Industry News

FDA warns the industry of possible contamination in the API baclofen from Taizhou Xinyou Pharmaceutical & Chemical Co., Limited.

EMA Executive Director Guido Rasi outlines his plan for the agency, including a focus on R&D.

Assembly Biosciences reported a successful clinical study validating the use of the Gemicel technology platform for the oral delivery of biologic medications.

The United States Pharmacopeial Convention announced the recipients of the 2015–2016 Global Fellowship Awards.

FDA approves Kanuma, the first treatment for patients with lysosomal acid lipase.

On Dec. 8, 2015, Sandoz, the generic pharmaceutical’s division of Novartis, announced that the European Medicines Agency (EMA) has accepted their marketing authorization application (MAA) for a biosimilar to Enbrel (etanercept), a tumor necrosis factor alpha (TNF-alpha) inhibitor.

FDA released an interim response to AbbVie’s citizen petition on the labeling of biosimilars.

FDA sets a July 2016 deadline for the final version of the rule on labeling changes for approved drugs and biologics.

Scientists at Rice University have developed a method to control the infectivity of viruses and gene delivery to the nuclei of target cells.

The agency publishes draft guidance on best practices for communication between FDA and IND sponsors during drug development.

Biogen, Genentech, Johnson & Johnson, Novartis, and Patheon publicize their support for action on climate change.

Express Scripts announced its plan to offer a $1 alternative to Daraprim, a generic drug used for the treatment of toxoplasmosis.

FDA should not release naming rules for biosimilars ahead of interchangeability guidelines, says the pharmacy benefit manager.

The agency promotes safer use of drugs and prevention of medication errors through a new webpage and practice guide.

Under the terms of the agreement, Xellia will acquire substantial parts of the Ben Venue site, including four sterile injectable manufacturing plants, which are not currently operational.

FDA seeks industry support for metrics program, emphasizing the surveillance focus.

Chugai Pharmaceuticals, a research-based company headquartered in Tokyo, opens new facility in Berkley Heights, NJ.

The 2015 UPS supply chain survey suggests that pharma companies need to improve cost control and planning for unexpected events.

Robert Califf addresses questions about drug pricing at the Senate hearing to weigh his appointment to be the next commissioner of FDA.

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.

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

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

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

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.

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

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

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.

The “next-generation” design for the pods will build on Pfizer’s existing modular prototype for oral solid-dose manufacturing.

The agency issued a draft guidance document on the requirements for submission of applications for liposome drug products.