Formulation and Drug Delivery

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.

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.

Atlangram will have access to Carlina’s lipid nanocapsule technology platform Soludots under the terms of the agreement.

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.

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

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

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.

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

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

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

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.

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

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.

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.

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.

Threshold Pharmaceuticals' anticancer drug TH-302 receives FDA Fast Track designation.

ANSM wants company data on the benefits and risks of using Avastin over Lucentis in the treatment of wet age-related macular degeneration.

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

AstraZeneca announced a partnership with Pharmacyclics and Janssen for combination trials of MEDI4736 (AstraZeneca) with Imbruvica (Pharmacyclics and Janssen) for the treatment of hematologic cancers.

Spectranetics announced that it acquired Covidien's drug-coated balloon platform, Stellarex, for $30 million.

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