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Pharma Pharmaceutical Industries & Biological Products (PPI), a prominent Saudi enterprise, and Koanna International FZ LLC UAE (Koanna), a wholly-owned subsidiary of Shilpa Medicare, today announced a definitive agreement to form a new joint venture company based in the Kingdom of Saudi Arabia. Leveraging their respective strengths, PPI will contribute its local market expertise, while the Shilpa Group will provide global R&D, manufacturing, and regulatory capabilities. The new limited liability company will be majorityowned by PPI (70%), with Koanna holding a 30% stake. The venture represents a significant step in Saudi Arabia's healthcare infrastructure and aligns with the Kingdom's Vision 2030 goals of economic diversification and localizing strategic industries. The partnership will be executed in two key phases to ensure a swift market entry and a robust long-term manufacturing strategy: - Phase One: Shilpa Group will supply finished products in bulk for repackaging at the new JV company's state-of-the-art facility. This ensures a rapid market entry for key products. Concurrently, PPI will be responsible for establishing this fully-equipped manufacturing facility with technical input from Shilpa Group. - Phase Two: Shilpa Group will execute a full technology transfer of its manufacturing processes to the JV. This will empower the JV to commence local...

Regeneron Pharmaceuticals (REGN.O), opens new tab said on Tuesday its experimental therapy significantly improved daily activities such as talking and eating in patients suffering from a rare immune disorder, meeting the main goal of a late-stage study. The therapy, cemdisiran, was being tested in adults with generalized myasthenia gravis. The condition is caused by an abnormal immune reaction in which the body mistakenly attacks itself, weakening the skeletal muscles, especially those controlling the eyes, mouth, throat and limbs, leading to fatigue, difficulty swallowing and breathing. Keep up with the latest medical breakthroughs and healthcare trends with the Reuters Health Rounds newsletter. Sign up here. Designed as a monotherapy injection under the skin, cemdisiran works by inhibiting the activity of the C5 protein, which triggers the body's immune response. In the trial, patients receiving cemdisiran reduced C5 levels by 74% on average when adjusted for placebo, on a commonly used scale for measuring disease impact on daily activities after 24 weeks. When combined with Regeneron's approved drug, pozelimab, branded as Veopoz, the reduction was nearly 99%. Both treatments met the main goals of the study. Cemdisiran alone showed slightly better results on measures specific to the condition including improvements in daily activities, Regeneron said. There was no...

AbbVie (ABBV.N), opens new tab will buy an experimental depression drug from partner Gilgamesh Pharmaceuticals for up to $1.2 billion, the companies said on Monday, seeking to access a fast-growing market for psychedelic-based treatments. The deal is the latest in the more than $20 billion AbbVie has spent on acquisitions since 2023 for drugs that can drive growth as its flagship rheumatoid arthritis treatment, Humira, lost patent protection. Keep up with the latest medical breakthroughs and healthcare trends with the Reuters Health Rounds newsletter. Sign up here. The companies had signed a partnership last year to develop therapies for psychiatric disorders, with privately held Gilgamesh set to receive up to $1.95 billion in option fees and milestone payments. The deals with Gilgamesh, which is also developing treatments for anxiety and post-traumatic stress disorder, also launch AbbVie into the race to develop psychedelic compounds for psychiatric conditions - a potential $50 billion market, according to Cantor Fitzgerald analyst Josh Schimmer. Earlier this year, Johnson & Johnson's (JNJ.N), opens new tab ketamine-derived Spravato became the first psychedelic-based standalone treatment for patients with severe depression to be approved by the U.S. Food and Drug Administration. Compass Pathways (CMPS.O), opens new tab, Atai Life Sciences (9VC.DE), opens new tab,...

•Aficamten shows cardiac benefits over blood pressure drug metoprolol •Analysts see potential for aficamten to replace beta-blocker drugs for treating HCM •Cytokinetics plans to submit data to regulators for expanded use next year Cytokinetics' CYTK experimental drug improved symptoms such as shortness of breath and chest pain better than a standard-of-care treatment in patients with a type of heart condition, detailed late-stage study data on Sunday showed. The findings, presented at the European Society of Cardiology Congress in Madrid, Spain, augment the promising evidence shared in May for the effectiveness of the drug, aficamten, over current treatments. Detailed results of the 175-patient trial indicated aficamten had clear cardiac benefits over the blood pressure drug metoprolol in the head-to-head study, including reduced blockage and improved blood outflow from the heart. The U.S. health regulator is expected to decide by December on the drug for patients whether or not they received the current standard treatment. After 24 weeks, patients with obstructive hypertrophic cardiomyopathy, an inherited condition, given aficamten showed an average increase of 1.1 millilitre per kg/minute in peak oxygen uptake, a key measure of heart function, while those on metoprolol saw a decline. Over half of the aficamten patients showed an improvement in physical limitations, compared to 26%...

Eli Lilly (LLY.N), opens new tab has temporarily paused shipments of its weight-loss drug Mounjaro in the UK, ahead of a new price hike for the treatment set to come into effect starting next month. Lilly said that, in order to manage its supply and ensure that patients maintain access, it has allocations in place for pharmacies and providers that order medicines from the company. There are legal protections in place to prevent inappropriate stockpiling of medicines by providers, the company said on Wednesday. It will resume orders on September 1. The drugmaker is set to increase the UK list price of the drug by up to 170% in September amid a White House push to get drugmakers to raise medicine prices in Europe to allow for price cuts in the United States. The price for a month's supply of the highest dose of the medicine will increase from 122 pounds to 330 pounds ($164.81 to $445.80).

A single pill containing medication to lower cholesterol and blood pressure and stop clotting is more successful at preventing further cardiac events after a heart attack, according to research presented at the European Society of Cardiology Congress in Barcelona. The study found that the pill was more effective at preventing another heart attack or stroke when compared with taking the drugs separately. Benefits of a polypill People who have a heart attack are prescribed several drugs, which effectively reduce the risk of another cardiac event. However, some patients do not consistently take all their medications – so it has been proposed that one pill would make it easier for them to adhere to their treatment. A trial called SECURE enrolled around 2,500 patients within six months of having a heart attack, and then randomly allocated them with either a ‘polypill’ or usual care. The polypill contained aspirin, a cholesterol-reducing drug called atorvastatin, and ramipril, which lowers blood pressure. Patients who were assigned usual care took all three drugs separately. Researchers then followed up with the patients after three years. They found that the number of deaths from heart and circulatory conditions, along with the number of further heart attacks or stroke, was lower in the...

The European Commission has granted marketing authorization for Gilead Sciences' (GILD.O), opens new tab twice-yearly injection for preventing HIV infection, the company said on Tuesday. The drug, known scientifically as lenacapavir, will be sold in Europe under the brand name Yeytuo. It was approved in June by regulators in the U.S., where it is marketed as Yeztugo. The EC approval applies to use in the European Union’s 27 member states, as well as Norway, Iceland and Liechtenstein. Before the drug can be made available to patients, Gilead will need to establish pricing and reimbursement terms with health systems in each country. In the United States, Gilead's list price for Yeztugo is over $28,000 a year. Some U.S. insurers are holding off on covering the new injection, citing its high price compared to generic pills. Analysts project the drug will have sales of over $4 billion a year by 2029, according to LSEG. The European Commission approved the drug for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually-acquired HIV in adults and adolescents at increased risk of contracting the deadly virus. Lenacapavir proved nearly 100% effective at preventing HIV in large trials last year, raising new hope of interrupting transmission of the virus that infects...

BioXcel Therapeutics (BTAI.O), opens new tab said on Wednesday it plans to seek expanded approval early next year for use of its agitation drug at home after it succeeded in a late-stage study of patients with bipolar disorder or schizophrenia. The drug, BXCL501 or dexmedetomidine, was well-tolerated in the study comprising more than 200 patients who had agitation episodes despite receiving prior treatment. Keep up with the latest medical breakthroughs and healthcare trends with the Reuters Health Rounds newsletter. Sign up here. The orally dissolving film form of the drug is sold as Igalmi in the U.S. for treating schizophrenia or bipolar disorder-related agitation with medical supervision. Early intervention at home can prevent symptom escalation and reduce emergency room visits, CEO Vimal Mehta said. BioXcel is considering partnerships and royalty deals ahead of the drug's approval and launch, he said. Shares of the company fell 20%, but analysts said it was not tied to the trial data. The stock has more than doubled in value this month since BioXcel said it plans to report data from the study. "Today's decline merely reflects what we would call selling on the news," said Mizuho analyst Graig Suvannavejh, adding that the company was in a precarious financial situation with cash in...

 Eli Lilly (LLY.N), opens new tab said on Tuesday its experimental GLP-1 pill helped overweight adults with type 2 diabetes shed 10.5% of body weight in a late-stage trial, after recent data from another study of the drug in patients without diabetes sent company shares tumbling. Shares of the drugmaker rose nearly 4% to $722 in early trading. The once-daily pill also helped 75% of patients who received the highest dose of orforglipron lower their A1C level - a measure of blood sugar over time - to at or below 6.5%, Lilly said, which is below the American Diabetes Association's target of less than 7% for most adults. Analysts said the data was in line with expectations, clearing an overhang for orforglipron's U.S. marketing application and potential launch next year. The weight loss seen at the drug's highest dose is competitive in diabetic patients with obesity, compared with rival Novo Nordisk's (NOVOb.CO), opens new tab Wegovy, and "could lead to investors warming up to the oral story once again," Barclays analysts wrote in a client note. Orforglipron is a small-molecule pill that is easier to manufacture and package than wildly popular injectable drugs for obesity, such as Lilly's Zepbound and Novo's Wegovy, which are peptide mimics of the appetite-controlling GLP-1...

Bavarian Nordic, subject of a takeover offer valuing the vaccine maker at about 19 billion Danish crowns ($3 billion), reported a higher than expected revenue for the second quarter on Friday, citing a strong performance in both its travel health and public preparedness businesses. WHY IT MATTERS A consortium led by Nordic Capital and Permira said in July it would launch a bid priced at 233 crowns per Bavarian Nordic share, which the Danish group's board is recommending to its stakeholders. The vaccine maker's main shareholder, Danish pension fund ATP, has said it has no intention of accepting the offer. ATP holds a 10% stake in Bavarian according to LSEG data. KEY QUOTE "If there are other interested parties, they know where we are," CEO Paul Chaplin said in an interview. "We're not actively seeking additional offers, but it is now a public transaction." CONTEXT Bavarian Nordic is a key vaccine supplier to governments globally, including public health preparedness programmes in the United States, where Health Secretary Robert F. Kennedy Jr. has been making sweeping changes to vaccine policies. Chaplin had said in November that Bavarian was not concerned about the vaccine scepticism Donald Trump's presidency and Kennedy's appointment would bring into the U.S. health policies, a...