Regulations

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.

Personalized medicine supply chain highly complex: Marken

26-Jul-2021 By Jenni Spinner

A clinical trial logistics expert discusses specialized concerns involved in transporting cell and gene products and other personalized medicine items.

Wave of acquisitions hits pharma industry this week

15-Jul-2021 By Jenni Spinner

The past several days have seen a relatively large number of industry acqusitions, with Lilly, Phillip Morris, WCG, CTI and others making notable buys.

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.

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.

CPHI NORTH AMERICA

Look for ‘supercharged’ collaboration in coming months: CPhI

28-Jun-2021 By Jenni Spinner

As the industry begins coming out of the COVID-19 pandemic, experts advise keeping an eye on growth and partnership opportunities in the US pharma market.

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.

DCAT Week 2021 to take on industry education, innovation

24-Jun-2021 By Jenni Spinner

The annual event (scheduled July 12-16 online) will feature educational sessions, presentations, and networking opportunities for drug manufacturing pros.

Tech Innovations: June 2021

23-Jun-2021 By Jenni Spinner

This month’s roundup of new equipment, materials, tech partnerships and other news includes items from Ajinomoto, Evonik, Quanticate, Pharmasol, and more.

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.