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Bora plants its flag in the US with $210M acquisition of generics manufacturer Upsher-Smith

Taiwan-based CDMO Bora Pharmaceuticals is expanding its business in the United States, acquiring Minnesota generics manufacturer Upsher-Smith Laboratories for $210 million. Upsher-Smith, which was established in 1919, brings two manufacturing facilities that are five miles apart in the suburbs of Minneapolis. These become Bora’s first facilities in the U.S. Bora also has a 170,000 square meter plant in Mississauga, Ontario, which acts as its North America headquarters. Upsher-Smith produces a portfolio of 48 generic products. Its plants can handle packaging and a range of formulations including oral solids, liquids and topical powders. The sites have a total annual capacity of 3.5 billion doses. “This is a significant milestone for Bora Group, marking the most critical expansion of Bora’s presence in the U.S. market and significantly enhancing Bora’s position as a global competitor,” Bora CEO Bobby Sheng said in a release. The acquisition also supports Bora’s commercial prescription business, TWi, which ...
- Source: drugdu
- 101
- January 20, 2024
Brush Biopsy Test Detects Oral Cancer without Surgery

Oral squamous cell carcinoma, the most common type of oral cancer and globally the ninth most prevalent cancer, currently relies on surgical biopsies for diagnosis. This additional referral step poses the risk of losing patients who may not return for follow-up until the cancer has progressed to advanced, more challenging stages. Additionally, surgical biopsies can be problematic as they often collect a mix of cell types, complicating the analysis, and creating the risk of spreading cancerous cells to other parts of the mouth. General blood tests looking for cancer’s genetic signals also have limitations, as they do not specify the tumor’s location, preventing quick initiation of treatment after detection. Now, a new test that allows dentists to screen for oral squamous cell carcinoma with a simple brush could early detection of oral cancer without surgery. The diagnostic kit, created by researchers at the University of Illinois Chicago (Urbana, IL, USA), ...
- Source: drugdu
- 125
- January 20, 2024
One-Minute COVID-19 Test Adaptable For Detecting Other Viruses with Spike-Like Proteins

Several animals ranging from fireflies to lantern fish have the chemical tools needed to produce light. Such a reaction usually requires the substrate luciferin and the enzyme luciferase. However, a class of less discriminating luciferins, termed as imidazopyrazinone-type (IPT) compounds, has the ability to glow upon coming into contact with other proteins, including ones that are not considered to be enzymes. Previous studies have suggested that IPT luciferins could act as the basis for a new type of medical test that utilizes luminescence to indicate the presence of a target protein in a specimen. Now, a team of researchers has developed a glowing test, based on their belief that an IPT luciferin can react with the SARS-CoV-2 spike protein, which allows the virus particles to invade cells and cause COVID-19. In their research, the team at the National Institute of Advanced Industrial Science and Technology (AIST, Ibaraki, Japan) focused on ...
- Source: drugdu
- 98
- January 20, 2024
Bayer’s Cost-Cutting Plans Take Aim at Multiple Layers of Management

CEO Bill Anderson said despite prior cost-cutting measures, Bayer still has too many layers of management and bureaucracy. A new restructuring will come with layoffs but the corporate shakeup plan does not yet include a separation of Bayer’s business units. By FRANK VINLUAN Bayer is implementing a corporate restructuring that will slash an unspecified number of jobs, particularly within management. But the strategy does not include a breakup of the conglomerate—at least not yet. In announcing its new strategy late Wednesday, Bayer said it aims to reduce hierarchies and eliminate bureaucracy in the company. The job cuts will happen over the coming months and will be completed by the end of next year at the latest, the company said. Bayer’s corporate shakeup is not entirely a surprise. CEO Bill Anderson, who joined Bayer last June after serving as the chief executive of Roche’s pharmaceuticals division, has been critical of bloat ...
- Source: drugdu
- 120
- January 20, 2024
Gearing Up to Challenge Pfizer in a Rare Disease, BridgeBio Secures Up to $1.25B

BridgeBio will receive $500 million in exchange for royalties from sales of acoramidis, a drug currently under FDA review for treating heart complications caused by the rare disease transthyretin amyloidosis. The deal also refinances lending agreements, providing BridgeBio with access to additional capital. By FRANK VINLUAN BridgeBio Pharma is preparing to compete against a blockbuster Pfizer product for a rare disease with few treatment options. A new financing deal provides the company with the capital to support planned commercialization of its drug, which is currently under FDA review. The agreement announced Thursday calls for Blue Owl Capital and Canada Pension Plan Investment Board to pay BridgeBio $500 million cash in exchange for royalties of 5% from sales of the biotech’s drug, acoramidis. The deal provides the Palo Alto, California-based biotech an additional $450 million in committed capital by refinancing its lending agreement with Blue Owl. The company could also receive ...
- Source: drugdu
- 177
- January 20, 2024
Smart Palm-size Optofluidic Hematology Analyzer Enables POCT of Patients’ Blood Cells

Variations in blood cell concentration can be indicative of several health conditions, including infections, inflammatory diseases, malignant blood disorders, and AIDS (Acquired Immune Deficiency Syndrome). Detecting these variations is crucial for diagnosing, treating, and managing these diseases. Traditional methods for measuring blood cell concentration, like using a hemocytometer, typically require an optical microscope. Alternatively, flow cytometers offer a more efficient method for sorting and counting blood cells in fluids, but they are often large and complex, weighing between 9-30 kg, thus limiting their use to laboratory and hospital settings. This restricts the availability of point-of-care testing (POCT) and can delay treatment for patients. Now, a proposed portable smart blood cell analyzer could help overcome the limitations of conventional methods for blood cell concentration detection. Developed by the Harbin Institute of Technology (HIT, Heilongjiang, China), this innovative analyzer integrates a miniature fluorescence microscope, typically used in neuroscience and behavioral research, with ...
- Source: drugdu
- 115
- January 19, 2024
Smart Palm-size Optofluidic Hematology Analyzer Enables POCT of Patients’ Blood Cells

Variations in blood cell concentration can be indicative of several health conditions, including infections, inflammatory diseases, malignant blood disorders, and AIDS (Acquired Immune Deficiency Syndrome). Detecting these variations is crucial for diagnosing, treating, and managing these diseases. Traditional methods for measuring blood cell concentration, like using a hemocytometer, typically require an optical microscope. Alternatively, flow cytometers offer a more efficient method for sorting and counting blood cells in fluids, but they are often large and complex, weighing between 9-30 kg, thus limiting their use to laboratory and hospital settings. This restricts the availability of point-of-care testing (POCT) and can delay treatment for patients. Now, a proposed portable smart blood cell analyzer could help overcome the limitations of conventional methods for blood cell concentration detection. Developed by the Harbin Institute of Technology (HIT, Heilongjiang, China), this innovative analyzer integrates a miniature fluorescence microscope, typically used in neuroscience and behavioral research, with ...
- Source: drugdu
- 121
- January 19, 2024
Gene-Edited Cell Therapy Casgevy Gains FDA Approval for Transfusion-Dependent Beta Thalassemia

Pharmaceutical Executive Editorial Staff Vertex Pharmaceuticals’ and CRISPR Therapeutics’ Cas9 therapy Casgevy approved as a one-time treatment for transfusion-dependent beta thalassemia on the heels of its approval last month for sickle cell disease. The FDA has granted another approval to Vertex Pharmaceuticals’ and CRISPR Therapeutics’ gene-editing therapy Casgevy (exagamglogene autotemcel [exa-cel]) as a one-time treatment for transfusion-dependent beta thalassemia (TDT) in patients 12 years of age and older.1 Last month, Casgevy became the first FDA-approved novel genome editing technology for sickle cell disease (SCD), which was a significant advancement in gene therapy. The latest approval was months ahead of the FDA’s assigned Prescription Drug User Fee Act (PDUFA) date. “We are pleased with the approval of Casgevy in TDT well ahead of the PDUFA date,” said Samarth Kulkarni, PhD, chairman and chief executive officer of CRISPR Therapeutics.2 “The approval is a reflection of the power and versatility of the CRISPR ...
- Source: drugdu
- 115
- January 19, 2024
Cell Therapy Startup With Stanford Roots Unveils $75M to Seek Inflammation Cures

Startup TrX1 develops cell therapies that function like a particular type of regulatory T cell, or Treg, whose role includes dampening inflammation and inducing long-term tolerance. Based on research from Stanford, TrX1’s lead program is a potential therapy for preventing graft-versus-host disease. By FRANK VINLUAN Post a comment / Jan 17, 2024 at 6:04 PM When immune cells go awry and spark inflammation, a different type of immune cell stands ready to counteract that effect and return the immune system to a state of balance. Therapies based on such cells are part of an emerging area of research for the treatment of a wide range of autoimmune diseases. The work of Tr1X focuses on a particular type of these cells and the startup has emerged from stealth with $75 million and a lead program on track for the clinic later this year. The cells that tamp down excessive immune responses ...
- Source: drugdu
- 114
- January 19, 2024
Coya stretches lead drug’s development to Parkinson’s and dementia

Coya Therapeutics is expanding its development plans to study the company’s lead combination therapy COYA-302 in frontotemporal dementia and Parkinson’s disease in addition to amyotrophic lateral sclerosis (ALS) This follows the announcement of successful pre-IND and Type C meetings between Coya and the US Food and Drug Administration (FDA) earlier this month about the candidate. The company plans to file an IND for developing the drug in frontotemporal dementia in Q2 2024 and start a Phase II study the same quarter. The plans for studying COYA-302 in Parkinson’s will follow later, with an IND filing and a Phase I/II start proposed in 2025. In a deal worth up to $677.25m, Dr Reddy’s Laboratories had signed a licence agreement with Coya in December to develop and commercialise COYA 302 to treat ALS in the European Union (EU), the UK, the US and Canada. Under the terms of the agreement, Coya can ...
- Source: drugdu
- 122
- January 19, 2024

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