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.
 
22.05.20 - 13:37
Antisense ATL1102 final phase 2 DMD results meet primary endpoint and exceed expectations on secondary endpoints (PBR)
 
Importantly, the final trial results have also confirmed the drug's positive effects on the secondary trial endpoints that assessed the drug's activity and efficacy including measuring the effects The post Antisense ATL1102 final phase 2 DMD resul...
22.05.20 - 13:25
Appili set to evaluate favipiravir as preventive measure against Covid-19 (PBR)
 
The Canadian biopharma company expects to immediately begin recruitment for the mid-stage trial of favipiravir with an aim to enroll nearly 760 subjects from both residents and staff The post Appili set to evaluate favipiravir as preventive measure ...
22.05.20 - 12:49
Nautilus Biotechnology raises $76m in series B funding to be first to quantify human proteome (PBR)
 
Nautilus' total funding now exceeds $100 million. The Nautilus platform will deliver single-molecule sensitivity more quickly, more completely, and less expensively than is possible with existing technologies. This The post Nautilus Biotechnology r...
22.05.20 - 11:13
Sunovion gets FDA nod for Kynmobi to treat Parkinson′s disease off episodes (PBR)
 
The approval enables to use of Kynmobi sublingual film for the acute and intermittent treatment of off episodes in patients with Parkinson's disease. Kynmobi, a novel formulation of The post Sunovion gets FDA nod for Kynmobi to treat Parkinson's d...
21.05.20 - 13:26
Gilead and Galapagos announce positive topline results of phase 2b/3 trial of filgotinib in moderately to severely active ulcerative colitis (PBR)
 
Filgotinib 200 mg achieved all primary endpoints in the study, inducing clinical remission at Week 10 and maintaining clinical remission at Week 58 in a significantly higher proportion The post Gilead and Galapagos announce positive topline results ...
21.05.20 - 11:37
LYNPARZA approved in US for HRR gene-mutated metastatic castration-resistant prostate cancer (PBR)
 
The approval by the US Food and Drug Administration (FDA) was based on results from the Phase III PROfound trial, which were published in the New England Journal The post LYNPARZA approved in US for HRR gene-mutated metastatic castration-resistant p...
21.05.20 - 11:37
FDA approves Octapharma USA′s IND application to begin trial with severe Covid-19 patients (PBR)
 
Octagam 10% is an immune globulin intravenous (human) liquid preparation designated to treat chronic immune thrombocytopenic purpura (ITP) in adults. According to the company, the primary objective of The post FDA approves Octapharma USA's IND appl...
20.05.20 - 13:25
Janssen announces phase 1 results for amivantamab in advanced NSCLC harbouring Exon 20 insertion mutations (PBR)
 
Amivantamab is an EGFR and MET-targeted bispecific antibody, which targets activating and resistance EGFR mutations, and MET pathway activation. Investigators assessed efficacy using overall response rate (ORR) per The post Janssen announces phase 1...
20.05.20 - 13:25
Rallybio raises $145m in Series B round for developing rare disease drug candidates (PBR)
 
According to Rallybio, new investors who took part in the funding round included Viking Global Investors, TPG's The Rise Fund, funds managed by Tekla Capital Management, F-Prime Capital, The post Rallybio raises $145m in Series B round for developi...
20.05.20 - 12:13
Tolero Pharmaceuticals submits investigational new drug application for experimental PKM2 a ctivator TP-1454 (PBR)
 
Under this IND, Tolero intends to conduct a Phase 1/1b, first-in-human, open-label, dose‑escalation, safety, pharmacokinetic and pharmacodynamic study, which will evaluate oral TP‑1454 alone, and in combination with The post Tolero Pharmaceutica...
20.05.20 - 11:14
Novartis firm AveXis gets EC nod for Zolgensma to treat spinal muscular atrophy (PBR)
 
The approval allows Zolgensma to treat patients with 5q SMA with a bi-allelic mutation in the SMN1 gene and a clinical diagnosis of SMA Type 1or patients with The post Novartis firm AveXis gets EC nod for Zolgensma to treat spinal muscular atrophy a...
19.05.20 - 12:37
FDA approves Genentech′s Tecentriq as first-line monotherapy for certain people with metastatic NSCLC (PBR)
 
“We are pleased to offer people with certain types of lung cancer a new chemotherapy-free option that can help prolong their lives and be administered on a flexible The post FDA approves Genentech's Tecentriq as first-line monotherapy for certain...
19.05.20 - 11:13
Moderna′s Covid-19 vaccine shows significant effect in early human trial (PBR)
 
The company has reported positive interim clinical data of mRNA-1273 from the phase 1 study by the National Institute of Allergy and Infectious Diseases (NIAID), part of the The post Moderna's Covid-19 vaccine shows significant effect in early huma...
18.05.20 - 12:25
Can-Fite announces pre-IND submission to US FDA for Piclidenoson in treatment of Covid-19 infected patients with moderate-to-severe symptoms (PBR)
 
Can-Fite BioPharma, a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, today announced it has filed a pre-Investigational New The post Can-Fite announces pre-IND sub...
18.05.20 - 11:25
Deciphera gets FDA nod for Qinlock to treat fourth-line gastrointestinal stromal tumour (PBR)
 
The FDA approval allows Qinlock, a kinase inhibitor, to treat adult patients with advanced GIST who have secured prior treatment with three or more kinase inhibitors, including imatinib. The post Deciphera gets FDA nod for Qinlock to treat fourth-li...
15.05.20 - 13:02
NantKwest and ImmunityBio to initiate a phase 2 study of immunotherapy for metastatic pancreatic cancer (PBR)
 
Four metastatic pancreatic cancer patients have been treated with PD-L1 t-haNK and N-803 under single patient INDs, with two patients on treatment for an evaluable period. One patient reported The post NantKwest and ImmunityBio to initiate a phase ...
15.05.20 - 12:01
Neuraptive Therapeutics announces FDA has granted fast track designation to NTX-001 clinical development programme to treat peripheral nerve injuries (PBR)
 
FDA Fast Track is a program designed to facilitate and expedite the development and review of a new drugs that demonstrates the potential to address an unmet medical The post Neuraptive Therapeutics announces FDA has granted fast track designation t...
15.05.20 - 11:48
Takeda gets expanded EC approval for lymphoma drug Adcetris (PBR)
 
Adcetris (brentuximab vedotin) is an antibody-drug conjugate (ADC) that includes an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent monomethyl auristatin E (MMAE) The post Takeda gets expanded ...
14.05.20 - 13:37
Cipla enters into a licensing agreement with Gilead to expand access to Covid-19 treatment (PBR)
 
This agreement is part of Cipla’s efforts to enhance global access to life-saving treatments for patients affected by the pandemic. As part of the agreement, Cipla will be The post Cipla enters into a licensing agreement with Gilead to expand acce...
14.05.20 - 12:49
Boehringer Ingelheim collaborates with CDR-Life to develop antibody fragment-based therapeutics for geographic atrophy (PBR)
 
GA is a progressive, irreversible retinal disease that occurs in patients with age-related macular degeneration (AMD) for which there is no current treatment. Together, with Boehringer Ingelheim's expertise The post Boehringer Ingelheim collaborate...
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