All news articles for September 2020

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CPhI Festival of Pharma

Vetter to profile cleanroom concept at CPhI

By Jenni Spinner

The aseptic technology specialist plans to discuss its V-CRT cleanroom technology at the upcoming CPhI Festival of Pharma online event in October.

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CPhI Festival of Pharma

Noble to address drug delivery evolution at CPhI

By Jenni Spinner

A leader from the pharma solutions firm will discuss the future of drug delivery at a keynote during the CPhI Festival of Pharma virtual event.

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CPhI Festival of Pharma

CPhI: SPI Pharma talks supply chain challenges

By Jenni Spinner

The pharma ingredients provider discusses new products, supply-chain obstacles, and what the future of the industry might hold, ahead of the online event.

© GettyImages/AndreyPopov

Crowdfunding COVID-19 vaccine development

By Jane Byrne

Axon Neuroscience is launching the world's first crowdfunding exercise for the development of a COVID-19 vaccine, following what it says are strong pre-clinical results for its candidate.

© GettyImages/ChooChin

UK market sees additional Herceptin biosimilar

By Jane Byrne

Accord Healthcare has announced the launch of a Herceptin biosimilar in the UK. Zercepac is the first monoclonal antibody (mAb) and fourth biosimilar launched by the company in Europe.

Pic:getty/licsiren

Johnson & Johnson starts Phase 3 trial for COVID-19 vaccine

By Rachel Arthur

Johnson & Johnson has launched its pivotal global Phase 3 trial for its COVID-19 vaccine candidate: anticipating the first batches of its vaccine will be available for emergency use authorization in early 2021.

A broad shift in the gene therapy space impacts demand for viral vectors. Pic: getty/yourphoto

Why viral vector manufacturing capacity is constrained

By Nick Taylor

Viral vector production capacity has become increasingly constrained in recent years due to increases in the therapies in development, the dosages given and the patient populations targeted. COVID-19 is exacerbating the situation.

AGTC's clinical pipeline is focused on rare genetic eye diseases, but is expanding. Pic:getty/drpas

Using HSV helper viruses to increase AAV production

By Nick Taylor

Recognizing the industry-wide need to improve adeno-associated virus (AAV) vector manufacturing, Applied Genetic Technologies Corporation (AGTC) has adopted changes intended to increase yield and purity.

© GettyImages/ipopba

Cytiva invests for global capacity expansion

By Jane Byrne

Cytiva is to invest US$500m over the next five years to raise manufacturing capacity, hiring nearly 1,000 personnel in Austria, China, Singapore, Sweden, and the US, and bringing on new manufacturing lines, 24/7 shift patterns, and increased automation.

© GettyImages/metamorworks

FDA calls for more data on Sarepta gene therapy for DMD

By Jane Byrne

An FDA regulatory request to Sarepta could delay the timeline for approval of its Duchenne muscular dystrophy (DMD) gene therapy if it results in a deferral of the start of a planned Phase 3 study for SRP-9001.

© GettyImages/vchal

Spotlight on Moderna funding declarations in patent filings

By Jane Byrne

Two US government agencies are investigating whether Moderna Therapeutics, the biotech company behind one of the leading Covid-19 vaccine candidates, was upfront about government funding in its filed or awarded patents, as required by federal law.