Melanie Sena is community editor of Pharmaceutical Technology.

Melanie Sena

has published the Process Safebook, a free guide to functional safety for process applications, to assist with the application of IEC61511. The guide discusses how to manage safety in electrical, electronic, and programmable electronic systems. It also provides guidance for engineers on how to integrate safety into a process system design. 

Articles

Rockwell Automation releases a new guide to functional safety for process applications.

Rockwell Releases Safety Guide for Process Applications

The biopharmaceutical company Ablynx and 

 have entered into a license agreement to develop and commercialize the anti-IL-6R Nanobody, ALX-0061, to treat inflammatory diseases.  ALX-0061 is Ablynx's proprietary anti-IL-6R Nanobody that successfully completed a Phase IIA study in February 2013. Nanobodies are Ablynx’s proprietary class of therapeutic proteins based on single-domain antibody fragments. Under the agreement, Ablynx will be responsible for completing Phase II clinical development in rheumatord arthritis and systemic lupus erythematosus. Upon the achievement of predefined success criteria, AbbVie will exercise its right to in-license ALX-0061 and be responsible for subsequent Phase III clinical development and commercialization.  Ablynx will retain an option for copromotion rights in Belgium, the Netherlands, and Luxembourg.  Ablynx will receive an upfront payment of $175 million, which will partly be used to fund the next phases of clinical development of ALX-0061.  Upon achievement of certain development, regulatory, commercial, and sales-based milestones, Ablynx will be eligible to receive additional milestone payments totaling up to $665 million as well as double-digit tiered royalties on net sales upon commercialization.

Ablynx and AbbVie sign license agreement for Anti-IL-6R Nanobody, ALX-0061 to treat inflammatory diseases.

Ablynx And AbbVie Sign License Agreement For Anti-IL-6R Nanobody

, an institute formed by Catalent Pharma Solutions, to promote collaboration between industry and academia, provide applied drug-delivery education and training, and advanced drug delivery, has appointed Claus-Michael Lehr, Head of the Department of Biopharmaceutics and Pharmaceutical Technology, Saarland University, Germany and Co-founder and Head of the Department “Drug Delivery” of the Helmholtz Institute for Pharmaceutical Research Saarlandto the institute’s advisory board.

Professor Lehr has t more than 15 years researching ways to overcome biological barriers to effective drug delivery and the development and formulation of appropriate carriers to transport active pharmaceutical and biopharmaceutical molecules to desired targets. He has co-authored many publications on the development of sophisticated 

 models that represent the epithelial cells and tissues concerned in transport, and the application of nanotechnology to improve 

Catalent Applied Drug Delivery Institute appoints Claus-Michael Lehr to advisory board.

Catalent Applied Drug Delivery Institute Appoints New Advisory Board Member

has received a Complete Response Letter from FDA for the resubmission of its new drug application for sugammadex sodium injection, Merck’s investigational medicine for the reversal of neuromuscular blockade induced by rocuronium or vecuronium. 
The FDA’s letter raised concerns about the operational aspects of a hypersensitivity study that the agency had requested in 2008. Merck is evaluating the Complete Response Letter and expects to be able to determine a path forward in the near future.

As previously disclosed, the FDA cancelled the discussion of sugammadex at the July 18th Anesthetic and Analgesic Drug Products Advisory Committee. At that time, the FDA advised Merck that the agency needed additional time to assess the results of the agency’s recently completed inspection of a clinical trial site conducting the hypersensitivity study.

Sugammadex is currently marketed in more than 50 countries other than the United States. If approved, sugammadex would be the first in a new class of medicines, known as selective relaxant binding agents, to be used in the US. 

Merck & Co. has received a Complete Response Letter from FDA for the resubmission of its new drug application for sugammadex sodium injection.

Merck & Co. Receives Complete Response Letter From FDA Regarding Sugammadex Sodium Injection

The Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh), a medicines regulatory body representing the EU member states, has endorsed the recommendation to suspend the marketing authorization of Numeta G13%E because of a risk of hypermagnesaemia. Numeta G13%E, which is given into a vein to premature babies to provide nutritional support, will remain suspended until a re-formulated preparation is made available.

For Numeta G16%E, used in full-term newborns and children up to 2 years, the CMDh agreed that the benefit-risk balance remains positive. Patients whose blood magnesium levels are elevated or signs of hypermagnesaemia are identified Numeta G16%E should be stopped or the infusion rate reduced.

The review of Numeta G13%E and Numeta G16%E was carried out by the 

EMA Pharmacovigilance Risk Assessment Committee

 (PRAC) following several reports of hypermagnesaemia in preterm infants. As a precautionary measure, the manufacturer decided to voluntarily recall Numeta G13%E in the EU. The PRAC assessed the available data on the risk of hypermagnesaemia with Numeta G13%E and Numeta G16%E preparations from clinical studies, post-marketing reports and the published literature and considered available treatment guidelines. 

The PRAC concluded that the administration of Numeta G13%E could lead to a higher risk of hypermagnesaemia, and noted that this risk is further increased in premature newborns because their kidneys are immature and less able to clear the body of magnesium. 

For Numeta G16%E, the PRAC concluded that although the magnesium content may result in a magnesium intake that is slightly higher than suggested in some guidelines, the proposed measures, including updating the product information and a further study, are sufficient to ensure the safe use of this product. In addition, the PRAC recommended a study be carried out to further evaluate blood magnesium levels observed in term newborn infants and children up to two years of age following use of Numeta G16%E.

As the PRAC recommendations were endorsed by consensus by the CMDh, they will now be implemented directly in all Member States, according to an agreed timetable.

The CMDh agrees to suspend the marketing authorization of Numeta G13%E because of a risk of hypermagnesaemia.

EU's CMDh Recommends to Suspend Authorization for Numeta G13%E

 reported that Bayer has received a positive opinion from the EMA Committee for Medicinal Products for Human Use (CHMP) recommending approval of Xofigo (radium Ra 223 dichloride) in Europe. The proposed indication is for the treatment of adults with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastases. The decision of the European Commission on the approval is expected in the fourth quarter of 2013.

Xofigo injection was approved by FDA in May 2013 for the treatment of patients with CRPC, symptomatic bone metastases and no known visceral metastatic disease and is now available in the US at licensed facilities.

In September 2009, Algeta signed an agreement with Bayer for the development and commercialization of Xofigo. Under the agreement, Bayer will develop, apply for health authority approvals worldwide, and commercialize Xofigo globally. Algeta is eligible for royalties and milestones based on Bayer's sales of Xofigo outside the US, and Algeta US, is co-promoting Xofigo with Bayer in the US.

The EMA Committee for CHMP recommends the approval of Xofigo in Europe.