News

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.

Company receives notice from FDA for not fully investigating foreign particles in APIs and finished products made from its facility in Ingelheim am Rhein, Germany.

The draft guidance describes how quality agreements can be used to delineate the responsibilities of contract manufacturers involved in the cGMP manufacture of APIs and finished drug products.

Johnson & Johnson anticipates submitting more than 10 new product filings and more than 25 significant brand line extensions by 2017; the announcement was made at a recent meeting with industry analysts. Upcoming new products include simeprevir for hepatitis C (already filed in Japan, Europe and the US); ibrutinib and daratumumab for haematologic malignancies; sirukumab and guselkumab for diseases of the immune system such as rheumatoid arthritis and psoriasis; and vaccines for influenza, rabies and polio.

The South Wales, UK contained-manufacturing operation was built in less than a year using design-to-manufacture and modular approaches.

USP defers implementation date to work closely with ICH Q3D. USP will also form a new advisory group for implementation of the new general chapters on elemental impurities.

Valeant Pharmaceuticals and Bausch + Lomb have entered into a definitive agreement under which Valeant will acquire Bausch + Lomb for $8.7 billion in cash.

New design meets new process requirements.

Partnership will support development of drugs to fight antibiotic resistance and bioterrorism.

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.

The U.S. Pharmacopeial Convention is offering free online access to public standards to help ensure the quality of the herbal ingredients used in medicinal products.

Actavis Inc. and Warner Chilcott plc have entered into a definitive agreement under which Actavis will acquire Warner Chilcott plc in a stock-for-stock transaction valued at approximately $8.5 billion.

Crushing, fracturing, and bending tests quantify hardness.

Program aims to develop a novel oral treatment.

Elan will purchase interest in four respiratory programs.

Thomson Reuters released a report that provides a view of the challenges facing companies entering the United States biosimilar drug market.

FDA has released guidance on best practices for conducting and reporting pharmacoepidemiologic safety studies.

Biotage issued a statement in response to a recent announcement from CEM Corporation about a patent issue with Biotage.

New Center for Pharmaceutical Advancement and Training increases number of experts and available tools in Sub-Saharan countries.

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.

CEM Corp. announced that its European Patent covering microwave assisted solid phase peptide synthesis has been upheld.

The workshop will cover a proposed new method for measuring moisture vapor transmission rate.

New line in Swiss facility produces ready-to-fill syringes.

EMA streamlines orphan drug application procedure.