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EirGenix and Sandoz win EU approval for Herceptin biosimilar

The European Commission has granted marketing authorisation to EirGenix’s Herceptin (trastuzumab) biosimilar for marketing in the European Union. The biosimilar has been approved as a treatment for human epidermal growth factor receptor 2 positive (HER2-positive) breast cancer and metastatic gastric cancers, as per a 22 November press release. Herceptin is a monoclonal antibody that binds to HER2 receptors, thereby priming these receptors for immune system targeting. The drug generated SFr1.26bn ($1.4bn) in year-to-date (YTD) sales in September, as per Roche’s Q3 financials. Sandoz is responsible for the worldwide commercialisation of EirGenix’s Herceptin biosimilar, except in Taiwan, China, Russia, and some Asian countries, based on the 22 November press release. Meanwhile, EirGenix holds the developmental, commercialisation and manufacturing rights for the biosimilar in countries not covered by Sandoz. In September, EirGenix’s Herceptin biosimilar received a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines ...
- Source: drugdu
- 178
- November 26, 2023
Flagship-Founded Microbiome Company Evelo Biosciences Throws in the Towel

By Kate Goodwin Pictured: Closed sign/iStock, StockSeller_ukr After a couple of disappointing years, a microbiome biotech founded by Flagship Pioneering is calling it quits. In an SEC filing Monday, Evelo Biosciences reported that dissolution is “in the best interest” of the company as well as its creditors and stockholders. The company was launched in 2015 by Flagship to develop inflammation-resolving microbe medicines to act on cells in the small intestine with systemic therapeutic effects for inflammatory diseases. However, the past two years have been tough for Cambridge, Mass.-based Evelo as one by one each of its assets disappointed. After a Phase II failure in April 2022, its second atopic dermatitis candidate in Phase II testing did not meet the trial’s primary endpoint in February 2023. The company pointed to an unusually high placebo response rate. The results sent Evelo’s stock tumbling 50% at the time and the company cut around ...
- Source: drugdu
- 173
- November 25, 2023
Darzalex Faspro in Multiple Myeloma, Imbruvica-Venclexta in Mantle Cell Lymphoma

By Tristan Manalac Ahead of the 65th Annual Meeting and Exposition of the American Society of Hematology, taking place Dec. 9 to 12, event organizers on Tuesday released late-breaking abstracts providing an early view of some of the most high-impact studies in blood disorders to be presented at the conference. Focus on two of those studies below. J&J, Genmab’s Darzalex Faspro Early data from the Phase III PERSEUS study showed that J&J and Genmab’s subcutaneous anti-CD38 antibody Darzalex Faspro (daratumumab and hyaluronidase-fihj) significantly prolonged progression-free survival (PFS) in patients with newly diagnosed multiple myeloma (NDMM). PERSEUS enrolled 709 patients in total, of whom 355 were randomly assigned to receive Darzalex Faspro combined with bortezomib, lenalidomide and dexamethasone (VRd). At a median follow-up of 47.5 months, patients treated with the Darzalex Faspro regimen saw a significantly better PFS versus comparators who received VRd alone. The effect had a hazard ratio of ...
- Source: drugdu
- 121
- November 25, 2023
White Bagging Policies Endanger the Lives of Cancer Patients

Earlier this year, a young man in his mid-thirties with non-Hodgkin’s Lymphoma came to my oncology clinic for a chemotherapy infusion while waiting on the development of his CAR-T treatment. Under normal circumstances, our practice can move quickly when scheduling patients for their treatments since our in-office infusion clinic maintains an inventory of necessary medications that we prepare ourselves onsite. But, unbeknownst to me, my patient’s health insurance plan included a policy called “white bagging,”- a policy which we soon discovered when they denied one of the chemotherapy drugs I prescribed. Our clinical team repeatedly appealed the denial; however, the plan refused to cover the drug unless it was fulfilled through an unspecified designated specialty pharmacy associated with the patient’s pharmacy benefit manager. Eventually, we were able to negotiate coverage through our practice’s internal inventory, but by the time the patient was able to receive the drug four weeks had ...
- Source: drugdu
- 152
- November 25, 2023
Breakthrough decoding of the Y chromosome revolutionizes digestive disease research

A major breakthrough in human genetics has been achieved with the complete decoding of the human Y chromosome, opening up new avenues for research into digestive diseases. This milestone, along with advancements in third-generation sequencing technologies, is poised to revolutionize our understanding of the genetic underpinnings of digestive disorders and pave the way for more personalized and effective treatment strategies. The Y chromosome, the smallest of the human chromosomes, has long been shrouded in mystery due to its complex repetitive structure. However, recent advancements in sequencing technologies have enabled researchers to unravel the intricate details of this genetic region, shedding light on its role in sex determination and its potential impact on various diseases, including those affecting the digestive system. Completing the Y chromosome sequence provides a comprehensive reference for identifying genetic variations that may contribute to digestive diseases. This information is crucial for understanding the “missing heritability” problem, where ...
- Source: drugdu
- 193
- November 25, 2023
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
- 140
- 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
- 148
- 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
- 127
- 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

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