Gilead resubmits application to FDA for twice-yearly HIV drug lenacapavir

Gilead Sciences (Nasdaq: GILD) has asked FDA for the second time in a year to approve the capsid protein inhibitor lenacapavir.

The drug won Breakthrough Therapy Designation from FDA in 2019 for HIV-1-infected individuals who are heavily treatment-experienced and have resistance to multiple drugs. The designation covered the potential use in tandem with other antiretroviral drugs.

In February, the FDA denied the approval of lenacapavir after concluding that the borosilicate glass vials containing the drug were incompatible with the medication as they could result in contamination with “sub-visible” glass particles.

Late last year, FDA placed a clinical hold on the use of the drug candidate in borosilicate vials for ongoing studies.

Foster City, California-based Gilead has also studied oral formulations of the drug.

Gilead included data on the drug used in vials made from aluminosilicate glass in its most recent new drug applicat…

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Gilead notches remdesivir indication to treat young children

FDA has announced that it has signed off on the use of COVID-19 therapy Veklury (remdesivir) from Gilead Sciences (Nasdaq:GILD) to include children at least 28 days old who weigh at least 3 kg (roughly 7 lb) and test positive results for COVID-19.

The indication is limited to children who are either hospitalized or have a high risk of developing severe COVID-19, including hospitalization or death.

In October 2020, remdesivir became the first FDA-approved COVID-19 treatment and is now the first drug to win approval for children under 12 years of age.

Remdesivir was formerly authorized for use in young children under emergency use authorization but was FDA-approved for COVID-19-infected individuals at least 12 years old who weigh at least 40 kg (roughly 88 lb).

“As COVID-19 can cause severe illness in children, some of whom do not currently have a vaccination option, there continues to be a need for safe and effective COVID-19 treatment options for …

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J&J and Roche named to Clarivate’s Top 100 Global Innovators list 

Photo by Chokniti Khongchum from Pexels

Few healthcare companies were included in the annual ranking of innovative companies from the analytics firm Clarivate plc (NYSE:CLVT).

Two companies in pharma and another in medtech, however, made the cut.

Johnson & Johnson was featured for the second consecutive year as a top 100 Global innovator.

Roche was included for the 11th consecutive year in the report.

In medtech, Philips was included for the second consecutive year.

Clarivate notes the fragmented nature of pharmaceutical research contributes to the limited number of companies in the ranking. Given the elevated role of academia and contract firms in drug discovery and development, it is more challenging for any single entity to stand out in the industry.

Additionally, Clarivate concluded that the ability of the pharmaceutical sector to innovate has fallen since last year…

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Biktarvy shows high efficacy at five years in treatment-naïve adults with HIV

Gilead Sciences (NSDQ:GILD) announced that Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets) offered sustained efficacy at week 240 in two Phase studies (Study 1489 and Study 1490).

The Foster City, California–based company noted that there were no cases of treatment failure as a result of viral resistance detected in the studies.

The company presented the data at the 29th Conference on Retroviruses and Opportunistic Infections.

FDA approved Biktarvy in 2018, expanding its use in 2021 to include some HIV-positive children.

“Many people living with HIV are concerned about the ability of their therapy to achieve long-term viral suppression since they will likely be on treatment for the duration of their lives,” said Dr. David Alain Wohl, professor of medicine, division of infectious diseases at the University of North Carolina at Chapel Hill, in a statement.

Gilead Sciences recently agreed to pay a 3% royal…

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Gilead to pay $1.25B in settlement with ViiV Healthcare 

Biktarvy image courtesy of Gilead Sciences

Gilead Sciences (NSDQ:GILD) will pay a 3% royalty on future U.S. sales of Biktarvy on top of a $1.25 billion upfront payment to settle global patent infringement litigation with ViiV Healthcare.

The royalty payments will be in effect until the expiration of the applicable patent (No. 8,129,385) on 5 October 2027.

Biktarvy generated $7.26 billion in sales in 2020 and $8.62 in 2021.

ViiV Healthcare is a joint venture between GSK (NYSE:GSK), Pfizer (NYSE:PFE) and Shionogi (TYO:4507). GSK is a 78.3% shareholder. Pfizer owns 11.7%, while Shionogi owns the remaining 10%.

The proceeds from the settlement will give a cushion to GSK, which is mulling spinning off its consumer healthcare division, but recently spurned Unilever’s overtures to buy the unit.

In 2018, GSK alleged that Gilead’s HIV drug Biktarvy had infringed on its unit ViiV Healthcare…

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Kyverna Therapeutics wins $85 million in Series B financing

The cell therapy company Kyverna Therapeutics (Emeryville, California) has closed an oversubscribed $85 million Series B funding round led by Northpond Ventures.

The company plans to use the funding to launch a Phase 2 trial for its lead asset, KYV-101, in the first half of 2022.

KYV-101 is an autologous anti-CD19 chimeric antigen receptor T-cell (CAR T) construct with potential applications in B cell-driven autoimmune diseases, including lupus nephritis, systemic sclerosis and inflammatory myopathies.

Kyverna secured rights to KYV-101 from the National Institutes of Health (NIH) for autologous and allogeneic CAR T-cell therapies.

Kyverna will also use the most recent funding to further the development of KYV-201, an investigational candidate that integrates its CD19 CAR T construct with Intellia’s (NSDQ:NTLA) ex vivoCRISPR/Cas9-based allogeneic platform.

The company also intends to use its recent funding to bolster its development activiti…

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FDA extends approval of remdesivir to encompass non-hospitalized high-risk

Gilead Sciences’ (NSDQ:GILD) Veklury (remdesivir) became the first FDA-approved COVID-19 drug when it was approved in October 2020.

Now, the company has announced that the FDA has granted expedited approval of a supplemental new drug application (sNDA) for the drug to treat non-hospitalized adult and adolescent patients with a high risk of progression to severe COVID-19, including hospitalization or death.

The drug was formerly approved for hospitalized adults and children in a hospital or healthcare setting capable of offering similar care. Now, it can be administered in some outpatient settings.

FDA also expanded the emergency use authorization of the drug for non-hospitalized children younger than 12 with a high risk of disease progression.

Demand has surged for COVID-19 therapies, including remdesivir that retain efficacy against the omicron variant of SARS-CoV-2.

Gilead first discovered and developed remdesivir in 2009 as a investigati…

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Gilead Sciences, Merck near the top of Newsweek’s most responsible companies list

A handful of big names in drug discovery and development are among the 500 “most responsible,” according to Newsweek.

The outlet published its “America’s Most Responsible Companies 2022” list, marking the third installment of the compilation (in partnership with Statista), this time expanded to include 500 of the largest public corporations around. Companies were judged with an overall score out of 100 that combined assessments on environmental, social and corporate governance performance.

Gilead Sciences (NSDQ:GILD), Merck (NYSE:MRK) and Pfizer (NYSE:PFE) were among the pharmaceutical companies to land a spot in the top-500, with a number of other drug development, pharmaceutical processing and manufacturing companies included.

The highest-ranking company was Gilead in sixth, landing an overall score of 89.9 points (90.6 environmental, 81.1 social and 98.2 corporate governance).

Merck was next-best in ninth at 89.3 points (94.6, 81.4, 92.…

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Baxter, 3M, Abbott near the top of Newsweeks’ most reponsible companies list

Several medtech, healthcare and life sciences companies, including big names like Abbott (NYSE:ABT), 3M (NYSE:MMM) and Baxter (NYSE:BAX), are among the 500 “most responsible,” according to Newsweek.

The outlet published its “America’s Most Responsible Companies 2022” list, marking the third installment of the compilation (in partnership with Statista), this time expanded to include 500 of the largest public corporations around. Companies were judged with an overall score out of 100 that combined environmental, social and corporate governance performance assessments.

Baxter, 3M, Abbott and BD (NYSE:BDX) were among the highest-ranking big-name medical device makers. Cancer diagnostic company Illumina was the highest-ranking company under the healthcare and life sciences umbrella, sitting in second behind HP.

In sixth sat Baxter, registering an overall score of 89.5 points, with its highest performance coming in environmental i…

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Appeals court invalidates $1.2 billion fine against Gilead Sciences

Gilead logo

The U.S. Court of Appeals for the Federal Circuit tossed a $1.2 billion fine against Gilead Sciences after invalidating portions of a Memorial Sloan Kettering Cancer Center patent licensed to a Bristol Myers Squibb subsidiary.

The patent was the basis for the previous ruling against Foster City, Calif.–based Gilead, which related to patent infringement claims associated with Yescarta, a CAR-T immunotherapy developed by Gilead’s Kite Pharma subsidiary. The Bristol Myers Squibb unit Juno Therapeutics had developed a similar treatment.

In a legal opinion representing a unanimous three-judge decision, Chief U.S. Circuit Judge Kimberly Moore reasoned that the portions of the Memorial Kettering Cancer Center patent lacked adequate details.

In 2019, a jury concluded that Kite Pharma had infringed on the patent and awarded the Memorial Sloan Kettering…

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Novartis’s Kymriah fails in study focused on aggressive B-cell non-Hodgkin lymphoma

Novartis (SWX:NOVN) has announced that the genetically modified autologous T cell immunotherapy Kymriah (tisagenlecleucel) failed to meet the primary endpoint in its Phase 3 BELINDA trial. That endpoint involved event-free survival for people with aggressive B-cell non-Hodgkin lymphoma compared to standard of care. To qualify for the study, patients needed to have primary refractory disease or have relapsed within 12 months of receiving first-line treatment. 

Two other companies, Bristol Myers Squibb (NYSE:BMY) and Gilead Sciences (NSDQ:GILD), recently announced successful data in similar studies involving Breyanzi and Yescarta, respectively.

Bristol Myers Squibb received FDA approval for Breyanzi as third-line therapy in February. 

FDA granted accelerated approval to Yescarta for relapsed or refractory follicular lymphoma in March. 

The standard of care in the treatment was salvage chemotherapy. Also known as rescue therapy, salvage chemotherapy …

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Gilead identifies counterfeit versions of two of its HIV drugs

Gilead Sciences (NSDQ: GILD) has announced that it has identified tampered and counterfeit versions of its HIV drugs Biktarvy and Descovy in the U.S. supply chain.

Biktarvy is a blockbuster drug cocktail, raking up $7.26 billion in sales last year. 2020 sales of Descovy were $478 million.

Foster City, Calif.–based Gilead said that unauthorized distributors have sold the drugs using genuine Gilead bottles but with a tampered counterfeit foil induction seal and drug.

The company is working to remove the counterfeit product from distribution.

“The safety of individuals taking Gilead medication is always our first priority,” said Dr. Merdad Parsey, chief medical officer and Gilead Sciences, in a statement. “We are taking aggressive action to ensure that healthcare providers and people who rely on our medicines can confidently distinguish authentic Gilead products from counterfeit drugs.”

The company also posted guidelines on its website to help…

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