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Theravance Biopharma Submits Investigational New Drug (IND) Application for TD-0714, an Inhibitor of Neprilysin (NEP)

R&DPharmacodia.com2015-10-14 00:00 Read   224

Phase 1 Trial of Potential Best-in-Class Neprilysin Inhibitor Planned for Q4 2015; Compound Designed for Broad Use in Major Cardiovascular and Renal Diseases

TPP Negotiations Resolved: Was It Really A Win For Global Biosimilar Market?

CommentsPharmacodia.com2015-10-14 00:00 Read   309

After a great amount of debate, the parties involved in hammering out biologics exclusivity rules in the Trans-Pacific Partnership (TPP) have finally settled on a deal. However, these final negotiations have garnered the ire of the pharmaceutical industry and nonprofit groups alike.

Global strategic partners bioeq and Formycon initiate pivotal phase III clinical trial with their Lucentis® biosimilar

RegulatorPharmacodia.com2015-10-13 00:00 Read   341

October 7, 2015, Formycon AG, Munich, Germany, and bioeq GmbH, Holzkirchen, Germany, today announced the initiation of a pivotal Phase III clinical trial with FYB201, an investigational biosimilar ranibizumab (Lucentis).

Rebiotix Receives Breakthrough Therapy Designation for RBX2660 -- A Microbiota Restoration Therapy (MRT) for the Treatment of Recurrent Clostridium difficile Infection

R&DPharmacodia.com2015-10-13 00:00 Read   479

October 12, 2015, Rebiotix Inc. today announced that U.S. Food and Drug Administration (FDA) has designated its lead Microbiota Restoration Therapy (MRT) RBX2660 as a Breakthrough Therapy for the treatment of recurrent Clostridium difficile (C diff) infection.

Biodel Announces Removal of Partial Clinical Hold for BIOD-531 and Plans for Potential Expansion of Target Patient Population

R&DPharmacodia.com2015-10-13 00:00 Read   366

October 12, 2015, Biodel Inc. (BIOD) today announced that the United States Food and Drug Administration (FDA) has removed the partial clinical hold for Biodel's previously initiated Phase 2b Study 3-250.

Lilly to Discontinue Development of Evacetrapib for High-Risk Atherosclerotic Cardiovascular Disease

R&DPharmacodia.com2015-10-13 00:00 Read   224

October 12, 2015, Eli Lilly and Company (NYSE: LLY) and the ACCELERATE study's academic leadership have accepted the recommendation of the independent data monitoring committee to terminate the Phase 3 trial of the investigational medicine evacetrapib.

Can GSK's volume strategy offset generic attack on blockbuster Avodart?

CommentsPharmacodia.com2015-10-13 00:00 Read   239

GlaxoSmithKline ($GSK) has one less tool for propping up its top line. The company's prostate drug Avodart now faces a generic version from Teva Pharmaceutical Industries ($TEVA), with more copycats expected next month.

One Year Data from Phase III Study Evaluating Oral OTEZLA® (apremilast) or Injectable etanercept versus Placebo in Patients with Moderate to Severe Plaque Psoriasis Presented at EADV

R&DPharmacodia.com2015-10-13 00:00 Read   227

October 12 2015, Celgene International Sàrl, a wholly owned subsidiary of Celgene 52 of Corporation (NASDAQ: CELG), today announced that results from its ongoing phase III LIBERATE™ trial evaluating Otezla (apremilast), the Company’s oral, selective inhibitor of phosphodiesterase 4 (PDE4), in patients with moderate to severe plaque psoriasis were presented as a late-breaker at the 24th European Academy of Dermatology and Venereology (EADV) Congress in Copenhagen, Denmark, October 7-11, 2015.

Hong Kong's cheaper prices for Sovaldi, Herceptin and other drugs draw throngs

CommentsPharmacodia.com2015-10-13 00:00 Read   951

Gilead Sciences' ($GILD) hep C drug Sovaldi is not yet available on mainland China, at least not legitimately. But it is in Hong Kong, and buyers who ask quietly at small pharmacies along Nathan Road can expect to get it, and many other top-tier drugs, without a prescription.

Lilly signs a $1B deal to deepen its oncology ties with China's Innovent

TrendPharmacodia.com2015-10-13 00:00 Read   251

Eli Lilly ($LLY) has expanded its R&D partnership with China's Innovent Biologics, bringing in three potential immunotherapies for cancer and adding another $1 billion in potential value to the existing alliance.

Novartis buys a bigger stake in Gamida, stopping short of a $600M plunge

TrendPharmacodia.com2015-10-13 00:00 Read   191

Novartis is forging ahead with a prospective stem cell biotech buyout, agreeing to pay $35 million to grab a sizable equity stake in Gamida Cell while executing a short term option deal that will allow the pharma giant ($NVS) the right to gobble up the company for another $600 million split up between a $165 million upfront payout with the rest up for grabs in development and sales milestones.

KEYTRUDA® (pembrolizumab) Receives New Draft Recommendation from National Institute for Health and Care Excellence (NICE) in U.K. for First-Line Treatment for Advanced Melanoma

RegulatorPharmacodia.com2015-10-12 00:00 Read   369

Merck, known as MSD outside the United States and Canada, announced the National Institute for Health and Care Excellence (NICE) of the United Kingdom (U.K.) has issued a draft recommendation, in the form of a Final Appraisal Determination (FAD), recommending KEYTRUDA (pembrolizumab) as a first-line treatment option for adults with advanced melanoma.