
The European Commission approved Rixathon for use in all indications of its reference medicine, MabThera.

The European Commission approved Rixathon for use in all indications of its reference medicine, MabThera.

The organization released principles related to workforce development, diversity, and inclusion that it believes are key to the biotechnology industry.

The RT-PCR kit can simultaneously screen samples for Zika, dengue, and chikungunya arbovirus RNAs.

The company announced its new ISQ EC Single Quadrupole mass spectrometer and the new range of Thermo Scientific MAbPac RP 1-mm columns.

The company was granted patent rights to the use of CRISPR in a genomic integration method for eukaryotic cells.

The company added new products to its InfinityLab LC Series which will be showcased at HPLC 2017 in Prague.

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.

Congressional measures lack the support to move forward.

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.

The landmark decision determined that biosimilar makers can notify manufacturers before receiving FDA approval.

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.

FDA asked Endo Pharmaceuticals to remove Opana ER from the market, citing the potential for abuse.

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.