Archive for January 2018
New Report: J&J Tops Employment Branding
The companies were evaluated extensively on Career Pages, Job Boards, Employee Reviews & Candidate Engagement, Accolades, Recruitment Marketing, and Social Responsibility. Source: BioSpace
Read MoreTrump Endorses 'Right to Try' Experimental Drug Bill at State of the Union Address
The bill would allow access to experimental treatments for patients with terminal conditions. Source: BioSpace
Read More3 Cases of Brain Damage Force the FDA to Slap a Hold on Bellicum's Lead Drug
The company is now waiting for the FDA to determine a path forward in resuming clinical studies. Source: BioSpace
Read MoreSoCal's Vical Terminates 54% of Workforce to Focus Resources on Two Clinical Programs
Vical announced its restructuring late Tuesday. Source: BioSpace
Read MoreDespite Spike, Why Investors Should Still Avoid MannKind Like the Plague
MannKind could be sent to dilute shares in a significant manner, warns Maxim analyst Jason Kolbert in a research note released today. Source: BioSpace
Read MoreMexican Manufacturer Cited For Quality, Conformance Issues
The FDA flagged a dozen deficiencies during a September inspection of a Schwabe Mexico facility, including testing and quality problems. Source: Drug Industry Daily
Read MoreJapanese Firm Slammed for Falsifying Certificates of Analysis
Japanese drugmaker Daito Kasei Kogyo was hit with a warning letter by the FDA for having inadequate testing procedures and falsifying certificates of analysis issued to customers from its facility in Bizen, Okayama. Source: Drug Industry Daily
Read MoreAradigm Receives CRL for Linhaliq, Citing Quality and Data Concerns
The FDA issued a complete response letter to Aradigm over its Linhaliq (ciprofloxacin liposomal) submission for non-cystic fibrosis bronchiectasis, a severe, rare lung disease frequently associated with chronic lung infections, saying the drug could not be approved in its current form. Source: Drug Industry Daily
Read MoreGottlieb Outlines FDA Plans for Compounding Enforcement to Lawmakers
In testimony before a House subcommittee Tuesday, FDA Commissioner Scott Gottlieb told lawmakers the FDA’s plans for regulating compounding pharmacies, including adapting GMP and oversight standards to a facility’s level of risk. Source: Drug Industry Daily
Read MoreU.K. Drugmaker Hit for Having No Quality Unit
The FDA served Sacutia Healthcare a Form 483 after discovering the company had no quality unit at its St. Helen’s, United Kingdom facility. Source: Drug Industry Daily
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