News

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

The EXcell 231 and EXcell 241 sensors from EXNER Process Equipment have updated software and connection features for improved flexibility and safety.

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

The companies will join forces to use artificial intelligence (AI) and machine learning to discover and develop new treatments for two chronic diseases.

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.

The company’s center of excellence for advanced analytical testing passed GMP inspection from the European Medicines Agency.

A new facility in Frederick County, MD, will expand the company’s cell therapy manufacturing capabilities.

Contract packaging and clinical supply service company Sharp invested $21 million to expand its packaging capacity and capabilities in Pennsylvania.

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.

Sandoz’s new CEO will assume responsibilities no later than Aug. 1, 2019.

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.

Expansion at GSK’s Hamilton, MT site is designed to boost vaccine production capacity.

The expansion of the CDMO’s Skokie, IL facility includes additional refrigeration and freezer space.

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

The company passed a seven-day FDA surveillance GMP inspection and announced two upcoming manufacturing partnerships.

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

Seqirus has taken the decision to make its cell-based flu vaccine, FLUCELVAX TETRA, using a completely cell-based production process.

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

Novartis has announced that FDA has accepted its biologics license application (BLA) for brolucizumab (RTH258) for the treatment of wet age-related macular degeneration (AMD).

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.

The companies will merge to offer a broader range of analytical data packages and regulatory support for biopharmaceuticals.

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.

Catalent’s acquisition of Paragon Bioservices will provide expertise in expanding gene therapy market.