Big Board Bios.
Life Technologies Corporation (NASDAQ: LIFE) has developed a complete rapid molecular testing workflow for multiple strains of pathogenic Shiga-toxin producing Escherichia coli (STEC), a bacteria found in undercooked beef.
Depomed, Inc. (NASDAQ: DEPO) today announced that a report of Phase 3 data published online this month, ahead of the print edition, in the Clinical Journal of Pain showed that once-daily Gralise® (gabapentin) tablets (1,800 mg) formulation significantly reduces intensity of pain in patients with postherpetic neuralgia (PHN).
The FDA is scheduled to make an announcement regarding the status of Amarin's (NASDAQ:AMRN) AMR101, a treatment for patients with very high triglyceride levels, on July 26. The time allotted for the agency to review the drug is due to expire on that day. A prescription-grade omega-3 fatty acid, AMR101 has significantly reduced the "bad" cholesterol of patients who take the drug in trials, compared with those who take placebos.
On May 29, Amarin announced that it had received a patent covering the pharmaceutical composition of AMR101. Last month the USPTO took positive action on three key Amarin patent applications, leading research firm Jefferies to predict that AMR101 could be protected through 2030. Meanwhile, in a note to investors earlier this morning, JPMorgan said there's a strong likelihood that AMR101 will be approved by the FDA on July 26.
Any delay in approval of the drug would be minor, said the firm, which thinks the drug could generate $1B+ in sales. JPMorgan believes that the stock could advance further following FDA approval, and the firm maintains a $22 target and Overweight rating on Amarin.
In early trading, Amarin rose 0.46% to $15.23, but closed Monday's session down one cent.
Pluristem Therapeutics Inc (NASDAQ:PSTI) will apply to the U.S. FDA for approval of its placenta-based stem cell treatment for aplastic bone marrow as an orphan drug or rare disease treatment.
Gaining orphan drug status is part of Pluristem's strategy for penetrating the bone marrow recovery market, starting with treatment of aplastic anaemia, a disease that affects five to 10 people in every million. Treatment costs range from $150,000 to $200,000 per person for the 60,000 bone marrow patients worldwide each year, though the majority of this is for hospitalisation. Pluristem said its treatment helps reduce hospitalisation time.
Orphan drug status has several potential benefits, including the possibility of an expedited regulatory process, availability of grant money, tax credits and seven years of market exclusivity.
In 2011, Pluristem received orphan drug status for its cell therapy in the treatment of Buerger's disease, a rare blood vessel disease.
Pluristem said on May 9 that its cells had saved the life of a seven-year-old girl suffering from aplastic bone marrow and who had undergone two failed bone marrow transplants. Its stock rose 32 percent.
"Orphan drug status in the U.S. would help accelerate our path to full FDA approval and we intend to apply for a similar designation in Europe and global territories," said Zami Aberman, chairman and CEO of Pluristem.
News 
Market Data 
Discover 
AI
