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Three focus areas to accelerate breakthrough drugs to market

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The pace of R&D innovation is getting treatments to patients faster, but it is also putting pressure on clinical operations teams. There are now more complexities in running trials and organizations have a greater need for improved trial efficiency.

The number of clinical trials taking place each year continues to rise. In fact, in 2018, the FDA approved a record-breaking 59 drugs[i]. Volumes are increasing, in part, due to the shift towards precision medicine. And the impact these drugs are having on patient lives is significant. For example, it was recently announced that NHS patients with lymphoma are being given a pioneering treatment that genetically reprograms their immune system to fight cancer.[ii]

Biotechnology Innovation Organization Chief to step down after US 2020 elections

Image Credit: CC BY-SA 3.0,

The Biotechnology Innovation Organization (BIO), the largest trade body representing the world’s biotechnology industry, has revealed that its President and CEO Jim Greenwood is to step down from the role following the 2020 US presidential election.

Greenwood has served in the position since 2004, succeeding founding President Carl Feldbaum who retired that year. His tenure saw the BIO triple in size to 176 employees, while its operating budget grew to $85 million.

Top Ten most popular articles on this week

It’s the end of the week and time for a rundown of our top most popular articles on Pharmafile these past 7 days. This week saw numerous FDA approvals as well as a few research collaborations that could see new treatments being fully developed over the coming years. Here they are:

10. Novartis' legelizumab outperforms Roche's Xolair in chronic urticaria clearance

The Lung Ambition Alliance: Stronger together

Published on 09/10/19 at 11:05am

Following our piece by AstraZeneca's Patrick Connor introducing the Lung Ambition Alliance, a new cross-functional collaboration which aims to double five-year survival in lung cancer by 2025, Pharmafocus spoke to head figures from three of the Alliance’s founding partners to get a feel for how it will operate, how it will deliver on its aspiring promises, and what sets it apart from previous collaborative efforts.

Gilead's CAR-T therapy Yescarta now available via NHS Scotland for two forms of B-cell lymphoma

News has broken that the Scottish Medicines Consortium (SMC) has chosen to approve the use of Gilead’s chimeric antigen receptor T cell (CAR-T) therapy Yescarta (axicabtagene ciloleucel) on the NHS in Scotland.

4D Pharma to collaborate with MSD in vaccine development

4D pharma, a leader in the development of live biotherapeutics, has announced it has entered into a research collaboration to discover and develop live biotherapeutics for vaccines.

Under the terms of the agreement 4D’s proprietary MicroRx platform will be paired with MSD’s expertise in the development and commercialisation of novel vaccines to develop LBPs as vaccines in up to three undisclosed indications.

Multiple Sclerosis Society launches fundraising appeal to raise £100m

The MS Society has launched a hard-hitting public appeal to raise £100m to stop multiple sclerosis.

The Stop MS Appeal will feature adverts showing real people living with the condition and aims to raise the £100m over 10 years to find treatments for everyone living with MS, which currently affects over 100,000 people in the UK.

Publicis Health and Mediacom have worked with the MS Society on the campaign, which features an emotive film produced award-winning director James Lawes.

FDA approves Novartis' Beovu injection for wet age-related macular degeneration

Novartis has secured FDA approval for its Beovu (brolucizumab) injection in the treatment of wet age-related macular degeneration (AMD), it has emerged.

The decision makes it the first anti-VEGF drug approved by the FDA to “maintain eligible wet AMD patients on a three-month dosing interval immediately after a three-month loading phase with uncompromised efficacy”, while also offering greater fluid resolution compared to Regeneron’s Eylea (aflibercept).

Pfizer to develop Akcea/Ionis’ Antisense Drug for up to $1.5bn

Pfizer and Akcea Therapeutics have entered into an exclusive worldwide licensing agreement for Akcea’s phase 2 cardiovascular and metabolic candidate AKCEA-ANGPTL3- LRx in a deal that could generate over $1.5 billion for Akcea and its parent company Ionis Pharmaceuticals.

AKCEA-ANGPTL3- LRx is an antisense therapy designed to reduce the produce of angiopoietin-like 3 (ANGPTL3) protein in the liver, which is a key regulator of triglycerides, cholesterol, glucose and energy metabolism.

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