The non­prof­it Bioethics In­ter­na­tion­al has come out with their lat­est score­card on da­ta trans­paren­cy among the big bio­phar­mas in the in­dus­try — flag­ging a few stand­outs while spot­light­ing some lag­gards who are con­tin­u­ing to un­der­per­form.

Now in its third year, the non­prof­it cre­at­ed a new set of stan­dards with Yale School of Med­i­cine and Stan­ford Law School to eval­u­ate the track record on tri­al reg­is­tra­tion, re­sults re­port­ing, pub­li­ca­tion and da­ta-shar­ing prac­tice.

Jen­nifer Miller YSM

“A goal of the GPS is to help set ethics and so­cial re­spon­si­bil­i­ty mea­sures in the phar­ma in­dus­try and pro­vide an in­de­pen­dent track­ing tool to both rec­og­nize best prac­tices and cat­alyze re­form, where need­ed, in com­pa­nies,” said Jen­nifer Miller, founder of Bioethics In­ter­na­tion­al, as­sis­tant pro­fes­sor at the Yale School of Med­i­cine and lead au­thor on the pa­per. 

Sev­er­al com­pa­nies — led by Roche/Genen­tech, No­var­tis and Mer­ck no­tably upped their game in this lat­est re­view of the Good Phar­ma Score­card. Stand­outs in­clude No­vo Nordisk, which cre­at­ed a mea­sure of suc­cess on pro­vid­ing da­ta that is ahead of the score­card’s stan­dard. Of­fered a chance to amend their ways, As­traZeneca set out new guide­lines on re­port­ing da­ta re­quests, while No­var­tis and Gilead added time­lines on da­ta shar­ing.

Still, there’s plen­ty of room for im­prove­ment, they add. Par­tic­u­lar­ly among the com­pa­nies dwelling at the bot­tom of the score­card.

The lag­gards: Al­ler­gan — soon to be ab­sorbed in Ab­b­Vie — is at the bot­tom of the list, with a poor trans­paren­cy score of 46%. And that is just one step be­low Am­gen, at 56%.

Al­ler­gan ac­tu­al­ly dropped from last year’s poor num­ber, along­side falling scores at As­traZeneca (83%) and J&J (90%, down from 100%).

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

US regulators cleared an ultra-rare drug from Pharming Group, by way of Novartis, on Friday afternoon.

The Dutch biotech said the FDA greenlit leniolisib for an immunodeficiency disease known as activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome, or APDS. People 12 years and older can receive the oral drug, to be marketed as Joenja, beginning early next month, Pharming said, five days ahead of the decision deadline set by the FDA as part of a priority review.