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

The CHMP has recommended that Sixmo (buprenorphine) be granted a marketing authorization in the EU as a substitution treatment for opioid dependence.

EMA has revealed that it is updating the prescribing information of Tyverb (lapatinib) as a result of the detection of errors in study results.

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.

Horizon Europe gains parliamentary endorsement, bringing it closer to becoming a reality.

The investment will increase patient-centric dosage form manufacturing capabilities at Catalent’s Winchester, KY, facility.

Regis Technologies reported that no Form 483 observations were issued following a routine FDA inspection.

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

Lonza’s SimpliFiH Services addresses bioavailability challenges with drug substance, solid-state characterization, and drug product for first-in-human studies.

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

Lonza’s fully automated plate-based PyroTec PRO Robotic Solution accelerates endotoxin testing of parenteral pharmaceuticals.

The World Health Organization (WHO) has welcomed the launch of a malaria vaccine in a pilot program taking place in Malawi, Africa.

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

Sterling Pharma Solutions has been granted a Queen’s Award for Enterprise in the field of International Trade.

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.

Start Codon strategic initiative has been launched, aimed at providing a life-science accelerator that offers funding and support to translate innovative research into start-up companies.

The Regulatory Affairs Professional Society (RAPS) has released an updated agenda for its forthcoming conference, RAPS Regulatory Conference-Europe 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.

Eli Lilly sold rights to two of its legacy antibiotics as well as its Suzhou, China, manufacturing facility, to China-based specialty pharmaceutical company Eddingpharm in a deal worth $375 million.

Expansion at the Eberbach, Germany facility includes two Vegicap encapsulation lines, printing, inspection, and packaging capabilities.

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

Cambrex’s expanded quality control laboratory supports generic API development.

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.

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

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