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Pharmaceutical companies developing new pediatric vaccines for diphtheria, tetanus and pertussis (DTaP) should conduct clinical trials using a single dosing schedule as a means to streamline the process, according to a new guidance from the European Medicines Agency. Read More
Drugmakers should develop assays, tests and other processes to identify and mitigate any impurities in their products that may cause cancer, according to a European Medicines Agency guideline set to take effect January 2016. Read More
Celgene’s psoriasis drug Otezla will soon be available to a new group of patients following the FDA’s approval this week of an extended indication. Read More
Canadian regulators plan to ratchet up scrutiny of patent litigation settlements between brand and generic drugmakers in search of antitrust deals that delay generic competition. Read More
Canada's Tekmira Pharmaceuticals received FDA clearance to provide its TKM-Ebola RNA interference therapeutic to patients with suspected or confirmed cases of the deadly disease. Read More
The European Ombudsman has accused EU regulators of blocking access to drug safety reports and other public documents in a new case that observers tell DID is part of the watchdog’s ongoing effort to bring greater transparency to the pharmaceutical industry. Read More
India’s drug regulatory authority has abruptly withdrawn a guideline for setting prices on many branded-generic drugs, a move that could help manufacturers press their case in a lawsuit against the government’s drug-pricing policies. Read More
Pfizer and Ranbaxy have asked a federal judge to follow his own precedent and dismiss all remaining class-action lawsuits alleging the companies colluded to delay generic versions of Pfizer’s blockbuster cholesterol drug Lipitor. Read More
Two New York congressmen have become the latest on Capitol Hill to question a proposed FDA rule that would give generics firms the same authority to change drug labels as brandmakers, a rule that GPhA has threatened to challenge in court if necessary. Read More
Generics firm Par Pharmaceuticals has agreed to pay Salix Pharmaceuticals $100 million to settle a patent infringement lawsuit over its version of Salix’s heartburn drug Zegerid. Read More
Drugmakers say they will be forced to abandon social media due to proposed FDA requirements to present both risk and benefit information in character-limited social media messages — a requirement they contend the agency doesn’t even follow. Read More