Remi Barbier, Cassava CEO

Cas­sa­va CEO goes on the of­fen­sive over da­ta al­le­ga­tions, shout­ing down 'short at­tack'

Alzheimer’s play­er Cas­sa­va Sci­ences has been un­der fire in re­cent days af­ter a cit­i­zen pe­ti­tion with the FDA sug­gest­ed the com­pa­ny was play­ing fast and loose with its da­ta. Now, the com­pa­ny’s CEO is fight­ing back — but maybe not with the an­swers in­vestors are look­ing for.

In a lengthy pub­lic state­ment, Cas­sa­va CEO Re­mi Bar­bi­er blast­ed what he called a “short at­tack” on the com­pa­ny’s stock while do­ing lit­tle to di­rect­ly re­spond to a se­ries of al­le­ga­tions over da­ta ma­nip­u­la­tion out­lined in the cit­i­zen pe­ti­tion from last week.

“Let me be very clear: I think these al­le­ga­tions are false,” Bar­bi­er said — a quote un­like­ly to soothe in­vestors’ opin­ion of the com­pa­ny.

In Bar­bi­er’s telling, a shad­owy net­work of short sell­ers is be­hind the claims lev­eled by law firm La­ba­ton Sucharow, which he dis­missed as lit­tle more than “in­flam­ma­to­ry.” But Bar­bi­er did add more de­tail to counter the al­le­ga­tions about the West­ern blot analy­sis, a vi­su­al tech­nique used to de­ter­mine the pres­ence of a spe­cif­ic pro­tein, that was the cen­ter­piece of the law firm’s claims Cas­sa­va was ma­nip­u­lat­ing da­ta.

Bar­bi­er not­ed the com­pa­ny doesn’t have ac­cess to the orig­i­nal da­ta analy­sis, which was per­formed at the CUNY lab of Hoau-Yan Wang. With­out that da­ta in hand, Bar­bi­er said he has asked CUNY for an in­ves­ti­ga­tion in­to Wang’s lab and to make the find­ings pub­lic.

Even as he ad­mit­ted his team’s fault, Bar­bi­er al­so ap­peared to go out of his way to dis­cred­it im­ages from Cas­sa­va’s sci­en­tif­ic lit­er­a­ture cir­cu­lat­ed on­line, ar­gu­ing that “trolls” were ca­pa­ble of ma­nip­u­lat­ing those im­ages to im­ply they were fab­ri­cat­ed.

“We all know that once a pho­to­graph is on the in­ter­net, the pix­els that make up that pho­to­graph can eas­i­ly be Pho­to­shopped, cropped or oth­er­wise dis­tort­ed to mean any­thing you want it to mean,” he wrote. “Fur­ther­more, in­ter­net pho­tos are res­o­lu­tion de­pen­dent. This means an in­ter­net pho­to can quick­ly lose qual­i­ty and look blur­ry or pix­e­lat­ed, or what­ev­er.”

Mean­while, Bar­bi­er ad­mit­ted that there were two “vi­su­al er­rors” in the com­pa­ny’s re­cent da­ta pre­sen­ta­tions, but he didn’t spec­i­fy which im­ages were found to be in­cor­rect.

“In all cas­es, the da­ta analy­sis is cor­rect; the vi­su­al dis­play of the da­ta is not cor­rect,” he said.

What­ev­er the in­tent of his state­ment, it ap­peared to be work­ing in the short term. Shares in $SA­VA were trad­ing up around 11% be­fore the bell Fri­day.

It’s the lat­est in an in­creas­ing­ly bizarre saga for Cas­sa­va, which saw its stock plum­met af­ter the cit­i­zen’s pe­ti­tion and then drop once again af­ter test­ing part­ner Quan­ter­ix open­ly de­nied it had in­ter­pret­ed or pre­pared key da­ta used in the biotech’s re­cent pre­sen­ta­tions.

That re­sponse came af­ter an un­usu­al Q&A style state­ment from Cas­sa­va out­lin­ing its re­sponse to the La­ba­ton Sucharow pe­ti­tion in which the biotech ap­peared to claim Quan­ter­ix had a hand in prepar­ing the da­ta.

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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David Ricks, Eli Lilly CEO (David Paul Morris/Bloomberg via Getty Images)

Eli Lil­ly set to in­vest $2.1B in home state man­u­fac­tur­ing boost

Eli Lilly is looking to expand its footprint in its home Hoosier State by making a major investment in manufacturing.

The pharma is investing $2.1 billion in two new manufacturing sites at Indiana’s LEAP Lebanon Innovation and Research District in Boone County, northwest of Lilly’s headquarters in Indianapolis.

The two new facilities will expand Lilly’s manufacturing network for active ingredients and new therapeutic modalities, including genetic medicines, according to a press release.

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US sees spike in Paxlovid us­age as Mer­ck­'s mol­nupi­ravir and As­traZeneca's Evusheld are slow­er off the shelf

New data from HHS show that more than 162,000 courses of Pfizer’s Covid-19 antiviral Paxlovid were administered across the US over the past week, continuing a streak of increased usage of the pill, and signaling not only rising case numbers but more awareness of how to access it.

In comparison to this week, about 670,000 courses of the Pfizer pill have been administered across the first five months since Paxlovid has been on the US market, averaging about 33,000 courses administered per week in that time.

Almirall is tapping artificial intelligence on behalf of its sales force for insights and efficiencies. (via Shutterstock)

Almi­rall rolls out sales rep ar­ti­fi­cial in­tel­li­gence sys­tem, cut­ting pre-call prep and 'wind­shield time'

Dermatology specialty pharma Almirall is making its sales reps smarter. Not with extra training or educational courses, but instead with artificial intelligence tools.

It began a soft launch of a sales rep AI and machine learning platform it calls Polaris last August in one of its 7 US coverage regions. The platform from Aktana gathers information from across Almirall internal sources and external ones – such as claims and prescribing data – to generate insights for reps. Now, instead of spending hours prepping for a sales call, Polaris can generate details about a physician’s preferences, past behaviors and prescription habits for reps in minutes, said Almirall head of commercial operations Vincent Cerio.

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Pfiz­er and CD­MOs ramp up Paxlovid man­u­fac­tur­ing with Kala­ma­zoo plant ex­pan­sion lead­ing the way

As the Covid-19 pandemic continues to evolve, pharma companies and manufacturers are exploring how to step up production on antivirals.

Pfizer is planning to expand its Kalamazoo-area facility to increase manufacturing capabilities for the oral Covid-19 antiviral Paxlovid, according to a report from Michigan-based news site MLive. The expansion of the facility, which serves as Pfizer’s largest manufacturing location, is expected to create hundreds of “high-skilled” STEM jobs, MLive reported. No details about the project’s cost and timeline have been released, but according to MLive, Pfizer will announce the details of the expansion at some point in early June.

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FDA spells out the rules and re­stric­tions for states seek­ing to im­port drugs from Cana­da

The FDA is offering more of an explanation of the guardrails around its program that may soon allow states to import prescription drugs in some select circumstances from Canada, but only if such imports will result in significant cost reductions for consumers.

While the agency has yet to sign off on any of the 5 state plans in the works so far, and PhRMA’s suit to block the Trump-era rule allowing such imports is stalled, the new Q&A guidance spells out the various restrictions that states will have to abide by, potentially signaling that a state approval is coming.

Greg Mayes, Antios Therapeutics CEO

An­tios' HBV col­lab axed af­ter clin­i­cal hold, but biotech be­lieves safe­ty in­ci­dent is not treat­ment-re­lat­ed

The FDA has placed a clinical hold on a Phase IIa study of Antios Therapeutics’ investigational hepatitis B med, CEO Greg Mayes confirmed to Endpoints News in an emailed statement.

A safety report was delivered to the biotech on May 17 after a patient dosed in a triple combination cohort of the study had experienced bradycardia and hypotension. The triple combo included Antios’ ATI-2173, Assembly Biosciences’ vebicorvir and Viread, an approved antiviral for HIV and hepatitis B.

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Tim Schoen, BioMed Realty CEO

Life sci­ences de­vel­op­er Bio­Med Re­al­ty buys San Fran­cis­co ho­tel for $75M — re­port

In a somewhat unconventional deal, life sciences real estate developer BioMed Realty has bought a 169-room Hilton Garden Inn in South San Francisco for $75 million, the San Francisco Business Times reported.

BioMed Realty, an affiliate of Blackstone, has multiple life sciences and technology office projects in the Bay Area, including three sites within a five-minute drive of the hotel.

While the sale of the hotel property was announced earlier this month, the sellers, Summit and GIC, did not identify the buyer at the time.

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Pfizer CEO Albert Bourla at the World Economic Forum (Gian Ehrenzeller/Keystone via AP Images)

All about ac­cess: Pfiz­er moves to a non-prof­it mod­el for drug sales in 45 low­er-in­come coun­tries

Leading the way to increase access to cheaper drugs worldwide, Pfizer said Wednesday it will provide all current and future patent-protected medicines and vaccines available in the US or EU on a not-for-profit basis to about 1.2 billion people in 45 lower-income countries.

Rwanda, Ghana, Malawi, Senegal and Uganda are the first five countries to sign on to this accord, which will also seek to blaze new paths for quick and efficient regulatory and procurement processes to reduce the usual delays in making new medicines and vaccines available in these countries.