President Trump calls for faster FDA approvals and lower drug prices.

Having an effective and granular data management process in place will enable companies to meet the requirements of IDMP as well as help usher in a new age of digital-based identification, in which organizations can easily share data across borders.

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.

FDA plans to initiate its quality metrics program as industry continues to push back.

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 conditional marketing authorization for the hormone replacement therapy for the treatment of chronic hypoparathyroidism.

Sarepta sold the priority review voucher for Exondys 51, a controversial treatment for Duchenne Muscular Dystrophy, to Gilead.

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 industry is becoming more consolidated, but there needs to be some strategy behind the mergers and acquisitions.

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.

The regulatory agency rejected the medication, citing various issues related to device use.

Momenta’s fill/finish contract manufacturer, Pfizer, was cited in the letter.

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.