Drug Discovery World

JUNE 1, 2023

Antibody-drug conjugates (ADCs) are biopharmaceutical products in which a monoclonal antibody (mAB) is linked to a small molecule drug with a stable linker 1. According to NCBI, most of the ADCs developed so far are for use in the treatment of cancer, but there is plenty of potential for using ADCs to treat other diseases 1.

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XTalks

NOVEMBER 3, 2021

Amid concerns of the rare adverse event of myocarditis in children and adolescents following vaccination with mRNA vaccines, the FDA conducted its own benefit-risk analysis that showed the benefit of vaccination outweighs the risk of myocarditis.

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The Pharma Data

JANUARY 11, 2021

a San Diego-based biotechnology company with an array of technology platforms for antibody discovery and optimization, and novel NK and T cell engager generation, today announced licensing of a panel of its anti-SARS-CoV-2 antibody clones to IGM Biosciences for COVID-19 therapy development.

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The Pharma Data

MARCH 18, 2021

GSK’294 is an investigational medicine with potential to be the first biologic to deliver long-acting suppression of IL-5 in patients with SEA from one subcutaneous injection every six months. These patients might benefit from more targeted therapies to better control their condition.

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The Pharma Data

APRIL 12, 2023

The abstracts showcase the strength and breadth of Roche’s Ophthalmology portfolio, including post-hoc data from phase III Vabysmo® (faricimab) studies that support its benefit in drying retinal fluid in neovascular or ‘wet’ age-related macular degeneration (nAMD) and diabetic macular edema (DME).

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Drug Discovery World

APRIL 15, 2023

BDC-3042 is an agonistic antibody targeting Dectin-2, an immune-activating receptor expressed by TAMs. The American Association for Cancer Research (AACR) Annual Meeting is taking place at the Orange County Convention Center in Orlando, Florida from April 14-19, 2023.

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The Pharma Data

APRIL 14, 2021

government for its neutralizing antibody therapies authorized for emergency use as a treatment for COVID-19. Lilly’s bamlanivimab was the first neutralizing monoclonal antibody to receive emergency use authorization from the U.S. government already purchased, some of which have already been delivered to sites of care.

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pharmaphorum

DECEMBER 22, 2022

Between 5% and 15% of patient with BTC survive five years. Imfinzi (durvalumab) is a human monoclonal antibody that binds to the PD-L1 protein and blocks the interaction of PD-L1 with the PD-1 and CD80 proteins. months of follow-up, whereas the interim analysis had shown a 20% reduced risk. months versus 11.3 with chemotherapy.

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XTalks

APRIL 11, 2024

On the other hand, Abecma is now approved as a third-line treatment for patients with triple-class-exposed disease, which means previous treatment with an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 monoclonal antibody. Plasma cells help fight infections by producing antibodies.

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pharmaphorum

JANUARY 10, 2023

It was approved by the FDA as Sotyktu last September; 5) Foscarbidopa/foslevodopa ( ABBV-951 ): Developed by AbbVie, the drug is a reformulation of a standard Parkinson’s treatment (carbidopa/levodopa) delivered by subcutaneous pump for hard-to-treat patients with advanced disease, and is in the latter stages of FDA review.

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The Pharma Data

NOVEMBER 10, 2020

First Ever Study with take-home capsules of Foralumab , a Fully Human Anti-CD3 Monoclonal Antibody. Oral and nasal administration routes are both physiologic approaches to stimulate the mucosal immune system to induce disease modifying benefits.”. Crohn’s Disease Therapeutics Market Size $4.7 Billion by 2025.

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The Pharma Data

DECEMBER 29, 2020

First antibody therapy to demonstrate anti-viral effect in patients hospitalized with COVID-19. NASDAQ: REGN) today announced encouraging initial data from an ongoing Phase 1/2/3 clinical trial of the Regeneron antibody cocktail, casirivimab and imdevimab, in hospitalized COVID-19 patients requiring low-flow oxygen. TARRYTOWN, N.Y. ,

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The Pharma Data

JUNE 29, 2021

This approval is based on results from the Phase 3 KEYNOTE-590 trial, in which KEYTRUDA plus 5-fluorouracil (5-FU) and cisplatin demonstrated statistically significant improvements in overall survival (OS) and progression-free survival (PFS) compared with 5-FU and cisplatin alone in all pre-specified study populations.

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The Pharma Data

MARCH 25, 2022

AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab), a long-acting antibody combination, has been recommended for marketing authorisation in the European Union (EU) for the pre-exposure prophylaxis (prevention) of COVID-19 in a broad population of adults and adolescents aged 12 years and older weighing at least 40 kg.

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The Pharma Data

OCTOBER 28, 2020

in May, is a human epidermal growth factor (HER2)-directed antibody drug conjugate. in May, is a human epidermal growth factor (HER2)-directed antibody drug conjugate. Antoine Yver, Executive Vice President and Global Head, Oncology Research and Development at Daiichi Sankyo, pictured above. Photo courtesy of Daiichi Sankyo.

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The Pharma Data

MARCH 22, 2021

Investigational antibody cocktail of casirivimab and imdevimab also significantly shortened the duration of symptoms by four days. The combination of casirivimab and imdevimab is the only monoclonal antibody treatment to retain potency against key emerging variants, based on the recently updated EUA guidance from the U.S.

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FDA Law Blog

FEBRUARY 29, 2024

A surrogate endpoint is a marker, such as a laboratory measurement, radiographic image, physical sign or other measure that is thought to predict clinical benefit but is not itself a measure of clinical benefit. Drug companies are still required to conduct studies to confirm the anticipated clinical benefit.

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The Pharma Data

APRIL 7, 2021

today announced new data from its expansive neuroscience portfolio will be presented at the 2021 American Academy of Neurology (AAN) Annual Meeting, to be held virtually from April 17-22. . vice president, neuroscience development, AbbVie. vice president, neuroscience development, AbbVie.

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The Pharma Data

JANUARY 27, 2021

RIIB antibody BI-1206 in combination with rituximab (anti-CD20 monoclonal antibody) in patients with indolent relapsed or refractory B-cell non-Hodgkin’s lymphoma (NHL). (Nasdaq: CASI), a U.S. CEO of BioInvent. Readout from two patients is still pending. Wei-Wu He , Ph.D.,

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Eye on FDA

MARCH 20, 2023

Customarily this culminates in the ultimate question whether the committee believes that the benefit/risk ratio is such that approval is warranted. Traditionally, committee votes can be taken on a range of topics during the course of the meeting.

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The Pharma Data

JUNE 25, 2021

With the results of KEYNOTE-564, pembrolizumab is the first immunotherapy to show a clinical benefit in the adjuvant setting in kidney cancer,” said Dr. Toni K. After a median follow-up of 24.1 months (14.9-41.5), 0.87]; p=0.0010). After a median follow-up of 24.1 months (14.9-41.5), 0.87]; p=0.0010). 0.96]; p=0.0164).

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Drug Discovery World

OCTOBER 21, 2022

The last month has seen a number of leaps in our understanding of difficult to treat and treatment resistant breast cancers, so here are Drug Discovery World’s top 5 research breakthroughs. 3D bioprinted breast cancer tumours. In a scientific first, researchers at Penn State successfully 3D bioprinted breast cancer tumours and treated them.

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The Pharma Data

MAY 15, 2023

Adverse events that were more commonly observed with Dupixent (≥5%) in either trial included nasopharyngitis and herpes viral infections. Dupixent also significantly improved health-related quality of life while reducing measures of skin pain and symptoms of anxiety/depression. Results from the trials were the basis for the U.S.

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The Pharma Data

MARCH 30, 2021

It is an anti-CD20 monoclonal antibody (mAb) self-administered by a once-monthly injection, delivered subcutaneously 2,3. EU approval follows recent approvals for Kesimpta including the US, Canada, Switzerland, Singapore, Australia and Japan. About Kesimpta ® (ofatumumab).

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The Pharma Data

MAY 18, 2021

5 percent of the tumour area) as determined by an FDA-approved test or are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. 5 percent of the tumour area) as determined by an FDA-approved test or are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status.

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The Pharma Data

DECEMBER 5, 2020

5, 2020 /PRNewswire/ — 63% response rate in patients treated with the highest reported dose. NASDAQ: REGN) today announced updated data for REGN5458, a BCMAxCD3 bispecific antibody, from the Phase 1 portion of a Phase 1/2 trial in patients with relapsed or refractory (R/R) multiple myeloma. Dose Levels 4, 5. (24,

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The Pharma Data

AUGUST 30, 2021

Roche is committed to following the science to better understand cancer, including which patients may benefit most from immunotherapy treatment. This decision only impacts the mTNBC indication in the US. It does not affect other approved indications for Tecentriq in the US and outside the US, including mTNBC.

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The Pharma Data

JANUARY 15, 2021

gastric cancer is more frequently diagnosed in the advanced stage, with only approximately 5% of patients surviving five years. (hereafter, Daiichi Sankyo) and AstraZeneca’s Enhertu ( fam-trastuzumab deruxtecan -nxki) has been approved in the U.S. In the U.S., 1,2 Approximately one in five gastric cancers are HER2 positive. Caruth, Jr.

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The Pharma Data

AUGUST 3, 2021

Key results include: Total revenues increased 5% to $6.5 Total Revenues $ 6,526 $ 6,206 5% GAAP Operating Income $ 828 $ 2,323 (64%) GAAP Net Income $ 464 $ 1,803 (74%) GAAP EPS $ 0.81 $ 3.05 (73%) Non-GAAP Operating Income $ 3,111 $ 3,247 (4%) Non-GAAP Net Income $ 2,522 $ 2,484 2% Non-GAAP EPS $ 4.38 $ 4.20 The Company generated $1.7

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The Pharma Data

JANUARY 13, 2021

Clinical trials for approved eosinophil-depleting drugs have shown that drugs that reduce eosinophil counts provide significant benefit for reduction in asthma exacerbations in patients with moderate-to-severe eosinophilic asthma. Dexpramipexole was well tolerated by patients at all doses tested. President and CEO of Knopp. study centers.

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The Pharma Data

APRIL 27, 2021

The FDA’s Accelerated Approval Program allows for conditional approval of a medicine that fills an unmet medical need for a serious condition, with specific postmarketing requirements (PMRs) to confirm the clinical benefit and convert to regular approval. Roche’s Chief Medical Officer and Head of Global Product Development. “We

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The Pharma Data

MARCH 23, 2022

5 The VISIBLE study is guided by the company’s strong commitment to bioethicsa and designed to help promote more diverse, equitable and inclusive clinical research in PsO through new approaches to enrollment and retention, broader community engagement and new data components.

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The Pharma Data

NOVEMBER 4, 2020

NASDAQ:ALXN) today announced that two abstracts on CAEL-101, a first-in-class amyloid fibril targeted therapy, have been accepted for presentation at the 62 nd American Society of Hematology (ASH) Annual Meeting and Exposition, taking place virtually from December 5 to 8, 2020. & BOSTON –(BUSINESS WIRE)–Nov. Abstract #729.

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The Pharma Data

MARCH 26, 2021

Benlysta, a BLyS-specific inhibitor, is a human monoclonal antibody that binds to soluble BLyS. The CHMP opinion is one of the final steps in the marketing authorisation procedure prior to approval by the European Commission. About the BLISS-LN study. About lupus nephritis. About Benlysta (belimumab).

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The Pharma Data

AUGUST 6, 2020

5 Patients with metastatic TNBC generally experience rapid progression and shorter OS compared to other subtypes of breast cancer. The data for the secondary endpoint of overall survival (OS) showed a negative trend, however, the study was not powered for the secondary endpoint of OS and data were immature at time of analysis.

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The Pharma Data

OCTOBER 25, 2021

While this trial didn’t confirm the benefit for all cases we hoped for, we’re amped by the overall Cover-1 findings as they support our commitment to continue studying canakinumab in lung cancer. These data support farther evaluation of canakunimab in lung cancer.

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The Pharma Data

OCTOBER 28, 2020

NASDAQ: REGN) today announced positive, prospective results from an ongoing Phase 2/3 seamless trial in the COVID-19 outpatient setting showing its investigational antibody cocktail, REGN-COV2, met the primary and key secondary endpoints. TARRYTOWN, N.Y. , 28, 2020 /PRNewswire/ — . Regeneron has shared these results with the U.S.

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