PharmTech Europe News
Diurnal’s Swiss Partner Submits MAA for Alkindi to Swissmedic
The Swiss marketing and distribution partner of Diurnal Group, EffRx Pharmaceuticals, has submitted a MAA for Alkindi to Swissmedic.
Nanoform Commences First Human Trial of Nanoformed Drug Candidate
Nanoform Finland will be initiating the first human trial of a drug candidate nanoformed using the company’s CESS technology in 2020.
Vetter Moves into New Headquarters and Continues Long-Term Investment
Vetter has moved into new headquarters located in Ravensburg, Germany, and plans to continue its long-term investment for corporate development.
Shimadzu Opens Branch Office in Denmark
Shimadzu, has opened a new branch office in Copenhagen, Denmark.
Cambrex Expands Solid Form Screening Facility in Scotland
Cambrex has completed the expansion of its solid form screening and crystallization process development facility in Edinburgh, Scotland.
FDA Grants Rare Pediatric Disease and Orphan Drug Designations to Oxular
Oxular has been granted rare pediatric disease and orphan drug designations by the US FDA for its proprietary drug, OXU-003.
MHRA Joins the Australia-Canada-Singapore-Switzerland Consortium
The UK's MHRA has joined the Australia-Canada-Singapore-Switzerland (ACSS) Consortium of regulators.
UK Biotech Investment Continues to be Strong, According to Data
Recent data, from BIA and Clarivate, has revealed that investment in UK biotech continues to be strong.
CPhI Announces 17th Annual CPhI Pharma Awards Winners
The winners were announced during day seven of CPhI Festival of Pharma.
Schott, Credence MedSystems Collaborate to Make Syringe Injections Safer
Schott and Credence MedSystems have formed a strategic collaboration to make syringe injections safer.
Roche Acquires Novel TMEM16A Potentiator Portfolio from Enterprise Therapeutics
Enterprise Therapeutics has announced that its novel TMEM16A potentiator portfolio has been fully acquired by Roche
Independent Research Demonstrates Effectiveness of Alfacyte Against SARS-CoV-2
Independent research performed at the University of St. Andrews in the UK has reportedly demonstrated the effectiveness of Alfacyte in-vitro against SARS-CoV-2.
2021 Event Details for CPhI and Pharmapack Europe Released
A complete listing of event dates for CPhI and Pharmapack Europe 2021 has been released.
EMA Confirms Standards for COVID-19 Treatment Evaluations
The agency sent an open letter to European Ombudsman Emily O’Reilly affirming the agency’s intention to apply the same standards to the evaluation of COVID-19 treatments as it does to other medicines.
Regulating with Flexibility: The Pandemic Effect
Regulatory bodies are adapting to new ways of working to cope with the impact of COVID-19.
Sterling Pharma Solutions Acquires US API Facility
Sterling Pharma Solutions has acquired Alcami’s API facility in Germantown, WI.
Symbiosis Successfully Completes MHRA Audit Inspection
Symbiosis has successfully completed a scheduled inspection by MHRA.
Optimus Holding Successfully Completes Acquisition of OM Pharma
Optimus Holding has successfully completed the acquisition of OM Pharma.
Recipharm, BIAL Extend Opicapone API Supply Agreement
Recipharm and BIAL have expanded their long-term supply agreement for the global manufacture and supply of opicapone API.
UK Prime Minister Visits Team Behind the Vaccines Manufacturing and Innovation Centre
UK's Prime Minister visited the site of the country’s VMIC in Oxfordshire, and met the teams working at the forefront of the national COVID-19 response.
CPhI Launches First Part of Annual Report Ahead of Digital Expo
CPhI has launched the first part of its Annual Report.
Advanco and Syntegon Launch Strategic Serialization Partnership
A strategic serialization partnership has been announced by advanco and Syntegon, aimed at tackling the global issue of counterfeit drugs.
Telstar Reinforces Consultancy Service in Accordance with New Annex 1
Telstar has reinforced its consultancy service to aid pharmaceutical companies in the compliance of the latest version of the EU GMP Annex 1 guidance.
Moderna, Chiesi Group Collaborate on Discovery and Development of mRNA Therapeutics
Moderna and Chiesi Group are collaborating on the discovery and development of mRNA therapeutics to treat pulmonary arterial hypertension.
ISPE Releases Cleaning Validation Guide
ISPE has released new guidance on the cleaning validation lifecycle, written by a group of experts and reviewed by regulators and practitioners.
Sanofi and GSK to Provide the EU with 300 Million Doses of its COVID-19 Vaccine Candidate
The companies will receive upfront funding from the European Union for the scale-up of manufacturing capabilities at industrial sites in Belgium, Italy, Germany, and France.
EMA Endorses Dexamethasone for Use in COVID-19 Patients on Oxygen Therapy
The agency’s human medicines committee is endorsing the use of dexamethasone in COVID-19 patients requiring oxygen therapy.
EMA Recommends Seven Medicines for Approval
The EMA recommendations include a meningococcal vaccine and the biosimilar Nyvepria.
Russia Completes Deals with India, Mexico, and Brazil for Sputnik V
The Russian Direct Investment Fund has announced three deals with India, Brazil, and Mexico, for the supply of doses of Sputnik V, a potential COVID-19 vaccine.
Valneva Enters into $1.6-Billion Partnership with UK Government for COVID-19 Vaccine
Valneva will supply the UK government with an initial 60 million doses of the vaccine in the second half of 2021, if successful, and will provide more doses thereafter.