PharmaFocus Today – Page 348 – media

Steroids linked to long-lasting heart disease risk and worse quality of life

Anabolic steroids not only can cause serious side effects during use, such as heart failure and depression, but can continue being harmful years after stopping, according to two studies presented at the 25th European Congress of Endocrinology in Istanbul. These studies were carried out by researchers from the Copenhagen University Hospital Rigshospitalet who investigated the impact of anabolic steroids in former users. Anabolic steroids—synthetic hormones that mimic the naturally-occurring sex hormone testosterone—are used to increase muscle mass and boost athletic performance. These performance-enhancing drugs have harmful side effects, for instance in men these include breast growth, hair loss, lower testosterone levels, erectile dysfunction, and an increased risk of heart disease, stroke, and liver or kidney failure. However, not much is known about the effects years after stopping their use. In one study, the researchers examined 64 healthy men, between the ages of 18 and 50, who did recreational strength training ...
- Source: drugdu
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- May 16, 2023
After costly setback, Astellas’ menopause drug crosses FDA finish line

After Astellas’ shot at a speedy FDA approval for its menopause drug was derailed in February, the therapy has finally crossed the FDA finish line. The drug, branded as Veozah, won FDA approval to treat moderate to severe menopause-related vasomotor symptoms. It’s the first nonhormonal neurokinin 3 (NK3) receptor antagonist approved to treat the condition. It’s been a bit of a bumpy road to the green light. After shelling out 13.1 billion Japanese yen ($97 million) to secure a priority review voucher and speed up the regulatory timeline, the FDA extended its review just days before the drug’s prior regulatory decision date. Vasomotor symptoms, or hot flashes and night sweats, are the hallmark of menopause. Some 60% to 80% of women experience the symptoms during or after menopausal transition, Astellas said in its release. The drug’s nonhormonal aspect is key because some people with menopause can’t take hormone therapies, the ...
- Source: drugdu
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- May 16, 2023
MyFitnessPal and Google Health Connect announce integration between two platforms to help people with diabetes

MyFitnessPal, the No. 1 global nutrition and fitness tracking app, and Google Health Connect today announced an integration between the two platforms at this year’s Google I/O developer conference. Individuals diagnosed with Type 1 and 2 diabetes who use select continuous glucose monitoring (CGM) tools integrated with Google’s Health Connect can now see their glucose data directly within the MyFitnessPal app. ”Our community will now have the critical capability to understand and visualize how the foods they eat affect their blood glucose levels throughout the day. Prior to this, someone could see spikes in their glucose, but not make the connection to what caused them. Our collaboration with Google builds on our innovation and commitment to bringing the latest technologies to consumers as they navigate their health and wellness journeys, particularly those with diet-related diseases.” Tricia Han, CEO, MyFitnessPal MyFitnessPal Android users with select glucose monitors now ...
- Source: drugdu
- 148
- May 15, 2023
Swiss researchers identify plastic-degrading microbial strains in the Alps and Arctic region

Finding, cultivating, and bioengineering organisms that can digest plastic not only aids in the removal of pollution, but is now also big business. Several microorganisms that can do this have already been found, but when their enzymes that make this possible are applied at an industrial scale, they typically only work at temperatures above 30 °C. The heating required means that industrial applications remain costly to date, and aren’t carbon-neutral. But there is a possible solution to this problem: finding specialist cold-adapted microbes whose enzymes work at lower temperatures. Scientists from the Swiss Federal Institute WSL knew where to look for such micro-organisms: at high altitudes in the Alps of their country, or in the polar regions. Their findings are published in Frontiers in Microbiology. “Here we show that novel microbial taxa obtained from the ‘plastisphere’ of alpine and arctic soils were able to break down biodegradable plastics at 15 ...
- Source: drugdu
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- May 15, 2023
Sandoz taps Evotec in long-term biosimilar development and manufacturing deal

As Novartis’ Sandoz unit prepares to go it alone, the off-patent medicines specialist is buckling up for the biosimilars long haul. Sandoz on Tuesday struck an accord with Just – Evotec Biologics to develop and manufacture biosimilar candidates over a multiyear stretch. The deal, which includes an “option for expansion,” marks the latest step in Sandoz’s quest to strengthen itself as a standalone company, the generics unit said in a release. The companies did not say how much they are paying for the deal. Last summer, Novartis telegraphed plans to spin off Sandoz. The decision came as part of a wider strategic review at the company that kicked off in October 2021. As of last August, the spinoff was expected to wrap up in the second half of 2023. Under its latest pact, Sandoz will get its hands on Just – Evotec Biologics’ drug substance development platform and manufacturing technology. Sandoz will use that ...
- Source: drugdu
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- May 15, 2023
reports

The costs for Roche to decommission and demolish its former API manufacturing plant in County Clare, Ireland, continue to climb, with the bill now reaching 57.3 million euros ($62.7 million) over a three-year period, according to local reports. In documents filed with the Companies Registration Office of Ireland, the Swiss pharma giant said it spent 11.53 million euros ($12.6 million) on winding down the facility in 2022. That’s in addition to the 23.4 million euros ($25.6 million) it shelled out dismantling the facility in the previous two years, The Irish Times reports. Roche also spent 13.18 million euros ($14.4 million) in related environmental costs last year, plus 9.1 million euros in that category through 2020 and 2021, according to the publication. “The company is continuing with its plan to decommission and demolish its assets,” Roche said in the filing, as quoted by The Irish Times. “It has successfully transitioned from a manufacturer ...
- Source: drugdu
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- May 15, 2023
Chiesi, Protalix’s PRX-102 secure FDA nod to treat Fabry disease

Chiesi Global Rare Diseases and Protalix BioTherapeutics have received approval from the US Food and Drug Administration (FDA) for PRX-102 (pegunigalsidase alfa) to treat Fabry disease in adult patients. The latest move follows the receipt of marketing authorisation for PRX-102 from the European Commission (EC) for the same indication. The PEGylated enzyme replacement therapy (ERT), PRX-102 is a recombinant human α‑Galactosidase‑A enzyme expressed in plant-cell culture that is designed for providing a long half-life. The therapy was found to have an initial half-life of 78.9 ± 10.3 hours, in clinical trials. Chiesi Global Rare Diseases head Giacomo Chiesi said: “While much progress has been made in the treatment of Fabry disease, there is still a need for new treatment options. “We established Chiesi Global Rare Diseases to deliver innovative therapies and solutions for people affected by rare diseases. “With the FDA approval of PRX-102, we can now offer people ...
- Source: drugdu
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- May 15, 2023
Ariceum and UCB link up to take on immune-related diseases

The companies will use proprietary technology to enable the discovery of peptide-radioisotope conjugates Ariceum Therapeutics and UCB have announced a research partnership agreement to establish and develop novel systemic targeted radiopharmaceuticals for the treatment of solid tumours and immune-related diseases. An essential part of the collaboration will involve the companies utilising each other’s proprietary technology platforms to enable the discovery of peptide-radioisotope conjugates as treatments for a variety of cancers and immune-related diseases. In addition, Ariceum will gain access to UCB’s experience in order to identify novel synthetic macrocyclic peptides by incorporating its mRNA-display technology platform, ExtremeDiversity. Similarly, UCB will benefit from Ariceum’s expertise in the areas of radiochemistry and labelling technology, thereby enhancing its ability to study how this type of technology could lead to the discovery of differentiated products for immune-related diseases. Indeed, the agreement means that each company will have the opportunity to explore multiple targets. Dhaval ...
- Source: drugdu
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- May 15, 2023
NHS misses targets in England to tackle care backlogs

IMAGE SOURCE,GETTY IMAGES By Nick Triggle Health correspondent Hospitals in England have failed to hit key targets to tackle the backlogs in cancer care and routine treatment. Waiting times show too many patients were still facing long waits at the end of March. The targets were to eliminate 18-month waits for planned care, such as knee and hip replacements, and to bring 62-day cancer waits to pre-pandemic levels. NHS England said huge progress had been made, particularly on routine care. The numbers waiting more than 18 months for treatment peaked in September 2021 at nearly 125,000. By the end of March, just over 10,700 were waiting that long – but NHS England said about 4,000 of them were complex cases or patients who had been offered treatment but had chosen to wait. Half of the people were concentrated in 10 NHS trusts. Overall, there are now a record 7.3 million ...
- Source: drugdu
- 109
- May 15, 2023
WHO declares global emergency over

IMAGE SOURCE,GETTY IMAGES Image caption, Monkeypox is caused by the monkeypox virus, a member of the same family of viruses as smallpox BBC By Michelle Roberts Digital health editor Monkeypox is no longer a global public health emergency, the World Health Organization (WHO) has said, almost a year after the threat was raised. The virus is still around and further waves and outbreaks could continue, but the highest level of alert is over, the WHO added. The global health body’s chief Tedros Adhanom Ghebreyesus called on countries to “remain vigilant”. It can be passed on by close contact with someone who is infected. What is monkeypox? Its official name is Mpox and it is caused by the monkeypox virus, a member of the same family of viruses as smallpox, although it is much less severe. Initial symptoms include fever, headaches, swellings, back pain, aching muscles. Once the fever breaks ...
- Source: drugdu
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- May 15, 2023

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