Stanford, NCI Researchers Discover New CAR-T Target With Early Study Data
Instead of targeting a molecule called CD19 on the surface of the cancer cells, the new therapy targets a molecule called CD22. Source: BioSpace
Amsterdam Named the New Home of the EMA
Pharma and biotech stakeholders applauded the vote as Amsterdam achieved the hightest rate of acceptance of the EMA staff for relocatation, according to a survey. Source: BioSpace
Medtech Innovative Health Solutions to Create New Jobs in Expansion
Less than one week after the FDA cleared Innovative Health Solutions' NSS-2 Bridge, the company announced it will expand its payroll to include a number of new businesses. Source: BioSpace
FDA Flags Drugmaking Problems at Chinese Company
The FDA cited a Chinese medical instrument company for problems in the manufacturing of drugs included in its production. Source: Drug Industry Daily
New York Indicts Pharmacist, Pharmacy Owner for Stealing from Medicaid
New York’s attorney general indicted a pharmacy owner, pharmacist and three pharmacies for defrauding Medicaid of $3 million in reimbursements for drugs that were never dispensed. Source: Drug Industry Daily
EMA Expands Safety Guidance for Developing Anticancer Drugs
The European Medicines Agency adopted the fifth revision of its substantive guideline covering all stages of oncology drug development, expanding upon the previous version’s section on safety data. Source: Drug…
The EMA Gets a New Home: Amsterdam
The European Union landed on Amsterdam as the new home for the European Medicines Agency headquarters, following three rounds of voting and a tiebreaker against Milan. The agency hopes to…
PTO Instructed to Allow Companies to Amend IPR-Challenged Patents
The Federal Circuit eased the ability for patent holders to amend their claims when challenged under inter partes review — a hurdle that pharmaceutical industry trade groups had previously described…
EMA Drops Req’s for Testing Untreated Patients in Hemophilia
The European Medicines Agency revised two guidelines on the development and labeling of factor VIII products used to treat hemophilia A, removing requirements for sponsors to conduct clinical trials in…
Indian Generics Manufacturer Failed to Meet Standards, U.K. Inspectors Say
U.K. regulators moved to block imports to the European Union from a generic drug manufacturer in India after reporting deficiencies in quality control, processing, laboratory testing and safeguards against contamination.…
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