PharmTech Europe News

The two countries have been included in the mutual recognition agreement between the EU and US for GMP inspections.

A taskforce evaluated the advantage of using Big Data in the evaluation of the benefits versus risks of medications.

The approval expands the indications for Sprycel (dasatinib) in Europe.

CatSci has announced an expansion of its offering to include end-to-end services with an additional focus on lead optimization.

Big data technology company, Aigenpulse, has been granted with International Organization for Standardization (ISO) 9001:2015 and ISO 27001:2013 certification.

Sharp has invested US$650,000 into enhancing its Interactive Response Technology (IRT) solution.

Zogenix has submitted an NDA to the US Food and Drug Administration and an MAA to the European Medicines Agency for FINTEPLA.

Pathios Therapeutics and Sygnature Discovery have signed a strategic and innovative partnership agreement aimed at accelerating Pathios’ drug discovery and development programs.

In a partnership with Thermo Fisher Scientific Pharma Services, Pacira added a manufacturing suite in Swindon, UK, that doubles the company’s capacity by mirroring the company’s facility in San Diego, CA.

Caron’s Wally CO2 incubators for laboratories are now available for purchase in the European Union.

The final part of the European Falsified Medicines Directive (EU FMD) is to come into force on Feb. 9, 2019, which means that all medicines within the European Union will need to comply with the safety features as laid out by the delegated regulation.

Nine award winners from the 2019 edition of Pharmapack Europe, covering innovations across drug delivery, packaging, and materials and components, have been announced by the event organizers.

The companies will jointly develop and commercialize an investigational bifunctional fusion protein immunotherapy currently in clinical development for cancer treatment.

The agency is requiring companies that make sartan blood pressure drugs to review their manufacturing processes due to the problem with impurities.

The agency recommended six medicines for approval at its January 2019 meeting, including treatments for lung cancer, HIV-1, and autoimmune disorders.

The companies will develop Amprologix’s lead epidermicin-based antibiotic candidate.

The company will open its first European manufacturing facility in Castlebar, Ireland.

Various groups and stakeholders from pharma, healthcare, and government are responding to a new draft environmental risk assessment guidance from EMA.

A new initiative has been launched to help stimulate industry discussion on innovative tech for use across the drug supply chain.

Pharmapack Europe event organizers have released a report titled, ‘European drug delivery and packaging’ that forecasts an increase in innovation from smaller European companies.

The ABPI has released a statement calling for action to address skills shortages in science within the UK, which could jeopardize the country’s position for medicines and vaccines R&D.

Validair Monitoring Solutions has secured new funding that will be used to support the growth of the company across the UK.

ChargePont Technology has revealed that it is now able to expand its smart monitoring technology into North America thanks to being granted HazLoc (Hazardous Area) certification.

A Memorandum of Understanding (MoU) has been signed by the UK’s MHRA and the State Institute of Drugs and Good Practices of the Ministry of Industry and Trade of the Russian Federation.

TrakCel and WindMIL Therapeutics have formed a partnership to build a custom-configured cellular supply chain tracking and orchestration platform.

Sphere Fluidics has closed its latest investment round in which it raised US$2 million (approximately £1.5 million).

Danapak Flexibles, a subsidiary of the Schur Flexibles Group, will be showcasing its flexible packaging solutions during Pharmapack Europe in Paris, 6–7 February 2019.

Visitors to Schubert-Pharma’s stand at Pharmapack Europe will learn about the company’s range of packaging solutions and engineering services for the pharma and healthcare industries.

Parker Bioscience Filtration added a cleanroom at its site in Birtley, UK for manufacturing single-use assemblies and sensors used in biopharmaceutical processing.

The European Medicines Agency has announced that its physical relocation to Amsterdam will be complete in March 2019.