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

The agency released guidance for industry regarding the United Kingdom’s withdrawal from the European Union.

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.

A recent survey suggests that 36% of pharmaceutical companies and contract development and manufacturing companies have not started working on serialization, and that those who are working on it are focusing on basic compliance rather than potential long-term business benefits.

Thermo Fisher will acquire Patheon for approximately $7.2 billion, including the assumption of approximately $2 billion of net debt.

The company purchased Cirara from Remedy Pharmaceuticals for $120 million.

Catalent has signed an agreement with Therachon to support preclinical and clinical development of TA-46, a novel protein being developed to treat achondroplasia.

The partnership provides Charter Medical the exclusive rights to market, sell, and distribute INCELL media products on a global basis.

MilliporeSigma released a new surface-active nonionic polymer to ensure lot-to-lot consistency.

The companies entered a license agreement that includes Sangamo’s SB-525, one of the company’s lead product candidates for the treatment of Hemophilia A.

More stringent R&D investment requirements for PhRMA membership reduces the association ranks by 22 associate and member companies.

FDA hopes to better use global resources and avoid duplicate inspections of foreign facilities.