AstraZeneca’s Imfinzi gets FDA priority review for extensive-stage SCLC

Imfinzi holds approvals for the curative-intent setting of unresectable, stage III non-small cell lung cancer (NSCLC) following chemoradiation therapy across 54 countries, including the US, the European Union,

The post AstraZeneca’s Imfinzi gets FDA priority review for extensive-stage SCLC appeared first on Pharmaceutical Business review.

Medincell receives $19m grant for mdc-WWM programme

It aims to fund preclinical activities and a phase 1 clinical trial for the injectable six-month bioresorbable contraceptive (mdc-WWM). The grant is structured in advanced installments to cover

The post Medincell receives $19m grant for mdc-WWM programme appeared first on Pharmaceutical Business review.

WuXi ATU and GeneMedicine sign development and manufacturing agreement for oncolytic virus products

This is the first international Chemistry, Manufacturing and Controls (CMC) development and manufacturing project empowered by the Oncolytic Virus contract development and manufacturing organization (CDMO) platform, which has

The post WuXi ATU and GeneMedicine sign development and manufacturing agreement for oncolytic virus products appeared first on Pharmaceutical Business review.

Novartis opens new cell and gene therapies facility in Switzerland

The new facility also facilitates the production of advanced and difficult-to-manufacture solid dosage forms such as tablets and capsules, in addition to the manufacturing of novel CAR-T cell

The post Novartis opens new cell and gene therapies facility in Switzerland appeared first on Pharmaceutical Business review.

Verrica Pharmaceuticals announces FDA filing acceptance of NDA for VP-102 to treat molluscum contagiosum

“There are no FDA-approved treatments currently available to patients diagnosed with molluscum, the majority of whom are children, leaving caregivers to choose between a wait-and-see approach or treatments

The post Verrica Pharmaceuticals announces FDA filing acceptance of NDA for VP-102 to treat molluscum contagiosum appeared first on Pharmaceutical Business review.

Evofem Biosciences resubmits new drug application to US FDA for Amphora for the prevention of pregnancy

“Today’s submission represents a significant step forward for Evofem and for the millions of women who are dissatisfied with their current contraceptive options and are eagerly awaiting a

The post Evofem Biosciences resubmits new drug application to US FDA for Amphora for the prevention of pregnancy appeared first on Pharmaceutical Business review.

FDA accepts Incyte’s NDA for priority review of pemigatinib to treat cholangiocarcinoma

The NDA has been accepted for the priority review of selective fibroblast growth factor receptor (FGFR) inhibitor pemigatinib to treat patients with previously treated, locally advanced or metastatic

The post FDA accepts Incyte’s NDA for priority review of pemigatinib to treat cholangiocarcinoma appeared first on Pharmaceutical Business review.

Lonza and DiNAQOR announce strategic collaboration to advance gene therapy programs for patients with monogenic cardiomyopathies

Under the terms of the collaboration, Lonza will provide DiNAQOR preclinical, clinical and commercial production support for the company’s lead preclinical program DiNA-001, an adeno-associated virus (AAV) gene therapy program

The post Lonza and DiNAQOR announce strategic collaboration to advance gene therapy programs for patients with monogenic cardiomyopathies appeared first on Pharmaceutical Business review.

FDA approves Oxbryta (Voxelotor), the first medicine specifically targeting the root cause of sickle cell disease

Oxbryta, an oral therapy taken once daily, is the first approved treatment that directly inhibits sickle hemoglobin polymerization, the root cause of SCD.2,3 The medicine is expected to

The post FDA approves Oxbryta (Voxelotor), the first medicine specifically targeting the root cause of sickle cell disease appeared first on Pharmaceutical Business review.

Asahi Kasei to acquire Veloxis Pharmaceuticals for $1.3bn

The Japanese conglomerate plans to acquire Veloxis Pharmaceuticals through its Danish subsidiary Asahi Kasei Pharma Denmark in a move to accelerate its transformation into a global healthcare company.

The post Asahi Kasei to acquire Veloxis Pharmaceuticals for $1.3bn appeared first on Pharmaceutical Business review.