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With promising RSV data in hand, Novavax wins $89M Gates grant for PhIII

CommentsPharmacodia.com2015-09-30 00:00 Read   194

Immunizing pregnant women with an RSV vaccine charged up levels of antibodies that should be able to protect infants during the first few months of their lives, Novavax reported Tuesday morning, adding that the Bill & Melinda Gates Foundation followed up with an $89 million grant to fund a pivotal study.

U.S. cancer drug prices up to 3X higher than in Europe: Study

CommentsPharmacodia.com2015-09-25 00:00 Read   352

Amid all the drug-pricing brouhaha this week, a British pharmacologist was preparing to unveil his research showing just how much more Americans pay for cancer therapies. And while it's well known that medications cost more in the U.S. than in other countries, this new study puts some surprising numbers to that spread.

FDA awards 18 grants to stimulate product development for rare diseases

RegulatorPharmacodia.com2015-09-22 00:00 Read   342

The U.S. Food and Drug Administration today announced it has awarded 18 new research grants totaling more than $19 million to boost the development of products for patients with rare diseases, which affect the lives of nearly 30 million Americans. These new grants were awarded to principal investigators in ten states, with research spanning clinical sites domestically and internationally.

Pivotal Phase 3 Studies of Bezlotoxumab, Merck’s Investigational Antitoxin to Prevent Clostridium Difficile Infection Recurrence, Met Primary Endpoint

R&DPharmacodia.com2015-09-22 00:00 Read   946

Merck, known as MSD outside the United States and Canada, today announced that the two pivotal Phase 3 clinical studies for bezlotoxumab, its investigational antitoxin for prevention of Clostridium difficile (C. difficile) infection recurrence, met their primary efficacy endpoint: the reduction in C. difficile recurrence through week 12 compared to placebo, when used in conjunction with standard of care antibiotics for the treatment of C. difficile. Based on these results, the company plans to submit new drug applications seeking regulatory approval of bezlotoxumab in the U.S., EU and Canada in 2015. Currently, there are no therapies approved for the prevention of recurrent disease caused by C. difficile.

Zai announces global collaboration and license agreement with UCB

TrendPharmacodia.com2015-09-22 00:00 Read   355

Zai Lab Ltd. announced today that it has entered into a worldwide collaboration and license agreement with UCB, a global biopharmaceutical leader (Euronext: UCB), to develop and commercialize a first-in-class monoclonal antibody for the potential treatment of autoimmune and other inflammatory diseases. The product is a clinical candidate ready for Investigational New Drug (IND)-enabling studies and expected to enter clinical Phase 1 in 2016.

Arno’s AR-12: first-in-class, novel mechanism, broad-spectrum antimicrobial drug

R&DPharmacodia.com2015-09-21 00:00 Read   427

Arno Therapeutics, Inc., a clinical stage biopharmaceutical company primarily focused on the development of therapeutics for cancer and other life threatening diseases, today announced promising data demonstrating novel activity of AR-12 as a broad-spectrum, anti-microbial drug.

Johnson & Johnson And Achillion Pharmaceuticals May Offer Fastest 100% Cure With Their HCV Combo

R&DPharmacodia.com2015-09-20 00:00 Read   319

Achillion Pharmaceuticals, Inc. reported on Thursday additional interim results from a mid-stage study evaluating safety and efficacy of its experimental hepatitis C drug, ACH-3102 (odalasvir), within six to eight weeks of treatment. The positive results might help to reinstate investor interest in the biotech company’s stock, after the year-to-date slump. Achillion stock traded up 7.38% on the news to close at $8.58 on Thursday.

Adding iridium may offer a new approach to antibiotic resistance

R&DPharmacodia.com2015-09-19 00:00 Read   241

Virginia Tech researchers say that they have developed a new antibiotic that includes iridium, a "transition metal" that keeps them from breaking down and improving delivery to fight infections.

FDA asks Pfizer for Zoloft label update highlighting birth defect risks

CommentsPharmacodia.com2015-09-19 00:00 Read   252

For years, Pfizer ($PFE) has shrugged off claims that its antidepressant Zoloft causes heart defects in newborns, fighting a raft of litigation alleging that the company did not adequately warn pregnant women taking the med about its potential risks. Now the FDA is weighing in on the issue, asking the company to acknowledge some studies that link Zoloft to heart defects in babies.

Zealand advances its proprietary, long-acting GLP-2 analogue, ZP1848, into clinical Phase II development for the treatment of Short Bowel Syndrome

R&DPharmacodia.com2015-09-17 00:00 Read   860

Zealand announces the initiation of a clinical Phase II development program for its proprietary peptide therapeutic, ZP1848, for the treatment of Short Bowel Syndrome (SBS). ZP1848 is a long-acting, stable and soluble GLP-2 receptor agonist invented and wholly owned by Zealand.

New data demonstrates Jardiance (empagliflozin) showed a significant reduction in cardiovascular risk in diabetes patients in a dedicated outcome trial

R&DPharmacodia.com2015-09-17 00:00 Read   658

Patients with type 2 diabetes at high risk for cardiovascular events who received empagliflozin, as compared with placebo, had a lower rate of the primary composite cardiovascular outcome and of death from any cause when the study drug was added to standard care.

Advaxis gets a whiplash after its upbeat assessment of PhII cancer vaccine data

R&DPharmacodia.com2015-09-17 00:00 Read   338

Advaxis says that a small study for cervical cancer produced promising outcomes for a significant number of the 26 patients involved.That assessment was initially spurned by the market, with the stock plunging close to 30% before immediately bouncing back and hovering around even Thursday afternoon.