Researchers show new therapeutic avenues in bone repair
Pharma Business International
by Tess Egginton
3d ago
Birmingham researchers have shown PEPITEM, a naturally occurring peptide (small protein) holds promise as a new therapeutic for osteoporosis and other disorders that feature bone loss, with distinct advantages over existing drugs. PEPITEM (Peptide Inhibitor of Trans-Endothelial Migration) was first identified in 2015 by University of Birmingham researchers. The latest research, published in Cell Reports Medicine, show for the first time that PEPITEM could be used as a novel and early clinical intervention to reverse the impact of age-related musculoskeletal diseases, with data demonstrating t ..read more
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HI-Bio acquired by Biogen in $1.8bn deal
Pharma Business International
by Tess Egginton
3d ago
Biogen is set to acquire Jeito Capital company HI-Bio, a clinical-stage portfolio biotechnology company focused on targeted therapies for patients with severe immune-mediated diseases (IMDs), for $1.15 billion upfront and up to $650 million in potential milestone payments. HI-Bio, is a San Francisco-based Phase II clinical-stage biopharma company with clinical development in Europe and the US. The company has several late-stage clinical development programs for felzartamab, its lead clinical therapeutic candidate, which are aimed at the treatment of four indications of severe immune-mediated ..read more
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Zai Lab and Innoviva Specialty Therapeutics secure approval for XACDURO for hospital-acquired and ventilator-associated pneumonia in China
Pharma Business International
by Tess Egginton
5d ago
China’s National Medical Products Administration (NMPA) has approved Zai Lab’s New Drug Application (NDA) for XACDURO® (sulbactam-durlobactam) for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex in patients 18 years of age and older. The World Health Organization considers Acinetobacter a top-priority pathogen worldwide that needs novel antibiotics. “The NMPA approval of XACDURO demonstrates Zai Lab’s commitment to developing and delivering innovativ ..read more
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AstraZeneca plans $1.5bn manufacturing facility for antibody drug conjugates in Singapore
Pharma Business International
by Tess Egginton
5d ago
AstraZeneca has revealed plans to build a $1.5 billion manufacturing facility in Singapore for antibody drug conjugates (ADCs), enhancing global supply of its ADC portfolio. ADCs are next-generation treatments that deliver highly potent cancer-killing agents directly to cancer cells through a targeted antibody. The planned greenfield facility, supported by the Singapore Economic Development Board (EDB), will be AstraZeneca’s first end-to-end ADC production site, fully incorporating all steps of the manufacturing process at a commercial scale. Manufacturing of ADCs is a multi-step process that ..read more
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Johnson & Johnson to acquire Proteologix
Pharma Business International
by Tess Egginton
5d ago
Johnson & Johnson has entered into a definitive agreement to acquire Proteologix, a privately-held biotechnology company focused on bispecific antibodies for immune-mediated diseases, for $850 million in cash, with potential for an additional milestone payment. Proteologix’s portfolio includes PX128, a bispecific antibody targeting IL-13 plus TSLP, which is ready to enter phase 1 development for moderate to severe atopic dermatitis (AD) and moderate to severe asthma, and PX130, a bispecific antibody targeting IL-13 plus IL-22, which is in preclinical development for moderate to severe AD ..read more
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FDA approves Amgen’s IMDELLTRA for the treatment of extensive-stage small cell lung cancer
Pharma Business International
by Tess Egginton
6d ago
The U.S. Food and Drug Administration (FDA) has approved Amgen’s IMDELLTRA (tarlatamab-dlle) for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. IMDELLTRA has received accelerated approval based on the encouraging response rate and duration of response (DoR) observed in clinical studies. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). “The FDA’s approval of IMDELLTRA marks a pivotal moment for patient ..read more
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Nuvalent receives U.S. FDA breakthrough therapy designation for NVL-655
Pharma Business International
by Tess Egginton
1w ago
The U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation (BTD) to Nuvalent’s NVL-655 for the treatment of patients with locally advanced or metastatic ALK-positive non-small cell lung cancer (NSCLC) who have been previously treated with two or more ALK tyrosine kinase inhibitors (TKIs). ALK rearrangements occur in up to approximately 5% of metastatic NSCLCs. At the time of diagnosis, up to 40% of these patients present with accompanying brain metastases, and approximately 50% of patients develop resistance mutations following treatment with currently avail ..read more
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WHO prequalifies new dengue vaccine
Pharma Business International
by Tess Egginton
1w ago
A new vaccine for dengue has received prequalification from the World Health Organization (WHO). TAK-003 is the second dengue vaccine to be prequalified by WHO. Developed by Takeda, it is a live-attenuated vaccine containing weakened versions of the four serotypes of the virus that cause dengue. WHO recommends the use of TAK-003 in children aged 6–16 years in settings with high dengue burden and transmission intensity. The vaccine should be administered in a 2-dose schedule with a 3-month interval between doses. “The prequalification of TAK-003 is an important step in the expansion of global ..read more
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Bristol Myers Squibb’s CAR T cell therapy Breyanzi approved by U.S. Food and Drug Administration for relapsed or refractory follicular lymphoma
Pharma Business International
by Tess Egginton
1w ago
The U.S. Food and Drug Administration (FDA) has granted accelerated approval for Bristol Myers Squibb’s Breyanzi ® (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy, for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received two or more prior lines of systemic therapy. This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory ..read more
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New 3D printing research paves way for personalised medication
Pharma Business International
by Tess Egginton
1w ago
A new technique for 3D printing medication has enabled the printing of multiple drugs in a single tablet, paving the way for personalised pills that can deliver timed doses. Researchers from the University of Nottingham’s Centre for Additive Manufacturing have led research alongside the Schools of Pharmacy and Life Sciences that has fabricated personalised medicine using Multi-Material InkJet 3D Printing (MM-IJ3DP). The research has been published in Materials Today Advances. The team have developed a cutting-edge method that enables the fabrication of customised pharmaceutical tablets with ..read more
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