News

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

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.

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.

Swedish CDMO, Recipharm AB, has entered into a long-term collaboration with Flamel Technologies SA, a drug-delivery company based in France. Under the terms of the agreement, Recipharm will acquire Flamel?s development and manufacturing facility located in Pessac, France, for EUR10.6 million plus the value of the inventory.

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.

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.

CDMO Vetter has opened a new representative office in Singapore in response to growing market demand in Asia.

USP and ChP jointly host two-day meeting to strengthen cooperation.

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.