Search Results for “Roche” – Page 12 – media

Pfizer’s First Gene Therapy Approval Sets Up a Showdown With CSL in Hemophilia B

The FDA has approved Beqvez, a Pfizer gene therapy developed for moderate-to-severe hemophilia B. The one-time treatment carries a $3.5 million price tag, the same as a CSL Behring gene therapy already available for treating the inherited bleeding disorder. By Frank Vinluan Pfizer’s first FDA-approved gene therapy is the second such treatment for the inherited bleeding disorder hemophilia B, introducing some competition to a therapeutic area that now has two of the most expensive medicines in the world. The FDA approval announced Friday covers the treatment of adults with moderate-to-severe hemophilia B. Known in development as fidanacogene elaparvovec, the Pfizer therapy will be marketed under the brand name Beqvez. The company expects this therapy will become available to patients later in the current quarter. Hemophilias stem from genetic mutations that lead to abnormally low levels of clotting proteins. These disorders mainly affect males and make patients susceptible to bleeding events ...
- Source: drugdu
- 74
- May 2, 2024
ETH Zurich researchers use AI to develop drug molecules based on protein structures

Researchers from ETH Zurich have developed a new generative artificial intelligence (AI)-based computer process to develop drug molecules based on a protein’s three-dimensional surface. The new process could revolutionise drug research, making it possible to generate active pharmaceutical ingredients quickly and easily. The new computer process’ algorithm was developed in collaboration with ETH’s professor Gisbert Schneider and former doctoral student Kenneth Atz, using AI to design new active pharmaceutical ingredients. Researchers trained the AI model with information from hundreds of thousands of known interactions between chemical molecules and the corresponding three-dimensional protein structures. The algorithm generates the blueprints for potential drug molecules that can increase or inhibit the activity of proteins with a known three-dimensional shape. The generative AI then designs molecules that bind specifically to the protein according to the lock-and-key principle to be interacted with. “This means that when designing a drug molecule, we can be sure that ...
- Source: drugdu
- 82
- May 1, 2024
Pfizer scores FDA nod for hemophilia B gene therapy, will charge $3.5M per dose

Pfizer will offer a warranty program for its first FDA-approved gene therapy. The hemophilia B treatment will go for $3.5M, matching the price tag on CSL and uniQure’s hemophilia B gene therapy Hemgenix. (Pfizer) Ten years after dipping its toes into the gene therapy pool in a licensing deal with Spark Therapeutics, Pfizer has gained FDA approval for the acquired treatment. The U.S. regulator has endorsed Beqvez (fidanacogene elaparvovec-dzkt) for adults with the bleeding disorder hemophilia B. It becomes the first FDA-approved gene therapy for Pfizer and the second in the indication following CSL and uniQure’s hemophilia B treatment Hemgenix, which became the world’s most expensive drug at $3.5 million when it was approved in 2022. Pfizer had the chance to undercut its rival on price but decided to charge the same $3.5 million for Beqvez. The therapy will be available to patients this quarter, a spokesperson confirmed on Friday ...
- Source: drugdu
- 87
- April 30, 2024
Vietnam Medipharm Expo 2024

Organiser: Ministry of Health of Vietnam Time:1 – 3 August 2024 address：Lawrence S. Ting Building 801 Nguyen Van Linh Parkway, Dist. 7 Ho Chi Minh City Vietnam Exhibition hall: Saigon Exhibition & Convention Center Product range: Medical products: medical equipment and instruments, medical consumables, medical dressings, surgical equipment, rescue equipment, diagnostic equipment and supplies, ophthalmic equipment and equipment, ENT equipment, dental equipment and supplies, medical reagents and equipment, medical health products and equipment, medical institutions and laboratory technical equipment, medical information and technical exchange, beauty equipment Analytical instruments: Optical analysis instruments, mass spectrometers, spectrometers, chromatographs, spectrometers, electrochemical analysis instruments, X-ray analysis instruments, gas chromatography, liquid chromatography, thermal analysis instruments, all kinds of portable instruments, surface analysis instruments, nuclear analysis instruments, elemental analysis instruments, process analysis instruments, composition analysis instruments, injection analysis instruments and other general analytical instruments Laboratory equipment: Laboratory instruments and equipment, laboratory automation and accessories, optical instruments and equipment, ...
- Source: drugdu
- 143
- April 23, 2024
UK charities condemn continued drug shortages

Ahandful of UK charities and community pharmacists urged the UK government to find a fix for the ongoing drug shortage issue to prevent further patient suffering. The UK Epilepsy Society, SUDEP Action, Epilepsy Action and Parkinson’s UK, joined forces to call for a meeting with the Health Secretary, Victoria Atkins. The Association of Independent Multiple Pharmacies (AIMp) found that community pharmacists are spending an average of two hours every day to find patients’ medications due to the disruptions. In a 11 April press release, Dr. Leyla Hannbeck, AIMp’s CEO, said, “The system is overly complex and shrouded in secrecy – what we need is openness and transparency. Pharmacists are in the same position as patients – we are at the end of the supply chain but are the last people to find out about medication shortages. Consequently, we are unable to plan in advance and support the people who rely ...
- Source: drugdu
- 160
- April 16, 2024
Candel wins FDA orphan drug designation for pancreatic cancer drug

The US Food and Drug Administration (FDA) has granted Candel Therapeutics’ immunotherapy candidate CAN-2409 (aglatimagene besadenovec) orphan drug designation for the treatment of pancreatic cancer. Orphan drug designations are granted to medicines intended to treat rare conditions and come with benefits such as tax credits for US-based clinical trials and potentially seven years of market exclusivity in the designated indication upon agency approval. Pancreatic cancer is one of the most lethal forms of cancer, with a survival rate beyond ten years of around 5%. CAN-2409 was also granted fast track designation in pancreatic cancer by the FDA in December 2023, meaning the candidate is in line for expedited development and review times. CAN-2409 is an off-the-shelf immunotherapy that is a combination of a genetically modified adenovirus and the herpes simplex virus thymidine kinase (HSV-tk) gene. The drug works by inducing T cell response at both the targeted tumour and at ...
- Source: drugdu
- 74
- April 16, 2024
Xilio fires 21% of its workforce and reprioritises pipeline

XIlio Therapeutics has implemented cost-cutting measures which include a 21% workforce reduction and the termination of investments for developing one of its assets, XTX202, as a monotherapy. Xilio expects to incur one-time cost of approximately $1m for reducing its workforce by 15 employees. The company has reported $44.7m in cash reserves, which are expected to fund the company’s activities into Q2 2025. The Waltham, Massachusetts-based company’s market cap currently stands at $42.1m. Following the recent round of layoffs, Xilio joins a list of pharmaceutical companies including Atreca, Candel Therapeutics, Kinnate Bio, and NexImmune that have fired workers to funnel more money into their clinical development pipelines in the last few months. The company plans to not investigate XTX202, a tumour-activated beta-gamma biased interleukin (IL)-2, as a monotherapy and instead will explore partnerships to develop the therapy as a combination treatment. The therapy was evaluated in an open label Phase I/II ...
- Source: drugdu
- 77
- April 5, 2024
Boundless Bio’s ‘BOLD’ IPO Reels In $100M for a New Kind of Cancer Drug

Cancer drug developer Boundless Bio is a pioneer in therapies that target extrachromosomal DNA. The IPO cash will support its pipeline, including a lead program on track to report preliminary data later this year. By FRANK VINLUAN Targeted therapies and immunotherapies offer new treatment options for more types of cancer, but these drugs are less helpful when tumors produce multiple copies of a gene. This gene amplification contributes to drug resistance. Boundless Bio’s research into the what drives this phenomenon has yielded new understanding of cancer biology. The company now has $100 million in IPO cash to support two programs in early clinical development and more in its pipeline. Boundless Bio late Wednesday priced its offering of 6.25 million shares at $16 each, which was the midpoint of the preliminary $15 to $17 price range the San Diego-based company set last week. Those shares will trade on the Nasdaq under ...
- Source: drugdu
- 158
- March 30, 2024
Precision Medicine Startup Mirador Unveils $400M for R&D of New I&I Drugs

Mirador Therapeutics applies machine learning to human data to discover new immunology and inflammation drugs. The startup’s management includes several from the executive team of Prometheus Biosciences, an immunology biotech bought by Merck last year. By FRANK VINLUAN Nearly a year ago, Merck struck a $10.8 billion deal to acquire Prometheus Biosciences, a clinical-stage company whose technology platform analyzed genetics and biology data to discover new drugs. The executive who led Prometheus to that buyout is now back with a new immunology startup supported by $400 million. Mirador Therapeutics launched Thursday, aiming to take the precision medicine approaches that have led to advances in cancer drugs and apply them to the research of new therapies for immunology and inflammation. It’s a similar strategy to the one taken by Prometheus under the helm of Mark McKenna, now the CEO of San Diego-based Mirador. There’s a plethora of immunology drugs on the ...
- Source: drugdu
- 117
- March 25, 2024
POC Finger-Prick Blood Test Determines Risk of Neutropenic Sepsis in Patients Undergoing Chemotherapy

Neutropenia, a decrease in neutrophils (a type of white blood cell crucial for fighting infections), is a frequent side effect of certain cancer treatments. This condition elevates the risk of infections, including neutropenic sepsis—a potentially fatal reaction to infection and a severe complication of chemotherapy. Identifying the signs of neutropenic sepsis can be challenging, leading to a stressful and expensive treatment process. Consequently, all chemotherapy patients feeling ill are advised to seek emergency care to check for neutropenic sepsis. Unfortunately, half of these patients do not receive antibiotics quickly enough, while the other half, not at risk of neutropenic sepsis, unnecessarily visit the emergency department. 52North Health Ltd. (Cambridge UK) has developed NeutroCheck, a groundbreaking approach aimed at enhancing the safety and well-being of cancer patients. This innovation combines a finger-prick blood test with an AI-powered digital platform, allowing patients to evaluate their neutropenic sepsis risk at home. This affordable, ...
- Source: drugdu
- 96
- March 22, 2024

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