
BeiGene and the Guangzhou Development District have established a joint venture to build a biologics manufacturing facility in China.

BeiGene and the Guangzhou Development District have established a joint venture to build a biologics manufacturing facility in China.

A blog posted on Health Affairs on March 7, 2017 presents a study that tested PhRMA’s long-standing argument that high prices for drugs fund research and development in the pharmaceutical industry.

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.

Siegfried Schmitt, PhD, Principal Consultant at PAREXEL, discusses how to mitigate risk in a global regulatory environment.

The Mutual Recognition Agreement will allow FDA and EU inspectors to recognize each other’s work and avoid the duplication of drug inspections.

A new software technology, CRISPETa, is designed to assist in the deletion of non-protein coding sections of DNA.

Drug type, potential sales, and ownership factor in the race to get drugs to market.

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

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

Pharmaceutical Technology Europe
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 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.

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.

PTSM: Pharmaceutical Technology Sourcing and Management
The company expanded fill/finish services at its facility in Kalamazoo, Michigan.

PTSM: Pharmaceutical Technology Sourcing and Management
Metrohm USA presented the Young Chemist Award to Aldin Malkoc for his work on cooperative, DNA-based molecular elements for electrochemical biosensors.

PTSM: Pharmaceutical Technology Sourcing and Management
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.

PTSM: Pharmaceutical Technology Sourcing and Management
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.