Sandoz (Holzkirchen, Germany), the generics division of Novartis (Basel, Switzerland) received European marketing authorization for its recombinant human growth hormone, ?Omnitrope? (somatropin), making it the first biogeneric product approved under the biosimilar pathway of the European Commission.
Being the first to gain the most is a fundamental principle in the generics business because several companies compete to create generics of successful products going off patent. For a generics company to maintain revenue growth in a market in which product prices continue to fall, it must secure a continuous flow of new products, with quality and speed to market being key drivers. Thus, generics companies must be highly skilled in product and process development (1), the generics business, and achieving bioequivalence-the most critical development area.
FTC Plans to Study Competitive Impacts of Authorized Generic Drugs
Reverse Genetics Avian Influenza Vaccine Approved in France
GSK Begins Clinical Trials of Two H5N1 Vaccines
Absorption promoters and enhancers and enzyme inhibitors, either alone or in combination, can play an important role in improving the bioavailability of oral insulin.
Cell-culture technology and financial incentives give influenza vaccine makers a much-needed shot in the arm, but many downstream processing issues remain unaddressed.
Could compounds in chocolate yield new pharmaceutical approaches to major disorders?
The discovery of suitable lead structures for new drugs from an inexhaustibly large reservoir of theoretically possible compounds is one of the biggest challenges for the pharmaceutical industry. In the last few years, combinatorial chemistry methods have been developed to synthesize a huge amount of diverse new chemical entities (NCEs), which may subsequently be tested for biological activity in vitro.
Pellets are a multiparticle, solid form of medication. The individual pellets are almost spherical with diameters usually between 100 and 2000 ?m.
Creation and qualification of scale-down models are essential for performing several critical activities that support process validation and commercial manufacturing. As shown in Figure 1, these activities include process characterization and production support studies that are performed to evaluate column and membrane lifetimes, demonstrate clearance of host-cell impurities and viruses and troubleshoot manufacturing issues. While the underlying fundamentals are relatively the same as those when scaling up, some unique considerations should be taken when scaling unit operations down.4
Once the brightest students are interested in bioprocessing, it is vital that they are prepared and inducted into industry.
New Biodegradable Polyketals Developed for Drug Delivery
Progress Continues in Vaccine and Antiviral Development
BMS, Sanofi-Aventis Settle Over Generic Plavix
Chiron Withdraws Measles Vaccine
GSK Loses Bid to Block Generic "Flonase"
Development Begins on Mutated H5N1 Virus Vaccine
Novavax, Bharat Biotech Team for Pandemic Influenza Vaccine Development
Polymorph farming on a chip is a promising strategy for rapid polymorph discovery by transforming crystallization?crystal isolation?characterization into one time-efficient step.
A modified modular high-pressure system can form nanosuspensions of model compounds by individually controlling cavitation, impact, and shear forces.
Quantitative data from the literature show strong relationships among average particle size, powder densification, tensile strength, and hardness.
Letter to the Editor: Glen Jon Smith
Transdermal matrix-type patches of Nefopam hydrochloride with a combination of pressure-sensitive adhesives were developed. The polymeric composition provided a controlled and sustained release of the drug from the patches and demonstrated favorable physicochemical characteristics.
GSK Gains Approval for Rotavirus Vaccine in Infants; FDA Review Extended for Merck’s Shingles Vaccine
