Hyderabad based NATCO Pharma Limited today confirmed that the company has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market lenalidomide capsules in 5, 10, 15 and 25mg strengths prior to the expiration of various U.S. patents. NATCO’s lenalidomide capsules are the generic version of Celgene Corporation’s Revlimid®.
On August 30, 2010, pursuant to the Hatch-Waxman Act, NATCO notified Celgene that its ANDA requesting approval from the FDA for a generic version of Revlimid® contained a paragraph IV certification asserting that various Revlimid® patents are invalid, unenforceable and/or not infringed. Lenalidomide, which is presently marketed as Revlimid by Celgene, is a derivative of thalidomide and is used in the treatment for multiple myeloma. Lenalidomide has also shown efficacy in the class of hematological disorders known as myelodysplastic syndromes (MDS). Read the rest of this entry »
A biotechnology company that holds patents on the BRCA1 and BRCA2 genes may lose them after a federal judge ruled that seven of their 23 patents involving the genes tied to breast and ovarian cancers should not have been granted, the New York Times reports. The American Civil Liberties Union and the Public Patent Foundation filed a suit last year, claiming that patents held by Myriad Genetics kept competitors from creating tests to find mutations in the genes and stifled research.If the court’s decision is upheld, the biotechnology industry would “have to get more creative about how to retain exclusivity and attract capital in the face of potentially weaker patent protection,” said Kenneth Chahine, who filed an amicus brief for Myriad, the Times reports. Read the rest of this entry »
THE GLOBAL generic drug industry has witnessed an almost decade-long sales euphoria and volumes and sales growth of prescription generic drugs continued to increase in 2009.
In the 12 months ended September 2009, global prescription sales growth of generic drugs climbed by 7.7%, up from 3.6% in 2008, according to US-based health care information and consulting company IMS Health. This compares with the 5.7% growth seen within the overall global pharmaceutical universe last year, says Doug Long, vice-president, industry relations at IMS Health. Read the rest of this entry »
The FDA today approved Cervarix, a new vaccine to prevent cervical cancer and precancerous lesions caused by human papillomavirus (HPV) types 16 and 18. The vaccine is approved for use in girls and women ages 10 years through 25 years. Read the rest of this entry »
Teresa Heinz, a part-time Wood River Valley resident for more than 30 years, has announced that she is being treated for breast cancer, but has a 95 percent chance of recovery.
Heinz, 71, and her husband, Massachusetts Sen. John Kerry, the 2004 Democratic presidential nominee, own a house just north of Ketchum along the Big Wood River. Read the rest of this entry »
The results of a recent study suggest that people suffering from Alzheimer’s disease are less likely to develop cancer and people with cancer are less likely to contract Alzheimer’s disease.
A group of 3,020 people aged 65 and older were selected. Of this group, 164 people already had Alzheimer’s disease and 522 people already had a cancer diagnosis. Researchers tracked the group for an average of five years to see whether they developed dementia and an average of eight years to see whether they developed cancer. Read the rest of this entry »
The initial data from a Phase III study using the Revlimid in multiple myeloma patients who had undergone stem cell transplant reported that the trial had met its primary endpoint of a statistically significant improvement in time to disease progression. Read the rest of this entry »
In patients with moderate to severe chronic obstructive pulmonary disease (COPD) and pulmonary hypertension (PH), bosentan plus best conventional care produced greater improvement in cardiovascular parameters than best conventional care alone. Read the rest of this entry »
“This novel proteasome inhibitor appears to improve response rates and
survival in patients with progressive multiple myeloma.” Read the rest of this entry »
Iressa (gefitinib) Improves Progression-free Survival over Standard Chemotherapy in Patients with NSCLC with EGFR Mutations. Read the rest of this entry »
Hyderabad based NATCO Pharma Limited today confirmed that the company has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market lenalidomide capsules in 5, 10, 15 and 25mg strengths prior to the expiration of various U.S. patents. NATCO’s lenalidomide capsules are the generic version of Celgene Corporation’s Revlimid®.
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