FDA Permits More Chinese Cancer Drug Imports As Shortage Hits Patients
Bloomberg reminds us that the ongoing drug shortage is forcing doctors to ration care and putting patients' lives at risk. Separately, the hot-topic weight-loss drugs Ozempic and Saxenda are being investigated in the EU due to reports of suicidal thoughts from some patients.
Bloomberg:
FDA Allows More Cancer Drug Imports From China Amid Shortage
US regulators are allowing imports of additional supplies of a cancer drug from China amid a nationwide shortage that has forced doctors to ration care, putting patients’ lives at risk. The Food and Drug Administration has allowed distribution of 10 more lots of cisplatin, an essential chemotherapy drug, from Qilu Pharmaceutical Co., an agency spokesperson said Monday. The FDA previously cleared four lots of Qilu’s version of the drug, which is unapproved in the US, but similar to approved cisplatin sold there. (Swetlitz, 7/10)
In other pharmaceutical news —
Bloomberg:
Ozempic, Weight-Loss Drugs Are Being Investigated For Suicide Risks
The European Medicines Agency is looking at adverse events noted by the Icelandic Medicines Agency, including two cases of suicidal thoughts linked to the drugs Saxenda and Ozempic, the EMA said in a statement Monday. One additional case relating to thoughts of self-injury has been raised in connection with Saxenda. The EMA did not report any cases of suicide, and suicidal behavior is not currently listed as a side effect in the EU product information of the drugs. (Ring, 7/10)
Axios:
Alzheimer's Drug Leqembi May Not Work As Well On Women
Some experts are questioning whether a newly approved Alzheimer's drug was shown in clinical trials to be less effective on women — even though the FDA didn't flag any such concerns when it was authorized last week. Nearly two-thirds of Americans living with Alzheimer's disease are female, according to the Alzheimer's Association. The $26,500 drug, Leqembi, also can cause significant side effects, and some experts question whether the benefits outweigh the risks even without accounting for any gender disparities. (Owens and Gonzalez, 7/11)
Bloomberg:
Nestlé Said To Weigh Sale Of Peanut Allergy Pill To Stallergenes
Nestlé SA is discussing a potential sale of its peanut allergy medicine to Swiss health-care group Stallergenes Greer, people with knowledge of the matter said. Stallergenes has been holding talks with Nestlé about a possible deal for the Palforzia treatment, the people said, asking not to be identified discussing confidential information. (Nair, 7/10)
