Amy Ritter, PhD

Stem cells are being developed to treat a diverse set of conditions, including spinal cord injury, amyotrophic lateral sclerosis, macular degeneration, Parkinsons disease, and Type I diabetes. But the challenges in moving from the laboratory to the clinic are formidable.

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 positions, mainly in the UK and the US.

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.

In January, 2011, FDA released its guidance, Process Validation, General Principles and Practices, describing process validation practices based on quality-by-design principles.

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.

Researchers from Heriot-Watt University in Edinbugh and Roslin Cellab in the UK describe a method for producing uniformly sized spheroids composed of human embryonic stem cells in the Feb. 4, 2013 issue of the journal Biofabrication.

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.

According to FDA, 75% of the products in shortage are generic sterile injectables; low-margin products that must be manufactured in specialized facilities and that must meet stringent quality metrics.

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

At the end of February, sunny southern California will be the site for a week-long conference devoted to the development and production of biopharmaceuticals.

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.

With the release of a draft guidance on the evaluation and labeling of abuse-deterrent opioid formulations, FDA is one step closer to clarifying its thinking on acceptable formulations for this product class.

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 USD 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 to discover and develop antisense drugs against three undisclosed targets to treat neurological or neuromuscular disorders.

Endo Pharmaceuticals, maker of the opioid medication Opana ER (oxymorphone HCl), is suing FDA to prevent generic manufacturers from entering the market with formulations of oxymorphone that are not abuse-resistant.

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

Annual employment survey results show greater confidence in the pharma industry.

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.

Yesterday, FDA Commissioner Dr. Margaret Hamburg testified before the House Energy and Commerce Committee on the fungal meningitis outbreak.

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.