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PBR Nachrichten

PBR (Pharmaceutical Business Review) ist ein Onlineportal mit News zur Pharma- und Biotechnologiebranche. Die Redaktion berichtet über neue Medikamente und deren Zulassungsverfahren, sowie über geschäftliche Entwicklungen von Pharmaunternehmen.
 
15.09.25 - 14:12
YolTech Therapeutics raises approximately $45m via Series B financing (PBR)
 
The funds will help YolTech in advancing its clinical programmes and global strategic execution. Established in 2021, YolTech Therapeutics is stated to be advancing next-generation in vivo gene-editing The post YolTech Therapeutics raises approximately $45m via Series B financing appeared first on Pharmaceutical Business review....
12.09.25 - 14:48
Dewpoint Therapeutics secures funding for DPTX3186 development (PBR)
 
The company aims to achieve early clinical proof-of-concept for the therapy by late 2026. Dewpoint noted that the financing will also expedite the development of its first-in-class c-mod The post Dewpoint Therapeutics secures funding for DPTX3186 development appeared first on Pharmaceutical Business review....
11.09.25 - 14:24
Odyssey Therapeutics raises $213m via Series D (PBR)
 
The Boston-based company secured backing from existing investors and new investors, including Affinity Asset Advisors, Dimension Capital, Jeito Capital, Lightspeed Ventures, TPG Life Sciences Innovations, and Wedbush Healthcare The post Odyssey Therapeutics raises $213m via Series D appeared first on Pharmaceutical Business review....
10.09.25 - 14:12
FDA grants breakthrough therapy status to Ionis ION582 to treat Angelman syndrome (PBR)
 
AS, a rare neurological disorder often diagnosed in infancy, affects approximately one in 21,000 individuals worldwide and is caused by the loss of function of the maternal UBE3A The post FDA grants breakthrough therapy status to Ionis ION582 to treat Angelman syndrome appeared first on Pharmaceutical Business review....
09.09.25 - 13:00
Novonesis and Novo Nordisk collaborate on gut microbiome research initiative (PBR)
 
The gut microbiome is composed of microorganisms, including viruses, bacteria, and fungi, that naturally reside in the human gut. The companies will work together to investigate solutions aimed The post Novonesis and Novo Nordisk collaborate on gut microbiome research initiative appeared first on Pharmaceutical Business review....
08.09.25 - 14:00
Takeda receives FDA approval for Vonvendi sBLA (PBR)
 
VWD is the most prevalent inherited bleeding disorder in the US, affecting over three million individuals, with both men and women equally susceptible. Vonvendi is also approved for The post Takeda receives FDA approval for Vonvendi sBLA appeared first on Pharmaceutical Business review....
05.09.25 - 13:24
FDA grants breakthrough therapy status to Eli Lilly’s olomorasib (PBR)
 
This designation applies when olomorasib is used in combination with the anti-PD-1 therapy Keytruda (pembrolizumab) for the initial treatment of unresectable advanced or metastatic non-small cell lung cancer The post FDA grants breakthrough therapy status to Eli Lilly's olomorasib appeared first on Pharmaceutical Business review....
04.09.25 - 14:12
Andelyn and Tern partner for gene therapy to treat CLN2 Batten disease (PBR)
 
This therapy is aimed at addressing vision loss in children with this disease, a rare paediatric neurodegenerative disorder for which there is currently no treatment available for its The post Andelyn and Tern partner for gene therapy to treat CLN2 Batten disease appeared first on Pharmaceutical Business review....
03.09.25 - 13:48
Polpharma Biologics signs biosimilars licensing deals with MS Pharma (PBR)
 
According to the agreements, MS Pharma will oversee the registration, marketing along with the distribution of vedolizumab (PB016), ocrelizumab (PB018), and guselkumab (PB019) throughout MENA. Polpharma Biologics will The post Polpharma Biologics signs biosimilars licensing deals with MS Pharma appeared first on Pharmaceutical Business review....
02.09.25 - 13:36
OMass signs deal with Genentech for IBD small molecules (PBR)
 
Genentech will obtain rights for OMass' preclinical oral small molecule programme for IBD, as part of the agreement. OMass Therapeutics CEO Ros Deegan said: “Using our OdyssION platform, The post OMass signs deal with Genentech for IBD small molecules appeared first on Pharmaceutical Business review....
01.09.25 - 13:12
FDA approves Eisai and Biogen′s Leqembi Iqlik BLA for early Alzheimer′s (PBR)
 
This new dosing option enables patients with mild cognitive impairment or mild dementia to receive treatment at home, following an initial intravenous (IV) administration. Leqembi Iqlik, administered through The post FDA approves Eisai and Biogen's Leqembi Iqlik BLA for early Alzheimer's appeared first on Pharmaceutical Business review....
29.08.25 - 13:24
EMA grants orphan designation to Aldeyra′s ADX-2191 for vitreoretinal lymphoma (PBR)
 
This is a rare and aggressive form of cancer for which there is no approved treatment currently. Aldeyra president and CEO Todd Brady said: “Primary vitreoretinal lymphoma is The post EMA grants orphan designation to Aldeyra's ADX-2191 for vitreoretinal lymphoma appeared first on Pharmaceutical Business review....
28.08.25 - 14:00
Leal Therapeutics raises $30m in Series A funding for neuro-metabolic therapies (PBR)
 
This round of financing was led by SV Health Investors' Dementia Discovery Fund (DDF), with contributions from existing investors including Newpath Partners, OrbiMed, Euclidean Capital, Chugai Venture Fund, The post Leal Therapeutics raises $30m in Series A funding for neuro-metabolic therapies appeared first on Pharmaceutical Business review....
26.08.25 - 14:36
FDA expands Amgen′s Repatha use to adults at risk of cardiovascular events (PBR)
 
This change eliminates the previous requirement for a cardiovascular disease diagnosis prior to treatment. Amgen global commercial operations executive vice president Murdo Gordon said: “Far too many adults The post FDA expands Amgen's Repatha use to adults at risk of cardiovascular events appeared first on Pharmaceutical Business review....
25.08.25 - 15:00
Piramal Pharma opens oral solid dosage suite in Pennsylvania, US (PBR)
 
The investment equips NewAmsterdam Pharma with the commercial capability to produce a fixed dose combination (FDC) of obicetrapib and ezetimibe, thereby addressing potential market demand. Piramal Pharma Solutions The post Piramal Pharma opens oral solid dosage suite in Pennsylvania, US appeared first on Pharmaceutical Business review....
22.08.25 - 14:24
BeOne Medicines receives EC approval for Brukinsa tablet formulation (PBR)
 
Brukinsa's recommended dose remains 320mg a day. The new tablets, each 160mg, allow patients to halve their intake of daily pill from four to two. Moreover, these tablets The post BeOne Medicines receives EC approval for Brukinsa tablet formulation appeared first on Pharmaceutical Business review....
21.08.25 - 14:36
BMS Secures Health Canada approval for dual immunotherapy (PBR)
 
Additionally, this combination is approved for the treatment of unresectable or advanced hepatocellular carcinoma (HCC). The approval introduces a dual immunotherapy option for two difficult-to-treat gastrointestinal cancers. Evidence The post BMS Secures Health Canada approval for dual immunotherapy appeared first on Pharmaceutical Business review....
20.08.25 - 14:36
Santhera signs deal with Uniphar for GCC distribution of Agamree (PBR)
 
The therapy is intended for the treatment of Duchenne muscular dystrophy (DMD) in patients aged four years and above. Sales are projected to begin on a named patient The post Santhera signs deal with Uniphar for GCC distribution of Agamree appeared first on Pharmaceutical Business review....
19.08.25 - 14:12
FDA grants orphan drug status to Soligenix′s dusquetide (PBR)
 
This designation comes after the FDA Office of Orphan Products Development reviewed recent Phase IIa clinical trial results, which showed both biological efficacy and safety in patients with The post FDA grants orphan drug status to Soligenix's dusquetide appeared first on Pharmaceutical Business review....
18.08.25 - 14:00
Halda receives FDA fast track status for HLD-0915 to treat prostate cancer (PBR)
 
The FDA's designation is designed to expedite the review of treatments. It offers opportunities for more frequent discussions with the FDA regarding the clinical development plan of a The post Halda receives FDA fast track status for HLD-0915 to treat prostate cancer appeared first on Pharmaceutical Business review....
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