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Roche’s Perjeta sees ‘impressive’ survival rates
Roche’s oncology drug Perjeta combined with other medicines can help certain breast cancer patients live longer. This is according to new trial data from the Swiss firm, presented at a conference of...
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Amgen biosimilar matches AbbVie’s Humira in psoriasis trial
Amgen is on track to launch a biosimilar competitor to AbbVie’s Humira – the biggest-selling pharmaceutical product in the world – after positive data in a phase III trial. The biotech major said that...
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EMA kritisch over Indiaas bio-equivalentieonderzoek
Het EMA start een herbeoordelingsprocedure van de bio-equivalentieonderzoeken uitgevoerd door de firma GVK Biosciences in Hyderabad, India. Na inspectie is gebleken dat dit bedrijf zich niet consequent...
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A decade of innovation in pharmaceutical R&D: the Chorus model
Chorus is a small, operationally independent clinical development organization within Eli Lilly and Company that specializes in drug development from candidate selection to clinical proof of concept....
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A new screening method may be able to identify toxic drugs earlier in...
A good drug is hard to design: to garner FDA approval and reach consumers, it must not only effectively treat a medical condition, but it must also do so without having side effects that outweigh its...
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Second late-stage COPD trial for GSK and Theravance
GlaxoSmithKline and Theravance have begun a second Phase III trial of their investigational triple combination COPD drug as the former company continues to recover its flagging respiratory business....
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Get real! The rise of observational data in healthcare
Real world data is now becoming a serious research tool for pharma, but just what can it add to the golden standard that is the randomised clinical trial?
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AbbVie hepatitis C cocktail succeeds in late-stage study
AbbVie Inc said on Wednesday that all patients in a late-stage study showed a sustained response to its cocktail of hepatitis C treatments, currently sold in the U.S. as Viekira Pak.
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Pfizer begins patient enrollment in phase 3 trial of rivipansel in sickle...
Pfizer Inc announced enrollment of first patient in the RESET (Rivipansel: Evaluating Safety, Efficacy and Time to Discharge) study – a phase 3 clinical trial assessing the efficacy and safety of...
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Geneesmiddelenwet- en regelgeving weinig stimulerend voor alternatieven voor...
De huidige geneesmiddelenwetgeving belemmert het gebruik van alternatieven voor dierproeven weliswaar niet, maar stimuleert dit ook nauwelijks. Het is toegestaan om alternatieven in te zetten, maar dan...
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The Pharmafocus ASCO round-up
As the curtain falls on another annual ASCO (American Society of Clinical Oncology) congress, catch up on all the biggest news with the Pharmafocus round-up.
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Gilead’s Zydelig passes EMA safety review
European regulators have ruled patients can continue to be treated with Gilead Sciences’ blood cancer drug Zydelig, despite it carrying a risk of serious infection.
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Takeda and TiGenix announce successful trial of Crohn’s disease drug
Takeda and TiGenix announced Phase 3 results from a trial looking into the investigational compound Cx601, a treatment for refractory complex perianal fistulas in sufferers of Crohn’s disease. The...
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Cyclacel’s leukemia drug for elderly patients fails in key study
Cyclacel Pharmaceuticals Inc said its experimental drug failed in a late-stage study on patients aged 70 years or more with newly diagnosed acute myeloid leukemia.
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Cuba begins Phase 1 testing of HIV vaccine
Cuba has announced that it has begun testing a HIV vaccine that looks to reduce the ‘payload’ of the virus within the patients. The study will examine a small number of patients to determine the safety...
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Letermovir Prevents CMV Infection Post-HSCT in Phase 3 Study
Merck has announced positive results from its Phase 3 trial of letermovir, an investigational antiviral medicine for the prevention of clinically-significant cytomegalovirus (CMV) infections in adult...
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Kite Pharma climbs on strong data showing in lymphoma trial
Kite Pharma released the news on Rare Diseases Day promising top-line data from a Phase 1/2 trial of its treatment for various types of non-Hodgkin lymphoma. The results displayed that approximately a...
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Roche’s neoadjuvant breast cancer combo therapy shows strong Phase 3 results
Roche’s combination treatment of Perjeta (pertuzumab), Herceptin (trasdtuzumab) and chemotherapy met its primary endpoint in a recent Phase 3 study, improving invasive disease-free survival (iDFS) in...
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Genentech plans second Phase 3 Alzheimer’s trial following endpoint failures
Genentech, Roche’s biotech group, has announced its plans to conduct a second Phase 3 study for crenezumab, its anti-Abeta antibody for the treatment of early Alzheimer’s disease. The trial is designed...
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Anticoagulants Compared in A-fib Patients Undergoing Catheter Ablation
New results from a study presented at the ACC.17 Scientific Session demonstrated a better safety profile for Pradaxa (dabigatran etexilate mesylate; Boehringer Ingelheim) vs. warfarin in atrial...
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