News

The agency has published draft guidance on safety assessment for investigational new drug application safety reporting.

The agency has launched a new web platform to foster scientific innovation.

Pharmaceutical CEO Martin Shkreli was arrested on Dec. 17, 2015 at his New York apartment and charged with securities fraud.Martin Shkreli, chief executive officer of Turing Pharmaceuticals and KaloBios Pharmaceuticals Inc., was arrested on Dec. 17, 2015 at his apartment in New York City for securities fraud.

The aim of the collaboration is to advance the use of Cellectar’s phospholipid drug conjugate platform for targeted delivery of a selection of Pierre Fabre’s cytotoxics.

AstraZeneca announced the completion of a tender offer for all of the outstanding ZS Pharma shares.

The new arrangement draws from a consignment approach, in which Walgreens will sell-but not directly own-Valeant’s products.

The company’s new version of its glycan analysis tool will help investigators determine the relative abundance of individual N-glycan structures in small biopharmaceutical samples.

Through a strategic alliance with WuXi AppTec and a $50 million facility investment, AstraZeneca announces biologics and small-molecule expansion in China.

AMRI adds analytical capabilities to its outsourcing services offerings with the acquisition of Whitehouse Labs.

Researchers from Oregon State University develop a new three-drug delivery system for cancer treatment.

Grand River Aseptic Manufacturing expands disposable technology capabilities at aseptic facility.

AstraZeneca partners with the Wallenberg Center for Protein Research to conduct studies on the Secretome.

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.

Changes in China’s Food and Drug Administration (cFDA) drug development and commercialization policies make it easier for multinationals and CMOs to manufacture in China for in-country use, reports CMO and consultant PaizaBio.

The company will in-license a novel antibody, which has a conformation that is associated with increased therapeutic efficacy.

An FDA panel recommended approval of Teva’s monoclonal antibody, reslizumab.

Protea will use Agilent’s mass spectrometry imaging technology to develop new methods to identify cell metabolites produced as a result of disease or drug exposure.

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.

Sanofi Pasteur was granted marketing authorization for Dengvaxia, the first vaccine for dengue fever.

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.

While stakeholders generally welcome improvements to quality initiatives, they are concerned with how the new requirements will be implemented for more complicated supply-chain models.

Amgen submitted a market authorization application to EMA for ABP 501, a biosimilar candidate to Humira.

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

TxCell signs strategic agreement with MaSTherCell for European manufacturing of its cell therapy products.

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