FarmavitaR+

1. Biosimilars: Key developments in the regulatory environment
(Reports/Product Report)

... biopharmaceutical products will exceed $135 billion by 2011. With some of the earliest biopharmaceuticals having already lost patent protection, the originators of biopharmaceutical products are facing ...

2. Business Advertising Activity
(Regulatory Affairs/European Union)

Business Advertising Activity Hungarian  National Institute of Pharmacy has published  new guidelines in order to ensure the protection of consumer interests and sustain market competition which serves ...

3. Benchmarking Patent Expiries
(Reports/Company Report)

... different levels of brand erosion depending upon their formulation. Lifecycle management strategies such as producing a range of different formulations can offer protection to branded revenues once the ...

4. Benchmarking key countries
(Reports/Market Report)

... Despite problematic intellectual property protection high market potential is attracting most multinational pharmaceutical companies. Healthcare system characteristics differ greatly between different ...

5. Patent Protection Strategies
(Reports/Market Report)

Patent Protection Strategies: Maximising product Revenues Patent Protection Strategies: Maximising product revenues explores the best methods of exploiting legislation to maximise revenue generation ...

6. IMS Global Report
(Reports/Market Report)

... emerging ones; new product adoption is not keeping pace with the loss of patent protection by established products; specialty and niche products are playing a larger role; and regulators, payers and consumers ...

7. Regulatory bodies and truth about cosmetic ingredients
(Regulatory Affairs/Regulatory Affairs News)

... Federal Institute for Risk Assessment (BfR). The Federal States Baden-Württemberg and Bayern have reported several problems related to UV filters in sun protection products9-14.1. Combined effects ...

8. Strategic RA Consulting
(Regulatory Affairs/Regulatory Affairs News)

... preserved cream can be sold in different European member states as a drug (for the treatment of eczema), a device (providing physical protection for the skin), a biocide (that 'disinfects' the skin) and ...

9. SEMISOLID DOSAGE FORM
(Professional Articles/Life Science Article)

... features as nanotechnology systems for a wide spectrum of application. Their solid matrix allows protection of chemically labile agents from degradation. The use of SLN in dermatics seems very attractive ...

10. Vardenafil
(Pharmaceutical product/Pharmaceutical product)

... of interest in this molecule by filing their own patent protection for methods to circumvent key innovator patents.  Mr. Howard also points out that “this is a clear signal that the generics industry is ...

11. Management Practice
(QA and GMP/GMP/GLP/GCP/GDP)

... on films, or spoken in conversation. Whatever form the information takes, or means by which it is shared or stored, it should always be appropriately protected.Information security is the protection of ...

12. Paediatric Medicines
(Regulatory Affairs/General Gulielines)

... fully with the paediatric study requirements and whose product is subsequently authorized in all member states, will be rewarded with the right to claim a six-month patent or supplementary protection certificate ...

13. Open Source Pharmaceuticals - New Business Model
(Regulatory Affairs/Other issues)

... of copyright and patent protection. This will lead to creation of additional works, which build upon previous work and add to greater social benefit. Additionally, some proponents argue that open source ...

14. Moxidectin
(Pharmaceutical product/Pharmaceutical product)

... expiry information. The US FDA Green Book lists five critical US patents, of which three relate to formulations, one to a combination of actives, and, most significantly, only one to protection of the ...

15. Rosiglitazone maleate
(Pharmaceutical product/Pharmaceutical product)

Avandia® Patents Afford Protection Against Generic Competition Generic pharmaceutical manufacturers should proceed with caution when developing generic versions of Avandia®, (Rosiglitazone maleate), ...

16. eClinical trials
(Clinical Trilas/Europe not-EU)

... virus protection and operating system upgrades can be handled by trained personnel at one centralized location only. It is not required to distribute neither software nor paper materials – sending the ...

17. Relpax
(Pharmaceutical product/Pharmaceutical product)

Full Story of Relpax Patent Protection Not Told by Orange Book? Pfizer’s oral anti-migraine medicine Relpax, (Eletriptan hydrobromide) appears to have more patent protection than meets the eye.    A ...

18. Biogenerics
(Biosimilars/Biosmimilars)

... 2010, when the market is forecast to be worth $53bn, biologicals which accrue an estimated $11bn worth of sales annually are expected to have lost patent protection in developed pharmaceutical markets. ...

19. Evergreening
(Regulatory Affairs/Other issues)

Evergreening through Patent Strategies One form of evergreening occurs when the originator manufacturer “stockpiles” patent protection by obtaining separate 20-year patents on multiple attributes of ...

20. Privacy Protection
(Uncategorised Content)

Our Commitment To Privacy Your privacy is important to us. To better protect your privacy we provide this notice explaining our online information practices and the choices you can make about the way ...