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NEWS

Boehringer Ingelheim Partners with Quallent Pharmaceuticals to Expand the Access of Cyltezo (Biosimilar, Humira) 
Shots:  Boehringer Ingelheim has signed an agreement with Quallent Pharmaceuticals to expand the access of citrate-free adalimumab-adbm, a biosimilar to Humira (adalimumab), across the US  As per the agreement, BI will handle the manufacturing activity of adalimumab-adbm for Quallent and will continue the commercialization of Cyltezo (adalimumab-adbm) injection and Adalimumab-adbm  Quallent will provide high-concentration (40mg/0.4mL)…
May 13, 2024
Xbrane Biopharma and STADA Team Up with Valorum Biologics for Commercializing Xlucane (Biosimilar, Ranibizumab) Across the US 
Shots:  Xbrane & STADA have signed an exclusive license agreement with Valorum Biologics to commercialize Xlucane, biosimilar of ranibizumab, across the US  As per the agreement, both companies will complete the regulatory approval process; Xbrane to handle commercial manufacturing & supply. Post approval, Valorum will take care of sales, marketing & other commercial activities of…
May 10, 2024
Azurity Pharmaceuticals
Azurity Pharmaceuticals’ Myhibbin (Mycophenolate Mofetil) Receives the US FDA’s Approval to Treat Organ Rejection 
Shots:  The US FDA has approved Azurity Pharmaceuticals’ Myhibbin oral suspension with its commercial availability anticipated in Q2’24   Myhibbin in addition to other immunosuppressants is intended for preventing organ rejection in adults & pediatric patients (age: ≥3mos.) of allogeneic kidney, heart, or liver transplant   Mycophenolate mofetil, an antimetabolite immunosuppressant, works on the immune system of…
May 6, 2024
Boehringer Ingelheim
The US FDA Approves High Concentration of Boehringer Ingelheim’s Cyltezo (Biosimilar, Humira) 
Shots:  Boehringer Ingelheim has received the US FDA’s approval for the high-concentration (100mg/mL), citrate-free formulation of Cyltezo (biosimilar to Humira) to treat various chronic inflammatory diseases. Its low concentration of 50mg/mL has been available since Jul 2023  The approval was supported partly by the data from P-I (VOLTAIRE-HCLF) evaluating the bioavailability of high-concentration vs low-concentration…
May 1, 2024
Aquestive
Aquestive Therapeutics’ Libervan Buccal Film Receives the US FDA’s Approval to Treat Seizure Activity  
Shots:   Aquestive’s Libervant buccal film (oral, 5mg, 7.5mg, 10mg, 12.5mg & 15mg) received the US FDA’s approval as an acute treatment of intermittent, stereotypic episodes of frequent seizure activity (seizure clusters, acute repetitive seizures), distinct from the usual pattern in epilepsy patients (2-5yrs.)  The company further provided an update on Anaphylm (epinephrine) sublingual film,…
April 29, 2024
Accord BioPharma’s Hercessi (Biosimilar, Herceptin) Receives the US FDA Approval
Shots:  Accord BioPharma's Hercessi (trastuzumab-strf; 150mg; IV), a biosimilar to Herceptin (trastuzumab), has been approved by the US FDA to treat HER2 overexpressing breast and G/GEJ cancer in the US  The approval was based on 2 studies incl. P-I (HLX02-HV01 & HLX02-HV02) trial assessing the single-dose, PK equivalence in healthy volunteers. P-III (HLX02-BC01) trial assessing…
April 29, 2024
Johnson& Johnson
Johnson & Johnson’s Sirturo Gains the CHMP’s Positive Opinion to Treat Multidrug-Resistant Tuberculosis 
Shots:  The CHMP has granted positive opinion to the company’s Sirturo (bedaquiline) and recommended approving its Type II variation plus transitioning its conditional marketing authorization into a standard marketing authorization  The opinion was based on the data from P-III (STREAM) stage 2 trial assessing the safety & efficacy of bedaquiline-containing regimen to treat MDR-TB, depicting…
April 29, 2024
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