Archive for the 'New Drugs' Category
April 26th, 2011 by admin
A researching team from the University of Leicester has offered the promise of a simple injection that could be developed to restrict the damage that results from heart attacks and strokes. Described by the lead researcher as ‘a fascinating new achievement’, work has already begun to translate the research into novel clinical therapies.
Continue reading ‘Preventing Damage from Heart Attacks & Strokes with an Injection’
April 20th, 2011 by admin
An investigational combination of drugs already approved to treat obesity, migraine and epilepsy produced up to a 10 percent weight loss in obese individuals participating in a one-year clinical trial, according to researchers at Duke University Medical Center.
Continue reading ‘New Drug Shows Unprecedented Weight Loss in Clinical Trials’
February 17th, 2011 by admin
Want proof that achieving FDA approval is more difficult than in the past? A study released by the BIO and BioMedTracker that the overall success rate for drugs moving through clinical trials to FDA approval from late 2003 to the end of 2010 is near one in 10. Previously the rate of approval were one in five to one in six. Oncology drugs faced the toughest road to approval despite the fact that the disease area is the most closely studied in all of drug development. And large molecule drugs are twice as likely to be approved than than small molecule drugs.
Continue reading ‘Rate of Drug Approvals Dropping’
February 14th, 2011 by admin
Every so often, someone sets up a dartboard of likely targets for Big Pharma buyouts. This time, the target-setter is Barron’s, and the focus is on companies with market values of $10 billion or less. Most of them have at least one marketed product: “It’s less dangerous playing smaller outfits with approved drugs than those with treatments still awaiting an okay from an increasingly demanding FDA,” the magazine points out.
Continue reading ‘Which Specialty Drugmakers Should Big Pharma Buy?’
January 13th, 2011 by admin
As investors lay down their final bets on the FDA’s looming decision on MannKind’s Afrezza, the company’s wealthy CEO has opted to put his money where his mouth has been–doubling down on an ambitious wager that the much-maligned inhaled insulin treatment Afrezza will get a green light from regulators.
Continue reading ‘Alfred Mann Doubles Down on Biotech’
December 14th, 2010 by admin
MedGadget blog tells us about a new dry powder inhaler that, according to Cambridge Consultants and India’s Sun Pharma Advanced Research Company (SPARC), delivers an even drug dose deep into the lungs no matter how strong the patient’s inhalation.
Continue reading ‘Dry Powder Inhaler Stays Strong Even if Breath is Weak’
November 30th, 2010 by admin
The FDA has some of its biggest decisions of the year looming in the next few months. The first new lupus drug in half a century, a blood-thinner with mega-blockbuster potential, controversial weight drugs and more are all up for regulatory decisions that can move markets and either throw a bucket of cold water or high octane gasoline on stock prices.
Continue reading ‘FDA’s Top Q4 Blockbuster Drug Decisions’
November 11th, 2010 by admin
The FDA’s marathon run toward a new set of regulations to govern the development of biosimilars is official. Regulators will host their first public meeting on follow-on drug regs, and you can expect to hear plenty from big companies like Amgen on the need for lengthy and expensive clinical trials.
Continue reading ‘Amgen Proposes Key Hurdles for Biosimilar Regs’
November 3rd, 2010 by admin
Swiss drugmaker Novartis AG wants to file its meningitis vaccine Menveo for use in small infants in the United States and Europe after a late-stage study with children of this age group was successful. In the phase III study, a high percentage of the 4,500 infants as young as 2 months showed the immune response when given Menveo, Novartis said. The vaccine was well tolerated, with a safety profile similar to routine infant vaccines.
Continue reading ‘Novartis to File Meningitis Vaccine for Infants’
November 2nd, 2010 by admin
The side effects of the standard medication for Parkinson’s disease have long been a preoccupation of brain researchers. Now Daniella Rylander has presented new findings in a recently defended PhD thesis at Lund University that provide hope of more effective medication for those who suffer from the nerve cell disease.
Continue reading ‘New Parkinson’s Drug Development’
