Regulatory affairs

‘Upper echelons of administration’ recognize need for growth in kidney disease treatments

19-Jul-2019 By Maggie Lynch

An Executive Order signed by President Trump aims to increase research, incentives, and treatment access for kidney disease patients and could 'fundamentally transform kidney therapeutics,' says president of the American Society of Nephrology....

Marken acquires three European firms, assessing additional deals: ‘Stay tuned,’ says CEO

18-Jul-2019 By Melissa Fassbender

Marken has purchased three European logistics firms and is assessing additional locations at which the CEO said it plans to either build or buy.

Regulations enable approvals and opportunities in rare disease drug development

17-Jul-2019 By Maggie Lynch

Regulatory actions by the FDA have enabled rare disease drug development to become a compelling space with orphan drug designations and approvals trending upward, says life sciences industry attorney.

Genetic testing and drug development: Use cases, regulations, and misconceptions

17-Jul-2019 By Melissa Fassbender

Scientific advances and regulatory incentives are driving the use of genetics in drug development, though the industry’s ability to perform wide-scale testing has outpaced its understanding of the results, the misinterpretation of which can have “disastrous”...

PPD expands patient access to clinical trials via collaboration with cancer center

16-Jul-2019 By Melissa Fassbender

PPD’s patient enrollment business expands access to cancer patients treated in the community setting as part of a new collaboration with a hospital and outpatient center network.

Japan-based CRO joins Align Clinical Group to aid global clinical trial execution

16-Jul-2019 By Maggie Lynch

CMIC Group is the first Japanese CRO to join the Align Clinical group and expects to improve execution of clinical trials and collaboration with life sciences companies as the industry grows globally.

PE firm continues investments in health care industry by taking a stake in Jaggaer

15-Jul-2019 By Maggie Lynch

The strategic sourcing software company Jaggaer has received an investment from international PE firm Cinven.

Reactor malfunction results in employee death at India-based CRO

11-Jul-2019 By Melissa Fassbender

One worker has died at GVK Bio’s Hyderabad site after a reactor malfunctioned, though the root cause remains unknown, according to the CRO.

DIA 2019

AI and pharmacovigilance: ‘We can cut out a lot of this work and focus our energies,’ says MHRA

10-Jul-2019 By Melissa Fassbender

Pharma and regulators are using machine learning to accelerate various pharmacovigilance activities – as the number of adverse event reports increases 10-12% each year, says Eli Lilly advisor.

Instem receives grant, enters consortium to mitigate late stage risks

08-Jul-2019 By Maggie Lynch

Notocord, an Instem company, will provide data acquisition and analysis services to a research and innovation program to improve risk prediction of cardiovascular adverse events.

Innovative Trials enters partnership to complete trial recruitment and retention

02-Jul-2019 By Maggie Lynch

Innovative Trials will work with an undisclosed global pharmaceutical company to speed up patient recruitment for clinical trials using its proactive site optimization service.

DIA 2019

‘Nothing about me, without me’: DIA panel addresses patient data and the future of research

02-Jul-2019 By Melissa Fassbender

Panelist during the opening session of the DIA Annual Meeting last week stressed the need to work collaboratively, bringing patients into the fold as co-creators of clinical trials to ‘create a whole new landscape for research.’

Navitas continues to expand capabilities with ThoughtSphere collaboration

01-Jul-2019 By Maggie Lynch

Navitas Life Sciences taps ThoughtSphere to power its digital and clinical analytics cloud-based clinical data SaaS OneClinical, as the company continues to grow after Kai Research acquisition.

Syneos launches ‘reimagined FSP model for today’s customer challenges’

27-Jun-2019 By Melissa Fassbender

Syneos Health this week unveiled FSP 360, combining the company’s functional service provider experience with its end-to-end capabilities, says EVP.

Phastar taps Medidata’s platform and announces additional global offices

26-Jun-2019 By Maggie Lynch

Phastar expands globally, adding offices in Japan and the US, and enters a partnership with Medidata to transform its increasing data points into insights.

Iqvia launches new eCOA platform to quantify the patient experience

25-Jun-2019 By Melissa Fassbender

Iqvia today launched a new “patient centered endpoints” solution, which captures the patient experience during clinical trials and real world studies, says SVP.

Parexel taps into CluePoints risk monitoring to improve clinical data accuracy

25-Jun-2019 By Maggie Lynch

Parexel and CluePoints to use CSM solutions for preclinical and clinical risk-based monitoring, after regulatory guidelines impact mutual acceptance of data across the US, EU and Japan.

FDA addresses lack of diversity in clinical trials in draft guidance

21-Jun-2019 By Melissa Fassbender

In a bid to increase clinical trial diversity, the FDA published a draft guidance suggesting sponsors rethink exclusion criteria, include children in adult studies when appropriate, use adaptive trials, and make sure other logistical barriers to participation...

Clinical trials center joins ProSciento’s program for NASH trial recruitment

20-Jun-2019 By Maggie Lynch

High Point Clinical Trials Center is partnering with ProSciento to accelerate clinical trial recruitment of patients with NASH and NAFLD.

Surrogate endpoints create potential, require statistical validation

19-Jun-2019 By Maggie Lynch

Transforming statistical data into a surrogate endpoint can enable comprehension of trial results sooner than usual, but few make the cut after formal validation, says drug development expert and DIA panelist.

Through the lens: Examining the opportunities and roles of females in clinical research

19-Jun-2019 By Maggie Lynch

Females as caregivers, clinical trial participants, and biopharma leaders are among the different roles to be carefully considered as the industry aims for increased inclusion, says BBK executive.

Artificial intelligence in drug development predicted to grow: DIA-Tufts study

19-Jun-2019 By Melissa Fassbender

In which areas is artificial intelligence most mature? What are the challenges to widespread adoption? Tufts and DIA recently teamed up to explore these questions.

DIA 2019: Genetics, big data, AI, and separating the hope from hype

19-Jun-2019 By Melissa Fassbender

New this year to the discussion at DIA is the conversation around data ownership, as the industry continues to face a deluge of information from more sources than ever.

LabCorp, Quest Diagnostics data breach under investigation. Did they do enough?

17-Jun-2019 By Melissa Fassbender

Two US Attorney Generals have opened an investigation into the data breach at AMCA that compromised a combined nearly 20 million patients at LabCorp and Quest Diagnostics – as the companies’ efforts to notify the public are called into question.

In the push for innovation, regulators are ahead of the curve as pharma and CROs lag behind

12-Jun-2019 By Melissa Fassbender

As regulators work to advance the modern clinical trial, the risk-averse clinical research industry is falling behind in the race to bring new therapies to patients, says an industry expert, echoing the former FDA commissioner’s calls for innovation.

TrialAssure launches portal for plain language clinical trial summaries

11-Jun-2019 By Melissa Fassbender

TrialAssure’s new online portal enables sponsors to publicly share plain language clinical trial summaries – as the industry faces continued pressure to post study results.

STA Pharma completes clinical supply of PhoenixMD’s breast cancer treatment

10-Jun-2019 By Maggie Lynch

Clinical trial supply for the first targeted treatment of triple-negative breast cancer completed through PhoenixMD and STA Pharmaceutical agreement.

Advarra finds new owner in Genstar Capital

06-Jun-2019 By Melissa Fassbender

Genstar Capital, the private equity firm behind CRF Bracket, is set to acquire Advarra from its current owners, Linden Capital Partners.

Global oncology market is being driven by decades of investment coming to fruition: Iqvia report

05-Jun-2019 By Melissa Fassbender

The global oncology market last year set several records, though the industry continues to struggle with long development timelines, which in 2018 averaged 10.5 years from patent filing to regulatory approval and launch, according to a recent Iqvia report.

Datavant’s Health Data Link acquisition brings together ‘siloed’ worlds

04-Jun-2019 By Maggie Lynch

Datavant acquired Health Data Link to integrate commercial data with research data to create deeper patient insights.

ASCO 2019

Relaxed eligibility criteria would double patient numbers in lung cancer studies: ASCO

04-Jun-2019 By Melissa Fassbender

Broader clinical trial eligibility criteria would double patient numbers in lung cancer studies, according to a new report from ASCO, which has been leading efforts to expand access to oncology clinical trials.

Scientist.com teams up with VC firm to create marketplace for biotech

03-Jun-2019 By Melissa Fassbender

The online marketplace for outsourced R&D services Scientist.com partners with 5AM Ventures to help researchers save time and money – as the industry is "caught between a rock and a hard place," says CEO.

People on the Move: Outsourcing-Pharma roundup May ‘19

31-May-2019 By Melissa Fassbender

This month’s roundup includes the first CFO for CytoReason, a new CEO at Certara and Factory-CRO, as well as an expanded leadership team at BioDuro, among other people on the move in May.

Parexel forms Oncology Center of Excellence

30-May-2019 By Melissa Fassbender

Parexel today unveiled its Oncology Center of Excellence as well as a new “early advisory service” focused on study design, regulatory strategy, and market access.

A ‘best practice’: ACRO, pharma respond to FDA draft guidance as RBM adoption increases

30-May-2019 By Melissa Fassbender

Risk-based monitoring should be described as a “best practice,” says ACRO, which recently released a survey that found the majority of new trial starts in 2018 employed some form of RBM.

England sees highest ever clinical trial participation rates: NIHR

28-May-2019 By Melissa Fassbender

Clinical research in England is growing at a record-setting pace with support from a recent £20.5bn investment to transform service delivery – as the NHS looks to conduct more studies in primary care settings.

SGS’ Glasgow biosafety facility doubles in size

28-May-2019 By Maggie Lynch

SGS’ completed the ₤8.7m expansion of its large molecule testing facility in Glasgow and made room to increase its existing biosafety service and PCR platform capabilities.

Combining capabilities to grow: Navitas acquires KAI Research

23-May-2019 By Maggie Lynch

Navitas has acquired KAI Research to expand its trial site footprint in North America and Africa as well as bolster its ability to manage clinical trials in a number of research areas.

BBK Holdings opens European subsidiary to support clinical trials

21-May-2019 By Maggie Lynch

BBK Holdings, parent company of BBK Worldwide, has established BBK Patient Experience Limited to support patient data protection in clinical trials and add to its footprint in the EU.

Marken taps into innovations to smooth clinical trial supply chain

21-May-2019 By Maggie Lynch

Marken executive says there is no such thing as a perfect clinical trial supply chain but with strategic planning and innovations there are opportunities to better serve the research industry.

WuXi AppTec taps Altasciences to support IND platform

20-May-2019 By Maggie Lynch

Altasciences will work with WuXi AppTec to support its investigational new drug platform designed to manage and accelerate IND applications.

Wasdell acquisition to support outsourced supply chain in Europe

20-May-2019 By Maggie Lynch

Wasdell Group has acquired specialist manufacturer and packager, Honeywood Limited in an aim to build its manufacturing and packaging capacity in the UK to support European supply chain.

Greenphire partners with Lazarex to ease oncology trial reimbursement

14-May-2019 By Maggie Lynch

Lazarex partners with Greenphire to implement the latter’s ClinCard reimbursement technology to improve patient participation in oncology trials.

Inhalation product solutions offering launched by Recipharm

13-May-2019 By Maggie Lynch

Recipharm is launching inhalation product solutions following its acquisition of Sanofi’s inhalation manufacturing business and increased use of inhaled drug products.

Third-party vendors a cybersecurity risk for big pharma?

08-May-2019 By Melissa Fassbender

Increasingly concerned with the potential for cyber attacks at third-party vendors, pharma looks to gain visibility into supplier performance, says industry expert after the recent breach at Charles River.

WuXi adds US-based clinical research firm to CRO business

07-May-2019 By Maggie Lynch

WuXi AppTec acquires Pharmapace to bolster its biometrics and clinical development service offerings worldwide.

Lonza serves small biotech with services to accelerate movement to the clinic

06-May-2019 By Maggie Lynch

Lonza announces service offering to accelerate the movement of poorly-soluble small molecules into first-in-human clinical trials.

People on the Move: Outsourcing-Pharma roundup April ‘19

03-May-2019 By Melissa Fassbender

Synteract adds to its therapeutic centers of development, Sterling Pharma continues growth in the US, and WCG’s site division sees the addition of several executives, among other people on the move this month.

ACRP 2019

Getting out of its own way: How pharma can use tech to transform

02-May-2019 By Maggie Lynch

Debbie Profit, vice president of applied innovation and process improvement at Otsuka Pharmaceuticals addressed ACRP in April and discussed the various technologies that could ‘transform’ the pharmaceutical industry.

Taking a better path: Fair trade data ‘is better data … there’s no question about it’

02-May-2019 By Melissa Fassbender

Hu-manity.co acquires Betterpath in a deal that will see both patients and pharma gain access to some 80% of health care’s “dark data” – information that comes with explicit consent under fair trade practices, which is not only a good ethical posture,...