FDA denies Public Citizen's petition for rulemaking to remove infant teething as an indication for OTC benzocaine and require a contraindication on labels advising against using gel and liquid products for teething pain. The agency has asked marketers for voluntary label changes and says a rulemaking would be too lengthy, but Public Citizen says a rulemaking started when the problem became known would already be completed.

Brazil’s first generic Sovaldi for hepatitis C is approved.

FTC Chief Administrative Law Judge finds procompetitive benefit of Endo-Impax patent settlement agreement outweighs unjustified no-authorized generic provision.

The most surprising proposal coming out the Rose Garden drug pricing event was a call for disclosure of prices in DTC ads. As a policy idea, it may be a dud – but that doesn’t mean it isn’t a critical element of the plan.

HHS secretary urges serious proposals from biopharma on enhancing price negotiation in Medicare Parts D and B, promising action from the Administration whether the industry cooperates or not.

Monotherapy patients with tumors that have low PD-L1 expression experienced decrease survival in two confirmatory trials; however, the immune checkpoint inhibitors’ accelerated approvals are unlikely to be affected pending final results comparing use in combination with chemotherapy to chemo alone.

From 'breakthrough' designations to manufacturing hiccups, numerous review and development challenges await the combined entity.

There's a lot of finger-pointing in the industry when it comes to why pharma has a bad reputation. Maybe it's time everyone who works in pharmaceuticals takes responsibility for it.

Sarepta is expecting the European Medicines Agency to recommend against EU approval of its Duchenne muscular dystrophy treatment eteplirsen. Persuading the agency to change its mind during the appeal will be an uphill task for the company.

A new US drug spending report from IQVIA parses out how rebates impact drug spending and explores affordability for patients. The data show drug makers offset about 28% of drug spending and provide some support to industry's arguments on drug pricing. 

While pressing the US trade representative for stronger IP protection, groups representing the brand biopharma sector remain silent on the Trump administration’s plan to hit China with 25% tariffs.

FDA denies Public Citizen's petition for rulemaking to remove infant teething as an indication for OTC benzocaine and require a contraindication on labels advising against using gel and liquid products for teething pain. The agency has asked marketers for voluntary label changes and says a rulemaking would be too lengthy, but Public Citizen says a rulemaking started when the problem became known would already be completed.

FDA is considering forcing off the market OTC benzocaine oral care products for treating infant teething pain, seven years after acknowledging the ingredient's link to a rare but potentially fatal condition, methemoglobinemia, and raising the possibility of requiring label changes.

AAM, CHPA, SOCMA and BPTF agree that proposed 25% tariffs on pharmaceuticals and APIs from China is a bad idea, unless perhaps it’s just a negotiating ploy.