News

Curida entered into a partnership with René Bommer, PhD, founder and owner of pharmAccel Consulting.

The lawsuit alleges EnzymeWorks and its founder engaged in willful patent infringement, misappropriation of trade secrets, and breach of confidence, in addition to other claims.

Sandoz filed a petition with the US Supreme Court to review a Federal Circuit Court’s July 2015 judgment of the Biologics Price Competition and Innovation Act (BPCIA). The pharmaceutical company filed the writ of certiorari with the court on Feb.

Researchers discovered more than 300 antibodies that reacted with the Ebola virus’s surface glycoprotein and could be used to neutralize many strains of the virus.

AAIPharma/Cambridge Major Labs plans to invest $10.7 million to relocate the company’s analytical testing facility to the Cortex Innovation Center in Missouri.

The agency published guidance on immunogenicity-related considerations for low molecular weight heparin.

The company issues a voluntary recall of a lot of 0.9% sodium chloride solution due to particulate matter.

The directorate is looking for experts to join the European Pharmacopoeia network.

Recipharm plans to invest €40 million in the project as a result of EMA decision to make serialization of licensed drug products a legal requirement by 2019.

Unchained Labs acquires Freeslate, marking the company’s fourth acquisition in the past 12 months.

The agency is continuing CDER’s Regulatory Project Management Site Tours and Regulatory Interaction Program.

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.

Vaccine R&D has grown exponentially in recent years, spurred by ethical and medical needs to combat lethal infectious outbreaks and increased funding from public and private agencies and organizations.

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.