News

Strengthening government control or striving for compliance with international standards?

Draft guidance combines and supersedes previous guidance documents.

USP is proposing a new performance testing standard for moisture permeation of pharmaceutical packaging.

In the context of international trade, the need to develop global quality standards for medicines is increasing.

Sound policies are needed to govern the substitution of interchangeable biologics.

Conference and exhibits provide a meeting place for professionals to exchange ideas.

Latest news about compound pharmacies, biosimilars, prescription drug purchases, and other regulatory topics.

Stem cells are being developed to treat a diverse set of conditions, including spinal cord injury, amyotrophic lateral sclerosis, macular degeneration, Parkinsons disease, and Type I diabetes. But the challenges in moving from the laboratory to the clinic are formidable.

Victor Hernandez of EMD Millipore discusses his upcoming session, "Current continuous process validation program: following FDA current guidelines,? which will be held at Interphex 2013

A roundup of additional company and people news from pharmaceutical and biopharmaceutical companies, their suppliers, and contract-service providers.

Shire has announced plans to acquire dry eye specialist SARcode Bioscience with the aim of expanding its ophthalmics portfolio. Under the terms of the agreement, Shire will pay $160 million upfront and SARcode shareholders will receive additional undisclosed payments upon achievement of certain clinical, regulatory and/or commercial milestones.

FDA's Commissioner discusses pharmacy compounding, EMA updates guidance

Merck's Januvia [sitagliptin] was named 2013 Brand of the Year by Pharmaceutical Executive magazine.

A Massachusetts-based compound pharmacy is voluntarily recalling all sterile compound products dispensed since Jan. 1, 2013 due to possible filament contamination.

AstraZeneca announced further downsizing in response to an expected period of declining revenues in the face of patent expirations. The company will eliminate 2300 positions in sales and general administration.

The New Jersey-licensed specialty pharmacy recalls magnesium sulfate products and halts all production operations.

A roundup of additional company and people news from pharmaceutical and biopharmaceutical companies, their suppliers, and contract-service providers.

Rigaku Raman Technologies announced an updated version of the FirstGuard handheld Raman analyzer at Pittcon 2013.

Metrohm and FOSS have entered into a strategic alliance in which Metrohm will become the sole global distributor of FOSS NIR instruments for the pharmaceutical sector.

The 2013 Excipient Information Package (EIP) User Guide is now available for free download from the International Pharmaceutical Excipients Council (IPEC)-Americas.

At Pittcon 2013, Bruker introduced a range of instruments and software updates including two LC-triple quadrupole (LC-TQ) mass spectrometers.

The Excellence Dynamic Mechanical Analyzer DMA 1, introduced by Mettler Toledo offers six different deformation modes to gauge materials performance.

Loss-in-weight feeders provide high accuracy for feeding powders.

Xceleron and JCL Bioassay have entered into a partnership that will offer drug developers access to a range of sensitive and robust analytical platforms for early clinical development across Asia, Europe, and North America.

ThromboGenics' eye drug, Jetrea (ocriplasmin) has been approved in the EU for the treatment of vitreomacular traction (VMT), including when associated with macular hole of diameter less than or equal to 400 microns.

AstraZeneca announced that it will consolidate its R&D capabilities into three centers located in Cambridge, UK; Gaithersburg, MD in the US; and M?lndal, Sweden. The reorganization will result in a net loss of 1600 positions, mainly in the UK and the US.

Thermo Fisher Scientific Inc. launched new software, instruments, consumables, and services for analytical applications at Pittcon 2013.

Shimadzu Scientific Instruments introduced several new products at Pittcon 2013.

At Pittcon 2013, Water Corp. announced improvement to chromatography systems and software.

Scientists and instrument manufacturers gather in Philadelphia for Pittcon 2013.