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11.07.25 - 14:00
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Secarna, Vect-Horus partner to develop RNA-targeted therapeutics (PBR)
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This partnership will combine the OligoCreator technology of Secarna with Vect-Horus' VECTrans system. The alliance uses Vect-Horus' expertise in delivering compounds across biological barriers using its VECTrans platform.
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10.07.25 - 14:24
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Simcere Pharmaceutical seeks China approval for atopic dermatitis treatment (PBR)
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This application aims to secure approval for treating adult and adolescent atopic dermatitis (AD). Under the partnership agreement, Connect Biopharma will receive up to approximately $110m in milestone
The post Simcere Pharmaceutical seeks China approval for atopic dermatitis treatment appeared first on Pharmaceutical Business review....
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09.07.25 - 12:48
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Rallybio sells REV102 programme to Recursion for up to $25m (PBR)
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The deal, valued at up to $25m, includes an upfront equity payment of $7.5m and near-term milestones, extending Rallybio's cash runway into mid-2027. The REV102 programme originated from
The post Rallybio sells REV102 programme to Recursion for up to $25m appeared first on Pharmaceutical Business review....
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08.07.25 - 12:48
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Sagent, Qilu partner to commercialise complex injectable products in US (PBR)
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Through this partnership, Sagent will gain sole rights to commercialise a select portfolio of Qilu's complex injectable products in the US. These products encompass high-impact therapeutic areas,
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07.07.25 - 13:12
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Biosynth opens expanded GMP bioconjugation facility in Germany (PBR)
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The new facility is claimed to enhance Biosynth's ability to manufacture GMP bioconjugates, supporting the production of intermediates and active pharmaceutical ingredients from early clinical stages till late-phase
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04.07.25 - 13:24
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FDA approves Hikma’s Tyzavan for multiple infections (PBR)
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Tyzavan is indicated for the treatment of several serious infections in adults and children one month and above, including septicemia, infective endocarditis, skin and skin structure infections, bone
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03.07.25 - 13:12
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FDA grants priority review for MSD′s Winrevair (PBR)
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This sBLA seeks to update the US product label reflecting the results from the Phase III ZENITH trial. Winrevair was initially approved in 2024 to treat adult people
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02.07.25 - 13:24
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Formycon, Bio Usawa to introduce ophthalmic medicine in Sub-Saharan Africa (PBR)
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Bioeq is also the exclusive holder of the global commercialisation rights for the medicine, Formycon's biosimilar candidate for Lucentis (ranibizumab). This agreement allows Bio Usawa to register and
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01.07.25 - 13:00
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Simtra BioPharma constructs production manufacturing building in Germany (PBR)
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The move is said to bolster the company's North America and Europe presence, meeting the worldwide demand for critical injectable therapeutics. This expansion has enlarged the total production
The post Simtra BioPharma constructs production manufacturing building in Germany appeared first on Pharmaceutical Business review....
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30.06.25 - 14:12
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Mabwell signs Albipagrastim alfa deal with Qilu Pharmaceutical (PBR)
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This agreement grants Qilu exclusive rights to develop, manufacture, enhance, utilise and commercialise Albipagrastim alfa for Injection in Greater China including Chinese Mainland, Macau, Hong Kong and Taiwan.
The post Mabwell signs Albipagrastim alfa deal with Qilu Pharmaceutical appeared first on Pharmaceutical Business review....
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27.06.25 - 13:36
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Innovent′s Mazdutide receives approval for chronic weight management in China (PBR)
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Mazdutide is a dual glucagon (GCG)/glucagon-like peptide-1 (GLP-1) receptor agonist. The therapy's unique dual mechanism not only promotes weight loss but also targets visceral fat and enhances metabolic
The post Innovent's Mazdutide receives approval for chronic weight management in China appeared first on Pharmaceutical Business review....
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26.06.25 - 14:12
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FDA approves Plus Therapeutics′ Reyobiq for paediatric brain cancer (PBR)
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Paediatric HGG, including ependymoma, are not only rare but also very difficult to treat, with current standard care failing to prevent recurrence and with five-year survival rates. Reyobiq
The post FDA approves Plus Therapeutics' Reyobiq for paediatric brain cancer appeared first on Pharmaceutical Business review....
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25.06.25 - 14:12
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EC grants orphan drug status to JR-446 for MPS IIIB (PBR)
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This follows a similar endorsement by the US Food and Drug Administration (FDA). Sanfilippo syndrome type B is an autosomal recessive disease marked by mutations in the N-acetyl-alpha-glucosaminidase
The post EC grants orphan drug status to JR-446 for MPS IIIB appeared first on Pharmaceutical Business review....
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24.06.25 - 14:00
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Optime Care collaborates with Tilde Sciences for Vecamyl tablets (PBR)
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This collaboration appoints Optime Care as the exclusive specialty pharmacy provider for the newly FDA-approved tablets, ensuring the medication's availability to patients. Optime Care general manager Bill Bertetto
The post Optime Care collaborates with Tilde Sciences for Vecamyl tablets appeared first on Pharmaceutical Business review....
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23.06.25 - 14:24
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Archeus Technologies gets FDA approval for ART-101 application (PBR)
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This new small molecule is designed for prostate cancer imaging and treatment. The FDA's approval allows Archeus to begin a Phase I clinical study targeting metastatic castration-resistant prostate
The post Archeus Technologies gets FDA approval for ART-101 application appeared first on Pharmaceutical Business review....
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20.06.25 - 13:12
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CHMP endorses ExCellThera’s stem cell transplantation product (PBR)
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The therapy is intended to treat the adult population with haematological malignancies needing an allogeneic haematopoietic stem cell transplantation after a myeloablative conditioning for those individuals with no
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19.06.25 - 12:48
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Johnson & Johnson submits sBLA to FDA to extend use of ustekinumab (PBR)
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The application is underpinned by the multi-centre, open-label Phase III UNITI-Jr clinical trial data, which assessed the therapy's safety, pharmacokinetics, and efficacy in paediatric subjects. At present, Stelara
The post Johnson & Johnson submits sBLA to FDA to extend use of ustekinumab appeared first on Pharmaceutical Business review....
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18.06.25 - 12:36
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Ferrer’s progressive supranuclear palsy therapy gains FDA fast track status (PBR)
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In-licensed from Asceneuron, this new molecular entity is currently undergoing a Phase II trial. The trial aims to assess the therapy's efficacy, pharmacokinetics, and safety in adults diagnosed
The post Ferrer's progressive supranuclear palsy therapy gains FDA fast track status appeared first on Pharmaceutical Business review....
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17.06.25 - 14:00
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FDA grants fast-track status to SolasCure’s gel for calciphylaxis ulcers (PBR)
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This status signifies the potential of the gel to broaden its therapeutic applications in chronic wound healing, accelerating its availability to patients. SolasCure noted that this hydrogel releases
The post FDA grants fast-track status to SolasCure's gel for calciphylaxis ulcers appeared first on Pharmaceutical Business review....
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16.06.25 - 13:24
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MRI and Astellas to support Japanese drug-discovery startups (PBR)
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This collaboration is expected to strengthen the country's role as an international hub for drug discovery. This new support is part of several programmes under the Medical Innovation
The post MRI and Astellas to support Japanese drug-discovery startups appeared first on Pharmaceutical Business review....
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