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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.

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

The company plans to reformulate injectable products to make them into inhaled and intranasal medications.

Adaptimmune Therapeutics and Universal Cells enter into collaboration and license agreement to develop universal allogeneic T-cell therapies.

Paragon Bioservices entered into a contract with the International Aids Vaccine Initiative for the process and analytical development and cGMP manufacturing of an HIV vaccine candidate.

The agency publishes draft guidance on best practices for communication between FDA and IND sponsors during drug development.

Seqirus, CSL Limited’s influenza vaccine business, announced the opening of their corporate headquarters in the United Kingdom.

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.

Amgen announced the submission of a BLA with the FDA for ABP 501.

Vetter receives AEO-F certificate from the European Union for global movement of goods.

The Committee on Energy and Commerce met to assess influenza vaccine effectiveness, and changes for the 2015-2016 season.

Paras Biopharmaceuticals and Novozymes will collaborate on the creation of an improved osteoporosis treatment.

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.

Growing differentiated cells from stem cells may now be a bit easier than before, thanks to the findings from a new study on the production of liver cells. The study, backed by the Centre for Regenerative Medicine and published in Stem Cell Reports, finds that laminins may be a crucial element for the successful clinical-scale production and culture of stem cell therapies. The UK Regenerative Medicine Platform, the European Union Seventh Framework Programme, and the German Federal Ministry of Education and Research funded the research.

The portal is an interactive tool that pulls together the innovation landscape, company base, and manufacturing sites for the entire medicines sector in the UK.

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.

The deal to acquire Allergan will cost Pfizer $160 billion, and if the merger does not go through, CNBC reports the break-up fee would be $3.5 billion. The amount of the termination fee was calculated in advance of any further restrictions on tax inversion deals, however.

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.