Top News

UK pharmaceutical companies face £45 million in fines after entering pay-for-delay agreements for generic versions of paroxetine.

Wyeth reaches agreement in principle to resolve Medicaid drug rebate claims for 2001-2006 period for Protonix.

FDA cracks down on makers of products extracted from Cannabis and says the products cannot be considered dietary supplements.

Pfizer names executive leadership team for combined organization upon close of proposed Allergan transaction.

There are no clinically meaningful differences between Celltrion’s CT-P13 and Remicade, according to an FDA briefing released ahead of the formal panel meeting.

In a hearing held on Feb. 4, 2016, executives from Valeant and Turing had a hard time explaining their rationales for exorbitant price hikes of older drugs.

Several biopharmaceutical companies announce plans to launch R&D into Zika vaccine candidates.

Novartis announced the companies plan to boost growth at Alcon, the company’s vision care division.

NICE announces plans to back biosimilar alternatives to Merck’s Remicade.

FDA’s Center for Drug Evaluation and Research publishes a list of upcoming new and revised guidance documents for 2016.

More than 80 pharmaceutical, biotechnology, generics, and diagnostics companies draft and sign the Declaration on Combating Antimicrobial Resistance.

Samsung Bioepis receives approval from the European Commission for the Enbrel Biosimilar, Benepali.

The denial marks a setback for Amgen, who’s Humira biosimilar ABP 501 is the first submitted to FDA for adalimumab.

The British Standards Institution (BSI) and the Alliance for Clinical Research Excellence and Safety (ACRES) announced a collaboration to develop global standards of excellence for clinical research sites.

Shire’s acquisition of Baxalta creates a leading company for rare disease drugs.

FDA approved 45 novel new drugs in 2015, the highest number of approvals since 1996 and second-highest ever.

The Office of Prescription Drug Promotion issues all-time low number of violation letters in 2015.

SCORR Marketing and Applied Clinical Trials release the results of EU clinical trials survey.

The Cell Therapy Catapult, University of Birmingham, and Cancer Research Technology collaborate on CAR-T cell immuno-oncology therapy development.

BioPharm highlights the monoclonal antibodies that may gain United States regulatory approval in 2016.

The revised USP Chapter 1207 gives best practices for obtaining reliable data in container closure integrity testing.

The National Institutes of Health released a strategic plan covering the fiscal years 2016-2020.

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

Sanofi enters into exclusive negotiations with Boehringer Ingelheim on a business asset swap.

Capsugel adds clinical trial and commercial manufacturing, as well as particle engineering services with two acquisitions.

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

Catalent has entered into an exclusive long-term supply agreement to produce Pfizer’s OTC proton-pump inhibitor for heartburn treatment, Nexium 24HR (esomeprazole), which is also marketed as Nexium Control outside the US.

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

The goal is to have all of Novo Nordisk’s production plants operating on renewable electricity with zero CO2 emissions by 2020.