Dr.Shruti Bhat, Leader Pharmaceutical R&D and Expert in hiTech formulation development for over 35 different therapeutic class of drugs moeities, brings to you some highlights from current pharma and clinical research news, views and data.
Presented below are updates in Pharmaceutical and clinical research-
Pioglitazone May Slow, Stop Progression Of Insulin Resistance To Full-Blown Diabetes.
According to research presented at the World Congress on Controversies to Consensus in Diabetes, Obesity, and Hypertension, "in patients with insulin resistance but near-normal glycated hemoglobin levels, pioglitazone (Actos) treatment cut the rate of progression to full-blown type 2 diabetes by 70% relative to placebo." Specifically, "the annual rate of progression to diabetes in the 602-patient trial was 1.8% with pioglitazone versus 6.0% in the placebo group," the study authors found.
Biosimilar Development Said To Be More Difficult Than Generic Endeavors.
Merck & Co.'s decision to end its effort to copy Amgen Inc.'s Aranesp (darbepoetin alfa) anemia drug may highlight the difficulties drugmakers face when developing biosimilars. The FDA is asking some companies to conduct extensive clinical trials, which increases the risk and may limit the industry to only the largest drug companies, the Journal notes. In addition, biosimilars will likely have their own brands and not be automatically substitutable for biotechnology therapies, as opposed to traditional generics, which can earn the majority of market share in months.
Biotech Industry Sees Profitable Year Following Research Cuts.
Bloomberg News reported "Biotechnology companies worldwide turned a profit last year for the first time since at least 1985 as those led by Celgene Corp. reduced spending on research while revenue increased." Ernst & Young Global Ltd.'s report on biotechnology in the US, Europe, Canada and Australia found that profit "in the industry was $3.7 billion, compared with a loss of $1.8 billion in 2008." About two-thirds of companies cut their research and development spending, which fell 13% in the US last year.
Gates Invests In Drug-Software Company To Aid Drug Development.
The Wall Street Journal reported Microsoft Corp. co-founder Bill Gates is investing $10 million in Schrodinger LLC, a pharmaceutical-software maker, as part of a bid to improve drug development. The investment will put Gates in a field looking to apply high-performance computers to simulate the process that chemists have used to find new drug compounds. Schrodinger says it will use Gates' money to hire more scientists and specialists to improve the software so it can make better predictions on which compounds will prove effective.
Remission In RA Possible With Biologic Drugs.
MedPage Today reported that "more than half of rheumatoid arthritis patients who achieved remission during treatment with infliximab (Remicade) were able to discontinue the drug for more than a year without flaring," according to a study published online in the Annals of the Rheumatic Diseases. Researchers found that, "of 102 patients, 55% had disease activity scores below 3.2 one year after withdrawal of the tumor necrosis factor inhibitor, indicating low disease activity." The researchers also found that "43% had scores below 2.6 after discontinuation, indicating that they were in remission."
Methadone Use During Pregnancy Associated With Risk Of Visual Problems In Babies.
MedPage Today reported that, according to a study published online in the British Journal of Ophthalmology, "infants whose mothers used methadone during pregnancy may be at risk for a range of visual problems." To arrive at this conclusion, Scottish researchers examined "records of children referred to a pediatric visual electrophysiology service." In 20 children, they found that "all but one...had reduced visual acuity, and 70% had nystagmus."
Liraglutide Added To Metformin May Benefit Patients With Type 2 Diabetes.
HealthDay reported that, according to a study published April 24 in The Lancet, "patients with type 2 diabetes who can't control their blood glucose levels with the drug metformin alone do better after adding injections of the drug liraglutide compared to oral doses of another drug called sitagliptin." In a study that randomized "patients whose blood glucose wasn't sufficiently controlled by metformin (Glucophage) to receive 26 weeks of treatment with liraglutide (Victoza) by injection or sitagliptin (Januvia) by mouth," investigators "found that the patients did better on liraglutide." An accompanying commentary noted that liraglutide "has improved benefits in terms of blood glucose control and weight reduction."
FDA Tightening Its Oversight Of Infusion Pumps.
Food and Drug Administration officials are "moving to tighten their oversight of medical devices, including one of the most ubiquitous and problematic pieces of medical equipment," the infusion pump. Approximately "two million infusion pumps are used in hospital and clinical settings, and hundreds of thousands more are used by" home-bound patients who need their medication, insulin, morphine, or cancer treatments delivered intravenously. Yet, "over the last five years, the agency says it has received reports of 710 patient deaths linked to problems with the devices."
In fact, there were 87 recalls between 2004 and 2009, 14 of which were prompted by potentially life-threatening issues, according to the Wall Street Journal. Apparently, the most frequent problem involved something referred to as "key bounce." There have been instances when a healthcare worker enters one number into the key pad, but it is actually recorded twice, which may cause the release of too much medication. "When I punch 10 digits in my cell phone...I don't get 11 or 12, and we should have that same expectation for infusion pumps...said," Jeffrey Shuren, the director of the FDA's device division.
Shuren added that, "in one instance, a nurse wanted to set an infusion pump to deliver 20 mL/h of heparin to a patient, but accidentally entered two zeroes instead of one, which infused the patient with 200 mL/h of the blood thinner," After 56,000 such "reports of infusion pump malfunction" were received, "Shuren said the agency decided the 'old approach isn't working." So, instead of "dealing with individual device makers as safety problems emerge," the FDA "is beefing up its premarket approval requirements for manufacturers of infusion pumps."
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