Dosage Forms

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.

Pfizer will pay $850 million upfront and as much as $2 billion later in a deal to jointly develop one of Merck?s cancer drugs.

Grand River Aseptic Manufacturing has announced that the company executed two commercial production contracts in one day.

Avastin plus chemotherapy for the treatment of ovarian cancer increased progression-free survival by 62% compared with chemotherapy alone.

After being plagued by numerous delays, Lemtrada (alemtuzumab) has finally been approved by FDA for the treatment of multiple sclerosis.

Advanced analytical methods are speeding up the targeted evaluation of potential viral contaminants.

Carrying on from our weekly column to help you eliminate a number of tablet manufacturing problems and tablet tooling failures with a simple seven-step tool-care process, we look at the third step, Repair.

Catalent has acquired Micron Technologies, a provider of particle size engineering technologies.

As the second part of this series, we look at the importance of ?assessing? the punches and dies to check their condition and how this step may help avoid any problems that may occur during tablet manufacture.

Catalent Pharma Solutions announces additional packaging and storage space for highly potent and cytotocix drugs at Kansas City facility.

Capsugel gives lead users access to intrinsically enteric capsule technology and support services.

Manufacturers face regulatory overhaul, while brand-generic debates escalate over biosimilars and labeling changes.

The parenteral manufacturing industry is taking action to address particulate contamination issues.

A G-CON, GEA, and Pfizer collaboration developed a PCMM (portable, continuous, miniature, and modular) system to produce oral solid-dosage drugs.