Industry News

The NECC supervisory pharmacist at the center of the 2012 fungal meningitis outbreak was sentenced to 8 years in prison.

The President described US drug costs as unfair and stated that prices will come down.

Federal agencies have partnered to develop a roadmap that offers a new framework for the safety testing of drugs and chemicals without the use of animals.

A collaboration between The Centre for Process Innovation and The Roslin Institute aims to develop commercially viable and scalable methods of producing biologics using transgenic animals.

FDA Commissioner Scott Gottlieb says FDA is committed to meet the challenges faced by the saline shortage during an aggressive flu season.

FDA and industry weigh broader use of prior knowledge in biotechnology testing and production.

A manufacturing disruption has led to an EpiPen shortage in Canada, which currently has no alternative auto-injectors available on the market.

EMA will be using temporary premises in the city while construction of the new building takes place, which is not ideal because it requires moving the agency's headquarters twice.

The agencies sent warning letters to several companies that the agencies say are illegally marketing unapproved products to treat opioid addiction and withdrawal.

The latest continuing resolution funds the government for three weeks.

The funding from the Walloon Region will enable Univercells to start developing a manufacturing platform aimed at driving down costs of biosimilars manufacturing.

The FDA center released its list of planned guidance documents for the rest of the year.

The agency is sending a survey out to pharmaceutical companies in the UK to gain information on their preparedness for Brexit.

Non-essential activities and new regulatory submissions are on hold until a federal government funding agreement is reached.

Frustrated with chronic shortages and high costs, hospitals form their own generic drug company.

Researchers at Purdue University and and industry experts have partnered up at the Advanced Lyophilization Technology Hub to optimize the 70-year-old freeze-drying process.

The company has expanded its voluntary nationwide recall to include a second lot of Nexterone injection. This recall is due to particulate matter found in the product.

FDA is monitoring the IV fluid shortage occurring due to Hurricane Maria and is asking companies to submit data for the possibility of extending expiration dates.

The two agencies have launched a program to develop safe and effective medical products to be used by American military personnel.

The agency has expanded the indication of AstraZeneca’s anti-cancer drug to include treatment for breast cancer with a certain inherited genetic mutation.

A new target for the treatment of multiple myeloma using CAR-T technology was discovered by researchers at Osaka University.

An antibody-based Zika virus therapeutic that protected monkeys from infection might be safe enough for administration to pregnant women.

The 2018 Short Course program at Pittcon, taking place Feb. 24–Mar. 1, will feature 23 new short courses geared towards laboratory professionals.

The company will use funding from the Bill & Melinda Gates Foundation to develop a new production method for artemisinin, a therapeutic used to treat malaria.

The agency is requiring safety label changes to limit the use of prescription opioid cough and cold medicines in children younger than 18 years old.

Will Alex Azar’s experience in the pharmaceutical industry help or hurt the initiative to keep medications affordable?

FDA Commissioner Gottlieb expects that the saline and amino acid drug shortages from Puerto Rican manufacturing facilities will improve in the early part of 2018.

FDA noted in a recent inspection that American CryoStem was receiving and processing adipose tissue into a product called Atcell, and then marketing the product without agency approval.

The company is voluntarily recalling product because of glass particles found in vials.

The IFPAC annual meeting on advancing the understanding and control of manufacturing processes using process analytical technology will be held Feb. 11-14, 2018.