PharmTech Europe News

Kapruvia has been approved by the European Commission for the treatment of moderate-to-severe pruritis in hemodialysis patients.

The new company has been appointed as a channel partner for Ireland by TSI Inc., a particle counter manufacturer.

VYDURA has been granted marketing authorization by the European Commission for both acute treatment of migraine and prophylaxis of episodic migraine.

EMA is recommending EU conditional approval of Roche’s potential first-in-class bispecific antibody mosunetuzumab for people with relapsed or refractory follicular lymphoma.

EMA has granted Novo Nordisk a positive scientific opinion on human insulin with more flexible storage without refrigeration.

The European Investment Bank has provided €15 million to fund coronavirus research at IRBM.

AmoyDX has entered a Master Collaboration Agreement with AstraZeneca for multiple companion diagnostics programs in China, EU, and Japan.

Achilles Therapeutics has announced that it will expand its clinical manufacturing capabilities in the UK and enter a partnership agreement for expansion in the US.

Swissmedic grants conditional marketing authorization for Novavax COVID-19 vaccine for individuals aged 18 years or older in Switzerland.

Tjoapack has doubled its packaging capacity with the completion of its Netherlands facility expansion.

Biomarker-guided trial led by University Hospital Hamburg-Eppendorf (UKE) opens new avenues for personalized medicine for treatment of COVID-19.

Orchard Therapeutics announces reimbursement agreement, which will make Libmeldy available for all eligible MLD patients in Italy.

Dupixent has been approved by the EC for children aged 6 to 11 years with severe asthma with type 2 inflammation.

Lonza and Asher Biotherapeutics have entered a manufacturing agreement for a cis-targeted IL-2 fusion protein, AB359.

ECDC and EMA have concluded that it is too early to consider using a fourth dose of mRNA COVID-19 vaccines in the general population.

Teva has initiated a voluntary nationwide recall of one lot of IDArubicin Hydrochloride Injection USP 5mg/5 mL due to the presence of particulate matter.

WeylChem has put a new multi-purpose custom manufacturing plant at its French site in Lamotte into operation.

UK’s MHRA has issued a positive opinion for the Early Access to Medicines Scheme for radioligand therapy in patients with advanced prostate cancer.

Catalent has acquired the Vaccine Manufacturing Innovation Centre in Harwell, Oxford to expand its biologics capabilities across the UK and Europe.

Stanley Capital has announced the acquisition of MyMeds&Me by its portfolio company Drug Safety and Pharmacovigilance Services Solutions.

ATMPS Ltd has been granted a patent from the United States Patent and Trademark Office for the use of its Hataali blockchain technology used in personalized medicines.

ten23 health is expanding its sterile drug product manufacturing site at Visp, Switzerland to enlarge cold storage and visual inspections capacity and add clean rooms.

Sterling Pharma Solutions has unveiled a £1 million expansion project to increase its capabilities and laboratories capacity at its Deeside, UK site.

UK government has awarded chemical producer Croda a £15.9 million grant to increase the UK’s capacity to manufacture key vaccine ingredients.

Lonza has joined IPAC-RS, providing benefits to Lonza’s inhalation- related businesses due to IPAC-RS’ global voice of the orally inhaled and nasal drug products industry.

ViiV Healthcare announced that FDA has approved Triumeq PD, a dispersible single tablet regimen containing dolutegravir, a once-daily treatment for children living with HIV.

Rentschler Biopharma and Vetter are unveiling a strategic collaboration called Xpert Alliance.

Symbiosis announced the successful completion of UK Research and Innovation project to enhance the manufacturing supply chain for ATMPs within the UK.

KeyPlants has shipped a first-of-its-kind vaccine manufacturing facility to Senegal in West Africa.

Sanofi and IGM Biosciences have announced a collaboration agreement for oncology, immunology, and inflammation targets.