News

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.

Yusef Manufacturing Laboratories, LLC received an FDA warning letter citing CGMP violations at its Clearfield, UT facility.

AAPS elections for Executive Council will be held in June/July 2017; results announced in August.

The company will be acquired for $21.75 per share in cash.

The new UPS facility in Columbia will serve the growing pharmaceutical, biopharma, and medical device industry in Latin America.

Phenomenex opened a new manufacturing and development facility in CA for the company’s gas chromatography columns.

The state is alleging that misleading marketing practices contributed to the opioid epidemic in Ohio.

The companies expanded their collaboration to evaluate Opdivo and Adcetris in a Phase III trial as a treatment for relapsed/refractory or transplant-ineligible advanced classical Hodgkin lymphoma.

The agency published an action plan to nurture innovation and drug development by SMEs.

Amgen filed a complaint against FDA claiming the agency unlawfully denied the company pediatric exclusivity for its secondary hyperparathyroidism treatment Sensipar.

Microdermics will focus on product development and clinical activities of new drug delivery methods, while Vetter’s primary role will be in the fill and finish aspect.

BioVectra will open its new microbial fermentation and complex chemistry site, including the capability to handle high-potency APIs, by the end of 2017.

The company was cited for cGMP violations at its Irvine, California facility.

The company entered two separate collaborations with Advaxis and Array Biopharma involving its PD-1 immune checkpoint inhibitor Opdivo.

The company entered a collaboration with Protagonist to develop, manufacture, and commercialize PTG-200.

This marks the first FDA approval of a treatment based on a specific biomarker.

The agency met with the representatives of the East African Community to discuss the creation of a networking agency.

The Competition and Market’s Authority is accusing Merck Sharp & Dohme of offering a discount for Remicade that may have restricted the sale of biosimilar competition in the UK.

The 2017 Global Healthcare Leaders Survey suggests that value-based and risk-sharing payment could have an even more transformative impact on the industry than scientific breakthroughs.

In Lazard's Global Healthcare Leaders 2017 survey, most respondents said pricing and reimbursement were the most significant challenge, but nearly half of the pharma executives who responded see value-based pricing as having the greatest impact on the business, potentially even more than scientific breakthroughs.

CBER is moving forward with the development and approval of regenerative medicine advanced therapies.

FDA’s new commissioner asks staff for suggestions for fighting the opioid crisis.

The agency has given a green light to a new system for collecting and monitoring suspected adverse reactions.

The agency’s Committee for Medicinal Products for Human Use recommended AstraZeneca’s brodalumab for the treatment of moderate-to-severe plaque psoriasis.

Ablynx will receive EUR15 million in milestone payment following Merck’s decision to advance ALX-1141 into clinical development. The nanobody was developed by Ablynx under a 2011 collaboration between both parties.

Janssen filed a lawsuit in a US District Court in New Jersey against Samsung Bioepis, claiming the company’s new biosimilar infringed on its Remicade patents.

The company installed the FlexFactory to support its biosimilar production.

The company developed proxy-CRISPR which provides access to previously unreachable areas of the genome.