The Pharma Data

JULY 21, 2021

These data were shared as a late-breaking oral presentation during the virtual 11 th International AIDS Society Conference on HIV Science (IAS 2021) and are a follow-up to the interim analysis that was presented earlier this year at the virtual 2021 HIV Research for Prevention Conference (HIVR4P 2021). Kenilworth, N.J.,

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The Pharma Data

NOVEMBER 4, 2020

Food and Drug Administration (FDA) Breakthrough Therapy and Fast Track Designations, is now in pivotal testing, and CTP-692 for schizophrenia is currently on track for topline data readout in the first quarter of 2021,” said Roger Tung, Ph.D., CTP-543 THRIVE-AA2 Phase 3 Trial Planned for First Half of 2021. Revenues.

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The Pharma Data

JULY 12, 2021

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the presentation of data from the company’s HIV clinical development program at the 11th International AIDS Society Conference on HIV Science (IAS 2021) from July 18-21. Late Breaking Oral Presentation OALC01LB03. E-poster Presentation PEB168.

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The Pharma Data

APRIL 8, 2021

OCREVUS data show its consistent benefit on slowing disease progression in relapsing multiple sclerosis (RMS) and primary progressive MS (PPMS). Data for ENSPRYNG in neuromyelitis optica spectrum disorder (NMOSD) reinforce safety and efficacy, including in patients with concomitant autoimmune diseases (CAIDs). Following U.S.

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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

DECEMBER 13, 2020

AMPK is a master regulator of several important metabolic pathways, including lipid metabolism, glucose control and inflammation, and is a novel target for NASH and additional chronic and rare metabolic diseases. The Phase 2b trial is expected to begin during the second half of 2021. Summary of New PXL770 Phase 2a Study Results.

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The Pharma Data

DECEMBER 5, 2020

57% of evaluable patients (4 of 7 patients) were minimal residual disease (MRD) negative. We are also expanding our odronextamab program with multiple pivotal trials in 2021.” REGN5458 and odronextamab are currently under clinical development, and their safety and efficacy have not been evaluated by any regulatory authority.

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Agency IQ

SEPTEMBER 15, 2023

The committee also made recommendations regarding pharmacokinetic and safety assessments. When looking at several pharmacokinetic studies, the FDA found that the 10 mg oral dose of phenylephrine has a very low bioavailability of less than 1% and, subsequently, low systemic alpha-1 adrenergic activity. billion for pseudoephedrine. “We

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The Pharma Data

MARCH 17, 2021

percent compared to ET alone – a statistically significant improvement in invasive disease-free survival for HR+, HER2- high risk early breast cancer (HR: 0.713; 95% CI: 0.583, 0.871; p = 0.0009). Gallen will be published in a supplement issue of The Breast, available on March 17, 2021. Available on-demand on March 10, 2021.

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The Pharma Data

MARCH 8, 2021

We are delighted to share our early data at CROI 2021 supporting the potential for a once-yearly dosing regimen for islatravir using a subdermal implant,” said Dr. Joan Butterton, vice president, global clinical development, infectious diseases, Merck Research Laboratories. “We Our Commitment to Infectious Diseases.

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The Pharma Data

DECEMBER 15, 2020

A healthy immune system defends the body against disease and other conditions. Autoimmune disease impacts different parts of the body, weakening functionality. Researchers are aware of more than 80 diseases that occur when the immune system attacks the body’s own organs, tissues and cells. It may be life-threatening.

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The Pharma Data

APRIL 7, 2022

announced today that the companies have entered into a definitive agreement under which Pfizer will acquire ReViral, a privately held, clinical-stage biopharmaceutical company focused on discovering, developing, and commercializing novel antiviral therapeutics that target respiratory syncytial virus (RSV). NYSE: PFE) and ReViral Ltd.

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The Pharma Data

JANUARY 17, 2021

The companies announced in January 2019 a collaboration agreement to develop, manufacture and commercialize SPR206 in the Territory. SPR206 is in clinical development as an innovative option for the treatment of multi-drug resistant (MDR) Gram-negative bacterial infections. SHANGHAI , Jan. SHANGHAI , Jan. ” About SPR206.

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Drug Discovery World

FEBRUARY 15, 2023

Cancer is a complex heterogenous multistep disease characterised by uncontrolled cell proliferation combined with a dysregulated immune response. Half of people diagnosed with cancer in England and Wales survive their disease for 10 years or more (2010-11) 1.

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The Pharma Data

DECEMBER 21, 2020

Phase I safety, tolerability, and pharmacokinetic study in healthy volunteers expected to start in coming weeks following acceptance of a request for a Clinical Trial Authorization (CTA) granted by the UK Medicines and Healthcare products Regulatory Agency (MHRA). ALLSCHWIL, Switzerland, Dec.

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The Pharma Data

MARCH 5, 2021

We are focused on quickly advancing the pirtobrutinib development program, including through a series of Phase 3 studies that will be initiated over the course of 2021.” Key secondary objectives include measures of safety, pharmacokinetics, and anti-tumor activity (i.e. About Pirtobrutinib (LOXO-305).

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The Pharma Data

JANUARY 17, 2021

18, 2021 /PRNewswire/ — Genkyotex SA , a subsidiary of Calliditas Therapeutics AB (publ) (“Calliditas”) (Nasdaq OMX – CALTX; NASDAQ – CALT), today announced positive Phase 1 data demonstrating a favorable safety and pharmacokinetic profile of high-dose setanaxib, Genkyotex’s lead asset.

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The Pharma Data

JANUARY 10, 2021

10, 2021 (GLOBE NEWSWIRE) — Ascendis Pharma A/S (Nasdaq: ASND), a biopharmaceutical company that utilizes its innovative TransCon technologies to create product candidates that address unmet medical needs, will provide an update on Vision 3×3 and the company’s 2021 key milestones at the 39 th Annual J.P. Pipeline Updates.

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The Pharma Data

MARCH 26, 2021

Preclinical data suggest VIR-7831 targets a highly conserved epitope of the spike protein, which may make it more difficult for resistance to develop. The multi-centre, double-blind, placebo-controlled COMET-ICE trial investigated VIR-7831 in adults with mild or moderate COVID-19 who are at high risk of progression to severe disease.

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The Pharma Data

MAY 7, 2021

The EMA will evaluate all data on sotrovimab, including evidence from clinical trials, as they become available. The multi-center, double-blind, placebo-controlled, Phase 3 COMET-ICE trial investigated sotrovimab in adults with mild or moderate COVID-19 at high risk of progression to severe disease.

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Agency IQ

AUGUST 16, 2024

And regardless of the type of therapy, dose-limiting toxicities may result in dosage interruption, de-escalation, and even discontinuation, in the clinical trial setting as well as with real-world dosing. In 2021, FDA’s efforts on dose optimization came to the forefront with the announcement of Product Optimus. What’s new?

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The Pharma Data

SEPTEMBER 15, 2020

Major revenue contributions through 2025 anticipated from Oncology, Vaccines, Rare Disease and Inflammation and Immunology. The company announced the initiation of its Phase 1b clinical trial to evaluate the safety of a novel investigational therapeutic for COVID-19, PF-07304814. Rare Disease. BNT162 mRNA-based Vaccine Program.

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Agency IQ

FEBRUARY 2, 2024

EMA finalizes clinical anticancer therapeutic guidance update In a newly finalized revision, the EMA’s guideline covering all aspects of clinical development of anticancer therapeutics has expanded its already broad scope. after ischemic heart disease and stroke. In 2019 more than one in four (28%) of deaths in the E.U.

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Agency IQ

JUNE 9, 2023

For this reason, animal models are still used both during drug discovery and the more intensive nonclinical studies conducted during clinical development. pre- and postnatal development (PPND) study or enhanced PPND (ePPND) study) as long as they demonstrate adequate exposure to the pharmaceutical.

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The Pharma Data

DECEMBER 29, 2020

(NYSE American:PLX) (TASE:PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx ® plant cell-based protein expression system, and Chiesi Global Rare Diseases , a business unit of Chiesi Farmaceutici S.p.A.,

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Agency IQ

DECEMBER 11, 2023

Diagnostic and therapeutic advances in oncology have moved many cancer types into the categories of curable or treatable diseases. For example, FDA’s Project Renewal was announced in 2021 as a concerted effort to update labeling information for “older oncology drugs to ensure information is clinically meaningful and scientifically up-to-date.”

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Agency IQ

SEPTEMBER 22, 2023

Since that time, the FDA’s use of single pivotal trials has become more common , especially due to FDA’s expanded reviews of products intended to treat, cure or prevent rare diseases or life-threatening conditions for which there is an unmet clinical need. When should this occur? at the end-of-phase 2 meeting).

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The Pharma Data

MARCH 20, 2023

Professor of Paediatric Neuromuscular Diseases at the MDUK Oxford Neuromuscular Centre. This trial included people with Type 2 and 3 SMA, including patients with advanced disease. Adverse events (AEs) and serious adverse events (SAEs) were reflective of the underlying disease. Food and Drug Administration in 2017.

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The Pharma Data

MARCH 30, 2021

More than 3,000 patients now treated with Evrysdi in clinical trial, compassionate use and real-world settings. SMA is a leading genetic cause of death in infants and 5q SMA is the most common form of the disease. Roche leads the clinical development of Evrysdi as part of a collaboration with the SMA Foundation and PTC Therapeutics.

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The Pharma Data

MARCH 16, 2021

SUNFISH Part 2 study population includes broad range of ages and disease severities, representing a real-world spectrum of people living with Type 2 or 3 SMA. More than 2,500 patients now treated with Evrysdi in clinical trial, compassionate use and real-world settings. Chief Medical Officer and Head of Global Product Development.

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The Pharma Data

OCTOBER 14, 2020

Priothera will use the funds to progress the clinical development of mocravimod, a modulator of sphingosine 1 phosphate (S1P) receptors, to enhance the curative potential of allogeneic hematopoietic stem cell transplantation (HSCT) for treating AML. Inventiva – The U.S. 1. -- -->. -- [if lte IE 8]--> .

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