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.

FDA Approval 101

FDA Approval Drugs Sales Development 101

Delveinsight

DECEMBER 7, 2020

For instance, the shortage of healthcare professionals can be tackled by creating better diagnostic and treatment procedures, integrating solutions developed by physicians worldwide, and providing them seamlessly over a platform accessed by all practicing physicians. In May 2018, Ava raised about $30 million in a Series B round.

Protein 56

Protein Insulin Hormones FDA Approval 56

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.

FDA Approval 52

FDA Approval Drugs Sales Development 52

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.

Drugs 52

Drugs Clinical Trials Clinical Trials Antibody 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

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

AUGUST 10, 2022

The drug is being jointly developed and commercialized by AstraZeneca and Japan’s Daiichi Sankyo. This is the first approved therapy for patients with the HER2-low breast cancer subtype, which is a newly defined subset of HER2-negative breast cancer. The receptor is involved in promoting cell growth.

FDA Approval 98

FDA Approval HR Hormones Antibody 98

The Pharma Data

FEBRUARY 8, 2021

“The TITAN final analysis data confirm the long-term clinical benefit and consistent safety profile of ERLEADA ® plus ADT without a compromise in health-related quality of life,” said Mary Guckert, RN, MSN, Vice President, Development Leader, Prostate Cancer, Janssen Research & Development, LLC. About ERLEADA ® (apalutamide).

HR 52

HR Hormones Development Production 52

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

Medicine In-Vitro Antibody Development 40

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

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.

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Sales Manufacturing FDA Approval Life Science 98

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. pts Research & Development $ 1,082 $ 964 12% $ 1,036 $ 936 11% % of product sales 17.7% GAAP earnings per share (EPS) decreased 73% to $0.81 39.3% (25.8)

Sales 52

Sales Production Antibody Development 52

The Pharma Data

DECEMBER 31, 2020

The messenger RNA (mRNA) vaccines encode a form of the spike (S) protein of SARS-CoV-2 virus. The vaccine teaches the cells to make a piece of the spike protein, which triggers an immune response to help prevent illness if later exposed to the virus. The partial piece of the spike protein cannot cause COVID-19 disease.

Vaccination 52

Vaccination Vaccine FDA Approval Hormones 52

Drug Discovery World

AUGUST 21, 2023

Diana Spencer investigates therapies in clinical development for triple-negative breast cancer and asks what future treatments might look like. However, because these cancers are not driven by any of the three molecules that can be blocked by targeted hormone receptor drugs, current treatment options are limited.

Protein 52

Protein Trials Clinical Trials Clinical Trials 52

XTalks

DECEMBER 22, 2021

The development and widespread adoption of new technologies is key to revolutionizing the way we diagnose, prevent, treat and manage disease. They can be developed and adapted quickly. It is also prone to quick destruction by the body’s immune system before it can be translated into protein in cells.

Life Science 98

Life Science RNA Vaccination Vaccine 98

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. Working with collaborators, we have conducted research where the original SARS-CoV-2 virus has been used to express the spike protein from new variants of concern.

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Research Vaccination Vaccine Drugs 112

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

Immune Response 52

Immune Response Medicine Protein Gene 52

The Pharma Data

APRIL 7, 2021

Trodelvy is directed to the Trop-2 receptor, a protein frequently expressed in multiple types of epithelial tumors, including TNBC, where high expression is associated with poor survival and relapse. Trodelvy also extended median overall survival (OS) to 11.8 months vs. 6.9 months (HR: 0.51; 95% CI: 0.41-0.62;

HR 52

HR Genotype FDA Approval Genotoxicity 52

The Pharma Data

FEBRUARY 8, 2021

Vice President, Late Development and Global Medical Affairs, Oncology, Janssen Research & Development, LLC. “In Food and Drug Administration (FDA) approval for nmCRPC on February 14, 2018 and was approved for mCSPC on September 17, 2019. 2 ERLEADA ® received U.S.

HR 52

HR In-Vitro Development Clinical Trials 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.

Medicine 40

Medicine Production FDA Approval Trials 40

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

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.

FDA Approval 40

FDA Approval Medicine Development Trials 40

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

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

SEPTEMBER 10, 2021

Senior Vice President, Chief Development Officer, Internal Medicine and Hospital, Global Product Development at Pfizer. “We The FDA approved MYFEMBREE for this indication on May 26, 2021, based on data from the Phase 3 LIBERTY program. Myovant and Pfizer are jointly developing and commercializing MYFEMBREE in the U.S.

Hormones 52

Hormones FDA Approval Drugs Development 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

Vaccination 40

Vaccination Vaccine Production Sales 40

Pharmaceutical Technology

JANUARY 22, 2023

In 2022, the FDA approved only 37 new medicines, an underwhelming number compared to 98 in 2018. However, while only around 34% of the approvals in 2018 were for orphan drugs, 54% new approvals in 2022 were for drugs to treat rare diseases. T3 is a major hormone in the blood that regulates thyroid levels.

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Drugs Gene Hormones Clinical Trials 317