News

Global spending on medications will continue to rise, and it is expected to increase by $349 billion on a constant-dollar basis by 2020-more than $150 billion more than it increased during the past five years, according to a new IMS Institute for Healthcare Informatics report, Global Medicines Use in 2020: Outlook and Implications. Although the spending increase is large, total spending on medicines is expected to increase at a slower rate than it did over the past five years, when spending on medicines increased approximately 35%.

Merck KGaA announces the completion of the acquisition of Sigma-Aldrich, a St. Louis-based life-sciences and technology company.

BioOutsource releases informational video detailing issues associated with ADCC assays and how to effectively analyze them.

The new executive director of the European Medicines Agency begins appointment.

A landmark study by the National Institutes of Health determines that Lucentis is highly effective as a treatment for diabetic retinopathy.

FDA grants accelerated approval for Darzalex (daratumumab) for the treatment of multiple myeloma.

A new consortium involving Arecor, FUJIFILM Diosynth Biotechnologies and the Center for Process Innovation will focus on formulation innovation as a way to improve downstream processing and reduce biopharmaceutical cost.

High-dose axalimogene filolisbac immunotherapy will advance to expansion phase.

An ABPI report found a lack of quality candidates for high-skilled roles in areas such as bioinformatics, translational medicine, clinical pharmacology, and pathology.

Panelists at the meeting will focus on clinical trial design, immunogenicity, and enhancing implementation plans for administering already-licensed vaccines to this patient population.

As a result of the acquisition, Merck will have access to Harrisvaccine’s proprietary RNA Particle technology production platform.

FDA seeks feedback on possible analytical standards and approaches to optimize regulation of next-generation sequencing (NGS)-based in vitro diagnostic tests.

A study and new index shows that only 65% of clinical trials are being registered and reported on. Nearly half of the new drugs approved by FDA in 2012 had one Phase II or III trial that was not disclosed. Regulatory ambiguities, mergers, and lack of enforcement action may be to blame

Lawsuit alleges birth control packaging error led to 113 unwanted pregnancies.

Connected Services program will link cGMP-manufacturing services with supply chain technology management solution.

The UK’s National Biologics Manufacturing Centre will use Novasep’s BioSC Lab for protein purification.

Even though rising production and use of generic pharmaceuticals is saving billions for the nation’s healthcare system, policy makers continue to slap the industry with policies it claims will limit product development and sales.

AstraZeneca has agreed to acquire ZS Pharma for $2.7 billion, according to a press release from AstraZeneca. 

The European agency presents guidelines for conducting post-authorization efficacy studies.

GE Healthcare's KUBio prebuilt modules were shipped from Germany to JHL Biotech in Wuhan, China.

The company said its DevClin business will continue to be an integral part of its long-term biologics business growth strategy.

The new IVIG products boast improvements in purity, safety, and yield.

The testing laboratory will add capacity to strengthen its early-stage drug research capabilities for its small and large biotech clients.

South Africa’s Biovac Institute, which develops and produces vaccines for the country, launched a public-private partnership with Pfizer to enable local manufacturing of Prevenar 13, a vaccine against pneumonia-causing bacteria.

According to Diplomat’s CEO Phil Hagerman, true specialty pharmacies are “not in the business of toenail fungus and teenage acne.”

According to Bio-Rad executives, the company’s adoption of its ERP system has created a backlog of projects.

All biosimilars for a specific product will be reimbursed with the same J-code under Medicare Part B regardless of manufacturer, according to a CMS rule that was proposed in July 2015 and finalized on Oct. 30, 2015. The rule was finalized prior to any formal guidance from FDA on interchangeable products.  CMS said it did not consider interchangeability into its decision, as there are no currently approved interchangeable biologics on the market.