The Pharma Data

AUGUST 17, 2021

Second FDA approved indication for dostarlimab in 2021 GARNET study demonstrated objective response rate of 41.6% This indication received accelerated approval based on tumour response rate and durability of response. This approval was based on data from cohort A1, which included 71 patients with dMMR endometrial cancer. [i]

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XTalks

FEBRUARY 5, 2024

This article serves as a resource for healthcare professionals, life sciences researchers and industry enthusiasts seeking to stay informed of the latest developments and success stories in oncology therapeutics. Pharmacyclics requested to voluntarily withdraw the approvals and decided to forgo an opportunity for a hearing.

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Delveinsight

AUGUST 2, 2020

Cachexia is observed as a result of underlying diseases, including cancer, AIDS, tuberculosis, chronic heart failure, hormonal deficiency, and others. NGM120 is a first-in-class antagonistic antibody, which binds glial cell-derived neurotrophic factor receptor alpha-like (GFRAL) and inhibits growth differentiation factor 15 (GDF15).

Marketing 94

Marketing Pharma Companies Development Hormones 94

pharmaphorum

DECEMBER 23, 2020

Originally developed to treat late-stage EGFR-mutated disease, the ADAURA study tested Tagrisso as an adjuvant treatment in patients with early disease following surgery. A molecule codenamed DNL151, currently in phase 1 development, has been selected to progress into late-stage clinical studies that are expected to begin in 2021.

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XTalks

MAY 10, 2023

The exact cause of lupus is not entirely understood, but it is thought to be from a combination of genetic, environmental and hormonal factors. GSK’s Benlysta (belimumab) is a monoclonal antibody that was approved by the US Food and Drug Administration (FDA) in 2011 for the treatment of SLE.

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The Pharma Data

AUGUST 30, 2021

Roche made this decision following consultation with the US FDA, based on the agency’s assessment of the current mTNBC treatment landscape and in accordance with the requirements of the accelerated approval programme. Roche’s Chief Medical Officer and Head of Global Product Development. “We About Tecentriq.

Medicine 52

Medicine Antibody Hormones FDA Approval 52

XTalks

SEPTEMBER 17, 2020

While the table lists acceptable surrogate endpoints for trials of more common conditions, such as asthma, type 2 diabetes and various cancer types, the document also provides key information to developers of certain rare disease therapies. Both surrogate endpoints could be used to support traditional approval of a new drug or biologic.

Trials 98

Trials Gene Hormones Clinical Trials 98

XTalks

AUGUST 10, 2022

The US Food and Drug Administration (FDA) has approved AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab-deruxtecan) for the treatment of patients with unresectable or metastatic HER2-low breast cancer. The drug is being jointly developed and commercialized by AstraZeneca and Japan’s Daiichi Sankyo.

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XTalks

FEBRUARY 7, 2023

The FDA approval is an important step forward for both women and men living with metastatic breast cancer, especially for those individuals whose tumor is no longer responding to endocrine-based therapies and who are facing a poor prognosis,” said Laura Carfang, executive director, SurvivingBreastCancer.org, in the press release.

HR 52

HR Hormones FDA Approval Antibody 52

The Pharma Data

APRIL 27, 2021

Today’s ODAC meeting is part of an industry-wide review of accelerated approvals with confirmatory trials that have not met their primary endpoint(s) and have yet to gain regular approvals. Roche’s Chief Medical Officer and Head of Global Product Development. “We

Medicine 40

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The Pharma Data

AUGUST 3, 2021

billion in acquired in-process research & development (acquired IPR&D) associated with our acquisition of Five Prime Therapeutics, partially offset by increased revenues. For the remainder of the year, we expect continued growth from Kyprolis use in combination with CD38 antibodies. driven by the write-off of $1.5 39.3% (25.8)

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XTalks

AUGUST 2, 2023

is a global pharmaceutical company, working across both developed and emerging markets. They are committed to capitalizing on growth opportunities primarily through the advancement of their own product pipeline and constantly improving their existing products, as well as through business development activities. Pfizer Inc.

Sales 98

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XTalks

NOVEMBER 20, 2023

AstraZeneca has won its first-in-class approval for its AKT inhibitor Truqap (capivasertib) in combination with Faslodex (fulvestrant) for treating patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer. billion to $1.28

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The Pharma Data

AUGUST 31, 2021

Vice President, Late Development and Global Medical Affairs, Janssen Research & Development, LLC. “We FDA approval for nmCRPC in February 2018, and was approved for mCSPC in September 2019.2To date, more than 40,000 patients worldwide have been treated with ERLEADA ®. 2] ERLEADA ® received U.S.

Drug Delivery Systems 52

Drug Delivery Systems Drug Delivery Trials Drugs 52

Pharmaceutical Technology

SEPTEMBER 13, 2022

Hormone receptor-positive/human epidermal growth factor negative (HR+/HER2-) breast cancer accounts for approximately 70% of all breast cancers, with close to 40,000 new cases diagnosed each year worldwide. Trop-2 is highly expressed across multiple cancer types, with expression detected in more than 90% of breast cancers.

HR 162

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XTalks

NOVEMBER 2, 2020

This includes compromising the functioning of the adrenal glands, which can potentially lead to adrenal insufficiency, resulting in inadequate production of steroid hormones. Fasenra is currently under development for other eosinophilic diseases and chronic obstructive pulmonary disease. a wholly-owned subsidiary of Kyowa Kirin Co.,

Trials 94

Trials FDA Approval Hormones Drugs 94

The Pharma Data

APRIL 4, 2023

First approved therapeutic regimen that combines an anti-PD-1 and an antibody-drug conjugate in the US in these patients Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Merck has the industry’s largest immuno-oncology clinical research program.

FDA Approval 40

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Pfizer

JANUARY 27, 2023

In the ongoing development of the Pfizer-BioNTech COVID-19 vaccine, Pfizer has not conducted gain of function or directed evolution research. This research provides a way for us to rapidly assess the ability of an existing vaccine to induce antibodies that neutralize a newly identified variant of concern.

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Research Vaccination Vaccine Drugs 112

The Pharma Data

APRIL 7, 2021

Prior to the FDA approval of Trodelvy, patients with previously treated metastatic TNBC had few treatment options in this high unmet-need setting. The FDA granted accelerated approval to Trodelvy in April 2020 based on objective response rate and duration of response results in a Phase 1/2 study.

HR 52

HR Genotype FDA Approval Genotoxicity 52

The Pharma Data

JANUARY 4, 2021

“We have been researching TIGIT as a novel cancer immunotherapy target for almost 10 years and we are pleased that the FDA has acknowledged the potential of tiragolumab to substantially improve outcomes for people with certain types of lung cancer,” said Levi Garraway, M.D., chief medical officer and head of Global Product Development. “We

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Immune Response Medicine Protein Gene 52

The Pharma Data

JULY 23, 2021

For the past three and a half years, Opdivo monotherapy has been an important option that physicians have relied on to address this need and is currently the most commonly used therapy in the post-sorafenib setting,” said Jonathan Cheng, senior vice president and head of oncology development, Bristol Myers Squibb.

Hormones 52

Hormones Trials Genome Genomics 52

The Pharma Data

MARCH 11, 2021

“We support the FDA’s efforts to evaluate accelerated approvals across the industry as an important element of how the agency ensures the integrity of the accelerated approval program,” said Ian M. development lead, gastrointestinal cancers, Bristol Myers Squibb. “In Waxman, M.D.,

Trials 52

Trials Hormones Genome Genomics 52

The Pharma Data

JUNE 18, 2021

vice president and global head of oncology development, AbbVie. “We are proud to be leading in the development of this combination to continue raising the standards of care for the blood cancer community.” The BTK protein sends important signals that tell B cells to mature and produce antibodies.

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The Pharma Data

APRIL 14, 2021

Accelerated Approval Granted for Locally Advanced or Metastatic Urothelial Cancer Following a Platinum-Containing Chemotherapy and a PD-1/PD-L1 Inhibitor –. – New Indication Marks Second FDA Approval for Trodelvy in 2021 –. Beyond the regulatory approvals of Trodelvy in the U.S., FOSTER CITY, Calif.–(BUSINESS

Genotype 52

Genotype Containment FDA Approval Genotoxicity 52

The Pharma Data

JUNE 18, 2021

Imbruvica Global Development Lead, Pharmacyclics LLC, an AbbVie company. ” The pivotal Phase 3 RESONATE-2 study served as the basis for the FDA approval of IMBRUVICA as a single-agent in first-line treatment for CLL/SLL in 2016, following initial approval for relapsed/refractory (R/R) patients in 2014 based on the RESONATE study.

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The Pharma Data

AUGUST 11, 2020

development lead, Gastrointestinal Cancers, Bristol Myers Squibb. We harness our deep scientific experience, cutting-edge technologies and discovery platforms to discover, develop and deliver novel treatments for patients. To date, the Opdivo clinical development program has treated more than 35,000 patients. Waxman, M.D.,

Trials 52

Trials Hormones Clinical Trials Clinical Trials 52

The Pharma Data

JUNE 18, 2021

vice president and head, global oncology development, AbbVie. “We remain steadfast in our commitment to continue the research and development of this combination as a potential treatment for CLL with the ultimate goal to put patients into remission with a fixed-duration, oral therapy.” and by AbbVie outside of the U.S.

Medicine 52

Medicine Production FDA Approval Trials 52

The Pharma Data

AUGUST 11, 2020

development lead, Gastrointestinal Cancers, Bristol Myers Squibb. “We We harness our deep scientific experience, cutting-edge technologies and discovery platforms to discover, develop and deliver novel treatments for patients. To date, the Opdivo clinical development program has treated more than 35,000 patients. Waxman, M.D.,

Trials 52

Trials Hormones Clinical Trials Clinical Trials 52

The Pharma Data

MAY 4, 2021

to $3.65, Primarily Reflecting Updates to Anticipated Contributions from BNT162b2 Partially Offset by Additional R&D Expenses for Vaccines to Protect Against COVID-19 as Well as Other mRNA-Based Development Programs and COVID-19 Antivirals. Raises Full-Year 2021 Guidance (3) for Revenues to a Range of $70.5 previously $59.4

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