News

WellSpring Pharma formed a strategic partnership with IDT Australia and invested $3 million in new equipment.

A report by Reuters found that four of the top 10 most widely used drugs increased 100% since 2011, while the other six increased 60%.

Inflectra is the second biosimilar to hit the market in the United States.

The companies announced that they have mutually decided to terminate the planned merger after the US Department of Treasury and the IRS issue temporary and proposed regulations on tax inversion.

The agency has announced the creation of the Combination Products Policy Council to address issues related to combination products.

The agency released a draft reflection paper on the extrapolation of data from adults to children in the development of pediatric drugs.

Aesica adds development capability at Queenborough with the opening of a new purpose-built facility.

EMVO appointed Andreas Walter general manager effective April 2016.

Jack Lew, Obama’s secretary of the treasury, announced on April 4, 2016, that the US Department of the Treasury and the Internal Revenue Service (IRS) is issuing temporary and proposed regulations to limit the “benefits of and limit the number of corporate tax inversions.” The government bodies also plan to address earnings stripping in these inversions, so it will examine past inversion deals that have already been completed.

Kollicoat MAE 100-55 from BASF can be used as a direct substitute in commercial enteric pharmaceutical formulations.

The company received a positive recommendation for it’s Remicade biosimilar, Flixabi (infliximab).

Sandoz Industrial Products GmbH will be renamed Corden BioChem and will be associated with the CordenPharma Group, ICIG’s pharmaceutical platform.

As part of the partnership, Zenith Technologies’ methodologies, systems, and libraries will be offered as a service to GE Healthcare’s clients in bioprocessing.

The company announced that it received EXCiPACT certification in December 2015.

The companies will merge to create a gene therapy biologics CDMO.

The European Medicines Agency report provides an analysis of the health-technology assessment pilot program, which began in 2010 and completed in March 2016.

The draft guidance states information concerning a clinical study of a biosimilar should only be included if it is necessary to demonstrate the safety and efficacy of the drug.

The service center will act as a hub for delivery, maintenance, calibration, and technical support for the company.

The companies will provide assays for functional comparability, for use in quality control, lot release, and stability testing of biosimilars and biobetters.

Researchers at the University of Pittsburgh say the compound may be more potent and selective than drugs currently available to treat epilepsy.

Schreiner MediPharm will introduce Flexi-Cap Protect, a label-and-cap combination with additional protection features, to the US market at INTERPHEX 2016.

Marchesini Group’s Extrafill, a filling and stoppering machine, contains a robotic arm gripper system designed to move like a human hand.

Steriline’s enhanced robotic aseptic vial filler and capper line includes RA-V4 Rotary Vial Washing Machine, a depyrogenation tunnel, the RVFCM50 Robotic Vial Filling and Capping Machine with Isolator, and an EDM-C External Decontaminating Machine.

The Planeta 200 Capsule Filler’s modular design can be configured for a variety of production requirements.

AdvantaPure’s BioClosure container closures are intended to save time and money on inventoried parts, assembly, and cleaning validations.

Optima introduces OPTIMA H4 and the Multiuse series for multiple filling operations.

The new research scheme will be based in GE’s Turkey-based innovation center, and will help support the region’s biopharmaceutical industry.

Industry is joining with academia and global health leaders to examine new approaches to biotech manufacturing.

The commercial partnership aims to use digital health tools including sensors, apps, analytics, personal feedback, and education to assist patients in monitoring respiratory diseases.

Cinqair is approved for patients that have a history of severe asthma attacks despite receiving their current asthma medication.