Clik here to view.
COMP issues positive opinion for ODD for avelumab in MCC
The European Medicines Agency (EMA)’s Committee for Orphan Medicinal Products (COMP) has issued a positive opinion for Orphan Drug designation (ODD) for avelumab, an investigational fully human...
View ArticleClik here to view.
BMS and Pfizer announce new data for Eliquis
Bristol-Myers Squibb and Pfizer have announced results from a post-hoc early time course subanalysis of the Phase 3 AMPLIFY trial of Eliquis (apixaban). The subanalysis demonstrated Eliquis was...
View ArticleClik here to view.
Merck KGaA and Pfizer advance avelumab clinical development programme
Merck KGaA, Darmstadt, Germany and Pfizer have announced the opening of trial sites for an international Phase III study of avelumab in patients with platinum-resistant/refractory ovarian cancer. The...
View ArticleClik here to view.
Trial to investigate avelumab and entinostat in ovarian cancer
Merck KGaA, Pfizer and Syndax Pharmaceuticals have entered into a collaboration agreement to evaluate avelumab in combination with Syndax’s entinostat in patients with heavily pre-treated, recurrent...
View ArticleClik here to view.
NICE recommends 7 DMARDs for severe rheumatoid arthritis
In final updated guidance published today, the National Institute for Health and Care Excellence (NICE) recommends seven biological disease modifying drugs (DMARDs) as options for treating severe...
View ArticleClik here to view.
European Pharmaceutical Review’s top 10 stories from 2015
Mega mergers, 3D printed drugs, a call for action on antimicrobial resistance: 2015 certainly was an interesting year for the pharmaceutical industry. Here we pick a selection of the top stories that...
View ArticleClik here to view.
BMS, Pfizer and Portola team up to bring andexanet alfa to Japan
Bristol-Myers Squibb and Pfizer have entered into a collaboration agreement with Portola to develop and commercialise andexanet alfa in Japan. Andexanet alfa, which is in Phase 3 clinical development...
View ArticleClik here to view.
Executive leadership team named for the combined Allergan Pfizer business
Pfizer has announced the executive leadership team for the combined Pfizer and Allergan business. Following the closing of the proposed transaction, Brent Saunders will become President and Chief...
View ArticleClik here to view.
Sandoz acquires rights to biosimilar infliximab in the EEA
Sandoz has acquired from Pfizer the rights for the development and commercialisation of PF-06438179 (biosimilar infliximab) in the 28 countries that form the European Economic Area (EEA). Infliximab is...
View ArticleClik here to view.
FDA approves expanded indication for Pfizer’s Ibrance
The US Food and Drug Administration (FDA) has approved a new indication expanding the use of Ibrance (palbociclib), Pfizer’s metastatic breast cancer therapy. Now the therapy is approved for the...
View ArticleClik here to view.
FDA approves sNDA for Xalkori in ROS1-positive NSCLC
The US Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Pfizer’s Xalkori (crizotinib) to treat patients with metastatic non-small cell lung cancer (NSCLC)...
View ArticleClik here to view.
Pfizer announces results from studies of tofacitinib in ulcerative colitis
Pfizer has announced detailed results from the first two pivotal Phase III studies from the OCTAVE programme. Results from OCTAVE Induction 1 and OCTAVE Induction 2, evaluating the efficacy and safety...
View ArticleClik here to view.
EMA accepts Pfizer’s MAA for Xeljanz in rheumatoid arthritis
The European Medicines Agency (EMA) has accepted for review Pfizer’s Marketing Authorisation Application (MAA) for Xeljanz (tofacitinib citrate) 5 mg tablets twice daily for the treatment of patients...
View ArticleClik here to view.
Counterfeit drugs: a global problem
In a recent issue of European Pharmaceutical Review, David Shore from Pfizer discussed his company’s progress in combatting the illegal trade of counterfeit drugs. The trade in fake drugs is...
View ArticleClik here to view.
Allergan and Pfizer terminate merger agreement
Allergan’s merger agreement with Pfizer has been terminated by mutual agreement. Had the merger gone ahead, the combined company, to be named Pfizer plc, would have been the biggest drug maker in the...
View ArticleClik here to view.
Positive top-line results from the Phase III PALOMA-2 trial
Pfizer has announced positive top-line results from the Phase III PALOMA-2 trial for Ibrance (palbociclib) in breast cancer. The study met its primary endpoint by demonstrating an improvement in...
View ArticleClik here to view.
Trial supports safety and efficacy profile of Pfizer’s varenicline
Pfizer has announced data from the largest ever randomised clinical trial of approved smoking cessation medicines, called EAGLES (Evaluating Adverse Events in a Global Smoking Cessation Study). EAGLES...
View ArticleClik here to view.
Studies demonstrate immunogenicity of Trumenba against MnB
Pfizer has announced results of two Phase III studies demonstrating the immunogenicity of Trumenba (Meningococcal Group B Vaccine) against invasive meningococcal B (MnB) strains representative of...
View ArticleClik here to view.
Champix label updated to include new safety and efficacy data
The European Summary of Product Characteristics (SmPC) and Package Leaflet for Pfizer’s Champix (varenicline) have been updated to include safety and efficacy data from the EAGLES trial.Varenicline is...
View ArticleClik here to view.
Positive top-line results for tofacitinib citrate in active psoriatic arthritis
Pfizer has announced top-line results from OPAL Beyond, the second Phase III study of Xeljanz (tofacitinib citrate) being investigated in patients with active psoriatic arthritis (PsA).This study...
View Article
