The generic-drugs market is poised to experience strong growth as key blockbuster products go off patent, but companies looking to benefit from this will have to be careful about the product segments where they compete, according to a report from Frost & Sullivan.
PTSM: Pharmaceutical Technology Sourcing and Management
The pharmaceutical majors advance vaccines for the developing world.
The authors designed an upper punch with a removable punch tip to determine a tablet formulation's propensity to stick by weighing the mass of powder adhered to the punch tip.
Challenges remain, particularly for early-stage biopharmaceutical companies.
Technology may expedite operations, but the absence of the human element could cost dearly.
To keep moving forward, the Pharmacopoeial Discussion Group needs industry participation.
Industry experts discuss formulation and technical challenges in multilayer tablet manufacture.
Nanosized systems are important in drug delivery. Such nanosized systems include liposomes, nanocrystals, micelles, colloidal particles, quantum dots, and dendrimers. Dendrimers are class of synthetic macromolecules with highly branched, monodispersed, circular, and symmetrical architecture that are used as carrier molecules in drug delivery.
The author describes how providing appropriate information about the API in the Common Technical Document can aid FDA's review of an abbreviated new drug application.
New product reviews for January 2012.
Pfizer and GlaxoSmithKline have announced separate agreements with the GAVI Alliance to supply pneumococcal vaccines to developing countries. Pneumococcal disease can lead to pneumonia, meningitis, and sepsis, and is one of leading causes of death in children under the age of five in developing countries.
AstraZeneca Acquires Chinese Generic-Drug Company; Takeda Makes Management Changes; and More.
Pfizer and GlaxoSmithKline have announced separate agreements with the GAVI Alliance to supply pneumococcal vaccines to developing countries.
Last week, the US Department of Health and Human Services and Novartis Vaccines and Diagnostics dedicated a manufacturing plant that can create influenza vaccine using cultured animal cells instead of the conventional expression system of fertilized eggs.
Samsung and Biogen Idec agreed to invest $300 million to establish a joint venture to develop, manufacture, and market biosimilars. The deal is Samsung's latest effort to strengthen its position in biosimilars.
On Dec. 6, 2011, FDA announced that a public meeting will be held on Dec. 16, 2011 to discuss recommendations for a user fee program for biosimilar biological products for fiscal years 2013–2017.
PTSM: Pharmaceutical Technology Sourcing and Management
Biosimilar manufacturers need better expression systems and analytical tools to compete.
Expansion activity was limited as fine-chemical producers and CMOs of API and intermediates grapple with changing industry fundamentals.
As the excipient supply chain becomes more complex, industry must up the ante to comply with new standards and regulations.
New product reviews for December 2011, focusing on manufacturing.
Drug shortages, supply-chain security, generic-drug incursion, and flexible manufacturing models are some of the issues shaping the bio/pharma industry.
Precedents set in the historic Barr case continue to raise questions over suitable sample-size criteria.
A Q&A with Deborah Tanner, executive vice-president and group president of R&D laboratories at Covance, on recent industry trends.
The authors developed a metronidazole-based floating drug-delivery system to investigate the effect of rate-controlling polymers on release pattern and duration of buoyancy in matrix tablets.
Readers react to the economic turmoil of the past year and look longingly forward to 2012.
