PharmaFocus Today – Page 316 – media

Bavarian Nordic Drops Out of RSV Vaccine Race with Phase III Flop

Pictured: Respiratory syncytial virus vial and syringe/iStock, Manjurul Bavarian Nordic’s portfolio has taken a hit as the company announced Saturday its respiratory syncytial virus vaccine candidate did not meet all primary endpoints in a Phase III study in older adults. While the vaccine candidate showed 59% efficacy in preventing at least two pre-defined lower respiratory tract disease (LRTD) symptoms from RSV, that number dropped to below the co-primary endpoint for severe LRTD in patients 60 and older. With the miss, Bavarian Nordic is discontinuing its RSV program. The decision also terminates its partnership with Nuance Pharma and chance for the coupled milestone payments of 195 million Danish kroner for developing and launching in select Asian markets. Bavarian Nordic CEO Paul Chaplin said in the release that the outcome was “unexpected” and will impact short-term growth expectations. However, the company said there is no impact on the financial guidance ...
- Source: drugdu
- 123
- July 26, 2023
Bavarian Nordic Falls by RSV Vaccine Wayside After Phase III Failure

The respiratory syncytial virus (RSV) vaccine arena lost a competitor on Saturday 21 July after Danish company Bavarian Nordic shelved its programme following missed endpoints in a Phase III trial. The candidate, named MVA-BN RSV, failed to meet the co-primary endpoint of severe lower respiratory tract disease (LRTD) based on at least three pre-defined symptoms, only demonstrating a 42.9% efficacy. The vaccine did, however, have a 59% efficacy in preventing at least two pre-defined LRTD symptoms. The randomised, double-blind Phase III trial (NCT05238025) involved 20,000 older adults across centres in the US and Germany. As a result of the programme termination, Bavarian Nordic has also ended its partnership with Nuance Pharma, a Chinese pharma company brought in to develop and launch the vaccine for Asian markets. Although Bavarian Nordic’s president and CEO Paul Chaplin said in a statement that the blow would impact short-term growth, ...
- Source: drugdu
- 121
- July 26, 2023
Johnson & Johnson to Reduce Its Kenvue Stake by at Least 80% Through Exchange Offer

Johnson & Johnson on Monday said it plans to reduce by at least 80% its stake in Kenvue, the consumer health business it spun out as an independent company earlier this year, via a stock exchange offer. J&J owns 89.6% of Kenvue’s common stock, which amounts to more than 1.72 billion shares. The exchange offer, also known as a split-off, will allow J&J shareholders to swap all or a portion of their shares for Kenvue’s common stock at a 7% discount. The offer is expected to be tax-free, J&J said in a release. The company noted that the split-off is voluntary for investors and is slated to close on Aug. 18, which is far earlier than expected. J&J said it received a waiver that dismisses the share lockup period associated with Kenvue’s initial public offering in May. That lockup agreement would have required J&J to ...
- Source: drugdu
- 134
- July 26, 2023
Roche Partners with Alnylam on Hypertension Therapy in Deal Worth up to $2.8bn

Roche has entered into a new partnership with Alnylam Pharmaceuticals to develop and commercialise a potential treatment for high blood pressure, with the deal worth up to $2.8bn. The candidate, zilebesiran, is an investigational, subcutaneously administered RNAi therapeutic currently in phase 2 development to treat hypertension in populations with high-unmet needs. Under the terms of the agreement, which provides Roche with exclusive commercialisation rights to the therapy outside of the US and joint commercialisation rights within the country, Alnylam will receive an upfront payment of $310m and is also eligible to receive certain milestone payments. Hypertension, the leading cause of cardiovascular disease, affects more than 1.2 billion adults worldwide. While several therapies exist, a significant unmet need remains, especially for high-risk patients. Zilebesiran works by preventing the production of angiotensinogen, a protein that plays a key role in raising blood pressure, in the liver. ...
- Source: drugdu
- 244
- July 26, 2023
Sandoz Granted Positive CHMP Opinion for Multiple Sclerosis Biosimilar

Sandoz, a Novartis division, has announced that its multiple sclerosis (MS) biosimilar has been recommended by the European Medicines Agency’s (EMA) human medicines committee as a single disease-modifying therapy in adults with highly active relapsing-remitting forms of the disease. The “first-of-a-kind” biosimilar natalizumab, developed by Polpharma Biologics, is a version of Tysabri (natalizumab). Biosimilars, according to the EMA, are biological products that are highly similar to a medicine already approved in the EU. The drugs have no clinically significant differences in terms of safety or effectiveness from the reference product, but they could potentially lower healthcare costs. Pierre Bourdage, chief commercial officer, Sandoz, said: “Access to affordable, high-quality treatments like disease-modifying therapies – which are a cornerstone in the treatment of MS – remains limited for many people living with this disease.” Over 2.8 million people worldwide are affected by MS, a disabling and unpredictable ...
- Source: drugdu
- 130
- July 26, 2023
Quality of Snacking Matters More Than Quantity or Frequency, Study Shows

Snacking is becoming increasingly popular, with more than 70% of people reporting they snack at least twice a day. In a new study involving more than 1,000 people, researchers examined whether snacking affects health and if the quality of snack foods matters. Kate Bermingham (PhD, postdoctoral fellow, King’s College London) said, “Our study showed that the quality of snacking is more important than the quantity or frequency of snacking, thus choosing high quality snacks over highly processed snacks is likely beneficial. Timing is also important, with late night snacking being unfavorable for health.” Bermingham will present the findings at NUTRITION 2023, the annual flagship meeting of the American Society for Nutrition held July 22-25 in Boston. The work is part of the ZOE PREDICT project, a group of large in-depth nutritional research studies designed to uncover how and why people respond differently to the same foods. ...
- Source: drugdu
- 120
- July 26, 2023
Daily Prune Consumption Has Promising Effects on Biomarkers Related to Cardiovascular Health

A pair of new studies presented as abstracts today at the American Society of Nutrition (ASN) annual meeting report that daily prune consumption has promising effects on several biomarkers related to cardiovascular health. Conducted in postmenopausal women and men 55 years and older, the studies reveal: In men, long-term prune consumption improved HDL cholesterol and the total cholesterol to HDL ratio, while decreasing oxidative stress and the inflammatory biomarker C-reactive protein (CRP). In older women, long-term prune consumption had no negative effect on various metabolic measures related to heart disease risk including total cholesterol, total triglycerides, fasting glucose, and insulin levels. The results of both studies were presented at the ASN annual flagship meeting in Boston, MA. The ASN convenes researchers, practitioners, global and public health professionals, policymakers and advocacy leaders, industry, media, and other related professionals to advance nutrition science and its practical application. “Currently, there ...
- Source: drugdu
- 251
- July 26, 2023
Study Links Associative Learning in the Cerebellum to Movement Control in Mice

The cerebellum, a region at the back of the brain under the cerebral cortex, has been found to support movement and muscle control, as well as memory, learning and other mental functions. Some neuroscience studies have hypothesized that the cerebellum refines the movements of humans and other mammals via associative learning, yet this has yet to be established with certainty. Researchers at the University of Colorado School of Medicine recently carried out a study exploring this possibility by changing the activity of the mouse cerebellum and observing how this impacted overall neural activity and the mice’s reaching behavior. Their findings, published in Nature Neuroscience, offer new valuable insight about the involvement of the cerebellum in motor control. “The cerebellum is prized by those of us who study it as a tractable circuit—it is set apart from the rest of the brain yet linked to the rest of the brain through ...
- Source: drugdu
- 148
- July 26, 2023
Roche Expands Into RNAi Through Alnylam Alliance on Hypertension Drug

Photo: Giuseppe Aresu/Bloomberg, via Getty Images Alnylam pioneered RNA interference drugs for rare disease. The biotech aims to bring RNAI to prevalent disorders and its alliance with Roche on the drug zilebesiran for hypertension better positions the company to achieve this goal. Cardiometabolic disease isn’t a big part of Roche’s drug portfolio or pipeline, but the pharmaceutical giant is trying to change that with a deal to share in the development of an experimental Alnylam Pharmaceuticals hypertension drug that could offer patients efficacy and dosing advantages. According to deal terms announced Monday, Roche is paying $310 million for outside-of-the-U.S. rights to the drug, zilebesiran. The companies will share in the development of the RNA therapy for hypertension. Roche has the opportunity to lead future development of the drug for other indications. Cambridge, Massachusetts-based Alnylam is a pioneer among companies developing therapies that leverage RNA interference, a pathway in ...
- Source: drugdu
- 120
- July 26, 2023
Top 5 Foods with the Highest Prebiotic Content

There is growing evidence that consuming prebiotics -; certain types of fiber often found in plants that stimulate beneficial bacteria in your gut -; can help to maintain a healthy gut microbiome. In a new study, scientists estimated the prebiotic content of thousands of food types by using preexisting literature to find out which foods offer the highest prebiotic content. According to the study, foods that pack the greatest prebiotic punch are dandelion greens, Jerusalem artichokes, garlic, leeks, and onions. In addition to supporting gut microbes, prebiotic rich foods contain high amounts of fiber -; something most Americans do not get enough of. “Eating prebiotic dense foods has been indicated by previous research to benefit health,” said Cassandra Boyd, a master’s student at San José State University who conducted the research with Assistant Professor John Gieng, PhD. “Eating in a way to promote microbiome wellness while eating ...
- Source: drugdu
- 236
- July 25, 2023

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