Drug Target Review

MARCH 3, 2025

The search for effective treatments for neurodegenerative diseases like Parkinson’s disease has long been hindered by the brain’s complexity and the absence of adequate models for drug discovery. “Then, the organoid model would be tested with, say, five, six, or seven drugs available on the market.

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Drug Target Review

NOVEMBER 7, 2023

To target proteins involved in causing or spreading disease, typically a drug will obstruct a protein’s active site so it cannot function. She continued: “The work done here is a clear look into a typically opaque intracellular process, and it’s shining a light on a new world of possible drug discovery.” “The References 1 Sun A.

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Drug Target Review

NOVEMBER 6, 2023

2 It is this complexity that necessitates powerful, targeted combination therapies. 2 It is this complexity that necessitates powerful, targeted combination therapies. To bring us closer to curing cancer, a combination of effective drugs with non-overlapping mechanisms of action is required.

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SugarCone Biotech

MARCH 24, 2025

Consequently, these drugs have limited ability to keep patients disease-free and limited impact on patient survival. When we look at how TCEs interact with targeted cancer cells we can quickly see how cancers respond to T Cell-based therapies. Other mechanisms that cancer cells use to escape from TCE treatment are less expected.

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New Drug Approvals

APRIL 25, 2025

3] Primary endocrine resistance was defined as relapse while on the first two years of adjuvant endocrine therapy (ET) and secondary endocrine resistance was defined as relapse while on adjuvant ET after at least two years or relapse within twelve months of completing adjuvant ET. [3] 3 November 2006. 3 November 2006. Retrieved 17 April 2025.

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The Pharma Data

NOVEMBER 9, 2020

Talaris Chief Executive Officer Scott Requadt sees FCR001, the company’s investigational cell therapy, as a potential pipeline in a product (an experimental treatment that could have multiple uses across a number of indications). Food and Drug Administration (FDA). When that unit dissolved, rights to FCR001 reverted to Regenerex.

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PPD

SEPTEMBER 6, 2023

Mixing of service models — a strategy that drug developers are leveraging now more than ever — can bring life-changing therapies to market faster. In 2018, market utilization of FSO models was at 72%, with usage of FSP models lagging at 28%. Growth of the FSP market is steadily increasing.

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The Pharma Data

DECEMBER 22, 2020

Tagrisso Approved as Adjuvant Therapy for NSCLC With EGFR Mutations. Food and Drug Administration announced Friday. Food and Drug Administration announced Friday. Tagrisso was approved in 2018 for first-line treatment of patients with metastatic non-small cell lung cancer with EGFR exon 19 deletions or exon 21 L858R mutations.

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Drug Target Review

OCTOBER 11, 2023

1,2 Many, however, do have dysfunctional proteins at their core, and for these diseases, a new option is being explored: autophagy-boosting therapies. One of our drug candidates at Samara activates Transient Receptor Potential Mucolipin 1 (TRPLM1), a protein that’s at the centre of the degradative machinery that’s so key to autophagy.

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Eye on FDA

AUGUST 27, 2023

But in fact, as can be seen in previous years such as 2019, 2018 and 2015, the mid-year tally (in red) is not always predictive of what we may see by year’s end (in blue). Other Approvals – Of course, there are many drugs approved that are not NMEs and which do not have Advisory Committee meetings.

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Drug Target Review

JANUARY 25, 2024

The peptide in development is based on a 2018 Cleveland Clinic discovery and serves as a proof-of-concept for this type of drug for triple-negative breast cancer. 2 The cells of this cancer lack certain receptors so drugs designed to treat other subtypes of breast cancer will not work.

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DrugBank

OCTOBER 4, 2024

For example, Gilead Sciences' acquisition of Immunomedics in 2020 included Trodelvy, an antibody-drug conjugate approved for treating triple-negative breast cancer. The IP surrounding Trodelvy , including patents covering the drug's composition, manufacturing process, and clinical use, was a significant valuation component.

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NIH Director's Blog: Drug Development

NOVEMBER 15, 2018

They’re synthesized in the lab, allowing Wimley and team to tweak their chemical structures and hopefully create ones with therapeutic potential, particularly as smart-delivery systems to target cells with greater precision and deliver biological cargoes such as drugs [1]. 2018 Jul 2;9(1):2568. [2] How can he tell the difference?

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Drug Target Review

MAY 23, 2023

Therapies developed in recent decades have transformed the treatment of IBD, making hospitalisation and surgery less common. However, many patients respond poorly to corticosteroid treatment, or their immune system responds unfavourably to biological therapies, such as the development of autoimmune diseases.

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DrugBank

FEBRUARY 19, 2025

The application of Artificial Intelligence (AI) in drug discovery is rapidly transforming the pharmaceutical industry, offering opportunities to accelerate the identification of novel therapeutic targets, optimize molecule design, and enhance clinical trial efficiency. billion in 2023 to $7.9 billion in 2023 to $7.9

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Eye on FDA

DECEMBER 6, 2023

During 2023, there were a total of 29 FDA Advisory Committee meetings related to human drugs, 25 of which were held to discuss either the approval of new drugs or the approval status of medicines approved under the accelerated approval pathway. The Antimicrobial and the Cellular, Tissue, and Gene Therapy each met three times.

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Drug Target Review

AUGUST 24, 2023

Neutralising GDF-15 with CatalYm’s anti-GDF-15 antibody visugromab was shown to reverse its inhibitory effects and to re-sensitise tumours to anti-PD-1 treatment, achieving commensurate survival benefit of anti-GDF-15-anti-PD-1 combination therapy in vivo.

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The Pharma Data

SEPTEMBER 8, 2020

Takeda has revealed it has agreed to divest its non-core portfolio of prescription therapies to Cheplapharm in exchange for an upfront payment of $562 million. The moves represent Takeda’s attempts to balance the books following its mammoth acquisition of Shire in 2018 for $62 billion. Matt Fellows. Source link.

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The Pharma Data

JANUARY 14, 2021

Food and Drug Administration (FDA) approved Pfizer ’s Xalkori (crizotinib) for pediatric patients one year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is anaplastic lymphoma kinase (ALK)-positive. Manuel Esteban/Shutterstock.

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Drug Target Review

JANUARY 17, 2024

This insight could lead to potential therapies to prevent treatment resistance. 2 Also, glioblastomas have a vast heterogeneity , which contributes to resistance by preventing a single drug controlling the entire tumour and facilitating escape mechanisms from targeted agents. This study was published in Cancer Cell.

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FDA Law Blog: Drug Discovery

DECEMBER 13, 2023

Drug development for these conditions has unique and complex challenges, therefore few treatments are available to patients.” However, there is tremendous potential in such a committee to advance rare disease drug development broadly. irritable bowel syndrome, primary biliary cholangitis).

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Drug Target Review

OCTOBER 31, 2023

Regulatory affairs workers get to tell a story about a drug to the regulators and – keeping the end in mind, which is the drug label or prescribing information – is a good way to communicate with regulators. Every drug has a story: an end game. I’ve been lucky to have seen several drugs make it all the way to market.

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The Pharma Data

DECEMBER 21, 2020

On Monday, the two companies said the investigational asset tezepelumab did not meet its primary endpoint in the Phase III SOURCE trial assessing the drug’s ability to generate a statistically significant reduction of corticosteroid use on top of standard of care treatment in some asthma patients. In 2018, the U.S.

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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. About Targeted Alpha Therapies (TAT) at Bayer Targeted Alpha Therapies (TAT) are an emerging class of radionuclide therapy for various difficult to treat tumors.

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New Drug Approvals

SEPTEMBER 8, 2024

2222514-07-8 ] Palopegteriparatide , sold under the brand name Yorvipath , is a hormone replacement therapy used for the treatment of hypoparathyroidism. [1] 5] Study drug and conventional therapy were subsequently adjusted according to the albumin-corrected serum calcium levels. [5] 48,000) consisting of 34 amino acid residues.

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New Drug Approvals

APRIL 19, 2025

Mode of action The drug acts as an ultra-short-acting 1-selective blocking agent. Contrary to landiolol, exposure to other -blockers such as esmolol amplifies the re-expression of -receptors which explains the drug tolerance effect seen during long-term esmolol infusion. Jump up to: a b “Novel Drug Approvals for 2024” U.S.

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Drug Target Review

APRIL 12, 2023

Researchers can avoid numerous delays by employing AI for drug discovery, often using computational approaches in combination with their own techniques, for a faster and smoother path to the clinic. Norman reflected that AI and machine learning will usher in an era of quicker, cheaper and more effective drug discovery. BCG Global.

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Common Sense for Drug Policy Blog

JUNE 6, 2024

The Market for Image and Performance Enhancing Drugs (IPEDs) "The market for image and performance enhancing drugs has undergone seismic changes in the last two decades and, as has been alluded to above, its partial digitisation has created something of a dual space of commerce (Gibbs, Forthcoming ). 2017 ; Greenway and Price 2018 ).

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The Pharma Data

JANUARY 18, 2021

FDA advisory committees recommended just 50 percent of the 18 new therapies and indications they reviewed in 2020, the lowest rate since 2007, and the agency seems to be reserving the panels for more problematic applications, according to Prevision Policy, a Washington, D.C.-based based research firm. Jason Scott. Source link.

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Drug Target Review

APRIL 3, 2024

Our company has identified a new role for Growth Differentiation Factor 15 (GDF-15) as a potent local immunosuppressor mediating cancer resistance to therapy. 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.

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DrugBank

JUNE 27, 2023

The general notion is that patients should be viewed individually, rather than strictly as members of some larger general population, and that their specific genetic background, environment, and lifestyle choices should be considered throughout drug development to the point of treatment and continuing patient care.

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The Pharma Data

DECEMBER 17, 2020

Opioid dependence is a serious, chronic, relapsing disease associated with a disproportionate amount of drug-related harm that includes infectious diseases and other health problems, mortality, unemployment, homelessness and social exclusion 6. Buvidal received market authorizations in EU and Australia in November 2018. About Camurus.

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The Pharma Data

MARCH 13, 2021

Takeda Pharmaceutical Company Limited ( TSE:4502/NYSE:TAK ) (“Takeda”) today announced that it has submitted a New Drug Application (NDA) to the Ministry of Health, Labour and Welfare (MHLW) in Japan for lanadelumab subcutaneous injection, a monoclonal antibody therapy for prophylaxis against attacks of hereditary angioedema (HAE).

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New Drug Approvals

SEPTEMBER 13, 2024

8] [9] [10] The drug has been found to dose-dependently block fentanyl -induced miosis at 25 mg and 60 mg in humans (with minimal to no blockade at doses of 4 to 10 mg), suggesting that the drug significantly occupies and antagonizes the MOR at a dose of at least 25 mg but not of 10 mg or less. [10] 2] Aticaprant is taken by mouth. [1]

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New Drug Approvals

SEPTEMBER 10, 2024

2] [3] It is the first approval by the US Food and Drug Administration (FDA) of a systemic therapy for people with grade 2 astrocytoma or oligodendroglioma with a susceptible isocitrate dehydrogenase-1 or isocitrate dehydrogenase-2 mutation. [2] Food and Drug Administration (FDA). April 2018). for 36 hr then at 100° C.

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National Drug & Alcohol Research Centre Blog

JULY 13, 2021

NCCRED was funded through the Strategy, and commenced in 2018, to build clinical research capacity and work towards establishing evidence-based treatment approaches for both methamphetamines and other emerging drugs of concern. Why do a clinical research priority setting study?

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The Pharma Data

SEPTEMBER 9, 2020

According to data harvested from two Phase 3 studies and a Phase 3b safety study, Ondexxya was shown to “markedly reduce” anti-factor Xa activity of apixaban and rivaroxaban, while 82% of evaluable patients receiving the drug saw their bleeding stop 12 hours after treatment compared to baseline. Matt Fellows. Source link.

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