Communicating the risks of pharmaceuticals has never been easy. Say too much and no-one wants to take your drug; say too little and politicians, competitors and soon, the entire social media, will fill in the gaps for you. Read more »
The US Food and Drug Administration approved the first generic version of the anticoagulant drug enoxaprin sodium injection on last Friday, July 23. Lovenox is the drug’s brand name, and it’s manufacturer, sanofi Aventis (Paris), was not happy about FDA’s decision. Read more »
It’s been a few months since President Obama signed into law the Patient Protection and Affordable Care Act (H.R. 3590). The bill includes a provision to “address gaps in quality, efficiency, comparative effectiveness information, and health outcomes measures and data aggregation techniques.”
Last week, the Partnership to Improve Patient Care (PIPC), which includes a wide range of healthcare organizations working to support the government’s role in and awareness of CE research, held a forum about delivering patient-centered comparative effectiveness (CE) research. Senator Max Baucus (D-MT) was the forum’s keynote speaker.
Publicity about substandard or contaminated products usually lights a fire under pharmaceutical companies, which then race to address their compliance problems. But a new US Food and Drug Administration inspection report shows that, despite a stream of product recalls and a Congressional investigation, Johnson & Johnson (J&J, New Brunswick, NJ) has not gotten its house in order yet. And the company’s latest problems conceivably could make things hot for one of its partners. Read more »
While the FDA’s November 2009 hearings on social media regulatory concerns focused primarily on guidelines governing pharma’s consumer communications, one issue was largely overlooked during the hearings and ignored in the media coverage: the use of highly targeted social media sites for healthcare companies to communicate with other businesses within the industry, as well as service providers across the industry. And though FDA’s oversight might indicate otherwise, this brand of business-to-business communication via secure online market places — used to accelerate dealmaking, sales and collaboration — is expanding. Read more »
There is no secret that China’s role in the current and future global pharmaceutical market is and will be substantial, but the mindset for Western pharmaceutical companies has largely focused on the opportunity in that country. In looking at recent investment trends, however, perhaps the bio/pharmaceutical industry needs to more fully consider the potential competition from domestic Chinese pharmaceutical companies. Read more »
Last week, the pharmaceutical industry struck a blow against sexism. In May, a US District Court found Novartis (Basel) guilty of gender discrimination. Novartis and the law firm that represented a class of 5600 female employees reached a settlement agreement that became public last Wednesday. The terms of the agreement seem to indicate that the company is making a legitimate effort to treat its employees fairly. Read more »
The European Union had all the right goals in mind when they launched the Innovative Medicines Initiative* (IMI) in 2007. In an effort to boost the floundering pharmaceutical sector, leaders decided to bring together public and private scientists across Europe to research and develop new drugs.
According to an analysis of the program in the July 13 issue of Nature, IMI received 138 “expressions of interest” from universities and research institutes when it first called for research-project proposals. The second call turned out 124 proposals. IMI’s executive office in Brussels believes these numbers are a “resounding success,” says the Nature report. But a joint letter from a group of 11 university and research organizations, including EARTO —which is the European trade association for more than 350 research and technology organizations—states otherwise, calling the first two call responses “well below potential.”
Companies always want the longest patent protection possible for their products — and with good reason considering the immense costs of R&D. However, some companies go a little too far in seeking patent protection to the point that they may even try to mislead the regulators in order to extend the life of patents. Read more »
Johnson & Johnson and its McNeil Consumer Healthcare unit have been all over the news lately for all the wrong reasons. Another recall was issued last week, as was news of a class-action lawsuit in the works against the company. The timeline below summarizes the recent events surrounding J&J/McNeil’s recalls and news. Read more »
From PharmTech.com