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Bills introduced in four states would grant terminally ill patients access to post-Phase-I experimental drugs without having to go through the FDA. Read More
The FDA chided positron emission tomography (PET) drug manufacturer IBA Molecular North America for not properly handling complaints and quality production. Read More
Regulators pushing for greater international cooperation cautioned that relying on other countries’ inspections would require overcoming crucial hurdles such as incompatible technology, language barriers and keeping trade secrets secret. Read More
GlaxoSmithKline’s vaccine plant in Canada received an FDA warning for a bevy of quality violations such as failing to prevent contamination in its manufacturing processes and water system. Read More
Teva is pointing to the Supreme Court’s recent ruling in a soft drink labeling case to claim immunity from GlaxoSmithKline’s lawsuit alleging the Israeli firm falsely advertised its generic antidepressant budeprion XL as bioequivalent to GSK’s Wellbutrin XL. Read More
Manufacturers of oral viscous lidocaine 2 percent solution must add a boxed warning to their product’s labeling that spells out the serious risks of using the painkiller to treat teething pain in children and infants. Read More
Top Republican lawmakers want the Obama administration to examine whether the FDA has the authority to impose a generic drug labeling rule, ratcheting up the rhetoric in an increasingly political battle over the controversial measure. Read More
The UK’s National Institute for Health and Care Excellence (NICE) said it will cover Johnson & Johnson subsidiary Janssen-Cilag’s diabetes drug Invokana (canagliflozin) as a treatment for people with type 2 diabetes. Read More
FDA advisors want more clinical data before recommending a green light for AstraZeneca’s latest ovarian cancer treatment, dealing a blow to the British drugmaker’s promising oncology pipeline. Read More
A federal judge tossed out Novartis’ lawsuit against generic firm Alvogen’s challenge to its dementia treatment Exelon Patch, claiming the brand firm failed to show the generic product contained a patented antioxidant. Read More