Drug Target Review

AUGUST 17, 2023

This novel mouse model, in addition to a previously generated human FcγRIIB transgenic (Tg) mouse, along with a panel of FcγRIIB mAbs, were used to develop a deeper understanding of FcγRIIB’s inhibitory functions during mAb immunotherapy and how optimal targeting of FcγRIIB would potentiate mAb therapy. 2011 Sep 1;118(9):2530-40.

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Creative Biolabs

JUNE 29, 2023

In 2011, some scientists published online for the first time that the single domain antibody recognized the activated conformation of β2AR and could stabilize the activated state of the receptor, thus deciphering the structure of β2AR in the active state.

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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]. Content Brief] [2].

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The Pharma Data

JANUARY 14, 2021

Xalkori is a tyrosine kinase inhibitor indicated since 2011 for patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are ALK- or ROS1-positive. Xalkoria received Breakthrough Therapy designation from the FDA in May 2018 for ALK-positive ALCL. It has also been approved for that indication in more than 90 countries.

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Creative Biolabs

JUNE 20, 2022

There are already targeted therapies for the BRAF V600E mutation, such as vemurafenib, which was approved by the U.S. Food and Drug Administration (FDA) in 2011. The challenge is: for a given mutation, how can we rapidly translate this knowledge into more mechanistic understanding and genotype-driven approaches to cancer therapy?

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The Pharma Data

APRIL 27, 2023

For patients in the EU, there is yet to be an approved therapy that targets the underlying cause of this disease, despite its global prevalence and debilitating symptoms,” said Roland Chen, M.D., Senior Vice President, Cardiovascular Development at Bristol Myers Squibb. “We

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New Drug Approvals

JANUARY 31, 2024

Thus, treatment of advanced prostate cancer involves androgen deprivation therapy (ADT) such as hormonal manipulation using gonadotropin-releasing hormone (GnRH) agonists/antagonists or surgical castration, AR antagonists or CYP17A1 inhibitors (such as abiraterone acetate in combination with prednisone). 71(20), 6503-6513, 2011).

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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. How does “potency” apply to cell and gene therapy (CGT) products?

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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.

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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. . ” Press Release.

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The Pharma Data

JANUARY 20, 2021

21, 2021 /PRNewswire/ — Dynacure , a clinical-stage company focused on developing and commercializing novel therapies to transform the lives of patients with rare diseases who have limited or no treatment options, announced today the appointment of Jean M. STRASBOURG, France and PHILADELPHIA , Jan. Franchi to its Board of Directors.

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The Premier Consulting Blog

NOVEMBER 20, 2024

Stages of process validation Process validation involves three distinct stages as described in the 2011 FDA guidance, “Process Validation: General, Principles and Practices.”

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The Pharma Data

DECEMBER 17, 2020

Goater is CEO at Surface Oncology, an immuno-oncology company developing next-generation antibody therapies. Thérin is the president of Advanced Therapies at Siemens Healthineers. Prior to SpringWorks, Smith was the executive vice president of Gene Therapy at Bamboo Therapeutics. Previously he was CFO of Voyager Therapeutics.

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The Pharma Data

NOVEMBER 5, 2020

Velders is presently chairman of HollandBIO, the association of Dutch biotech companies, and provides years of experience, specifically in the cell and gene therapy areas. Taveras will lead all research and non-clinical development functions supporting the company’s pipeline of investigational therapies.

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Common Sense for Drug Policy Blog

JUNE 6, 2024

Analogous substances like post-cycle therapy drugs and human growth hormone, on the other hand, are generally produced in licit pharmaceutical laboratories in jurisdictions with more lax regulations and subsequently imported or removed from domestic pharmaceutical supply chains by illicit actors (Fink et al. 2021 ; Harvey et al.

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New Drug Approvals

SEPTEMBER 13, 2024

2] It first appeared in the scientific literature in 2010 or 2011. [16] 19] As of 2016, aticaprant has reached phase II clinical trials as an augmentation to antidepressant therapy for treatment-resistant depression. [20] 2] It first appeared in the scientific literature in 2010 or 2011. [16] December 2011). nM vs. 24.0

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The Pharma Data

DECEMBER 16, 2020

The decision makes Benlysta the first lupus therapy authorized to treat this potentially life-threatening complication of the disease. The FDA first approved Benlysta for lupus in 2011. Up to 60 percent of people with lupus will develop lupus nephritis. Benlysta is a human monoclonal antibody sold by GSK.

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Advarra

NOVEMBER 10, 2022

However, it’s important to remember the foundation of these changes: modernizing requirements to better address the way research is currently conducted, reducing burdens, and adding efficiencies to help research progress more quickly and ultimately deliver better therapies for patients.

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The Pharma Data

AUGUST 9, 2020

Etrolizumab failed to meet its primary endpoint versus placebo as maintenance therapy in people with ulcerative colitis. 2011; 162(8):1855-70. [8] Etrolizumab met its primary endpoint of inducing remission versus placebo for people with ulcerative colitis in only two of three studies. Gastroenterology 1994; 107(1):3-11. [7]

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The Pharma Data

NOVEMBER 15, 2020

iSTAR Medical was founded in 2011 and is headquartered in Wavre, Belgium. 3,4 MIGS is the most promising and fastest-growing glaucoma therapy due to its enhanced safety profile. About iSTAR Medical iSTAR Medical SA is a medtech company developing minimally invasive ophthalmic implants for treatment of patients with glaucoma.

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Trials Clinical Trials Treatment Engineering 52

FDA Law Blog: Biosimilars

JULY 24, 2023

In rejecting Avadel’s argument for Priority Review, Jazz explains that FDA must have determined that Lumryz did not represent a “significant improvement” over existing therapies, including Xywav, and thus the clinical superiority determination conflicts with the Priority Review determination.

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FDA Regulations Clinical Trials Drugs 52

The Pharma Data

NOVEMBER 15, 2020

This prestigious group of professionals will help lead the Company as it prepares for potential commercialization of its investigational cell therapy, MultiStem ®. Prior to Celgene, she held leadership roles in marketing, sales and new business development from 2002 to 2011 at Johnson & Johnson. Before that, Ms. About MultiStem ®.

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Agency IQ

JUNE 7, 2024

Active medical devices fall into these categories: MD 1100 general active medical devices, MD 1200 devices for imaging, MD 1300 monitoring devices, MD 1400 devices for radiation and thermo therapy. Series AIMD 0100 describes all active implantable device types.

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Broad Institute

JANUARY 14, 2025

When I received my genetic test report in 2011, the world had never heard of base editing. Theres still a long way to go to make this a therapy, Minikel said. Tags: Neurodegeneration Rare Disease Gene therapy The findings appear in Nature Medicine. But its really exciting to see how much is possible. Nature Medicine.

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Agency IQ

SEPTEMBER 15, 2023

This new body of data includes environmental exposure studies and clinical trials from Merck and Johnson and Johnson collected between 2011 and 2018. Since the 2007 NDAC meeting, several clinical trials have been conducted by industry to assess new phenylephrine doses and formulations—consistently failing to outperform placebo.

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PLOS: DNA Science

MARCH 21, 2024

The Food and Drug Administration just announced approval of Lenmeldy (atidarsagene autotemcel), a gene therapy to treat the neurological condition metachromatic leukodystrophy (MLD). The history of gene therapy for MLD is compelling – DNA Science covered it for Rare Disease Day in 2021, here. She passed away in 2013.

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Sygnature Discovery

APRIL 7, 2025

Since 2011, Sygnature Discovery has delivered 56 novel pre-clinical and 34 clinical compounds, with its scientists named on over 225 patent applications. Q3: What if my targeted therapy (small molecule or biologic) has systemic on-target toxicity so efficacy is limited by side effects. ?

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The Pharma Data

DECEMBER 17, 2020

Food and Drug Administration (FDA) has approved belimumab (Benlysta®), the first-ever treatment for adults with lupus nephritis (LN) who are currently receiving standard therapy. First approved in 2011, belimumab is now the first and only biologic approved for both SLE and LN in over a half-century. MacroGenics Inc. Genentech Inc.

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Codon

APRIL 9, 2024

With help from the Global Fund to Fight AIDS, Tuberculosis, and Malaria (GFATM), artemisinin-based combination therapy became much more economically accessible worldwide. Miller and Su published an article on Tu’s story in Cell in 2011. It was only in 2005, after the emergence of widespread resistance of P.

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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. The team found that deleting the gene Ptpn2 made tumors sensitive to PD-1 therapy, and they published their findings in Nature in 2017.

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Drug Target Review

JUNE 21, 2023

Enabling the systematic discovery of these largely uncharted targets can be a valuable opportunity for development of novel therapies. Genetic-based therapeutics hold significant promise in the clinic Despite the growing number of genes linked to human disease, the proportion of genes targeted by approved therapies remains low.

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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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The Pharma Data

JANUARY 20, 2021

The combination therapy involves an injectable medication called extended-release naltrexone and a daily generic pill called bupropion. A separate NIDA study finds that methamphetamine overdose deaths in the United States surged from 2011 to 2018, increasing fivefold in just eight years. WEDNESDAY, Jan. That report was published Jan.

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Drug Target Review

SEPTEMBER 4, 2023

7,9 Dihydrofolate reductase-thymidylate synthase (DHFR) have been successfully exploited for the therapy of bacterial infections and other parasitic diseases such as malaria. 2011): State of the Art in African Trypanosome Drug Discovery, Current topic of medical chemistry. link] Ojewale Kayode (2018). and Margaret, A. Rafael, M.

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Common Sense for Drug Policy Blog

JANUARY 5, 2024

This estimate is more than 5 times the most recent US estimate of ∼774,000 from 2011 [ 25 ]. Much of this increase is likely attributable to increases in IDU, but it is important to consider methodological differences in the creation of this 2018 estimate vs the 2011 estimate. during the past decade.

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The Pharma Data

NOVEMBER 10, 2020

While the world is facing a severe shortage of specific antiviral drugs, a new treatment developed by Asclepius Meditec highlights the potential of hydrogen-oxygen therapy in tackling COVID-19. Founded in 2011, Shanghai Asclepius Meditec is the first company globally to launch clinical research on hydrogen-oxygen medicine.

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Hospitals Clinical Trials Treatment Therapies 52

The Pharma Data

MAY 5, 2021

Farxiga received fast track, breakthrough therapy and priority review designations for the current indication. . 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. . blind, placebo?controlled

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