Industry News

The European Medicines Agency releases findings from marketing authorization application analysis.

WHO says that results from clinical trials should be reported within 12 months of completion of the study

FDA extends ANDA rule comment period to June 8, 2015 after requests for more time.

The Ph. Eur. contemplates adding specifications for sub-visible particles in eye drops and eye lotions to its monograph.

At the request of FDA, US Marshals seize unapproved prescription drugs from Florida distributor.

India may go to the World Trade Organization if the EU does not reconsider its decision to suspend the sale of about 700 generic drugs that were approved based on clinical trials by GVK Biosciences.

The document serves as guidance for the pharmaceutical industry in data integrity issues and complements existing EU GMP relating to APIs and dosage forms.

CPhI report notes that the Indonesian pharma market is on the brink of a regional manufacturing boom, with market capitalizations and company values rising.

The European Medicines Agency releases guidelines for addressing and reporting risks associated with medication errors.

The pharmaceutical market in Japan is moving towards generic and innovative products, and is expected to hit US$166 billion by 2023.

Agency teams work together to encourage manufacturers to seek approval for previously unapproved drugs.

Aptar Pharma has partnered with Shanghai Sine Promod Pharmaceutical to develop and launch its new budesonide dry powder inhaler (DPI), which features Aptar Pharma’s user-friendly and cost-effective Twister DPI.

Cornell Stamoran, Catalent Pharma Solutions vice-president, is elected to the board of trustees of the Pharma & Biopharma Outsourcing Association.

The move was made to meet an upsurge in Phase I/II GMP campaigns from clients in Europe and the United States.

Facilities in China, Ireland, Germany, and the United States have been recognized by ISPE in the 2015 Facility of the Year Awards program.

The agency outlines recommendations for the development and submission of near infrared analytical procedures.

The White House confirmed that it would release a plan to tackle the growing problem of antibiotic-resistant superbugs.

Adroit Science AB will support Recipharm’s pharmaceutical development with solid-state characterization services.

Germany is a mature market with high healthcare expenditure and pharmaceutical production but future growth could be potentially hindered by cost-saving government policies.

The commission adopts 24 new and 72 revised texts for inclusion in the European Pharmacopoeia.

The event will take place at the Jakarta International Expo, Indonesia from April 8–10, 2015.

The agency provides guidance on determining the need for environmental assessments for gene therapies, vectored vaccines, and viral and microbial products.

Guidance provides labeling standards and an implementation guide for electronic submission of lot distribution reports.

International day for fighting infection sees European infection specialists advocating vaccines as a viable solution to tackle antimicrobial resistance.

Sharon Johnson, senior vice president, Global Quality & Regulatory Affairs, will head the organization.

NSF's consensus-based standard incorporates multiple regulatory and industry requirements into a single rigorous standard for the manufacturing and distribution of pharmaceutical excipients.

McNeil-PPC pleads guilty in connection with adulterated infants' and children's over-the-counter liquid medications.

Canon announced that it established Canon BioMedical, a wholly owned biomedical business to develop, manufacture, and market operations related to Canon’s life-science and molecular diagnostics platform.

The Pharma & Biopharma Outsourcing Association announced its support of legislation that would preserve FDA user fees from sequestration.

Turing Pharmaceuticals announced the launch of its company, the acquisition of three assets from Retrophin, and a new senior management team.