Pharmaceutical Technology

JANUARY 2, 2023

Danicamtiv is under clinical development by Bristol-Myers Squibb and currently in the Phase I and Phase II in clinical pathway. Danicamtiv overview Danicamtiv (MYK-491, DCM-1) is under development for the treatment of dilated cardiomyopathy (DCM), atrial fibrillation and systolic heart failure.

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Pharmaceutical Technology

JANUARY 2, 2023

Lifirafenib maleate is under clinical development by BeiGene and currently in the Phase II in clinical pathway. The drug candidate is administered orally. It is specialized in the development and commercialization of immuno-oncology medicines to treat cancers. BeiGene overview BeiGene is a biotechnology company.

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Pharmaceutical Technology

MARCH 10, 2023

The US Food and Drug Administration (FDA) has granted approval for Pfizer ’s Zavzpret (zavegepant) for the acute treatment of migraine in adult patients with or without aura. The regulator granted the approval based on two pivotal placebo-controlled, double-blind, randomised trials.

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Scienmag

SEPTEMBER 8, 2021

BORDEAUX & NARBONNE, France – The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) apply an aligned and complimentary mindset when advising the clinical development steps for live biotherapeutic products (LBPs), YSOPIA Bioscience and the Pharmabiotic Research Institute have found.

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Pharmaceutical Technology

JANUARY 2, 2023

BI-1361849 is under clinical development by Boehringer Ingelheim International and currently in the Phase II in clinical pathway. GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their BI-1361849 Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

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Drug Discovery World

FEBRUARY 12, 2024

DDW’s Megan Thomas spoke to experts from the drug discovery industry about their predictions on what 2024 holds for our sector. In the upcoming year, we will see the expansion of new, more complex markets and updated requirements from regulators. The challenge is harnessing the power of AI within a highly regulated industry.

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pharmaphorum

JANUARY 21, 2022

The US regulator has granted biliary tract cancer therapy Silmitasertib orphan drug designation. There are currently no treatments for this rare cancer, and the US food and Drug Administration (FDA) hopes that pharmaceutical firm Senhwa’s drug will meet the significant need for new biliary tract cancer options.

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Drug Discovery World

MAY 6, 2024

In this article, DDW’s Diana Spencer highlights several prominent hotspots that are taking the lead on advancing European drug discovery and development. Even before this, however, Amsterdam was established as an important centre for drug development. The CDD will sponsor and manage KWF-supported trials.

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Pharmaceutical Technology

MAY 19, 2023

SiteOne Therapeutics has received a $15m grant from the National Institute on Drug Abuse (NIDA) to develop the investigational selective NaV1.8 The company stated that the grant from NIDA will support the clinical development of its NaV1.8 inhibitors to provide relief for patients across various pain conditions.

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FDA Law Blog

AUGUST 8, 2023

Failure to detect nitrosamines, failure to notify FDA when nitrosamines appear in finished drug products, failure to identify impurities in drugs that may be nitrosamines, even having a deviation in pH of an Active Pharmaceutical Ingredient that might conceivably contribute to the formation of nitrosamines in a finished drug product.

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Pharmaceutical Technology

OCTOBER 25, 2022

Additionally, Astellas will obtain an exclusive option for licencing two clinical-stage programmes of Taysha, namely TSHA-102 and TSHA-120, for Rett syndrome and GAN, respectively. Astellas will also receive specific rights linked to any possible change of Taysha’s control.

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BioPharma Reporter

OCTOBER 18, 2023

Emma Harvey is global head of medical affairs at F2G Ltd, a UK and Austria based biotech where she is responsible for the global medical and commercial strategies for a novel antifungal drug for serious systemic infections, in clinical development.

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pharmaphorum

DECEMBER 28, 2022

Biogen’s efforts to replenish its multiple sclerosis pipeline have suffered a setback, after the FDA placed a clinical hold on a drug candidate it licensed from China’s InnoCare last year for $125 million upfront. InnoCare says it will also introduce the restrictions on studies ongoing outside the US.

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Pharmaceutical Technology

NOVEMBER 2, 2022

According to GlobalData’s Drugs Intelligence Database, from 2020 to 2022, the number of innovator small molecule approvals in China shrank by 21%. According to the GlobalData’s Drug Database, the number of innovator small molecule approvals for rare diseases rose steadily over three years, from three approved in 2019 to 12 last year.

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Pharmaceutical Technology

FEBRUARY 24, 2023

(Lopinavir + ritonavir) is under clinical development by Douglas Pharmaceuticals and currently in Phase I for Genital Warts (Condylomata Acuminata). According to GlobalData, Phase I drugs for Genital Warts (Condylomata Acuminata) have a 91% phase transition success rate (PTSR) indication benchmark for progressing into Phase II.

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Pharmaceutical Technology

FEBRUARY 24, 2023

(Lopinavir + ritonavir) is under clinical development by Douglas Pharmaceuticals and currently in Phase I for Cervical Intraepithelial Neoplasia (CIN). According to GlobalData, Phase I drugs for Cervical Intraepithelial Neoplasia (CIN) have a 92% phase transition success rate (PTSR) indication benchmark for progressing into Phase II.

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The Pharma Data

JULY 28, 2021

Food and Drug Administration (FDA) granted Breakthrough Therapy Designation (BTD) to TAK-994, 1 its Phase 2 investigational oral orexin agonist, which is designed to selectively target orexin 2 receptors. – If Approved, Investigational TAK-994 May Provide a Future Treatment Option Targeting the Orexin Deficiency Underlying NT1.

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VirTrial

FEBRUARY 28, 2024

If you missed Signant’s February 2024 webinar about optimizing patient-reported outcomes measurement strategy throughout oncology drug development, we’ve summarized the key takeaways and provided a link for you to watch the recording. Watch the recording You can watch the recorded webinar here.

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Pharmaceutical Technology

FEBRUARY 26, 2023

CUE-102 is under clinical development by Cue Biopharma and currently in Phase I for Metastatic Colorectal Cancer. According to GlobalData, Phase I drugs for Metastatic Colorectal Cancer have an 85% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. Buy the report here.

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Pharmaceutical Technology

FEBRUARY 26, 2023

CUE-102 is under clinical development by Cue Biopharma and currently in Phase I for Gastroesophageal (GE) Junction Carcinomas. According to GlobalData, Phase I drugs for Gastroesophageal (GE) Junction Carcinomas have a 90% phase transition success rate (PTSR) indication benchmark for progressing into Phase II.

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pharmaphorum

AUGUST 12, 2020

The enzyme replacement therapy (ERT) – also known as PRX-102 – has been granted a priority review by the US regulator, and is the top prospect in Chiesi’s recently formed rare diseases division. Market research firm Optima Insights has predicted that sales of Fabry disease drugs will more than double from around $1.8

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pharmaphorum

DECEMBER 21, 2021

Novartis has joined the ranks of big pharma companies developing TIGIT-targeted drugs for cancer, and found its candidate in an existing partner, Chinese biotech BeiGene. billion in milestones – shortly after its own PD-1 drug candidate spartalizumab failed a phase 3 trial in melanoma.

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pharmaphorum

NOVEMBER 12, 2020

Swiss startup Synendos Therapeutics has raised CHF 20 million (almost $22 million) in first-round financing that will be used to develop its endocannabinoid drugs for central nervous system disorders. Synendos says the cash will allow it to take its lead product SYT-510 through preclinical and proof-of-concept clinical development.

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Drug Discovery World

OCTOBER 3, 2023

The US Food and Drug Administration (FDA) has announced a pilot programme with the aim of accelerating the development of novel drug and biological products for rare diseases. The post FDA pilot programme to boost rare disease therapies appeared first on Drug Discovery World (DDW).

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The Pharma Data

SEPTEMBER 29, 2021

Food and Drug Administration (FDA) supported the positive results of the FIDELIO-DKD phase III clinical trial study for patients with CKD and T2D. They also control how much water and electrolytes are in the body, regulating blood pressure. In July, finerenone was approved under the name Kerendia® by the us (U.S.)

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pharmaphorum

MAY 14, 2021

China’s Kintor Pharmaceutical has begun late-stage US clinical development of its potential COVID drug proxalutamide – but there is scepticism over the company’s claims about its research. Lu declined to comment further on its announcement that the first patient had been dosed with the drug in the US trial.

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pharmaphorum

NOVEMBER 11, 2022

Understanding commercial and market access risks and opportunities at an early stage in biopharmaceutical product development is essential for optimizing commercial success. Several decisions are made in the early stages of clinical development that have key implications for entering markets successfully.

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XTalks

OCTOBER 7, 2020

Not only did this baby survive to do all these things, but he became a poster child for gene therapy with the regulators at the U.S. Food and Drug Administration (FDA). Born with spinal muscular atrophy (SMA), the little boy was saved by the drug Zolgensma, a one-time intravenous infusion that restored the child’s defective SMN1 gene.

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Camargo

DECEMBER 20, 2021

One of the biopharmaceutical industry’s most closely watched forthcoming regulatory developments is the FDA’s imminent reauthorization of the Prescription Drug User Fee Act (PDUFA). The increase is designed to strengthen CBER’s capacity and capabilities for regulating cell and gene therapies. 2024: 48 staffers. 2027: 4 staffers.

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Drug Discovery World

MARCH 26, 2024

DDW’s Megan Thomas caught up with Oliver Rausch, Chief Scientific Officer at Storm Therapeutics, following the ESMO Targeted Anticancer Therapies Congress 2024, a global meeting focusing on promising new anticancer targets and agents, focusing on those in early phase clinical development. MT: What’s next for STORM’s research?

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pharmaphorum

SEPTEMBER 8, 2021

The orally-active drug can be used in patients aged 12 and over after two other systemic therapies have been tried, and is thought to work by downregulating inflammatory immune cells and boosting the levels of T cells that help to regulate the immune system.

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Drug Discovery World

JUNE 15, 2023

The International Society for Cellular Therapy (ISCT) is a global society of clinicians, regulators, technologists, and industry partners with a shared mission to drive the translation of all cell and gene (CGT) therapies for the benefit of patients worldwide. That doesn’t help in recruiting patients and getting clinical results.

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pharmaphorum

JANUARY 30, 2022

The FDA has approved Roche’s much-anticipated faricimab for two major causes of blindness, setting up a market clash with Bayer and Regeneron’s market leading drug Eylea. The post Roche grabs FDA okay for would-be blockbuster eye drug faricimab appeared first on. Image by analogicus from Pixabay .

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Drug Discovery World

SEPTEMBER 14, 2023

joined Pfizer’s Executive Leadership Team as Chief Oncology Research and Development Officer and Executive Vice President reporting to Chairman and Chief Executive Officer, Albert Bourla. In July 2023, AstraZeneca and Ionis Pharmaceuticals expanded their existing collaboration on eplontersen to also include Latin America. Chris Boshoff, M.D.,

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Drug Discovery World

JULY 6, 2023

The first patient has been dosed in the clinical Phase I evaluation of the Sema3A monoclonal antibody, part of the Evotec-Bayer multi-target research collaboration in kidney diseases. Semaphorin-3A is an extracellular guidance protein and a well-known regulator of the actin cytoskeleton.

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The Pharma Data

MAY 2, 2022

Nasdaq: BIIB) initiated a rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for zuranolone in the treatment of major depressive disorder (MDD). Zuranolone is an investigational two-week, once-daily oral drug being developed for MDD and postpartum depression (PPD).

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XTalks

MARCH 28, 2024

Italy-based drugmaker Italfarmaco has won US Food and Drug Administration (FDA) approval for its oral medication Duvyzat (givinostat) for the treatment of Duchenne muscular dystrophy (DMD) in patients six years of age and older. The drug generated domestic sales of $200.4 million last year, of which $131.3

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