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.
More stringent R&D investment requirements for PhRMA membership reduces the association ranks by 22 associate and member companies.
The company has formed a Pediatric Center of Excellence in support of the development and manufacture of dosage forms for pediatric indications.
FDA hopes to better use global resources and avoid duplicate inspections of foreign facilities.
Licensing agreement will expand Oxford Genetics bio-therapeutic discovery, design, and development service business.
Bosch’s Xelum platform is designed for continuous production of oral solid-dosage forms.
The new DoseGuard design is compatible with standard 20-mm containers.
The company is expanding their April 2017 voluntary recall of phenobarbital tablets.
The agency released its report on pilot project to involve patients in the assessment of medicines.
FDA sent a warning letter to Pharmaceutic Labs, LLC for deficiencies in producing sterile drugs.
User fee reauthorizations, a hiring freeze, and opioid epidemic await the new FDA commissioner Scott Gottlieb.
Many pharmaceutical companies are sceptical about IDMP despite the business benefits and its contribution to patient safety.
The Identification of Medicinal Products (IDMP) standards requires regulatory teams to efficiently collate data from multiple sources and functions.
Biomedical researcher shares insights from a career dedicated to advancing therapeutic innovations for unmet medical needs.
The company is the first multi-site excipient supplier to achieve accreditation across production facilities.