PharmaFocus Today – Page 375 – media

Perrigo’s OTC birth control pill aces FDA expert meeting

The jury has spoken, giving a unanimous “yes” to push Perrigo’s birth control tablet Opill over the counter. Wednesday, experts from a joint FDA meeting of outside experts voted 17 to 0 in favor of Opill’s over-the-counter approval pivot. If approved later this year by the FDA, Opill would become the first OTC daily hormonal birth control pill cleared in the U.S. The unanimous vote came despite a number of big questions from the FDA about the potential for Opill’s responsible over-the-counter use in the real world. The FDA does not have to follow the advice of its advisory committees when making an approval vote, though it often does. Panelists had one main question to consider. Namely: Was there “adequate information to conclude that consumers will be likely to use [Opill] properly, such that the benefits of making this available for nonprescription use … exceed the risks.” Overall, panelists concluded ...
- Source: drugdu
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- May 12, 2023
Teva CEO Richard Francis, after 4 months at the helm, preps grand strategic reveal

After a little over four months as Teva’s CEO, Richard Francis is getting ready to debut his long-term vision for the drugmaker. In Francis’ first quarter as Teva’s CEO, the Israeli pharma giant pulled down $3.7 billion in sales, a flat number versus the same period last year. In Europe, the company posted a 9% sales gain, Teva said Wednesday. Huntington’s disease and tardive dyskinesia med Austedo delivered a 10% global revenue gain to $170 million during the first quarter, while migraine prevention drug Ajovy posted a 35% increase to $95 million. Overall, first-quarter revenues came in around estimates, Barclays analysts wrote in a note to clients. In an investor presentation (PDF), Francis highlighted key attributes of the company, including its innovative pipeline and a “balanced risk portfolio.” The generics group is “a strong business that generates significant cash,” he added on Teva’s first-quarter earnings conference call. But what has ...
- Source: drugdu
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- May 12, 2023
New drug delivery system delivers antioxidant directly to mitochondria in the liver

A new drug delivery system delivers an antioxidant directly to mitochondria in the liver, mitigating the effects of oxidative stress. Mitochondria are microscopic organelles found within cells, and are well-known as the “powerhouse of the cell.” They are by far the largest producer of the molecule adenosine triphosphate (ATP), which provides energy to many processes in living cells. The process by which mitochondria synthesize ATP generates a large amount of reactive oxygen species (ROS), chemical groups that are highly reactive. In a healthy cell, the ROS are controlled by the mitochondria; however, when this balance is lost, the excess ROS damages the mitochondria and subsequently cells and tissues. This phenomenon, known as oxidative stress, can cause premature aging and disease. The ROS that cause oxidative stress can be controlled by antioxidants. A research team led by Professor Yuma Yamada, Distinguished Professor Hideyoshi Harashima and Assistant Professor Mitsue Hibino at ...
- Source: drugdu
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- May 12, 2023
GSK’s RSV vaccine approved by FDA for older adults

GSK’s respiratory syncytial virus (RSV) vaccine has been approved in the US for the prevention of RSV-caused lower respiratory tract disease (LRTD) in adults aged 60 years and older. The US Food and Drug Administration’s (FDA) decision makes Arexvy the first RSV vaccine for older adults to be approved anywhere in the world. RSV is a common contagious virus characterised by several mild, cold-like symptoms. Although most people can recover within a week or two, older adults are at a high risk for severe disease. This is partly due to age-related decline in immunity. RSV can also exacerbate other conditions, including chronic obstructive pulmonary disease, asthma and chronic heart failure. Overall, RSV infections in older adults account for over 170,000 hospitalisations and approximately 14,000 deaths each year in the US. The company’s application was supported by positive results from its phase 3 AReSVi-006 trial, in which the vaccine showed ...
- Source: drugdu
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- May 12, 2023
Understanding the adverse events profile of MVA-BN vaccine for Mpox

A recent study published in the Journal of American Medical Association (JAMA) evaluated adverse events following the Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN) vaccination for mpox. Background Australia adopted a dose-sparing approach due to the shortage of MVA-BN vaccines in the recent mpox outbreak. Accordingly, a 0.1 ml intradermal dose was recommended for pre-exposure prophylaxis and a 0.5 ml subcutaneous dose for post-exposure prophylaxis in a two-dose regimen four weeks apart. The study and findings In the present study, researchers assessed adverse events following MVA-BN vaccination using data from AusVaxSafety, Australia’s vaccine safety surveillance system. Individuals vaccinated with MVA-BN from August 2022 to March 2023 at AusVaxSafety surveillance sites were asked to participate, which covered three-fourths of mpox vaccination sites. Participants received a survey link seven days after vaccination to complete a questionnaire on adverse events. Responses were considered for analysis if completed within seven days. Demographic details and vaccination ...
- Source: drugdu
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- May 12, 2023
AstraZeneca’s heart failure treatment approved for expanded use in US

AstraZeneca’s (AZ) Farixga (dapagliflozin) has been approved for extended use in the US, meaning adult patients with heart failure (HF) can benefit from the treatment regardless of their left ventricular ejection fraction status (LVEF). Farxiga, sold as Forxiga in certain markets, was previously approved in the US for HF patients with reduced ejection fraction (HFrEF) which is equal to or less than 40%. HF affects approximately seven million people in the US and is associated with substantial morbidity and mortality, with chronic HF the leading cause of hospitalisation for those over the age of 65. Roughly half of all HF patients have mildly reduced ejection fraction (HFmrEF) or preserved ejection fraction (HFpEF), with few therapeutic options available. As well as the greater risk of death and hospitalisations, patients with HFmrEF or HFpEF experience an especially high burden of symptoms and physical limitations. The US Food and Drug Administration’s (FDA) ...
- Source: drugdu
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- May 12, 2023
BMS, after last year’s West Coast purge, lays off 48 in New Jersey

While smaller biotech outfits have certainly taken the brunt, the layoff deluge of the past year hasn’t spared big pharmas either. Now, after unveiling more than 250 job cuts in San Diego in September, Bristol Myers Squibb is turning its staff reduction campaign northeast. Starting at the end of May, BMS will roll out job cuts for 48 employees in Princeton, New Jersey, according to a new Worker Adjustment and Retraining Notification (WARN) alert filed with the state. The BMS site in question is a 650,000-square-foot facility that houses employees from the commercial team, plus commercialization and late-stage development partners from the R&D unit. The plant also hosts members of BMS’ global product development and supply teams, according to the company’s website. It’s not immediately clear what types of roles will be affected. Putting the cuts into context, Bristol’s business model is “evolving to support our mission to discover, develop and deliver innovative ...
- Source: drugdu
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- May 11, 2023
First Of Its Kind Urine Biomarker Methylation Test Predicts Bladder Cancer Recurrence

By LabMedica International staff writers Bladder EpiCheck is the first urine biomarker methylation test of its kind to be FDA cleared for NMIBC surveillance (Photo courtesy of Nucleix) Bladder cancer ranks as the sixth most common cancer in the U.S., with around 700,000 individuals living with the disease and over 80,000 new cases detected each year. The majority of these cases are classified as non-muscle invasive bladder cancer (NMIBC). Although NMIBC can be treated surgically and therapeutically, it has a high recurrence rate (up to 70% over five years), necessitating frequent monitoring to detect high-grade recurrence and treat it promptly. The standard of care involves regular and invasive cystoscopies, which patients undergo up to four times annually for a minimum of five years or, in some cases, for their entire lives. Now, a simple, objective urine test for recurrent bladder cancer is set to become commercially available in the ...
- Source: drugdu
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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
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- May 11, 2023
Most antidepressants prescribed for chronic pain lack reliable evidence of efficacy or safety, scientists warn

Most antidepressants used for chronic pain are being prescribed with “insufficient” evidence of their effectiveness, scientists have warned. A major investigation into medications used to manage long-term pain has found that harms of many of the commonly recommended drugs have not been well studied. Published in the Cochrane Database of Systematic Reviews, the study led by scientists from several UK universities including Southampton and Newcastle, examined 176 trials consisting of nearly 30,000 patients involved in assessments which prescribed antidepressants for chronic pain. Among the drugs studied were amitriptyline, fluoxetine, citalopram, paroxetine, sertraline, and duloxetine—with only the latter showing reliable evidence for pain relief. One third of people globally are living with chronic pain, World Health Organization data shows, with many prescribed antidepressants for relieving symptoms. Lead author Professor Tamar Pincus from the University of Southampton said, “This is a global public health concern. Chronic pain is a problem for millions ...
- Source: drugdu
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