French dairy giant Lactalis has extended to 83 countries the recall of more than 12 million boxes of salmonella-contaminated powdered baby milk products. The firm said it will pay damages to the 37 families affected by the contaminated infant formula in France, Spain and Greece.
Patient-advocate group Eurodis raised concerns that Brexit will affect access to drugs for rare diseases and inhibit their research and development. "If the UK leaves the single market, there will likely be an inflation in the costs of pharmaceutical products as, unless a special agreement is reached, industry will have to adopt costly measures to run regulatory affairs in the UK and also in the EU," said Virginie Hivert, speaking for the organization.
AstraZeneca's Lynparza, or olaparib, has been approved by the FDA to treat patients with metastatic HER2-negative breast cancer whose malignancy involves mutations in the BRCA1 or BRCA2 genes. The drug, which was previously approved for treatment of advanced ovarian cancer, is the first PARP inhibitor to win FDA approval against breast cancer.
A pair of collaborations was launched by Stanford University spinout Forty Seven to evaluate its drug candidate Hu5F9-G4 in combination with Merck's Bavencio, or avelumab, in patients with ovarian cancer, and Genentech's Tecentriq, or atezolizumab, in patients with acute myeloid leukemia and with urothelial cancer. Values of both deals were not disclosed.
Concert Pharmaceuticals' CTP-543, which is being developed as a treatment for patients with moderate to severe alopecia areata, was given fast-track designation by the FDA. The treatment is in a midstage study.
Data from a study by Boston Scientific on spinal cord stimulation therapy for pain relief showed better outcomes among patients who had an implanted spinal cord stimulation system and had the option to receive both subperception and paresthesia-based therapy than those who had only one therapy option. The company reported that on average, baseline pain scores were reduced from 7.2 to 2.5 with use of paresthesia-based therapy and from 7.1 to 3.8 with subperception therapy.
European regulators gave Abbott CE mark approval for its sensor-enabled Advisor HD Grid mapping catheter, which is intended to be used in any of the heart's chambers during cardiac ablation. The device allows for horizontal and vertical data collection along a grid configured with 16 sensors to avoid signal loss.
A proposal to alter the definition of "intended use" to include the "totality of evidence" standard in a regulation involving tobacco for medicinal use was delayed indefinitely while the FDA considers already-submitted comments and accepts more through Feb. 5. "We need more time to consider the feedback we received and to make sure that our approach is guided by our public-health mandate and to ensure the clarity of our rules on the subject," said FDA Commissioner Scott Gottlieb about the expanded definition, which could also apply to other medical products.
GlaxoSmithKline received approval from the FDA to use its Fluarix Quadrivalent in patients as young as 6 months for active immunization against influenza A subtype viruses and type B viruses. The vaccine was previously approved for individuals at least 3 years old.
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