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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.
 
15.02.19 - 11:49
Clinigen to acquire US rights to Novartis cancer drug Proleukin (PBR)
 
Proleukin is approved in the US for the treatment of metastatic melanoma and metastatic renal cell carcinoma. As per the terms, Clinigen will make an initial payment of The post Clinigen to acquire US rights to Novartis cancer drug Proleukin appeare...
15.02.19 - 09:49
Vor Biopharma receives $42m funds to advance development of cell therapy product candidate for acute myeloid leukemia (PBR)
 
Johnson & Johnson Innovation - JJDC, Inc. (JJDC), Novartis Institutes for BioMedical Research (NIBR), and Osage University Partners also participated in the round along with Vor Co-founder PureTech The post Vor Biopharma receives $42m funds to advan...
15.02.19 - 09:49
SK, Arvelle sign $530m deal for antiepileptic drug cenobamate (PBR)
 
Cenobamate is a novel and small molecule investigational antiepileptic drug being developed to treat partial-onset seizures in adult patients. Under exclusive licensing agreement, Arvelle will develop and commercialize The post SK, Arvelle sign $530...
15.02.19 - 09:49
FDA declines to approve Motif Bio′s iclaprim for ABSSSI treatment (PBR)
 
In the complete response letter (CRL) it issued to the company, the FDA said that it cannot approve the New Drug Application (NDA) of iclaprim in its present The post FDA declines to approve Motif Bio's iclaprim for ABSSSI treatment appeared first ...
15.02.19 - 08:49
Boehringer Ingelheim and Lilly announce the CAROLINA cardiovascular outcome trial of Tradjenta met its primary endpoint of non-inferiority compared with glimepiride (PBR)
 
CAROLINA is the only active-comparator cardiovascular outcome trial for a dipeptidyl peptidase-4 (DPP-4) inhibitor. The trial evaluated the cardiovascular safety of Tradjenta (5 mg once daily) compared with The post Boehringer Ingelheim and Lilly an...
14.02.19 - 10:01
World’s largest pharmaceutical firm selects ValGenesis to standardize corporate validation process enterprise-level (PBR)
 
For over a century, the company has developed differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. It is the world leader The post World’s largest pharmaceutical firm ...
14.02.19 - 08:50
FDA approves Novartis′ Egaten to treat fascioliasis (PBR)
 
Egaten is claimed to be the only FDA-approved drug to treat fascioliasis, which is a neglected tropical disease. Fascioliasis, which is commonly known as liver fluke infestation, is The post FDA approves Novartis' Egaten to treat fascioliasis appea...
14.02.19 - 08:02
Mayne Pharma launches Lexette (halobetasol propionate) foam 0.05% in the US (PBR)
 
Plaque psoriasis affects approximately 7.5 million Americans with potent topical corticosteroids prescribed to approximately 80% of psoriasis patients diagnosed. LEXETTE is part of the US$600m potent topical corticosteroid The post Mayne Pharma laun...
13.02.19 - 10:27
FDA takes action against 17 companies for illegally selling products claiming to treat Alzheimer′s disease (PBR)
 
These products, which are often sold on websites and social media platforms, have not been reviewed by the FDA and are not proven safe and effective to treat The post FDA takes action against 17 companies for illegally selling products claiming to t...
13.02.19 - 10:01
Redx says in vivo data indicates potential of ROCK2 in fibrosis treatment (PBR)
 
The company said that new data from three independent preclinical animal models of lung, kidney and liver fibrosis have yielded promising preclinical efficacy data for its ROCK2 compound. The post Redx says in vivo data indicates potential of ROCK2 ...
13.02.19 - 09:49
US court rejects Indivior′s appeal on Suboxone generic version (PBR)
 
The US Court of Appeals for the Federal Circuit (CAFC) has rejected Indivior’s motion to stay issuance of the mandate following its ruling vacating the preliminary injunction (PI) The post US court rejects Indivior's appeal on Suboxone generi...
13.02.19 - 08:01
Boehringer Ingelheim, IBM to integrate blockchain technology into clinical trials (PBR)
 
This collaboration underscores Boehringer Ingelheim’s commitment to healthcare innovation and marks the first time that blockchain technology will be explored in a clinical trial setting in Canada. Based The post Boehringer Ingelheim, IBM to i...
12.02.19 - 09:49
Gilead′s liver disease drug selonsertib fails to meet primary endpoint in Stellar-4 study (PBR)
 
Selonsertib has failed to meet the pre-specified week 48 primary endpoint of a '‰¥ 1-stage histologic improvement in fibrosis without worsening of NASH. Stellar-4 is a phase 3 The post Gilead's liver disease drug selonsertib fails to meet prim...
12.02.19 - 09:24
NeoTX Therapeutics announces immuno-oncology clinical trial collaboration with AstraZeneca (PBR)
 
These studies are expected to begin in 2019. Naptumomab is the lead drug in NeoTX's novel Selective T cell Redirection ("STR) platform. Naptumomab's dual mechanism of action coats The post NeoTX Therapeutics announces immuno-oncology clinical tri...
12.02.19 - 07:49
AbbVie and Teneobio announce a strategic transaction to develop a new treatment for multiple myeloma (PBR)
 
B-cell maturation antigen (BCMA) has emerged as an attractive target for multiple myeloma therapeutics. TNB-383B is a bispecific antibody that simultaneously targets BCMA and CD3, utilizing Teneobio’s unique The post AbbVie and Teneobio announ...
11.02.19 - 12:01
Samsung Bioepis, C-Bridge Capital to develop and commercialize next-generation biosimilars in China (PBR)
 
The agreement covers multiple biosimilar candidates from Samsung Bioepis, including third-wave biosimilar candidates SB11 and SB12, which reference LUCENTIS (ranibizumab) and SOLIRIS (eculizumab), respectively, as well as SB3, The post Samsung Bioep...
11.02.19 - 12:01
Evotec, Galapagos enter into collaboration in fibrosis field (PBR)
 
The collaboration concerns a small molecule programme, currently in pre-clinical development for the treatment of fibrotic diseases of the liver and other organs. The target has been identified The post Evotec, Galapagos enter into collaboration in ...
11.02.19 - 09:25
Finch gets FDA breakthrough therapy status for CP101 to treat recurrent C. Difficile infection (PBR)
 
Finch has designed CP101 therapeutic candidate for the prevention of recurrent C. difficile, which is a bacterial infection affecting more than 500,000 patients per year. The Centers for The post Finch gets FDA breakthrough therapy status for CP101 ...
08.02.19 - 12:13
Ligand announces OmniAb partnership with Genagon Therapeutics (PBR)
 
Under the terms of the partnership, Genagon gains access to the full OmniAb platform including OmniRat, OmniMous, OmniFlic and OmniChicken in their drug discovery efforts. Ligand received an The post Ligand announces OmniAb partnership with Genagon ...
08.02.19 - 09:25
FDA extends review period for Incyte′s GVHD treatment Jakafi (PBR)
 
The 24 May is the new Prescription Drug User Fee Act (PDUFA) target action date for Jakafi, which is the treatment for patients with GVHD who have had The post FDA extends review period for Incyte's GVHD treatment Jakafi appeared first on Pharmaceu...
08.02.19 - 08:02
TamRx launches to develop pipeline of immuno-oncology products for treatment of cancers (PBR)
 
The new company will focus on the development of a novel family of small molecule inhibitors designed to block tumor growth and stimulate the immune system to fight The post TamRx launches to develop pipeline of immuno-oncology products for treatmen...
07.02.19 - 09:25
Frazier Healthcare Partners launches Recida Therapeutics to develop novel therapeutics for serious antibiotic-resistant infections (PBR)
 
Recida's lead program, RC-01, is a novel, IND-stage LpxC inhibitor for the treatment of multidrug-resistant gram-negative infections. Recida has licensed development and commercialization rights to RC-01 from FUJIFILM The post Frazier Healthcare Pa...
07.02.19 - 09:01
Sanofi gets FDA nod for blood disorder drug Cablivi (PBR)
 
Cablivi has been approved in combination with plasma exchange and immunosuppression to treat acquired thrombotic thrombocytopenic purpura (aTTP) in adults. Cablivi is said to be the first FDA-approved The post Sanofi gets FDA nod for blood disorder ...
07.02.19 - 08:49
AstraZeneca’s RSV drug MEDI8897 gets FDA’s breakthrough therapy designation (PBR)
 
MEDI8897, which is a single dose extended half-life anti-RSV F monoclonal antibody (mAb), is being developed jointly by AstraZeneca's biologics research and development arm MedImmune and Sanofi Pasteur. The post AstraZeneca’s RSV drug MEDI889...
07.02.19 - 08:49
PCI Pharma Services announces bottling line expansion at Rockford (PBR)
 
Construction of the additional packaging suites began in March 2018 to add considerable footprint for primary and secondary packaging operations equipped with high speed tablet filling, cartoning, as The post PCI Pharma Services announces bottling l...
06.02.19 - 10:49
Moderna announces dosing of first monoclonal antibody encoded by mRNA in clinical trial (PBR)
 
This is the first monoclonal antibody encoded by mRNA to be dosed in a human and the first development candidate from the Company's systemic therapeutics modalities to start The post Moderna announces dosing of first monoclonal antibody encoded by ...
06.02.19 - 09:51
GSK, Merck enter into €‚¬3.7bn deal for novel cancer treatment (PBR)
 
The M7824 is an investigational bifunctional fusion protein immunotherapy, which is currently under clinical development, including potential registration studies, for multiple difficult-to-treat cancers. Bintrafusp alfa is said to The post GSK, Mer...
06.02.19 - 08:49
Amprologix wins DHSC backing for new antibiotic (PBR)
 
The contract from the Small Business Research Initiative (“SBRI”), administered by Innovate UK, will be used to make the Company’s epidermicin NI01 antibiotic ready for phase 1 human The post Amprologix wins DHSC backing for new an...
05.02.19 - 14:49
Roche seeks FDA approval for Kadcyla in HER2-positive early breast cancer (PBR)
 
The approval being sought from the US Food and Drug Administration (FDA) is for the post-surgery use of Kadcyla in patients with HER2-positive early breast cancer with residual The post Roche seeks FDA approval for Kadcyla in HER2-positive early bre...
05.02.19 - 09:25
Eisai and Purdue Pharma present efficacy and safety data from second pivotal phase 3 insomnia study (PBR)
 
Data were presented at the Sleep Research Society’s Advances in Sleep and Circadian Science conference, taking place in Clearwater Beach, Florida, Feb. 1-4, 2019. SUNRISE 2 was a The post Eisai and Purdue Pharma present efficacy and safety dat...
05.02.19 - 09:03
IQVIA launches IQVIA Biotech, dedicated to emerging biotech and biopharma industry (PBR)
 
This solutions suite, supported by more than 1,000 dedicated employees, will deliver simplified operating procedures, specialized teams, and services to provide a more agile way for these innovators The post IQVIA launches IQVIA Biotech, dedicated t...
05.02.19 - 09:03
Verseon begins dosing in phase 1 trial of VE-1902 oral anticoagulant (PBR)
 
The early-stage trial will study safety, pharmacokinetics, and pharmacodynamics of VE-1902 in 100-120 participants. The blood thinner is the first PRrecision Oral AntiCoagulant (PROAC) of the US-based pharma The post Verseon begins dosing in phase 1...
05.02.19 - 08:51
CHMP recommends Keytruda-chemo combo in squamous NSCLC (PBR)
 
The CHMP's positive opinion for Keytruda in combination with carboplatin and either paclitaxel or nab-paclitaxel is for the first-line treatment of metastatic NSCLC in adults. Keytruda is an The post CHMP recommends Keytruda-chemo combo in squamous...
04.02.19 - 10:37
Newron completes patient enrollment in STARS Study (PBR)
 
Newron expects to report top line results from the STARS study in Q4 2019. Rett syndrome, a severe neuro-developmental orphan disease with no approved treatment options, overwhelmingly affects The post Newron completes patient enrollment in STARS St...
04.02.19 - 09:26
AstraZeneca’s Forxiga recommended for marketing authorization in EU (PBR)
 
The CHMP's positive opinion for the marketing authorization of Forxiga is for use as an oral adjunct treatment to insulin in adults with T1D. Forxiga, which is a The post AstraZeneca’s Forxiga recommended for marketing authorization in EU app...
04.02.19 - 08:37
Neuraxpharm acquires CNS specialty pharma company Farmax (PBR)
 
Farmax, located in Hradec Králové, Czech Republic, was the commercial division of SVUS Pharma, and has a strong distribution presence in the Czech Republic, Slovakia as well as The post Neuraxpharm acquires CNS specialty pharma company Farmax appea...
01.02.19 - 10:25
Fortress Biotech announces CAEL-101 strategic partnership with Alexion Pharmaceuticals (PBR)
 
CAEL-101 is a first-in-class amyloid fibril targeted therapy designed to improve organ function by reducing or eliminating amyloid deposits in patients with AL amyloidosis. AL amyloidosis is a The post Fortress Biotech announces CAEL-101 strategic p...
01.02.19 - 09:25
Janssen, MeiraGTx sign $440m deal to develop gene therapy programs for IRDs (PBR)
 
MeiraGTx has five programs in clinical development and a pipeline of preclinical and research programs. As part of a worldwide collaboration and license agreement, the partnership will develop, The post Janssen, MeiraGTx sign $440m deal to develop g...
01.02.19 - 09:25
Genentech halts two phase 3 AD trials of crenezumab over futility (PBR)
 
The two trials, dubbed CREAD 1 and CREAD 2, will be discontinued as a pre-planned interim analysis indicated that crenezumab was not likely to meet their primary endpoint, The post Genentech halts two phase 3 AD trials of crenezumab over futility ap...
01.02.19 - 08:01
Hitachi Chemical to acquire apceth Biopharma (PBR)
 
This acquisition is expected to close in April 2019. Founded 2007, apceth is a pioneer in cell and gene therapy and has developed into a leading European contract The post Hitachi Chemical to acquire apceth Biopharma appeared first on Pharmaceutical...
31.01.19 - 12:37
Eureka Therapeutics announces US FDA clearance of IND application for trial of ET140202 Artemis T-Cell therapy (PBR)
 
The company plans to initiate its Phase 1/2 US multicenter clinical trial in the first half of 2019. The Phase 1 dose escalation portion of the trial will The post Eureka Therapeutics announces US FDA clearance of IND application for trial of ET1402...
31.01.19 - 09:37
Roche to discontinue phase III CREAD 1 and 2 clinical studies of crenezumab in early Alzheimer′s disease (PBR)
 
The decision was based on the results of a pre-planned interim analysis assessing the safety and efficacy of crenezumab conducted by the Independent Data Monitoring Committee, which indicated The post Roche to discontinue phase III CREAD 1 and 2 cli...
31.01.19 - 09:25
Merck′s 15-valent pneumococcal conjugate vaccine gets FDA breakthrough therapy designation (PBR)
 
The breakthrough therapy designation has been granted for V114 to prevent invasive pneumococcal disease (IPD) caused by the vaccine serotypes in pediatric patients aged between six weeks and The post Merck's 15-valent pneumococcal conjugate vaccine...
31.01.19 - 09:12
Dewpoint Therapeutics launches with $60m Series A to advance proprietary platform for drugging condensates (PBR)
 
Founding investor Polaris Partners led the equity round and was joined by Samsara BioCapital, 6 Dimensions Capital, EcoR1 Capital, Alexandria Venture Investments, and Leaps by Bayer. Dewpoint is The post Dewpoint Therapeutics launches with $60m Seri...
30.01.19 - 09:13
Pfizer and Lilly announce top-line results from second phase 3 study of tanezumab in osteoarthritis pain (PBR)
 
The tanezumab 5 mg treatment arm met all three co-primary endpoints at 24 weeks, demonstrating a statistically significant improvement in pain, physical function and the patients' overall assessment The post Pfizer and Lilly announce top-line resul...
30.01.19 - 08:25
Takeda′s TAK-003 dengue vaccine candidate succeeds in phase 3 efficacy trial (PBR)
 
The first analysis of the tetravalent immunization against dengue efficacy study (TIDES) trial demonstrated that TAK-003 effectively prevented dengue fever caused by any of the four serotypes of The post Takeda's TAK-003 dengue vaccine candidate su...
30.01.19 - 08:25
Shield Therapeutics Feraccru yields positive results in extended phase 3 trial (PBR)
 
The AEGIS-CKD study of Feraccru was a phase 3 randomized, placebo-controlled, double-blind trial. Compared to placebo, Shield Therapeutics' ferric iron therapy showed superiority in changing haemoglobin (Hb) levels The post Shield Therapeutics Fera...
30.01.19 - 07:49
Lyndra Therapeutics raises $55m in Series B financing (PBR)
 
All original investors from the company's $23 million Series A round, led by Polaris Partners, resubscribed, and new investors include HOPU Investments, Gilead Sciences, Invus, the Bill & The post Lyndra Therapeutics raises $55m in Series B financi...
29.01.19 - 09:37
Alexion announces phase 3 study of ULTOMIRIS achieves primary objective in complement inhibitor-naïve patients with aHUS (PBR)
 
In the initial 26 week treatment period, 53.6 percent of patients (95% CI [39.6%, 67.5%]) demonstrated complete thrombotic microangiopathy (TMA) response. ULTOMIRIS provided immediate and complete inhibition of The post Alexion announces phase 3 stu...
29.01.19 - 09:01
FDA approves Imbruvica combo for treatment-naive CLL patients (PBR)
 
Imbruvica in combination with obinutuzumab is said to be the first approved non-chemotherapy combination regimen for treatment-naïve patients with CLL/SLL, which is the most common form of leukemia The post FDA approves Imbruvica combo for treatmen...





































 

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