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FDA approves new erectile dysfunction drug

The FDA has approved Vivus’ erectile dysfunction drug Stendra, and the firm hopes its rapid mode of action will help take market space away from its key competitors. 

Stendra (avanafil) will rival Pfizer’s Viagra (sildenafil), which was the first ED drug to market.  But Vivus believes that Stendra as an edge over Viagra, as it can provide an erection in around 15 minutes – half the time of Pfizer’s drug. Vivus’ drug, which is licensed from Mitsubishi Tanabe Pharma Corporation, may see peak annual revenue of $450 million by 2017, according to analysts.

Sanofi: αύξηση τζίρου 7% με τη συμβολή της Genzyme το 1ο τρίμηνο

Αύξηση πωλήσεων κατά 7% στα 8,511 δις. ευρώ παρουσίασε κατά το πρώτο τρίμηνο του 2012 η Sanofi, πετυχαίνοντας ταυτόχρονα αύξηση των καθαρών κερδών δραστηριοτήτων της κατά 8,4% στα 2,442 δισ. ευρώ. Τα ενοποιημένα καθαρά αποτελέσματα για το πρώτο τρίμηνο του 2012 ανήλθαν σε 1.827 εκατ. ευρώ, έναντι 1.218 εκατ. ευρώ κατά το 1ο τρίμηνο του 2011.

Novartis drug Signifor® approved in the EU as the first medication to treat patients with Cushing's disease

Novartis announced that the European Commission has approved Signifor® (pasireotide) for the treatment of adult patients with Cushing's disease for whom surgery is not an option or for whom surgery has failed[1]. 

Signifor is the first medicine to be approved in the European Union (EU) targeting Cushing's disease. The approval is based on data from the largest randomized Phase III study to evaluate a medical therapy in patients with Cushing's disease, a disorder caused by excess cortisol in the body due to the presence of a non-cancerous pituitary tumor[1],[2],[3].

Pfizer, Crestor tops for global promotional spend in 2011

Total global pharma promotional spending fell 3.4% to $92.2 billion in 2011, according to Cegedim Strategic Data, led by a 4.7% decline in detailing spend.

Pfizer remains the industry's top promotional spender, despite a 12% drop in spending to $6 billion in 2011. That puts the New York firm well ahead of No. 2 Novartis, which cut marketing and advertising spend by 10% to $5 billion, and was followed closely by Merck ($4.9 billion, down 7% over 2010). Just two of the top ten advertisers in the sector—No. 4 AstraZeneca and No. 6 Boehringer Ingelheim—increased spending. AstraZeneca marketers saw a 5% bump to their budgets, which totaled $4.2 billion, while Boehringer dialed up its promotional spending by a whopping 19% to $3.3 billion.

Sandoz to Acquire Fougera Pharmaceuticals, Becoming the Number One Generic Dermatology Medicines Company Globally and in the US

Basel, May 2, 2012 - Novartis has signed a definitive agreement to acquire specialty dermatology generics company Fougera Pharmaceuticals. Under the terms of the agreement, Novartis will acquire the business, which is based in Melville, New York, for USD 1.525 billion in an all-cash transaction.

The sellers are comprised of a consortium of private equity funds led by Nordic Capital, DLJ Merchant Banking (a Credit Suisse affiliate) and Avista Capital Partners.

Reflection paper on classification of advanced therapies released for public consultation

The European Medicines Agency released a reflection paper on the classification of advanced-therapy medicines for public consultation yesterday.

The paper clarifies the legal basis for the classification of medicines as advanced therapies and provides information on how these medicines are classified as gene therapy, somatic-cell therapy, tissue-engineered or combined medicines.

It also gives details on the types of information that applicants need to submit to the Agency when applying for classification of their medicine as an advanced therapy, and discusses of some borderline cases and areas where scientific knowledge is limited or evolving rapidly.

Advanced therapies are medicines that are made from genes and cells and may offer groundbreaking new treatment opportunities for many diseases and injuries. As part of its role, the Agency's Committee for Advanced Therapies (CAT) issues opinions on whether a medicine can be classified as an advanced therapy, and can therefore be assessed for a European-wide marketing authorisation via the European Medicines Agency.

The reflection paper is open for comments until 31 July 2012. Comments should be sent to advancedtherapies@ema.europa.eu.

Στον Εθνικό Οργανισμό Παροχής Υπηρεσιών Υγείας (ΕΟΠΥΥ) εντάχθηκαν από χθες οι ασφαλισμένοι του ΤΑΥΤΕΚΩ.

Πρόκειται για τους κλάδους ασθένειας ΚΑΠ - ΔΕΗ (προσωπικό ΔΕΗ), ΤΑΠΑΕ - ΕΘΝΙΚΗ («Εθνική Ασφαλιστική»), ΤΑΠ - ΗΣΑΠ, ΤΑΠ - ΗΛΠΑΠ, ΤΑΠ - ΕΤΒΑ ΤΑΠ - ΕΤΕ (Εμπορική Τράπεζα), ΤΑΠ - ΟΤΕ και ΤΑΑΠΤΠΓΑΕ (προσωπικό Πίστεως, Γενικής και American Express).

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