sitefansalaran Industry News

South Africa's Aspen Pharmacare (APNJ.J), opens new tab said on Monday it had secured regulatory approval to market Eli Lilly's (LLY.N), opens new tab blockbuster diabetes and obesity drug, Mounjaro, for chronic weight management in the country. The greenlight follows Aspen's earlier approval and launch of the drug, chemically called tirzepatide, in South Africa last December as a treatment for Type 2 diabetes. Aspen, a sales agent for Lilly, will launch Mounjaro for weight management in South Africa as an easy-to-use KwikPen injector device. The company has been betting on Mounjaro's imminent launch to compete against Novo Nordisk's (NOVOb.CO), opens new tab rival product, Wegovy, which the Danish drugmaker had debuted in South Africa in August, eight months after Eli Lilly. The approval by the South African Health Products Regulatory Authority positions Aspen to tap into the booming weight-loss drug market, which is estimated to reach at least $100 billion by the end of the decade, as global demand for obesity treatments continues to soar.

Roche Diagnostics (ROG.S), opens new tab said on Monday the U.S. Food and Drug Administration cleared its and partner Eli Lilly's (LLY.N), opens new tab blood test as an aid in the initial assessment for Alzheimer's disease. This comes at the heel of FDA's nod for Fujirebio Diagnostics' blood test Lumipulse in May, the first such device to get approval to diagnose the brain-wasting condition. Roche's test Elecsys measures pTau181, a key protein associated with Alzheimer's disease. It is intended for patients ages 55 and older presenting signs, symptoms or complaints of cognitive decline. Blood tests could speed up diagnosis of the disease and make it easier to access treatments such as Biogen (BIIB.O), opens new tab and Eisai's (4523.T), opens new tab Leqembi and Eli Lilly's Kisunla, since traditional tests are often costly or uncomfortable. Other options to detect Alzheimer's include procedures such as a spinal tap, which requires an invasive puncture to collect spinal fluid, or an expensive PET brain scan that may not be reimbursed by health insurers. Analysts have said blood-based diagnostics could be positive for Alzheimer's drugs that have been facing slow starts due to concerns over cost, efficacy and side effects. In July, Biogen said improved rates of blood tests to diagnose the memory-robbing condition have helped with the uptake...

Johnson & Johnson is in discussions to buy Protagonist Therapeutics, a source familiar with the matter told Reuters. Shares of Protagonist surged more than 30% in afternoon trading. The company had a market capitalization of $4.2 billion as of Thursday's close. The two companies are working on the development of an oral treatment, icotrokinra, for immune diseases, including plaque psoriasis and ulcerative colitis, with J&J holding the exclusive rights to commercialize the product. Protagonist declined to comment, and J&J did not immediately respond to Reuters' requests for comment. The Wall Street Journal reported the matter earlier in the day.

-Novo Nordisk (NVO) said on Thursday it would buy U.S.-based Akero Therapeutics (AKRO) for up to $5.2 billion to add its promising experimental liver disease drug, in the first major deal by the Danish drugmaker's new CEO to boost growth. Shares of Akero jumped more than 18% in premarket trading, while Novo's Denmark-listed shares were down nearly 2%. The deal underscores new Novo Nordisk CEO Mike Doustdar's efforts to revive sales growth and fend off intense competition from U.S. rival Eli Lilly. Doustdar, who took over the reins in July, last month also announced the company would cut 9,000 jobs. Akero is testing its drug, efruxifermin, in a late-stage trial of patients with severe liver scarring, or cirrhosis, due to a type of fatty liver disease known as metabolic dysfunction-associated steatohepatitis (MASH). Efruxifermin could be a potential breakthrough in treatment of fatty liver disease and become a "cornerstone" treatment either on its own or in combination with Wegovy, Doustdar said in a statement on Thursday. Under the deal, Novo would pay Akero shareholders $54 per share upfront in cash, which represents a premium of about 16.2% to Akero's last close of $46.49 on Wednesday. The Danish drugmaker will also pay an additional $6 per share...

-Novo Nordisk has cut its cell therapy division, where it was trying to find a cure for type 1 diabetes, Bloomberg News reported on Friday. It also cited Danish newspaper Borsen, which reported that the company would lay off nearly all of the unit's 250 employees. Novo was testing its cell therapy to generate insulin-producing beta cells for patients with type 1 diabetes in a preclinical study, along with another cell therapy candidate for Parkinson's disease in early-stage trials. The latest move is part of CEO Mike Doustdar's plan to reduce headcount by 11% and reallocate resources to high-priority research areas, the Bloomberg report said. Novo did not immediately respond to a Reuters request for comment. The Danish drugmaker is seeking partners to continue developing its innovations, according to the report. It has laid off dozens of employees at the largest U.S. manufacturing site for its blockbuster obesity and diabetes drugs, Reuters reported earlier this week, citing a review of LinkedIn posts. Novo said on Thursday it would buy U.S.-based Akero Therapeutics for up to $5.2 billion to gain access to a promising liver disease drug candidate in the first major deal by the Danish drugmaker's new CEO to spur growth. Earlier this month, it called off...

A new mRNA vaccine developed in Japan has been shown to suppress abnormal blood vessel growth in the retina of mice, offering hope for patients with age-related macular degeneration (AMD). Current treatments require repeated injections directly into the eye, but this vaccine can be delivered intramuscularly, making it less invasive and easier to administer. By targeting LRG1, a protein linked to abnormal angiogenesis, the vaccine triggered strong antibody responses that reduced retinal damage by up to 85% in mouse models. If successful in humans, this approach could transform AMD treatment and significantly reduce the burden of eye injections. Key Facts • Mechanism: The vaccine blocks LRG1, a protein promoting abnormal blood vessel growth. • Effectiveness: Reduced retinal leakage by 85% and lesion size by 82% in mouse models. • Advantage: Works as well as anti-VEGF therapy but requires only a simple arm injection. Source: Institute of Science Tokyo An mRNA vaccine developed by researchers from Japan suppressed abnormal blood vessel growth or neovascularization in the retina of mouse models. Neovascularization is a condition that is caused by age-related macular degeneration (AMD), a leading cause of vision loss for elderly people. The vaccine can be delivered intramuscularly and is as effective as current therapies that require frequent eye injections,...

Peter Marks, the former top vaccine regulator who was ousted from the U.S. Food and Drug Administration earlier this year, has joined Eli Lilly (LLY.N), opens new tab, the drugmaker told Reuters on Tuesday. Marks will oversee molecule discovery and infectious diseases at Lilly, starting this month. "Peter's expertise strengthens our abilities across multiple areas, both in our existing portfolio and in our work in emerging areas," the company said. Lilly added it continually evaluates breakthrough science which could benefit patients. Marks, who played a key role in U.S. President Donald Trump's first term in developing COVID-19 vaccines, resigned in March after being forced out by U.S. Health Secretary Robert F. Kennedy Jr. Shares of U.S. drugmakers fell, when reports on Marks' ouster from the FDA first came out in late March. As director of the FDA's Center for Biologics Evaluation and Research, Marks had publicly supported programs that expedited the development of rare disease treatments and gene therapies during his tenure. "We believe that Dr. Marks can bring significant value to Lilly given his tremendous experience and background," said Leerink Partners analyst David Risinger. Marks' move follows similar transitions by other senior FDA officials such as former head of the FDA's drug evaluation unit, Patrizia...

A new clinical case study, presented today by Qure.ai and Hacettepe University, Turkey, at the IASLC World Conference on Lung Cancer 2025 in Barcelona, shows that Artificial Intelligence (AI) can detect potentially malignant pulmonary nodules on routine chest X-rays (CXRs), even when the imaging was ordered for unrelated, non-respiratory conditions. This adds to the growing body of evidence that AI can act as a disruptor in early lung cancer detection strategies. It can provide an early warning system in countries without formal lung cancer screening programs or complement CT-based screening programs by going beyond smoker/ex-smoker cohorts. By expanding and improving the number of early-detected lung cancer patients, survival rates will increase through early surgical or pharmaceutical interventions. “By finding high-risk nodules earlier and diagnose lung cancer at early stages, AI not only improves, but also accelerates diagnosis and treatment,” said Dr. Deniz Koksal at Hacettepe University in Ankara, Turkey. “This enables early surgical interventions while reducing the need for more expensive treatments such as targeted therapies and immunotherapies.” The case series, ‘Chest X-Ray Analysis with Artificial Intelligence Software Aids in the Early Diagnosis of Lung Cancer’, conducted at Hacettepe University in Ankara, Turkey, utilised data from the CREATE study—a coordinated, five-country research initiative....

AstraZeneca said on Tuesday its experimental drug baxdrostat significantly lowered blood pressure during a 24-hour window of monitoring in a late-stage trial of patients with treatment-resistant hypertension. The company said the drug met the main goal of the study when compared to placebo at the end of 12 weeks. Patients in the trial had received 2 milligrams of baxdrostat or placebo on top of standard care. AstraZeneca has previously said that it expects to file for regulatory approval of the drug before the end of the year. Baxdrostat is currently being investigated for four indications, including chronic kidney disease and prevention of heart failure.

LONDON/COPENHAGEN (Reuters) -Wegovy-maker Novo Nordisk has laid off dozens of employees at the largest U.S. manufacturing site for its blockbuster obesity and diabetes drugs, a Reuters review of LinkedIn posts showed, a signal of where it is making cuts in a major restructuring under new CEO Mike Doustdar. The previously unreported cuts included staff in manufacturing roles, from quality control to production line technicians, at Novo's major Clayton, North Carolina, plant and other facilities in the state, an analysis of 73 posts and profiles show. The layoffs, while only a small part of a planned 9,000 job cuts globally, underscore how Novo is cutting back even on frontline production in the top market for Wegovy as it looks to sharpen its focus, trim costs, and claw back lost ground in fierce competition with rival Eli Lilly. The cuts, which follow earlier ones focused on the obesity education team in the U.S., come as the administration of President Donald Trump pressures pharmaceutical companies to expand U.S. drug production and create more domestic jobs. The Danish drugmaker last year became Europe's most valuable listed company on unprecedented demand for weight-loss drugs before a sharp share price slide as sales growth slowed. It is now trying...