News

The acquisition will bolster Celgene’s immunotherapy pipeline.

Consisting of a needle hub and a needle shield, the new syringe closure system is partly produced by means of a two-component injection molding process of polypropylene and thermoplastic elastomer.

Two companies have been fined a total of GBP550,000 for faulty insulin syringes, which contained no drug and caused the death of a diabetic patient.

The collaboration will address the need for novel analytical approaches for the characterization of glycans.

FDA released news of the ban of Emcure’s Hinjewadi manufacturing plant after it determined the plant did not meet basic quality standards.

A report released by PhRMA in conjunction with the Epilepsy Foundation reveals that the pipeline is dominated by biologics.

The new sizes follow the 2014 launch of the company’s fully disposable purifier.

This collaboration is said to be the first established between the Crick and a pharmaceutical company.

The agency requires early notification of potential drug shortages.

The International Conference on Harmonization has moved ICH M7(R1) Addendum to 3 of the ICH process.

The new project will increase fill/finish manufacturing capacity for select products on FDA’s Drug Shortage Index.

The 21st Century Cures Act took a giant step forward with a 344-77 approval in the House; the Senate debate is still ahead.

 The United States Treasury Department introduced policy in September 2014 to discourage companies from merging with foreign companies in another fiscal jurisdiction to escape tax responsibilities. The policy was enacted to make inversion more difficult and to curb a company’s acquisition of a related foreign company for the sole purpose of avoiding United States corporate tax rates.

Charles Rivers strengthens its endotoxin testing and bacterial identification detection capabilities with the addition of Celsis’ products.

A large health system will use the biosimilar version of infliximab from Hospira after the company offered a discount of 45%.

The offer, valued at $3 billion, represents a 42% increase in Depomed’s share price.

The amendment suggests modifications to the calculation of a drug's average manufacturing price and to the reimbursement rate for infused medications.

Catalent’s licensing of Excelimmune’s antibody combination therapy platform can enable more consistent, cost effective production of antibody combinations.

Catalent licenses Excelimmune’s antibody combination therapy platform toenable the manufacture of multiple recombinant antibodies in a single batch culture.

The European Pharmacopoeia has incorporated new provisions to encourage the use of in-process quality control methods.

According to Sartorius Stedim Biotech, this acquisition expands its service offering for process development.

Biogen plans to build a biologics manufacturing plant in northwest Switzerland using next-generation technologies to create efficiency and sustainability.

The addition of a new manufacturing line at Lonza’s Portsmouth, NH site enables Alexion to add dedicated product supply for 10 years.

The new facility expands the company’s commercial manufacturing capability at its Bend, Ore. site.

The agency gives a limited reprieve to dispensers but requires other trading partners to provide product tracing information.

The partnership will focus on the development of CAR T-cell therapies and other programs related to T-cell technology.

GSK will invest in an additional downstream isolation facility for amoxicillin production in Singapore.

The GPhA-run organization asks regulatory agencies to keep international nonproprietary naming conventions intact for biosimilars.