PharmaFocus Today – Page 375 – media

In $2.6B cell and gene therapy expansion, Sartorius buys viral vector specialist Polyplus

[Before the Sartorius buyout, Polyplus had itself been expanding through multiple acquisitions. (Sartorius)] As the biopharma industry struggles with a dire shortage of viral vectors to make cell and gene therapies, contract manufacturers are busy beefing up their capabilities. In the latest example of biopharma’s ongoing investment in cell and gene therapy production, Sartorius has agreed to acquire French company Polyplus for 2.4 billion euros ($2.6 billion), the German CDMO said Friday. The deal gives Sartorius additional know-how in nucleic acid delivery, including transfection reagents and plasmid DNA design, all of which are key elements in the production of viral vectors for building cell and gene therapies. Formed in 2001, Polyplus employs about 270 people in several locations in France, Belgium, the U.S. and China. Before the Sartorius buyout, Polyplus had itself been expanding through M&A deals. In 2021, Polyplus bought Asia-Pacific-focused reagent supplier Biowire. ...
- Source: drugdu
- 268
- April 4, 2023
Nightmares and Dementia

Bad dreams are common and rarely are a sign of significant health concerns. However, several new studies have found potentially troubling associations between frequent or persistent nightmares and future cognition. These findings, along with recent insights into a potential intervention, have resulted in the top trending clinical topic this week. Previous investigations have found a link between sleep problems in adulthood, including nightmares, and the onset of neurodegenerative diseases. A recent analysis determined a possible association between distressing dreams during childhood and cognitive health concerns (see Infographic). A prospective, longitudinal analysis used data that included all people born in Britain during a single week in 1958. At age 7 years (in 1965) and 11 years (in 1969), mothers were asked to report whether their child experienced “bad dreams or night terrors” in the past 3 months. Among 6991 children (51% girls), 78.2% never had bad dreams, 17.9% had transient bad ...
- Source: drugdu
- 128
- April 4, 2023
Cancer drug leaflets for patients in Europe omit important facts

Cancer drug information leaflets for patients in Europe frequently omit important facts, while some are “potentially misleading” when it comes to treatment benefits and related uncertainties, researchers have found. Cancer is the biggest killer in Europe after heart conditions, with more than 3.7m new cases and 1.9m deaths every year, according to the World Health Organization. Medicines are a vital weapon against the disease. But critical facts about them are often missing from official sources of information provided to patients, clinicians and the public, according to a study led by researchers from King’s College London, Harvard Medical School and the University of Sydney, among others. “Regulated information sources for anticancer drugs in Europe fail to address the information needs of patients,” the study’s authors wrote in The BMJ journal. “If patients lack access to such information, clinical decisions may not align with their preferences and needs.” To receive and participate in medical care, patients ...
- Source: drugdu
- 197
- April 3, 2023
Frozen Strawberries Recalled As Hepatitis A Outbreak Has Left 2 Hospitalized

This news isn’t “berry” good if you like strawberries. A hepatitis A outbreak has resulted in at least five people infected and two people hospitalized, according to the Centers for Disease Control and Prevention (CDC). This, in turn, has left those selling certain brands of frozen organic strawberries in a bit of a jam. The U.S. Food and Drug Administration (FDA) has indicated that the likely culprits behind this outbreak are soft, juicy, and red. We’re talking about strawberries—not all strawberries, but those specifically imported in 2022 by a supplier from particular farms located in Baja California, Mexico. That’s led to two companies that used these strawberries in their frozen products and one retailer to issue voluntary recalls. One of these companies is California Splendor, Inc., based in San Diego, California. They’ve recalled certain lots of their Kirkland Signature 4-lb. bag Frozen Organic Whole Strawberries that have been sold in Costco stores in Los Angeles ...
- Source: drugdu
- 128
- April 3, 2023
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
- 333
- 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
- 159
- 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
- 139
- 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
- 188
- 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
- 149
- 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
- 384
- March 30, 2023

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