approved U.S. Roche’s Chief Medical Officer and Head of Global Product Development. with Xolair since its initial approval in 2003.

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The Pharma Data

NOVEMBER 3, 2020

This is an important milestone towards establishing an appropriate coding and reimbursement environment for our intracanalicular products and in realizing our goal of replacing eye drops for certain conditions,” commented Antony Mattessich, President and Chief Executive Officer of Ocular Therapeutix. About DEXTENZA. Ocular Therapeutix, Inc.

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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. “The Chief Medical Officer and Head of Global Product Development, Roche. A decision on U.S.

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Alta Sciences

APRIL 17, 2024

The FDA approved the first gene therapy in 2017 for certain pediatric and young adult patients with a form of acute lymphoblastic leukemia (ALL), and as of December 2023, there are over 30 approved cell and gene therapies on the market in the U.S.A. Asia, and Europe.

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The Pharma Data

JANUARY 7, 2021

Cerecor intends to use the net proceeds of the offering for general corporate purposes and working capital, primarily to support the ongoing clinical development of key assets within its pipeline and for general and administrative expenses. The company is also developing two monoclonal antibodies, CERC-002, and CERC-007.

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The Pharma Data

JANUARY 13, 2021

Harpoon has four drug product candidates in clinical development for the treatment of solid and hematologic malignancies based on its proprietary TriTAC platform. President and Chief Executive of Harpoon Therapeutics. About the Phase 1/2 Trial for HPN217.

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Codon

MARCH 24, 2024

The market for semaglutide-based products is projected to swell to $71B in less than a decade. All of this future value, of course, relies upon these companies actually making enough of their product to meet the growing demand. In November, Novo Nordisk invested $6B in additional production capacity.

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The Connected Lab

APRIL 8, 2020

For patients suffering from an illness with no approved treatment, the wait can be unnerving. To this day, more than 400 million people suffer from rare diseases and 95% of rare diseases lack an FDA approved treatment 3. By utilizing these products, all data can be stored in one central system, facilitating machine learning.

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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

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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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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The Pharma Data

JANUARY 17, 2021

The primary endpoint of this trial is to evaluate patients for complete histological clearance of the tumor cells within the treated BCC lesion with secondary endpoints, evaluating subjects for investigational product treatment related adverse events, as well as serious adverse events, and cutaneous skin reactions. Chief Medical Officer.

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The Pharma Data

DECEMBER 18, 2020

Roxadustat Roxadustat, an oral medicine, is the first in a new class of medicines called HIF-PH inhibitors that promotes erythropoiesis, or red blood cell production, through increased endogenous production of erythropoietin, improved iron absorption and mobilisation, and downregulation of hepcidin. . Source link.

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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

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. Through its Shielded Living Therapeutics platform, the company is developing functional cures for chronic diseases.

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The Pharma Data

OCTOBER 30, 2020

Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to eight FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories.

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The Pharma Data

OCTOBER 25, 2020

Food and Drug Administration (“FDA”) for the treatment of agitation associated with delirium. With no FDA-approved treatments for this condition, current guidelines recommend sedative medications to maintain a light level of sedation in adult patients, which is frequently not achieved with commonly used therapies.

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The Pharma Data

JANUARY 31, 2021

These findings give confidence that Clover’s COVID-19 vaccine candidates are suitable for further clinical development.” Trimer-Tag© is an innovative drug development platform which allows the production of novel, covalently-trimerized fusion proteins. S-Trimer is intended to be adjuvanted. About Dynavax.

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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. Garcia Jimenez et al., Chen 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. Garcia Jimenez et al., Chen et al.,

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The Pharma Data

JULY 29, 2021

econd Quarter 2021 Product Sales Increased 21% Year-Over-Year Primarily Driven by Veklury. Product Sales Performance. Total second quarter 2021 product sales increased 21% to $6.2 Total product sales excluding Veklury increased 5% to $5.3 Total product sales excluding Veklury increased 5% to $5.3

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The Pharma Data

JUNE 26, 2021

The extensive clinical program for Libtayo is focused on difficult-to-treat cancers. Current clinical development programs include Libtayo in combination with chemotherapy for advanced NSCLC irrespective of PD-L1 expression and Libtayo monotherapy for advanced cervical cancer. The generic name for Libtayo in its approved U.S.

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The Pharma Data

JANUARY 24, 2021

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. The global esophageal cancer drugs market is estimated to grow by USD $1.5

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The Pharma Data

MAY 31, 2022

The FDA grants priority review to therapies that have the potential to provide significant improvements in the treatment, diagnosis or prevention of serious conditions. Additional regulatory filings outside of the US are also planned in 2022.

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The Pharma Data

APRIL 4, 2022

The potential use of Dupixent in EoE is currently under clinical development, and the safety and efficacy have not been fully evaluated by any regulatory authority. Priority review is granted to therapies that have the potential to provide significant improvements in the treatment, diagnosis or prevention of serious conditions.

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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

NOVEMBER 30, 2020

In return, Sosei Heptares will receive an upfront payment of US$10 million in the form of cash consideration and Biohaven common shares, research funding, and is eligible to receive additional development, regulatory and commercialization milestone payments of up to US$370 million. Vlad Coric , M.D., GPCR – G protein-coupled receptors.

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The Pharma Data

DECEMBER 29, 2020

Senior Vice President and Head of Global Clinical Development at Regeneron. Regeneron continues to increase in-house production of casirivimab and imdevimab, and the company has partnered with Roche to increase the global supply beginning in 2021. and Roche will develop, manufacture and distribute it outside the U.S.

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The Pharma Data

JUNE 26, 2021

The extensive clinical program for Libtayo is focused on difficult-to-treat cancers. Current clinical development programs include Libtayo in combination with chemotherapy for advanced NSCLC irrespective of PD-L1 expression and Libtayo monotherapy for advanced cervical cancer. The generic name for Libtayo in its approved U.S.

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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. in July 2019, who have recently initiated a Phase 1 study with their formulation.

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NIH Director's Blog: Drug Development

JUNE 14, 2016

The study, which analyzed vast troves of genomic and clinical data collected over many years from more than 50,000 people with and without diabetes, indicates that anti-diabetes therapies that lower glucose by targeting the product of a specific gene, called GLP1R , are unlikely to boost the risk of cardiovascular disease.

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