Some Big Phar­mas stepped up their game on da­ta trans­paren­cy — but which flunked the test?

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%).

Ugur Sahin, BioNTech CEO (Bernd von Jutrczenka/dpa via AP Images)

BioN­Tech is spear­head­ing an mR­NA vac­cine de­vel­op­ment pro­gram for malar­ia, with a tech trans­fer planned for Africa

Flush with the success of its mRNA Covid-19 vaccine, BioNTech is now gearing up for one of the biggest challenges in vaccine development — which comes without potential profit.

The German mRNA pioneer says it plans to work on a jab for malaria, then transfer the tech to the African continent, where it will work with partners on developing the manufacturing ops needed to make this and other vaccines.

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How one start­up fore­told the neu­ro­science re­nais­sance af­ter '50 years of shit­show'

In the past couple of years, something curious has happened: Pharma and VC dollars started gushing into neuroscience research.

Biogen’s controversial new Alzheimer’s drug Aduhelm has been approved on the basis of removing amyloid plaque from the brain, but the new neuro-focused pharma and biotechs have much loftier aims. Significantly curbing or even curing the most notorious disorders would prove the Holy Grail for a complex system that has tied the world’s best drug developers in knots for decades.

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Why is On­col­o­gy Drug De­vel­op­ment Re­search Late to the Dig­i­tal Bio­mark­ers Game?

During the recent Annual ASCO Meeting, thousands of cancer researchers and clinicians from across the globe joined together virtually to present and discuss the latest findings and breakthroughs in cancer research and care. There were more than 5000+ scientific abstracts presented during this event, yet only a handful involved the use of motion-tracking wearables to collect digital measures relating to activity, sleep, mobility, functional status, and/or quality of life. Although these results were a bit disappointing, they should come as no surprise to those of us in the wearable technology field.

Art Levinson (Calico)

Google-backed Cal­i­co dou­bles down on an­ti-ag­ing R&D pact with Ab­b­Vie as part­ners ante up $1B, start to de­tail drug tar­gets

Seven years after striking up a major R&D alliance, AbbVie and Google-backed anti-aging specialist Calico are doubling down on their work with a joint, $1 billion commitment to continuing their work together. And they’re also beginning to offer some details on where this project is taking them in the clinic.

According to their statement, each of the two players is putting up $500 million more to keep the labs humming.

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Busi­ness­es and schools can man­date the use of Covid-19 vac­cines un­der EUAs, DOJ says

As public and private companies stare down the reality of the Delta variant, many are now requiring that their employees or students be vaccinated against Covid-19 prior to attending school or to returning or starting a new job. Claims that such mandates are illegal or cannot be used for vaccines under emergency use authorizations have now been dismissed.

Setting the record straight, the Department of Justice on Monday called the mandates legal in a new memo, even when used for people with vaccines that remain subject to EUAs.

Bob Bradway, Amgen CEO (Scott Eisen/Bloomberg via Getty Images)

Am­gen bel­lies back up to the M&A ta­ble for an­oth­er biotech buy­out, this time with a $2.5B deal for an an­ti­body play­er fo­cused on PS­MA

Five months after Amgen CEO Bob Bradway stepped up to the M&A table and acquired Five Prime for $1.9 billion, following up with the smaller Rodeo acquisition, he’s gone back in for another biotech buyout.

This time around, Amgen is paying $900 million cash while committing up to $1.6 billion in milestones to bag the privately held Teneobio, an antibody drug developer that has expertise in developing new bispecifics and multispecifics. In addition, Amgen cited Teneobio’s “T-cell engager platform, which expands on Amgen’s existing leadership position in bispecific T-cell engagers by providing a differentiated, but complementary, approach to Amgen’s current BiTE platform.”

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UP­DAT­ED: Pan­el of neu­ro­science ex­perts lays out the com­pli­ca­tions with us­ing Bio­gen's new Alzheimer's drug

Treatment of early Alzheimer’s patients with Biogen’s new drug Aduhelm should closely resemble how the drug was studied in its pivotal clinical trials, according to new recommendations from a panel of neuroscience experts led by UNLV’s Jeffrey Cummings.

“Those considering aducanumab therapy should understand that the expected benefit is slowing of cognitive and functional decline; improvement of the current clinical state is not anticipated,” they wrote Tuesday in The Journal of Prevention of Alzheimer’s Disease, noting that some of their recommendations are more specific or more restrictive than the information provided in the FDA’s prescribing information.

Frank Pallone (Kevin Dietsch/Pool via AP Images)

House com­mit­tee seeks more from FDA on in­spec­tion back­log, when to restart work on for­eign sites

House Energy & Commerce committee leaders are raising fresh questions about the FDA’s ability to conduct foreign manufacturing site inspections and bring down its growing backlog.

“While we understand that the emergence of COVID-19 required the agency to suspend in-person inspection activities temporarily, we remain concerned that more than one year into the pandemic, the strategy for resuming all inspections and addressing the backlog of delayed inspections remains unclear,” E&C chair Frank Pallone (D-NJ) and a group of five other bipartisan leaders of the committee wrote to FDA acting commissioner Janet Woodcock.

Eye­ing quick ap­proval, Ab­b­Vie of­fers a close-up on their pres­by­opia drug da­ta

AbbVie picked up some bonus points earlier this year as one of its pipeline adds from the $63 billion Allergan buyout hit its top-line marks. And now the researchers have produced the detailed data on the case they are making with regulators, with an eye on a major new market and a hoped-for approval before New Year’s.

AGN-190584 is aiming to be the first easy-on eyedrop for presbyopia, a common ailment for large numbers of people who find it harder and harder to read things like a watch or cell phone close up. Anyone who’s held a book out at arm’s length in order to read it will be very familiar with the condition, if not the exact diagnosis.