PharmaFocus Today – Page 357 – media

FDA’s cancer chief weighs in on common chemo shortages — report

Tyler Patchen Richard Pazdur, director of the FDA’s Oncology Center of Excellence, attributes the current shortage of two cancer drugs to drug companies that haven’t invested in building out their production capacity. In an interview with The Cancer Letter, a weekly cancer publication, Pazdur said that the current shortages of cisplatin and carboplatin, a pair of drugs used to treat a wide range of cancer patients, are the result of two problems: manufacturers not investing in enhancing production capacity, and drug companies being dependent on one supplier of raw ingredients. The cisplatin shortage followed an inspection that revealed quality issues at a manufacturing facility, which then led to the shutdown of production. This led to a surge in carboplatin demand, creating a secondary shortage. The shortages are causing oncologists across the US to ration platinum-based drugs, according to The Cancer Letter. To restore the supply of cisplatin, the FDA is ...
- Source: drugdu
- 126
- June 2, 2023
Cats can play a role in transmitting COVID-19, finds new study

Cats can play a role in the transmission of SARS-CoV-2 and their contaminated environment (pens in this study) can be infectious, according to new research. The study is published in Microbiology Spectrum. “In practice, after the introduction of SARS-CoV-2 in our household, we should see our cat as part of the family regarding virus transmission,” said study co-author Wim van der Poel DVM, Ph.D., Professor of Emerging and Zoonotic Viruses, Wageningen University and Research, in the Netherlands. Dr. van der Poel and colleagues conducted the study to gain better insight into the risk of COVID-19 infection that could arise from cats infected with SARS-CoV-2. In the study, 16 cats were either directly exposed to SARS-CoV-2 virus obtained from a naturally infected human patient, exposed indirectly from a directly exposed cat, or exposed from the pen in which an infected cat was housed. All cats were regularly sampled during the whole ...
- Source: drugdu
- 148
- June 1, 2023
More depressed patients than previously estimated could have increased activation of their immune system

New research from the Institute of Psychiatry, Psychology & Neuroscience (IoPPN) at King’s College London has used an assessment of gene expression involved in the immune response to show that there could be more patients with major depressive disorder (MDD) with activated immune systems than research has previously estimated. By identifying the molecular mechanisms involved in this association, the research could pave the way to better identify those patients with an immune component to their depression which would potentially help to provide more personalized approaches to treatment and management of MDD. The research, published in Translational Psychiatry builds on previous findings that there is an activated immune response in many people with MDD. However, most of the research in this area has focused on the levels of inflammation related proteins like C-reactive protein (CRP). Studies using CRP have found that about 21 to 27 % of people with depression have ...
- Source: drugdu
- 133
- June 1, 2023
Titan licenses robotic surgery intellectual property to Intuitive after failing to find buyer

Dive Brief Intuitive Surgical has paid $7.5 million for a nonexclusive license to most of Titan Medical’s intellectual property. The deal gives Intuitive access to patents related to the enhancement of robotic-assisted surgery, including ways to enter the body through a single access point. Titan licensed the patents after failing to find a company willing to buy its business. The failure of the search for a buyer led Titan to further reduce its headcount to lower its operating costs. Dive Insight Titan has been struggling for years. In 2019, cash constraints forced it to rethink its timeline for seeking 510(k) clearance for its single-port robotic surgical system. After further delays, the company started to look for strategic alternatives such as the sale of some or all of its business late last year. Titan contacted “over 55 potential counterparties,” it said in a statement. None of the parties expressed an interest ...
- Source: drugdu
- 125
- June 1, 2023
Cortisol levels in late pregnancy can predict sleep health of infants

Cortisol levels in late pregnancy can predict the sleep of infants, according to a new study to be presented at the SLEEP 2023 annual meeting. Results show that newborns with higher levels of cortisol in their hair samples took longer to fall asleep at 7 months of age. Neonatal hair cortisol is a measure of fetal cortisol in the last trimester of pregnancy. Melissa Nevarez-Brewster (lead co-author, graduate student, University of Denver) said, “Although increases in cortisol across pregnancy are normal and important for preparing the fetus for birth, our findings suggest that higher cortisol levels during late pregnancy could predict the infant having trouble falling asleep. We are excited to conduct future studies to better understand this link.” The researchers collected hair cortisol from 70 infants in the first days after birth; 57% of the infants were female. Parents then completed a sleep questionnaire when their child was 7 ...
- Source: drugdu
- 132
- June 1, 2023
Alnylam sticks with aggressive litigation strategy against Pfizer and Moderna, filing yet another patent lawsuit

Alnylam Pharmaceuticals isn’t letting up with its COVID-19 vaccine patent allegations. Late last week, the company filed its third set of lawsuits against the two largest manufacturers of coronavirus vaccines. Once again, RNA specialist Alnylam is accusing Pfizer and Moderna of violating its lipid particle delivery technology with their lucrative COVID-19 vaccines. Specifically, Alnylam claims that Pfizer stepped on four of its patents and that Moderna infringed three. With the lawsuits, it’s seeking a “reasonable royalty” for the alleged damages. The new suits come after Alnylam originally sued the two last March, arguing that it invented the delivery tech utilized by the vaccines more than a decade ago. Then, in July, the biotech followed up with new claims. Earlier this month, Moderna hit back against the claims in a set of countersuits, alleging that Alnylam “baselessly seeks to profit” from its inventions. Moderna pointed out that the company “based its ...
- Source: drugdu
- 126
- June 1, 2023
After price cuts, Eli Lilly inks $13.5M settlement in long-running insulin lawsuit

Eli Lilly has agreed to pay $13.5 million to end a six-year, class-action lawsuit that alleged the company overpriced its insulin. As part of the settlement, which was recorded (PDF) in a federal district court in New Jersey, Lilly has agreed to cap out-of-pocket costs for its insulin at $35 per month for four years. The deal comes three months after the company said it would slash price of the type 1 diabetes treatment to the same level to “make it easier to access Lilly insulin and help Americans who may have difficulty navigating a complex healthcare system.” Lilly’s initial move had come a month after President Joe Biden, in his State of the Union address, called on Congress to limit insulin costs for all patients to $35 per month. The Inflation Reduction Act already had limited insulin costs for patients on Medicare at $35 per month. The lawsuit was ...
- Source: drugdu
- 125
- June 1, 2023
UK life sciences sector to receive £650m in government funding

The UK government has announced a £650m funding package to support the continued growth of the life sciences sector. Unveiled by chancellor Jeremy Hunt, the ‘life sci for growth’ package includes £121m to speed up clinical trials and improve access to real-time data, as well as £48m to support scientific innovation in preparing for potential health emergencies. Another £154m has been committed to increase the capacity of the UK Biobank – the biomedical database containing the in-depth genetic information of half a million UK citizens. This funding will go towards a new facility at Manchester Science Park, a new hub to help small to medium sized enterprises (SMEs) collaborate with industry and academia, and better IT to accommodate multi-disciplinary data. A new call for proposals has also been released as part of the initiative that will offer £250m to incentivise pension schemes to invest in the UK’s science and technology ...
- Source: drugdu
- 121
- June 1, 2023
EMA recommends revoking marketing authorisation for Novartis’ sickle cell disease drug

The European Medicines Agency’s (EMA) human medicines committee has recommended revoking the conditional marketing authorisation for Novartis’ sickle cell disease (SCD) drug Adakveo (crizanlizumab). The recommendation follows a review by the Committee for Medicinal Products for Human Use (CHMP) that concluded the benefits of the drug, which is indicated for preventing painful crises in SCD patients aged 16 years and older, did not outweigh its risks. The CHMP’s review looked at results from the phase 3 STAND study, which compared the safety and efficacy of Adakveo with placebo. While the study did not raise new safety concerns, it showed a higher rate of severe and serious treatment-related side effects for Adakveo compared with placebo, the regulator said. The study also showed that Adakveo did not reduce the number of painful crises leading to a healthcare visit, with patients in the Adakveo group experiencing an average of 2.5 over the first ...
- Source: drugdu
- 109
- June 1, 2023
Study identifies new genes associated with heart attack risk largely affecting younger women

Research led by the National Institute for Health and Care Research (NIHR) Leicester Biomedical Research Centre (BRC) and Universite Paris Cite, and supported by worldwide partners in Canada, the USA and Australia, has identified new genes that are associated with an increased risk of a type of heart attack primarily affecting young to middle-aged women. The results are published in Nature Genetics today, 29 May 2023. SCAD – or Spontaneous Coronary Artery Dissection – is when a bruise or bleed occurs in the wall of a coronary artery, cutting off the blood to part of the heart. This leads to a heart attack. Unlike other types of heart attack, SCAD is most common in women under the age of 60 and is a leading cause of heart attacks around the time of pregnancy. Furthermore, people who have had a SCAD tend to be generally healthy and SCAD can sometimes happen ...
- Source: drugdu
- 110
- May 31, 2023

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