Dosage Forms

Understanding and preventing protein aggregation is crucial to ensuring product quality and patient safety.

Entrectinib has received FDA’s orphan drug and rare pediatric disease designations for the treatment of neuroblastoma.

The Cell Therapy Catapult, a UK non-profit center for advancing cell and gene therapies, will manage the manufacturing center, which will be used for late-phase clinical trials and commercial supply.

FDA has scheduled a public meeting in early January to assess and weigh data on the first United States application for a biosimilar therapy.

FDA funded projects at Rutgers' C-SOPS and at UMass Lowell to develop flow-sheet model algorithms for use in risk assessment, and start-up company Continuus Pharmaceuticals is making progress on their integrated system.

Baxter announced that it had entered into an agreement to sell its Vero cell technology and related assets to Nanotherapeutics.

The development and approval of new vaccines and antivirals to contain and treat the Ebola virus outbreak has become a top priority for the federal government and Congress, as seen in new policies to spur R&D and added funding for these efforts.

US Department of Health and Human Services announced a declaration to provide immunity to legal claims made in the US in relation to three investigational Ebola vaccines.

On December 8, Pfizer announced that it will establish a research program in gene therapy, and collaborate with Spark Therapeutics in Philadelphia, to develop potential gene therapy treatments for hemophilia.

Sandoz announces their version of filgrastim, a follow-on biologic for the treatment of neutropenia, is as safe and effective as Amgen's Neupogen.

The final article of this series will look at the last two steps of the PharmaCare seven-step process?Lubricate and Store.

No evidence that Fluad vaccine caused deaths in Italy, says EMA.

Ranbaxy and Epirus announce the launch of India's first biosimilar for Remicade.

Lung Therapeutics announced that it received Orphan Drug Designation for LTI-01, an injectable designed for the treatment of loculated pleural effusion.

Dual sourcing is one of many possible solutions to securing the supply chain.

In anticipation of this mandatory switch from Oxyfume 2000 to 100% EtO for BI testing, comparison studies were performed to determine if the switch from Oxyfume 2000 to 100% EtO would have any impact on BI resistance label claims.

Solving the problem of tablet spots or specks involves prevention and thorough investigation.

Dr. Thomas Hein, Director Business Development and Regulatory Affairs at Hermes Pharma, discusses the difference between user-friendly dosage forms and conventional tablets and capsules.

Dalton Pharma Services announced it was awarded funding from ISTPCanada for its project to develop vaccines for respiratory syncytial virus and parainfluenza type 3.

A good cleaning regime goes hand in hand with a good polishing regime, which forms Step 5 of the process and is arguably the next most critical step. It is cleaning and polishing that deliver most noticeable benefit into production, reducing tablet press down time and helping to increase productivity.

Opdivo and investigational agent FPA008 will be tested in combination for their efficacy in boosting antitumor immune response.

Aurobindo Pharma USA issued a voluntary nationwide recall of Northstar Label Gabapentin Capsules, USP 300 mg, due to complaints of empty capsules.

Merck announced an agreement with NewLink Genetics to acquire exclusive rights to its experimental Ebola vaccine, rVSV-EBOV, for $50 million.

Approximately 40% of total global growth will come from specialty medications, according to a new report from the IMS Institute for Healthcare Informatics.

GSK Australia's Boronia site will install next-generation blow-fill-seal machinery for aseptic filling.

FDA opens public docket on proposed criteria for “first generic” ANDAs.

Over the last three weeks, we have been looking at each step and the benefit of adopting the process. This week, we look at Step 4, Measure.

Ralph G. Neas, president and CEO of the Generic Pharmaceutical Association, requests that Congress get involved in the support of a more competitive drug market.

Although the source of spots and specks on tablets is sometimes difficult to identify, following good maintenance and manufacturing practices can help solve or even prevent the problem.

A new report from The Pharmaceutical Care Management Association alleges that FDA hinders competition in the pharmaceutical industry and influences how a drug's price is calculated.