How adverse reactions from GSK’s abacavir help the FDA spot drug allergies

GlaxoSmithKline (NYSE:GSK) AIDS drug abacavir holds a hidden key to understanding allergic reactions that some patients experience from other drugs.Abacavir, which is marketed under the name Ziagen, is already known to cause allergic reactions ranging from mild skin irritation to severe allergic shock in certain patients. It can also lead to death. U.S. Food and [...]

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Celebrex creator Talley working on a new anti-inflammatory drug for cancer

In his latest project, Dr. John Talley, the lead scientist behind Pfizer’s Celebrex and seven other drugs that have been marketed in the U.S., is trying his hand at developing a cancer medication with improved efficacy and safety.He’s the chief scientific officer at Euclises Pharmaceuticals, a St. Louis, Missouri startup currently looking to raise a [...]

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Novo Nordisk gets FDA approval to expand type1 diabetes drug to young children

Novo Nordisk (NYSE:NVO) has received approval from the U.S. Food and Drug Administration to expand its type 1 diabetes drug Levemir to children as young as 2 years old.The man-made insulin is the only basal insulin analog approved for children 2 to 5 years old, the company said in a statement. Basal dosage is the [...]

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Advanced breast cancer drug produces positive phase 2 results

A pharmaceutical company has produced positive phase 2 results for its drug to treat advanced breast cancer with an oral version of a chemotherapy treatment. The findings come at a critical time for the drugmaker and could lead to additional investment as it seeks to advance the drug’s development.Genta’s (OTCBB:GNTA) lead drug is tesetaxel, a [...]

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Chelsea Therapeutics to modify Northera study, resubmit NDA in 2013

Chelsea Therapeutics (NASDAQ:CHTP), regrouping from orphan drug Northera’s failure to secure regulatory approval, now plans to resubmit a new drug application in early 2013 with data from a modified phase 3 study.The Charlotte, North Carolina drug developer announced the plans following its meeting with the U.S. Food and Drug Administration to discuss the complete response [...]

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Quintiles report: Healthcare payers to get greater drug development role

Pharmaceutical companies and insurers are still figuring out how they’ll work with each other, but a clear majority of both camps surveyed in Quintiles‘ annual New Health Report expect that there will be more collaborations in the future.The survey included more than 1,350 healthcare stakeholders ranging from healthcare payers, executives, patients and investors in the [...]

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GSK inks testosterone replacement therapy co-promotion deal

Specialty pharmaceutical company Auxilium Pharmaceuticals (NASDAQ:AUXL) has inked a deal with GlaxoSmithKline (NYSE:GSK) to co-promote its testosterone replacement therapy gel Testim in a bid to grab a bigger slice of the primary care physician market, which accounts for 70 percent of TRT gel prescriptions, according to a conference call detailing the deal.The deal, scheduled to [...]

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Biopharma raising $500K eyes competitive asthma/COPD drug market

A biopharmaceutical startup developing a new treatment for asthma that targets the nitric oxide signaling system has raised $50,000 of a planned $500,000 fundraise, according to recently filed U.S. Securities and Exchange Commission documents.SAJE Pharma LLC’s lead compound appears to have been discovered at Johns Hopkins University and is in preclinical stages. Aside from respiratory [...]

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BDSI’s cancer pain product preps for Europe, triggers $2.5M milestone

The breakthrough cancer pain treatment developed by BioDelivery Sciences (NASDAQ:BDSI) International is making progress toward entering the European market, triggering a $2.5 milestone payment from BDSI’s drug partner Meda Pharmaceuticals.The milestone was triggered by registration and pricing approval of the drug Breakyl in Europe. Raleigh, North Carolina-based BDSI is due another $2.5 million upon commercial [...]

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5 innovative new solutions for treating diabetes

Drugs that mimic beneficial bacteria found in the human gut, implantable and incisionless weight loss devices and stem cells that restore pancreatic function.If the world is going to make a dent in the diabetes epidemic, it’ll require innovative approaches like those mentioned above – and more.Solutions to the “whole body” problem of diabetes are coming [...]

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