A few months ago, I blogged about how theft of pharmaceutical cargo—from warehouses, parking lots, and even the road—is on the rise. This week, FDA issued a letter to stakeholders about this very problem (the letter is posted on the Rx-360 website. Read more »
A committee of the European Parliament voted yesterday to regulate online pharmacies to prevent falsified medicines from entering the legal supply chain. The committee agreed that the provision should be included in new draft EU legislation regarding falsified medicines and pharmacovigilance. Read more »
Margaret Hamburg, commissioner of the US Food and Drug Administration, spoke at the United States Pharmacopeial (USP) Convention last week and put forth her underlying philosophy as commissoner: building collaborative models to address ongoing challenges to secure public health, which includes oversight of pharmaceutical products. Part of that effort involves building greater cooperation with USP in working on the development and modernization of USP monographs as well as strategies for combating adulteration of products and ensuring product quality. Read more »
Patients rely on doctors to make impartial decisions about the most effective treatments for their conditions. In recent years, public advocates have agitated for restrictions on pharmaceutical companies gifts’ (e.g., meals, honoraria, or entertainment) to medical professionals on the grounds that they could unduly influence prescribing habits. In what seems like a fight against transparency, Pfizer (New York) sent employees to Connecticut’s capitol to protest a state bill that would restrict such gifts and require reporting. Read more »
The aisles were packed at this year’s Interphex conference in New York City with industry professionals seeking the latest and greatest in pharma manufacturing equipment—and so were the conference sessions. PharmTech presented three Signature Series sessions at this year’s show featuring officials from FDA, PharmSource’s Jim Miller, and Hovione CEO Guy Villax. Our staff was also busy at the Main Stage conducting live, videotaped interviews—be sure to check our site to watch us in action. Here’s a preview of the first day of vidcasts from the Interphex site.
The European Medicines Agency (EMA) has recently undergone a year-long evaluation by Ernst & Young assessing its effectiveness and efficiency, and the results are largely positive for the agency. Read more »
Novartis (Basel), one of the drug industry’s heavyweights, became the subject of unwelcome publicity last week when it began to defend itself against a class-action lawsuit. More than 5600 female sales representatives and entry-level managers claim that Novartis’s US arm denied them equal pay and discriminated against them during employment evaluations and promotions. Read more »
Puerto Rico, long a mainstay of solid-dosage manufacturing, is not only continuing its efforts in that area, but is further diversifying in the life sciences by building its position in biopharmaceuticals and by moving further up in the pharmaceutical value chain through supporting research and development. I am here on the island this week on the occasion of the opening of a new solid-dosage manufacturing facility by Blu Pharmaceuticals, a Kentucky-based generic-drug manufacturer and distribution company, and am visiting with the Puerto Rico Industrial Development Company (PRIDCO), the economic development agency of Puerto Rico, to gain an update of bio/pharmaceutical investment in the commonwealth. Read more »
Patent expiries and the imminent threat of competition from generics is the bane of many pharmaceutical companies’ lives and I’m frequently reading and writing about the doom and gloom pharma is facing because of these issues. This is of course a serious issue for the industry, but there are many beneficiaries, including healthcare providers. Read more »
In the name of accountability, the World Health Organization (WHO) seems to be commissioning a 29-member external panel to examine how it addressed and managed the H1N1 swine-flu pandemic. H1N1 presented quite a scare to Americans and individuals around the world during the past year, and the disease’s presence is likely to remain for years to come. Several national governments and health regulatory agencies, including those in the US, took quick action to ensure that individuals had access to a swine-flu vaccine (see back story, “Swine Flu Update” and FDA’s end-of-year response to 2009 efforts ). The World Health Organization (WHO) also played a major role in the global response to the pandemic. Now, according to a story in the Canadian Press, a panel of experts is expected to spend 13 months reviewing and critiquing how WHO handled the situation.
From PharmTech.com