Pfiz­er’s hot hand in on­col­o­gy con­tin­ued this week with an FDA OK for glas­deg­ib, an oral drug de­signed to throw a mon­key wrench in­to the bi­ol­o­gy dri­ving the hedge­hog path­way in acute myeloid leukemia.

The drug, Pfiz­er’s fourth on­col­o­gy prod­uct ap­proval in just two months, will now be sold as Dau­ris­mo in com­bi­na­tion with chemo for new­ly di­ag­nosed cas­es of AML, when pa­tients can’t tol­er­ate the kind of in­ten­sive chemo regime need­ed to rein in the blood can­cer. 

In what has be­come stan­dard op­er­at­ing pro­ce­dure, Pfiz­er got the ap­proval on Phase II da­ta, with an over­all sur­vival rate that av­er­aged 8.3 months com­pared to 4.3 months for pa­tients re­ceiv­ing on­ly LDAC.

Pfiz­er CEO Ian Read re­cent­ly shrugged off the need to rack up new M&A deals be­cause of its late-stage pipeline, which scored an ap­proval for lor­la­tinib, now head­ed for the mar­ket as Lor­bre­na, just 2 weeks ago. Its PARP ta­la­zoparib was ap­proved in Oc­to­ber. Da­comi­tinib, a ki­nase in­hibitor now head­ed for front­line du­ty against non-small cell lung can­cer, was OK’d in late Sep­tem­ber.

Richard Paz­dur

“In­ten­sive chemother­a­py is usu­al­ly used to con­trol AML, but many adults with AML are un­able to have in­ten­sive chemother­a­py be­cause of its tox­i­c­i­ties,” says Richard Paz­dur, the FDA’s on­col­o­gy czar, who helped cre­ate the reg­u­la­to­ry short­cut that now ex­ists for new can­cer drugs. “To­day’s ap­proval gives health care providers an­oth­er tool to use in the treat­ment of AML pa­tients with var­i­ous, unique needs. Clin­i­cal tri­als showed that over­all sur­vival was im­proved us­ing Dau­ris­mo in com­bi­na­tion with LDAC com­pared to LDAC alone for pa­tients who would not tol­er­ate in­ten­sive chemother­a­py.”

Belgian biotech Confo Therapeutics has landed $183 million, plus potential royalties, in a drug-discovery deal with Daiichi Sankyo.

Early Thursday, Confo Therapeutics put out word of the deal that will be focused on small molecule antagonists to go after an undisclosed target that the company says is associated with CNS diseases.

Confo CEO Cedric Ververken told Endpoints News that Daiichi originally reached out to learn about the biotech’s technology. He added that Confo, founded in 2015, will use its platform to drug a GPCR target that Daiichi has struggled with internally.

Paul McKenzie took over as CEO of Australian pharma giant CSL this month, following in the footsteps of long-time CSL vet Paul Perreault.

With an eye on mRNA, and quickly commercializing its new, $3.5 million-per-shot gene therapy for hemophilia B, McKenzie and chief medical officer Bill Mezzanotte answered some questions from Endpoints News this afternoon about where McKenzie is going to take the company and what advances may be coming to market from CSL’s pipeline. Below is a lightly edited transcript.

Boehringer Ingelheim reported human pharma sales of €18.5 billion on Wednesday, led by type 2 diabetes and heart failure drug Jardiance and pulmonary fibrosis med Ofev. Jardiance sales reached €5.8 billion, growing 39% year over year, while Ofev took in €3.2 billion, notching its own 20.6% annual jump.

However, Boehringer is also looking ahead with its pipeline, estimating “In the next seven years the company expects about 20 regulatory approvals in human pharma.”

The FDA today approved Emergent BioSolutions’ Narcan brand naloxone nasal spray for over-the-counter sales. The nod was expected and comes on the heels of a unanimous 19-0 advisory committee vote in favor of approval last month.

The move to OTC means the opioid overdose reversal agent will now be available on grocery, convenience and gas stations shelves, as well as potentially for purchase online.