Industry News

M&A transactions accounted for nearly $15 billion more this year than for the same period a year ago.

The final guidance explains some principles for developing biosimilars and establishes some rules about extrapolation across indications for various medical conditions.

Pfizer's Trumenba is the first FDA-approved immunization against meningococcal disease for individuals 10-25 years old.

The company receives backing to continue its work in research services, process development, and cGMP manufacturing activities.

The agency recommends that companies developing drugs to treat Ebola apply for orphan drug designation.

FDA approved a Cook Pharmica facility and a Patheon facility for manufacturing of Halozyme products.

Many European biosimilar groups argue that biological qualifiers should not be implemented in countries where the brand name or INN of a drug is already well established.

The International Society for Pharmaceutical Engineering (ISPE) released its Drug Shortages Prevention Plan as part of an initiative to address drug shortage prevention due to manufacturing and quality issues.

CPhI released Part 3 of its annual industry report featuring three experts in the pharmaceutical industry.

The National Institutes of Health announces grants for the development of strategies for the utilization of biomedical data sets.

CSL Behring announced that it plans to invest $450 million to expand its Melbourne, Australia and Kankakee, Illinois facilities, which will increase production of albumin and plasma intermediates.

New investments, expansions, and company rebranding are discussed at CPhI.

FDA outlines procedures for having a Critical Path Innovation Meeting with CDER.

FDA draft guidance outlines ways to minimize risk from acetaminophen-containing over-the-counter pediatric liquid drug products.

Celebrating the best of pharma and recognizing companies that turn inspiration into innovation.

FDA releases question and answer draft guidance on drug product tracing and licensing requirements.

Inversions in the pharmaceutical sector could become less lucrative as a result of new tax laws.

NIH seeks new therapeutic products to bolster the protective properties of vaccines.

Partnership is awarded for licensing of low-cost vaccine for the treatment of bacterial meningitis.

The Purple Book will list biologic and biosimilar products and will serve as a guide for interchangeability.

NIH continues funding for tissue chips to be used in the development of therapeutics.

FDA report details risk mitigation projects.

USP expresses its support for a consensus-based global approach to the naming of biologics.

Regulations, product protection, and cost management are top concerns of supply chain decision makers.

PCI's acquisition of Biotech Services International expands the packaging services provider's presence in Europe.

GS1 publishes a healthcare industry guideline describing how to implement GS1 standards to support requirements of the 2013 US Drug Supply Chain Security Act.

GPhA throws its support behind a bill to prohibit companies from using REMS practices to deter competition.

European Commission granted the first biosimilar insulin to receive regulatory approval in Europe.

Roche?s RoACTEMRA receives EU approval for use in patients with early rheumatoid arthritis.

ProBioGen, a biopharmaceutical drug manufacturer in Berlin, spends ?20 million to double its workforce.