FDA sent a warning letter to Stemell, Inc. for manufacturing and distributing unapproved products derived from umbilical cord blood and umbilical cord and for significant deviations from current good tissue practice and current good manufacturing practices.
FDA announced it is developing a series of guidance documents to promote methodological patient-focused drug development.
A US District Court judge in Tennessee entered a consent decree of permanent injunction against Basic Reset and Biogenyx after multiple FDA inspections of the companies’ facility found violations of the Federal Food, Drug, and Cosmetic Act.
EMA has started a data review of Picato (ingenol mebutate) to investigate the potential for skin cancer risk.
A new report by GlobalData projects 2.9% growth by 2028 for the hemophilia A and B market across the eight major world markets.
JW Pharmaceutical Corp will acquire the rights to 100% of the shares of Euvipharm along with a state-of-the-art pharmaceutical plant located in Vietnam.
The new facility will handle clinical supply management, primary and secondary packaging, complex labeling services, clinical storage, distribution, and drug returns and destruction and will include stability chambers.
The drug will improve the treatment and prevention of invasive fungal infections.
The drug displayed improvement in progression-free survival and increased the time patients lived without disease progression or death by a median of 18.9 months.
In a Phase III trial for advanced small-cell lung cancer, the investigational antibody drug conjugate, Rova-T (rovalpituzumab tesirine), did not demonstrate a survival benefit for patients taking it.
The company has received breakthrough therapy designation for its prophylactic respiratory syncytial virus vaccine candidate for treating adults aged 60 years or older.
Roche has extended its offering period for the purchase of Spark to provide US and UK regulatory authorities with additional time to complete their review of the acquisition.
Vertex will use the acquisition to develop cell-based treatments for type 1 diabetes.
Novartis revealed results from two new clinical trials indicating that Entresto (sacubitril/valsartan) significantly improves measures of cardiac structure and function in heart failure with reduced ejection fraction.
Roche revealed that the European Commission has approved the combination of Tecentriq (atezolizumab) with Abraxane for the treatment of adult patients with PD-L1-positive, metastatic triple-negative breast cancer.
Findings from a real-world data analysis have been released from the Bristol-Myers Squibb-Pfizer Alliance, demonstrating that Eliquis is associated with lower rate of major bleeding compared with vitamin K antagonist, dabigatran or rivaroxaban.
Valo Therapeutics has acquired a technology from Helsinki University that is expected to broaden its approach and expand the capability of its cancer vaccines platform, PeptiCRAd.
Gerresheimer has announced it will be expanding its ClearJect product line of pre-fillable syringes with a new 2.25-mL cyclic olefin polymer (COP) staked in needle (SIN) syringe.
The multitude of health reform measures emerging on Capitol Hill has accelerated lobbying action across the board, along with campaign donations to candidates from all sides.
AbbVie has closed the Phase III trial that was evaluating Rova-T as no survival benefit for patients receiving treatment for advanced small-cell lung cancer (SCLC) was found during the interim analysis.
PCI has divulged that it is making significant investment at its site near Dublin, Ireland to strengthen its position globally and to ensure pharmaceutical supply is uninterrupted for its customers after Brexit.
A District Court for the US District of Delaware has ruled in favor of Sanofi and Regeneron in the patent case targeting proprotein convertase subtilisin/kexin type 9 (PCSK9).
The new facility, located in Ness Ziona, Israel, will support clinical phage manufacturing and can be expanded in the future to support commercial-scale manufacturing.
The partnership will provide cost effective biologics for the world market.
The joint venture, named BacThera, will operate out of headquarters in Basel, Switzerland and will serve pre-clinical to Phase II projects, with the ability to expand to Phase III and commercial manufacturing in the future.
A global agreement with Polpharma Biologics gives Sandoz commercialization rights to a proposed biosimilar natalizumab for relapsing-remitting multiple sclerosis.
Government statistics show that pharma can be an illustrious career for graduates, which must be taken advantage of by industry to avoid skills shortages.
As a potential ‘no-deal’ Brexit looms, pharma companies and industry bodies are preparing for the worst-case scenario but hoping that the UK won’t end up with a disorderly exit from the EU.
EMA is seeking ways to improve the effectiveness of its PRIME scheme, so that scientific innovations and new technologies more readily lead to novel medicines.
Regulatory bodies are taking a more stringent approach to excipient quality, but unlike guidance on GMP for APIs, those for excipients offer a framework only, meaning the onus lies with the manufacturer or supplier.