This week’s headlines include, cancer drugs gaining faster approvals, two new cancer treatments, innovative stem Cell Therapy developments, and a special report on the large numbers of substandard active pharmaceutical ingredients from China.
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Get More InformationHeadlines:“Tufts: Cancer Drugs Win a Speedier Race to the FDA Goal Line,” Fierce Biotech
Anyone trying to explain the onrush of new cancer therapies in the pipeline should check out a new report from the Tufts Center for the Study of Drug Development, which found that cancer drugs have enjoyed faster approval times at the FDA than all other disease categories combined. And the center concluded that cancer drugs claimed a growing share of the orphan drug market as the total time it requires to take a fast-track drug through development to an approval shrunk by an impressive 1.7 years over the past decade.
If you like this story, please see our blog titled “Defined Supplements – The Role of Recombinant Proteins in Biopharmaceutical Manufacturing”“Special Report: China’s “Wild East” Drug Store,” Reuters
Philippe Andre, a detective in the murky world of Chinese pharmaceuticals, has some alarming tales to tell. Four years ago, Beijing promised to clean up its act following the deaths of at least 149 Americans who received contaminated Chinese supplies of the blood-thinner heparin. But an examination by Reuters has found that unregulated Chinese chemical companies making active pharmaceutical ingredients (API) are still selling their products on the open market with few or no checks.
If you like this story, please see our blog titled “Reducing cGMP Compliance Challenges is Key to Public Vaccine Confidence and Industry Success”“Stem Cells Bring Back Feeling for Paralyzed Patients,” New Scientist
For the first time, people with broken spines have recovered feeling in previously paralysed areas after receiving injections of neural stem cells. Three people with paralysis received injections of 20 million neural stem cells directly into the injured region of their spinal cord. The cells, acquired from donated fetal brain tissue, were injected between four and eight months after the injuries happened. The patients also received a temporary course of immunosuppressive drugs to limit rejection of the cells.
If you like this story, please see our blog titled “Ten Companies with Innovative Stem Cell Therapies in Clinical Trials Part I”“Bayer Submits “Son of Nexavar” Cancer Drug for FDA Approval,” San Francisco Business Times
Bayer Healthcare Pharmaceuticals Inc.’s experimental cancer drug regorafenib, viewed as the “son of Nexavar” from Bayer and Onyx Pharmaceuticals Inc. was submitted Thursday for approval to the Food and Drug Administration, the companies said. Bayer said the new drug application was submitted for regorafenib’s treatment of metastatic or unresectable gastrointestinal stromal tumors in patients whose cancer continues despite prior treatments.
If you like this story, please see our blog titled “Serum Free Hybridoma Culture – Key Recommendations”“$36.4 M Funds for Radiation Syndrome Cell Therapy,” Genetic Engineering News
Cellerant Therapeutics won a $36.4 million Biomedical Advanced Research and Development Authority (BARDA) grant to support advanced development of allogeneic cell-based therapy CLT-008, for the treatment of acute radiation syndrome (ARS). This third year of funding follows on from $80 million already awarded over an initial two years, and is part of a five-year award that could be worth $169.9 million.
CLT-008 is an off-the-shelf cryopreserved cell-based therapy comprising human myeloid progenitor cells derived from hematopoietic stem cells, which can mature in vivo into functional granulocytes, platelets, and red blood cells. For ARS applications the product is expected to provide hematopoietic cell support after exposure to ionizing radiation. Cellerant says preclinical studies suggest a single dose could effectively treat ARS in an emergency situation, even when administered up to five days post-exposure.
If you like this story, please see our blog titled “Neonatal Stem Cells for Research and Clinical Applications”“Pfizer Hands over Cancer Compound to VLST,” PharmaTimes
Pfizer has out-licensed an early-stage cancer monoclonal antibody to US biotech firm VLST Corp. The privately-held Seattle-based company is getting hold of CP-870,893, an anti-CD40 monoclonal antibody that has been evaluated “in a number of preclinical and clinical trials” which have established its safety and maximum tolerated dose. VLST, which recently raised $5 million in a series B financing, plans to advance the compound “into efficacy studies in an oncology setting [and] is currently evaluating multiple clinical opportunities”.
If you like this story, please see our blog titled “Venture Capital Investment in the Life Science Sector is Down for 2012 – Is There a Light at the End of the Tunnel?”