Amy Ritter, PhD

Ontario-area scientists discuss approaches to development of stem-cell therapies.

AstraZeneca announced further downsizing in response to an expected period of declining revenues in the face of patent expirations. The company will eliminate 2300 positions in sales and general administration.

AstraZeneca announced that it will consolidate its R&D capabilities into three centers located in Cambridge, UK; Gaithersburg, MD in the US; and M?lndal, Sweden. The reorganization will result in a net loss of 1600 position, mostly in the US and the UK.

INTERPOL and 29 of the world's largest pharmaceutical companies have joined forces in an initiative to battle counterfeit drugs.

Mylan announced that it has signed an agreement to acquire the generic injectables unit Agila Specialties from Strides Arcolab for $1.6 billion in cash.

FDA approved Roche?s antibody-drug conjugate, Kadcyla (trastuzumab emtansine or T-DM1), for the treatment of people with HER2-positive metastatic breast cancer.

Protein Sciences announced that the Biomedical Advanced Research and Development Authority (BARDA) will continue to support the company?s influenza vaccines program.

Eli Lilly and Co. announced that it will discontinue its Phase III rheumatoid arthritis program for tabalumab, an anti-BAFF (B cell activating factor) monoclonal antibody, because of lack of efficacy.

FDA has released a list of more than 50 guidance documents planned for 2013.

FDA has released a list of more than 50 guidance documents planned for 2013.

Ben Venue Laboratories announced that it has voluntarily entered into a consent decree with FDA over violations of cGMP.

According to the Federal Trade Commission, the number of potentially anticompetitive patent dispute settlements between branded and generic drug companies increased between 2011 and 2012.

Lonza will invest CHF 14 million ($15.1 million) to double the existing large-scale manufacturing capacity in Visp, Switzerland.

AbbVie, a research-focused, specialty biopharmaceutical company that was spun off from Abbott Pharmaceuticals, was officially launched on Jan. 2, 2013.

Amgen has agreed to pay $762 million to resolve criminal liability and false claims act allegations.

Anthrax antitoxin is the first monoclonal antibody approved under FDA's Animal Efficacy Rule, and the first product from BARDA's Project Bioshield to receive FDA approval.

Pfizer has agreed to pay $55 million plus interest to settle charges that Wyeth (acquired by Pfizer in October, 2009) improperly promoted the drug Protonix (pantoprazole).

Biogen Idec and Isis Pharmaceuticals announced that they have entered into a global collaboration agreement under which the companies will discover and develop antisense drugs against three undisclosed targets to treat neurological or neuromuscular disorders.

Eli Lilly released its annual report containing updates on progress and new initiatives in corporate responsibility.

Recent research examines the sequence of events underlying cellular reprogramming, which may aid in better control of the production of induced pluripotent stem cells.

Results from the 2012 employment survey.

Novartis announced that it has received FDA approval for a seasonal influenza vaccine produced in cell culture, the first seasonal vaccine produced by this method to be approved in the US.

FDA announced the availability of the guidance, “Q11 Development and Manufacture of Drug Substances,†in the Nov. 20, 2011 edition of the Federal Register.

House Democrats have requested the Government Accountability Office (GAO) to conduct an inquiry into factors leading to an increased reliance on compounded products.

An operation spanning 16 African countries and conducted by the World Customs Organization (WCO) in partnership with the Institute of Research against Counterfeit Medicines (IRACM) led to the seizure of more than 82 million doses of counterfeit medicines.

Boehringer Ingelheim agreed to pay $95 million to settle allegations that it improperly promoted four of its drugs.

Industry experts from GE Healthcare, Tarpon Biosystems, Polybatics, Merck Millipore, and Repligen discuss the challenges of adapting disposable technology to the chromatography process.

Creating an effective nucleic acid-based vaccine requires protecting the fragile nucleic acid from degradation, effective transfection of the targeted cells, and producing high enough levels of antigen to evoke a robust immune response.

Watson Pharmaceuticals has received clearance from the Federal Trade Commission (FTC) for its acquisition of generic drug manufacturer, Actavis.

FDA announced that it is working closely with the Centers for Disease Control to identify the source of an outbreak of meningitis among patients who had received an epidural steroid injection.