The Committee for Medicinal Products for Human Use recommended seven new medicines at a December 2014 meeting, including weight management and Parkinson’s disease treatments.

The European Medicine’s Agency announced recommendations regarding the use of antibiotics in animals to limit resistance in humans.

A global framework of standards enabling collaboration among industry stakeholders is needed to battle the increasing threat of counterfeit medicines.

Fujifilm Diosynth Biotechnologies announced the completion of the acquisition of Kalon Biotherapeutics, a company that specializes in advanced biologics development manufacturing.

ICH elemental impurities guideline sets a global policy for limiting metal impurities in drug products and ingredients.

Actavis announced a senior leadership team comprised of both Actavis and Allergan leaders designed to facilitate dynamic company growth.

FDA drug approvals are up in 2014 with biologics drugs representing more than 25% of FDA approvals to date.

The agency publishes two guidance documents on providing regulatory submissions in electronic format.

A statement from GPhA’s president expresses the organization’s support of FDA’s proposed rule to amend labeling regulations.

FDA’s pre-approval inspection of Hovione’s facility in Loures, Portugal confirms site to be GMP-compliant.

The multi-product biopharmaceutical manufacturing facility is scheduled to start up in 2017.

Biomanufacturing capacity expansion uses modular cleanroom design and single-use technologies.

Patient access to critical experimental medicines continues to grab public attention as states enact “Right-to-Try” laws and Congress eyes establishing a national policy to provide not-yet-approved therapies to terminally ill patients.

Baxter announced that it had entered into an agreement to sell its Vero cell technology and related assets to Nanotherapeutics.

The Singapore Workforce Development Agency collaborated with governmental groups and industry players to develop a plan to supply biologics-manufacturing workforce demand.

The agency expresses its support for the adaptive pathway approach to bringing new drugs to patients.

The development and approval of new vaccines and antivirals to contain and treat the Ebola virus outbreak has become a top priority for the federal government and Congress, as seen in new policies to spur R&D and added funding for these efforts.

Atlangram will have access to Carlina’s lipid nanocapsule technology platform Soludots under the terms of the agreement.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) and the European Generic medicines Association (EGA) have announced the reiteration of their joint Europe 2020 Strategy submission ahead of the adoption of the European Commission Work Programme.

The agency emphasizes the need for robust scientific assessment and more information on safety and efficacy profiles of Ebola therapies in development.

BioCity has announced a new investment fund, created following a significant contribution by AstraZeneca. The £5 million fund will be managed by BioCity and will make equity investments, typically between £50,000 and £250,000, in life-science companies based at Alderley Park, Cheshire, United Kingdom.

Venair Biotech specializes in single-use products for the biotech and pharmaceutical sectors.

FDA announced the approval of Gardasil 9 for the prevention of certain diseases caused by nine types of HPV, five more than the previously FDA-approved Gardasil.

US Department of Health and Human Services announced a declaration to provide immunity to legal claims made in the US in relation to three investigational Ebola vaccines.

Vetter has added a third cleanroom as part of an expansion of its US early-stage development site at the Illinois Science and Technology Park in suburban Chicago.

On December 8, Pfizer announced that it will establish a research program in gene therapy, and collaborate with Spark Therapeutics in Philadelphia, to develop potential gene therapy treatments for hemophilia.

Under an NIH contract, Paragon Bioservices will design a manufacturing process for recombinant human rhE-selectin protein.