Search Results for “Gilead Sciences” – Page 4 – media

U.S. Food and Drug Administration Approves Gilead’s Biktarvy® (Bictegravir, Emtricitabine, Tenofovir Alafenamide) for Treatment of HIV-1 Infection

Gilead Sciences, Inc.(NASDAQ:GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved Biktarvy® (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg, BIC/FTC/TAF), a once-daily single tablet regimen (STR) for the treatment of HIV-1 infection. Biktarvy combines the novel, unboosted integrase strand transfer inhibitor (INSTI) bictegravir, with the demonstrated safety and efficacy profile of the Descovy® (FTC/TAF) dual nucleoside reverse transcriptase inhibitor (NRTI) backbone, and is the smallest INSTI-based triple-therapy STR available.
- Source: gilead
- 906
- February 26, 2018
Biktarvy FDA Gilead Sciences HIV-1 infection
U.S. Food and Drug Administration Approves Gilead’s Biktarvy®

Gilead Sciences, Inc. on February 7 announced that the U.S. Food and Drug Administration (FDA) has approved Biktarvy (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg, BIC/FTC/TAF), a once-daily single tablet regimen (STR) for the treatment of HIV-1 infection.
- Source: Finchannel
- 787
- February 9, 2018
Biktarvy HIV-1 New Approvals STR
China Food and Drug Administration Approves Gilead’s Sovaldi® (Sofosbuvir) for Treatment of Chronic Hepatitis C Virus Infection

Gilead Sciences, Inc. (NASDAQ: GILD) announced that the China Food and Drug Administration (CFDA) has approved Sovaldi® (sofosbuvir 400mg), a once-daily oral nucleotide analog polymerase inhibitor for the treatment of chronic hepatitis C virus (HCV) infection. Sovaldi was approved for the treatment of adults and adolescents (aged 12 to 18 years) infected with HCV genotype 1, 2, 3, 4, 5 or 6 as a component of a combination antiviral treatment regimen. Sovaldi is the first Gilead HCV medicine approved in China.
- Source: Gilead
- 776
- November 27, 2017
CFDA Gilead Sciences HCV New Approvals Sovaldi®
Over $440 million! Jiahe Biologics’ new dual-antibody drug goes overseas

On August 5, Hong Kong-listed innovative pharmaceutical company Jiahe Biologics (06998.HK) announced that the group entered into a licensing agreement and equity agreement with TRC2004, Inc. on August 2. Pursuant to the License Agreement, the Group has agreed, among other things, to grant TRC2004 an exclusive global license (excluding Mainland China, Hong Kong, Macau and Taiwan) to develop, use, manufacture, commercialize and otherwise exploit GB261. According to the terms of the license agreement and equity agreement, as consideration for the license, the Group will receive a considerable amount of equity in TRC2004, an down payment of tens of millions of US dollars, milestone payments of up to US$443 million, and a single-digit to double-digit share of net sales. percentage tiered royalties. CD3/CD20 inhibitor potential stocks. GB261 is a new type of differentiated CD20/CD3 bispecific T cell engager (TCE) and the first T cell engager (T-cell Engager) that binds to CD3 ...
- Source: drugdu
- 66
- October 11, 2024
What is the impact of the House of Representatives’ passage of the draft biosafety law amid the controversy on WuXi

On September 9, the House of Representatives of the United States Congress returned from a summer break and immediately scheduled a series of legislative votes, including the draft Biosafety Act (H.R. 8333). The draft biosecurity law passed the House of Representatives with 306 votes in favor and 81 votes against, but the 70% support rate made it the most divisive draft bill in the same batch, and even narrowly fell below the “bottom line” of more than two-thirds of the votes to pass the bill. The draft Biosafety Act places five companies, including WuXi AppTec and WuXi Biologics, on the list of “biotechnology companies of concern” on the grounds of “national security”, and intends to restrict the use of funds, loans or subsidies from the United States government to cooperate with these companies. Unlike previous committees that voted in small groups, this time there were several members of the House ...
- Source: drugdu
- 79
- October 6, 2024
Fosun Pharma continues to strengthen the research and development of innovative cancer drugs, and will build the most comprehensive cell therapy pipeline in Pudong

Cell therapy brings a paradigm revolution that can bring hope for a cure to cancer patients. The first cell therapy product to be launched is Yikaida ® It’s a good example. Cell therapy is a key focus of Fosun Pharma’s future development During a recent interview with Zhang Wenjie, CEO and Chairman of Fosun Pharma, he stated that Fosun Pharma is focusing on niche markets with broad prospects in the pharmaceutical industry. Just this month, Fosun Pharma announced that it will fully control Fosun Kate, which is planning to be renamed Fosun Carey and will serve as Fosun Pharma’s core platform in the field of cell therapy technology, continuing to focus on the field of tumor immunotherapy. It is reported that Fosun Kate, located in Pudong, is planning to build the strongest and most comprehensive cell therapy pipeline in China and even globally. Building a powerful CAR-T product pipeline In ...
- Source: drugdu
- 93
- September 29, 2024
Digital Therapeutics Sector See Billing Codes as Key to Breaking Free of Reimbursement Rut

Medicare’s physician fee schedule includes billing codes for digital therapeutics for the first time. Stakeholders say these codes could help turn around reimbursement challenges weighing on the entire digital medicines sector. By Frank VinluanWhen the FDA approves a drug, passing that regulatory bar of safety and efficacy puts it on the path toward likely reimbursement by government and commercial payers. The same has not been true for digital therapeutics. A proposal from the Centers for Medicare and Medicaid Services signals a change in federal thinking about such technologies, which could pave the way for broader coverage of novel digital medicines. For the first time, CMS’s proposed physician fee schedule, a comprehensive annual listing of the fees that Medicare uses to pay doctors, now includes digital therapeutics. The proposal does not cover all digital therapeutics under multiple benefit categories, as the Digital Therapeutics Alliance (DTA) had asked nearly a year ago. ...
- Source: drugdu
- 70
- August 21, 2024
Ipsen, Genfit Drug That Missed in MASH Wins FDA Approval in a Much Rarer Liver Disease

Iqirvo failed as a treatment for the fatty liver disease MASH, but the drug is now FDA approved in primary biliary cholangitis. An Intercept Pharmaceuticals drug already treats this rare liver disease and Gilead Sciences is poised to compete with its PBC drug approaching an FDA decision this summer. By Frank VinluanA rare liver disease that can progress to organ failure now has a new FDA-approved therapy, a drug from Ipsen that brings a novel approach to treating the chronic condition. The Ipsen drug, elafibranor, treats primary biliary cholangitis (PBC). The regulatory decision announced late Monday makes the drug just the third approved therapy for the chronic liver disorder, but competition in this indication is heating up. Paris-based Ipsen will market its new product under the brand name Iqirvo. PBC is an autoimmune condition in which bile and toxins build up in the liver, leading to inflammation and damage to ...
- Source: drugdu
- 130
- June 13, 2024
GlobalData

Biopharmaceutical companies are regaining interest in metabolic dysfunction-associated steatohepatitis (MASH) innovator drug development. MASH innovator drugs witnessed over $2.5 billion increase in the total value of partnership deals from 2020 to 2024 year-to-date (YTD), with more than $2 billion forged in Q1 2024 alone, reveals GlobalData. MASH, previously known as nonalcoholic steatohepatitis (NASH), is a disease characteriSed by liver inflammation and damage caused by the accumulation of fat. Madrigal Pharmaceuticals’ Rezdiffra (resmetirom), a small molecule THRB agonist, was the first drug approved by the FDA for MASH in March 2024. Alison Labya, Business Fundamentals Analyst at GlobalData, comments, “Interest in MASH has returned in light of the FDA approval of Madrigal’s Rezdiffra, as well as the success of GLP-1 obesity drugs and their potential efficacy in MASH, as demonstrated by Eli Lilly’s Zepbound (tirzepatide; also known as Mounjaro for type 2 diabetes) in its Phase II SYNERGY-NASH trial readout.” However, ...
- Source: drugdu
- 131
- April 20, 2024
AstraZeneca, Daiichi Sankyo Drug Enhertu Becomes First Tumor-Agnostic ADC Cancer Med

The FDA expanded Enhertu’s approval to encompass advanced solid tumors positive for the HER2 cancer protein, regardless of tumor type. Analysts say the regulatory decision paves the way for similar broader approvals of other medications in the ADC cancer drug class.The AstraZeneca and Daiichi Sankyo targeted cancer drug Enhertu is now the first therapy in its class approved for treating solid tumors regardless of either the cancer type or where the disease started in the body. Enhertu had previously won FDA approvals for treating certain advanced cases of breast, gastric, and lung cancers that express a protein called HER2. Late Friday, the FDA expanded the drug’s approval to broadly include the treatment of adults who have HER2-expressing solid tumors. These patients must have a cancer that cannot be removed surgically or has advanced following a prior systemic treatment. The expanded approval came nearly two months ahead of the May 30 ...
- Source: drugdu
- 86
- April 11, 2024

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