BioPharm International Editors

The company has voluntarily recalled Clindamycin Injection USP ADD-Vantage Vials to the hospital/retail level because of a lack of sterility assurance.

The company recalled a variety of products due to the potential of microbial contamination.

The agency’s management board discussed plans for the relocation of EMA at its June 2017 meeting.

The company is voluntarily recalling all unexpired lots of nitroglycerin products produced at its Houston location for potency issues.

Basilea Pharmaceutica International Ltd. entered into a distribution and license agreement with Pfizer and Avir Pharma Inc. to distribute Basilea’s antifungal treatments.

Selexis will be integrated with KBI Biopharma, which was acquired by JSR Life Sciences in 2015.

The companies announced an agreement where Dorizoe will work with Baxter to develop more than 20 generic injectable products.

Sartorius Stedim Biotech combined the company’s ambr 15 bioreactor system with the Nova BioProfile FLEX2 cell culture analyzer for laboratory experiments.

The agency sent a warning letter to A-S Medication Solutions LLC after it found the company didn’t comply with drug listing file requirements.

The company added a 40,000-ft2 purpose-built R&D center at 17112 Armstrong Ave, Irvine, CA.

FDA Commissioner Scott Gottlieb announced the July meeting as part of his commitment to address opioid abuse.

The companies are partnering to provide new fill/finish facilities and solutions for biopharmaceutical products.

FDA sent a warning letter to drug compounder DCA, Inc. dba Beacon Prescriptions for failing to ensure sanitary conditions.

The companies are collaborating to interface the Waters Acquity QDa Mass Detector with the IonSense DART ionization source.

The company said it expects to transaction to close on June 16, 2017.

The three regulatory agencies have agreed to data requirements for development of new antibiotics.

In its June meeting, the agency’s Pharmacovigilance Risk Assessment Committee discussed medicine safety reviews.

The companies will collaborate on the development of dual amylin calcitonin receptor agonists for patients with Type 2 diabetes.

The company released an interim analysis from its JULIET study with CTL019.

The new training center will feature technologies that boost biomanufacturing.

The United Kingdom’s Center for Process Innovation (CPI) is investing in a new project, Microstar, which seeks to reduce risk for formulators through the development of accelerated screening methods for predictive design.

Yusef Manufacturing Laboratories, LLC received an FDA warning letter citing CGMP violations at its Clearfield, UT facility.

AAPS elections for Executive Council will be held in June/July 2017; results announced in August.

The company will be acquired for $21.75 per share in cash.

The new UPS facility in Columbia will serve the growing pharmaceutical, biopharma, and medical device industry in Latin America.

Phenomenex opened a new manufacturing and development facility in CA for the company’s gas chromatography columns.

The state is alleging that misleading marketing practices contributed to the opioid epidemic in Ohio.

The companies expanded their collaboration to evaluate Opdivo and Adcetris in a Phase III trial as a treatment for relapsed/refractory or transplant-ineligible advanced classical Hodgkin lymphoma.

The agency published an action plan to nurture innovation and drug development by SMEs.

The agency released guidance for industry regarding the United Kingdom’s withdrawal from the European Union.