- GlaxoSmithKline (GSK) is reporting encouraging rates of efficacy from the world's first national meningitis B immunisation program with Bexsero
As reported in a recent press release posted on GSK’s official website, ‘real world’ data shows 83 percent effectiveness for Bexsero in infants in first year of UK national meningitis B immunisation program.
- The Ministry of Health has published draft project "Priority Actions Burns"
Echoing priority actions aimed at ensuring high treatment costs of major emergencies at intra-hospital, "Priority Actions Burns" was developed by the Ministry of Health for the same purpose, but comes with two premieres in the Romanian health system.
- NMMDA informs interested parties with regard to checks carried out regarding market surveillance of medical devices
The National Medicines and Medical Devices Agency (NMMDA) issued a new announcement for interested parties with respect to distribution and marketing of certain medical devices.
- Sandoz's Enbrel biosimilar endorsed in US
According to media reports, Sandoz’s Erelzi has become the first biosimilar of Amgen’s Enbrel (etanercept) blockbuster inflammatory diseases drug to receive consent form Food and Drug Administration (FDA).
- Edible battery could power medical devices of the future
As recently reported in the media, forthcoming biomedical devices may find their source of power from biodegradable battery pills.
- EMA: Better monitoring of biological medicines
The European Medicines Agency (EMA) has adopted a new chapter to its guidelines on good pharmacovigilance practices (EU-GVP), entitled “Product- or population-specific considerations II: Biological medicinal products”.
- AstraZeneca to sell small molecule antibiotics business to Pfizer
According to the announcement freshly posted on its website, AstraZeneca has entered into an agreement with Pfizer to sell the commercialisation and development rights to its late-stage small molecule antibiotics business in most markets globally outside the United States (US).
- UK grants patients early access to AbbVie/Roche leukaemia drug
The UK’s Medicines and Healthcare products Regulatory Agency gave Venclexta® (venetoclax), co-developed with Roche’s Genentech unit, a positive scientific opinion through its Early Access to Medicines Scheme (EAMS).
- AstraZeneca receives approval in the EU for Qtern (saxagliptin and dapagliflozin) for treatment of Type 2 diabetes
According to a press release recently published on AstraZeneca’s website, the European Commission (EC) has approved Qtern (saxagliptin/dapagliflozin) tablets for the treatment of type 2 diabetes in all 28 EU member countries plus Iceland, Liechtenstein and Norway.
- AstraZeneca's antibiotic Zavicefta met primary endpoints in Phase III trial for treatment of hospital-aquired pneumonia
AstraZeneca recently announced in a press communique positive results from the Phase III REPROVE trial for Zavicefta (ceftazidime-avibactam), a new combination antibiotic for the treatment of a broad range of serious Gram-negative bacterial infections in hospitalised patients.
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