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1-15 of 2292 results
AstraZeneca recalls physician sample bottles of BRILINTA heart drug
AstraZeneca said that it is voluntarily recalling one lot of professional (physician) sample bottles containing eight tablets of BRILINTA (ticagrelor) 90mg tablets as a precautionary measure.
Drug Research > Drug Delivery > News
EC launches probe into Aspen's pricing practices for cancer drugs
The European Commission has initiated a formal investigation to see whether Aspen Pharma had excessively priced five life-saving cancer medicines.
Drug Research > Drug Delivery > News
Clinigen, Tesaro partner to supply ovarian cancer drug in Europe
Clinigen Group’s Idis Managed Access division and Tesaro have partnered to launch a Managed Access Program (also known as an Early Access Program) in Europe for niraparib, the investigational PARP 1/2 inhibitor, for patients with recurrent ovarian cancer.
Drug Research > Drug Delivery > News
Sunesis withdraws leukemia drug marketing application in Europe
Sunesis Pharmaceuticals said it will withdraw its European Marketing Authorization Application (MAA) for vosaroxin as a therapy for acute myeloid leukemia (AML) both in relapsed and refractory forms in patients aged 60 years and older.
Drug Research > Drug Delivery > News
Teva launches generic Vytorin tablets in US
Teva Pharmaceutical Industries has launched the generic Vytorin (ezetimibe and simvastatin) tablets in the US.
Drug Research > Drug Delivery > News
Lack of demand forces uniQure to withdraw Glybera gene therapy in Europe
By PBR Staff Writer
uniQure said that due to low patient demand it will not pursue a renewal of its European marketing authorization for Glybera (alipogene tiparvovec), which is due to expire on 25 October.
Drug Research > Drug Delivery > News
FDA advisory committee to review Puma’s NDA for neratinib
The US Food and Drug Administration (FDA) has scheduled Puma Biotechnology’s New Drug Application (NDA) for neratinib for discussion by the Oncologic Drugs Advisory Committee (ODAC) on 24 May 2017.
Drug Research > Drug Delivery > News
Immuno-oncology company Agenus to cut 50 jobs in reorganization
Clinical-stage immuno-oncology firm Agenus is reorganizing its business and operations to straighten its focus on clinical development of its two checkpoint inhibitor antibodies and vaccine program.
Drug Research > Drug Delivery > News
Oxford BioDynamics participates in rheumatoid arthritis triggers study
Oxford BioDynamics is participating in a collaboration to identify the biological factors that trigger disease relapses, known as flares, in Rheumatoid Arthritis (RA), entitled the BIO-FLARE study (Biological factors that limit sustained remission in Rheumatoid Arthritis).
Drug Research > Drug Delivery > News
UK's MHRA grants early access to Sanofi’s dermatology treatment
The UK's Medicines and Healthcare Products Regulatory Agency (MHRA) has granted Sanofi’s dupilumab, an investigational treatment for atopic dermatitis (AD), a positive scientific opinion through the Early Access to Medicines Scheme (EAMS).
Drug Research > Drug Delivery > News
Pfizer launches Zavicefta in UK and Germany
Pfizer has launched Zavicefta (ceftazidime/avibactam), a combination antibiotic to treat Gram-negative bacterial infections requiring hospitalization, in the UK and Germany.
Drug Research > Drug Delivery > News
Lilly's Trulicity label updated to include use in combination with basal insulin for type 2 diabetes
Eli Lilly and Company has updated label of its once-weekly Trulicity (dulaglutide) to include use in combination with basal insulin for adults with Type 2 diabetes.
Drug Research > Drug Delivery > News
US FTC sues Shire ViroPharma for delaying generic entry of Vancocin
By PBR Staff Writer
The US Federal Trade Commission (FTC) has charged that Shire ViroPharma abused government processes via serial, sham petitioning to delay generics and maintain its monopoly over Vancocin HCl Capsules.
Drug Research > Drug Delivery > News
Soligenix's SGX301 secures PIM status from UK MHRA to treat cutaneous T-cell lymphoma
Soligenix has secured Promising Innovative Medicine (PIM) designation from the UK Medicines and Healthcare Products Regulatory Agency for SGX301 (synthetic hypericin) to treat cutaneous T-cell lymphoma (CTCL).
Drug Research > Drug Delivery > News
Spero Therapeutics acquires antibacterial candidates from Pro Bono Bio
Spero Therapeutics has acquired a next generation set of antibacterial candidates from Pro Bono Bio Ltd (PBB) to bolster its pipeline addressing the increased prevalence of multi-drug resistant forms of Gram-negative bacteria.
Drug Research > Drug Delivery > News
1-15 of 2292 results