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Gilead wins ruling against alleged counterfeiters in HIV drug case

A federal judge ruled against two defendants accused of selling counterfeit HIV medications, denying their motions to lift existing asset freezes obtained by pharmaceutical company Gilead Sciences in the ongoing lawsuit. Judge Ann M. Donnelly of the United States District Court for the Eastern District of New York converted the temporary asset freezes into preliminary injunctions, allowing Gilead to preserve funds for a potential award in the still undecided case. The judge had frozen the assets in 2022.

Gilead alleges the defendants were part of a counterfeiting ring that sold fake versions of its HIV medications. In the Gilead HIV drug case, the company obtained asset freezes against defendant Scripts Wholesale, a drug distributor and defendant Peter Khaim, a supplier.

Scripts and Khaim moved to lift the freezes. The court denied both motions. On Scripts’ motion, Judge Donnelly found Gilead showed a likelihood of success on its Lanham Act claims that Sc…

The 50 best-selling pharmaceuticals of 2022: COVID-19 vaccines poised to take a step back

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The COVID-19 pandemic has had a profound impact on the best-selling pharmaceuticals, leading to shifts in the list with Pfizer and BioNTech’s Comirnaty surpassing AbbVie’s Humira for the No. 1 spot in 2021. That momentum continued in 2022, with Pfizer and BioNTech jointly raking in $59.1 billion in revenue from the sales of the COVID-19 vaccine. Although Comirnaty maintained its position as the best-selling pharmaceutical of 2022, it experienced a roughly 5% drop in sales compared to the previous year.

As the best-selling pharmaceuticals of 2022 demonstrate, signs are emerging that the reign of COVID-19 vaccines and other therapies appears to be slipping.. The two companies — and Moderna — plan on hiking prices to address the weakening demand.

Humira: The second best-selling pharmaceutical of 2022 looking strong

Meanwhile, the heavyweight tumor necrosis factor (TNF) block…

100 top cell and gene therapy companies to watch in 2023

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The cell and gene therapy sector is poised to deliver a wave of new therapies that could potentially cure rare and common diseases. As many as 13 new cell or gene therapies could be approved for use in the U.S., Europe, or both by the end of 2023.

While manufacturing and regulatory challenges remain, the cell and gene therapy industry continues to offer significant therapeutic potential and commercial opportunities.

This year, we have beefed up our list of leading cell and gene therapy companies, doubling the number of organizations from 50 to 100.

In selecting the companies for this list, we weighed public companies’ degree of involvement in cell and gene therapy, including drug developers, equipment vendors and CDMOs specializing in the area. For private companies, we factored in their funding levels, pipeline and degree of history for the list.

B…

Gilead gains ground in HIV drug counterfeit litigation

A New York federal judge has frozen the assets of several individuals and entities for their alleged role in distributing counterfeit versions of Gilead Science’s (Nasdaq:GILD) HIV medications.

Presiding over the U.S. District Court for the Eastern District of New York, Judge Ann M. Donnelly also denied the defendants’ motion to dismiss the case for lack of personal jurisdiction and improper venue and permitted the case to proceed.

The defendants in the case are suppliers, distributors and pharmacies accused of operating an HIV drug counterfeiting ring. The lawsuit accuses three companies of involvement in the counterfeit ring, including Synergy Group Wholesalers, Cesar Castillo Wholesalers and DNS Distributor. It also states that Julio Martin Gonzalez assisted in the scheme.

According to recently unsealed court documents, Lazaro Roberto Hernandez and Armando Herrera were cited as the two kingpins involved in the scheme to market counterfeit …

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…

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 …

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…

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…

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…

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…

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…

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.…