Pharmaceutical Technology Editors

The conference will include 55 speakers at more than 44 sessions.

The innovations-oriented Think Tank combines academic-scientific and technical expertise to use Shimadzu’s expertise to provide even more customer-focused service.

The UK Stem Cell Bank released validated stem-cell lines for researchers developing novel cell-based therapies for clinical trials.

The agency cited the company’s Kansas facility with CGMP violations similar to problems found at other Hospira facilities.

The new company links and manages aspects of treatment delivery, facilitating access for patients to treatments by serving as a connector between manufacturers, patients, physicians, and payors.

Avella issued a nationwide recall of sterile products produced at the Advanced Pharma Houston location due to inaccurate labeling.

Sanofi and Lonza formed a joint venture to build and operate a large-scale mammalian cell culture facility for monoclonal antibody production in Visp, Switzerland.

The company is voluntarily recalling one lot of Edex due to a lack of container closure integrity.

Thermo Fisher Scientific will provide cryo-TEM for small-molecule and biologic drug discovery.

The agency’s CHMP recommended six drugs for market approval, including one orphan drug, during its February meeting.

The agency’s CHMP recommended conditional marketing authorization for the hormone replacement therapy for the treatment of chronic hypoparathyroidism.

In 2016, FDA approved 630 ANDAs and tentatively approved 183 ANDAs, the highest number to date, according to the report.

The company will hold its annual extrusion seminar in June 2017.

The company expanded fill/finish services at its facility in Kalamazoo, Michigan.

Metrohm USA presented the Young Chemist Award to Aldin Malkoc for his work on cooperative, DNA-based molecular elements for electrochemical biosensors.

The company opened a new bioconjugation unit to support the clinical and commercial manufacturing of ADCs.

The conference will gather more than 3000 attendees from 64 countries.

The company announced that no Form 483 was observed at the company’s facility in Bangalore, India.

The district court ordered Pick and Pay Inc./Cili Minerals to cease operations after it unlawfully manufactured and distributed unapproved new drugs, misbranded drugs, adulterated dietary supplements, and misbranded dietary supplements.

The companies have developed a Level 4 traceability solution to manage pharmaceutical regulatory requirements.

FDA granted inotuzumab ozogamicin priority review and accepted its BLA for filing.

CellGenix will add R&D, production, and warehouse space in Freiburg, Germany for GMP-grade raw materials for cell therapy, gene-therapy, and tissue-engineered products.

Under the agreement, Abzena will manufacture magacizumab, an antibody created using the ‘Abzena inside’ Composite Human Antibody technology.

BPS-804, which is being developed for the treatment of osteogenesis imperfecta (brittle bone disease), has been granted orphan drug designation by both FDA and the European Commission.

Recipharm’s addition of Kemwell’s Bengaluru, India facility expands its solid- and liquid-dosage capabilities.

Sartorius and EMBL have entered into a corporate partnership program to foster advanced training.

The ICH Q11 Q&A discusses the development and manufacture of drug substances and the selection and justification of starting materials.

SGS expands its elemental impurity testing services at its laboratory in Villeneuve-la-Garenne, France.

FDA sent a warning letter to Sato Pharmaceutical Co., Ltd. after inspectors found deviations in the facility’s aseptic processes.

FDA approved Valeant’s brodalumab with a boxed warning for suicidal ideation.