Global regulatory agencies had a busy 2018. Here, we take a look back at some of the key developments throughout the year, as the industry navigated challenging politics, pressure to increase transparency, and the rapidly evolving digital health space.
TrialScope this year awarded several companies for their clinical trial data transparency efforts as the industry makes strides to engage patients and the larger health care community.
The owners of Synteract, Amulet Capital Partners, have acquired a global health communications and market access group with plans to merge it with Peloton Advantage, which it purchased earlier this year.
ICH E6 R2 sparked a paradigm shift, though 2019 will see the clinical trials industry transition from a risk-based monitoring approach to risk-based quality management.
The new year will bring more data than the last 500 decades, information that will be used to improve clinical trial design and shorten drug development timelines, say industry experts.
The industry has a “tremendous opportunity” to build on its progress by further improving operational performance in the face of pricing and patient access challenges.
Throughout 2018 the industry worked to listen more closely to the voice of the patient, though to secure this data, it must navigate currently misunderstood GDPR requirements in the new year.
Potentially increasing costs and dropping returns from investing in innovative medicines and devices will be among the main challenges faced in 2019, says industry analyst.
Access to medicines across the English Channel could be ‘significantly’ reduced for up to six months, if the UK leaves the EU without a deal, according to MP.
A lobby group has filed a complaint alleging illegal discrimination by airlines refusing to transport lab animals – a battle that will be difficult to win, says an industry expert.
Mylan has requested all lots of valsartan, as well as combination amlodipine/valsartan, and valsartan/ hydrochlorothiazide tablets, be returned in the US.
The US FDA’s New Inspection Protocol Project represents an “improvement process step” towards a risk-based site selection model, according to the Swedish CDMO.
The Asia-Pacific CRO Novotech has grown its operations in South Korea, a market that has seen greater interest from North American and European companies, says exec.
The US Court of Appeals for the Federal Circuit removed the injunction against Dr. Reddy’s, which prevented the company from selling its Suboxone generic.
ABL named a successor to its previous CEO, Syneos has two new hires, and BTS Research appointed a VP to push its growth model. These, among other people on the move this month.
Bayer looks to boost investor confidence by cutting away its animal health unit, selected consumer health brands and a number of jobs to focus on its life sciences businesses.
Novartis has announced plans to move its UK headquarters to an ‘emerging life sciences cluster’ in West London, 50 minutes’ drive from its current location in Surrey.
WHO recently assessed Biopharma Services, which demonstrated compliance across multiple regulatory and organizational guidelines – opening the doors to conduct more work with the WHO foundations.
Takeda’s aim to acquire Shire for $62bn received a boost after regulators vote positively to approve the transaction following the divestment of Shire’s IBD drug.
Moving forward, China will take a more integral role in global drug development, following several regulatory changes designed to accelerate innovation.
As sponsors drive CROs to consolidate, building a firm the size of Iqvia would take more than 20 years organically, says consultant – who shares the stuff of nightmares (and dreams).
Dr. Reddy’s Laboratories site in Visakhapatnam, India, was issued a Form 483 last month, yet shares rose after a more recent audit where zero observations were noted.
The predictive value of animal models is less than 50%, which makes them less informative than a coin flip, says AAPS speaker – who also argues that clinical trial participants are not fully aware of the risks.
