News

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.

In a press release, Momenta announced on Feb. 16, 2017 that Momenta/Sandoz’s fill/finish contract manufacturer, Pfizer, received a warning letter for the manufacture of the 40 mg of Glatopa (glatiramer acetate injection), Momenta’s generic version of the drug Copaxone. Pfizer said in the statement that the warning letter does not affect the production or shipment of the 20 mg version of the drug, which is already approved by FDA.

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

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

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.

PhRMA submits comments to the The Office of the United States Trade Representative encouraging protection of US innovation in foreign markets.

The Patent Trial and Appeal Board ruled in favor of the Broad Institute, allowing the company to keep patents for their CRISPR-Cas9 gene-editing technology.

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

South East Asian pharma manufacturers seeking region growth expected to attend CPhi South East Asia.

The directorate says monographs are flexible and changeable and their compliance does not on its own determine biosimilarity in biosimilars.

The company has voluntarily recalled all lots of of human chorionic gonadotropin because of a lack of sterility assurance.

The agency sent a warning letter to Resonance Laboratories Pvt. Ltd. after an inspection found possible contamination problems.

Evaluate and BioPharm International highlight the antibody-based therapeutics that may have 2017 launch dates in the United States.

Aurobindo has added four cell-culture derived biosimilars to its product line.

The Generic Pharmaceutical Association announces a rebranding campaign to expand access to medicines.

Drug companies are pushing Congress to action on funding for FDA programs and staff to expedite drug reviews and approvals.

EvaluatePharma and BioPharm International highlight the antibody-based therapeutics that may gain United States Regulatory approval in 2017.

The company announced results from a Phase II trial with its THC:CBD drug for the treatment of glioblastoma multiforme.

The companies entered into a license agreement for Immunomedic’s antibody-drug conjugate sacituzumab govitecan.

EMA announces that the European Union’s PAS Register has received its 1000th upload.

A total of 166 biotech executives penned an open letter expressing concern over President Donald Trump’s executive order on immigration.

The company is voluntarily recalling product due to particulate matter.

Modular Automated Sampling Technology (MAST) allows direct aseptic transfer of bioreactor samples to analytical devices, providing rapid and reliable data in bioprocessing.

The investment will be used to advance Nemaura’s R&D programs, which include liquid vaccines that have been reformulated for administration through the skin using its micropatch drug delivery technology.

On a recent call, Catalent revealed that it has reached more than 90% of its current capacity and discussed how tax policy changes could affect the outsourcing industry.