Regulatory affairs

Clinical research trends include increased emphasis on study design: Advarra

15-Feb-2022 By Jenni Spinner

An expert from the institutional review board services company advises what trends to look for in the clinical trial industry over the course of coming months.

ViiV Healthcare long-acting HIV treatment secures FDA approval

07-Feb-2022 By Jenni Spinner

The HIV-focused pharma company announced the agency has approved Cabenuva for administration as few as six times a year for adults living with the virus.

WORLD CANCER DAY

Global campaign aims to increase equity in cancer care

01-Feb-2022 By Jenni Spinner

On World Cancer Day, the Union for International Cancer Control is launching a three-year campaign with the goal to improve cancer care around the globe.

Biogen promises increased diversity in Phase 4 Aduhelm trial

31-Jan-2022 By Rachel Arthur

Biogen releases further details on how its Phase 4 post-marketing confirmatory study for Alzheimer’s drug, Aduhelm, will run: including increased enrolment and enhanced efforts to encourage diversity.

Altimmune obesity drug candidate lands IND clearance from the FDA

31-Jan-2022 By Jenni Spinner

The pharma firm has announced the agency has approved the company’s investigational new drug application for its Phase II trial of pemvidutide for obesity.

New FDA draft guidance document gets real about RWD use

28-Jan-2022 By Jenni Spinner

A representative from IQVIA discusses the particulars of the US agency’s new draft document and shares what it might mean for clinical trial data evaluation.

SCOPE 2022

Time to change thinking around patient recruitment: Elligo

26-Jan-2022 By Jenni Spinner

A leader from Elligo Health Research (a SCOPE 2022 exhibitor ) discusses flaws in traditional recruitment approaches and offers up some fresh new ideas.

Multi-national studies call for informed approach: Firma Clinical Research

25-Jan-2022 By Jenni Spinner

An expert from the CRO discusses unique challenges associated with running clinical trials that stretch across national boarders and how to conquer them.

FDA approves IND for clinical trial evaluating CBD-based drug

25-Jan-2022 By Jenni Spinner

The agency has given the go-ahead on an IND application for a study evaluating Ananda Scientific’s Nantheia ATL5, a candidate for treating opioid use disorder.

Pfizer: COVID-19 treatment shows promise against omicron variant

18-Jan-2022 By Jenni Spinner

The pharmaceutical company reports studies have demonstrated the main protease inhibitor of Paxlovid maintains in vitro efficiency against the variant.

UK agency opens future of clinical trials to the public

18-Jan-2022 By Jenni Spinner

The Medicines and Healthcare Products Regulatory Agency has released proposals to bolster trials legislation, asking citizens for input on the suggestions.

Europe launches initiative to transform clinical trials

18-Jan-2022 By Rachel Arthur

Regulatory bodies in the European Union have launched an initiative to develop the region as a focal point for clinical research and to better integrate clinical research in the European health system.

AML digital therapeutic lands Breakthrough Device Designation from FDA

17-Jan-2022 By Jenni Spinner

Blue Note Therapeutics has announced the status has been granted to BNT200, a device to treat anxiety and depression in acute myeloid leukemia patients.

WHO grants seal of approval to two new COVID-19 treatments

14-Jan-2022 By Jenni Spinner

The World Health Organization has recommended the drugs for COVID-19 patients, broadening the range of therapies to combat the virus behind the pandemic.

More than ever expected of today’s data managers: IQVIA

13-Jan-2022 By Jenni Spinner

With the amount of available data increasing and technology evolving, says a company leader, the job of data manager is more demanding than ever before.

Expect higher prices, limited availability of materials in 2022: CPhI Worldwide

06-Jan-2022 By Jenni Spinner

In a report outlining predictions for the coming year, the organization advises industry professionals to brace themselves for supply chain challenges.

People on the Move: January 2022

06-Jan-2022 By Jenni Spinner

This month’s news on mergers and acquisitions, hires, and other developments includes notable firms like Altasciences, Protocol First, WuXi STA, and more.

Dogs, VR, and rock stars: OSP’s favorite items of 2021

22-Dec-2021 By Jenni Spinner

It has been a pleasure for the OSP team to connect with a long list of fascinating industry minds and share the stories; here are a few of our favorites.

Purchases, pandemic, and potential treatments: 2021’s greatest hits

22-Dec-2021 By Jenni Spinner

OSP’s list of the year’s most-read stories shows readers are interested in M&A activities, new drug candidates, COVID-19 developments, and other hot news.

2021 year-end wrapup

Industry insights: obstacles, positives, and looking ahead

16-Dec-2021 By Jenni Spinner

Professionals from various corners of the life-sciences field share views on significant challenges of 2021, bright spots, and what to look for in 2022.

2021 year-end wrapup

‘Data transformation’ helping adverse event case processing: IQVIA

16-Dec-2021 By Jenni Spinner

A leader from the company discusses how advanced analytical tools can be put to work to help tackle adverse event case processing and compliance issues.

Pfizer shares more promising results from COVID-19 study

14-Dec-2021 By Jenni Spinner

According to the company, the latest Phase II/III study results show its novel oral treatment candidate is effective in reducing hospitalizations and deaths.

Former biopharmaceutical executives nabbed for insider trading

09-Dec-2021 By Jenni Spinner

The US Department of Justice has charged a former CFO and a former head of corporate communications for allegedly conducting an insider trading scheme.

Decentralized trials dramatically transforming clinical research: ICON

02-Dec-2021 By Jenni Spinner

An expert from the contract research organization discusses the impact decentralized trials have had on the industry, and how that transformation is likely to continue.

Automating safety processes can benefit DCTs: Pharmasol

01-Dec-2021 By Jenni Spinner

A leader from the pharmacovigilance solutions firm discusses the ins and outs managing safety documentation and offers advice on how to deal with them.

Trial recruitment improving more rapidly in some populations than others: Phesi

30-Nov-2021 By Jenni Spinner

Patient data from the clinical solutions company indicates that gains in recruitment of Black participants is outpacing that of patients from other groups.

FDA approves BioMarin drug to treat dwarfism in children

22-Nov-2021 By Jenni Spinner

The US agency has granted approval to Voxzogo, an injectable drug designed to aid growth in children with achondroplasia, the most common form of dwarfism.

Pfizer inks COVID-19 treatment licensing agreement with MPP

16-Nov-2021 By Jenni Spinner

The pact between the drug firm and the group is aimed at giving equitable access to treatments and vaccines for people in disadvantaged parts of the world.

Johnson & Johnson to spin off consumer health business

12-Nov-2021 By Rachel Arthur

Johnson & Johnson has announced its intent to separate its Consumer Health business into a new publicly traded company: allowing J&J to put a sharpened focus on pharmaceuticals and medical devices.

CPHI WORLDWIDE

Pharmaceutical industry confidence on the rise: CPhI Worldwide

09-Nov-2021 By Jenni Spinner

At the open of the global pharmaceutical industry gathering, a survey of executives from around the globe indicates a rosy mood among professionals in the field.

CPhI Worldwide

Expert offers prescription for improving medicine production in Europe

02-Nov-2021 By Jenni Spinner

A leader from Medicines for Europe will share with CPhI Worldwide attendees a look at medicine production and offer solutions for elevating the industry.

CPHI WORLDWIDE

Hybrid CPhI Worldwide 2021 a ‘celebration’ of pharma industry

02-Nov-2021 By Jenni Spinner

The global pharmaceutical industry event is returning to the real world November 9-11 this year, with online content for professionals opting not to travel.

Study coordinator pleads guilty to trial data falsification

01-Nov-2021 By Jenni Spinner

A former employee of Tellus Clinical Research in Miami has admitted to charges related to a conspiracy to falsify data on a list of clinical drug trials.

Gilead, Merck launch Phase II trial evaluating oral regimen for HIV-1 treatment

01-Nov-2021 By Jenni Spinner

The trial will evaluate a weekly regimen of islatravir and lnecapavir in HIV patients who are virologically suppressed while on antiretroviral therapies.

Notre Dame lab partners with Artifacts to halt substandard generics

21-Oct-2021 By Jenni Spinner

The Distributed Pharmaceutical Analysis Lab and the blockchain-based platform provider will work to prevent fake and low-quality drugs from circulating.

Digital revolution transforming drug development: West Pharma

18-Oct-2021 By Jenni Spinner

A leader from the drug development and manufacturing firm talks about the ways in which advanced digital tools stand to revolutionize the pharma field.

AAPS PharmSci 360

PharmSci 360 invites industry pros to ‘rethink and evolve’

14-Oct-2021 By Jenni Spinner

The conference (with online and in-person content) is slated to gather professionals for deep conversations and lively collaboration on important topics.

CDC turns to PointClickCare to gain insights from patient data

12-Oct-2021 By Jenni Spinner

The US agency plans to use the software firm’s Lighthouse technology to improve understanding of COVID-19 and other conditions in long-term care facilities.

Increasing trial diversity ‘top of mind’ for Lilly Oncology

12-Oct-2021 By Jenni Spinner

A leader from the division of Eli Lilly explains the importance of driving greater trial inclusivity, and why collaboration is vital in making progress.

ViiV submits FDA application for pediatric HIV treatment

07-Oct-2021 By Jenni Spinner

The HIV treatment specialist has sent an application to the agency for tolutegravir, a single-tablet treatment indicated for children living with the virus.

People on the Move: October 2021

07-Oct-2021 By Jenni Spinner

This month’s news on appointments, expansions, acquisitions and other events includes Nanoform, Elligo Health Research, Curavit, and other organizations.

Generics price fixing charges land pharma firms $447.2m penalty

05-Oct-2021 By Jenni Spinner

The US Department of Justice reports three generic drug manufacturers have been socked with the hefty fine to resolve alleged False Claims Act violations

When choosing a pharmacovigilance partner, pick a safety-minded CRO

04-Oct-2021 By Jenni Spinner

Leaders from ArisGlobal and Eversana explain the benefits of carefully selecting a research partner with a robust set of capabilities to see a project through.

Merck: COVID-19 oral antiviral drug reduces risk of death

01-Oct-2021 By Jenni Spinner

The pharma firm reports molnupiravir was shown to cut risk of hospitalization or death by 50% compared to placebos in a positive interim Phase III analysis.

Patients want to see more health industry collaboration: survey

30-Sep-2021 By Jenni Spinner

A study by Charles River finds patients believe the overall quality of healthcare would increase if stakeholders across the life sciences collaborated more.

Remarque lands patent for risk-based quality management platform

27-Sep-2021 By Jenni Spinner

The technology is designed to enable connection to any source data system, enabling connectivity in identifying, monitoring, and managing trial risks.

Update on FDA COVID approvals, actions, and advice

24-Sep-2021 By Jenni Spinner

As COVID-19 and its variants continue their attack, the agency maintains its position of overseer and giver of advice on various treatments and vaccines.

Connections, collaboration key to executing global trials: ICON

22-Sep-2021 By Jenni Spinner

A logistics leader from the CRO offers advice on navigating borders, cultures, regulatory issues and other important considerations on worldwide studies.

Rare-disease initiative collaborators work to advance research innovation

16-Sep-2021 By Jenni Spinner

Stakeholders in the Rare Disease Cures Accelerator-Data and Analytics Platform initiative are partnering in hopes of bringing treatments to patients faster.

FDA approves IND application for peanut allergy drug candidate

16-Sep-2021 By Jenni Spinner

The US agency has given the go-ahead to Cour Pharmaceuticals to evaluate the safety and efficacy of CNP-201, a drug intended to treat peanut allergies.