Regulatory affairs

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.

NIH offers $185m to further understanding of the human genome

13-Sep-2021 By Jenni Spinner

The US medical research agency plans to offer funding over five years through a newly launched consortium, expected to include 30 sites across the country.

Pfizer, Myovant announce sNDA review for endometriosis treatment

13-Sep-2021 By Jenni Spinner

The two companies are collaborating on development of Myfembree, a combination therapy to treat the painful condition affecting millions of women worldwide.

Recent FDA COVID-19 actions and updates

10-Sep-2021 By Jenni Spinner

The US agency continues to oversee vaccine and drug development, and to share information and advice for life-sciences professionals and civilians alike.

GSK rhinosinusitis drug receives thumbs up from the FDA

09-Sep-2021 By Jenni Spinner

Nucala, a monoclonal antibody indicated for patients with chronic rhinosinusitis with nasal polyps, has been approved by the Food and Drug Administration.

Patient-centric mindset can enhance international trials: Medable

08-Sep-2021 By Jenni Spinner

Two leaders from the decentralized trial solutions provider discuss the complex pieces of a global clinical study and how to work to fit them all together.

Biomarker panel to elevate prostate cancer diagnostics: Berg

07-Sep-2021 By Jenni Spinner

The clinical-stage biotech firm and a number of high-profile partners have collaborated on biomarker technology to deliver a more accurate, less invasive option.

People on the Move: September 2021

02-Sep-2021 By Jenni Spinner

This month’s news on new hires, board launches, acquisitions, and other important news includes items on Pfizer, Javara, Clinical Ink, and other companies.

Johnson & Johnson pulls HIV vaccine trial in Africa; but pledges to continue with Phase 3 Mosaico study

01-Sep-2021 By Rachel Arthur

Johnson & Johnson has announced results from the primary analysis of its Imbokodo Phase 2b HIV vaccine clinical trial, with data showing the investigational HIV vaccine candidate did not provide sufficient protection against HIV infection. A Phase...

Study: cancer patients frustrated with slow rate of treatment innovations

31-Aug-2021 By Jenni Spinner

Cota has released a survey revealing about two-thirds of cancer patients and their families are unsatisfied at the speed of cancer treatment development.

WashU report highlights vulnerabilities in US pharma supply chain

24-Aug-2021 By Jenni Spinner

According to the study, the country’s overreliance on pharmaceutical ingredients manufactured in overseas factories threatens national security and health.

MMS support program to help ultra-rare disease research

24-Aug-2021 By Emily Jarecki

The CRO has launched an initiative that offers help navigating regulatory issues for ultra-rare disease patient advocacy groups that demonstrate a need.

Inflammasome develops combo HIV/birth control implant

23-Aug-2021 By Jenni Spinner

Thanks in part to grants from the Gates Foundation, the company has come up with a bioerodible implant that combines HIV prevention and birth control.

Latest COVID-19 updates from the FDA

19-Aug-2021 By Jenni Spinner

The US Food and Drug Administration continues to review potential preventatives and treatments for the virus, and to offer advice to life-sciences professionals and civilians alike.

Tech Innovations: August 2021

17-Aug-2021 By Jenni Spinner

This month’s roundup of equipment, decentralized technology, partnerships and other items includes news from Medidata, PerkinElmer, Syneos and other firms.

WHO COVID-19 trial moves ahead with three drug candidates

12-Aug-2021 By Jenni Spinner

The World Health Organization’s Solidarity PLUS trial will kick off in 52 countries, trialing three drugs to treat patients hospitalized with COVID-19.

Current FDA COVID-19 related actions and advice

11-Aug-2021 By Jenni Spinner

The US Food and Drug Administration has kept its staff busy with approvals, authorizations, and warnings related to various coronavirus-centered products.

Philip Morris acquires another inhaled-drug pharma firm

10-Aug-2021 By Jenni Spinner

The US-based company continues its move away from smoking products with the purchase of drug developer OtiTopic, as part of its Beyond Nicotine initiative.

Pharmaceutical industry must fix broken supply chain: Phlow

03-Aug-2021 By Jenni Spinner

A leader from the company says to ensure medicines keep reaching the patients that need them, the industry must revamp outdated technologies and techniques.

AstraZeneca lupus treatment Saphnelo obtains FDA approval

02-Aug-2021 By Jenni Spinner

The drug, intended for adult patients with moderate-to-severe systemic lupus erythematosus, is the only new therapy approved for SLE in more than a decade.

Navigating regulatory landscape tough for topical generics: MedPharm

29-Jul-2021 By Jenni Spinner

A leader from the topical solutions centered CDMO discusses the differences between approaches by the FDA and EMA, and how to deal with them effectively.

FDA grants Breakthrough Device designation to digital therapeutic

29-Jul-2021 By Jenni Spinner

The BiovitalsHF, from Biofourmis, is intended to augment decision-making in clinical environments, and to supplement traditional pharmaceutical therapies.

Recent FDA actions and responses on COVID-19 pandemic

26-Jul-2021 By Jenni Spinner

The US Food and Drug Administration has stayed on top of developments around the pandemic, including research into potential vaccines and treatments.

WHO issues position statement on TB clinical trial design

19-Jul-2021 By Jenni Spinner

The World Health Organization hopes to encourage the development of novel therapies for tuberculosis by spotlighting key clinical study characteristics.

Biden executive order could impact pharmaceutical industry

13-Jul-2021 By Jenni Spinner

US President Joe Biden singled out the pharmaceutical industry in his recently issued Executive Order on Promoting Competition in the American Economy.

ReiThera’s COVID-19 vaccine looks to Phase 3 trial after preliminary Phase 2 data

12-Jul-2021 By Rachel Arthur

Antibody responses against the SARS-CoV-2 spike protein were found in 99% of volunteers after the second dose of ReiThera’s COVID-19 vaccine candidate, according to Phase 2 preliminary data.

WHO tuberculosis guidelines expanded to include Roche diagnostics

12-Jul-2021 By Jenni Spinner

The agency’s effort to fight the deadly disease now includes taps the pharma company’s testing tools to help speed up diagnosis and grow treatment access.

FDA lead calls for independent inquiry into Biogen drug approval

12-Jul-2021 By Jane Byrne

Acting US FDA commissioner, Janet Woodcock, has called for an independent federal review of interactions between officials at her agency and representatives of Biogen, prior to the recent approval of the pharma company’s treatment for Alzheimer’s disease....

Rare disease specialists talk resources, research and hope

09-Jul-2021 By Jenni Spinner

During the Rare/Orphan Diseases, Special Patient Population webinar, a group of industry experts discussed challenges and opportunities faced in the field.

Brace yourselves for clinical trial guideline update: Remarque Systems

01-Jul-2021 By Jenni Spinner

A leader from the trial management specialist says sites and sponsors prepare for International Council for Harmonization guideline changes on the horizon.

Recent FDA COVID-19 actions and updates

25-Jun-2021 By Jenni Spinner

The agency has been busy with actions related to the virus behind the pandemic, keeping an eye on vaccinations, emerging variants, and other concerns.

Athira Pharma CEO on leave following alleged ethics violations

18-Jun-2021 By Jenni Spinner

The current COO will assume leadership of the neuro-focused pharma firm while the company board investigates questions on Leen Kawas’s doctoral research.

Australia, NZ appealing to clinical researchers: Greenphire

14-Jun-2021 By Jenni Spinner

Thanks in part to swift COVID-19 response and relatively low infection rates, more sites and sponsors are looking at the region to locate their studies.

BioCelerate, FDA forge nonclinical data partnership

10-Jun-2021 By Jenni Spinner

The two organizations have formed a public-private partnership aimed at improving nonclinical research through better practices and standardization.

Update on FDA COVID-19 activity, advice, and action

08-Jun-2021 By Jenni Spinner

The US agency’s latest actions and advice against the virus include information on test recalls, , approval and reauthorization of treatments, and more.

FDA approves Biogen’s Alzheimer's drug, Aduhelm

07-Jun-2021 By Rachel Arthur

The US Food and Drug Administration (FDA) has approved Biogen’s Aduhelm (aducanumab) for the treatment of Alzheimer’s: making it the first new treatment approved for the disease since 2003.

Novo Nordisk weight-management drug lands FDA approval

07-Jun-2021 By Jenni Spinner

The pharmacy company's Wegovy (semaglutide) is the first therapy designated for chronic weight management that the agency has granted approval since 2014.

Group unites industry leaders to streamline digital clinical solutions

04-Jun-2021 By Jenni Spinner

The Digital Health Measurement Collaborative Community is bringing together stakeholders to improve approaches and technologies in research and healthcare.

Verily hires former FDA leader to head clinical research platforms

04-Jun-2021 By Jenni Spinner

The life-sciences data outfit has chosen former FDA principal deputy commissioner Amy Abernethy to serve as president of its clinical research business.

KU Cancer Center forges SIP partnership with Complion

03-Jun-2021 By Jenni Spinner

The University of Kansas Cancer Center has joined with trial tech provider Complion to develop a shared investigator platform for use in a range of studies.

BIO DIGITAL 2021

BIO Digital lands at a time of ‘unprecedented industry collaboration’

02-Jun-2021 By Jenni Spinner

The online pharma event will address the COVID-19 pandemic’s impact on the industry (and vice versa) and innovation in the face of formidable challenges.

BIO DIGITAL 2021

BMS drug Opdivo lands FDA approval for gastro cancers

02-Jun-2021 By Jenni Spinner

The therapeutic has been approved as an adjuvant treatment for varieties of esophageal cancers in patients who have received neoadjuvant chemoradiotherapy.

Special Edition: BIO DIGITAL 2021

‘HIV remains a pandemic of inequalities’: The fight against HIV/AIDS, 40 years on

02-Jun-2021 By Rachel Arthur

June 2021 marks the 40th anniversary of the publication of the first reported cases of AIDS in the US. A session at BIO Digital – featuring Dr. Anthony Fauci, Director of NIAID at the NIH – will focus on four decades of innovation as well as the critical...

COVID-19 pandemic fueled growth for CDMO market: CPhI Discover

27-May-2021 By Jenni Spinner

A panel of experts at the online pharma event discussed how the pandemic created opportunities for the field but could also lead to significant challenges.