Indian manufacturers are moving towards high-value, low-volume work, with complex chemistry and intellectual property challenges.

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

Japanese drugmaker Otsuka announced plans to buy CNS-specialist Avanir Pharmaceuticals for $3.5 billion in an all-cash tender offer.

On Oct. 7, 2014 at CPhI Worldwide in Paris, France, UBM Live announced the winners of the 11th annual CPhI Pharma Awards.

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

Medtronic announced that it received clearance from both the FTC and European Commission to acquire Covidien for $43 billion.

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

The company's lead candidate, MGB-BP-3, has shown promising results against a broad range of multi-resistant Gram-positive strains.

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.

The Baxter recall in the US of one lot of highly concentrated potassium chloride is due to a mislabeled overpouch.

The Singapore API facility will be operational by 2016.

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

Thermo Fisher Scientific announced a collaboration with Samsung to design, develop, and market new solutions for point-of-care.

The more than $200 million project will increase production capacity at the facility to support AstraZeneca':s maturing pipeline.

Margaret Hamburg, FDA Commissioner, visited China recently to oversee efforts to strengthen inspection and regulatory reviews and to attend the Ninth International Summit of Heads of Medicines Regulatory Agencies Meeting

An index from the Access to Medicine Foundation ranks GSK as most effective in making products accessible.

Ulf Wiinberg has resigned as Lundbeck's CEO over unapproved acceptance of shares in a biotech company.

GSK and Novartis announced a meeting on Dec. 18, 2014 to discuss the $20 billion asset swap between the two companies.

Tufts research suggests costs to launch a new drug have doubled since 2003, but some question conclusions.

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

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.

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

The United States government is ramping up support for formulation, production, and packaging of Ebola treatments.

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

Revised EMA policy reflects more balanced approach and experts are to submit updated declarations of interests by end of January 2015.

Shire will establish its US operational headquarters in Massachusetts and relocate staff from Pennsylvania.