Mexichem announced that it acquired the distribution and sale license for HFC-227ea/P from Du Pont.

Bristol-Myers Squibb announced that it stopped its study of Opdivo for the treatment of 2nd line squamous cell lung cancer due to superior overall survival of study participants.

NovoBiotic’s first-in-class antibiotic, teixobactin, proves strong in the battle to kill drug-resistant bacteria.

Single-use components aid efficiency in automated personalized therapy manufacturing.

A guidance document published just before the Jan. 1, 2015 deadline adds a four-month grace period.

The acquisition of Aptuit's Glasgow, UK and Indiana, US facilities will add sterile injectable formulation development and expand AMRI's analytical services capabilities.

An FDA expert committee has recommend approval of Zarizio, the first US biosimilar application from Sandoz, setting a milestone for generic biologic drugs and setting the stage for future approvals.

Impax Pharmaceuticals received FDA approval of Rytary for use in patients with Parkinson’s disease.

Cardio3 BioSciences acquired Celdara Medical’s immuno-oncology platform, OnCyte, for up to $180 million in cash, stock, and royalties.

The FDA center released a list of the guidance documents it plans to publish in 2015.

The exclusivity deal mirrors that of the recent deal between Express Scripts and AbbVie for Viekira Pak.

Isis Pharmaceuticals announced that it entered into an agreement with Janssen Biotech to discover and develop antisense drugs for autoimmune disorders of the GI tract.

Bio/pharmaceutical manufacturers in the UK face challenges in proving that their drugs are worth the price.

Risks associated with single-use technologies, such as product loss and sterility assurance, are magnified in the filling operation because of its closeness to the product in its final form. A thorough evaluation of the assembly design process, manufacture, and use can assist in identifying and mitigating these risks.

The Parenteral Drug Association report addresses prevention and communication of drug shortages caused by manufacturing and quality related disruptions.

The European Commission’s new structure has sparked controversy about its allocation of responsibilities and the impact on the development and approval of new medicines.

In late 2014, standards organizations continued to work towards harmonization and securing drug safety.

New designations lead to faster drug approvals, but there is more work to be done.

FDA delays enforcement of product tracing requirements to May 1, 2015, providing trading partners more time to comply.

Analytical and procedural deficiencies result in FDA warning letter for Novacyl Wuxi Pharmaceutical.

Valeant voluntarily recalled one lot of Virazole due to sterility problems; no adverse events have been reported to date.

Hospira issued a voluntary worldwide recall due to confirmed subpotency and elevated impurity levels.

Roivant Neurosciences acquired GlaxoSmithKline’s selective 5-HTC receptor antagonist for the treatment of various neurological disorders, specifically Alzheimer’s disease.

Although competing therapies will continue to be released in the immuno-oncology space, efficacy profiles, combination regimens, and administration setting may influence a drug’s preferred status more than price.

Roche’s LightMix Ebola test can give results in around three hours.

When used in combination with chlorambucil to treat chronic lymphocytic leukemia, Gazyva was found to be more effective than Rituxan.

Entrectinib has received FDA’s orphan drug and rare pediatric disease designations for the treatment of neuroblastoma.