Rolling reviews: a useful tool to speed up the regulatory review process

Regulators around the globe have reviewed marketing authorisation applications (MAAs) for COVID-19 vaccines and treatments at record speed. One of the tools they used to speed the review cycle is the use of so-called
rolling reviews or rolling applications.

With rolling reviews, data are submitted and reviewed as they become available instead of waiting for the full data package – nonclinical, clinical and quality – to be available and submitted at the same time. By being able to review data as they become available, regulators can assess and request additional information and clarifications quicker than in a traditional review pathway.

Open Orphan (LON:ORPH) was founded in 2017, with the goal of rapidly building Europe’s leading pharma services company by a management team with extensive industry and financial expertise. The company comprises of two commercial specialist CRO services businesses (Venn Life Sciences and hVIVO) and is also developing a genomics data platform business (Genomic Health Data).

Click to view all articles for the EPIC: ORPH
Or click to view the full company profile:
Open Orphan plc

Open Orphan name change to hVIVO effective 26th October 2022

25th October 2022

Open Orphan plc (LON:ORPH), a rapidly growing specialist contract research organisation (CRO) and world leader in testing infectious and respiratory disease products using human challenge clinical trials, has announced that further to its announcement on 8 September 2022,

Open Orphan to hold a Capital Markets Day on 2 November 2022

20th October 2022

Open Orphan plc (LON:ORPH), (to be renamed hVIVO plc (AIM: HVO) effective 26 October 2022), a rapidly growing specialist contract research organisation (CRO) and world leader in testing infectious and respiratory disease products using human challenge clinical trials, has

Open Orphan announces experienced chartered accountant as new CFO

19th October 2022

Leading firm in tackling infectious diseases, Open Orphan, has announced a new chief financial officer and executive director. Stephen Pinkerton, 59, will tae over both roles at the contract research organisation, following the departure of Leo

Open Orphan appoints Stephen Pinkerton as CFO

18th October 2022

Open Orphan plc (LON:ORPH), (to be renamed hVIVO plc (Ticker: HVO) effective 26 October 2022), a rapidly growing specialist contract research organisation (CRO) and world leader in testing infectious and respiratory disease products using human challenge clinical

Celebrating 25th Anniversary in DE STAL in Leiden

12th October 2022

Venn Life Sciences would like to invite you to celebrate their 25th anniversary in DE STAL in Leiden on October 18th. We are delighted to present our team members who will give a short talks on biologics

Why it’s important to stay hydrated when you have asthma

3rd October 2022

During the last 10 years, it has been proven that there could be a connection and repercussion between hydration and different respiratory diseases. Dehydration is a common symptom of allergies but an unusual trigger for asthma.

Open Orphan further positive data for FLU-v

30th September 2022

Open Orphan three upcoming scientific presentations

27th September 2022

Open Orphan plc (LON:ORPH), (to be renamed hVIVO plc (LON:HVO) effective 26 October 2022), a rapidly growing specialist contract research organisation (CRO) and world leader in testing infectious and respiratory disease products using human challenge clinical trials,

Open Orphan reiterates £50m profit guidance

26th September 2022

Dublin and London-listed pharmaceutical company Open Orphan announced on Thursday that it will rename itself Hvivo from next month. The rare and orphan drug consulting services platform also reported results for the first half of the

Open Orphan rebrands to Hvivo

20th September 2022

Open Orphan is changing its name as CEO Yamin Khan said the company achieved its ‘key goal’ of double-digit earnings for the first time. Dublin-based pharma services company Open Orphan announced today (8 September) that it

hVIVO says 3rd virus challenge contract is sign of growing demand

12th September 2022

Open Orphan subsidiary hVIVO has been hired to make H1N1 influenza virus for a Phase IIa study of a developmental antiviral drug. The UK-based contract research organization (CRO) announced the £10.4 million ($12.1 million) contract this

Open Orphan to change name to hVIVO plc

8th September 2022

Open Orphan continued its profitable momentum into 2022

8th September 2022

Open Orphan plc (LON:ORPH), (to be renamed hVIVO plc (LON:HVO) effective 26 October 2022), a rapidly growing specialist contract research organisation (CRO) and the world leader in testing infectious and respiratory disease vaccines and antivirals using human

Open Orphan inks £10.4M deal to produce new H1N1 challenge virus

7th September 2022

Open Orphan subsidiary hVIVO has inked a 10.4 million pound sterling ($12.3 million) deal with a large, unnamed pharmaceutical company to produce a novel batch of H1N1 influenza challenge virus. In a challenge trial, healthy patients are deliberately

Would you deliberately get infected with flu for £3,250?

1st September 2022

Scientists will pay you £3,250 to get infected with flu as part of a drug trial. Healthy 18 to 55-year-olds are being invited to take part in a human challenge study, which will see them infected

Open Orphan’s hVIVO awarded CAP accreditation