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 cited the facility for violations of quality management and data integrity CGMPs.
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 is warning drug manufacturers about Burkholderia cepacia complex after product recalls due to contamination.
The agency’s Committee for Medicinal Products for Human Use recommended AstraZeneca’s brodalumab for the treatment of moderate-to-severe plaque psoriasis.
The company expanded its UK storage facility to meet increasing demand from its growing customer base.
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 compendium provides a resource to identify and locate targeted suitable patient-derived xenografts based on specific histology and molecular properties.
The company developed proxy-CRISPR which provides access to previously unreachable areas of the genome.
The new storage and distribution facility provides PCI with additional space, complementing its existing footprint currently used for specialist clinical-trial logistics as well as packaging, labeling, and qualified person activities for investigational medicinal products.
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.
Due to weak penalties and lax enforcement, illicit pharmaceuticals continue to slip into the US, European and global supply chains.
The agency released several new and revised guidance documents regarding product-specific generic drug development.
Saneca has been granted approval to manufacture and supply multiple dosage forms to Russia.
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.
Catalent has been working together with Lexicon to develop the drug formulation of Xermelo, which has now been approved by FDA for the treatment of carcinoid syndrome diarrhea.
Aptar Pharma’s e-Lockout device uses advanced electronic technology to limit the number of doses available during a 24-hour period, thereby ensuring safe patient compliance to Takeda’s pain-relieving nasal spray.
The existing, obsolete highpurity water generation system and water-forinjection generation system were replaced with new, reliable technologies.
The company invested approximately $26 million to update its sterile pharmaceutical and development service suites.
The company held a ribbon cutting ceremony at its new Center for Innovation in Advanced Development and Manufacturing in Maryland.
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.
FDA sent a warning letter to the company in India for delaying and limiting an FDA inspection in addition to problems related to cGMP.