The Pharma Data

JANUARY 6, 2021

The REVIVAL Phase III pivotal trial is a randomized, double-blind, placebo-controlled, two-arm, parallel-group, multi-center trial to evaluate the efficacy and safety of AM-Pharma’s proprietary human recombinant alkaline phosphatase for the treatment of patients with SA-AKI. Nature Reviews Nephrology, 2011; 7(4): 209-217.

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Broad Institute

OCTOBER 11, 2023

By Allessandra DiCorato October 11, 2023 In 2011, Robert Manguso was working in a cell biology lab when his mother was diagnosed with Merkel cell carcinoma, a rare and aggressive skin cancer. By then, a few cancer immunotherapies had entered clinical trials and only a handful had been approved by the FDA.

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New Drug Approvals

NOVEMBER 13, 2023

Phase 1 Trial of Vodobatinib, a Novel Oral BCR-ABL1 Tyrosine Kinase Inhibitor (TKI): Activity in CML Chronic Phase Patients Failing TKI Therapies Including Ponatinib. amcrasto@amcrasto /////////// Ref [1]. amcrasto@amcrasto /////////// Ref [1]. Exp Hematol. 2019 Sep;77:36-40.e2. Content Brief] [2].

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Drug Target Review

NOVEMBER 1, 2023

The mission of the CCDD is to discover novel small-molecule therapeutics for the treatment of cancer and progress them to hypothesis testing phase 1 clinical trials. 2011) D67, 386-394) using PDB ID 4GV1 which was published as part of Addie et al. Although we are an academic centre we work very much like industry. Acta Cryst.

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FDA Law Blog: Drug Discovery

FEBRUARY 28, 2024

This is the third withdrawal of an accelerated approval FDA has performed, following Avastin in 2011 and Makena in 2023. In contrast , the two previous withdrawals, Makena in 2023 and Avastin in 2011, took 30 months and 11 months, respectively. All in all, the new expedited procedures took about 7 months from proposal to withdrawal.

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Drug Target Review

AUGUST 17, 2023

As a result of this study a Phase I clinical trial sponsored by BioInvent International is currently underway (ClinicalTrials.gov ID: NCT05555251), which aims to investigate the efficacy of an engineered Fc-null anti-FcγRIIB (clone BI-1607) in combination with Transtuzumab (anti-HER2) in HER2-positive advanced solid tumours.

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New Drug Approvals

AUGUST 21, 2023

7] A one-year trial did not demonstrate a significant benefit on lung density in moderate-to-severe emphysema secondary to severe α(1)-antitrypsin deficiency. [8] 18] In December 2022, the FDA declined to approve palovarotene for the fibrodysplasia ossificans progressive without additional clinical trial data. [19] April 2011).

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The Pharma Data

AUGUST 11, 2020

.–( BUSINESS WIRE )– Bristol Myers Squibb (NYSE: BMY) today announced the Phase 3 CheckMate -577 trial evaluating Opdivo (nivolumab) as an adjuvant therapy for patients with resected esophageal or gastroesophageal junction (GEJ) cancer met its primary endpoint of disease-free survival (DFS) at a pre-specified interim analysis.

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FDA Law Blog: Biosimilars

SEPTEMBER 15, 2024

The PREVAIL Act In short, the PREVAIL Act is intended to, among other things, reform the Inter Partes Review (“IPR”) process created by the 2011 Leahy-Smith America Invents Act. 2220, the Promoting and Respecting Economically Vital American Innovation Leadership Act (“ PREVAIL Act ”); and (2) S. inventors to compete.

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Codon

AUGUST 26, 2024

One large-scale clinical trial found that it only reduces the relative risk of death by about ten percent in hospitalized patients. Companies may lack incentives to conduct human clinical trials for drug-free antivirals or repurposed drugs. Nor was remdesivir as effective as people hoped. Unsubscribe any time.

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The Pharma Data

AUGUST 11, 2020

The safety profiles of Opdivo and chemotherapy in this trial are reflective of the known safety profiles of Opdivo and chemotherapy in first-line gastric and esophageal cancers. The company remains blinded to data from this arm and the trial continues in follow-up to allow the data to mature. PRINCETON, N.J.–(

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The Pharma Data

APRIL 27, 2023

The positive opinion is based upon efficacy and safety results from two Phase 3 trials, EXPLORER-HCM and VALOR-HCM. Results from the Phase 3 EXPLORER-HCM trial, which evaluated CAMZYOS in patients with symptomatic obstructive HCM versus placebo, met all primary and secondary endpoints with statistical significance.

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The Pharma Data

AUGUST 17, 2021

Applications based on positive results from the Phase 3 CheckMate -648 trial, in which both Opdivo -based combinations demonstrated a significant survival benefit over chemotherapy alone. Bristol Myers Squibb thanks the patients and investigators involved in the CheckMate -648 trial. On March 25, 2011, the U.S.

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The Pharma Data

MAY 5, 2021

Ferriprox was originally approved in 2011 as a therapy for patients with transfusional iron overload due to thalassemia syndromes for whom chelation therapy was not adequate. . The approval was based on results in a prespecified interim analysis of the first 264 patients of the ongoing KEYNOTE-811 trial. blind, placebo?controlled

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The Pharma Data

JANUARY 20, 2021

But between 2017 and 2019, more than 400 adults with moderate-to-severe methamphetamine use disorder participated in a combination treatment trial, and the results suggest the combination works. In prior testing, neither of these meds was effective when taken individually. National Institute on Drug Abuse (NIDA), which funded the study.

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The Pharma Data

DECEMBER 13, 2020

A biosimilar is like a generic version of a biologic, but unlike a generic, which is a direct copycat of a branded drug, a biosimilar is “similar,” and as a result has to undergo a regulatory and clinical trial process similar to that of new drugs. The studies found no clinically meaningful differences between ABP 798 and Rituxan.

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The Pharma Data

NOVEMBER 10, 2020

Innovent has established a robust pipeline of 23 valuable assets, including four launched products, four products in pivotal trials, and multiple prioritized assets such as CD47, PDL1/CD47, TIGIT, VEGF/complement protein etc. that are fast progressing clinical trials. TYVYT® is the only PD-1 inhibitor included in the NRDL.

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The Pharma Data

JANUARY 14, 2021

The approval was based on data from Study ADVL0912, a multicenter, single-arm, open-label trial in 121 patients ranging in ages from one to 21, and included 26 patients with r/r/, systemic ALK-positive ALCL after at least one systemic treatment. About 90% of ALCL cases in young people are ALK-positive.

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Agency IQ

APRIL 12, 2024

Draft guidance on potency assays for CGT products garners extensive stakeholder input Late last year, the FDA published a draft update to its 2011 guidance on potency assays for cell and gene therapy products, unveiling a major shift in approach to the issue. As a result, the 2011 guidance was generally seen as basic and outdated.

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The Pharma Data

DECEMBER 21, 2020

DFS results in the overall trial population of patients with Stage IB-IIIA disease showed Tagrisso reduced the risk of disease recurrence or death by 80% (HR 0.20; 95% CI 0.15-0.27; The safety and tolerability of Tagrisso in this trial was consistent with previous trials in the metastatic setting. 0.23; p<0.0001).

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The Pharma Data

FEBRUARY 25, 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., It is not for use to improve glycemic control in adults with type 2 diabetes with an eGFR below 30 mL/min/1.73

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NIH Director's Blog: Drug Development

FEBRUARY 4, 2014

References: [1] Trial watch: phase II and phase III attrition rates 2011-2012. I think there are a whole lot more PCSK9’s out there waiting to be discovered [3]. We just need to assemble the right teams to help us find the right targets—and AMP has the right stuff to do that. Arrowsmith J, Miller P. Nat Rev Drug Discov. 2013 August.

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The Pharma Data

FEBRUARY 22, 2022

After ten years at Sony France as Chief Financial Officer (2000-2002), and then General Secretary, she was appointed Chief Financial Officer of Europacorp Group in 2011. She began her career in 1992 at PricewaterhouseCoopers where she worked as an auditor and then a financial advisor.

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The Pharma Data

NOVEMBER 23, 2020

The authors used longitudinal data on 10,676 Medicare-enrolled participants aged 65 years and older from the National Health and Aging Trends Study 2011 to 2018 cycles to assess the likelihood of developing functional visual impairment over time given baseline dementia, and vice versa. ” Abstract No. Abbott, M.D.,

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The Pharma Data

JUNE 30, 2021

Findings from the EMPRISE real-world evidence study complement insights from the EMPA-REG OUTCOME ® trial, which showed that empagliflozin provides cardiovascular and renal benefits, in addition to metabolic effects, in people with type 2 diabetes and established cardiovascular disease. Source link: [link].

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The Pharma Data

NOVEMBER 10, 2020

The therapy has also been included in Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia (Trial version 7 and 8), and Diagnosis and Treatment Protocol for Severe and Critical Cases of Novel Coronavirus Pneumonia (Trial version 3), released by National Health Commission & State Administration of Traditional Chinese Medicine.

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The Pharma Data

NOVEMBER 10, 2020

About NCT03763149 Trial. NCT03763149 is a phase 1a clinical trial conducted in the United States to evaluate the tolerance, safety, and PK/PD properties of Letaplimab monotherapy for advanced malignancies. In this study, 7 dose groups ranging from 0.1mg/kg to 30mg/kg were preset. .

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New Drug Approvals

SEPTEMBER 13, 2024

2] As of July 2022, it is in phase 3 clinical trials for major depressive disorder. [2] hours following a single dose of 10 mg, which supported the 4 mg to 25 mg dosages that aticaprant is being explored at in clinical trials. [13] 2] It first appeared in the scientific literature in 2010 or 2011. [16] nM vs. 24.0 nM vs. 24.0

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LifeSciVC

DECEMBER 13, 2022

In the spring of 2011, we came out of stealth with a blog “ Discovering Nimbus ”, which highlighted the three key elements of the “experiment”: a cutting edge in silico discovery engine, with a truly virtual and globally distributed operating model, and a unique asset-centric LLC-based corporate structure (also described here ).

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The Pharma Data

DECEMBER 16, 2020

The FDA first approved Benlysta for lupus in 2011. Last year, GSK announced positive results from a two-year clinical trial involving several hundred people with active lupus nephritis treated with Benlysta. .” . Benlysta is a human monoclonal antibody sold by GSK. About Lupus.

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Drug Target Review

JUNE 21, 2023

Strikingly, a strong genetic link between target and disease biology is emerging as a predictor for success in clinical trials. Why Clinical Trials Stop: The Role of Genetics. Nature 477 , 220–224 (2011). Sci Transl Med. 2017 Mar 29;9(383):eaag1166. Doi: 10.1126/scitranslmed.aag1166. PMID: 28356508; PMCID: PMC6321762.

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Advarra

NOVEMBER 10, 2022

multisite research and trials). Many industry sponsors already request participating sites in multisite trials rely on the study’s central IRB as a way to reduce the administrative burden of managing multiple IRB requirements, processes, and timelines, citing FDA’s 2006 guidance on centralized IRB review.

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Agency IQ

SEPTEMBER 22, 2023

Traditionally, FDA has interpreted the need for “well-controlled investigations” to mean at least two clinical trials for new drugs, or applications for supplemental indications. When looking at all drugs approved between 2011 and May 2020, 136 drugs were approved on the basis of a single pivotal trial, according to AgencyIQ’s research.

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Drug Target Review

JUNE 19, 2024

That would provide wonderful information as we think about then going into a first-in-human clinical trial. MSTX), from 2010, and was also a member of its board of directors from 2011, until Mast’s merger with Savara, Inc. Do they affect the hearing capability of this species? SVRA) in April 2017.

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Sygnature Discovery

JULY 31, 2023

Founded in 2011, NuChem Sciences delivers expert integrated and standalone discovery solutions across medicinal, synthetic, scale-up, process and computational chemistry, as well as DMPK, in vitro biology and in vivo pharmacology.

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The Pharma Data

SEPTEMBER 8, 2021

CheckMate -743 remains the only Phase 3 trial to show a survival benefit with first-line immunotherapy treatment in patients with MPM. First-line nivolumab + cabozantinib vs sunitinib in patients (pts) with advanced renal cell carcinoma (aRCC) in subgroups based on prior nephrectomy in the CheckMate 9ER trial. Dr. Camillo Porta.

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Agency IQ

OCTOBER 6, 2023

This was more than twice the volume seen in FY 2022 and the second highest percentage of novel drug approvals in a given year dating back to 2011. This was followed by a reminder that the NDA annual report must include a status summary regarding the confirmatory trial ( see example here ). of all NME approvals this year.

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