pharmaphorum

MARCH 15, 2022

Sanofi has agreed a deal with life sciences investor Blackstone to help fund clinical trials of a new formulation of Sarclisa for blood cancer multiple myeloma, accelerating its development. The post Blackstone funds new trials of Sanofi’s Sarclisa in myeloma appeared first on.

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pharmaphorum

OCTOBER 3, 2022

Amylyx Pharmaceuticals’ Relyvrio – a new treatment for amyotrophic lateral sclerosis (ALS) approved by the FDA on Thursday, after review of the data from its phase 2 trial – was the next day set at a list price of $158,000 per year in the US, sparking outcry. ALS affects over 30,000 people in the US.

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The Pharma Data

JANUARY 10, 2021

The new year began with a fairly low level of clinical trial news. Arcturus Therapeutics got the FDA go-ahead for its Phase II trial of its COVID-19 vaccine candidate ARCT-021. The trial will enroll 600 participants, with 450 receiving ARCT-021 and 150 receiving placebo. Here’s a look.

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Drug Discovery World

OCTOBER 19, 2022

Following the news that the number of clinical trial recruiting sites in Ukraine has dropped by half since the Russian invasion, DDW’s Diana Spencer examines clinical trial data from analytics company Phesi and speaks to Dr Olena Karpenko , Clinical Research Director at Medical Center Ok!Clinic+

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Delveinsight

DECEMBER 22, 2020

Vorasidenib is an investigational, brain-penetrant, dual inhibitor of mutant IDH1 and IDH2 in a Phase III trial in patients with IDH-mutant low-grade glioma, AG-270 is an investigational first-in-class methionine adenosyltransferase 2a (MAT2A) inhibitor while AG-636 is a novel inhibitor of dihydroorotate dehydrogenase.

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The Pharma Data

JULY 29, 2021

Eisai and Biogen Present Preliminary Assessment of the Clinical Effects of Lecanemab Following 18 Months of Treatment in the Open-Label Extension of the Phase 2 Proof of Concept Study at 2021 Alzheimer’s Association International Conference (AAIC) . United States and virtually from July 26 to 30, 2021 (Presentation No.:

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The Pharma Data

JUNE 25, 2021

KEYNOTE-564 is the First Phase 3 Study to Show Positive Results for Adjuvant Immunotherapy in RCC. 41.5), KEYTRUDA demonstrated a statistically significant and clinically meaningful reduction in the risk of disease recurrence or death by 32% compared to placebo (HR=0.68 [95% CI, 0.53–0.87]; KENILWORTH, N.J.–(BUSINESS months (14.9-41.5),

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The Pharma Data

DECEMBER 17, 2020

PARIS–( BUSINESS WIRE )– Regulatory News: Lysogene (Paris:LYS) (FR0013233475 – LYS), a phase 3 gene therapy platform Company targeting central nervous system (CNS) diseases, announces a change in the governance and control of KGA, a company co-owned by Karen Aiach and which currently owns approximately 6% of Lysogene’s capital.

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XTalks

SEPTEMBER 28, 2020

Related: Liquid Biopsies Help Match Cancer Patients to Phase I Trials. The test is based on the detection of actionable genes – genes with known driver mutations that can be targeted by an approved therapy (or investigational therapies in clinical trials).

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The Pharma Data

DECEMBER 27, 2020

PARIS–( BUSINESS WIRE )– Regulatory News: Lysogene (FR0013233475 – LYS) (Paris:LYS), a phase 3 gene therapy platform company targeting central nervous system (CNS) diseases, today reports positive biomarker data from the ongoing AAVance clinical trial with LYS-SAF302 for the treatment of MPS IIIA (NCT03612869).

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The Pharma Data

APRIL 28, 2021

Deal expands anti-infectives pipeline with addition of novel antifungal Phase 2 candidate, Fosmanogepix (APX001). NEW YORK–(BUSINESS WIRE)– Pfizer Inc. million deaths annually *iii , accounting for two of the World Health Organization’s top ten causes of death worldwide iv. and Scedosporium spp).

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The Pharma Data

JANUARY 20, 2021

The approval of Verquvo by the FDA, which is the first treatment for chronic heart failure approved specifically for patients following a hospitalization for heart failure or need for outpatient IV diuretics, is based on the results of the pivotal Phase 3 VICTORIA trial and follows a priority regulatory review.

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The Pharma Data

JUNE 18, 2021

In this study, patients who responded to 12 weeks of risankizumab intravenous (IV) induction treatment (in a prior study) were re-randomized to receive risankizumab 180 mg, risankizumab 360 mg or withdrawal from risankizumab treatment (risankizumab IV induction-only control group). NORTH CHICAGO, Ill. NORTH CHICAGO, Ill.

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The Pharma Data

SEPTEMBER 16, 2020

New and updated data from across our broad cancer portfolio including phase III results in breast, lung and prostate cancers. New integrated analyses from our tumour agnostic Rozlytrek ® (entrectinib) clinical development programme.

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The Pharma Data

JANUARY 26, 2021

Reddy’s”) and Global Response Aid FZCO (GRA) today announced the termination of Avigan Trial Study conducted in Kuwait focused on moderate to severe COVID patients in a hospital setting. GRA delivers innovative, effective healthcare solutions through a range of pharmaceutical products and technology platforms.

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The Pharma Data

JUNE 18, 2021

years, with no new safety risks observed. In this study, a higher proportion of patients treated with RINVOQ 15 mg achieved and maintained clinical remission and low disease activity compared to those treated with HUMIRA, through three years. Clinical remission per DAS28-CRP<2.6 Clinical remission per CDAI?2.8

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The Pharma Data

AUGUST 3, 2021

end-stage renal disease (ESRD) bundled payment system, dialysis clinics rapidly implemented new treatment protocols, switching patients from Parsabiv to generic oral cinacalcet. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

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The Pharma Data

JULY 21, 2021

A BTD is intended to expedite the development and review of medications to treat a serious medical condition and is granted when preliminary clinical evidence indicates the investigational therapy may demonstrate substantial improvement over existing therapies. ” This designation is supported by data from the Phase 1b M15-531 study.

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ACRP blog

AUGUST 30, 2023

Food and Drug Administration (FDA) seems to be approving drugs after fewer trials (accelerated approval) and releasing less data from those trials, one experienced principal investigator (PI) cautions that public perceptions of clinical research may take a hit.

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XTalks

OCTOBER 6, 2020

According to Janssen , Simponi Aria is the first and only fully human anti-tumor necrosis factor (TNF)-alpha biologic agent administered by intravenous (IV) infusion approved for pediatric use in both pJIA and PsA. FDA approval for the treatment was based on results from the Phase III GO-VIVA clinical trial.

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XTalks

MARCH 2, 2021

The 66 percent efficacy determined for the J&J vaccine is for the prevention of mild to moderate disease, an average derived from the companies’ global Phase III trials. Timing of COVID-19 Clinical Trials. Hospitalizations are also reduced by nearly 100 percent.

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The Pharma Data

JANUARY 24, 2021

With a presidential inauguration and a federal holiday, it wasn’t an enormously busy week for clinical trial news, but there was a fair amount, nonetheless. It inked a deal with the National Institute of Allergy and Infectious Diseases (NIAID) to launch a Phase I trial. Read on to see. COVID-19-Related.

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The Pharma Data

SEPTEMBER 2, 2020

New data further reinforce OCREVUS (ocrelizumab) as a highly effective treatment option offering a favourable and consistent benefit:risk profile, with high treatment persistence and adherence. Initiation of Phase IIIb OCREVUS higher dose clinical trial programme and Phase IV study evaluating OCREVUS in minority populations.

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Drug Discovery World

OCTOBER 25, 2022

Clinical stage company Beckley Psytech has entered into an agreement to acquire clinical-stage life science company, Eleusis Therapeutics. . The acquisition adds ELE-101, a next-generation, short-duration psychedelic ready for Phase I clinical trials, to Beckley Psytech’s pipeline. .

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The Pharma Data

DECEMBER 20, 2020

Many companies appear to be getting their clinical trial news updated ahead of the holidays. CureVac announced it has enrolled the first volunteer in the pivotal Phase IIb/III trial of its own mRNA vaccine candidate, CVnCoV against COVID-19. Here’s a look. COVID-19-Related.

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The Pharma Data

FEBRUARY 24, 2022

“In its phase III trials, empagliflozin has shown a statistically significant and clinically meaningful benefit in patients with heart failure across the spectrum of ejection fraction,” said Javed Butler, M.D., In the trial, Jardiance demonstrated a 21% relative risk reduction (3.3%

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The Pharma Data

DECEMBER 20, 2020

Pending Health Canada’s approval, the Phase 1 trial is designed to test the safety, tolerability and pharmacokinetics of ALS-4 in healthy volunteers. ALS-4 is an orally administered drug and thereby aligning with global healthcare policy to actively promote the switch from an IV to oral based antimicrobial treatment 1,2,3.

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The Pharma Data

OCTOBER 18, 2020

The principal investigator Professor Christophe Le Tourneau will present results from a pooled analysis of the Phase 1b/2 trial, including response rate, median progression-free survival, as well as the impact of patient/disease characteristics on outcome and immunogenicity. 19, 2020 05:30 UTC. Christophe Le Tourneau, M.D.,

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The Pharma Data

OCTOBER 26, 2020

The purpose of this exploratory Phase 1b/2 trial was to evaluate the safety and efficacy of the combination of TG4001 and an immune checkpoint inhibitor in a heterogeneous group of patients with aggressive, recurrent and/or metastatic HPV16-positive cancers. Key findings of the trial: .

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The Pharma Data

JUNE 18, 2021

Additionally, there are other ongoing company-sponsored and investigator-initiated trials exploring the potential of ibrutinib and venetoclax in combination for CLL treatment, including the Phase 3 GLOW study. IMBRUVICA is the most comprehensively studied BTK inhibitor, with more than 150 ongoing clinical trials.

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The Pharma Data

JUNE 18, 2021

“With CLL being one of the most common types of blood cancer, the expansion of research into additional treatment options for patients is an important clinical undertaking,” said Arnon Kater , M.D., IMBRUVICA is the most comprehensively studied BTK inhibitor, with more than 150 ongoing clinical trials.

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Pfizer

NOVEMBER 2, 2022

Pfizer and BioNTech Initiate Phase 1 Study of Single Dose mRNA-Based Combination Vaccine Candidate for Influenza and COVID-19. Pfizer and BioNTech Initiate Phase 1 Study of Single Dose mRNA-Based Combination Vaccine Candidate for Influenza and COVID-19. About the Phase 1 Study . Wed, 11/02/2022 - 15:44. Pfizer Disclosure Notice.

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Pfizer

DECEMBER 8, 2022

Fast Track is a process designed to facilitate the development and expedite the review of new drugs and vaccines intended to treat or prevent serious conditions and address unmet medical need. Influenza is another respiratory disease that also requires repeated vaccinations due to continuous mutations in the surface hemagglutinin protein.

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The Pharma Data

OCTOBER 30, 2020

Monthly News Roundup – October 2020. Veklury is used in adults and children (12 years and older and weighing at least 40 kg) and is given by intravenous (IV) infusion once a day for 5 to 10 days based on patient status. Approval was based on an interim analysis from the Phase 3 CheckMate-743 trial.

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XTalks

SEPTEMBER 14, 2020

By the end of August, the World Health Organization (WHO) counted 33 vaccine candidates in some stage of clinical trial evaluation. As of July, the company and its federal partner stated that it is on track to supply between 500 million to 1 billion doses a year at a dose of 100 µg now selected for their Phase III trial.

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