Regulatory affairs

CRAACO

CRAACO tackles ways to strengthen care, patient connection

26-Apr-2021 By Jenni Spinner

The 6th annual Clinical Research as a Care Option conference, taking place April 26-27, brings together experts seeking solutions to elevate the industry.

FDA rebuff for Keytruda in breast cancer indication

30-Mar-2021 By Jane Byrne

A couple of new developments to report in relation to Merck, known as MSD outside the US and Canada: the first being the rejection by the US FDA of the company’s application to use its anti-PD-1 therapy, Keytruda, in certain breast cancer patients.

Rare-disease researchers face unique obstacles: Minoryx

29-Mar-2021 By Jenni Spinner

A representative of the rare-disease specialist firm outlines the unique obstacles of orphan CNS disease research, and how professionals can overcome them.

Amgen v Sanofi ruling: It is time to kiss goodbye to broad, functional patent claims for antibodies

25-Mar-2021 By Jane Byrne

A US court’s recent decision to find in favor of Sanofi and invalidate Amgen's broad antibody patent claims has biotech manufacturers concerned about how to preserve their IP.

CPhI: expect surge in IND applications, FDA approvals by 2025

23-Mar-2021 By Jenni Spinner

A new report from the organization forecasts a wave of pharma innovation over the next four years could lead to 75 FDA drug approvals annually by 2025.

FDA current COVID-19 updates, actions and advice

17-Mar-2021 By Jenni Spinner

As the vaccine goes into the arms of more people around the country, the US agency keeps on top of issues around the virus, offering resources and guidance.

Sagent issues voluntary recall of phenylephrine hydrochloride vials

15-Mar-2021 By Jenni Spinner

The company is recalling 10 mg/mL vials of phenylephrine hydrochloride due to potential lack of sterility assurance in several lots of the product.

US Army taps PPD to conduct PTSD treatment research

04-Mar-2021 By Jenni Spinner

The CRO will receive funding to fuel a five-year Research Project Award, with the goal to design and conduct research of potential PTSD treatment options.

AstraZeneca joins with Care Access Research on COVID-19 antibody trial

23-Feb-2021 By Jenni Spinner

The pharma firm is partnering with the decentralized research organization on a Phase III trial testing a long-acting antibody combination treatment.

Developing vaccines and therapeutics for virus variants: FDA releases new guidance

23-Feb-2021 By Rachel Arthur

The US Food and Drug Administration (FDA) has issued guidance for companies developing vaccines, diagnostics and therapeutics against new variants of SARS-CoV-2.

COVID-19 accelerating RWE use in clinical settings: ConcertAI

16-Feb-2021 By Jenni Spinner

A leader from the clinical data solutions firm explains how the challenges created by the pandemic have helped fuel creativity and innovation in studies.

AHA training aids researchers with heart-to-heart talks

14-Feb-2021 By Jenni Spinner

The American Heart Association’s Heart of Communicating Science modules are designed to help experts break complex talk into easy-to-understand language.

Latest FDA COVID-19 updates and activity

09-Feb-2021 By Jenni Spinner

The federal agency continues to keep researchers, pharma firms and citizens apprised of current happenings and research related to the virus and pandemic.

World Cancer Day

Lung cancer community severely impacted by COVID: report

04-Feb-2021 By Jenni Spinner

A report from the World Economic Forum and Lung Ambition Alliance outlines the impacts the pandemic is having on lung cancer diagnoses and treatment.

Designated ‘Breakthrough Therapies’ draw support from Calyx

28-Jan-2021 By Jenni Spinner

The company’s medical imaging technology and other eClinical solutions reportedly played a part in half of the treatments to receive the FDA designation.

FDA COVID-19 responses and recommendations this week

28-Jan-2021 By Jenni Spinner

As the COVID-19 vaccines continue the early stages of circulation in the US, the agency keeps an eye on industry actions and offers advice to key players.

FDA approves injectable treatment for HIV patients

25-Jan-2021 By Jenni Spinner

The agency has given the thumbs up to ViiV’s once-a-month Cabenuva, the first FDA-approved injectable, complete regimen for adults diagnosed with HIV.

Continuus lands $69.3m US drug manufacturing contract

21-Jan-2021 By Jenni Spinner

The small-molecule pharmaceuticals manufacturer secured a DoD/HHS government contract to manufacture critical medicines for a range of conditions.

COVID-19 a ‘catalyst’ for innovation in 2020: Oracle

18-Jan-2021 By Jenni Spinner

A leader from Oracle Health Sciences examines the dynamic, challenging year and highlights creativity and ingenuity displayed by research professionals.

Widening access to COVID-19 data

18-Jan-2021 By Rachel Arthur

California information technology and services company Syntegra and the National Institutes of Health (NIH) have signed a partnership to 'democratize access to the largest set of COVID-19 patient records': with the use of Syntegra's synthetic...

Fight against pharma counterfeiting must go deeper: TruTag

13-Jan-2021 By Jenni Spinner

A leader from the anti-counterfeit solutions firm says that while packaging-level efforts may have an effect, on-dose technology is worth a closer look.

LA customs agents seize $19m in counterfeit Viagra pills

13-Jan-2021 By Jenni Spinner

Authorities discovered the fake Pfizer erectile-dysfunction tablets in one of three cargo containers full of fraudulent goods, recently arrived from China.

Counterfeit Janssen HIV drug discovered in US pharmacies

13-Jan-2021 By Jenni Spinner

The pharmaceutical firm reports a counterfeit version of its Symtuza HIV treatment has been found and pulled from shelves at three American pharmacies.

FDA COVID-19 weekly action and advice update

13-Jan-2021 By Jenni Spinner

Industry professionals and consumers alike continue to look to the US agency for action, advice and news related to the global COVID-19 response.

Florida doctor pleads guilty to clinical trial data fraud

12-Jan-2021 By Jenni Spinner

A Miami physician has owned up to falsifying research data and patient participation figures for a pediatric asthma trial conducted from 2013 to 2016.

First FDA COVID-19 update of 2021

04-Jan-2021 By Jenni Spinner

As healthcare providers and other high-priority patients begin receiving the vaccines, the agency continues to act to help the national pandemic response.

Looking back, thinking ahead: industry leaders talk trends

16-Dec-2020 By Jenni Spinner

Experts from a variety of research and drug development organizations share their thoughts on highlights from 2020, and predict what 2021 might hold.

2020 was ‘the year our industry got it right’: pharma veteran

16-Dec-2020 By Jenni Spinner

William Carson says while the past year was full of challenges, embracing AI and other advanced technology led to impressive progress and opportunity.

FDA grants orphan status to Rafael Pharmaceuticals cancer drug

10-Dec-2020 By Jenni Spinner

The company’s cancer drug, devimistat, has received orphan status from the agency for treating clear-cell sarcoma, pancreatic cancer, and other diseases.

Current FDA COVID-19 developments

09-Dec-2020 By Jenni Spinner

The agency continues to offer advice, resources and oversight during the pandemic to help develop tests, treatments and other solutions for the virus.

CPhI report looks ahead to post-COVID pharma world

08-Dec-2020 By Jenni Spinner

The industry analysis dives into likely developments in supply chain, impact of the new White House occupant, CDMO growth and other key areas.

Latest FDA COVID-19 news

03-Dec-2020 By Jenni Spinner

As the pandemic continues to impact the globe, the agency has kept busy issuing EUAs for potential treatments, and cited sellers of unapproved treatments.

NIAID kicks off fourth iteration of COVID-19 trial

30-Nov-2020 By Jenni Spinner

The division of the National Institutes of Health has begun enrolling hospitalized patients in a trial investigating various potential COVID-19 treatments.

New EU pharma strategy looks to future-proof healthcare sector, stimulate innovation and boost access to biosimilars and generics

25-Nov-2020 By Jane Byrne

The new EU Pharmaceutical Strategy, adopted today by the European Commission, is designed to improve and accelerate patients’ access to safe and affordable medicines and address unmet medical needs in the areas of antimicrobial resistance, cancer, and...

Advarra acquires Longboat

25-Nov-2020 By Jenni Spinner

The clinical site services provider continues its series of strategic company purchases by bringing the Irish trial technologies firm under its umbrella.

FDA grants EUA for combo COVID-19 treatment

23-Nov-2020 By Jenni Spinner

The agency has given the go-ahead for use of baricitinib in conjunction with remdesivir for treating patients hospitalized with severe cases of the virus.

FDA COVID-19 news roundup this week

18-Nov-2020 By Jenni Spinner

The federal agency has offered updates, advice and action regarding the COVID-19 pandemic, helping life-sciences professionals stay on top of developments.

Latest FDA updates on COVID-19 battle

12-Nov-2020 By Jenni Spinner

As the pandemic maintains a grip on the globe, the federal agency continues to offer advice and take action to guide life-sciences professionals.

NIH: hydroxychloroquine no use to hospitalized COVID-19 patients

10-Nov-2020 By Jenni Spinner

Preliminary results from a recent clinical trial indicate the drug touted by US leaders as a possible treatment offers no significant benefit to patients.

DARPA selects continuous manufacturing partner

04-Nov-2020 By Jenni Spinner

The agency has chosen Continuity Pharma to aid in development and advancement of continuous manufacturing technology, with the help of a $1.5m grant.

CRAACO 2020

Elligo: clinical trials can learn from healthcare

30-Oct-2020 By Jenni Spinner

During the CRAACO conference, a leader from the study solutions firm will discuss how researchers can learn and benefit from the other industry.

FDA COVID-19 advice and announcements this week

28-Oct-2020 By Jenni Spinner

The latest coming from the agency includes word of the first FDA-approved treatment for the virus, template for test developers and other resources.

Saama introduces ASAP pharmacovigilance platform

27-Oct-2020 By Jenni Spinner

Built with Gilead, the RWD-based technology is designed to offer pharma firms and research partners a more effective way to verify product safety.

FDA okays first COVID-19 treatment

26-Oct-2020 By Jenni Spinner

The agency has approved the antiviral drug Veklury (remdesivir), produced by Gilead, for hospitalized patients 12 years and over diagnosed with the virus.

BARDA enlists Current Health in COVID-19 monitoring

22-Oct-2020 By Jenni Spinner

The collaboration will target signs of early deterioration in patients, and predict infection severity to let caregivers know when to escalate care.

NIH kicks off COVID-19 immune modulator trial

21-Oct-2020 By Jenni Spinner

The US agency has launched a large clinical trial to examine the viability of using immune modulators to treat patients hospitalized with COVID-19.

WuXi AppTec: think ahead when dual-filing IND applications

20-Oct-2020 By Jenni Spinner

A leader from the company advises planning ahead when filing investigational new drug applications to avoid wasting time, work and money later.

COVID-19 response makes NZ an appealing trial destination

20-Oct-2020 By Jenni Spinner

A leader from a New Zealand-based CRO talks about the country’s handling of the pandemic, and how their low rates are making sponsors take notice.

CPhI Festival of Pharma

CPhI Pharma Awards recognize industry achievements

19-Oct-2020 By Jenni Spinner

The 17th annual awards program, announced during the CPhI Festival of Pharma virtual event, hails professionals from various aspects of the industry.

WHO: remdesivir shows little effect on COVID-19

19-Oct-2020 By Jenni Spinner

The agency’s Solidarity Therapeutics Trial examined a range of drugs repurposed for COVID-19 treatment, finding nearly no effect on patient mortality.