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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.
 
11.12.18 - 12:25
Alnylam, Silence Therapeutics settle patent dispute (PBR)
 
The agreement allows both firms to resolve all litigation across the world. It will enable Alnylam to reduce the costs and distraction linked with continued litigation in various The post Alnylam, Silence Therapeutics settle patent dispute appeared ...
11.12.18 - 11:37
e-therapeutics, Novo Nordisk enter into research collaboration agreement (PBR)
 
Type 2 diabetes currently accounts for approximately 90% of the estimated 425 million people with diabetes globally[1], and new treatments are urgently required to tackle the growing incidence The post e-therapeutics, Novo Nordisk enter into researc...
11.12.18 - 09:13
PCI expands cold chain storage capabilities at UK site (PBR)
 
The announcement is the latest in a series of strategic investments at PCI, demonstrating its market-leading presence in Biotech therapies, supporting medicines destined reach to more than 100 The post PCI expands cold chain storage capabilities at ...
11.12.18 - 09:01
BMS, Vedanta Biosciences to evaluate Opdivo-VE800 combo in metastatic cancers (PBR)
 
In this connection, the Bristol-Myers Squibb and Vedanta Biosciences, an affiliate of PureTech Health, have entered into a clinical collaboration. Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor, The post BMS, Vedanta Biosciences t...
10.12.18 - 11:37
French pharma firm Cristers selects Adents Prodigi serialisation solution (PBR)
 
Jointly developed with Microsoft and powered by Azure, Adents Prodigi allows for secure data exchange and helps leverage the power of serialisation data to improve business practices. Cristers The post French pharma firm Cristers selects Adents Prod...
10.12.18 - 11:13
Eisai, UCL to launch phase I trials of E2814 for Alzheimer’s disease (PBR)
 
The candidate, known as E2814, is an anti-tau monoclonal antibody set to be tested in human trials for the first time to assess its ability to slow the The post Eisai, UCL to launch phase I trials of E2814 for Alzheimer’s disease appeared firs...
10.12.18 - 11:01
AstraZeneca′s Imfinzi fails to improve OS in head and neck cancer trial (PBR)
 
The phase II Eagle trial is a randomized, open-label and multi-centre trial designed to assess Imfinzi monotherapy and Imfinzi in combination with anti-CTLA4 antibody tremelimumab against SoC chemotherapy The post AstraZeneca's Imfinzi fails to imp...
07.12.18 - 03:25
AstraZeneca divests asthma and rhinitis drug rights to Covis Pharma (PBR)
 
The divested rights by the UK-based AstraZeneca to Covis Pharma cover markets outside the US and the US royalties for the three over-the-counter (OTC) drugs. In 2017, AstraZeneca The post AstraZeneca divests asthma and rhinitis drug rights to Covis ...
06.12.18 - 10:12
Mereo BioPharma, OncoMed Pharmaceuticals proposes merger deal (PBR)
 
The Transaction has been unanimously approved by the Board of Directors of each company. Subject to potential adjustment as described below, based upon an OncoMed net cash balance The post Mereo BioPharma, OncoMed Pharmaceuticals proposes merger dea...
06.12.18 - 09:25
Biopharmaceutical firm UCB to invest £1bn in UK for research and development (PBR)
 
UCB will build a new £150mto £200m research and development facility as part of the total investment over the next five years. The transition to the facility will The post Biopharmaceutical firm UCB to invest £1bn in UK for research and development ...
06.12.18 - 09:25
Tris Pharma recalls infants’ liquid Ibuprofen in US (PBR)
 
The recalled lots of the product have been found to potentially have higher concentrations of ibuprofen. There is a remote possibility that infants, who may be more susceptible The post Tris Pharma recalls infants’ liquid Ibuprofen in US appea...
05.12.18 - 12:49
Novartis initiates phase III trials of ligelizumab in urticaria (PBR)
 
Phase III studies PEARL1 and PEARL 2 are planned to include more than 2,000 CSU patients. Charité-Universitätsmedizin Allergie-Centrum-Charité Department of Dermatology and Allergy Dermatology and Allergy Professor and The post Novartis initiates ...
05.12.18 - 12:49
DeepMind’s AlphaFold uses AI technology to predict protein shapes (PBR)
 
DeepMind further claimed that its AI-driven system, AlphaFold, is capable of generating 3D models of proteins that are highly accurate and potentially capable of solving one of the The post DeepMind’s AlphaFold uses AI technology to predict pr...
05.12.18 - 11:50
Ixico secures expanded contract from major biopharmaceutical firm (PBR)
 
Additional services will be provided, increasing the value of the contract by $2.4m over the remaining 6-year term of the agreement. As a result, the contract value has The post Ixico secures expanded contract from major biopharmaceutical firm appea...
05.12.18 - 11:37
J&J′s Darzalex reduces disease progression in multiple myeloma study (PBR)
 
The phase 3 MAIA study showed that the daratumumab, in combination with lenalidomide and dexamethasone (Rd), has reduced the risk of disease progression or death in patients with The post J&J's Darzalex reduces disease progression in multiple myelo...
04.12.18 - 11:01
Momenta revises regulatory strategy for proposed Humira biosimilar (PBR)
 
Momenta had previously guided that it planned to file a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) in the fourth quarter of this The post Momenta revises regulatory strategy for proposed Humira biosimilar appe...
04.12.18 - 10:24
TRIGR Therapeutics, ABL Bio sign license agreement for bispecific antibody candidate (PBR)
 
The license agreement is exclusive and global, excluding the Republic of Korea for all oncology indications and excluding the Republic of Korea and Japan for all ophthalmology indications. The post TRIGR Therapeutics, ABL Bio sign license agreement ...
04.12.18 - 09:36
GSK to buy oncology-focused biopharmaceutical firm Tesaro for $5.1bn (PBR)
 
Based in Waltham of Massachusetts, Tesaro is a commercial-stage firm engaged in the development of advanced therapies to treat cancer. As per the terms of the deal, GSK's The post GSK to buy oncology-focused biopharmaceutical firm Tesaro for $5.1bn...
04.12.18 - 09:36
FDA fast tracks Novartis’ Zolgensma SMA gene replacement therapy (PBR)
 
Zolgensma was previously granted breakthrough therapy designation by the US regulator. Novartis expects a regulatory action to be taken on the gene replacement therapy in May 2019. According The post FDA fast tracks Novartis’ Zolgensma SMA gen...
03.12.18 - 12:01
Crown Laboratories buys select OTC consumer healthcare brands from GSK (PBR)
 
GSK's consumer healthcare portfolio has long been regarded as high quality, safe and effective, maintaining a quality image and loyal base of consumers. OTC medications allow practitioners and The post Crown Laboratories buys select OTC consumer he...
03.12.18 - 11:13
Redx expects to start first-in-man studies with RXC006 during 2020 (PBR)
 
RXC006 is being developed as an orally administered and first-in-class treatment for the orphan disease idiopathic pulmonary fibrosis (IPF), which is a chronic lung condition. RXC006, which is The post Redx expects to start first-in-man studies with...
03.12.18 - 11:01
Biopharmaceutical firm Aprea Therapeutics raises €‚¬50m in financing (PBR)
 
The Series C financing round was led by the Redmile Group, with participation by new investor Rock Springs Capital and existing investors 5AM Ventures, Versant Ventures, HealthCap, Sectoral The post Biopharmaceutical firm Aprea Therapeutics raises &...
30.11.18 - 11:01
WuXi, ABL Bio to collaborate on multiple bispecific antibodies (PBR)
 
The partnership is for up to 8 antibody therapeutics including ABL Bio's biologics pipelines and collaboration programs between ABL Bio and I-Mab Biopharma (I-Mab). The agreement showcases the The post WuXi, ABL Bio to collaborate on multiple bispe...
30.11.18 - 10:49
Novartis′ Gilenya gets approval in Europe to treat children and adolescents with MS (PBR)
 
Gilenya is claimed to be the first and only oral disease-modifying treatment approved for children and adolescents in the Europe. The approval allows the company to market Gilenya The post Novartis' Gilenya gets approval in Europe to treat children...
30.11.18 - 09:01
AbCellera, Autolus partner on antibody discovery project (PBR)
 
Under the partnership, AbCellera is applying its microfluidic single-cell screening platform to find novel antibodies which can be used for the development of new Chimeric Antigen Receptor (CAR) The post AbCellera, Autolus partner on antibody discov...
29.11.18 - 11:25
PureTech′s Vor secures US patent for compositions and methods to treat hematologic malignancies (PBR)
 
This foundational patent is the first of its kind in the immuno-oncology field and it broadly covers compositions and therapeutic methods related to using novel modified HSCs to The post PureTech's Vor secures US patent for compositions and methods...
29.11.18 - 10:49
Cyxone MS drug T20K succeeds in preclinical program (PBR)
 
According to Cyxone, T20K during the preclinical program has been shown to be safe for people to ingest. The Swedish clinical biotech company, which has concluded the preclinical The post Cyxone MS drug T20K succeeds in preclinical program appeared ...
29.11.18 - 10:49
HOOKIPA, DarwinHealth to collaborate on immunotherapies development (PBR)
 
DarwinHealth is a precision-focused cancer medicine company, utilizing systems-biology derived algorithms to identify appropriate therapies for cancer patients and to systematically discover and prioritize the next generation of The post HOOKIPA, Da...
29.11.18 - 10:37
Teva, Celltrion get FDA nod for biosimilar to Roche′s cancer drug Rituxan (PBR)
 
Truxima, a monoclonal antibody (mAb), has been approved to treat adult patients with relapsed or refractory, low-grade or follicular, CD20-positive, B-cell non-Hodgkin's lymphoma (NHL) as a single agent. The post Teva, Celltrion get FDA nod for bio...
28.11.18 - 11:14
Vedanta Biosciences starts phase 1 study of VE202 to treat IBD (PBR)
 
Janssen Research & Development is undertaking the study. Vedanta Biosciences had granted the licensing rights of VE202 in 2015 to Janssen Biotech. The microbiome-derived product candidate is being The post Vedanta Biosciences starts phase 1 study of...
28.11.18 - 11:01
QPS expands US phase I clinical trial capabilities (PBR)
 
To fill their drug pipelines, large pharmaceutical and biotechnology companies are buying promising drug compounds that have been developed by small biotech companies up to the point of The post QPS expands US phase I clinical trial capabilities app...
28.11.18 - 11:01
BeiGene acquires rights to Zymeworks′ ZW25 and ZW49 bispecific candidates in Asia-Pacific (PBR)
 
In addition, Zymeworks granted BeiGene a license to Zymeworks’ proprietary Azymetric and EFECT platforms to develop and commercialize globally up to three other bispecific antibodies using the platforms. The post BeiGene acquires rights to Zym...
28.11.18 - 10:25
Roche′s Genentech agrees to buy Jecure Therapeutics (PBR)
 
Based in San Diego of California, Jecure Therapeutics is engaged in the discovery of therapeutics to treat non-alcoholic steatohepatitis (NASH) and liver fibrosis. Jecure Therapeutics president and CEO The post Roche's Genentech agrees to buy Jecur...
27.11.18 - 12:02
Cyclica, Bayer partner to advance drug discovery programs (PBR)
 
The companies will advance drug discovery programs by gaining insights into the polypharmacological profiles of small molecules, while further evolving Cyclica's integrated network of enabling technologies. Through a The post Cyclica, Bayer partner...
27.11.18 - 11:49
(PBR)
 
This approval is an important achievement for the company and most importantly, represents major progress for patients and physicians. Octapharma board member Olaf Walter said: "The development of The post appeared first on Pharmaceutical Business ...
27.11.18 - 10:37
BMS′ Opdivo plus Yervoy fails to improve OS in lung cancer study (PBR)
 
The trial has not achieved its primary endpoint of OS with Opdivo (nivolumab) 1mg/kg in combination with Yervoy (ipilimumab) 3mg/kg against placebo as a maintenance therapy for patients The post BMS' Opdivo plus Yervoy fails to improve OS in lung c...
26.11.18 - 15:01
AstraZeneca′s Fasenra secures FDA orphan drug designation for EGPA (PBR)
 
Developed by AstraZeneca with MedImmune, its research and development arm, Fasenra was in-licensed from BioWa, a subsidiary of Japanese pharma company Kyowa Hakko Kirin. Considered to be a The post AstraZeneca's Fasenra secures FDA orphan drug desi...
26.11.18 - 11:37
Poxel begins part 2 of phase 1a study for NASH treatment PXL065 (PBR)
 
This second part of the Phase 1a study will enroll six healthy subjects per group, with a primary objective to assess safety and tolerability and a secondary objective The post Poxel begins part 2 of phase 1a study for NASH treatment PXL065 appeared...
26.11.18 - 10:37
Actinogen Medical enrolls last patient in phase 2 Alzheimer′s trial (PBR)
 
A total of 186 patients have been enrolled into the study, surpassing the Company's initial target of 174 patients. The increased enrolment numbers followed high engagement from study The post Actinogen Medical enrolls last patient in phase 2 Alzhe...
26.11.18 - 10:25
Mundipharma’s Neulasta biosimilar Pelmeg secures approval in Europe (PBR)
 
The approval of Pelmegis follows the recommendation of the Medicinal Products for Human Use (CHMP), which was based on regulatory submission of significant biosimilarity data from analytical, biofunctional The post Mundipharma’s Neulasta biosi...
26.11.18 - 06:49
Spark secures EC approval for Luxturna for inherited retinal disease (PBR)
 
The European approval for Luxturna is for the treatment of inherited retinal dystrophy caused by confirmed biallelic RPE65 mutations in both adult and pediatric patients who have sufficient The post Spark secures EC approval for Luxturna for inherit...
23.11.18 - 12:13
Vineti, Tessa partner to advance cancer immunotherapies (PBR)
 
Tessa Therapeutics (Tessa), an international clinical stage biopharmaceutical company focusing on cellular immunotherapy treatments for cancer, is a leading developer of personalized T cell therapies for solid tumors, The post Vineti, Tessa partner ...
23.11.18 - 11:13
Camurus gets EU nod for weekly and monthly Buvidal for opioid dependence (PBR)
 
This marks the first approval of a long-acting treatment for opioid dependence in the EU. London's King’s College National Addiction Centre director professor Sir John Strang, said: “Patients The post Camurus gets EU nod for weekly and ...
23.11.18 - 08:49
Cambrex to acquire contract drug developer Avista Pharma for $252m (PBR)
 
Through the acquisition of Avista, Cambrex will be adding early stage small molecule development and testing services to its capabilities. Avista, which is a portfolio company of Ampersand The post Cambrex to acquire contract drug developer Avista P...
23.11.18 - 08:49
GSK, Kyowa Hakko Kirin to commercialize anemia drug daprodustat in Japan (PBR)
 
Daprodustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, which is under phase 3 development by GSK to treat anemia associated with chronic kidney disease (CKD). Inhibition of The post GSK, Kyowa Hakko Kirin to commercialize anem...
22.11.18 - 09:49
Pfizer’s Daurismo gets FDA approval to treat elderly adults with AML (PBR)
 
Daurismo is claimed to be the first and only FDA-approved Hedgehog pathway inhibitor for AML. Daurismo, which is taken in combination with low-dose cytarabine (LDAC), has not been The post Pfizer’s Daurismo gets FDA approval to treat elderly a...
22.11.18 - 09:37
Evotec, Immuneering to work on AI-driven ligand identification for rare hereditary metabolic diseases (PBR)
 
The research collaboration brings together Evotec's leading induced pluripotent stem cell (iPSC) platform and broad drug discovery capabilities with Immuneering's unique artificial intelligence-driven drug discovery platform to accelerate The post...
22.11.18 - 08:49
EC approves Takeda′s acquisition of Shire (PBR)
 
The EC's approval is conditional on Takeda and Shire fulfilling commitments given to the EC in connection with the clearance. Specifically, in relation to the future potential overlap The post EC approves Takeda's acquisition of Shire appeared fir...
21.11.18 - 11:02
Dr. Reddy’s gets favorable decision in buprenorphine and naloxone sublingual film patent case (PBR)
 
This decision vacates the District Court's preliminary injunction that had prohibited Dr. Reddy's from selling its generic version of Suboxone (buprenorphine and naloxone) sublingual film. As a result The post Dr. Reddy’s gets favorable deci...
21.11.18 - 11:02
LEO Pharma, PellePharm form $760m rare skin disease collaboration (PBR)
 
LEO Pharma research vice president Thorsten Thormann said: "We are very excited about the partnership with PellePharm, who are pioneers in Gorlin Syndrome and experts in rare skin The post LEO Pharma, PellePharm form $760m rare skin disease collabor...





































 

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