News

Aprecia Pharmaceutical’s SPRITAM levetiracetam gains FDA approval for the treatment of epilepsy.

FDA issues draft guidance on dissolution testing for immediate-release solid oral dosage forms.

FDA issues guidance regarding fees for drug compounding outsourcing facilities.

Paperless operations improve efficiency and increase assurance of product quality.

The trend towards personalized medicines in Europe requires a more integrated framework that regulates the approval of devices and diagnostics.

FDA notes progress in drug development, but cites scientific and funding roadblocks.

China’s emergence as a significant commercial market is forcing manufacturers to re-evaluate their overall business model.

Within the past few years, key players have left the sterile manufacturing business. Can new technology and investment revitalize this critical market?

The investment doubles the company’s capacity to meet increasing demand for its biologics contract testing and biosimilar characterization services.

Competitive pressures are driving more companies to repurpose APIs that had originally been developed for other indications. The industry has only "scratched the surface" of what might be possible, says consultant Hermann Mucke

Drug development is South Korea is being driven by the government’s R&D strategy under its Pharma 2020 Vision.

The new service offering includes feasibility studies, process and analytical development, and scale-up from milligram to gram quantities required for pilot and subsequent commercial scale.

Teva Parenteral Medicines initiates voluntary nationwide recall of select lots of Adrucil due to particulate matter.

Baxter has recalled of one lot of IV solution due to the potential for leaking containers, particulate matter, and missing port.

“Rough notes” documentation and data management failures lead to warning letter for Mahendra Chemicals.

Investment in Powdersize adds particle-size control solutions to Xcelience’s capabilities.

Lupin acquires businesses in Germany, the US, Russia, Brazil, and South Africa.

Avista grows its contract services business, and Scynexis focuses on antifungal development.

ARGX-110-based combination therapies have demonstrated potential in treatment-resistant cancers.

The new biotech company, Mereo, is based in the United Kingdom, and kicks off with three mid-stage assets from Novartis.

The Generic Pharmaceutical Association and the Biosimilars Council wrote an open letter to President Barack Obama protesting the patent protections outlined in the Trans-Pacific Partnership.

The broader aim of FDA's metrics initiative is to encourage quality manufacturing operations that will help avoid drug shortages.

The contract is a memorandum of understanding for the manufacturing by MaSTherCell of clinical batches of TxCell’s Ovasave.

The purchase will strengthen Hikma’s position in the US generic drug market.

The collaboration will focus on advancing bi-specific antibodies that target hematologic and solid cancers, either as monotherapies or in combination regimens with other immune modulating treatments.

FDA’s quality metrics draft guidance details the types of data the agency plans to request and the quality metrics it plans to calculate.

The deal to acquire Allergan’s generic-drug business is valued at $40.5 billion.

FDA approved the drug for a more narrow indication in the US than did EMA for Repatha, Praluent’s fiercest competitor.

Moses Lake Professional Pharmacy issues recall due to lack of sterility assurance.

EMA’s revised guideline on the implementation of accelerated assessment is open for public consultation.