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18 April 2024

WHO alarm over Indian TB drug supplier

Published
By AFP

A major Indian supplier of tuberculosis drugs to developing countries has been severely criticized by the World Health Organization for inadequate manufacturing standards and poor testing procedures. The United Nations agency issued a warning letter to Mumbai-based Svizera Labs, part of Maneesh Pharmaceuticals, stating that the approval and use of its products would be suspended if "critical and major observations are not corrected within a reasonable time frame".

As US Legionnaires' cases rise, so do expert theories on causes

Cases of Legionnaires' disease have been increasing dramatically in the United States, with reported cases in August alone more than doubling from expected levels for that period, US health officials say. Infectious disease experts say they cannot pinpoint a single reason for the surge, but believe a combination of factors is at play, including an aging population that is more vulnerable to illness, better diagnostics, increased awareness of the disease, and possibly environmental factors.

Arthritis may be worse in poor countries but seem worse in rich ones

A study of people with rheumatoid arthritis (RA) finds that those in wealthy nations are more troubled by it, even though people in poor countries have more severe symptoms.  The results, tallied from 17 countries, suggest that cultural factors may influence patients' perception of their illness, and possibly even the results of clinical trials in different locations, researchers say.

Roche hemophilia drug wins fast-track FDA designation

Roche said on Friday it had won breakthrough therapy designation from the US Food and Drug Administration for an experimental hemophilia medicine, aiming for a piece of the $11 billion hemophilia drug market. The Swiss drugmaker said its US-based Genentech unit's ACE910 secured the fast-track designation as the company prepares separate Phase III trials in 2015 and 2016, the first in patients with hemophilia A with factor VIII inhibitors and the second for patients without inhibitors.

Informing athletes about concussions may not change behaviour


Educating athletes about the risk of concussion may do little to change long-term behaviour, a new qualitative research review has found.  Based on 89 peer-reviewed articles, two books and two Web sites, researchers say the most successful approaches included interactivity and varied kinds of presentations and were part of mandated training or legislation, according to their report online August 25 in the British Journal of Sports Medicine.

Reproductive control can be a form of partner violence

Intimate partner violence or abuse can take the form of birth control sabotage, pregnancy pressure or coercion, which can have devastating consequences including unintended pregnancy, abortion and psychological trauma, according to a new review. This type of intimate partner violence is called 'reproductive coercion,' and health care providers should know how to screen for it and intervene effectively, the authors write.

Novartis wins EU approval for multiple myeloma drug Farydak

Novartis AG said on Friday it received European Union approval for Farydak, a treatment for multiple myeloma that the company said gives new options for adult patients whose disease has progressed following standard therapy. Novartis received similar approval for Farydak from the US Food and Drug Administration in February for treating multiple myeloma, a form of blood cancer that arises from plasma cells found in bone marrow.

FDA delays decision on key Alexion drug by 3 months

Alexion Pharmaceuticals Inc said the US Food and Drug Administration would delay by three months its decision on approving a key drug the company got through the acquisition of Synageva BioPharma Corp. European health regulators on Tuesday approved the drug, Kanuma, to treat lysosomal acid lipase deficiency (LAL-D), a progressive metabolic disease that often leads to liver failure, multi-organ damage and premature death.