PharmaFocus Today – Page 433 – media

Action To Reform Drug Pricing Increasingly Likely

The pressure on pharmacy benefit managers (PBMs) is ramping up. Both Congress and the Federal Trade Commission (FTC) are probing alleged anti-competitive practices by PBMs, and they’re doing so in parallel. Given the intense bipartisan pressure on PBMs, it’s increasingly likely that action of some kind will be taken to reform the drug pricing system. Last month, in a bipartisan vote of 18-9, the Senate Committee on Commerce, Science and Transportation advanced a bill, the Pharmacy Benefit Manager Transparency Act, to increase PBM transparency and crack down on what legislators and many policymakers are calling “deceptive practices.” Specifically, the bill stipulates what it deems are “unlawful activities” for PBMs to engage in. These include spread pricing – charging payers more than PBMs pay the pharmacy for a medication and then keeping the “spread” or difference as profit – and clawing back reimbursement payments from pharmacies. Regarding claw backs, PBMs assess direct and ...
- Source: drugdu
- 379
- April 3, 2023
After drug rejection, Vanda scores courtroom win over FDA in records case

Vanda Pharmaceuticals has scored a legal win in its long-running dispute with the FDA surrounding the agency’s 2018 rejection of Hetlioz in jet lag disorder. After months of litigation and years of back-and-forth, a court ruled that the FDA must turn over records relating to its denial of the label expansion, Vanda said in a Wednesday release (PDF). After the drug rejection in 2018, the company disputed the decision and last July requested an FDA hearing. The FDA “privately” agreed to the hearing but never published a notice in the Federal Register, meaning the process couldn’t move forward, Vanda said in its September lawsuit. Aside from its lawsuit, the company has been seeking records through a Freedom of Information Act request. In the suit, Vanda argued that the agency failed to act on its application and on its hearing request within timelines stipulated by the law. When Vanda filed the ...
- Source: drugdu
- 196
- March 31, 2023
mRNA vaccine beats infection for key defense against COVID-19, Stanford Medicine scientists find

Stanford Medicine researchers have shown that prior SARS-CoV-2 infection reduces killer T cells’ response to vaccination. These cells are crucial for eliminating the virus from the body. March 28, 2023 – By Bruce Goldman T cells are more difficult to measure than antibodies, but they play a crucial role in fighting pathogens.Kateryna Kon/Shutterstock.com The Pfizer/BioNTech mRNA vaccine directed at COVID-19 is much better than natural infection at revving up key immune cells called killer T cells to fight future infection by SARS-CoV-2, the virus that causes COVID-19, Stanford Medicine investigators have found. The scientists also showed, in a study published online in Immunity, that getting infected by SARS-CoV-2 before getting vaccinated lowers the vaccine’s otherwise exceptional ability to spur proliferation and activation of killer T cells directed at SARS-CoV-2. Their finding suggests that those hoping to avoid the manifold health risks associated with COVID-19 would do well to get vaccinated before they contract ...
- Source: drugdu
- 181
- March 31, 2023
UK monkeypox vaccine rollout to wind down

The UK Health Security Agency (UKHSA) has announced its vaccination programme against mpox will end this summer. Cases of the disease have fallen from a peak of 350 per week in July to just six new cases so far in 2023, three of which were caught overseas. First doses of the vaccine will remain available to those at highest risk until 16 June, with second doses available until the end of July. The UKHSA says it will monitor cases and restart the programme if needed. While the mpox, formerly known as monkeypox, virus can infect anyone, most UK cases were among men who have sex with men. Anyone eligible who has not yet received a vaccine is being encouraged to book an appointment to protect themselves before summer. Greg Owen, from sexual health and Human Immunodeficiency Virus (HIV) charity the Terrence Higgins Trust, said: ...
- Source: drugdu
- 230
- March 30, 2023
Is Parkinson’s disease, ‘world’s fastest growing brain disease,’ mostly preventable?

Researchers warn that a colorless chemical known as trichloroethylene (TCE) — which has been used to dry-clean clothes, degrease metals and decaffeinate coffee — may be linked to the dramatic increase in Parkinson’s disease (PD) cases. They recently published a series of seven cases in the Journal of Parkinson’s disease that illustrate TCE’s harmful health effects and the potential PD association. “TCE is associated with a 500% increased risk of Parkinson’s disease,” lead author Dr. Ray Dorsey, professor of neurology at the University of Rochester in New York and author of “Ending Parkinson’s Disease,” told Fox News Digital. The chemical reproduces the features of the neurological disease in laboratory animals. It impairs the function of the energy-producing parts of cells called mitochondria, which are known to be damaged in Parkinson’s disease, Dorsey added. Widespread applications of TCE TCE was first synthesized in the lab in ...
- Source: drugdu
- 182
- March 30, 2023
‘Overwhelming’ support for regulation of vape imports amid ‘health emergency’, TGA reports

An “overwhelming” number of health experts and authorities support tightening border controls around nicotine vaping products, with many wanting an import ban on non-nicotine vaping products as well, Australia’s drugs regulator has told the government. On Thursday afternoon, the Therapeutic Goods Administration (TGA) published the almost 4,000 public submissions made in response to the government’s proposed vaping reforms, aimed at tackling rising youth vaping rates and a burgeoning black market. “All state and territory governments supported tightening border controls for nicotine vaping products, with most also supporting closing the personal importation scheme and requiring import permits,” the TGA summary said. Health professional bodies, public health associations, individual health professionals and university researchers “overwhelmingly supported tightening border controls,” the TGA said. “Many public health experts and bodies submitted that border controls should be also be placed on non-nicotine vaping products.” The importation of all vaping products should be banned “as soon ...
- Source: drugdu
- 429
- March 30, 2023
Vaccination, Paxlovid decrease risk of long Covid, studies show

People who are vaccinated or who take Paxlovid during a Covid-19 infection have a lower risk of developing long Covid, new research shows. The US Centers for Disease Control and Prevention defines long Covid as new, returning or ongoing health issues more than four weeks after an initial infection. According to the CDC, 1 in 5 Covid-19 survivors ages 18 to 64 and 1 in 4 survivors 65 or older have an ongoing health issue that might be attributable to Covid-19 infection。 A study published Thursday in JAMA Internal Medicine analyzed data from 41 studies, including more 860,000 people around the world. Of the four studies with vaccination information of nearly 250,000 people, those who had been vaccinated against Covid-19 had almost half the risk of long Covid than people who weren’t vaccinated. “These findings are important because they enable us to better understand who may develop ...
- Source: drugdu
- 162
- March 30, 2023
Royal Papworth Hospital robot for thoracic surgery to be UK first

A cutting-edge surgical robot is to be installed at the Royal Papworth Hospital in Cambridge. The Versius technology mimics human arm joints but has up to four times more rotation than the human wrist. It will be used in thoracic surgery, which includes heart and lungs, in a first for the UK. The device should make the surgery less invasive, improve outcomes and speed up patients’ recovery times, the hospital said. Staff at the hospital are to undergo a full training programme, with the first treatment due to start this spring. The technology is a partnership between the Royal Papworth and Cambridge-based company CMR Surgical. The robot is smaller than previous examples and is portable so it can be used in different theatres and for different specialities, which could include transplantation. “Our vision is to provide tomorrow’s treatment to today’s patients,” said Tim ...
- Source: drugdu
- 162
- March 30, 2023
International trade of colistin in animal feed continues unabated

In a recent study published in the journal The Lancet’s Microbe, researchers investigate Enterobacterales species resistance to colistin in Pakistan. Moreover, the researchers report on colistin import and export, use, and socioeconomic variables associated with colistin resistance. Background Studies have reported that colistin use in farming in China has driven Mcr-1-mediated resistance in Escherichia coli (MCRPEC), particularly in animal feed and prophylaxis. As a result, a ban on the agricultural use of colistin was enforced in April 2017, which reduced the prevalence of MCRPEC. However, colistin is used widely in food-producing animals in other nations for growth, prophylaxis, and treatment of colibacillosis. The spread of plasmid-mediated colistin resistance in Enterobacterales in the environment, among humans and food-producing animals has raised population health concerns. Even though colistin resistance decreased in China following its ban, colistin manufacture and export as pharmaceutical raw materials (PRMs) or feed additives continues. About the ...
- Source: drugdu
- 158
- March 30, 2023
prioritizing efficacy when considering quality of life

It is an exciting yet challenging time to be a treating physician in oncology, particularly in kidney cancer. The last decade of scientific innovation has brought an unprecedented shift in treatment options, and people now live longer than before with kidney cancer. Despite this, kidney cancers are the tenth most common cancer globally, with renal cell carcinoma (RCC) the most common type of kidney cancer, making up about 85% of diagnoses. There is no known cure for people living with advanced RCC, and the 5-year survival rate is around 12%, demonstrating the importance of continuing to find new innovative treatments. The introduction of next-generation tyrosine kinase inhibitors, immunotherapy-based agents, and, more recently, combination therapies have transformed the clinical outcomes of people living with RCC. However, with innovation comes more choice and increasingly complex therapeutic decision-making – often raising questions around the optimal sequence of treatments, particularly in more advanced ...
- Source: drugdu
- 318
- March 30, 2023

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