PharmTech Europe News

Analysts examine the latest trends in finished dosage forms.

The company will showcase its injectable grade pharmaceutical oils at CPhI Worldwide.

The company will display new products such as the Opadry QX, a tablet film coating.

The panel includes 12 experts from a variety of disciplines.

The agency published a guideline for the implementation of ICH Q3D.

Regulatory agencies meet to discuss approaches to the development of antibacterial agents.

The company invested SEK 72 million ($9 million) to expand manufacturing capacity at its Karlskoga facility in Sweden.

CSafe completed the acquisition of Kallibox, a manufacturer of cold-chain packaging solutions.

CPhI Worldwide’s Pre-Connect Congress will discuss current trends in the pharmaceutical industry.

The bio-incubator, located at the James Cook University Hospital, will give early-stage biotechnology and life-sciences companies access to facilities to support biomedical research.

The agency has adopted guidelines on the pharmacovigilance of biological drugs.

Jacobs Engineering will provide engineering and construction services to expand the Novartis site in Huningue, France.

The agency released the GMP guidance to help manufacturers ensure accurate data and minimize risk.

The three-year report emphasizes the roll of collaboration in drug safety.

The report addressed how the agency might support medicine development for patients’ unmet medical needs.

The agency launched a public consultation on the revised guidance for new medicines to treat tuberculosis.

A new era has begun to address the deadly innovation gap in tackling the antimicrobial resistance crisis.

The agency will review Mylan and Biocon’s biosimilar to pegfilgrastim.

The agency recommends suspending drugs developed with bioequivalence studies performed at Semler Research Centre Private Ltd, Bangalore, India.

The agency has recommended granting marketing authorization in the EU for Truvada.

FDA issued a warning letter to the Worthing, UK facility for cross contamination and microbial contamination cGMP violations.

This new method uses inter-alpha inhibitors to promote attachment and long-term growth in stem cells.

The agency reviews hemophilia A, skin, and diabetes treatments, among others.

The agency completes its risk assessment of the blood cancer treatments.

The company will invest €100 million in the expansion of its Athlone facility.

The agency says, for now, it’s business as usual.The European Medicines Agency (EMA) says the future location of the agency will be determined by common agreement between representatives of the Member States, according to a July 6, 2016 statement. Until then, EMA says it will be conducting business as usual, and the outcome of the June 23 referendum will not affect the agency’s operations.

The agency is following up on a February 2016 inspection of the facility that found GMP violations.

In the wake of Britain’s decision to exit the EU, pharma companies face uncertainty.

The agency recommends Zalmoxis, a new cell-based therapy to support stem cell transplantation in patients with high-risk blood cancer.

The agency has suspended recommendation of Riluzole Alkem due to flawed study results.