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Pharma news in brief

Our weekly round-up of news affecting the industry

Pliva under patent pressure

Pliva, the Croatian drug manufacturer, has signed a three-year agreement with Pfizer to supply top-selling antibiotic, azithromycin, in bulk. Pfizer sells Pliva's azithromycin in the US under the name Zithromax - an arrangement that nets the Croatian company around $150m in royalties each year. However, with patent protection for azithromycin due to expire in November, east Europe's largest drug firm by sales is under intense pressure to plug the revenue gap. Analysts estimate that Pliva will receive less than half the royalties it currently gets when its antibiotic goes off patent.

Merck ex-head of research quizzed

Edward Scolnick, former head of research at Merck & Co, has been questioned about the emails he wrote confessing his concerns about the safety of Vioxx. A lawyer for Frederick Humeston, a Vioxx user who blames the painkiller for his heart attack four years ago, questioned Scolnick via a video link and asked him about emails he wrote in April 2000 and conflicting emails sent in November 2001. `My worry quotient is high', wrote Scolnick in April 2000. 'I am actually in minor agony'. Yet in November 2001 an email written by him stated: `I assure you that I will not sign off any label that had a cardiac warning.' In his deposition played for the jury, Scolnick said that he initially had concerns about the safety of Vioxx and wanted to conduct a bigger trial but later concluded that the drug was safe. The case continues.

New portal post trial data

A website giving details of clinical trials on new medicines has been launched by the global pharma industry in an attempt to allay patients' fears over drug safety. The move comes as the industry counters continuing allegations that it manipulates, or suppresses, results of clinical trials in order to produce favourable conclusions. The International Federation of Pharmaceutical Manufacturers and Associations developed the portal (www.ifpma.org/clinicaltrials), which will contain detailed information about new clinical trials, however companies still have the option to withhold some information. Early-stage phase I trials are exempt and companies are not obliged to reveal results of studies before product approval. GlaxoSmithKline, Pfizer, AstraZeneca, Merck & Co and sanofi-aventis have backed the site.

Frist under investigation

US Senate majority leader, Bill Frist, has been contacted by federal prosecutors as part of an inquiry into the sale in June of his stock in the Hospital Corporation of America (HCA). Frist sold his stake in HCA just weeks before the organisation revealed that it would not meet second-quarter Wall Street earnings estimates - an announcement that sent shares down by 9 per cent. While Frist's office has said that he has not yet received a subpoena, the mere prospect of a federal inquiry comes at a very bad time. Frist is planning to run for the White House in 2008.

EMEA aims for improvements

The European Medicines Agency (EMEA) has launched a two-month public consultation on proposed improvements to the way it provides scientific advice on R&D for new drugs. The main feature of the revised process could include the earlier and greater involvement of external experts in developing advice, and the faster delivery of advice to sponsors. Providing sponsors, whether pharmaceutical industry or other researchers, is one of EMEA's top priorities and is a crucial element in the agency's response to the EU strategy for improving the competitiveness of European-based R&D. With more and earlier involvement of experts and assessors at all stages of the revised procedure, EMEA hopes to reduce the timelines for response to sponsors from 100 days to between 40 and 70 days.

Double blow for Pfizer

The US Food and Drug Administration (FDA) has rejected Pfizer's application for approval of its injectable pain treatment, Dynastat. The move strikes another blow at the heart of the COX-2 class, which has taken a hammering since the withdrawal of Vioxx a year ago. Pfizer has said that it received a 'non-approvable letter' from the FDA and stressed that it disagreed with the regulators conclusions on Dynastat, an injectable form of its withdrawn COX-2 Bextra. The decision follows hard on the heels of the regulators rejection of Pfizer's selective oestrogen receptor modulator, Oporia. The `not approvable verdict' is the worse outcome for a new drug, as it suggests that the product may never be approved.

30th September 2008

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