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16-30 of 2302 results
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
US Court Of Appeals affirms Cumberland's victory in patent litigation case
The US Court of Appeals for the Federal Circuit ruled in favor of Cumberland Pharmaceuticals in a patent case associated with its Acetadote product.
Drug Research > Drug Delivery > News
Cellestia Biotech raises CHF8m seed financing
Cellestia Biotech has raised CHF8m in funding from private investors and PPF Group to advance its lead anti-cancer compound CB-103 to clinical development stage.
Drug Research > Drug Delivery > News
Intrexon to buy clinical-stage gene delivery firm GenVec
Intrexon has agreed to acquire clinical-stage company GenVec which has developed the AdenoVerse gene delivery technology.
Drug Research > Drug Delivery > News
European Medicines Agency accepts to review Novelion’s MAA for metreleptin
The European Medicines Agency (EMA) has accepted for review Novelion Therapeutics' Marketing Authorization Application (MAA) for metreleptin as replacement therapy to treat complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy (GL) and in a subset of patients with partial lipodystrophy (PL).
Drug Research > Drug Delivery > News
EMA validates Validates Gilead’s MAA for chronic hepatitis C therapy
The European Medicines Agency (EMA) has validated and is assessing Gilead Sciences’ Marketing Authorization Application (MAA) for the investigational, once-daily, single tablet regimen of sofosbuvir 400 mg, velpatasvir 100 mg and voxilaprevir 100 mg (SOF/VEL/VOX) for the treatment of chronic hepatitis C virus (HCV)-infected patients.
Drug Research > Drug Delivery > News
16-30 of 2302 results