FDA puts the brakes on experimental pain drugs. Johnson & Johnson (NYSE:JNJ) was advised by the Food & Drug Administration that its drug fulranumab and others in a class known as nerve growth factor inhibitors, could be associated with a condition that can result in the need for total joint replacements, reports Reuters. AstraZeneca plc (NYSE:AZN) biologics unit MedImmune, Pfizer (NYSE:PFE), Regeneron Pharmaceuticals Inc. (NSDQ:REGN) and Sanofi-Aventis SA (NYSE:SNY) have also put studies of NGF drugs on hold, according to The Wall Street Journal.
A pacemaker for your tongue to treat sleep apnea. Scientists from the Minneapolis-based Inspire Medical Systems will soon begin a study on a pacemaker-like medical device that would send mild electric shocks to the tongues of sleeping sleep-apnea sufferers, reports The Associated Press.
Smith & Nephew receives warning from FDA over German plant. The FDA warned Smith & Nephew plc (NYSE:SNN) for a second time over manufacturing problems at the company’s Tuttlingen, Germany orthopedic plant, reports Bloomberg.
Indian biologics? Not yet. BIO’s Executive Vice President of Emerging Companies and Business Development, Alan Eisenberg, gave a quick post-mortem on the first BIO India International Partnering Conference in September. It’s clear how hungry the industry is to get to India’s brain power – and how much work still needs to be done in that country to make the biotech industry comfortable with seriously working there.
Discussions at the BIO India meeting highlighted the need for a concerted effort to develop a comprehensive regulatory framework for the approval of biologics in India, including the approval of biosimilars.
Biosimilars are similar to, but not the same as, innovator biologics. Biosimilars are not like generic pharmaceuticals, which can be analyzed in a laboratory to confirm that they are exact copies of chemical drugs. Biosimilars are typically much more complex than traditional pharmaceuticals, therefore producing an exact duplicate of an existing biologic is not possible with today’s science.
In order to ensure that new pioneer biotechnology products continue to reach patients and physicians, approval criteria for both biologics and biosimilars must protect patient safety and preserve incentives to innovate. Well-crafted pathways for the approval of these drugs will lower costs through increased competition, expand access to lifesaving medicines, protect patient safety and promote further biomedical innovation.
Hospital drug shortage looms. Propofol, heparin and doxorubicin are all in short supply. “I’ve been in practice more than 30 years and this is the first time I’ve encountered shortages that may affect patient care,” said Dr. Michael Link, president-elect of the American Society of Clinical Oncology.
Underrated Medtronic. Motley Fool continued to focus its Perfect Stock series on the medical device industry. It gave a big thumbs down to Boston Scientific earlier, but Medtronic fared much better: getting a passing grade in seven out of 10 categories. Sayeth Motley Fool: “With favorable demographics supporting future medical device use for decades to come, Medtronic is arguably the best positioned to take advantage.”
Hope for 2011: Less (screening) is more. Gary Schwitzer says the lack of reporting on the pros and cons of screening tests is “a key health policy issue” and hopes for an end to screening madness.
Even in 300 words, even on deadline, journalists can easily start to insert into their stories that in health care, more is not always better, newer is not always better, and screening tests don’t always make sense for everyone. Stories about screening tests are health policy stories – health care reform stories. Or they should be.
Dealflow. Diabetes drug company DiaMedica has raised $2.7 million and ReSearch Pharma has sold to Warburg Pincus for $227 million.
Material from MedCity News was used in this report.
