Adeline Siew, PhD

A multifaceted approach is needed to resolve the myriad of challenges in developing oral formulations of poorly soluble drugs.

Amgen and Astellas have entered into a strategic alliance to provide new medicines for serious unmet medical needs of Japanese patients. The alliance leverages the complementary capabilities of both companies through an innovative business model that combines Amgen's pipeline candidates with Astellas' deep knowledge of Japanese patient and physician needs, long-term commercial and regulatory experience, and strong presence as a leading company in Japan.

Pfizer has discontinued a Phase III study of its investigational cancer drug, inotuzumab ozogamicin, in relapsed or refractory aggressive non-Hodgkin lymphoma (NHL) after it failed to show benefit in overall survival.

Novo A/S, the holding company of Denmark's Novo Nordisk, has acquired Xellia Pharmaceuticals and purchased all shares of the group for approximately US$ 700 million.

AbbVie and Galapagos have extended their collaboration on the clinical development of GLPG0634 to include Crohn's disease.

AstraZeneca announced that three of its cancer compounds-moxetumomab pasudotox, olaparib and selumetinib-will be moving forward to Phase III clinical development. Oncology is one of the company's core therapy areas and accelerating the development of a number of new molecular entities in its pipeline is a strategic priority.

Eli Lilly reported that enzastaurin did not meet the primary endpoint in a Phase III study, which evaluated the agent as a monotherapy for the prevention of relapse in patients with diffuse large B-cell lymphoma (DLBCL).

Amgen and Zhejiang Beta Pharma have signed an agreement to form a joint venture to commercialize Amgen's Vectibix (panitumumab) in the Chinese market. The aim is to quickly and efficiently deliver Vectibix to patients in China. Vectibix is a fully human anti-epidermal growth factor receptor (EGFR) antibody approved by FDA for the treatment of metastatic colorectal cancer.

Takeda and US vaccines maker Inviragen jointly announced that they have entered into a definitive agreement for Takeda to acquire Inviragen for an upfront payment of US$35 million and future payments of up to US$215 million upon achievement of key commercial milestones, linked to the progress of clinical development.

In its commitment to transparency, GlaxoSmithKline (GSK) has outlined plans to share detailed data from its clinical trials. GSK is to establish a new online system that will enable researchers to request access to anonymised patient level data.

Lyophilization technologies for controlled nucleation.

Genentech announced that FDA has approved Actemra (tocilizumab) for the treatment of polyarticular juvenile idiopathic arthritis (PJIA) in children aged two years and older.

Pharmaco-Kinesis Corporation (PKC) announced that it is developing the first nanodrug combination of Merck's temozolomide and Celgene's thalidomide (in a 50:50 ratio) for the treatment of gliomas and other cancers. PKC will collaborate with the University of California, San Diego's department of nano-engineering at the Moores cancer centre to develop the nanodroplet formulation.

Bayer announced that it has signed a merger agreement with US-based birth-control specialist Conceptus.

Catalent Pharma Solutions, a provider of drug and biologic development services, delivery technologies and supply solutions, has officially opened a new biomanufacturing center of excellence in Madison. The facility, which was constructed in response to customer demand, is expected to quadruple Catalent's current biologics manufacturing capacity and extensively utilise single-use technology for greater flexibility and efficiency. It will allow the company to extend its offerings in the biologics sector while enhancing the efficiency and output of its proprietary GPEx cell line engineering technology as well as other mammalian cell lines.

Lundbeck has launched Selincro in Norway, Finland, Poland and the Baltic countries of Latvia, Lithuania and Estonia for the treatment of alcohol dependence in patients with high-risk drinking levels. According to Lundbeck, the launch marks the first introduction of a new treatment for alcohol dependence in Europe for more than a decade.

BioOutsource, a contract testing services provider to the biopharmaceutical industry, has opened a new facility in Cambridge, Massachusetts. The facility marks the company's first North American offices, which were opened in response to increasing demand for the company's bioanalytical and biosafety services, particularly in the field of biologic and biosimilar characterisation.

EMA has upgraded its EudraGMP database to include information on GDP in addition to GMP. The new EudraGMDP database is a key deliverable of the Falsified Medicines Directive (FMD) that came into effect in January 2013. The aim is to increase supply chain security in the EU by making supervision of manufacturing and distribution of medicines more robust to ensure supplier compliance.

AstraZeneca and BIND Therapeutics have formed a strategic collaboration to develop and commercialise BIND's Accurin, a targeted and programmable cancer nanomedicine, based on a molecularly targeted kinase inhibitor developed and owned by AstraZeneca.

Cipla has launched the first biosimilar of etanercept in India for the treatment of rheumatoid disorders. The product will be marketed under the brand name Etacept. The launch of Etacept marks Cipla's entry into the biologics market, offering a low-cost alternative to Pfizer and Amgen's rheumatic disorder blockbuster Enbrel in India.

Eli Lilly has announced positive top-line results for two of its Phase III trials, AWARD-2 and AWARD-4, which evaluated dulaglutide as a once-weekly treatment in patients with type 2 diabetes. Both trials met the primary efficacy endpoints, demonstrating non-inferiority of dulaglutide compared to insulin glargine, measured by a reduction of hemoglobin A1c (HbA1c) levels at the 1.5 mg dose level.

Oval Medical Technologies, an autoinjector company based in Cambridge, UK, reported that a variety of highly viscous solutions have been successfully delivered through a 25-gauge thin-wall needle, in less than 7 seconds, using its innovative autoinjector. The technology provides solutions to problems in the industry for drug containment and the end user.

Regeneron, a biopharmaceutical company based in New York, has announced plans to expand its corporate headquarters and laboratories in Westchester. This expansion will create more than 400 new highly skilled jobs and further cement Hudson Valley's reputation as an emerging epicenter for biopharmaceutical growth.

Teva and Lonza have announced that their joint venture will continue to develop, manufacture and market affordable, efficacious and safe biosimilars.

Astellas and Ambrx have entered into a collaboration to discover and develop novel antibody drug conjugates (ADCs) for an undisclosed number of targets in oncology. ADCs enable targeted delivery of drugs to the target tissue.

Experts describe best practices for sterility assurance in parenteral drug manufacturing. This article contains bonus online-exclusive material.

Shire has announced plans to acquire dry eye specialist SARcode Bioscience with the aim of expanding its ophthalmics portfolio. Under the terms of the agreement, Shire will pay $160 million upfront and SARcode shareholders will receive additional undisclosed payments upon achievement of certain clinical, regulatory and/or commercial milestones.

Xceleron and JCL Bioassay have entered into a partnership that will offer drug developers access to a range of sensitive and robust analytical platforms for early clinical development across Asia, Europe, and North America.

ThromboGenics' eye drug, Jetrea (ocriplasmin) has been approved in the EU for the treatment of vitreomacular traction (VMT), including when associated with macular hole of diameter less than or equal to 400 microns.

Roche and BioLamina have entered into a research and development agreement to jointly develop new cell culture systems for various applications, including stem cell research. The collaboration will assess laminin-based in-vitro cell culture matrices that can offer physiological microenvironments for living cells.