The NIH has launched a Phase I clinical trial in humans of an investigational Zika vaccine.

A $2-million, three-year grant will explore how statistically-based pharmaceutical quality standards might be established.

Jacobs Engineering Group was awarded a contract to provide engineering services and procurement for Alnylam Pharmaceuticals’ new manufacturing facility in Norton, Massachusetts.

The manufacturing subsidiary of Astellas Pharma in Oklahoma has been transferred to CMO Avara and renamed Avara Pharmaceutical Technologies.

The cyclin dependent kinase inhibitor received Breakthrough Therapy Designation as a first line treatment for advanced breast cancer.

FDA approved Natco and Alvogen’s generic Tamiflu to treat and prevent influenza.

After divesting 79 generics businesses, the company completed its acquisition of Actavis Generics, including its over-the-counter business, on August 2. The following day, it bought Anda, Inc., the fourth largest generics distributor in the United States.

Xiamen Origin Biotech Co., Ltd, was cited, not only for inadequate quality management, but for falsifying information on certificates of analysis, having fictional employees sign CoAs, and having employees lie to inspectors.

The company will install new vial-filling and lyophilization capacity, including an isolator-based filling machine. The new filling equipment will result in a five-fold increase in the company's current filling capacity.

The collaboration will focus on methods to eradicate cancer stem cells

The acquisition will add to the company's cell therapy base and potential impact in treating rare diseases.

An MIT-developed system uses microbes for manufacturing small amounts of vaccines and other therapies.

The new materials handling laboratory will be used for storage, dispensing, inventory management, and distribution of non-GMP materials.

Congressional partisanship creates noise, but no funding for Zika virus research.

Galvani Bioelectronics will be based in Stevenage, UK, and headed by Kris Famm, GSK's vice president of bioelectronics R&D

Amgen discussed the drug-delivery approaches to two of its biologics in a recent second-quarter earnings call.

NIST’s monoclonal antibody reference material can be used as a standard for biopharmaceutical analytical quality control.

The investment will be spread across three sites: Barnard Castle in County Durham; Montrose, Scotland; and Ware, Hertfordshire.

The move follows a warning from FDA wherein FDA cited ALK-Abello with numerous manufacturing violations.

FDA and industry seek speedy Congressional approval of new user fee plan.

The Phase I trial will test Bavarian Nordic’s vaccine, which is manufactured using a vaccine vector based on smallpox.The recent resurgence of yellow fever incidences over the past six months has prompted health officials to ramp up the fight against the virus. Like the Zika virus, yellow fever is transmitted primarily through the bite of infected female Aedes aegypti mosquitoes.

On July 27, 2016, John C. Lechleiter, PhD, chairman, president, and CEO of Eli Lilly, announced his retirement from the company. This decision is effective December 31, 2016, however, Lechleiter will remain on the company’s board of directors until May 31, 2017 as a non-executive chairman. Lechleiter joined the company in 1979 as a senior organic chemist in process R&D. He has served as CEO of Eli Lilly since April 2008.

The affinity purification company will set up shop at the former Merck & Co./GlycoFi facility in the Dartmouth Regional Technology Center in New Hampshire.

The project involves installation of a small-scale pressured agitated nutsche filter dryer in glass, integrated in a high-containment isolator to achieve an occupational exposure limit of less than 1 microgram per meter cube, 8-hour time weighted average.

A new era has begun to address the deadly innovation gap in tackling the antimicrobial resistance crisis.

CDMO Saneca Pharma has sold registration dossiers for more than 20 pharmaceutical products to Xantis Pharma and will hold an exclusive five-year contract manufacturing agreement for the products with Xantis Pharma.

The therapeutic candidate AZD8601is an investigational mRNA-based therapy that will be tested for its ability to regulate the protein that influences vascular tissue growth.

The mAb, in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, was granted a Breakthrough Therapy Designation from FDA for the treatment of multiple myeloma.