News

FDA Places Clinical Hold on BioMarin’s Phase I/II Gene Therapy Study

September 09, 2021

FDA placed a clinical hold on the BMN 307 Phearless Phase I/II study, which was evaluating an investigational PAH gene therapy in adults with PKU.

Thermo Fisher to Establish Single-Use Technology Site in US

September 09, 2021

Thermo Fisher Scientific plans to expand its Nashville, Tenn., site by establishing a dedicated single-use technology manufacturing facility at the site, doubling capacity.

Impel NeuroPharma Gets FDA Approval for Nasal Spray Migraine Treatment

September 09, 2021

Impel Neuropharma’s Trudhesa, a nasal spray, received FDA approval for treating migraines in adults with and without aura.

FDA Launches Novel Excipient Review Pilot Program

September 07, 2021

The Novel Excipient Review Pilot Program will allow excipient manufacturers to obtain FDA review of certain novel excipients prior to use in drug formulations.

Polaryx Therapeutics Receives FDA Orphan Drug Designation for PLX-200 for Treatment of Krabbe Disease

September 07, 2021

Orphan drug designation for Polaryx’s PLX-200 will facilitate research into its use treating Krabbe Disease, a rare lysosomal genetic disorder.

Thermo Fisher Scientific to Expand Pipette Tip Manufacturing Under $192.5 Million Government Contract

September 03, 2021

The US government has granted Thermo Fisher Scientific a $192.5 million contract that the company will use to expand domestic manufacturing for pipette tips.

Setting a Clear Strategy for Primary Packaging

September 03, 2021

Alternative materials, as well as supply-chain planning, are essential to ensure a reliable supply for parenteral drug packaging.

Getting a Nose for Vaccines

September 03, 2021

The intranasal route of administration is showing clinical promise, particularly for COVID-19, but there are multiple hurdles to overcome to ensure successful formulation.

Diffusion Pharmaceuticals Announces FDA Clearance of IND Application for TSC

September 02, 2021

FDA clearance of trans sodium crocetinate allows Diffusion to proceed with their latest Phase II oxygenation trial.

Element Acquires Impact Analytical

September 02, 2021

Element’s acquisition of Impact Analytical expands their life sciences footprint in North America.