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106-120 of 2298 results
Kite Pharma granted access to PRIME regulatory support for KTE-C19 to treat chemorefractory DLBCL
The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) and Committee for Advanced Therapies (CAT) has granted access to Kite Pharma's newly established Priority Medicines (PRIME) regulatory initiative for KTE-C19 in the treatment of patients with refractory diffuse large B-cell lymphoma (DLBCL).
Drug Research > Drug Delivery > News
European CHMP adopts positive opinion for Gilead’s Epclusa to treat all genotypes of chronic hepatitis C
The Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has adopted a positive opinion on Gilead Sciences' Marketing Authorization Application (MAA) for Epclusa, an investigational, pan-genotypic, once-daily tablet containing the nucleotide analogue polymerase inhibitor sofosbuvir (SOF) 400 mg and velpatasvir (VEL) 100 mg, an investigational pan-genotypic NS5A inhibitor, for the treatment of chronic hepatitis C virus (HCV) infection.
Drug Research > Drug Delivery > News
CHMP backs extended approval of Takeda Pharmaceutical's Adcetris
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the extension of the current conditional approval of Takeda Pharmaceutical's ADCETRIS (brentuximab vedotin) and recommended its approval for the treatment of adult patients with CD30+ Hodgkin lymphoma at increased risk of relapse or progression following autologous stem cell transplantation (ASCT).
Drug Research > Drug Delivery > News
Shire gets positive CHMP opinion in Europe for Revestive for paediatric patients with SBS
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the extension of the approval of Shire's Revestive (teduglutide) 5 mg powder and solvent for solution for injection in paediatric patients (aged one to 17 years) with short bowel syndrome (SBS).
Drug Research > Drug Delivery > News
Indivior secures FDA fast track status for 6000 buprenorphine monthly depot to treat opioid use disorder
The US Food and Drug Administration (FDA) has granted Fast Track designation for Indivior's RBP-6000 buprenorphine monthly depot, an investigational new drug for the treatment of opioid use disorder as part of a complete treatment plan to include counseling and psychosocial support.
Drug Research > Drug Delivery > News
Baxalta unveils positive phase 1 results for BAX 930, investigational recombinant ADAMTS13 to treat hTTP
Baxalta has reported positive results from a Phase 1 open-label, dose escalation study assessing the safety and pharmacokinetic (PK) profile of BAX 930, an investigational recombinant ADAMTS13 for the treatment of patients with severe hereditary thrombotic thrombocytopenic purpura (hTTP).
Drug Research > Drug Delivery > News
Eli Lilly says it has potential to launch 20 new products in 10 years
In a presentation to the investment community, Eli Lilly and Company stated it has the potential to launch 20 new products in the 10 years beginning in 2014 and extending through 2023.
Drug Research > Drug Delivery > News
Zambon launches Xadago in UK for patients with mid- to late-stage Parkinson’s Disease
Zambon and its partner Newron Pharmaceuticals announced the availability of Xadago (safinamide) in the UK.
Drug Research > Drug Delivery > News
Martindale Pharma announces expansion of European commercial activities
Martindale Pharma announced the approval and supply of Noyada in France, under an ATU de’ Cohorte (“Temporary Authositaion for Use”) programme which will commence in June.
Drug Research > Drug Delivery > News
EAG unveils further investments to improve ABC Laboratories' biopharmaceutical characterization capabilities
EAG has unveiled a major investment in ABC Laboratories' capacity and analytical capabilities to meet the pharmaceutical industry's need for high-end biopharmaceutical analysis.
Drug Research > Drug Delivery > News
Neos Therapeutics launches Adzenys XR-ODT in US to treat ADHD in patients six years and older
Neos Therapeutics announced that Adzenys XR-ODT is in distribution channels and is now available to prescribe to patients with ADHD in the US.
Drug Research > Drug Delivery > News
AHF urges Congress to authorize funding for Zika virus
By PBR Staff Writer
AIDS Healthcare Foundation (AHF) has urged the US Congress to fund the Zika virus prevention and research.
Drug Research > Drug Delivery > News
US CDC unveils funds to fight Zika locally
By PBR Staff Writer
The US health department has made available more than $85m in redirected funds to fight Zika infection in the country.
Drug Research > Drug Delivery > News
Horizon Pharma settles PENNSAID 2% w/w patent litigation with Teligent
Horizon Pharma's affiliates have entered into a settlement and license agreement with Teligent, Inc. to resolve pending patent litigation involving PENNSAID (diclofenac sodium topical solution) 2% w/w (PENNSAID 2%).
Drug Research > Drug Delivery > News
Caladrius Biosciences secures FDA orphan drug designation for CLBS03 to treat type 1 diabetes
The US Food and Drug Administration (FDA) has granted orphan-drug designation to Caladrius Biosciences' CLBS03 to treat type 1 diabetes mellitus with residual beta cell function.
Drug Research > Drug Delivery > News
106-120 of 2298 results