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89bio wins EMA priority status for MASH candidate pegozafermin

The European Medicine’s Agency (EMA) has granted priority medicines (PRIME) status to 89bio’s pegozafermin, a drug being evaluated to treat patients with non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with advanced forms of fibrosis. The EMA’s PRIME scheme is designed to expedite the development of medicines that meet an unmet need, such as rare diseases. The agency upgraded the scheme last year to enhance scientific advice and regulatory package preparation for sponsors of the scheme. 89bio’s pegozafermin was granted PRIME status based on positive data from the company’s Phase IIb ELIVEN trial (NCT04929483), according to a 27 March press release. The randomised trial saw three doses of the drug administered either once weekly or biweekly in 192 patients with non-cirrhotic MASH with fibrosis (F2-F3) and MASH with compensated cirrhosis (F4). Patients in the biweekly 44mg and once-weekly 30mg treatment groups saw significant one-stage fibrosis improvement without MASH worsening. MASH resolution without worsening ...
- Source: drugdu
- 93
- April 2, 2024
J&J reportedly eyeing Shockwave Medical for takeover

Johnson & Johnson (J&J) is allegedly looking to strengthen its presence in the cardiovascular device market with the acquisition of medical device company Shockwave Medical, as first reported by the Wall Street Journal (WSJ) on 26 March. The WSJ cited people familiar with the matter who claimed that a finalised deal could be around the corner pending successful acquisition talks. However, the report also noted that another suitor could emerge to merge with Santa Clara, a California-based medical device manufacturer. WSJ did not mention the valuation of the potential acquisition. This is not the first time Shockwave has been involved in acquisition rumours, as Bloomberg reported that Boston Scientific was eyeing Shockwave for a takeover in April 2023. Since the publication of the WSJ report, Shockwave’s stock price has increased by 3.8%. Shockwave has a market cap of $12.3bn. As per a 15 February press release, Shockwave has commenced the ...
- Source: drugdu
- 116
- April 2, 2024
Hengrui’s Clinical Application for New Drug Indicated for Psoriasis Approved

Today (March 29), according to the official website of CDE, Guangdong Hengrui Pharmaceutical Co., Ltd. (hereinafter referred to as “Hengrui Pharmaceutical”) class 1 new drug SHR-1139 injection indicated for psoriasis application obtained approval. Psoriasis is a chronic inflammatory skin disease that is stimulated by environmental factors, genetic control, and immune media. According to relevant data, there are more than 7 million psoriasis patients in China. Fhstrilin predicts that China’s psoriasis market will increase to US $ 9.5 billion in 2030, with a compound annual growth rate of 27.1%. Globally, the number of patients with psoriasis is on the rise. At present, biopharmaceuticals have gradually become one of the mainstream therapies of psoriasis in China. Related drugs are mainly focused on targets such as TNF-α and IL families. Hengrui Pharmaceutical also deployed psoriasis therapy drugs, of which Fu Niqizumab (SHR-1314) targets IL-17A targets. Following the CDE acceptance of the listing of ...
- Source: drugdu
- 94
- April 2, 2024
March 29, 2024

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Thursday, the FDA made several updates to the Mammography Quality Standards Act and Program section on the FDA Website to enhance user experience and provide the most up-to-date information, including reordering and renaming the landing pages so the information is easier to find and updating and deleting old data to provide the public with current information. On Thursday, the FDA launched the Searchable Tobacco Products Database, a new user-friendly list of tobacco products—including e-cigarettes—that may be legally marketed in the United States. The database is designed to serve the public—especially retailers—by providing this key information in a single location, with easy-to-use search capabilities. The database, which can be accessed here. The database will be updated on a monthly basis. On Wednesday, the FDA authorized marketing of the Medline Autologous Regeneration of ...
- Source: drugdu
- 108
- April 2, 2024
Altamira Therapeutics partners with Univercells Group on nanoparticle-delivered mRNA vaccines

Under the terms of the agreement, Univercells will test in vitro and in vivo a proprietary mRNA vaccine delivered with Altamira’s SemaPhore nanoparticle platform Altamira Therapeutics, a company providing nanoparticle-based technology for efficient RNA delivery to extrahepatic targets has announced that it has entered into a collaboration agreement with Univercells Group to evaluate the use of the Company’s proprietary SemaPhore platform for the delivery of mRNA vaccines. Univercells is a global life sciences company creating platforms for developing and manufacturing biologics, including mRNA vaccines and therapeutics, in a simple, scalable and cost-efficient way. Under the terms of the agreement, Univercells will test in vitro and in vivo a proprietary mRNA vaccine delivered with Altamira’s SemaPhore nanoparticle platform. Should the experiments prove successful, Univercells and Altamira intend to discuss and negotiate a commercial agreement for the development and manufacturing of nanoparticle-based mRNA vaccines using Univercells’ production platform. Covadonga Pañeda, PhD, Altamira’s ...
- Source: drugdu
- 81
- April 2, 2024
Novo Nordisk to acquire Cardior Pharmaceuticals to strengthen pipeline in cardiovascular disease

The agreement includes Cardior’s lead compound CDR132L, currently in phase 2 clinical development for the treatment of heart failure Novo Nordisk and Cardior Pharmaceuticals has announced that Novo Nordisk has agreed to acquire Cardior for up to 1.025 billion Euros, including an upfront payment and additional payments if certain development and commercial milestones are achieved. The agreement includes Cardior’s lead compound CDR132L, currently in phase 2 clinical development for the treatment of heart failure. Martin Holst Lange, executive vice president for Development at Novo Nordisk said, “By welcoming Cardior as a part of Novo Nordisk, we will strengthen our pipeline of projects in cardiovascular disease where we already have ongoing programmes across all phases of clinical development. We have been impressed by the scientific work carried out by the Cardior team, especially on CDR132L, which has a distinctive mode of action and potential to become a first-in-class therapy designed to ...
- Source: drugdu
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- April 2, 2024
Cambodia Phar-Med Expo 2024

Organiser: Minh Vi Exhibition & Advertisement Services Co., Ltd. Time:28 – 30 August 2024 address：Diamond Island Phnom Penh Cambodia Exhibition hall: Diamond Island Convention & Exhibition Center Product range: Medical equipment and equipment: medical aid equipment, rehabilitation physiotherapy equipment, medical vehicle, bed, table, medical aid equipment, surgical equipment, preventive medical equipment, examination equipment, monitoring equipment, treatment equipment, inspection and analysis equipment, special surgical equipment, first aid equipment, surgical equipment, diagnostic equipment and supplies, analysis and control, Monitoring equipment, corrective equipment, ophthalmic instruments and equipment, ENT equipment, dental supplies and equipment, radiological medicine equipment, medical reagents and equipment, prosthetics and rehabilitation equipment, medical and health products and equipment, disinfection and sterilization equipment, traction, diagnostic equipment, treatment equipment, inspection and analysis equipment, etc Medical institutions and laboratory technical equipment: laboratory furniture, laboratory automation and accessories, optical instruments and equipment, dressings, wound care materials, catheters, medical experimental analysis and diagnostic instruments, biopharmaceutical instruments, cell biology ...
- Source: drugdu
- 174
- April 2, 2024
FDA hits Renovo with warning letter over reprocessed medical devices

Dive Brief Renovo received a warning letter in October for supplying reprocessed medical devices without seeking 510(k) clearance from the Food and Drug Administration. The letter, which the FDA published Tuesday, accuses Renovo of providing reprocessed models other than the ones covered by its 510(k) clearances. Renovo failed to evaluate how cleaning and re-sterilization of the additional models could affect performance and reliability. FDA inspectors also identified problems with Renovo’s approach to air particulate sampling that prompted warnings about the failure to establish control procedures. Dive Insight Renovo cleans medical devices that have been used in procedures such as the ablation of soft tissue for reuse. Renovo has multiple 510(k) clearances that permit the company to supply reprocessed versions of devices such as Depuy Mitek Ablation Wands and Ethicon Bladeless Trocars. The problem, according to the FDA, is that Renovo has reprocessed models that are outside of the scope of ...
- Source: drugdu
- 130
- April 1, 2024
Roche wins FDA approval for first molecular malaria blood donor screening test

Dive Brief Roche has received Food and Drug Administration approval for the first molecular test to screen U.S. blood donors for malaria, the company said Tuesday. In 2022, the FDA recommended preventing people from giving blood for a time after they return from an area with malaria because there was no licensed test to screen donors. Other countries including Australia, England and France use antibody testing to avoid excluding potential donors. Roche’s Cobas malaria molecular test screens whole blood samples for the five main species of parasites that cause infections. The company is pitching the test as a way to improve the safety and availability of blood. Dive Insight Around 2,000 people are diagnosed with the mosquito-borne disease in the U.S. each year, typically after traveling to a country where malaria transmission occurs. The potential for donors to unknowingly pass the parasite on to recipients of their donations led the ...
- Source: drugdu
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- April 1, 2024
Strand Therapeutics develops new class of mRNA molecules for cancer

The self-replicating mRNA molecule could be used in cancer and potentially a broad range of other diseases Strand Therapeutics, a Massachusetts Institute of Technology (MIT) spinout, has developed a new class of advanced mRNA molecules for more targeted and powerful treatments for cancer. The new class of mRNA molecules is designed to sense what type of cells they encounter in the body and express therapeutic proteins once they have entered diseased cells. Most next-generation cancer immunotherapies are based on recombinant proteins, which are challenging to deliver to specific targets in the body and do not remain active for long enough to create a durable response. Strand has developed the world’s first mRNA programming language to improve mRNA molecules’ ability to sense their environment and generate targeted responses where needed most, allowing the company to specify the tissues its mRNAs express proteins in. In addition, the company uses techniques such as ...
- Source: drugdu
- 83
- April 1, 2024

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