Chi­na: Fraud not the on­ly rea­son 1,193 drug ap­pli­ca­tions were with­drawn; Ad­vax­is shares drop

Just how much fraud is in­volved in clin­i­cal tri­als in Chi­na? Some re­cent re­ports sug­gest­ed that the rate is 83%, but Chi­nese of­fi­cials beg to dif­fer. While it’s true that 1,193 ap­pli­ca­tions have been with­drawn fol­low­ing a pe­ri­od of self-ex­am­i­na­tion — out of 1,429 that were put un­der the spot­light — the gov­ern­ment notes that there are plen­ty of rea­sons be­sides fraud for a with­draw­al. Why, some just had in­com­plete or in­suf­fi­cient da­ta on safe­ty and ef­fi­ca­cy, which didn’t nec­es­sar­i­ly re­ly on fraud. And there were some for “un­truth­ful da­ta,” which could in­clude fraud. The CF­DA con­cludes: “By the end of Sep­tem­ber, 2016, 117 reg­is­tra­tion ap­pli­ca­tions have been ver­i­fied, 30 of which were re­ject­ed due to de­fects with au­then­tic­i­ty, ac­count­ing for about 2% of the to­tal num­ber of reg­is­tra­tion ap­pli­ca­tions for self-ex­am­i­na­tion and ver­i­fi­ca­tion. 27 ap­pli­ca­tions, as well as 11 clin­i­cal tri­al in­sti­tu­tions and the CROs sus­pect­ed of pro­vid­ing fraud­u­lent da­ta have been in­ves­ti­gat­ed.”

Shares of Ad­vax­is $ADXS took a hit this morn­ing af­ter the biotech tried to ex­plain the da­ta it had col­lect­ed in a mid-stage study of ax­al­imo­gene filolis­bac in pa­tients with per­sis­tent or re­cur­rent metasta­t­ic (squa­mous or non-squa­mous cell) car­ci­no­ma of the cervix. The biotech had com­plet­ed stage 1 of the tri­al and had en­rolled 24 pa­tients for stage 2 when the FDA dropped a clin­i­cal hold on the work last fall, pre­vent­ing it from be­ing com­plet­ed fol­low­ing the death of a pa­tient. The biotech says that the study high­light­ed a “mean­ing­ful im­prove­ment in 12-month over­all sur­vival rate com­pared to his­tor­i­cal GOG stud­ies.” But in­vestors were stuck on the clin­i­cal hold which pre­vent­ed the tri­al from wrap­ping up as planned.

Catal­ent Phar­ma So­lu­tions is ex­pand­ing its op­er­a­tions in Madi­son, WI, with plans to add 100 new staffers over the next two years. Catal­ent is spend­ing $34 mil­lion on a project that will add 22,000 square feet of op­er­at­ing space.

Swe­den’s Oas­mia has ac­quired a pre­clin­i­cal can­cer drug from Karo for a batch of stock.

Biogen CEO Michel Vounatsos (via Getty Images)

With ad­u­canum­ab caught on a cliff, Bio­gen’s Michel Vounatsos bets bil­lions on an­oth­er high-risk neu­ro play

With its FDA pitch on the Alzheimer’s drug aducanumab hanging perilously close to disaster, Biogen is rolling the dice on a $3.1 billion deal that brings in commercial rights to one of the other spotlight neuro drugs in late-stage development — after it already failed its first Phase III.

The big biotech has turned to Sage Therapeutics for its latest deal, close to a year after the crushing failure of Sage-217, now dubbed zuranolone, in the MOUNTAIN study.

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As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

Af­ter Ko­dak de­ba­cle, US lends $1.1B to a syn­thet­ic bi­ol­o­gy com­pa­ny and their big Covid-19, mR­NA plans

In mid-August, as Kodak’s $765 million government-backed push into drug manufacturing slowly fell apart in national headlines, Ginkgo Bioworks CEO Jason Kelly got a message from his company’s government liaison: HHS wanted to know if they, too, might want a loan.

The government’s decision to lend Kodak three quarters of a billion dollars raised eyebrows because Kodak had never made drugs before. But Ginkgo, while not a manufacturing company, had spent the last decade refining new ways to produce materials inside cells and building automated facilities across Boston.

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News brief­ing: FDA re­quests new tri­al for Reata's Friedre­ich's atax­ia pro­gram; J&J's Trem­fya picks up ex­pand­ed la­bel in Eu­rope

Three months after Reata Pharmaceuticals suggested its Friedreich’s ataxia program omaveloxolone could be delayed, the company revealed that is indeed going to be the case.

Reata $RETA shares took a nosedive Wednesday after the biotech revealed that the FDA said supplemental data for its pivotal trial did not strengthen the case for approval. As a result, the drug is likely to need another study before the FDA takes up the case.

News brief­ing: Gilead part­ner Gala­pa­gos sells off CRO for $37M; Polyphor bags $3.3M from CF Foun­da­tion

Close Gilead ally Galapagos is selling off one of its contract research organizations to a Polish pharma company.

Galapagos has agreed to sell 100% of the outstanding shares in the CRO Fidelta to Selvita, in a deal worth roughly $37 million expected to close in the first week of January. The acquisition is expected to nearly double Selvita’s revenues, the company says, as well as expand its drug discovery efforts.

The ad­u­canum­ab co­nun­drum: The PhI­II failed a clear reg­u­la­to­ry stan­dard, but no one is cer­tain what that means any­more at the FDA

Eighteen days ago, virtually all of the outside experts on an FDA adcomm got together to mug the agency’s Billy Dunn and the Biogen team when they presented their upbeat assessment on aducanumab. But here we are, more than 2 weeks later, and the ongoing debate over that Alzheimer’s drug’s fate continues unabated.

Instead of simply ruling out any chance of an approval, the logical conclusion based on what we heard during that session, a series of questionable approvals that preceded the controversy over the agency’s recent EUA decisions has come back to haunt the FDA, where the power of precedent is leaving an opening some experts believe can still be exploited by the big biotech.

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John Maraganore, Alnylam CEO (Scott Eisen/Bloomberg via Getty Images)

Al­ny­lam gets the green light from the FDA for drug #3 — and CEO John Maraganore is ready to roll

Score another early win at the FDA for Alnylam.

The FDA put out word today that the agency has approved its third drug, lumasiran, for primary hyperoxaluria type 1, better known as PH1. The news comes just 4 days after the European Commission took the lead in offering a green light.

An ultra rare genetic condition, Alnylam CEO John Maraganore says there are only some 1,000 to 1,700 patients in the US and Europe at any particular point. The patients, mostly kids, suffer from an overproduction of oxalate in the liver that spurs the development of kidney stones, right through to end stage kidney disease.

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Bob Nelsen (Photo by Michael Kovac/Getty Images)

Bob Nelsen rais­es $800M and re­cruits a star-stud­ded board to build the 'Fox­con­n' of biotech

Bob Nelsen spent his pandemic spring in his Seattle home, talking on the phone with Luciana Borio, the scientist who used to run pandemic preparedness on the National Security Council, and fuming with her about the dire state of American manufacturing.

Companies were rushing to develop vaccines and antibodies for the new virus, but even if they succeeded, there was no immediate supply chain or infrastructure to mass-produce them in a way that could make a dent in the outbreak.

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News brief­ing: Ab­b­Vie part­ner Teneo­bio ex­pands tech li­cense with CAR-T play­er Po­sei­da; Ar­genx buys PRV from Bay­er for $98M

Teneobio may be best known for its pact with AbbVie and Gilead, but before its big break the bispecific player had licensed its antibodies for a different use: as binders in CAR-T therapies being developed by Poseida.

Now, the biotechs are expanding their partnership, with Poseida exercising four options to deploy Teneobio’s heavy chain only domain antibodies commercially.

The commercial licensing fees remained under wraps, but Teneobio is eligible for $250 million in milestones for these CAR-Ts against undisclosed targets.