Drugmakers should clean out their data closets and turn over to regulators every bit of research and analysis they have, according to some healthcare experts, who point to documents released in litigation against Boehringer Ingelheim, with the company's blockbuster anticoagulant Pradaxa as prime evidence.
After two stinging rejections sent it back to the lab, Anika Therapeutics has secured the FDA's blessing for an osteoarthritis pain injection, propelling the biotech's shares up more than 40%.
Iontophoresis--the use of electric current to deliver drugs and diagnostics--has come back under the FDA's radar as the authorities look at whether restrictions for the decades-old technique should be eased as technology advances.
OrbusNeich has enrolled its first patient in a two-country proof-of-concept study for its innovative dual-therapy stent.
European regulatory authorities gave Teva a positive opinion for its DuoResp Spiromax inhalation powder, designed to treat asthma and chronic obstructive pulmonary disease. With the recommendation from the Committee for Medicinal Products for Human Use, Teva hopes to have final approval within a few months.
In an effort to get itself into a place where it can again ship from its FDA-approved plants in India, Ranbaxy Laboratories says it is taking a hard look at how it runs its API operations.
One of the issues that the FDA has uncovered at several Indian drug manufacturing plants it has inspected is a penchant for messing with drug analytics to get the data companies need for drugs to be approved. Now the FDA has sent a warning letter to yet another Indian drugmaker accusing its analytics lab of making up sample weights used to test drugs, then using the results in FDA drug applications.
The FDA approved AstraZeneca's drug for a diabetes-related rare disease, but, following a vote from a panel of advisers, only for a portion of a tiny patient population, putting a clamp on already staid sales estimates.
India moved one step closer to approving critical changes to laws governing its medical devices. In a regulatory push, the country's health ministry agreed to examine recommendations of the standing committee on a new amendments bill, the Indo Asian News Service reported.
The cost-effectiveness agency recommended that Bristol-Myers Squibb's widely embraced Yervoy (ipilimumab) should not be used as a first-line treatment for melanoma. The agency does recommend the drug for second-line treatment, but says BMS needs to do more clinical trials to prove its "clinical effectiveness" for earlier use.