PharmaFocus Today – Page 225 – media

Smith+Nephew to buy CartiHeal and its knee cartilage healing tech

Agili-C is a porous, biocompatible, and resorbable scaffold for cartilage regeneration in the knee. [Image courtesy of CartiHeal and Smith+Nephew] Smith+Nephew (LSE:SN, NYSE:SNN) announced today that it has agreed to acquire CartiHeal and its novel sports medicine technology. CartiHeal’s Agili-C is an off-the-shelf, porous, biocompatible, and resorbable scaffold. Approved by the FDA in 2022, it promotes natural regeneration of the articular cartilage — and restoration of its underlying subchondral bone. Under the acquisition agreement, Smith+Nephew will pay an initial $180 million for CartiHeal. There’s also the potential for CartiHeal’s present owners to receive a further $150 million contingent on financial performance. “The acquisition of this disruptive technology supports our strategy to invest behind our successful Sports Medicine business,” S+N CEO Deepak Nath said in a news release. “Agili-C’s superior clinical performance makes it highly complementary to our existing knee repair portfolio, and with our proven commercial expertise in high-growth biologics, ...
- Source: drugdu
- 138
- November 25, 2023
Sunnyside Secures $11.5M To Help People Build Healthier Drinking Habits

Sunnyside, which offers an app to help consumers moderate their drinking, has raised $11.5 million in Series A funding. The round was led by Motley Fool Ventures and will be partially used for product development. By MARISSA PLESCIA About two-thirds of adults in the U.S. drink alcohol, but about one in three are trying to drink less. Sunnyside, which announced it raised $11.5 million in Series A funding last week, aims to help people cut back on their drinking without having to quit altogether. The San Francisco-based startup offers an app for consumers. At $99 a year, users of Sunnyside have access to drink tracking, daily reminders of their goals, personalized recommendations, community support with other users of the app and one-on-one peer support. “This approach provides a much-needed alternative for those looking to change their relationship with alcohol, but who aren’t open to quitting drinking entirely,” said Nick Allen, ...
- Source: drugdu
- 145
- November 25, 2023
Boehringer Ingelheim to acquire T3 Pharmaceuticals in deal worth over $500m

Boehringer Ingelheim has said it will be acquiring bacterial cancer therapy specialist T3 Pharmaceuticals in a deal worth over $500m, marking a significant boost to its immuno-oncology portfolio. Boehringer said it is seeking to “significantly increase” the current 15 to 20% remission rate in cancer patients by utilising complementary immuno-oncology platforms such as T-cell engagers, oncolytic viruses and cancer vaccines. T3, founded in 2015 as a spinout from the University of Basel in Switzerland, has developed a proprietary therapy platform that uses live bacteria to deliver immune-modulating proteins directly to cancer cells and tumour micro-environments while sparing healthy tissues. The bacteria can be loaded with multiple immune-modulatory proteins of choice, allowing the design of immuno-oncology combination therapies in one single agent. Michel Pairet, member of the board of managing directors at Boehringer with responsibility for the Innovation Unit, said: “The acquisition of T3 Pharma will significantly expand our immuno-oncology pipeline ...
- Source: drugdu
- 106
- November 25, 2023
Levofloxacin revealed as first effective treatment for multi-drug resistant TB

Two landmark clinical trials involving researchers at University College London (UCL) have demonstrated that levofloxacin is the first effective treatment to prevent multidrug-resistant tuberculosis (MDR-TB). Results from both trials were announced at the Union World Conference on Lung Health in Paris, France. Annually, around 500,000 people develop tuberculosis (TB), an infectious disease caused by a type of bacteria that affects the lungs, that is resistant to multiple antibiotics. Led by Stellenbosch University in South Africa, with the MRC Clinical Trials Unit (CTU) at UCL responsible for trial management and statistical analysis, the TB-CHAMP trial involved 922 children and adolescents exposed to an adult with MDR-TB in their household. Results showed that levofloxacin reduced the risk of MDR-TB disease by 56%, with very few side effects reported. Additionally, after one year, only 1.1% of children developed TB, compared to 2.6% who received a placebo. The second trial, VQUIN, led by the ...
- Source: drugdu
- 126
- November 25, 2023
Merck to acquire Caraway Therapeutics in a deal worth up to $610m

Merck & Co – known as MSD outside the US and Canada – has entered into a definitive agreement to acquire Caraway Therapeutics, with the deal worth up to $610m. The acquisition gives Merck access to the preclinical biopharma’s pipeline of small-molecule therapeutics for genetically defined neurodegenerative and rare diseases. Mutations that impair cellular clearance pathways are associated with multiple neurodegenerative and rare diseases, including neurodegenerative disorders characterised by cognitive dysfunction, according to Caraway. The company focuses on discovering small molecules that activate cellular recycling processes to clear toxic materials and defective cellular components by modulating lysosomal function. George Addona, senior vice president, discovery, preclinical development and translational medicine at Merck Research Laboratories, said: “Caraway’s multidisciplinary approach has yielded important progress in evaluating novel mechanisms of modulation of lysosomal function with potential for the treatment of progressive neurodegenerative diseases. “We look forward to applying our expertise to build upon this ...
- Source: drugdu
- 230
- November 25, 2023
European Patent Office Declares One of Moderna’s mRNA Patents Invalid

By Tristan Manalac The European Patent Office has decided that a hotly contested mRNA patent held by Moderna pertaining to its COVID-19 vaccine is invalid, Reuters reported on Tuesday. The patent in question covers betacoronavirus vaccines that use at least one RNA polynucleotide with an open reading frame that encodes at least one betacoronavirus antigenic peptide, according to its claims document listed in the European Patent Register. While the patent battle is over the use of this technology to produce COVID-19 vaccines, the claims document also seeks to protect its use for other viral respiratory infections, including MERS and SARS. Several biopharma companies have lodged their opposition to these claims, including BioNTech and Pfizer—Moderna’s chief competitors in the coronavirus vaccine market—as well as Sanofi, according to the patent’s listing on the register. A BioNTech spokesperson in a statement to Fierce Pharma said that the company “welcomes” the European Patent Office’s ...
- Source: drugdu
- 107
- November 24, 2023
InDex Scraps Phase III Ulcerative Colitis Trial on Disappointing Data

By Tristan Manalac InDex Pharmaceuticals on Tuesday announced that it is discontinuing the Phase III CONCLUDE program, which was evaluating its investigational immunomodulatory therapeutic cobitolimod in ulcerative colitis. The decision to terminate the late-stage study is in line with the recommendations of an Independent Data Monitoring Committee, which found during a planned dose selection, safety and futility analysis that cobitolimod is “unlikely” to meet the study’s primary endpoint, according to the company’s announcement. At the same time, InDex noted that the committee’s advice to discontinue the study was not due to any safety concerns. InDex CEO Jenny Sundqvist in a statement called the committee’s recommendation “surprising and disappointing,” adding that cobitolimod’s failure in CONCLUDE highlights the “complexity of the disease” and points to the need for more research to address the “high unmet medical need” in ulcerative colitis. The company’s stock was trading approximately 59% lower on Wednesday morning in ...
- Source: drugdu
- 142
- November 24, 2023
Cosmic radiation and microgravity linked to erectile dysfunction in astronauts

During missions into space, astronauts are exposed to high levels of galactic cosmic radiation and weightlessness. Simulation experiments in male rats indicated that these aspects of spaceflight can negatively affect vascular tissues relevant to erectile dysfunction, even after a period of long-term recovery. The research, which is published in The FASEB Journal, indicated that vascular alterations are induced by relatively low doses of galactic cosmic radiation and to a lesser extent simulated weightlessness, primarily through increases in oxidative stress. Treatment with different antioxidants could counter some of these effects. Justin D. La Favor, PhD, corresponding author of Florida State University, said, “With manned missions to outer space planned for the coming years, this work indicates that sexual health should be closely monitored in astronauts upon their return to Earth. While the negative impacts of galactic cosmic radiation were long-lasting, functional improvements induced by acutely targeting the redox and nitric oxide ...
- Source: drugdu
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- November 24, 2023
FDA concerned Cardinal Health failed to mitigate risk of incompatible syringes

Dive Brief The Food and Drug Administration voiced concerns in a Monday letter that Cardinal Health failed to sufficiently mitigate the risk of incompatibility between its syringes and certain pumps in its communication to healthcare providers. Cardinal wrote to its customers in September to explain that some lots of Monoject Luer-lock tip syringes are incompatible with certain infusion pumps, leading to a Class I recall notice covering the device correction. The recall affects more than 32 million syringes. Days after posting the Class 1 notice, the FDA revised recommendations for healthcare providers. It said the dimensional changes made to Cardinal Health’s Monoject syringes, when used with syringe pumps or patient-controlled analgesia (PCA) pumps, may result in issues that include overdose, underdose, or delays in therapy or occlusion alarms. Dive Insight On Monday, the FDA moved to clarify the advice for healthcare providers in a notice titled “Do Not Use Cardinal ...
- Source: drugdu
- 102
- November 24, 2023
Investigating Industry Involvement in Modern Clinical Trials

Don Tracy, Associate Editor Study aims to find ways industry gets involved in the most influential clinical trials, and how transparent these trials are. In a study published earlier this month by JAMA, the authors aimed to discover how the pharmaceutical industry gets involved in the most influential modern clinical trials and how they fare in terms of transparency. Crediting the major impact of these clinical trials on medical practice, the authors believed that it was important to evaluate the extent of industry involvement and the use of transparency practices in such studies published in the last few years. In order to find a sufficient answer, the study relied on a meta-research assessment consisting of 600 randomized and nonrandomized clinical trials published in 2019 or later. Trials that attracted the highest number of number of citations in Scopus as of December 2022 were selected for analysis, occurring from March to ...
- Source: drugdu
- 109
- November 24, 2023

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