News

FDA fast-tracked the monoclonal antibody based on early clinical data from a Phase I trial.

The collaboration will allow the companies to develop and manufacture novel inhaled therapeutics.

This marks Vetter’s fourth internationally recognized award for its syringe closure system, Vetter-Ject.

Growth in finished dosage formulations triggers a new CPhI Worldwide event.

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

Sartorius announced the release of the company’s new Tacta pipettes.

Sandoz reveals plans to complete a Phase III development program for Pfizer’s infliximab and file for registration in the EU.

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

GRAM completed a fourth FDA inspection of its parenteral manufacturing facility with no Form 483 observation issues.

There was scant praise from the medical community for the eighth and final budget plan from the Obama administration.

Metrohm USA awards the 2016 Young Chemist Award to PhD candidate developing wearable sensors that can non-invasively monitor physiologically relevant chemicals.

3M Drug Delivery Systems, Ei Solutionworks, IDT Biologika join CMO/CDMO association

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

On Feb. 9, 2016, an FDA Arthritis Advisory Committee will meet to discuss a biologics license application (BLA) for CT-P13 (Remsima), a proposed biosimilar to Janssen Biotech's Remicade (infliximab), by South Korea’s Celltrion in partnership with Pfizer. The BLA was submitted via the abbreviated 351(k) pathway and seeks to cover all of the eight indications that are approved for Remicade.

The agency prepares a plan to implement new packaging safety features.

Researchers describe a new method to compare the higher-order structure of a reference biologic with its proposed biosimilar product candidates.

FDA granted Immunomedics breakthrough therapy designation for the company’s investigational antibody drug conjugate for treatment of triple negative breast cancer.

FDA staff said Celltrion’s biosimilar form of infliximab is highly similar to Remicade.

Barvarian Nordic, Evaxion Biotech, and the Technical University of Denmark announced plans to collaborate on the development of a vaccine for MRSA.

During a Q4 call with Merck, executives admitted the company's market share for Remicade (infliximab) has begun to dwindle. Remicade's share of the market decreased 5% (from 90% to 85%) from the third quarter to the fourth quarter. 

ViaCyte and Janssen Biotech have entered Phase I/Phase II clinical trials for VC-01, a candidate treatment for the treatment of type 1 diabetes.

Sartorius releases financial results for 2015, announcing a 16% increase in group sales revenue.

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.

LabConnect built a biorepository facility in Tennessee.

AstraZeneca received conditional marketing authorization for Tagrisso, a tablet for the treatment of adults with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer.

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

The International Society for Pharmaceutical Engineering (ISPE) Facility of the Year Awards (FOYA) program announced its 2016 Category Award winners for operational excellence, sustainability, process innovation, project execution, equipment innovation, and facility integration.

Can the feds negotiate Medicare Part D prices?