With moth­ers on erec­tile dys­func­tion drug, 11 new­born ba­bies die af­ter tri­al trig­gers lung prob­lems

A clin­i­cal tri­al in the Nether­lands has gone hor­ri­fy­ing­ly south, with news this morn­ing that 11 new­born ba­bies have died af­ter their moth­ers took a drug best known for erec­tile dys­func­tion dur­ing preg­nan­cy.

The drug was a gener­ic form of silde­nafil, which works by di­lat­ing the blood ves­sels. The brand­ed ver­sion of this drug is Vi­a­gra, but Pfiz­er was quick to note it had no in­volve­ment with this study. More on that lat­er.

The study was ini­ti­at­ed by re­searchers at the Am­s­ter­dam Uni­ver­si­ty Med­ical Cen­ter. They rea­soned — and had an­i­mal ev­i­dence to hope —  the drug might boost the growth of ba­bies who weren’t de­vel­op­ing well in the womb by en­cour­ag­ing bet­ter blood flow through the pla­cen­ta.

The tri­al was ter­mi­nat­ed last week, how­ev­er, when an in­de­pen­dent com­mit­tee found that a trou­bling num­ber of ba­bies were be­ing born with lung prob­lems. The tri­al, led by Am­s­ter­dam Uni­ver­si­ty Med­ical Cen­tre, in­clud­ed 93 women on the drug. Sev­en­teen of the ba­bies de­vel­oped lung prob­lems, and 11 have since died. Of the 90 women in the con­trol group on place­bo, 3 ba­bies de­vel­oped the same lung prob­lems but no ba­bies died.

Pfiz­er blast­ed state­ments out to all me­dia who picked up on this sto­ry, not­ing that they had no in­volve­ment.

“Pfiz­er was not in­volved in any as­pect of this tri­al, and nei­ther fund­ed nor pro­vid­ed prod­uct for the tri­al,” the com­pa­ny said in a state­ment. “In ad­di­tion, the prin­ci­ple in­ves­ti­ga­tors at the Am­s­ter­dam Uni­ver­si­ty Med­ical Cen­tre have con­firmed a non-Pfiz­er man­u­fac­tured gener­ic ver­sion of silde­nafil was used but that no clin­i­cal tri­al par­tic­i­pants were ad­min­is­tered Vi­a­gra, Pfiz­er silde­nafil or any oth­er Pfiz­er med­i­cine.”

Sad­ly, some­where be­tween 10 and 15 Dutch women are still wait­ing to find out if their child has been af­fect­ed by the drug. It is feared the drug caused high blood pres­sure in the lungs, lead­ing to the ba­bies re­ceiv­ing too lit­tle oxy­gen.

The hos­pi­tal said this in a state­ment to The Guardian:

An in­ter­im analy­sis by Am­s­ter­dam UMC, lo­ca­tion AMC, showed that silde­nafil may be detri­men­tal to the ba­by af­ter birth. The chance of a dis­ease of the blood ves­sels of the lungs ap­pears to be greater and the chance of death af­ter birth seems to have in­creased. The re­searchers found no pos­i­tive ef­fect for the chil­dren on oth­er out­comes. All ad­verse ef­fects oc­curred af­ter birth. Based on these find­ings, the study stopped im­me­di­ate­ly. All par­tic­i­pants were ap­proached per­son­al­ly and al­most every­one was in­formed and know by now whether they have tak­en the drug or the place­bo.

Paul Hudson, Sanofi CEO (Getty Images)

Sanofi CEO Paul Hud­son has $23B burn­ing a hole in his pock­et. And here are some hints on how he plans to spend that

Sanofi has reaped $11.1 billion after selling off a big chunk of its Regeneron stock at $515 a share. And now everyone on the M&A side of the business is focused on how CEO Paul Hudson plans to spend it.

After getting stung in France for some awkward politicking — suggesting the US was in the front of the line for Sanofi’s vaccines given American financial support for their work, versus little help from European powers — Hudson now has the much more popular task of managing a major cash cache to pull off something in the order of a big bolt-on. Or two.

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As­traZeneca trum­pets the good da­ta they found for Tagris­so in an ad­ju­vant set­ting for NSCLC — but many of the ex­perts aren’t cheer­ing along

AstraZeneca is rolling out the big guns this evening to provide a salute to their ADAURA data on Tagrisso at ASCO.

Cancer R&D chief José Baselga calls the disease-free survival data for their drug in an adjuvant setting of early stage, epidermal growth factor receptor-mutated NSCLC patients following surgery “momentous.” Roy Herbst, the principal investigator out of Yale, calls it “transformative.”

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The Advance Clinical leadership team: CEO Yvonne Lungershausen, Sandrien Louwaars - Director Business Development Operations, Gabriel Kremmidiotis - Chief Scientific Officer, Ben Edwards - Chief Strategy Officer

How Aus­tralia De­liv­ers Rapid Start-up and 43.5% Re­bate for Ear­ly Phase On­col­o­gy Tri­als

About Avance Clinical

Avance Clinical is an Australian owned Contract Research Organisation that has been providing high-quality clinical research services to the local and international drug development industry for 20 years. They specialise in working with biotech companies to execute Phase 1 and Phase 2 clinical trials to deliver high-quality outcomes fit for global regulatory standards.

As oncology sponsors look internationally to speed-up trials after unprecedented COVID-19 suspensions and delays, Australia, which has led the world in minimizing the pandemic’s impact, stands out as an attractive destination for early phase trials. This in combination with the streamlined regulatory system and the financial benefits including a very favourable exchange rate and the R & D cash rebate makes Australia the perfect location for accelerating biotech clinical programs.

Pablo Legorreta, founder and CEO of Royalty Pharma AG, speaks at the annual Milken Institute Global Conference in Beverly Hills, California (Patrick T. Fallon/Bloomberg via Getty Images)

Cap­i­tal­iz­ing Pablo: The world’s biggest drug roy­al­ty buy­er is go­ing pub­lic. And the low-key CEO di­vulges a few se­crets along the way

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Over the last 24 years, Legorreta’s Royalty Pharma group has become, by its own reckoning, the biggest buyer of drug royalties in the world. The CEO and founder has bought up a stake in a lengthy list of the world’s biggest drug franchises, spending $18 billion in the process — $2.2 billion last year alone. And he’s become one of the best-paid execs in the industry, reaping $28 million from the cash flow last year while reserving 20% of the cash flow, less expenses, for himself.

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Dan O'Day, Gilead CEO (Andrew Harnik, AP Images)

UP­DAT­ED: Gilead leas­es part­ner rights to TIG­IT, PD-1 in a $2B deal with Ar­cus. Now comes the hard part

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Hotly rumored for weeks, the 2 players have formalized a 10-year alliance that starts with rights to the PD-1, zimberelimab. O’Day also has first dibs on TIGIT and 2 other leading programs, agreeing to an opt-in fee ranging from $200 million to $275 million on each. There’s $500 million in potential TIGIT milestones on US regulatory events — likely capped by an approval — if Gilead partners on it and the stars align on the data. And there’s another $150 million opt-in payments for the rest of the Arcus pipeline.

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Bryan Roberts, Venrock

Ven­rock sur­vey shows grow­ing recog­ni­tion of coro­n­avirus toll, wan­ing con­fi­dence in ar­rival of vac­cines and treat­ments

When Venrock partner Bryan Roberts went to check the results from their annual survey of healthcare leaders, what he found was an imprint of the pandemic’s slow arrival in America.

The venture firm had sent their form out to hundreds of insurance and health tech executives, investors, officials and academics on February 24 and gave them two weeks to fill it out. No Americans had died at that point but the coronavirus had become enough of a global crisis that they included two questions about the virus, including “Total U.S. deaths in 2020 from the novel coronavirus will be:”.

Roger Perlmutter, Merck R&D chief (YouTube)

UP­DAT­ED: Backed by BAR­DA, Mer­ck jumps in­to Covid-19: buy­ing out a vac­cine, part­ner­ing on an­oth­er and adding an­tivi­ral to the mix

Merck execs are making a triple play in a sudden leap into the R&D campaign against Covid-19. And they have more BARDA cash backing them up on the move.

Tuesday morning the pharma giant simultaneously announced plans to buy an Austrian biotech that has been working on a preclinical vaccine candidate, added a collaboration on another vaccine with the nonprofit IAVI and inked a deal with Ridgeback Biotherapeutics on an early-stage antiviral.

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David Hoey (Vaxxas)

In for the long vac­cine game, Mer­ck buys in­to patch de­liv­ery tech with pan­dem­ic po­ten­tial

When Merck dived into the R&D fray for a Covid-19 vaccine earlier this week, execs made it clear that they’re not necessarily looking to be first — with CEO Ken Frazier throwing cold water on the hotly-discussed 12- to 18-month timelines. But when it does emerge from behind, the pharma giant clearly expects to play a significant part.

Part of that will depend on next-generation delivery technology that reshapes the world’s imagination of a vaccine.

No­var­tis jumps in­to Covid-19 vac­cine hunt, as Big Phar­ma and big biotech com­mit to bil­lions of dos­es

After spending most of the pandemic on the sidelines, Novartis is offering its aid in the race to develop a Covid-19 vaccine.

AveXis, the Swiss pharma’s gene therapy subsidiary, has agreed to manufacture the vaccine being developed by Massachusetts Eye and Ear and Massachusetts General Hospital. The biotech will begin manufacturing this month, while the vaccine undergoes further preclinical testing. They’ve agreed to provide the vaccine for free for clinical trials beginning in the second half of 2020, but have not disclosed financials for after.

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