Markets & Regulations

Report on MediLedger blockchain network submitted to the FDA

25-Feb-2020 By Vassia Barba

A group of 24 companies is set to support blockchain technology to ensure compliance with the FDA’s DSCSA requirements and to tackle counterfeiting.

Covance aims to increase big pharma win rate to drive growth

24-Feb-2020 By Nick Taylor

Covance outlines plans to use oncology capabilities to win more business from big pharma.

Taro recalls seizure medicine over suspension problems

24-Feb-2020 By Ben Hargreaves

Taro instigates a voluntary recall of phenytoin oral suspension after two lots are found not to re-suspend when shaken.

Merck KGaA sells allergy business to focus on innovative medicine

24-Feb-2020 By Ben Hargreaves

Dermapharm will pick up the business unit for an unspecified fee, whilst Merck will retain the development of its adrenaline autoinjector project.

AntTail tracks temperature changes from pallets to patients’ homes

20-Feb-2020 By Ben Hargreaves

AntTail builds an end-to-end application that is able to track temperature of medicine and detect evidence of tampering.

FDA and Indian agencies discover 500 illegal shipments entering the US

20-Feb-2020 By Vassia Barba

The drugs including unapproved cancer, HIV, and opioid treatments, which were identified during a three-day operation at a mail facility.

'Significant problems' at outsourcing sites prompt Trump to plan FDA budget boost

19-Feb-2020 By Nick Taylor

President Trump proposes extra cash for US FDA to address “significant problems at many inspected outsourcing facilities.”

Lupin denies quality is a company-wide issue despite run ins with FDA

18-Feb-2020 By Nick Taylor

Lupin refutes suggestion that history of manufacturing quality failings highlighted by the US FDA reflect a company-wide issue.

PCI acquires Bellwyck Pharma Services

17-Feb-2020 By Jenni Spinner

The purchase follows PCI’s plans to expand its clinical trial services globally, including in North America and Europe.

Dr Reddy’s picks up portfolio and facility from rival for $259m

17-Feb-2020 By Ben Hargreaves

Wockhardt sells part of its domestic business to fund growth in international markets and to develop its biosimilar business.

Industry demands ‘closest possible relationship’ between UK and EU

13-Feb-2020 By Ben Hargreaves

European industry organizations call for trade negotiations between the UK and the EU to begin with a mutual recognition agreement.

Three companies combine to form consulting CRO

13-Feb-2020 By Vassia Barba

Aiming to support drug developers in issues related to market insights, engagement, and access, Synaptiq enters the market backed by three consultancy agencies.

Evoke tasks Eversana with handling US launch of Gimoti

12-Feb-2020 By Nick Taylor

Evoke Pharma tasks commercial service provider Eversana with supporting US drug launch.

Telehealth: The trial site at the other end of the line

12-Feb-2020 By Vassia Barba

Participants in a clinical trial can virtually ‘visit’ their physicians at the trial site with Firma’s telehealth software.

Virtual approaches: Come for the cost-cutting, stay for the endpoints

12-Feb-2020 By Vassia Barba

The potential of a virtual approach in eliminating site management costs during clinical trials is the main motive, even for ‘conservative’, hesitant developers, says Syneos.