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With patents expiring on several blockbuster drugs in 2014, generic competition and cost-containment policies around the globe will hold brand pharma’s revenue growth at bay this year. Read More
Over the next five years, the FDA plans to release a host of guidances to implement the standardization of electronic drug applications and other regulatory submissions. Read More
While MiMedx disagrees with the FDA’s reasoning for requiring BLAs — and, hence, clinical trials — for its regenerative, human cellular and tissue-based products (HCT/Ps), the company says it will oblige the agency to set precedence for future products developed by competitors. Read More
The push for trial data transparency — by regulators and pharma alike — kept sponsors and clinical sites on their toes in 2013. Both sides agreed that more transparency is needed, but they diverged on how to accomplish the goal. India announced new standards for ethics boards and patient compensation, while Japan’s Pharmaceutical and Medical Devices Agency launched an R&D and strategy consulting arm to fine-tune the development of novel products and speed regulatory approvals. Buzz words included “personalized medicine,” “enrichment trials” and “centralized monitoring.” Use this roundup of news highlights in 2013 to plan your clinical trial strategy for the year ahead.Read More
Drugmakers should evaluate a product’s UV-visible absorption spectrum before starting clinical development, the ICH says in a new guideline that will standardize photosafety testing standards across the EU, Japan and U.S. Read More
Less than a month after AstraZeneca said it was buying out Bristol-Myers Squibb’s part of its diabetes pipeline partnership, the FDA Wednesday approved their type 2 diabetes drug Farxiga. Read More
The Clinical Data Interchange Standard Consortium (CDISC) is asking for input on a new data submission standard that could give clinical trial sponsors and reviewers greater flexibility if adopted by the FDA for drug review applications. Read More
The FDA is encouraging drugmakers to work together to get agency qualification for drug development tools (DDTs), which can then be used to aid in development and review of multiple companies’ drugs. Read More
The FDA is approving fewer breakthrough therapy designation requests from drugmakers and agency officials say the need for more evidence of effectiveness is the reason. Read More
Generic drugmakers are pushing back against proposed new tight deadlines for responding to FDA questions about ANDAs, and the industry also wants the agency to show greater leniency in dealing with deficiencies in applications. Read More
The FDA, showing no signs of easing its advertising and marketing enforcement, has rapped DARA BioSciences for omitting risk information about its cancer drug Soltamox in a sales aid. Read More