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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
- 115
- July 19, 2023
Portable, Low-Cost Tech Tracks Uterine Contractions

Chakrabartty’s lab created a battery-powered portable instrumentation that connects with a stretchy patch that places electrodes around the wearer’s abdomen. The electrodes detect both maternal heartbeat and EMG signals, which correspond to uterine contractions. Chuan Wang created flexible electrodes that Chakrabartty’s group used to build the device. Credit: Washington University in St. Louis Keeping track of pregnancy requires a dizzying array of gargantuan and expensive machines. An MRI machine is the size of a room and can cost up to $1 million. But the care such equipment provides is a critical part of prenatal care, especially for dealing with complications like preterm birth. To get this care, pregnant people frequently need to visit a hospital, a significant burden for underserved and disadvantaged communities. In a paper published May 19 in early access online in IEEE Transactions on Biomedical Circuits and Systems, a collaboration of researchers at Washington University St. ...
- Source: drugdu
- 100
- July 19, 2023
Eli Lilly Strengthens the Case for Going Early in Alzheimer’s Treatment

Alzheimer’s disease patients in the earliest stages of their disease benefited the most from Eli Lilly drug donanemab, which is expected to receive an FDA decision by the end of 2023. Full results from the drug’s pivotal study were presented during the during the Alzheimer’s Association International Conference. Eli Lilly has submitted its Alzheimer’s disease drug candidate for FDA review, and the pharmaceutical giant is now revealing a more complete look at the clinical data supporting an application that could make the therapy the second anti-amyloid antibody to win full regulatory approval. Lilly had previously said its drug, donanemab, led to a 35% slowing in the decline associated with Alzheimer’s. Those results were for patients with intermediate levels of tau, another protein that’s also characteristic of Alzheimer’s progression. In patients with low-to medium-levels of tau, representing an earlier stage of the disease, treatment with the Lilly drug led to a ...
- Source: drugdu
- 111
- July 19, 2023
Citius Seeks Approval for I/ONTAK Ahead of Spin-Off Plans

Citius Pharmaceuticals is planning to spin out its immune asset I/ONTAK into a separate publicly-traded entity, pending the FDA’s verdict on the candidate, due July 28. I/ONTAK, which Citius is proposing as a treatment for T-cell lymphoma, is a reformulation of Eisai’s Ontak (denileukin diftitox), which won initial approval in 1999 for the same indication. Citius’ candidate is a recombinant fusion protein that combines a diphtheria toxin with the interleukin-2 protein. It works by specifically binding to IL-2 receptors to precisely deliver its toxic payload, thereby preventing protein synthesis in malignant T cells. I/ONTAK also targets the immunosuppressive regulatory T cells, which in turn allows the body to produce a stronger immune response against the cancer. The therapeutic fusion protein is approved in Japan, where it is marketed under the brand name Lymphir. The FDA accepted Citius’ Biologics License Application for I/ONTAK in December 2022 and initially gave it a target action ...
- Source: drugdu
- 99
- July 19, 2023
Verrica Hopes Third Time’s the Charm for Viral Skin Disease Treatment

On July 23, the FDA is set to make a decision on Verrica Pharmaceuticals’ investigational topical treatment VP-102 (cantharidin 0.7% topical solution), which is being proposed to treat molluscum contagiosum. If approved, VP-102 would become the first authorized treatment for this viral skin infection. Affecting some six million patients in the U.S. —primarily children—molluscum contagiosum is a highly contagious viral skin disease characterized by distinctive, raised pinkish lesions that are itchy and sometimes painful. In some cases, these bumps can also lead to inflammation and increase the risk of infection. Molluscum contagiosum is caused by a pox virus that is easily transmissible via fomites or direct skin-to-skin contact. Though usually mild or benign, the disease can persist for several months or years when left untreated. VP-102 is a drug-device combination containing a 0.7% formulation of cantharidin delivered through a single-use applicator that ensures precise dosing. Verrica ...
- Source: drugdu
- 120
- July 19, 2023
FDA to Decide on Daiichi Sankyo’s Quizartinib for AML

Following a three-month delay to provide more time for review, the FDA is scheduled on July 24 to decide on Daiichi Sankyo’s proposal to administer quizartinib in combination with standard chemotherapy to treat patients with acute myeloid leukemia (AML). The FDA first accepted Daiichi Sankyo’s NDA in October 2022 and granted it Priority Review, which is meant to accelerate the regulator’s decision. However, in April 2023, the FDA pushed the action date back by three months to accommodate updates to the proposed Risk Evaluation and Mitigation Strategies for quizartinib. Daiichi Sankyo is backing its NDA with data from the Phase III QuANTUM-First trial, which demonstrated that quizartinib can cut the risk of death by 22.4% in AML patients compared to chemotherapy alone. This advantage persisted until 40 months of follow-up, at which point the quizartinib arm had more than double the median overall survival of placebo comparators. ...
- Source: drugdu
- 115
- July 18, 2023
Roche in Talks to Buy Stomach Drug from Roivant for $7B

Ulcerative colitis and Crohn’s disease are big business, and Roche could be all in, according to a report that has the Swiss pharma in talks to acquire a late-stage candidate from Roivant Sciences for upwards of $7 billion. The deal—which would be one of the largest struck by newly seated CEO Thomas Schinecker—could be announced in the coming days, according to The Wall Street Journal, which broke the news Thursday evening. Sources familiar with the talks cautioned that they could still break down and that another suitor could emerge, the WSJ reported. The drug at the center of the rumored discussions is RVT-3101, an anti-TL1A antibody that recently showed positive results in a Phase IIb study in patients with moderate to severe ulcerative colitis (UC). After 56 weeks of treatment, 36% of participants who received the optimum dose of the drug achieved clinical remission, according to Roivant, which announced the results in June. This was a marked increase ...
- Source: drugdu
- 123
- July 18, 2023
Obesity Drug Maker Versanis to Be Bought by Eli Lilly for $1.9 Billion

Eli Lilly on Friday said it will acquire Versanis, a privately held obesity drug maker, for up to $1.93 billion to boost the pharmaceutical giant’s weight loss treatment portfolio. Eli Lilly agreed to pay Versanis shareholders in cash, which will consist of an upfront payment and potentially subsequent payments if Versanis achieves certain “development and sales milestones.” Oakland, California-based Versanis, which was founded in 2021 by biotech investment firm Aditum Bio, has one experimental drug for obesity and potentially other conditions. Eli Lilly’s stock price rose 3% on Friday following the announcement. The deal is Eli Lilly’s latest attempt to capitalize on the weight loss industry gold rush, which began last year after Novo Nordisk’s blockbuster injections Wegovy and Ozempic boomed in popularity. An estimated 40% of U.S. adults are obese. Analysts project that the global weight loss drug market could be worth $100 ...
- Source: drugdu
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- July 18, 2023
Bicycle Therapeutics Plans $200m Public Offering

NASDAQ-listed Bicycle Therapeutics has announced that $200m worth of shares will be available at a price of $21.25 each. The company, which has offices in the UK and US, expects the underwritten public offering to close around 17 July. On 13 July, more than 12 times the volume of shares were traded on the exchange, compared to the previous day. The underwriters will also have the option to purchase a further $30m of shares in a 30-day period. The company has recently signed two lucrative deals with Novartis and Bayer for the use of its peptide technology to develop radio-conjugates. In March, Novartis paid an upfront sum of $50m, and a possible $1.7bn in milestone payments. Bayer then followed suit in May, with a $45m upfront deal, with a possibility of a further $1.7bn. Both partnerships involve undisclosed oncology targets. The company reported net losses of ...
- Source: drugdu
- 113
- July 18, 2023
In Talc Defense, Johnson & Johnson Sues 4 doctors Over Their ‘Junk Litigation Opinions’

As Johnson & Johnson awaits a decision on its second attempt to resolve talc lawsuits through a bankruptcy ploy, the company is attempting another legal tactic to free itself from those liabilities—suing doctors who say that its iconic baby powder can cause cancer.In federal district court in New Jersey, J&J’s talc subsidiary LTL Management has filed two suits against four doctors who authored studies that described a link between J&J’s talc-based products and cancer. Last week, J&J filed suit against New Hampshire physician Richard Lawrence Kradin and Virginia doctors Theresa Swain Emory and John Coulter Maddox. In a separate suit in May, J&J sued New York physician Jacqueline Miriam Moline. In the most recent suit, J&J claims that the three doctors cited 75 people with malignant mesothelioma who had been exposed to cancer-causing asbestos only by using Johnson’s Baby Powder or another J&J talc product, Shower to Shower. ...
- Source: drugdu
- 106
- July 18, 2023

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