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Merck sues US government over Medicare drug price negotiation programme

Merck & Co – known as MSD outside the US and Canada – has filed a lawsuit against the US government over the Medicare drug price negotiation element of President Biden’s Inflation Reduction Act (IRA). The IRA, which was enacted last year, allows Medicare – the government health plan for older adults – to negotiate lower prices for a selected group of prescription medicines. Merck argues that this violates the part of the Fifth Amendment to the US Constitution that requires the government to pay just compensation if it takes private property for public use. The lawsuit, filed in the US District Court for the District of Columbia, also argues that companies will be forced to sign agreements conceding that the prices are fair, which the drugmaker claims is a violation of the First Amendment’s protections of free speech. “These constitutional violations cannot be swept under the rug by pretending ...
- Source: drugdu
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GSK’s RSV vaccine approved by EC for older adults

GSK’s respiratory syncytial virus (RSV) vaccine has been approved by the European Commission (EC) for the prevention of RSV-caused lower respiratory tract disease (LRTD) in adults aged 60 years and older. The EC’s decision, which follows a recent recommendation from the European Medicines Agency’s human medicines committee, makes Arexvy the first RSV vaccine for older adults to be granted European Marketing Authorisation. RSV is a common contagious virus characterised by several mild, cold-like symptoms. Although most people can recover within a week or two, older adults are at a high risk for severe disease. This is partly due to age-related decline in immunity. RSV can also exacerbate other conditions, including chronic obstructive pulmonary disease, asthma and chronic heart failure. Overall, RSV infections in older adults account for over 270,000 hospitalisations and approximately 20,000 in-hospital deaths each year in Europe. GSK’s EU application was supported by positive results from its phase ...
- Source: drugdu
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- June 9, 2023
Biosimilars ‘Fulfilling Their Promise’ of Lowering Biologic Prices

By Tristan Manalac Pictured: Cancer patient in bed looking out window / iStock, Ridofranz The entry of biosimilars promotes healthy market competition. It can reduce the prices of branded biologic medicines, according to a new study from the University of Southern California’s Leonard D. Schaeffer Center for Health Policy & Economics. The study, published online Tuesday in the journal Health Affairs, focused on Genentech’s (Roche) breast cancer treatment Herceptin (trastuzumab) and its five biosimilar competitors that entered the U.S. market starting in 2019: Amgen’s Kanjinti, Viatris’ Ogivri, Pfizer’s Trazimera, Teva’s Herzuma and Organon’s Ontruzant. Study results showed that when Herceptin’s first biosimilar competitor—Kanjinti—hit the market, its average price dropped around 21%, from $101 to $80 per 10 mg. By the second quarter of 2022, toward the end of the study’s analysis period, biosimilars maintained an average sales price of 28% to 58% of Herceptin’s pre-competition average sales price. “Trastuzumab is ...
- Source: drugdu
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- June 9, 2023
Moderna, Pfizer Hit with New COVID Vaccine Patent Lawsuits

By Tristan Manalac Pictured: Scales of justice/Kanizphoto, iStock Tuesday, New York-based Promosome filed separate lawsuits against Moderna and Pfizer, accusing both companies of violating patent protections related to mRNA technology, according to a report by Reuters. In the filings submitted to the Southern District Court of California, Promosome claims that in 2009 company-affiliated scientists “discovered a method for increasing protein expression by making small changes to the mRNA that could affect the amount of protein produced without altering the amino acid sequence encoded by the mRNA.” This method is protected by U.S. Patent No. 8,853,179, also known as the ’179 Patent. Promosome scientists, including Nobel laureate Gerald Edelman, gave the company exclusive license to the ’179 Patent. Promosome eventually disclosed the protected technology to Moderna—which ultimately declined to license it—and to Katalin Karikó, who served as senior vice president and top mRNA scientist at BioNTech at the time of the ...
- Source: drugdu
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- June 9, 2023
Novo Nordisk says in talks to acquire French device-maker Biocorp for $165M

Dive Brief Novo Nordisk said it is in exclusive talks to buy French medical device company Biocorp. Novo Nordisk will buy out Biocorp’s main shareholder, Bio Jag, for 35 euros per share, and then make a tender offer for any outstanding shares at the same price, the companies said Monday. The offer would value all of the company at 154 million euros ($165 million). Denmark-based Novo Nordisk, which makes pharmaceutical products and insulin pens, has been collaborating with Biocorp since 2021 on a smart pen cap that tracks information on dose, date and time of injection. Dive Insight Novo Nordisk wants to innovate faster and develop new connected devices, and expects that Biocorp would complement its internal efforts, said Marianne Ølholm, Novo Nordisk’s senior vice president of devices and delivery solutions. Novo Nordisk will work with Biocorp to invest in new devices and drug delivery solutions for people with chronic ...
- Source: drugdu
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- June 8, 2023
New type of wound dressing could enhance the healing process for burn patients

One of the challenges in treating burn victims is the frequency of dressing changes, which can be extremely painful. To bring relief to this and other problems, University of Waterloo researchers have created a new type of wound dressing material using advanced polymers. This new dressing could enhance the healing process for burn patients and have potential applications for drug delivery in cancer treatment as well as in the cosmetic industry. “To treat burn victims, we can customize the shape using a 3D printer, secondly, the material has fine-tuned surface adhesion, which is a key feature”, said Dr. Boxin Zhao, a professor in Waterloo’s Department of Chemical Engineering, whose team has made significant strides in developing intelligent hydrogel materials for use as a reusable wound dressing. “The material can easily adhere to the skin and be taken off. It’s a very delicate balance within the material to make the adhesion ...
- Source: drugdu
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- June 8, 2023
Movement symptoms in dystonia found to be caused by spinal cord dysfunction

Many neurological conditions that involve involuntary muscle contractions have long been considered as diseases of the brain. However, both the brain and the spinal cord contain many nerve cells associated with movement. New research, published in Science Translational Medicine, used state-of-the-art mouse genetics to distinguish whether the brain or spinal cord was responsible for the disorganization of movement experienced by dystonia patients. Focusing on the most common inherited form of dystonia called DYT1, UCL scientists confined a genetic mutation to the spinal cord of the mice, while sparing nerve cells in the brain. They discovered that the mice consequently developed signs of dystonia that were remarkably similar to those seen in people with the condition. The researchers also observed how specific nerve cells in the spinal cord were affected through the course of the disease. The team hope that their findings will help towards the development of new treatments. Corresponding ...
- Source: drugdu
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- June 8, 2023
Study identifies two brain mechanisms for picking speech out of a crowd

Researchers led by Dr. Nima Mesgarani at Columbia University, US, report that the brain treats speech in a crowded room differently depending on how easy it is to hear, and whether we are focusing on it. Publishing June 6th in the open access journal PLOS Biology, the study uses a combination of neural recordings and computer modeling to show that when we follow speech that is being drowned out by louder voices, phonetic information is encoded differently than in the opposite situation. The findings could help improve hearing aids that work by isolating attended speech. Focusing on speech in a crowded room can be difficult, especially when other voices are louder. However, amplifying all sounds equally does little to improve the ability to isolate these hard-to-hear voices, and hearing aids that try to only amplify attended speech are still too inaccurate for practical use. In order to gain a better ...
- Source: drugdu
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- June 8, 2023
Study

Reviewed by Lily Ramsey, LLMJun 7 2023 The expected course of a patient’s cancer prognosis has traditionally been judged by its type, stage and microscopic aggressiveness, but patients with the same presentation can still have widely divergent outcomes. Researchers from Vanderbilt-Ingram Cancer Center have discovered that differences in tumor mutation burden are a major reason for this divergence. The study, published in JCO Precision Oncology, has revealed that mutation burden is a fundamental predictor of survival, independent of the clinical presentation metrics currently used. The researchers state in the study that mutational indices can be “used to predict disease course as effectively as (cancer) stage or grade.” A major insight of the study was the observation that survival was better at both low and high extremes of tumor mutation burden.” William Dupont, Study Corresponding Author and Professor, Biostatistics, Health Policy, and Preventive Medicine, Vanderbilt University Medical Center The study investigated ...
- Source: drugdu
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- June 8, 2023
Biogen cuts PhIII Parkinson’s program over ‘long timeline’

Nicole DeFeudis Editor Biogen is calling it quits on a late-stage Parkinson’s trial as part of an ongoing R&D reorganization. The Cambridge, MA-based biotech announced Monday morning that it’s discontinuing a Phase III program evaluating BIIB122 as a treatment for patients with Parkinson’s disease related to LRRK2 mutations with partner Denali Therapeutics. The study, dubbed LIGHTHOUSE, kicked off in September; it was slated for completion in 2031. Biogen said the decision was made in consideration of the study’s “complexity including the long timeline.” “These modifications are not based on any safety or efficacy data from studies of BIIB122,” the company said in a statement. “Denali and Biogen have a strategic collaboration to jointly develop and commercialize small molecule inhibitors of LRRK2 and remain committed to advancing the development of BIIB122.” Back in 2020, Biogen shelled out more than $1 billion upfront — including $560 million in cash and $465 million ...
- Source: drugdu
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