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The agency releases guidance on controlled correspondences related to generic-drug development.

The US Pharmacopeial Convention preposts its new chapter on sterile preparations for compounding pharmacies for public review.

MedImmune and 3M Drug Delivery Systems collaborate to develop toll-like receptor (TLR) agonists for immuno-oncology.

US Compounding, Inc. issues voluntary recall of all sterile products.

A drug price hike like that of the one seen in the highly publicized case of Turing Pharmaceuticals' Daraprim is prompting a public outcry and is demonizing the industry for those who see Martin Shkreli as representative of all pharmaceutical executives. But capping drug price increases may affect actual patient costs less than imagined, and may have a bigger impact on pharmacy benefit managers and insurance companies.

Hillary Clinton unveiled a new plan on Sept. 22 during a community forum in Des Moines, Iowa to tackle high drug prices. The plan reveal was a follow-up to a tweet from the presidential candidate a day prior, on Sept.

ABP 215, an investigational biosimilar for Avastin, was shown to be as safe and effective as its branded counterpart in trials for the treatment of advanced non-squamous non-small cell lung cancer.

In testifying before Congress on FDA regulation of long-awaited biosimilars, Janet Woodcock emphasized the importance of ensuring that the evaluation of new therapies is based on sound science.

Six grants from the NIH will help identify variants in the genome’s regulatory regions that affect disease risk, using new computational approaches.

Novo Nordisk will build a local manufacturing plant for FlexPen prefilled insulin delivery devices in Iran.

Tomas Salmonson is re-elected as Chair of the Committee for Medicinal Products for Human Use.

The fully humanized monoclonal antibody is licensed to Bristol-Myers Squibb.

FDA issues warning letter to Jaychem Industries, Auckland, New Zealand for violating CGMP regulations.

The agency cited Pan Drugs Limited with improper cleaning of facilities and equipment.

Under terms of the agreement, Amgen will license Xencor’s XmAb technology platform for five Amgen programs and one Xencor program.

The protective suit was recently honored by Fast Company’s 2015 Innovation by Design Awards.

Novovax’s investigational vaccine targeting respiratory syncytial virus (RSV) demonstrated clinical effectiveness in animal models.

The White House nominates Robert Califf to head FDA, but will he be confirmed?

Nexvet Biopharma, a veterinary biologics developer, secured a dedicated, cGMP biologics manufacturing facility in Tullamore, Ireland, and plans to invest in disposable technology.

Daiichi Sankyo signed an exclusive licensing agreement with clinical-stage biopharmaceutical company Translational Sciences to develop and commercialize its novel thrombus (blood clot) dissolving agent, TS23.

Preventing contamination requires quality systems to be in place, including routine cleaning, a robust cleaning validation program, and preventive maintenance.

President Obama will nominate Rob Califf, current deputy commissioner for medical products and tobacco, as FDA commissioner.

Manufacturers challenge details in new policies designed to promote access to important therapies.

Abenza acquired biopharmaceutical CDMO PacificGMP and expanded the company’s San Diego facility.

According to AstraZeneca, the purchase of the biologics bulk plant will double the company's biologics manufacturing capacity in the US.

FDA announced the recall, citing deficiencies in Medistat’s aseptic processing areas and in its environmental monitoring procedures.

Wilden’s Saniflo Hygienic Series pumps use a new, energy-efficient air distribution technology.

The RAN 3080 exterior washing machine from Bosch cleans filled and closed vials, ampuls, and cartridges using a high-pressure process and special transportation system.

Aragen Bioscience has licensed ProteoNic Biotechnology’s 2G UNic recombinant protein production technology, which increases manufacturing efficiency and reduces cost of goods for recombinant biologicals.

FDA warns that compounded or repackaged drugs stored in certain syringes made by Becton-Dickinson may lose potency because of an interaction with the rubber stopper.