Archive for the ‘Novartis’ Category
May
11
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Videos by rmcbride
India's drug regulators are ensnared in a scandalous fix. Days after a parliamentary report noted shoddy oversight of approvals, the Indian government has mounted an investigation into the alleged misdeeds. Meanwhile, big names in biopharma have surfaced in the sea of allegations.
As The Wall Street Journal reports, India's ministry said Friday it has created a special group to probe the long list of grievances in the report, with an eye toward repairing the infrastructure in place for approving drugs in the country. If the allegations in the parliamentary review are true, the Indian government believes that laws were broken and drugs arrived in pharmacies without undergoing required clinical studies.
Drugs from several of the largest drug companies--including Bayer, GlaxoSmithKline ($GSK), Novartis ($NVS) and Sanofi ($SNY)--were listed among those that were approved without standard clinical evaluation. Many of the drug manufacturers have professed their innocence after the report cited alleged collusion between pharma groups and India's drug regulator, Central Drugs Standard Control Organization.
- read the WSJ's article (sub. req.)
- see Reuters' report
Related Articles:
Indian panel accuses Big Pharma of colluding with regulators
Subpar clinical trials probed in India's review of regulation
May
10
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Indian lawmakers and patient advocates charge that their regulator rubber-stamped drugs to be sold in the county without required clinical trials. And a parliamentary report heaps blame for poor adherence to trials standards on Big Pharma groups, the national regulator and other stakeholders in a scathing review of approvals in the country.
The investigation probed the approvals of 42 drugs from groups such as the global heavyweights GlaxoSmithKline ($GSK), Novartis ($NVS) and Sanofi ($SNY), finding that certain meds were cleared for the market in India after being banned in developed countries or got approvals without being studied in enough patients, Bloomberg reported. For instance, India's Central Drugs Standard Control Organization approved Sanofi's dronedarone and Novartis' aliskiren based on trials with fewer than 50 patients, allegedly allowing the companies to skirt the minimum 100-patient requirement.
"There is sufficient evidence on record to conclude that there is collusive nexus between drug manufacturers, some functionaries of CDSCO and some medical experts," the report said, as quoted by Bloomberg. "Such irregular approvals spare drug producers the cost and efforts but put Indian patients at risk."
Novartis and GSK, for starters, reacted quickly to the news. Switzerland-based Novartis stated that the company follows the same ethical standards for all of its studies around the world, and has mounted an investigation of its own into regulatory activity in India. In its own defense, GSK got Indian regulators to waive trial requirements for the London-based drugmaker's niche hypertension drug ambrisentan, the London-based drug giant told Bloomberg.
The report is a clear signal that Indian lawmakers and advocates are pushing for tighter control of drug regulation in the country, which has been a rapidly growing market for drug development and pharma sales.
- see Bloomberg's report
- check out Reuters' story
Related Articles:
Reactions to poor practices, 'Dateline' special on CROs differ in India
Indian government defends country's generics industry
Bayer slams Indian government, Cipla on Nexavar copies
May
07
Posted under
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Novartis ($NVS) has met the main goal of a late-stage study of the company's experimental drug against a rare endocrine disorder. The Swiss drug giant says its experimental drug pasireotide LAR beat the standard of care in the largest Phase III study involving patients with acromegaly, which triggers overproduction of growth hormone and leads to enlarged feet, hands and organs.
Patients on pasireotide, code named SOM230, gained full control of their disease in 31.3% of cases compared with 19.2% of patients on the standard therapy, octreotide LAR, marketed as Sandostatin. Patients treated with Novartis' drug were also 63% more likely to gain full control than patients on Sandostatin, according to the company. Adverse events in the 358-patient study included hyperglycemia, diarrhea, nasopharyngitis and headaches.
"The positive results seen in the Phase III trial point to the potential role of pasireotide LAR in treating patients with acromegaly, a condition for which there remains an unmet need," said Hervé Hoppenot, president of Novartis Oncology. "These findings are welcome news as we continue our research efforts to discover treatments for patients with pituitary-related conditions."
Novartis' results were presented at the 2012 joint 15th International Congress of Endocrinology and 14th European Congress of Endocrinology meeting in Florence, Italy.
- here's the release
- and Reuters' update
Special Report: Novartis - The world's biggest R&D spenders
Apr
25
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Videos by john
Over the past few years, there's been no end of discussion about the need to find more efficient ways to discover and develop new drugs. Giants like GlaxoSmithKline ($GSK), Sanofi ($SNY) and Pfizer ($PFE) have been retooling pipelines and demanding better results from investigators. New analysis, meanwhile, has pointed to the persistent megablockbuster cost of drug development at most companies, as consultants and analysts pondered the effects of a long drought in the approval process.
Last year, pharma did better on the development front, seeing a modest increase in new drug approvals, which helped inspire talk of a turnaround. But long after all the economizing and efficiency reviews have been launched, R&D expenses continue to go up. This past year, the top 10 collectively registered expenses of a bit more than $70 billion, up slightly over the year before, according to the figures we collected.
Pfizer has yet to deliver on the bulk of the $1.5 billion in cost cuts that it has promised--though that is still in the works. And faced with paltry results from R&D, AstraZeneca ($AZN) is ordering some deep cuts. So the trend to ever-higher annual expenses may yet be challenged by the Big 10. But for every big cost-cutting effort, you'll see more examples of big companies holding the line or spending slightly more. Companies like Novartis ($NVS), Eli Lilly ($LLY) and Merck ($MRK) show no sign of backing down on R&D budgets--though this year at least two of those companies are going to face growing demands to either put up impressive pivotal data or start changing strategies.
Drug research remains one of the ultimate long shots in the tech industry. Finding a rational balance between what's spent and what's produced will continue to be one of the biggest challenges the industry faces. -- John Carroll, Editor-in-Chief. Follow me on Twitter and LinkedIn.