Algorithms are intended to help predict incoming workload, which will be used to help set user fees.

The Therapeutic Goods Administration is urging companies to update their medicine labels and documentation with new ingredient names.

Groups oppose use of quality-adjusted life year metric, noting ICER’s work is becoming more influential among payers. However, patient advocates do not suggest a uniform methodological alternative.

US FDA has seen little success in ending gaming of the patent process by brand name manufacturers. One problem: the agency’s referrals to FTC on anti-competitive cases appear go into a black box.

Finance Committee chairman wants a provision allowing Medicaid to make installment payments for high-cost curative treatments in drug pricing legislation. But Democrats worry such a model might encourage high prices.

Kinome-focused Blueprint Medicines plans to follow up its first NDA, for all lines of therapy in patients with exon 18 mutant GIST or fourth-line use in non-genomically selected patients, with submissions for third-line GIST and advanced systemic mastocytosis in 2020.

Data on the number of ANDAs submitted with valid paragraph IV certifications shows some products with strong generic interest and others with almost none.

News and views from day four of the BIO International Convention: Former FDA official Amy McKee said "everything worked right" with accelerated approval and removal of Lilly's Lartruvo; emerging company M&A deals nearly double in 2018; and the ASCO effect on the 3-6 June BIO meeting.

Much like Genzyme’s Ceredase did two decades ago, Novartis’ Zolgensma is setting a new pricing benchmark. The first million-dollar product is launching in the US and it will actually cost more than $2 million.

News and views from day one of the BIO International Convention: Merck reaffirms commitment to antibiotic space the same day Zerbaxa picks up a new indication; US FDA regenerative medicine advanced therapy designations now outnumber breakthrough designations for cell/gene therapies; BIO survey finds out-licensing cash for emerging firms more than doubled in 2018.

The saga of tainted valsartan has taken another turn with an online pharmacy that tests its medications before dispensing them finding yet another probable carcinogen in lots of the blood pressure medication from multiple manufacturers. The pharmacy filed a citizen petition asking the US FDA to tighten its globally harmonized limit for the residual solvent.