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March 31, 2014

March’s top stories: Abide and Celgene partner, AstraZeneca’s FDA approval

Abide Therapeutics formed a strategic partnership with Celgene to discover and develop new drugs in inflammation and immunology ,while AstraZeneca received US Food and Drug Administration (FDA) approval for its Bydureon Pen to treat type 2 diabetes. Pharmaceutical-technology.com wraps-up the key headlines from March 2014.

By admin-demo

Abide

Abide and Celgene partner to develop new drugs in inflammation and immunology

Biopharmaceutical firm Abide Therapeutics formed a strategic partnership with Celgene to discover and develop new drugs in inflammation and immunology.

Abide has engineered technologies to selectively target serine hydrolases, one of the largest enzyme families involved in regulating human physiology.

The proprietary Abide technology platform provides a unique highly selective small molecule collection that specifically targets the common catalytic site of serine hydrolases, conferring a rapid and effective method for target identification and validation.

AstraZeneca obtains FDA approval for Bydureon Pen to treat type 2 diabetes

AstraZeneca received approval from the US Food and Drug Administration (FDA) for its Bydureon Pen (exenatide extended-release for injectable suspension) 2mg as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes.

Bydureon Pen is a pre-filled, single-use pen injector that eliminates the need for patients to transfer medication between a vial and syringe during self-injection.

It contains the same formulation and dose as the original Bydureon single-dose tray, providing the same continuous release of exenatide.

Eisai and Biogen partner to develop new treatments for Alzheimer’s

Eisai

Japanese pharmaceutical firm Eisai entered into a collaboration with US-based Biogen Idec for the development and commercialisation of Eisai’s two clinical candidates E2609 and BAN2401 for treating Alzheimer’s disease (AD).

As part of the collaboration, Eisai has an option to jointly develop and commercialise two of Biogen Idec’s candidates, an anti-amyloid beta (Aß) antibody BIIB037 and an anti-tau monoclonal antibody for AD.

The deal will intially focus on the co-development and co-commercialisation of Eisai’s two candidates E2609, a ß-site amyloid precursor protein cleaving enzyme (BACE) inhibitor and BAN2401, an anti-Aß antibody.

AstraZeneca introduces combination drug Xigduo in UK for type 2 diabetes

AstraZeneca

AstraZeneca launched its twice-daily tablet Xigduo (dapagliflozin and metformin hydrochloride in 5mg/850mg and 5mg/1000mg tablets) in the UK to treat patients with type 2 diabetes.

Xigduo is the first fixed-dose combination of Forxiga (dapagliflozin), a selective and reversible inhibitor of SGLT2, and metformin hydrochloride (HCI), to be available in the UK.

The tablet is currently available for use on NHS England and NHS Wales only, as the National Institute for Health and Care Excellence (NICE) and All Wales Medicines Strategy Group (AWMSG) have decided not to appraise it, on the basis that the current guidance for dapagliflozin already covers all patients that Xigduo would be clinically suitable for.

TC BioPharm collaborates with Medinet for new cancer immuno-cell therapy

TC Biopharm

Scotland-based biotechnology firm TC BioPharm (TCB) entered into a strategic collaboration with Medinet, a Japanese immuno-cell therapy company, for developing a new treatment for different types of cancer.

As part of the deal, Medinet will license its new cell therapy technology to TC Biopharm for clinical development in Europe.

The technology involves using patients’ own immune cells grown in culture to target cancer, and is claimed to have safely treated patients in Japan.

Merck’s NOXAFIL injection secures US FDA approval

The US Food and Drug Administration approved Merck’s antifungal agent NOXAFIL (posaconazole) injection (18mg/ mL), a new formulation for intravenous (IV) use.

The antifungal agent is also marketed as NOXAFIL (100mg) delayed-release tablets and NOXAFIL (40mg/mL) oral suspension.

NOXAFIL injection, delayed-release tablets and oral suspension are indicated for prophylaxis of invasive Aspergillus and Candida infections.

Novo Nordisk spends $100m on new purification pilot facility in Denmark

Novo Nordisk has reported that it is increasing its drug development capacity by investing kr500m ($100m) in a new R&D facility in Bagsværd, Denmark.

The new pilot facility will expand the company’s ability to make active pharmaceutical ingredients (APIs) for a growing number of diabetes drugs under development.

The new 2,700m² pilot plant will be fully operational by late 2016 and will be run by CMC Supply (Chemistry, Manufacturing and Control Supply), a unit within Novo Nordisk R&D.

Pfizer’s vaccine candidate bivalent rLP2086 obtains breakthrough status from FDA

The US Food and Drug Administration (FDA) has granted breakthrough therapy status to Pfizer’s vaccine candidate, bivalent rLP2086, currently being investigated for the prevention of invasive meningococcal disease due to Neisseria meningitidis serogroup B in people aged ten to 25.

Globally, there are between 20,000 and 80,000 cases per annum due to the disease caused by Neisseria meningitidis serogroup B.

Caused by Neisseria meningitidis serogroup B, the disease can result in death or significant long-term disabilities, including brain damage and hearing loss.

European Commission approves GSK’s diabetes drug Eperzan

The European Commission (EC) granted marketing approval for GlaxoSmithKline’s (GSK) once-weekly diabetes drug albiglutide, which is marketed as Eperzan.

The drug is indicated for treatment of type 2 diabetes mellitus in adults to improve glucose control.

GSK said that the drug is used as monotherapy, when diet and exercise alone do not provide adequate glycaemic control in patients for whom the use of metformin is considered inappropriate due to contraindications or intolerance.

Roche’s subcutaneous formulation of lymphoma drug MabThera gets approval in Europe

The European Commission (EC) approved Roche’s new subcutaneous (SC) formulation of MabThera (rituximab) for treatment of patients with follicular lymphoma and diffuse large B-cell lymphoma.

This is the second European approval for a new subcutaneous formulation of one of Roche’s oncology products and follows the approval of Herceptin SC in September 2013.

MabThera is a therapeutic monoclonal antibody that binds to a particular protein, the CD20 antigen, on the surface of normal and malignant B-cells and later it recruits the body’s natural defences to attack and kill the marked B-cells.

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