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Novartis divests “front of eye” ophthalmology assets to Bausch + Lomb

Written by | 11 Jul 2023

Novartis announced that it has signed an agreement to divest ‘front of eye’ ophthalmology assets to Bausch + Lomb, a global eye health company, in a transaction valued… read more.

FDA action for BLA for bimekizumab for the treatment of adults with moderate to severe plaque psoriasis is now shifted to Q3 2023 – UCB

Written by | 10 Jul 2023

UCB, a global biopharmaceutical company,announced that the Biologics License Application (BLA) for bimekizumab for the treatment of adults with moderate to severe plaque psoriasis remains under review with… read more.

MAA submitted to the European Medicines Agency for approval of single tablet combination therapy of macitentan and tadalafil for treatment of pulmonary arterial hypertension – Jansen Pharmaceuticals

Written by | 9 Jul 2023

The Janssen Pharmaceutical Companies of Johnson & Johnson announced the submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking approval of a single… read more.

Complete Response Letter for AVT 02 biosimilar candidate for Humira – Alvotech

Written by | 8 Jul 2023

Alvotech announced that the FDA has issued a complete response letter (CRL) for Alvotech’s second Biologics License Application (BLA) for AVT 02, a high-concentration biosimilar candidate for Humira… read more.

CHMP positive for Jesduvroq to treat symptomatic anemia in adults with chronic kidney disease who are on dialysis – GSK

Written by | 7 Jul 2023

Jesduvroq (daprodustat) from GSK received a positive opinion from the CHMP for the treatment of adult patients for for the treatment of symptomatic anaemia in adults with chronic… read more.

Late-breaking efanesoctocog alfa data presented at ISTH demonstrates highly effective bleed protection in children with severe haemophilia A with once-weekly dosing – SOBI + Sanofi

Written by | 6 Jul 2023

Pivotal data from the Phase III XTEND-Kids study evaluating efanesoctocog alfa [Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein] once-weekly prophylaxis in previously treated patients younger than 12 years of… read more.

FDA approval of Rystiggo for the treatment of adults with generalized myasthenia gravis – UCB

Written by | 5 Jul 2023

UCB announced Rystiggo (rozanolixizumab-noli) has been approved by the FDA for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AchR) or anti-muscle-specific… read more.

Xigduo XR approved in China for adults with type-2 diabetes – AstraZeneca

Written by | 4 Jul 2023

AstraZeneca’s Xigduo XR (dapagliflozin and metformin hydrochloride extended-release), a once-daily fixed-dose combination, has been approved by China’s National Medical Products Administration (NMPA) for the treatment of adults with… read more.

New topline Olinvyk data highlighting reduced cost per admission from ARTEMIS real-world outcomes study – Trevena Inc

Written by | 3 Jul 2023

Trevena, Inc. announced new topline Olinvyk data from the ARTEMIS study. The ARTEMIS study was an electronic medical records (EMR) based assessment focused on clinical and health resource… read more.

CHMP positive for Mircera to treat paediatric patients with anaemia associated with CKD – Roche

Written by | 2 Jul 2023

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Mircera… read more.

MAA submitted to the European Medicines Agency for dasiglucagon for treatment of severe hypoglycemia in diabetes – Novo Nordisk + Zealand Pharma

Written by | 1 Jul 2023

Zealand Pharma A/S a biotechnology company focused on the discovery and development of innovative peptide-based medicines, announced it has submitted a Marketing Authorization Application (MAA) to the European… read more.

CHMP extends the indication of Refixia to prophylaxis of bleeding in patients 12 years and above with haemophilia B – Novo Nordisk

Written by | 30 Jun 2023

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Refixia…. read more.

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