Drug Target Review

AUGUST 24, 2023

She joined the company in November 2018 with more than 10 years of experience in drug discovery and non-clinical development of immunomodulatory drugs in the immuno-oncology space. Author bio: Christine Schuberth-Wagner Christine Schuberth-Wagner serves as Chief Scientific Officer at CatalYm.

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Metabolite Tales Blog

JANUARY 26, 2023

Metabolism of 2022 FDA approved small molecule drugs – Part 1 Does CYP3A4 still rule? By Julia Shanu-Wilson It won’t come as much surprise to learn that of the 17 small molecules* approved by the FDA in 2022, CYP3A4 was the major player in drug metabolism.

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The Pharma Data

JANUARY 6, 2021

7, 2021 /PRNewswire/ — UNION therapeutics A/S ( UNION ) today announces that the US Food and Drug Administration (FDA) has approved an Investigational New Drug program (IND) for oral orismilast; a next generation PDE4-inhibitor for the treatment of plaque psoriasis in adults. 2018)2: Menter MA, Armstrong AW, Gordon KB, Wu JJ.

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The Pharma Data

JANUARY 4, 2021

From 2016 to 2018, he served as chief development officer for oncology at Pfizer, where he was responsible for leading clinical research, development, and lifecycle management of all promising oncology products. BioSpace reached out to Rothenberg for comment and will update following a response.

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Metabolite Tales Blog

APRIL 4, 2023

Metabolism of 2022 FDA approved small molecule drugs part 2 Mixing it Up By Julia Shanu-Wilson In Part 1 of this topic we looked at metabolism of the small molecule drugs approved by the FDA in 2022 that were mediated by CYP3A4. Tapinarof is metabolised by multiple pathways including oxidation, glucuronidation, and sulfation.

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The Pharma Data

NOVEMBER 10, 2020

Growing into a biopharmaceutical company, Innovent has built an integrated platform covering from drug discovery, CMC, clinical development and commercialization. By joining Innovent, Dr. Liu will be responsible for global R & D, pipeline strategy, business development and international operations.

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The Pharma Data

APRIL 29, 2022

Roche leads the clinical development of Evrysdi as part of a collaboration with the SMA Foundation and PTC Therapeutics. Evrysdi was granted PRIME designation by the European Medicines Agency (EMA) in 2018 and Orphan Drug Designation by the U.S. Food and Drug Administration in 2017.

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The Pharma Data

JUNE 28, 2021

Bayer’s acquisition of Noria and PSMA Therapeutics, which have nurtured Dr. Babich’s radiopharmaceutical and diagnostic technology, is an important milestone in drug development, and we look forward to the advances this collaboration can make to enhance prostate cancer therapies.”. CA: A Cancer Journal for Clinicians.

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The Pharma Data

JANUARY 13, 2021

PITTSBURGH–( BUSINESS WIRE )– Knopp Biosciences LLC today announced positive top-line results in a Phase 2 dose-ranging trial of the novel oral drug dexpramipexole in patients with moderate-to-severe eosinophilic asthma. Knopp’s pipeline consists of investigational drug products that have not been approved by the U.S.

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The Pharma Data

DECEMBER 1, 2020

333-228656) previously filed with the Securities and Exchange Commission (the “SEC”) on December 3, 2018, and declared effective by the SEC on December 26, 2018. If adequate funds are not available on a timely basis, Allena may be required to delay, limit, reduce or terminate its clinical development of reloxaliase.

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Drug Target Review

OCTOBER 3, 2024

Since the 1970s, when hybridoma technology enabling the generation of monoclonal antibodies (mAbs) was first developed, 1 antibody-based therapeutics have become one of the most rapidly growing drug categories, with applications across cancer indications, immune disorders and infections.

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The Pharma Data

JANUARY 20, 2021

The securities are being offered pursuant to a registration statement that was filed with the Securities and Exchange Commission (“SEC”) on November 6, 2018, amended on February 6, 2019, and was declared effective on February 11, 2019.

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The Pharma Data

DECEMBER 17, 2020

Kurtz brings more than 26 years of experience in global manufacturing, engineering, supply chain, CMC development and program management for drugs and devices at various stages of development. Cadavid will be responsible for the strategy, direction and execution of the company’s clinical development programs.

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The Pharma Data

MAY 31, 2022

Food and Drug Administration (FDA) has approved a label extension for Evrysdi® (risdiplam) to include babies under two months old with spinal muscular atrophy (SMA). 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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PPD

DECEMBER 14, 2023

In this blog, we’ll explore the benefits associated with employing global resources across time zones for FSP engagements and how PPD ® FSP solutions utilize different regions to drive more efficient clinical development operations.

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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

APRIL 6, 2022

Change in Global Drug Development (GDD) Leadership. as President, Global Drug Development and Chief Medical Officer effective May 16th, 2022. Aradhye has dedicated his entire professional career to improving patient lives, first as an academic clinician and then as a drug developer and business leader.

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The Pharma Data

NOVEMBER 1, 2020

. Program-related investment estimated at up to US$65M (~AU$90M) for clinical costs associated with the development of the therapeutic products in the Territory, to align with Telix’s global clinical development programs. 6 Globocan 2018 [link] 7 Chang L, et al. . .

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The Pharma Data

JANUARY 21, 2021

Prior to co-founding privately held Viridian Therapeutics, Violin had founded and served as CEO of two virtual drug discovery companies, Quellis Biosciences and Dianthus Therapeutics, and co-founded and held several executive positions at Trevena, Inc. since May 2018. Rauch will remain as strategic advisor for the company.

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The Pharma Data

APRIL 8, 2021

Roche will present data from five studies from the EVRYSDI clinical development programme, which was designed to represent a broad spectrum of people living with SMA. The full range of data from Roche’s clinical development programme in neuroscience being presented at 2021 AAN include: Medicine and/or Therapeutic Area.

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The Pharma Data

JULY 22, 2021

“Building on Pfizer’s established leadership position in breast cancer science and CDK 4/6 inhibition, we are excited to work with Arvinas to maximize ARV-471, the first PROTAC for breast cancer with encouraging early clinical data and a potential novel hormonal therapy backbone for HR+ breast cancer,” said Jeff Settleman, Ph.D.,

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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.

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Metabolite Tales Blog

JANUARY 23, 2024

Metabolism of 2023 FDA Approved Small Molecules – PART 1 By Julia Shanu-Wilson 2023 was a fruitful year for drug approvals by the FDA, with a crop of 34 small molecules out of a total of 55 new drugs [1]. This constitutes an interesting subset of 9 drugs, constituting over 25% of the new small molecule drug approvals in 2023!

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Conversations in Drug Development Trends

FEBRUARY 22, 2023

I was fortunate to understand how the clinical development sausage is made and was frustrated by the fact that we could do a better job to incorporate the patient perspective into the studies we design and the therapies we commercialize. So, I decided to pivot.

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The Pharma Data

AUGUST 19, 2021

Food and Drug Administration (FDA) approval for patients with locally advanced or metastatic NSCLC with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, based on data showing an ORR of 40 percent (95 percent CI, 29 – 51) and median duration of response of 11.1 In 2018, Janssen Biotech, Inc.

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The Pharma Data

SEPTEMBER 19, 2020

Basel, 19 September 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that it presented the latest results from three Phase III studies from the Tecentriq® (atezolizumab) clinical development programme in triple-negative breast cancer (TNBC) at the European Society for Medical Oncology (ESMO) Virtual Congress 2020.

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The Pharma Data

DECEMBER 15, 2020

The dual combination study was conducted under a clinical trial collaboration agreement signed in 2016 between BioLineRx and MSD, through a subsidiary, where MSD provided KEYTRUDA ® and BioLineRx was the study sponsor and owns all rights to motixafortide. a company that supports oncology drug development. of new cancer cases.

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The Pharma Data

OCTOBER 14, 2020

2018) PLoS One. 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. *TNX-1800, 1 Noyce RS, et al. 13(1):e0188453. About Tonix Pharmaceuticals Holding Corp.

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Agency IQ

JULY 13, 2023

BY ALEXANDER GAFFNEY, MS, RAC JUL 10, 2023 10:02 AM CDT As of FY2023, the FDA has five user fee programs applicable to its life sciences portfolio: PDUFA (for non-generic prescription drugs and certain biologics), MDUFA (for medical devices), GDUFA (for generics), BsUFA (for biosimilars), and OMUFA (for over-the-counter monograph products).

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Agency IQ

SEPTEMBER 15, 2023

FDA’s nonprescription advisors find no efficacy for phenylephrine This week, FDA’s Nonprescription Drugs Advisory Committee (NDAC) voted unanimously that current scientific data do not support the efficacy of oral phenylephrine as a nasal decongestant, aligning with FDA analysis — and re-analysis — of data.

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The Pharma Data

SEPTEMBER 2, 2020

On 14 August, ENSPRYNG was approved by the US Food and Drug Administration (FDA) as the first and only subcutaneous treatment for adults living with anti-aquaporin-4 (AQP4) antibody positive NMOSD, a rare disabling neurological disorder often mistaken for MS. ENSPRYNG has been designated as an orphan drug in the US, Europe and Japan.

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The Pharma Data

NOVEMBER 10, 2020

“We’re excited to be collaborating with Tiziana to support the development of a novel, oral therapy that could provide Crohn’s patients with another option in their repertoire of treatments to combat this devastating disease.”. Grand View Research August 2018 ( [link] ). Cited References: 1. da Cunha, A. and Weiner, H.

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PPD

APRIL 14, 2025

The SELECT trial set out to understand whether the drug has similar effect on patients without diabetes. Participant fatigue in GLP-1 clinical trials The success of GLP-1 drugs in SELECT and other trials has biotech and biopharma companies racing to find which indications respond well to similar treatment.

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Drug Target Review

JUNE 21, 2023

A significant challenge in developing novel therapies is the limited understanding of how the target gene influences the underlying disease biology, which contributes to the considerable attrition observed in investigative therapies. Leveraging genetic evidence to develop new therapeutics has been successful in the past.

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The Pharma Data

DECEMBER 21, 2020

UBX1325 is developed from BM-962, a Bcl-xL inhibiting compound licensed to UNITY by Ascentage Pharma for the treatment of age-related diseases. This progress in clinical development qualifies Ascentage Pharma for a milestone payment according to the terms of the licensing agreement. SUZHOU, China and ROCKVILLE, Md. ,

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The Pharma Data

JANUARY 24, 2021

Sairiyo is a biotechnology company focused on repurposing and developing improved formulations of naturally derived compounds for serious, rare, and life-threatening diseases with the aim to obtain European Medicines Evaluation Agency and U.S. Food and Drug Administration (“FDA”) approval.

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The Pharma Data

JUNE 28, 2021

Bayer today announced the submission of a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) and a marketing authorization application (MAA) to the European Medicines Agency (EMA) seeking approval of the novel combination of the cancer treatments copanlisib and rituximab. for FL and MZL.

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