Industry News

The company is recalling one lot of Mycophenolate Mofetil for Injection, USP because of glass fragments found in a vial after reconstitution.

Dengvaxia is the first FDA-approved vaccine for dengue disease caused by all dengue virus serotypes for individuals ages 9 through 16 who have laboratory-confirmed previous dengue infection and who live in endemic areas.

The company is recalling one lot of Ketorolac Tromethamine Injection, USP, 60mg/2mL because of a lack of sterility assurance.

The agency recommended marketing authorization for two orphan drugs and treatments for opioid dependence, HIV, cancer, and more.

Intertek has announced the expansion of its pharmaceutical services laboratory in Melbourn, near Cambridge, UK, through the acquisition of a new 20,000 sq. ft facility.

Biocatalysts, a global biotechnology company, has announced it has been named as one of the winners of the Queen’s Awards for Enterprise in Innovation.

University of Southern California scientists have made an advancement in chimeric antigen receptor (CAR) T-cell therapy that seems to eliminate its severe side effects, making the treatment safer and potentially available in outpatient settings.

CDER Director Janet Woodcock is finalizing this more streamlined approach process for evaluating new drugs to handle the surge in drug application submissions.

The agency provides recommendations for the development of bispecific antibody development programs that include regulatory, quality, nonclinical, and clinical considerations.

AstraZeneca and MSD have announced the EC's approval of Lynparza (olaparib) as a monotherapy in the treatment of advanced or metastatic breast cancer.

Former US Senator Jeff Flake and Brandon Allgood, PhD, will be the keynote speakers at the 2019 installment of CPhI North America, in Chicago, IL.

Sharpless will seek further solutions to the opioid crisis and work to reduce cigarette use in adults and kids.

The program and speakers for CPhI North America’s third Women in Leadership Forum have been announced, happening on Thursday, May 2 from 8:00am–11:00am in Chicago, IL.

FDA sent a warning letter to RIJ Pharmaceutical LLC after an inspection of the company’s Middletown, NY facility found CGMP violations.

The agency sent a warning letter to Luen Fook Medicine Sdn., Bhd. for CGMP violations found at the company’s Malaysia facility.

The partnership includes a $10,000 donation to fund Illinois Biotechnology Innovation Organization (iBIO) STEM programming for girls in grades three through eight.

EMA is evaluating the safety of Lemtrada (alemtuzumab) after new side effects were reported.

Brexit has the potential to rumble on until Oct. 31, 2019 as the UK is granted a further six-month extension by European Union leaders.

The European Medicines Agency weighs in on the role of regulators in determining added benefits of novel therapies.

Concerto HealthAI’s real-world data and artificial intelligence capabilities are expected to accelerate outcomes studies and patient insights for Pfizer’s investigational therapies and commercialized therapeutics.

From April 1, 2019 non-pharmacovigilance fees that applicants and marketing authorization holders need to pay to the European Medicines Agency (EMA) have increased by 1.7%.

A look at the Univercells' NevoLine bio manufacturing platform, which incorporates principles of automated and continuous bioprocessing.

Globally accepted products are becoming increasingly in demand, leading to more need for regulatory harmonization, particularly for biosimilars.

ABPI has asked for a temporary ban to be put in place on drug exports by wholesalers to protect the National Health Service (NHS) from potential shortages in a ‘no-deal’ Brexit scenario.

NJII and Pall collaborate to address biomanufacturing technology and workforce development challenges.

Valitacell, Solentim, and Microcoat were awarded EUR 3.5 million (US$4 million) to produce an integrated platform to deposit, culture, profile, and select optimal cells for biologic drug manufacturing.

The agency published guidance on how to determine the placement and content of pediatric information in the labeling of drugs and biologics.

The agency has published a Q&A document to answer questions about what EMA is doing to prevent medicine shortages during Brexit.