News

The project involves installation of a small-scale pressured agitated nutsche filter dryer in glass, integrated in a high-containment isolator to achieve an occupational exposure limit of less than 1 microgram per meter cube, 8-hour time weighted average.

A new era has begun to address the deadly innovation gap in tackling the antimicrobial resistance crisis.

CDMO Saneca Pharma has sold registration dossiers for more than 20 pharmaceutical products to Xantis Pharma and will hold an exclusive five-year contract manufacturing agreement for the products with Xantis Pharma.

The therapeutic candidate AZD8601is an investigational mRNA-based therapy that will be tested for its ability to regulate the protein that influences vascular tissue growth.

The mAb, in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, was granted a Breakthrough Therapy Designation from FDA for the treatment of multiple myeloma.

On July 25, 2016 Kite Pharma entered into an agreement with the University of California, Los Angeles,  (UCLA) to advance development of off-the-shelf allogenic T-cell therapies from renewable pluripotent stem cells. The company entered into an exclusive license agreement with UCLA for an artificial thymic organoid (ATO) cell culture system. The ATO replicates the human thymic environment to support efficient ex vivo differentiation of T-cells from primary and reprogrammed pluripotent stem cells.

The companies filed a BLA for romosozumab, an investigational monoclonal antibody for the treatment of osteoporosis.

The vaccine candidate has also won a Priority Medicines (PRIME) status from EMA.

The companies will test the efficacy of Rova-T in combination with Opdivo, and Opdivo + Yervoy as a treatment for extensive-stage small cell lung cancer.

The agency will review Mylan and Biocon’s biosimilar to pegfilgrastim.

The agency recommends suspending drugs developed with bioequivalence studies performed at Semler Research Centre Private Ltd, Bangalore, India.

The agency has recommended granting marketing authorization in the EU for Truvada.

The company will expand its service offerings to include oligonucleotide API development and manufacture.

The Nexera-i MT from Shimadzu incorporates two flow lines, which allow for both UHPLC and HPLC analysis.

The pen injectors will be produced at Catalent’s Brussels, Belgium facility.

Curida will manufacture PCI Biotech’s Amphinex, a drug used to treat bile duct cancer.

Zenith appointed Carlos Machado as serialization director to lead the company’s sales, operations, and post project support services.

The company opened a new service center in San Juan, Puerto Rico.

The company announced that its facilities and laboratories have completed FDA pre-qualification inspection.

The company will invest €18 million in its Kaysersberg facility to expand blow-fill-seal capacity.

The conference will return to the COEX center in Seoul for the third year from August 23¬–25, 2016.

The company manufactures biological drug products and intermediates for the allergy vaccine market.

The company voluntarily recalls all lots of lyophilized HCG and sermorelin.

Amgen and Allergan’s biosimilar to popular breast cancer drug Herceptin is comparable to the innovator molecule, Amgen recently announced.

GenPak Solutions is cited by FDA for cGMP violations at its Hilliard, Ohio facility.

Generic versions of AstraZeneca’s blockbuster Crestor will hit the US market after a federal judge refused to issue a restraining order blocking the approval of rosuvastatin ANDAs.

A new website collects and rates information about life-science supplies from academic journals to simplify researcher purchasing decisions.

Thirty percent of current Remicade patients could be eligible for a switch to competitors such as Inflectra, according to estimates, although J&J doubts this will occur in the United States in 2016.

The company plans to purchase and develop an 18-acre site in Des Plaines, Illinois.

The company announced that it will be relaunching its customer collaboration centers.