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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.

Backlash rages on over Purdue's pediatric OxyContin approval

CommentsPharmacodia.com2015-10-12 00:00 Read   237

Back in August, the FDA approved Purdue's powerful painkiller, OxyContin, for children ages 11 to 16. But nearly two months later, the public backlash hasn't died down.

Sun kills lawsuit Ranbaxy filed against FDA for pulling its Nexium generic

CommentsPharmacodia.com2015-10-12 00:00 Read   268

When the FDA last year yanked away its initial approval of Ranbaxy's generics of two blockbusters including the heartburn med Nexium, the Indian drugmaker fired back with a lawsuit against the FDA.

Advera Health Analytics: Novartis, Allergan Alzheimer's meds linked to abnormal behavior, blood pressure side effects

CommentsPharmacodia.com2015-10-12 00:00 Read   477

Alzheimer's drug development is a difficult venture, as pharma knows all too well. The meds' troubling side effects and potential safety issues make marketing a risky game, with few companies grabbing a seat at the table.

BioMed Realty Enters Into Definitive Agreement To Be Acquired By Blackstone For $23.75 Per Share In $8 Billion Transaction

TrendPharmacodia.com2015-10-12 00:00 Read   280

BioMed Realty Trust, Inc. announced that it has entered into a definitive agreement with affiliates of Blackstone Real Estate Partners VIII, under which Blackstone will acquire all outstanding shares of common stock of BioMed Realty for $23.75 per share in an all-cash transaction valued at $8 billion.

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.