Af­ter a month-long break from ad­vi­so­ry ap­point­ments, John Maraganore is once again be­ing tapped to join an­oth­er biotech.

The RNA-fo­cused start­up an­nounced Maraganore’s ap­point­ment this morn­ing, with the Al­ny­lam found­ing CEO join­ing up as a strate­gic ad­vi­sor to Pro­QR’s su­per­vi­so­ry board.

Mon­day’s move comes a few weeks af­ter the biotech’s lead can­di­date for the rare ge­net­ic eye dis­ease, Leber con­gen­i­tal amau­ro­sis, had shown no dif­fer­ence be­tween place­bo and any oth­er ef­fi­ca­cy mea­sures. Maraganore said in a state­ment that he first met Pro­QR CEO Daniel de Boer more than a decade ago through for­mer Gen­zyme CEO Hen­ri Ter­meer, be­fore his pass­ing in 2017.

With the new gig at Pro­QR, it brings Maraganore up to 11 po­si­tions across biotech and VC since he an­nounced last year he would be leav­ing the com­pa­ny he found­ed. — Paul Schloess­er

FDA grants pri­or­i­ty re­view for Servi­er’s plans to move Tib­so­vo up the lines

Servi­er is one step clos­er to the bright fu­ture it en­vi­sions for Tib­so­vo.

The FDA has grant­ed pri­or­i­ty re­view for its sN­DA tar­get­ing pa­tients with pre­vi­ous­ly un­treat­ed IDH1-mu­tat­ed acute myeloid leukemia, the French drug­mak­er said.

First de­vel­oped by Agios and even­tu­al­ly sold to Servi­er as part of an on­col­o­gy busi­ness in a $2 bil­lion-plus deal, Tib­so­vo tar­gets can­cer me­tab­o­lism by hit­ting mu­tat­ed IDH1 en­zymes. It’s cur­rent­ly ap­proved for that par­tic­u­lar sub­set of re­lapsed or re­frac­to­ry AML — as well as new­ly di­ag­nosed IDH-1 mu­tat­ed AML pa­tients who are old­er than 75 or have co­mor­bidi­ties that make in­ten­sive chemother­a­py a bad idea. More re­cent­ly, Servi­er nabbed an OK to treat IDH1-mu­tat­ed cholan­gio­car­ci­no­ma.

In a Phase III study fo­cus­ing on pre­vi­ous­ly un­treat­ed AML pa­tients, Agios and Serv­er showed that Tib­so­vo not on­ly im­proved event-free sur­vival, but al­so helped pa­tients live longer when giv­en in com­bi­na­tion with chemother­a­py. — Am­ber Tong

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 biotech Monopar Therapeutics is putting a kibosh on a study for its drug to prevent severe oral mucositis (SOM) in patients who are going through chemoradiotherapy for oropharyngeal cancer.

The interim analysis for Monopar’s Phase IIb/III had around 50% of the planned patients enrolled. An independent data safety monitoring board let Monopar know that the trial did not meet the threshold for efficacy. The trial was looking for a 15% of absolute difference in SOM prevention between its drug, Validive, and placebo. Monopar will now discontinue the study as well as the development of Validive.

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.