Search Results for “Gilead Sciences” – media

Continuing to Increase Investment in China and Bringing Chinese Innovative Medicines to the World

“This is our third time participating in the China International Import Expo. Over the past few years, we have leveraged the platform of the expo to share our R&D achievements and business progress, while accelerating the launch of our innovative products in China to benefit more groups as soon as possible. Ultimately, through the expo, we have carried out various collaborations and signed agreements with different partners, thereby speeding up our development process in China,” said Jin Fangqian, Gilead Sciences’ Global Vice President and General Manager for China, during an interview with media outlets like Times Finance during the 7th China International Import Expo. At this year’s expo, Gilead Sciences announced significant progress regarding its core product, Lenacapavir, in the field of HIV prevention. Lenacapavir is the world’s first approved HIV capsid inhibitor and offers a long-acting treatment regimen needing administration only twice a year. The drug has been approved ...
- Source: drugdu
- 52
- November 9, 2024
FDA Awards Accelerated Approval to Gilead Sciences Drug for Rare Liver Disease

Livdelzi is now FDA-approved for treating the rare liver disease primary biliary cholangitis. Gilead Sciences added the drug to its pipeline via the $4.3 billion acquisition of CymaBay Therapeutics earlier this year. By Frank Vinluan A Gilead Sciences drug acquired earlier this year in a multi-billion dollar deal is now FDA approved as new treatment for primary biliary cholangitis (PBC), a rare liver disease that can lead to liver failure. The approval announced Wednesday for the drug covers the treatment of adults whose disease is inadequately managed by the standard of care PBC drug as well as those who cannot tolerate that drug. The Gilead therapy, seladelpaar, will be marketed under the brand name Livdelzi. PBC is a rare, progressive autoimmune condition that leads to inflammation and scarring of the liver’s bile ducts. The chronic disorder, which impairs liver function, mainly strikes women over 40 years of age. Gilead estimates that ...
- Source: drugdu
- 75
- August 16, 2024
Gilead Sciences Signs Yet Another R&D Alliance for Multi-Target Cancer Therapies

Gilead Sciences’ partnership with Merus could yield novel antibody drugs capable of binding to three targets simultaneously. The alliance follows a collaboration that Gilead started last year with Tentarix Biotherapeutics, a startup also developing antibodies that bind to multiple targets. By FRANK VINLUAN Bispecific antibody drugs have shown that binding to two targets simultaneously can be a powerful and effective way to treat cancer. Binding to three targets could be even better, and Gilead Sciences is turning to biotech company Merus to find out. Under the collaboration agreement announced Wednesday, Gilead is paying Merus $56 million up front and making a $25 million equity investment in the biotech. Netherlands-based Merus focuses on developing antibody therapies that bind to two or three targets at the same time. This capability could block multiple receptors that drive tumor growth and survival. It could also coax a patient’s immune cells to kill tumors. So ...
- Source: drugdu
- 104
- March 8, 2024
Gilead Sciences opens a new chapter, publishes the world’s ‘hardest book to read’ to reveal patients stuck in the margins

Depicting the plight of patients with chronic and potentially fatal diseases is always a challenge for pharma companies, but Gilead Sciences has quite literally found a novel way forward.Teaming up with British historian, presenter and writer Professor David Olusoga, OBE, Gilead is launching “From the Margins,” (PDF) in what is intended to be one of the most difficult books to read. That’s because the book has every word printed entirely in the margins of the pages in what Gilead and Prof. Olusoga see as a direct inversion of a normal book. The idea is simple: “To tell the profoundly moving personal stories of marginalized people living with HIV, Hepatitis C and cancer,” according to a statement sent to Fierce Pharma Marketing. Gilead markets drugs for all three diseases. The book is specific to Britain and being run to “to raise awareness of the issue of marginalization and health inequality in ...
- Source: drugdu
- 114
- September 16, 2023
Gilead Sciences to Acquire Cell Design Labs for $567 Million

Gilead Sciences, Inc. GILD and its newly acquired cell therapy subsidiary -Kite Pharma- announced that they have inked an agreement to acquire Cell Design Labs, Inc. for $567 million. Gilead will also acquire 12.2% of Cell Design shares which are owned by Kite Pharma.
- Source: qc.nasdaq
- 427
- December 11, 2017
Arcus Biosciences obtains loan facility with Hercules Capital worth $250m

Arcus Biosciences has announced a loan from financer Hercules Capital valued at as much as $250m, contingent on the advancement of the company’s therapeutic candidates. Arcus released the news after the markets closed yesterday (27 August), outlining an initial $50m granted at the deal’s close, with another $100m available at Arcus’s discretion. Provided Hercules Capital approves, a further $100m can be drawn. The five-year loan and four-year interest-only period may each be extended another year should Arcus initiate Phase III trials for its cancer therapies, a HIF-2α inhibitor casdatifan and the CD73 inhibitor quemlicustat, and meet regulatory milestones, respectively. The deal comes as the company continues its financial recovery. Arcus’s share price dropped from a high of $49.1 in November 2021 to $13.10 in November 2023. When the market opened today (28 August), the share price stood at $17.3; the company is valued at $1.6bn. Arcus CEO Dr. Terry Rosen ...
- Source: drugdu
- 72
- August 30, 2024
FDA Grants Accelerated Approval to Gilead’s Livdelzi for the Treatment of Primary Biliary Cholangitis

By Don Tracy, Associate Editor Approval of Livdelzi is based on results from the Phase III RESPONSE study, which demonstrated improved key biochemical markers and reduced pruritus. The FDA has granted accelerated approval to Livdelzi (seladelpar), Gilead’s treatment for primary biliary cholangitis (PBC) in adults who either have an inadequate response to ursodeoxycholic acid (UDCA) or cannot tolerate it. According to the company, the approval was based on positive results from the Phase III RESPONSE study, where Livdelzi significantly improved key biochemical markers and reduced pruritus, a debilitating symptom of PBC. Accelerated approval was based on a reduction of ALP.1 “More people are being diagnosed with PBC, impacting people of varied ages, gender, race and ethnicity. Those living with PBC share common symptoms, including incessant itching or skin-crawling sensations, as well as debilitating fatigue that is made worse by the itching at night,” said Carol Roberts, president, The PBCers Organization, ...
- Source: drugdu
- 105
- August 19, 2024
Gilead’s PBC therapy Livdelzi bags accelerated approval

Gilead Sciences’ Livdelzi (seladelpar) has received an accelerated approval from the US Food and Drug Administration (FDA) to treat primary biliary cholangitis (PBC). The approval is based on results from the Phase III RESPONSE trial (NCT04620733), which demonstrated Livdelzi to be the first treatment yielding significant reductions in alkaline phosphatase (ALP) normalisation and pruritus—significant markers of PBC progression. ALP levels normalised at 12 months for 25% of Livdelzi-treated patients compared to none on placebo. Change in pruritus score at six months was significantly reduced among Livdelzi-treated patients compared to those taking placebo. Overall, 62% of patients on Livdelzi achieved composite biochemical response at 12 months, achieved by just 20% of placebo patients. With this regulatory nod, Livdelzi enters a space dominated by other approved therapies like Ocaliva (obeticholic acid) and ursodeoxycholic acid. Ocaliva was developed by Intercept Pharmaceuticals, which was acquired by Alfasigma in late 2023. Gilead gained the rights ...
- Source: drugdu
- 66
- August 17, 2024
Gilead expands FDA label for Biktarvy with Phase I pregnant HIV patient data

Gilead Sciences has received a US Food and Drug Administration (FDA) approval for the label expansion of its human immunodeficiency virus -1 (HIV-1) fixed dose combination therapy, Biktarvy (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg). The therapy is approved in pregnant patients in their second and third trimesters and up to 16 weeks following delivery (postpartum) with suppressed viral loads of HIV-1. The FDA first approved Biktarvy as a complete regimen for treating HIV-1 in adults who either have no antiretroviral treatment history or as a replacement for the current antiretroviral regimen in those who are virologically suppressed, in 2018.The FDA label expansion was based on the data from an open-label Phase Ib trial (study 5310). The single-arm study evaluated the pharmacokinetics, safety, and efficacy of Biktarvy in 32 pregnant patients with suppressed viral loads of HIV-1. All the participants maintained viral suppression during pregnancy and through 18 weeks postpartum, with lower ...
- Source: drugdu
- 80
- May 5, 2024
Gilead writes $2.4B off Trodelvy as CEO underscores ‘time of focused execution’

The flurry of Trodelvy developments accentuates what Gilead CEO Dan O’Day called “a time of focused execution” at the California biotech. (Jim Watson/AFP/Getty Images) After a negative phase 3 readout, Gilead Sciences is taking a $2.4 billion impairment charge on Trodelvy, which serves as the cornerstone of the company’s solid tumor ambition. Gilead has cut the carrying value of Trodelvy to $3.5 billion in its first-quarter report, from $5.9 billion at the end of 2023, CFO Andrew Dickinson told investors during a call Thursday. The move comes after a January report of a phase 3 trial that the TROP2-directed antibody-drug conjugate failed to significantly extend the lives of patients with previously treated non-small cell lung cancer compared with chemotherapy. The bad news at that time caused a 10% slide in Gilead’s stock price. The write-off reflects a “smaller addressable market that Trodelvy could serve among second-line-plus metastatic non-small cell lung ...
- Source: drugdu
- 126
- April 30, 2024

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