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This round will also bolster the company's manufacturing offerings and support additional pipeline therapies. It was jointly led by OrbiMed, Frazier Life Sciences, ARCH Venture Partners and Revelation The post Aspen closes $115m in Series C to advance Parkinson's cell therapy appeared first on Pharmaceutical Business review....

The authorisations cover Gobivaz in both 100mg/ml and 50mg/0.5ml formulations, provided in pre-filled syringes with autoinjector formats and passive needle safety guards, to treat adults with axial spondyloarthritis, The post Alvotech and Advanz announce EC approval for Gobivaz biosimilar appeared first on Pharmaceutical Business review....

This is in breach of the Texas Health Care Program Fraud Prevention Act. The ADHD drugs case centred on the medication Quillivant XR, provided to children on Medicaid. The post Pfizer and Tris reach settlement with Texas over ADHD drug allegations appeared first on Pharmaceutical Business review....

This is in breach of the Texas Health Care Program Fraud Prevention Act. The ADHD drugs case centred on the medication Quillivant XR, provided to children on Medicaid. The post Pfizer and Tris agree with Texas over ADHD drug allegations appeared first on Pharmaceutical Business review....

The approval follows positive results from the Phase I/II GO29781 study, which demonstrated that Lunsumio SC has pharmacokinetic non-inferiority to intravenous (IV) administration. No unexpected safety issues were The post EC authorises Roche's Lunsumio SC for follicular lymphoma appeared first on Pharmaceutical Business review....

The protection for this patent will last until 2037. Genprex has also obtained similar patent protection for the gene therapy used with PD-L1 antibodies in Korea, and is The post USPTO grants patent to Genprex's Reqorsa gene therapy appeared first on Pharmaceutical Business review....

This is the first approved treatment for NCFB in the European Union (EU). Approval followed evaluation of data from the Phase III Aspen and Phase II Willow studies The post Insmed receives EC approval for Brinsupri to treat NCFB appeared first on Pharmaceutical Business review....

The acquisition brings Halda's lead candidate, HLD-0915, a clinical-stage treatment for prostate cancer, into Johnson & Johnson's oncology portfolio. This once-daily therapy presents an opportunity to enhance patient The post Johnson & Johnson to acquire Halda Therapeutics for $3.05bn appeared first on Pharmaceutical Business review....

The fund will focus on medical technology and biopharmaceutical companies that seek to meet pressing unmet clinical needs, leveraging Sofinnova's multi-strategy platform and investment team. It will leverage The post Sofinnova closes €650m healthcare fund for early-stage ventures appeared first on Pharmaceutical Business review....

Leqembi is a humanised anti-soluble aggregated amyloid-beta monoclonal antibody. The development follows the August 2024 approval for treating mild cognitive impairment (MCI) and mild dementia caused by Alzheimer's The post Eisai and Biogen report Leqembi's MHRA approval for Alzheimer's appeared first on Pharmaceutical Business review....

This collaboration is intended for the development of advanced biological signatures to improve targeted treatment strategies. It centres on leveraging BostonGene's AI-powered omnimodal platform to analyse tumour molecular The post BostonGene and Kyoto University link on oesophageal cancer drug appeared first on Pharmaceutical Business review....

The RMAT designation was based on initial data from March Bio's ongoing multi-centre Phase II clinical trial, which indicated clinical activity and a manageable safety profile in a The post March Bio's MB‑105 gains FDA RMAT for CD5+ T‑cell lymphoma appeared first on Pharmaceutical Business review....

The new site increases capacity and strengthens the company's supply chain capabilities for RLTs in the US. The facility in Carlsbad, filed with the US Food and Drug The post Novartis opens California site for RLT manufacturing appeared first on Pharmaceutical Business review....

These candidates will be developed using SanegeneBio's tissue-selective ligand and enhancer assisted delivery (LEAD) technology. The partnership focuses on advancing new therapies that can potentially be administered subcutaneously The post SanegeneBio and Lilly sign RNAi licence deal for metabolic diseases appeared first on Pharmaceutical Business review....

The authorisations are granted for Gobivaz in 50 mg/0.5 mL and 100 mg/mL formulations, available in pre-filled syringes and autoinjectors. The medication is indicated for the treatment of The post Alvotech and Advanz announce MHRA marketing authorisations for Gobivaz appeared first on Pharmaceutical Business review....

The designation highlights the considerable unmet medical needs of patients with AML and recognises LTI-214's therapeutic potential as a new treatment for this aggressive form of blood cancer. The post Leukogene Therapeutics gains FDA ODD status for M2T-CD33 appeared first on Pharmaceutical Business review....

This agreement will involve the development and commercialisation of the anaesthetic intended for managing postoperative pain. The deal includes $5m upfront to AmacaThera and up to $225m in The post AmacaThera and Pacira sign agreement for AMT-143 appeared first on Pharmaceutical Business review....

Sativex is indicated for the enhancement of symptoms in adult patients experiencing moderate to severe spasticity due to multiple sclerosis (MS) who have not responded sufficiently to other The post CNX Therapeutics expands CNS portfolio with Sativex acquisition appeared first on Pharmaceutical Business review....

CAL101 is intended for the treatment of idiopathic pulmonary fibrosis (IPF). It is currently studied in the Phase II AURORA trial, with patient recruitment underway in the US, The post Calluna secures FDA orphan drug designation for CAL101 in IPF appeared first on Pharmaceutical Business review....

This topical, steroid-free formulation is applied once daily and can be used for long-term disease control without limits on duration or body surface area. Clinical trials have shown The post Arcutis introduces roflumilast cream for paediatric atopic dermatitis appeared first on Pharmaceutical Business review....