Search Results for “Gilead Sciences” – Page 3 – media

Gilead-backed Lyndra Therapeutics cuts nearly a quarter of staff as ph. 3 data nears

Lyndra Therapeutics is laying off roughly 23% of its staff, two months after the company swapped out longtime CEO Patricia Hurter, Ph.D., and as a pivotal trial for a long-acting, oral schizophrenia drug nears an interim readout. The cuts come after the company’s recent decisions to outsource commercial manufacturing and partner on both the development and commercialization of “all future products,” a spokesperson said Friday. The company is also leaving its headquarters in Watertown, Massachusetts, and is consolidating at a nearby location in Lexington. “With our topline data readout from our pivotal trial of oral weekly risperidone expected in the next few weeks, we feel these changes will set us up to successfully navigate the regulatory pathway ahead and ultimately bring oral weekly medications to patients,” the spokesperson said. The company plans to partner up on lead asset LYN-005, though a collaborator has not been disclosed or named, the spokesperson ...
- Source: drugdu
- 155
- September 19, 2023
Gilead’s COVID-19 Treatment Approved by FDA for Patients with Severe Renal Impairment

Gilead Sciences has announced that its COVID-19 treatment, Veklury (remdesivir), has been approved by the US Food and Drug Administration (FDA) to treat patients with severe renal impairment, including those on dialysis. The drug is already approved in the US to treat COVID-19 in adults and paediatric patients who are hospitalised or have mild-to-moderate COVID-19 and are at high risk for progression to severe illness. However, its use has previously been limited among patients with severe renal impairment due to insufficient data. The FDA’s latest decision makes Veklury the first and only approved antiviral COVID-19 treatment that can be used across all stages of renal disease. Gilead’s supplemental new drug application was supported by positive results from a phase 1 study as well as data from the phase 3 REDPINE trial that demonstrated the efficacy and safety profile of Veklury among patients with moderately and severely ...
- Source: drugdu
- 118
- July 19, 2023
Gilead’s chronic hepatitis D antiviral shows long-term efficacy in late-stage trial

Gilead Sciences has shared positive results from a late-stage study of its chronic hepatitis D virus (HDV) treatment, Hepcludex (bulevirtide). Gilead said the new 96-week data from the phase 3 MYR301 trial, which was presented at this year’s European Association for the Study of the Liver Congress, “reinforces the role of Hepcludex as an efficacious and well-tolerated treatment for the management of chronic HDV”. Data shows that the combined virological and biochemical response rates continued to increase through week 96, with response rates of 55% and 56% at the 2mg and 10mg dose levels, respectively. An additional analysis from the trial, presented in a late-breaker, also showed that study participants who appeared to not respond or only partially respond to the antiviral at week 24 went on to achieve a virological response at 96 weeks. The safety profile at week 96 was consistent with what was observed at week 48, ...
- Source: drugdu
- 110
- June 26, 2023
US appeal in high-stakes Gilead patent case garners support from patient advocates

Weeks after Gilead Sciences prevailed over the U.S. government in a high-stakes HIV patent case, patient advocates are backing the U.S.’ push to appeal. In a letter to Attorney General Merrick Garland and Department of Health and Human Services (HHS) Secretary Xavier Becerra, more than 30 organizations said they “commend the decision” by the Department of Justice (DOJ) to keep fighting in the case. After the recent trial went in Gilead’s favor on May 9, the DOJ is seeking a new trial, according to the letter. The groups said they “strongly support HHS’s and DOJ’s decision to contest the surprising verdict,” arguing that the government’s case remains “fundamentally strong.” The U.S. first sued Gilead in 2019, saying that taxpayers funded research in the early 2000s that eventually went into the company’s lucrative HIV prevention medicines. U.S. officials said they sought to license the patented technology to Gilead for many years ...
- Source: drugdu
- 163
- June 2, 2023
Gilead, Teva reach 11th-hour settlements with some groups in HIV antitrust case

Right before opening arguments were set to begin in Gilead Sciences and Teva’s HIV antitrust trial, the two came to a last-minute settlement with some of the plaintiff groups. Both companies settled with the pharmacy plaintiffs, a group that includes CVS Pharmacy, Rite Aid and Walgreens, while Gilead made a deal with the direct purchasers. Now, indirect purchasers and others involved in the suit can take their claims to a California federal jury. Gilead and Teva confirmed the settlements, and Gilead noted that the lawsuit with the other parties is ongoing. “The claims against Gilead in this lawsuit lack merit, do not accurately reflect antitrust laws, and ignore Gilead’s history of innovation and scientific advancements to help address the pressing challenges of the HIV epidemic,” a Gilead spokesperson said over email. The deals mark an eleventh hour end to a sprawling case that dates back to 2019, when plaintiffs including ...
- Source: drugdu
- 112
- May 31, 2023
Gilead notches trial win in high-stakes HIV patent case against US government

It’s extremely unusual for the U.S. government to go after a pharmaceutical company for alleged patent infringement, much less take the case to trial. But in the government’s case against Gilead Sciences, the California drugmaker has come out on top.After years of litigation, Gilead prevailed following the trial in a Delaware federal court. The jury found the patents at issue were invalid, The New York Times reports.With that, the company doesn’t have to pay the more than $1 billion that the government sought with its patent infringement case. The company is “pleased” with the decision, Gilead’s executive vice president of corporate affairs and general counsel Deb Telman said in an emailed statement. “Today’s decision confirms our longstanding belief that we have always had the rights to make Truvada and Descovy for PrEP available to all who need it,” Telman said. “Gilead will continue to champion collaborations, including our efforts with the ...
- Source: drugdu
- 135
- May 11, 2023
Positive opinion for Gilead’s Hepcludex

The vital recommendation ensures marketing authorisation for treating the hepatitis delta virus Gilead Sciences has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has provided a positive opinion for Hepcludex. Also known as bulevirtide, the therapy concerns adults with chronic hepatitis delta virus (HDV) and compensated liver disease. Meanwhile, the recommendation grants full marketing authorisation (MA) which will no longer be subject to certain obligations. Initially, Bulevirtide was granted conditional marketing authorisation in 2020 in order to treat particular HDV patients who required urgent access to treatment. The CHMP recommendation for full MA of bulevirtide arrives after the submission of phase 3 MYR301 week 48 study data, which reinforces its safety and efficacy profile. HDV remains the most severe form of viral hepatitis and impacts around 5% of people living with hepatitis B (HBV). Furthermore, there is a prevalence of ...
- Source: drugdu
- 232
- May 9, 2023
Gilead’s Trodelvy scores accelerated approval in advanced bladder cancer

Gilead’s antibody drug conjugate (ADC) Trodelvy has received an accelerated approval from the US Food and Drug Administration (FDA) for the treatment of locally advanced or metastatic urothelial cancer (UC), the most common form of bladder cancer. The approval covers the use of Trodelvy (sacituzumab govitecan-hziy) in patients with advanced UC who have previously received a platinum-containing chemotherapy and either a PD-1 or PD-L1 inhibitor. Trodelvy was approved on the basis of results from Gilead’s Phase II TROPHY study, which evaluated the drug as monotherapy or as a combination therapy in patients with metastatic UC after progression on a platinum-based chemotherapy and PD-1/L1 inhibitor. In 112 patients who were evaluable for efficacy, 27.7% of those who were treated with Trodelvy responded to treatment, with 5.4% experiencing a complete response and 22.3% experiencing a partial response. The study also found a median duration of response of 7.2 months for those treated ...
- Source: drugdu
- 179
- April 15, 2021
bladder cancer
Gilead’s Veklury should be effective against COVID-19 variants

Gilead Sciences has released a statement regarding the efficacy of its antiviral treatment Veklury (remdesivir), maintaining confidence in the its continued benefit against new COVID-19 variants. The new COVID-19 variants were discovered in the UK and South Africa, respectively. The UK variant, known as B117, was identified in the UK in early December, and was discovered to be much more transmissible than the original strain. The South African variant, known as B1351 or 501.V2, carries a number of mutations and is also thought to be more contagious. “We have completed genetic analysis of publicly available sequences for the UK and South African variants of SARS-CoV-2 and we believe remdesivir will continue to be effective against these variants,” said Gilead. “The mutations identified in these new variants have not significantly altered the part of the virus that remdesivir targets or have any association with known mutations conferring reduced susceptibility of coronaviruses ...
- Source: drugdu
- 204
- January 27, 2021
COVID-19 variants
Gilead inks $90m deal with Verily to create “molecular map” of inflammatory disease

Gilead Sciences (NSDQ:GILD) is reportedly slated to pay Alphabet’s Verily Life Sciences $90 million over three years to analyze cells from patients with rheumatoid arthritis, inflammatory bowel disease and lupus-related diseases.
- Source: drugdeliverybusiness
- 632
- May 2, 2018
Gilead Market Views rheumatoid arthritis

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