The agency announced that FDA scientists have developed candidate vaccine viruses that may be used to produce influenza vaccines.

The guidance describes an optional streamlined submission process for use of an investigational in vitro diagnostic in a clinical trial for oncology therapies.

The transaction is set to be completed at the end of the first quarter of 2020.

AstraZeneca received approval from FDA for Fasenra Pen, a pre-fillled auto-injector pen that allows for self-administration of its asthma biologic therapy, Fasenra (benralizumab).

The companies will collaborate to identify and develop in-vivo genome editing therapeutic candidates for genetic diseases, including hemophilia.

The collaboration aims to reduce “vein-to-vein” time for patients and to optimize manufacturing and supply operations.

The new location will handle logistics, development, data, service support, FAT, and project management.

CPI, the University of Strathclyde, GSK, and AstraZeneca Collaborate on a continuous direct compression digital twin for pharmaceutical formulation optimization.

In an Oct. 10, 2019 press release, ChargePoint Technology announced that its smart monitoring system, Verifi, is now available for the biopharma market.

Novasep has revealed in an Oct. 1, 2019 press release that is has launched a dedicated unit in Seneffe, Belgium, offering fill/finish clinical and commercial services for biological products.

Following the publication of a statement from the United Kingdom’s Secretary of State for Health and Social Care, Matt Hancock, on the continuity of medicines supply in a ‘no-deal’ Brexit scenario, the UK BioIndustry Association (BIA) has issued a response on Oct. 9, 2019.

Developer of software for drug discovery, Optibrium, has announced in an Oct. 10, 2019 press release the introduction of its Augmented Chemistry services, which incorporate artificial intelligence technologies to help guide drug discovery.

Fujifilm Irvine Scientific has revealed, in an Oct. 8, 2019 press release, that it is has received CE mark approval for key Assisted Reproductive Technologies (ART) products, which are now available in Europe.

MilliporeSigma will now be the first company to make acoustic technology available for cell therapy manufacturing.

The new device protects children from accidentally taking painkillers, antidepressants, or medical cannabis with a new opening mechanism.

The company will present its solutions to reduce procurement costs for customers and help them bring their products to market faster.

The acquisition comes after Bormioli became an independent company owned by Triton Investment Fund in December 2017.

The new facility raises production capacity by an additional 19,100 m2 and creates 200 new full-time jobs.

The increased capacity will enable the company to guarantee short production timelines.

The collaboration focuses on baculovirus/Sf9 expression system for Prevail's pipeline of novel AAV9-based gene therapy programs neurodegenerative diseases.

The new services provide rapid production of antibody drug conjugates (ADCs) for best candidate selection.

Under a collaboration potentially worth more than $1.5 billion, the companies aim to develop the antisense therapy to treat patients with certain cardiovascular and metabolic diseases.

When the injector design is finalized, Stevanato Group will produce it at one of its manufacturing facilities using extensive tooling, molding, and assembly expertise.

Data from BIA and Informa Pharma Intelligence have shown that, despite investment slowing across all sectors, the biotech sector of the UK is still managing to raise significant funds.

Glenmark Pharmaceuticals has been granted marketing approval from the Russian Ministry of Healthcare for its film-coated tablets, Montlezir, to treat seasonal and perennial allergic rhinitis.

GSK invested $139 million to its Rockville, MD site to support demand for Benlysta.

The agency has approved Gilead Sciences’ Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg) for reducing the risk of HIV-1 infection.

The tables can be used for new drug applications, biologics license applications, and supplements to these applications.