Pfizer Announce Positive Preliminary Phase III Clinical Results

Pfizer Announce Positive Preliminary Phase III Clinical ResultsPfizer yesterday announced positive results from their phase III clinical trial comparing prophylaxis regimen of BeneFIX Coagulation Factor IX (Recombinant) 100 IU/kg once-weekly, with on-demand treatment for moderately severe to severe hemophilia B.

Top-line results showed that the clinical trial met its primary endpoint, with a statistically noteworthy reduction in the annualised bleeding rate in comparison to on-demand treatment of the drug.

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Positive Results for Pfizer’s Lung Cancer Therapy, Xalkori

Postive Results for Pfizer’s Lung Cancer Therapy, XalkoriPfizer have announced positive late-stage clinical data from a phase III trial of Xalkori, in comparison to chemotherapy.

Pfizer revealed that the clinical study met the primary objective of significantly prolonging progression-free survival in previously-untreated patients with anaplastic lymphoma kinase (ALK)-positive advanced non-squamous non-small cell lung cancer (NSCLC), when compared to standard platinum-based chemotherapy regimens.

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Positive Clinical Study Results for Pfizer’s Chantix

Positive Clinical Study Results for Pfizer’s ChantixPfizer announced yesterday that Chantix/Champix (varenicline) has been shown to help smokers unable to quit ‘cold turkey’ kick their habit by slowly reducing the amount of cigarettes they smoke.

The initial clinical study to assess the drug demonstrated that Chantix/Champix helped improve abstinence rates, in people wanting to reduce smoking prior to quitting.

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Pfizer’s Partners with Scottish Health Boards for New INSPIRE Site

Pfizer’s Partners with Scottish Health Boards for New INSPIRE SiteFour Scottish health boards have partnered up with Pfizer to become the organisation’s second INSPIRE site within the UK, aimed at driving clinical research.

The four health boards are NHS Grampian, Greater Glasgow & Clyde, Lothian and Tayside.

The health boards have already heavily invested in the research endeavour through NHS Research Scotland (NRS), a collaboration involving Scottish NHS Boards and the Scottish government’s Chief Scientist Office.

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NICE Draft Recommendation Rejects Pfizer’s Bosulif

Pfizer LogoIt is looking unlikely that Pfizer’s Bosulif (also known as Bosutinib) will be made available on the NHS, after cost regulator, NICE, released preliminary draft guidance rejecting the drug’s use in patients with chronic myeloid leukaemia (CML).

Bosulif has already been approved in Europe as well as the US for use after treatment with one or more tyrosine kinase inhibitor, i.e. Novartis’ Gleevec and Tasigna or Bristol-Myers Squibb’s Sprycel.

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Pfizer’s Xeljanz Approved by US FDA

Pfizer LogoPfizer are celebrating today after US regulators approved their rheumatoid arthritis drug, Xeljanz, yesterday.  The treatment is the first Janus kinase (JAK) inhibitor to be approved for rheumatoid arthritis.

The US Food and Drug Administration (FDA) have given the green light to Xeljanz (tofacitinib) 5mg twice-daily for the medication of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate.

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Scottish Medicines Consortium Approves Pfizer’s Xiapex

Pfizer LogoThe Scottish Medicines Consortium (SMC) has authorised the use of Pfizer’s Xiapex (collagenase clostridium histolyticum) on the NHS for patients with Dupuytren’s contracture, reversing their earlier decision to reject the drug.

Xiapex is the first medication available for the condition, which previously was only treatable with surgery, meaning that the SMC’s endorsement good news for patients who are entitled to receive it.

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Ranbaxy Launches Generic Lipitor in Four European Countries

Ranbaxy Laboratories LogoRanbaxy Laboratories has launched generic versions of Pfizer’s Lipitor in four European countries, a couple of months prior to the patents running out on the cholesterol blockbuster.

Ranbaxy is launching copies in Italy, the Netherlands and Sweden and noted that market sizes in these countries are $377 million, $164.4 million and $55 million, respectively. The company has also announced that their Basics affiliate has paired with Daiichi Sankyo (which has a majority stake in Ranbaxy) to launch the drug in Germany, where it will be known as Sortis.

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FDA Approves Teva’s Generic Version of Lipitor

TEVA LogoGenerics major Teva Pharmaceutical Industries is set to enter the lucrative market created in the USA by the patent expiry on Pfizer’s Lipitor but not until Ranbaxy Laboratories’ 180-day exclusivity period runs out.

The Israeli drugmaker noted that the US FDA (Food and Drug Administration) have granted tentative approval for their generic version of Lipitor, Pfizer’s cholesterol blockbuster which had yearly sales of $7.8 billion in the USA as of September 2011.  Teva’s drug will be launched at the end of Ranbaxy’s six-month exclusivity.

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