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New Data Show Greater Bone Mineral Density Gains With Prolia® (Denosumab) Compared With Zoledronic Acid

R&DPharmacodia.com2015-10-12 00:00 Read   752

Amgen announced findings from a randomized, double-blind, double-dummy, multicenter Phase 4 study showing that Prolia® (denosumab) achieved greater gains in bone mineral density (BMD) than the intravenous bisphosphonate zoledronic acid in postmenopausal women with osteoporosis following previous treatment with oral bisphosphonates.

Novartis presents new data showing that the majority of patients are able to maintain clear or almost clear skin with Cosentyx across 3 years

R&DPharmacodia.com2015-10-11 00:00 Read   981

October 10, 2015, Novartis announced today new late-breaking data demonstrating that CosentyxTM (secukinumab) provides high levels of skin clearance and sustained efficacy in patients with moderate-to-severe plaque psoriasis while maintaining a favorable safety profile across three years.

Full Results of PEARL IV Study Presented at the European Society of Gynaecological Endoscopy (ESGE) Congress Confirms the Efficacy of Ulipristal Acetate 5 mg for the Long Term Management of Uterine Fibroids

R&DPharmacodia.com2015-10-11 00:00 Read   428

Gedeon Richter Plc. ("Richter") announces results of the PEARL IV study at ESGE. PEARL IV was a Phase III, randomized, double-blind, parallel group study investigating the efficacy and safety of repeated 3 months treatment courses of daily 5mg or 10mg ulipristal acetate (UPA) for the long-term management of symptomatic uterine fibroids, characterized by heavy bleeding.

AstraZeneca halts a pair of lung cancer trials over a safety scare

R&DPharmacodia.com2015-10-10 00:00 Read   243

AstraZeneca is pressing pause on trials combining two of its most important pipeline cancer treatments after tracking reports of lung disease, halting enrollment as it gathers more information.

Alnylam Initiates Phase 1 Open Label Extension (OLE) Study with ALN-AT3, an Investigational RNAi Therapeutic for the Treatment of Hemophilia and Rare Bleeding Disorders

R&DPharmacodia.com2015-10-10 00:00 Read   653

Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, announced today that it has initiated a Phase 1 open-label extension (OLE) study with ALN-AT3, a subcutaneously administered, investigational RNAi therapeutic targeting antithrombin (AT) for the treatment of hemophilia and rare bleeding disorders. The Phase 1 OLE study will evaluate the long-term safety and efficacy of ALN-AT3 and provide people with hemophilia enrolled in the Phase 1 study the opportunity for continued dosing. The company plans to report clinical data from the Phase 1 OLE study at least once per year, beginning in 2016.

Positive safety and tolerability for novel potentiator GLPG1837

R&DPharmacodia.com2015-10-10 00:00 Read   275

Galapagos NV presents topline Phase 1 results with novel potentiator GLPG1837 at the North American Cystic Fibrosis Conference (NACFC) in Phoenix this week. GLPG1837 was shown to be safe and well-tolerated and demonstrated favorable drug-like properties in the study .

Johnson & Johnson starts clinical trial of Ebola vaccine in Sierra Leone

R&DPharmacodia.com2015-10-10 00:00 Read   219

Oct 9, 2015: Johnson & Johnson has begun a clinical trial of a two-shot Ebola vaccine in Sierra Leone, underlining its determination to push ahead with development, even as the epidemic fades out in West Africa.

Institute of Human Virology Begins Phase 1 Clinical Trials of HIV Vaccine Candidate

R&DPharmacodia.com2015-10-10 00:00 Read   227

Maryland Lt. Governor Boyd Rutherford announced today that the Institute of Human Virology (IHV) at the University of Maryland School of Medicine launched its Phase 1 clinical trials of a novel HIV vaccine candidate.

Results from ZINBRYTA™ (Daclizumab High-Yield Process) Phase 3 DECIDE Study Highlighting Efficacy Compared to Interferon Beta-1a Published in the New England Journal of Medicine and Presented at ECTRIMS

R&DPharmacodia.com2015-10-09 00:00 Read   477

Full results from the Phase 3 DECIDE study published this week in the New England Journal of Medicine (NEJM), as well as new post-hoc analyses of Phase 3 clinical data presented at an international congress, show once-monthly, investigational ZINBRYTA™ (daclizumab high-yield process [HYP]) improved results on key measures of multiple sclerosis (MS) disease activity in patients with relapsing-remitting MS (RRMS) compared to interferon beta-1a 30 mcg intramuscular (IM) injection.

OPKO Presents Clinical Data on its Long-acting Human Growth Hormone (hGH-CTP) in Two Oral Presentations at the 54th Annual Meeting of the European Society for Pediatric Endocrinology (ESPE)

R&DPharmacodia.com2015-10-09 00:00 Read   365

OPKO Health, Inc. presented clinical data from its completed 12-month hGH-CTP Phase 2 pediatric growth hormone deficiency clinical study in two oral presentations at the 54th Annual Meeting of the European Society for Paediatric Endocrinology on October 3, 2015, in Barcelona, Spain. The presentations included pharmacokinetic, pharmacodynamic, safety and efficacy data of OPKO's hGH-CTP in comparison to a daily Genotropin arm.

UCB with positive results for Vimpat® (lacosamide) in EU Phase 3 monotherapy study

R&DPharmacodia.com2015-10-09 00:00 Read   665

UCB announced positive results of a Phase 3 non-inferiority study designed to compare efficacy and safety of lacosamide to carbamazepine-CR (controlled release; retard tablets) as monotherapy in newly or recently diagnosed adult patients with partial-onset seizures. The study met its primary endpoint for the proportion of patients remaining seizure free for six consecutive months of treatment. UCB plans to submit to the European Medicines Agency (EMA) these data as part of its variation file to extend the marketing authorization of lacosamide as monotherapy , which is planned in the first half of 2016.

Long-term efficacy of Gilenya® reinforced by new 'no evidence of disease activity' (NEDA-4) analysis in MS patients over seven years

R&DPharmacodia.com2015-10-09 00:00 Read   533

Novartis announced today a new analysis from the phase III FREEDOMS and FREEDOMS II trials reinforcing the long-term efficacy profile of Gilenya® (fingolimod). The analysis evaluated the proportion of Gilenya patients with relapsing multiple sclerosis (RMS) achieving 'no evidence of disease activity' (NEDA-4) every year over seven years.