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European and Canadian trade negotiators reportedly have finalized the text of an historic deal that will bring Canada’s intellectual property regulations for pharmaceuticals closer to those of the EU, although it may take another two years before the agreement is actually implemented. Read More
The FDA is explaining how generics firms can receive timely responses to their requests for information in a guidance that defines a new communications process known as “controlled correspondence. Read More
The FDA for the first time has published a reference list for biologics, known as the Purple Book, that will list all brand products and any biosimilars with which they are interchangeable. Read More
The Federal Trade Commission is suing AbbVie and its partner Besins Healthcare, along with generic firm Teva, over an alleged pay-for-delay deal that put off generic entry of AbbVie and Besins’s blockbuster testosterone gel AndroGel 1%. Read More
Australia’s pharmaceutical regulatory body has adopted European guidance on good pharmacovigilance practices for vaccines, including the reporting of reduced effectiveness or vaccine failure, and implementing a recall or halting distribution of batches. Read More
The European Commission has approved a new indication for Roche’s rheumatoid arthritis drug RoActemra to treat patients in the early phase of the disease. Read More
New Jersey-based compounder Pharmacy Creations is recalling one lot each of four products after a former testing laboratory found that the lots in question may not be sterile. Read More
The UK’s drug pricing watchdog is recommending Alexion’s blood disease drug Soliris for a life-threatening blood disorder that affects roughly 200 people in England, although the agency is urging the National Health Service and the company to find ways of reducing the high cost of treatment. Read More
The FDA denied Teva its 180-day exclusivity period for a version of Warner Chilcott’s osteoporosis drug Actonel 150 mg because the agency itself didn’t tentatively approve Teva’s ANDA fast enough, according to an internal agency document. Read More
Starting this month, active substances found only in medicines authorized at the country level in the EU are subject to centralized review of period safety update reports by the European Medicines Agency. Read More
Biological manufacturers should submit their lot distribution reports (LDRs) using the same electronic messaging standard as those used for drug registration and labeling content of BLAs, says a new draft guidance on LDR electronic submissions. Read More
A federal judge last week denied PhRMA’s request to vacate HHS’s recently modified rule requiring drugmakers to offer steep discounts on some orphan drugs sold to hospitals that serve the poor. In turning down the request, the judge also told the trade group that it must file a new lawsuit to pursue its claims against the department. Read More