Drug Discovery World

NOVEMBER 14, 2023

billion by 2031, growing at a CAGR of 7% from 2022 to 2031 2 , but is also reflected in data by The Antibody Society, which shows that of the over 100 approved mAbs, around 40% are for cancer 3. billion in 2022 to $53.81 This is not only made clear by the fact that the global cancer mAbs market size was valued at $55.6

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Drug Discovery World

NOVEMBER 24, 2023

7,8 Results from the primary endpoint of the TOPAZ-1 Phase III trial showed that durvalumab, in combination with standard of care gemcitabine plus cisplatin (chemotherapy) demonstrated a clinically meaningful and durable overall survival (OS) benefit as a treatment for patients with advanced BTC.6 Innovative Licensing and Access Pathway.

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Drug Discovery World

APRIL 20, 2023

Regulators are therefore used to seeing cognitive data as primary or secondary outcomes in clinical trials, and are familiar with the instruments and methodological nuances of such data. 2022, doi: 10.1016/S2215-0366(22)00260-7. 2022, doi: 10.1016/j.euroneuro.2022.04.004. 2022, doi: 10.1038/s41586-022-04569-5. 82–92, Jun.

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Drug Discovery World

AUGUST 23, 2022

If approved, ASTX727 would be the first and only oral hypomethylating agent licensed in the European Economic Area (EEA) for the initial treatment of adults with AML who are ineligible for intensive chemotherapy, offering a potentially more convenient treatment regimen. . Abstract P573.

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Drug Discovery World

NOVEMBER 8, 2022

Merck has exercised its option to jointly develop and commercialise personalised cancer vaccine (PCV) mRNA-4157/V940 pursuant to the terms of its existing collaboration and license agreement with Moderna. . KEYNOTE-942 is an ongoing randomised, open-label Phase II trial that enrolled 157 patients with high-risk melanoma.

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Drug Discovery World

JANUARY 15, 2024

Chiesi and Oak Hill Bio intend to continue a Phase IIb clinical trial in 2024 in the United States, Europe, and Japan. The agreement expands the collaboration initiated in February 2022 to include an additional target programme and names VantAI and Blueprint Medicines as the exclusive partners.

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The Pharma Data

JULY 18, 2021

Food and Drug Administration (FDA) granted Priority Review designation for the Biologics License Application (BLA) for their mRNA vaccine to prevent COVID-19 in individuals 16 years of age and older. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is in January 2022.

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Drug Discovery World

AUGUST 21, 2023

Medications containing semaglutide such as Ozempic, licensed for diabetes, and Wegovy, for weight loss, are being studied to see if they can treat a range of different conditions, including addiction and dementia. In February 2022, a Danish study showed that the dementia rate was lower in patients randomised to GLP-1 RAs versus placebo.

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Drug Discovery World

FEBRUARY 9, 2023

This means durvalumab is eligible for inclusion in the Innovative Licensing and Access Pathway (ILAP). 4 Durvalumab plus chemotherapy was generally well-tolerated in the TOPAZ-1 trial. This means durvalumab is eligible for inclusion in the Innovative Licensing and Access Pathway (ILAP). 4 Updated median OS was 12.9 Poster 56P.

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The Pharma Data

DECEMBER 13, 2020

The FDA also recommended that Gamida Cell generate additional manufacturing-related data prior to requesting a pre-Biologics License Application (BLA) meeting. The revised plan could support a potential commercial launch of omidubicel in the United States as early as mid-2022. chief executive officer of Gamida Cell.

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Drug Discovery World

AUGUST 3, 2023

Even still, these approved drug products require a licensed healthcare provider’s prescription. Significantly, in January 2023, the FDA finalised a 2020 draft guidance outlining how sponsors and investigators can conduct clinical trials for certain drugs containing cannabis or cannabis-derived compounds without running afoul of federal law 2.

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Drug Discovery World

MARCH 7, 2023

In its ‘Women in Business 2022’ report, Grant Thornton reported that at 39%, the healthcare industry had the highest proportion of women in senior management out of the 15 industries surveyed. She has also been awarded the 2022 Liverpool Women In Business, Woman of the year Award. Dr Loubna Bouarfa, Founder and CEO, OKRA.ai

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Drug Discovery World

MAY 6, 2024

In 2022, the continent held a 22.4% billion on R&D during 2021, with Germany and Switzerland being the biggest contributors, and around one fourth of clinical trials worldwide were performed in Europe 1. The CDD will sponsor and manage KWF-supported trials. share of global pharma revenues, according to analysts Statistica 1.

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Sygnature Discovery

NOVEMBER 29, 2023

A new treatment for G4-targeted solid tumors including pancreatic cancer has been administered to patients for the first time in a Phase 1a clinical trial. This latest development follows the US Food and Drug Administration (FDA) giving clearance for QN-302 in July 2023 to proceed to this initial clinical trial stage.

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Drug Discovery World

AUGUST 31, 2022

Moderna first started developing this chemical modification in 2010 and validated it in human trials in 2015. The company updated its stance in March 2022 when supply was less of a barrier in parts of the world. The company is also not seeking damages for activities occurring before March 8, 2022. Official comments.

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The Pharma Data

JUNE 7, 2022

The new findings from the Phase 3 clinical trials (ADvocate 1 and 2) showed eight out of ten patients who achieved clinical response (EASI-75*) with lebrikizumab monotherapy at 16 weeks maintained skin clearance at one year of treatment with the once every two weeks or four weeks regimen. Almirall S.A.’s Source link: [link].

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Drug Discovery World

JULY 2, 2024

Mazzetti and Schneider continue: “The transfer of technologies from the lab to the market, especially in the field of life sciences is no longer purely via IP out licensing, but rather via start-up M&A deals – start-ups being the de-risking vehicle for large corporates, especially in the life sciences and biotherapeutics sector.

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Drug Discovery World

SEPTEMBER 7, 2022

From research to clinical trials, FDA assessment and monitoring beyond, the process is by no means quick; anything that helps expediate the route for getting a drug to market is desirable. We are well aware of the time and cost involved in developing a new drug. Examples of the implementation of AI within drug discovery are plentiful.

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DrugBank

AUGUST 15, 2024

This includes funding large-scale clinical trials and establishing robust manufacturing/distribution networks. Their established infrastructure, including access to patient populations and clinical trial sites, can significantly accelerate the development timeline. In 2022 alone, global sales of Repatha reached $1.28

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Sygnature Discovery

NOVEMBER 29, 2023

A new treatment for G4-targeted solid tumors including pancreatic cancer has been administered to patients for the first time in a Phase 1a clinical trial. This latest development follows the US Food and Drug Administration (FDA) giving clearance for QN-302 in July 2023 to proceed to this initial clinical trial stage.

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New Drug Approvals

AUGUST 21, 2023

6] It was approved for medical use in Canada in June 2022, [4] and in the United States in August 2023. [5] 4] [5] History Palovarotene is a retinoic acid receptor gamma (RARγ) agonist licensed to Clementia Pharmaceuticals from Roche Pharmaceuticals. 24 January 2022. . 24 January 2022. 20 June 2022. Grogan, D.

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New Drug Approvals

DECEMBER 19, 2022

FDA 12/1/2022, To treat adults with relapsed or refractory acute myeloid leukemia with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation, Rezlidhia Olutasidenib , sold under the brand name Rezlidhia , is an anticancer medication used to treat relapsed or refractory acute myeloid leukemia. [1] 1 December 2022. 1 December 2022.

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Drug Discovery World

SEPTEMBER 26, 2022

Indeed, having a safety profile already established could entice patients to enter clinical trials more readily than with ‘unknown’ compounds. . Remote trials, wearable devices and advancements in genomic sequencing means that clinical data is now more abundant than ever and is only set to grow. . Volume 23 – Issue 4, Fall 2022.

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New Drug Approvals

SEPTEMBER 10, 2024

2022 Aug;87(2):306-313. Epub 2022 Mar 29. August 2022). “Phase 2 randomized, dose-ranging trial of CTP-543, a selective Janus Kinase inhibitor, in moderate-to-severe alopecia areata” Journal of the American Academy of Dermatology. J Am Acad Dermatol. doi: 10.1016/j.jaad.2022.03.045. 2022.03.045.

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Drug Discovery World

NOVEMBER 29, 2022

This ranges from understanding disease processes and identifying possible drug targets, to organising testing, rolling out clinical trials, negotiating complex regulations and licensing and finally, treating patients. Drug development and clinical trials: How drugs are discovered and developed as medicines.

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Drug Discovery World

FEBRUARY 12, 2024

There was great fanfare recently for a new Alzheimer’s drug, lecanemab (brand name Leqembi), which was shown in a trial to reduce the rate of cognitive decline in people with mild impairment. This was confirmed in human trials and the drug was subsequently approved by the FDA.

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Drug Discovery World

JANUARY 31, 2023

But first, there is the urgency of getting the new drug application (NDA) or biologics license application (BLA) filing into the hands of the respective regulatory authorities. Mature organisations must race to deliver key new patient therapeutics while meeting market revenue expectations.

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Drug Discovery World

MARCH 29, 2023

Moreover, an extra six months of RDP for drugs with full comparator clinical trials (rather than showing only that a drug is no worse than the standard of care). Will this be a viable solution? Clinical trials The draft outlines the requirement for clinical trials in children where a drug is approved in adults for a different disease.

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The Pharma Data

APRIL 29, 2022

SK bioscience and GSK announced submission of a biologics license application for SKYCovione™ a recombinant protein-based COVID-19 vaccine candidate adjuvanted with GSK’s pandemic adjuvant, to the Korean Ministry of Food and Drug Safety (KMFDS) following positive Phase III clinical data.

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New Drug Approvals

DECEMBER 24, 2023

December 2022). Eplontersen , sold under the brand name Wainua , is a medication used for the treatment of transthyretin-mediated amyloidosis. [1] 1] It is a transthyretin-directed antisense oligonucleotide. [1] 1] It was developed to treat hereditary transthyretin amyloidosis by Ionis Pharmaceuticals and AstraZeneca. [2] 330 (15): 1448–1458.

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FDA Law Blog: Drug Discovery

DECEMBER 7, 2022

Valentine — On November 22, 2022, FDA approved CSL Behring’s BLA for Hemgenix (etranacogene dezaparvovec), an AAV-based gene therapy for the treatment of adults with Hemophilia B who currently use Factor IX prophylaxis therapy, have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes.

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Drug Discovery World

OCTOBER 4, 2022

million from the National Institute on Aging of the National Institutes of Health, the company plans to begin a Phase Ia clinical trial evaluating its lead tau self- association small molecule inhibitor OLX-07010. . million in 2022 to 12.7 Diseases such as PSP and FTD have no licensed and available treatments.

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LifeSciVC

JANUARY 25, 2024

Testing drugs that make it into clinical trials has its own specific challenges. Designing trials to show safety and efficacy in people and doing it in a way that complies with all the regulatory and ethical guidelines is where many drugs fail. We have never seen the number of layoffs in biotech that happened in 2022 and 2023… ever.

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Agency IQ

JANUARY 4, 2024

The Swiss Federal Council confirmed its intention to continue to follow European device regulations in mid-2022, even in the face of rising concern around the implementation of the European MDR. Swissmedic reported a cash reserve of CHF 100 million, or about $118 million, at the end of 2022. What does this mean for manufacturers?

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The Pharma Data

NOVEMBER 25, 2020

Under the agreement, which may generate revenue for BioInvent of up to SEK 30 million , BioInvent will provide process development, scale-up, supply of material for toxicological studies and clinical grade material in 1000L scale for use in phase I and II clinical trials. The Company’s validated, proprietary F.I.R.S.T

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Codon

JANUARY 21, 2024

Human challenge trials were an indispensable part of the development of the malaria vaccine, R21/Matrix-M, endorsed by the World Health Organization last October. But for all of their benefits, human challenge trials have their drawbacks. Jake himself has participated in both Zika and Shigella challenge trials.

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The Pharma Data

APRIL 18, 2022

Novavax licensed and transferred its manufacturing technologies to enable Takeda to develop and manufacture the vaccine at its facility in Hikari. Interim results from the Phase 1/2 study in Japan were positive and consistent with previously reported clinical trial results. TAK-019 Clinical Trial.

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