News

GW Pharmaceuticals released Phase III trial results on Epidiolex, which was shown to decrease monthly convulsive seizures in children by 39%.

Doctors and oncologists agree with pharma companies in opposing the latest proposal from the CMS to revise how it pays for drugs administered in doctors’ offices.

The company recalls one lot of amikacin sulfate injection USP, 1 gram/4mL (250 mg/mL) vials due to the potential presence of glass particulate in one vial.

The committee suggests there may be a connection between the Zika virus and other neurological disorders in some affected areas.

The group argues that the so-called “incentives” for physicians to prescribe more costly medications are essentially non-existent following a handful of prior cuts to Medicare Part B reimbursement.

Concerns that physicians are not prescribing the most cost-effective medications available have prompted the Centers for Medicare and Medicaid Services to propose a set of new potential reimbursement schemes for Part B drugs in Medicare. CMS says the new proposed rule will test new payment approaches to reward good patient outcomes and will inject value into the system.

The module was installed in the company’s Watson laboratory information management system in Poitiers, France.

The group is inviting additional industry stakeholders to participate in the technology roadmapping process to address complexity of the current industry structure, which the group says has held back innovation.

The company will showcase workflow solutions for sample prep and data analysis.

Sagent Pharmaceuticals issues a nationwide recall of Fluconazole injection, USP, due to out of specification impurity results.

The agency strengthens its support for treatments of unmet medical needs with launch of new PRIME scheme.

Clinical trials of Eli Lilly’s ixekizumab showed the drug displayed clinically meaningful improvements in patients with moderate-to-severe plaque psoriasis.

The inspection confirmed that the facility was compliant with GMP guidelines.

The researchers examine the top 20 cancer drugs dosed by body size in the US, and estimate that drug companies will earn $1.8 billion in 2016 in revenue from leftover cancer drugs.

TxCell’s new facilities are based in Sophia Antipolis, France, on the premises of GenBiotech.

The US DEA will allow Kannalife access to pharmaceutical-grade cannabidiol to conduct feasibility studies for a potential treatment for neurodegenerative diseases.

This marks the first time a biologic manufactured in China has been released for use in a clinical trial in Europe.

The pharma company revealed in a fourth quarter call that it will improve its cell-culture capabilities by focusing on the use of naïve, highly proliferative cells to manufacture its CAR-T drug candidate.

The new group is made up of over 15 scientists who formerly worked in GSK's computational biology and genetics departments

In the U.K., a new four-year initiative has been launched to streamline drug development and manufacturing by leveraging better computer-based process modeling and simulation.

A reformulated version of Rose Bengal, PV-10, may be used to treat melanoma when injected directly into tumors.

The program is intended to provide support to ongoing efforts in rare disease product development.

The Eppendorf and Science Prize for Neurobiology is a research prize of $25,000, given to young scientists for their contributions in neurobiology.

The agency has revised its good pharmacovigilance practices guide on risk management systems.

Repligen reported a revenue increase of 45% at constant currency in the fourth quarter of 2015, which was driven primarily by strong growth in sales of its bioprocessing products, Jon K. Snodgrass, CFO of Repligen, noted during a fourth-quarter conference call. Specifically, the increased revenue came from the sales of its growth factors, ATF (alternating tangential flow) systems and consumables, and products from its chromatography group (e.g., OPUS columns, Protein A resins, and ELISA kits).

The advanced capillary electrophoresis system, Maurice, from ProteinSimple is used for the quantitative analysis of identity, purity, and heterogeneity profiles of biopharmaceuticals.

The collaboration is part of Innovate UK’s competition for the development of regenerative medicines.

Under the agreement, Caribou has granted IDT worldwide rights to commercialize CRISPR-Cas9 reagents under Caribou’s intellectual property.