News

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.

Multiple data-integrity violations results in FDA warning letter for Mumbai, India-based Ipca Laboratories.

MPI Research plans to renovate more than 55,000 square feet of facility space as part of the company’s plan to invest in upgrades and department expansion.

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.

Biocorp’s Easylog smart sensor for insulin delivery devices enhances compliance.

Innovations awarded at Pharmapack Europe include improvements for patient compliance and protection from errors, tampering, or misuse.

Ashland Chemical’s Calvert City, KY, facility is the first in the US to receive EXCiPACT certification for GMPs of pharmaceutical excipients.

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.

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.

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.

Stephen Ostroff published a blog on FDA regarding goals to modernize the generic drug review process in an effort to increase patient access to generics.

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

FDA officials said on Feb. 5, 2016 that Celltrion’s biosimilar to infliximab was “highly similar” to Johnson & Johnson’s (J&J) Remicade, according to a report by Reuters.

AMETEK announced the acquisition of Brookfield Engineering Laboratories, a Massachusetts based manufacturer of viscometers and rheometers.

Although switching has occurred in European markets for some biosimilars, most biosimilar manufacturers will focus on securing new users, according to Merck.

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

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.

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.

Common defects in tablet film coating can be minimized by effective design of the tablet core and the coating process.