A closely watched trial that many hoped would help clarify a contentious battle over access to generic drugs instead ended in disappointment last week. In fact, the outcome only seems to have underscored the difficulty in sorting out so-called pay-to-delay deals, a topic that has embroiled the pharmaceutical industry, regulators and the courts for years.
Read more – Pharmalot – WSJ
Panacea Biotec has gained 7% to 165 on the Bombay Stock Exchange (BSE) after the company announced that it has entered into a strategic alliance with Apotex Inc. for research, development, license and supply of two drug delivery-based generic products for US, Canada, Australia and New Zealand.
Read more – Business Standard News
Drug firm Lupin has launched in the US market the generic version of Celebrex capsules used for treatment of osteoarthritis, rheumatoid arthritis and acute pain.
Its US subsidiary, Lupin Pharmaceuticals Inc has launched the authorised generic for GD Searle LLC’s (a subsidiary of Pfizer) Celebrex capsules of strength of 50 mg, 100 mg, 200 mg and 400 mg, the company said in a statement today.
Read more – The Economic Times
Biotech companies and biosimilars makers have been squabbling for years about the way the lower-cost copies will be prescribed and distributed. Brand makers wanted to raise hurdles to replacing their meds with biosimilar versions. But now, with biosimilars nearing their U.S. debut, the two sides have reached a compromise.
Read more – FiercePharma
Novartis ($NVS) continues the protracted drawdown at its Diovan plant in New York, telling the state nearly two dozen more jobs will be whacked starting at the end of March. It will be the third round of cuts since the Swiss drugmaker announced nearly a year ago that it would whittle away all of the 525 jobs at the plant by 2016 and then close and demolish it.
Read more – FiercePharma Manufacturing
AstraZeneca ($AZN) has been fighting a losing legal battle to protect the patent on its asthma drug Pulmicort Respules, and a plant in Massachusetts will pay part of the price. The U.K. drugmaker says it will close the plant next year, putting 180 workers out of jobs.
Read more – FiercePharma Manufacturing
With just weeks left until new tracking standards come into effect, the US Food and Drug Administration (FDA) is releasing new recommendations it hopes will better secure the pharmaceutical supply chain from accidents and counterfeiters alike.
Read more – RAPS
Last month, the United States and India announced an important breakthrough concerning India’s “right-to-food” program. The Indian government subsidizes food for its poorest citizens through a system of price supports and public stockpiling. The program is critical to India’s future: According to Unicef, one in three of the world’s malnourished children lives in India.
But as India’s policy has expanded, it has come into conflict with World Trade Organization rules on agriculture. The impasse now seems to be resolved…
This positive development on food, however, is in stark contrast to the United States’ approach to India’s policies on affordable medicines…
Read more – NYTimes.com
The Indian Pharmaceutical Alliance says the quality of US FDA inspections has “significantly deteriorated” this year, and their approach is creating a climate of fear among Indian manufacturers.
Read more – in-Pharmatechnologist.com
After three years of declining returns on R&D spend, the 12 largest operations have finally achieved an uptick in what they receive for each dollar of outlay. But the result is more of a bottoming out than a major turnaround, with returns still well below levels seen in 2010 and at least one company posting a negative yield.
Read more – FierceBiotech
Germany’s drug regulator has banned the sale of 80 generic medicines with immediate effect on the grounds that their clinical trials conducted by India’s pharmaceutical research company GVK Biosciences were “insufficient”.
The Federal Institute for Drugs and Medical Devices said on Tuesday it had ordered drug manufacturers, wholesale dealers, medical stores and other outlets not to sell or use these medicines any longer.
Read more – Livemint
The title, according to the magazine, goes to an individual or group who, for better or worse, has had the biggest impact on the world and the news over the course of the previous year.
“It’s an incredible honor,” Dr. Kent Brantly, medical missions advisor for Samaritan’s Purse and the first American to be affected with the virus, said Wednesday on TODAY of the shared title.
Read more – TODAY.com
Daewoong Pharmaceutical said it will build a $188.3 million facility in South Korea that the company expects will be completed by 2016.
The new 66,000-square-meter pharmaceutical manufacturing facility will be located in the Osong BioValley in Chungcheong Province, and will meet U.S. standards for design, monitoring and control of production, The Korea Herald reported.
Read more – FiercePharma Manufacturing
Germany has named 16 generic drugmakers, including Stada and Dr. Reddy’s, that produce drugs affected by its suspension of marketing approval over concerns about clinical trials conducted by an Indian company.
Regulators in France, Germany, Belgium and Luxembourg last week suspended marketing approval for 25 drugs over the quality of trial data from India’s GVK Biosciences.
Read more – Reuters
The U.S. arm of India’s Zydus Cadila has initiated its second recall in the U.S. in the last 7 months, this time because tablets of a drug for high blood pressure were found to have brown spots.
Read more – FiercePharma Manufacturing
