News

Roche will use Dutalys’ DutaMab technology for the engineering of bispecific therapeutic antibodies.

Roche will use Dutalys’ DutaMab technology for the engineering of bispecific therapeutic antibodies.Roche Acquires Bispecific Antibody Developer Dutalys

Fujifilm Diosynth Biotechnologies announced the completion of the acquisition of Kalon Biotherapeutics, a company that specializes in advanced biologics development manufacturing.

Xencor's technology focuses on the use of antibody and protein biotherapeutics to treat immune-related diseases.

Biomanufacturing capacity expansion uses modular cleanroom design and single-use technologies.

Halozyme will receive an initial payment of $15 million for Enhanze, its technology that enables biologics to be delivered as a simple subcutaneous injection.

The agency publishes two guidance documents on providing regulatory submissions in electronic format.

A statement from GPhA’s president expresses the organization’s support of FDA’s proposed rule to amend labeling regulations.

New organization offers support to contract research organizations and contract manufacturing organizations in the New England area.

The new bill calls for a data exclusivity period of 15 years for drugs that treat diseases with unmet medical need.

Patient access to critical experimental medicines continues to grab public attention as states enact “Right-to-Try” laws and Congress eyes establishing a national policy to provide not-yet-approved therapies to terminally ill patients.

NICE OKs biologics for the treatment of ulcerative colitis, changing its preliminary guidance that recommended against their use.

Baxter announced that it had entered into an agreement to sell its Vero cell technology and related assets to Nanotherapeutics.

FDA announced the approval of Gardasil 9 for the prevention of certain diseases caused by nine types of HPV, five more than the previously FDA-approved Gardasil.

Reference product manufacturers and trade groups support automatic medication switches in new biosimilar “compromise” terms.

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.

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.

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

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