
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.

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.

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.

New platform technologies and polymer chemistries may facilitate self-administration, longer-term delivery, and targeted delivery of parenteral drugs.

Pfizer has launched a prescription-fulfillment website for Viagra tablets in an effort to combat the online sale of counterfeited medicine.

The Global Vaccine Action plan maps out a strategy to increase access and R&D for vaccines.

More than 12,000 industry professionals, including 8,100 show attendees, participated in INTERPHEX 2013, a 20% increase over the 2012 show.

While there are those who want combination products to be controlled by a centralized pharmaceutical-type approval system, the majority of the medical technology industry wants to retain a decentralized device-focused approach.