Regulatory affairs

CPHI Pharma Award finalists announced

26-Oct-2022

The awards cover innovations spanning the full pharmaceutical supply chain and feature many of pharma’s biggest names and breakthrough companies.

Industry body points to ‘clear and serious threat’ to clinical research in UK

26-Oct-2022 By Ben Hargreaves

The ABPI releases a report that shows the number of clinical trials taking place in the UK fell by a large amount between the years 2017 and 2021.

Heron scoops approval for IV postoperative nausea treatment

24-Oct-2022 By Ben Hargreaves

Heron Therapeutics receives approval for its intravenous (IV) injection version of aprepitant, which had previously only been delivered orally.

Use of RWE, AI elevating drug development: Sidley

12-Sep-2022 By Jenni Spinner

A fleet of legal professionals offers advice and perspective on important considerations when harnessing artificial intelligence and real-world evidence.

Precision delivery device offers hope for menstrual migraine patients

08-Sep-2022 By Jenni Spinner

Impel Pharmaceuticals’ Trudhesa treatment, paired with its Precision Olfactory Delivery system, reportedly shows promise to women suffering from the condition.

DiMe releases digital health resources for atopic dermatitis endpoint

08-Sep-2022 By Jenni Spinner

The Digital Medicine Society is offering a library of resources to help promote the use of nocturnal scratch as an endpoint for the troubling skin condition.

Patient-centric approach benefits more than the patient: Quanticate

06-Sep-2022 By Jenni Spinner

A representative from the biometric contract research organization explains how taking a ‘patient comes first’ attitude can lead to a range of improvements.

Syneos joins with physIQ, InCarda on atrial fibrillation study

30-Aug-2022 By Jenni Spinner

The physIQ monitoring platform will be used to evaluate an inhaled treatment, developed by InCarda, that is intended to treat atrial fibrillation patients.

Cutting ‘pain points’ can streamline chemical reporting: ACD/Labs

30-Aug-2022 By Jenni Spinner

A representative from the R&D tech provider offers advice on how to wrangle with a stressful, complicated process for better results and fewer headaches.

Impel Pharmaceuticals reports progress with ASD-related drug trial

29-Aug-2022 By Jenni Spinner

The company reports dosing of the first subject in a Phase IIa proof-of-concept study investigating a drug for an autism spectrum disorder related condition.

NIH awards SBIR grant to AVM for lymphoma drug research

25-Aug-2022 By Jenni Spinner

The National Institutes of Health grant to AVM Biotechnology will be used to evaluate a drug to treat non-Hodgkin’s lymphoma combined with standard of care.

BMS expands precision oncology portfolio with Turning Point acquisition

18-Aug-2022 By Jenni Spinner

The pharmaceutical company has completed acquisition of Turning Point Therapeutics, a company specializing in precision medicine solutions for cancer patients.

Parkinson’s monitoring tech advances in NICE approval process

16-Aug-2022 By Jenni Spinner

The National Institute for Health and Care Excellence is weighing the viability of PD Neurotechnology’s PDMonitor system for Parkinson’s disease patients.

Alzheimer’s research data questioned by Department of Justice

09-Aug-2022 By Jenni Spinner

After scientists and reporters raised red flags about a study, Cassava Sciences is being accused of falsifying data in pursuit of an Alzheimer’s treatment.

Pfizer to acquire sickle cell disease specialist for $5.4b USD

08-Aug-2022 By Jenni Spinner

Biopharmaceutical company Global Blood Therapeutics specializes in conditions that often disproportionately impact underrepresented communities, such as SCD.

Medical specialty societies can benefit from regulatory progress: IQVIA

04-Aug-2022 By Jenni Spinner

An expert from the trial tech firm explains how the 21st Century Cures Act and other recent regulatory advancements can elevate clinical data registries.

GCP update: advice on what to expect and how to prepare

01-Aug-2022 By Jenni Spinner

With updates to the Guideline for Good Clinical Practice Advancements on the horizon, an industry expert offers some perspective on what might be ahead.

Incorporating patient voice elevates rare-disease trials: Casimir

28-Jul-2022 By Jenni Spinner

During the World Orphan Drug Congress, a co-founder of the CRO outlined how patient perspective can be vital to better results in rare-disease research.

Cancer Moonshot meeting brings together survivors, industry leaders

26-Jul-2022 By Jenni Spinner

The gathering, convened by patient advocacy group Fight Colorectal Cancer, responded to President Biden’s call to improve screening and treatment options.

Patient advocacy foundation holds listening session with FDA

19-Jul-2022 By Jenni Spinner

The Foundation for Sarcoidosis Research hosted more than 50 agency leaders in a session that addressed patient concerns in research, care, and diagnosis.

Patient voice, empathy key to pediatric study design: ICON

18-Jul-2022 By Jenni Spinner

A pediatric clinical trial expert from the CRO discusses the unique challenges involved in designing a study when the patients involved are little ones.

Online event centers on decentralized study solutions

18-Jul-2022 By Jenni Spinner

Taking place July 20, the Decentralized Trial Technology webinar will share insights and experiences from a group of knowledgeable virtual trial experts.

Precision medicine advancements good news for drug development

12-Jul-2022 By Jenni Spinner

A leader from healthcare commercial intelligence company Definitive Healthcare discusses the rise of precision medicine and the benefits the field can yield.

Tech advances making decentralized trial growth possible: ICON

11-Jul-2022 By Jenni Spinner

In this second of a two-part series, a leader from the CRO discusses the types of technologies supporting DCTs and what might lie on the horizon for the field.

Building resilience into biotech supply chains: 'COVID-19 will not be the last major crisis of the 21st century'

08-Jul-2022 By Rachel Arthur

Biotech supply chains face an uncertain future in 2022 and beyond: up against myriad challenges ranging from future pandemic outbreaks to geopolitical tensions – and, indeed, unforeseen threats. Communication and collaboration between policymakers and...

Phesi analysis highlights extent of cancer trial inclusion issues

07-Jul-2022 By Jenni Spinner

The latest indepth report from the AI-centric analytics provider reveals nearly half of US cancer clinical studies enroll no Latino patient participants.

Decentralized clinical trial transformations are ‘here to stay’: ICON

06-Jul-2022 By Jenni Spinner

In this first of a two-part series, an expert discusses various factors behind the DCT format’s rapid rise and likely longevity in the drug development arena.

Indiana University Health enlists LifeOmic platform for cancer research

06-Jul-2022 By Jenni Spinner

The academic research center has adopted the life science technology company’s cloud-based platform for cancer research, drug discovery, and clinical trials.

Eli Lilly gets speedy NICE recommendation for breast cancer treatment

06-Jul-2022 By Jenni Spinner

England's cost-effectiveness watchdog has recommended Eli Lilly’s Verzenios treatment as an option for adjuvant treatment of certain forms of breast cancer.

Intelligent eCOA use enhances trials, amplifies patient voice: Medable

28-Jun-2022 By Jenni Spinner

An expert from the decentralized trial solutions company shares how eCOA and ePRO can be useful tools that improve the collection and quality of such data.

Janssen invests $5m in Stand Up To Cancer’s health equity effort

27-Jun-2022 By Jenni Spinner

The sponsorship from Janssen Pharmaceutical Companies will be used by the cancer support network to boost diversity in Phase I and Phase 2 clinical trials.

HistoSonics hits enrollment target en route to FDA filing for liver cancer therapy

22-Jun-2022 By Nick Taylor

The company reports it has met the enrollment target for a trial of its sonic beam therapy, one step closer to submitting for FDA approval of the product.

BIO research outlines risks in changing accelerated approval pathway

21-Jun-2022 By Rachel Arthur

If new restrictions are placed on the FDA’s Accelerated Approval pathway, as many as two thirds of the treatments that use this pathway would never reach patients, according to research released at the BIO International Convention last week.

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Pandemic highlights need for supply chain visibility, partnerships

14-Jun-2022 By Jenni Spinner

During BIO International, US leaders shared lessons learned from COVID-19, and how government and industry are collaborating to avoid future supply chain crises.

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BIO panel takes on patient recruitment, retention challenges

09-Jun-2022 By Jenni Spinner

Representatives from Clincierge, Rare Patient Voice, Insight and Measurement, and Ultragenyx Pharmaceutical will lead the lively panel discussion on June 13.

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DIA offers tracks to deliver focused educational experience

08-Jun-2022 By Jenni Spinner

Offering 13 topic tracks to choose from, the DIA Global Annual Meeting (scheduled June 19-23) lets attendees chose the path that fits their unique interests.

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Can the industry elevate the success rate of cancer trials?

07-Jun-2022 By Jenni Spinner

During the upcoming BIO International Convention, experts from CerFlux, the MD Anderson Cancer Center, and Aga Khan University will weigh in with insights.

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BIO International 2022 to bring insights, athletes to San Diego

06-Jun-2022 By Jenni Spinner

Coming back to the real world June 13-16, the industry event will offer face-to-face learning, networking opportunities, and fun, star-studded opportunities.

Sanofi hemophilia A drug lands breakthrough therapy designation

06-Jun-2022 By Jenni Spinner

Efanesoctocog alfa is an investigational factor III therapy designed to prevent bleeds and bleeding episodes in patients diagnosed with the rare disorder.

Danish National Genome Center, Lifebit form personalized medicine partnership

01-Jun-2022 By Jenni Spinner

The Lifebit CloudOS will be employed to create a Federate Trusted Research Environment within the center’s supercomputing cluster to handle data management.

How Lithuania aims to become a leading European biotech hub

01-Jun-2022 By Ben Hargreaves

Lithuania’s life sciences industry is growing at one of the fastest rates in Europe. Ahead of BIO, Innovation Agency Lithuania explains what the country’s plans are for future growth in the area and how this is built upon students heading into STEM studies.

Digital health initiative offers resources to increase inclusivity

25-May-2022 By Jenni Spinner

The DATAcc has released a collection of open-access resources that are intended to help users build inclusivity into digital health measurement products.

Virtual care tech firm Biofourmis lands $300m vote of confidence

24-May-2022 By Jenni Spinner

The digital medicine solutions developer has received $300m in a Series D investment round, which will be used to help scale up its virtual care offerings.

Regeneron and Sanofi’s Dupixent FDA-approved for eosinophilic esophagitis

23-May-2022 By Jenni Spinner

The approval is the first that the Food and Drug Administration has granted for a drug intended to treat eosinophilic esophagitis, a chronic immune disorder.

NIH awards $577m to antiviral drug developers

20-May-2022 By Rachel Arthur

The National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health, has awarded a total of $577m to establish nine Antiviral Drug Discovery (AViDD) Centers for Pathogens of Pandemic Concern.

Lilly deploys AI-powered tech to expedite drug approval process

18-May-2022 By Jenni Spinner

The pharmaceutical company is partnering with Yseop to install the software company’s Augmented Analyst, designed to elevate and accelerate data analysis.

FDA lifts clinical hold on Gilead’s investigational HIV treatment

17-May-2022 By Jenni Spinner

The agency has removed the hold placed on the pharmaceutical company’s IND for injectable lenacapavir, which is intended for HIV treatment and prevention.

Collaboration, communication can benefit patient advocacy groups: IQVIA

12-May-2022 By Jenni Spinner

Leaders from the biotech company share advice on how such organizations can make the most of often limited resources via smart strategy and collaboration.

AstraZeneca metastatic breast cancer treatment secures FDA approval

10-May-2022 By Jenni Spinner

The US agency has approved Enhertu for patients diagnosed with HER2-positive metastatic breast cancer previously treated with an anti-HER2-based regimen.

FDA outlines benefit-risk approach to drug or biologic product quality assessment

10-May-2022 By Jane Byrne

The US FDA released new draft guidance yesterday discussing, among other challenges, how unresolved product quality issues might be addressed in the context of regulatory decision-making.