PharmaFocus Today – Page 350 – media

Otsuka, Lundbeck’s Rexulti nabs new use in Alzheimer’s disease agitation

After Lundbeck and Otsuka’s Rexulti cleared a key advisory committee hurdle, the FDA has given the drug the go-ahead to treat dementia-associated agitation in Alzheimer’s disease patients With the approval, Rexulti becomes the first drug approved for this use in the United States. The FDA granted the nod based on data from two 12-week studies in which patients showered statistically significant and clinically meaningful improvements on the Cohen-Mansfield Agitation Inventory scale, according to the FDA. The metric looks at the frequency and intensity of dementia-related agitation. In the studies, Rexulti demonstrated a 31% improvement from baseline agitation symptoms compared with placebo. Agitation symptoms cover a wide group of behaviors including pacing, gesturing, profanity, shouting, and physical outbursts, Otsuka said in a release. The symptoms are the leading causes of assisted living or nursing room placement and have been known to be associated with accelerated disease progression, Tiffany Farchione, director ...
- Source: drugdu
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- May 13, 2023
Sobi Emerges as Savior for CTI Biopharma Cash Crunch With $1.7B M&A Deal

CTI Biopharma has something many biotech companies aspire to achieve—revenue. Sales of its approved cancer drug are growing, but commercialization comes with costs as does development of the molecule for additional indications. CTI expects it will need to raise money, but the dismal financial conditions mean fundraising prospects for any biotech company could remain challenging for the foreseeable future. Enter Swedish Orphan Biovitrum (Sobi), the Stockholm-based rare diseases biopharmaceutical company. Sobi has agreed to acquire CTI in a cash deal that values the Seattle-based biotech at $1.7 billion. According to the terms of the deal, Sobi will pay $9.10 for each share of CTI, which represents an 89% premium to the stock’s price before the deal was announced Wednesday. The heart of the acquisition is Vonjo, a drug for myelofibrosis, a rare bone marrow cancer that impairs the production of red blood cells. Last year, the FDA granted accelerated approved ...
- Source: drugdu
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- May 13, 2023
Pfizer CEO says Medicare will likely face legal action over drug price negotiations

Pfizer CEO Albert Bourla on Thursday said pharmaceutical companies will likely take legal action against Medicare drug price negotiations, which aim to cut costs for older Americans, but will likely reduce company profits. “I think that there will be legal action, but I’m not sure if we’ll be able to stop anything before 2026 or not,” Bourla said during a live-streamed interview with Reuters. Bourla referred to a provision in the Biden administration’s Inflation Reduction Act that will allow the Medicare program to negotiate prices on the costliest prescription drugs each year. The first negotiations start in September and new prices will go into effect in 2026. He said the most “certain way” to stop negotiations would be to call on Congress to introduce legislation that will revise the federal government’s plan. But Bourla noted he is “not optimistic” about that happening. Democrats control the Senate and President Joe ...
- Source: drugdu
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- May 13, 2023
European Commission green lights Servier’s Tibsovo

Treatment concerns patients with IDH1-mutated acute myeloid leukaemia and IDH1-mutated cholangiocarcinoma Servier has revealed that the European Commission (EC) has approved Tibsovo – also known as ivosidenib tablets – as a therapy in two vital indications. The first is in combination with azacitidine for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) with an isocitrate dehydrogenase-1 (IDH1) R132 mutation. These individuals will not have been eligible to receive standard induction chemotherapy. The second is as a monotherapy among adult patients with locally advanced or metastatic cholangiocarcinoma in addition to a IDH1 R132 mutation who have previously undergone treatment using at least one prior line of systemic therapy. Tibsovo remains the only IDH1 inhibitor approved across Europe, while it has also received orphan medicine designation recognising the significant benefit brought to patients by the drug. Philippe Gonnard, executive vice president, global product strategy at Servier, explained: “IDH1 ...
- Source: drugdu
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- May 13, 2023
First US cases of treatment-resistant ringworm found in patients in New York City

By Jen Christensen, CNN Could zombie fungi take over humans? Dr. Gupta explains CNN — The US Centers for Disease Control and Prevention is reporting the first known cases of an antifungal-resistant ringworm in the United States and urging providers to be on the lookout for such infections. The details of the cases were reported to the CDC in February and shared in a report published Thursday. The patients – two unrelated women in New York City – first had symptoms in 2021 and 2022. One patient had no international travel history, suggesting that there is some community spread in the US. Despite the name, ringworm is not caused by a worm; rather, it is caused by one of 40 species of fungus. In this case, the infections were caused by Trichophyton indotineae, a recently discovered fungus. Cases were first concentrated in patients in South Asia, but they’ve now also ...
- Source: drugdu
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- May 13, 2023
Experiment shows thoughts influence tactile perception

If we sincerely believe that our index finger is five times bigger than it really is, our sense of touch improves. Researchers at Ruhr University Bochum demonstrated that this is the case in an experiment in which the participants were put under professional hypnosis. When the participants signaled that they understood the opposite hypnotic suggestion that their index finger was five times smaller than it actually was, their sense of touch deteriorated accordingly. The study shows that our tactile perception is affected and can be altered by our mental processes. The scientific community has been divided on this issue. Headed by PD Dr. Hubert Dinse, Professor Albert Newen and Professor Martin Tegenthoff, the researchers published their findings in the journal Scientific Reports on April 21, 2023. Two needles feel like one The researchers measured the tactile perception of their 24 test participants using the two-point discrimination method. This involves the ...
- Source: drugdu
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- May 13, 2023
Mirati’s KRAS drug beats estimates in Q1, but Keytruda combo plan remains unclear

Just as Amgen’s KRAS contender Lumakras suffered a sequential sales decline, Mirati Therapeutics’ rival drug Krazati has surprised analysts in its first full quarter on the market. But investors remain more interested in Mirati’s plan for newly diagnosed lung cancer patients. After an FDA approval in KRAS-mutated non-small cell lung cancer (NSCLC) in December, Krazati generated $6.3 million in the first three months of 2023, coming in ahead of Wall Street’s expectation of $3.4 million. Krazati delivered that beat just as Lumakras’ sales in the U.S. slumped by $14 million, or 23% lower than its haul in the fourth quarter of 2022. In a sign of early interest in the therapy, Krazati has captured a third of new patient starts, Mirati’s chief commercial officer Ben Hickey told investors during a call Tuesday. Among the top 50 doctors that Mirati is targeting with its awareness efforts, 80% have prescribed Krazati, he ...
- Source: drugdu
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- May 13, 2023
Cancer drugs among top 5 most affected by shortages in the US

By Deidre McPhillips, CNN CNN — As the US faces a near-record number of drug shortages, cancer treatments are among the hardest hit. There is an active shortage of about two dozen chemotherapy drugs, the fifth most of any drug category, according to data from the end of March from the University of Utah Drug Information Service. “The fact that we have this many chemo drugs in shortage is really concerning,” said Michael Ganio, senior director of pharmacy practice and quality at the American Society of Health-System Pharmacists. Unlike some other drugs that also rank among the top five categories for shortages, such as antimicrobials, there aren’t often alternatives for chemotherapy drugs, he said. And the shortages are affecting treatment for a broad range of cancers. “One of the key predictors of how well a patient will respond to treatment is getting a full dose on the right schedule,” Ganio said. “So when ...
- Source: drugdu
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- May 13, 2023
Capsule captures first look inside digestion in healthy people

Using a specially designed capsule, researchers can now voyage through the digestive system, collecting new data about digestion and microorganisms. The work by a team including researchers at the University of California, Davis, Stanford University and Envivo Bio Inc., is published May 10 in papers in Nature and Nature Metabolism. Most of the process of digestion takes place in our small intestine, where enzymes break down food so it can be absorbed through the gut wall. “The small intestine has so far only been accessible in sedated people who have fasted, and that’s not very helpful,” said Professor Oliver Fiehn, director of the West Coast Metabolomics Center at UC Davis. Metabolomics is the study of the metabolome, the small molecules involved in metabolism in cells, tissues and organs. Fiehn is senior author on the Nature Metabolism paper and co-corresponding author on the Nature paper. Jacob Folz, a postdoctoral researcher at UC Davis, is first author on the Nature ...
- Source: drugdu
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- May 12, 2023
Experts call for monitoring of respiratory vaccine after trials suggest possible increase in preterm births

Experts have called for further scrutiny of a new Pfizer vaccine given during pregnancy to prevent respiratory infection in infants, after trials of a similar GSK vaccine were stopped after a rise in preterm birth and infant deaths. Pfizer says its vaccine is safe and effective, but experts contacted as part of an investigation published by The BMJ today, say Pfizer’s trial data should be reviewed in light of the signal for preterm births seen in GSK’s trial. Pfizer’s maternal RSV vaccine aims to protect infants from severe illness caused by the respiratory syncytial virus (RSV). RSV is very common but can be fatal, especially in young children. In 2019, an estimated 3.6% of all deaths worldwide in children aged 1–6 months were due to RSV, with 97% of these deaths occurring in low and middle income countries. The vaccine has not yet been approved for use, but a decision by the U.S. Food and Drug Administration is ...
- Source: drugdu
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- May 12, 2023

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