News

Under an NIH contract, Paragon Bioservices will design a manufacturing process for recombinant human rhE-selectin protein.

The acquisition will enhance Merck's "superbug" medication portfolio.Merck announced Dec. 8, 2014 that it would acquire Cubist Pharmaceuticals for a total transaction value of approximately $9.5 billion, including a little over $1 million in debt. The deal will add to Merck’s portfolio of drugs treating antibiotic-resistant bacteria, such as Cubist’s antibiotic Cubicin (daptomycin for injection), the only approved once-a-day therapy for both Staphylococcus aureus bacteremia and complicated skin and skin structure infections.

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

Sanofi executives are being charged in a whistleblower lawsuit for allegedly granting illicit payments to healthcare providers.

Amgen's bispecific T-cell engager (BiTE) antibody constructs help the body fight malignant cancer cells.

Enhanced R&D efforts and the growing manufacture of finished-dosage drugs in India will shape the country's future success, according to a new report from CPhI.

CytRx receives formal written communication from FDA on a prior decision for a partial clinical hold for CytRx's trials involving chemotherapeutic agent aldoxorubicin.

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

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

Roche announced the acquisition of Ariosa Diagnostics, a molecular diagnostics testing service provider and maker of the prenatal blood test, Harmony.

Biotech drug manufacturers' emails may have been hacked by individuals with sophisticated investment banking skills, according to a report from the New York Times.

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

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

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.

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

FDA will delay its decision regarding the new drug application for panobinostat.

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

The announcement calls attention to another partnership in the growing T-cell receptor engineering space.

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

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

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

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

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

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

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.

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.