Sen­a­tors ac­cuse Te­va, My­lan of stonewalling price fix­ing probe; Myr­i­ad Ge­net­ics shares skid on dis­mal quar­ter­ly re­sults

→ US law­mak­ers have writ­ten to Te­va $TE­VA, My­lan $MYL and pri­vate­ly-held Her­itage Phar­ma­ceu­ti­cals ask­ing for doc­u­ments as part of a sweep­ing con­gres­sion­al probe in­to gener­ic drug price hikes, ac­cus­ing the com­pa­nies of “ap­par­ent ef­forts to stonewall” the in­ves­ti­ga­tion, Reuters re­port­ed. The probe was first launched in 2014, and ear­li­er this year 44 US states filed a law­suit al­leg­ing drug price-fix­ing by the trio of drug­mak­ers. Now, sen­a­tors Eli­jah Cum­mings and Bernie Sanders are in­ves­ti­gat­ing a pur­port­ed “co­or­di­nat­ed ob­struc­tion” of the probe, cit­ed in the State’s com­plaint, the re­port said.

→ Shares of mol­e­c­u­lar di­ag­nos­tic test mak­er Myr­i­ad Ge­net­ics $MYGN tum­bled about 34% to $29.41 on Wednes­day morn­ing, af­ter the com­pa­ny post­ed dis­ap­point­ing fis­cal fourth quar­ter re­sults and ini­tial 2020 guid­ance. “MYGN once again faced a num­ber of neg­a­tive sur­pris­es in the quar­ter dri­ven by im­pact of LBM (Lab Ben­e­fit Man­agers) on its Car­ri­er test­ing busi­ness com­bined with re­cent­ly height­ened FDA scruti­ny of phar­ma­coge­nom­ic test­ing (Gen­e­Sight). MYGN con­tin­ues to dis­agree on changes re­quired to the test, and we be­lieve that will con­tin­ue to re­main an over­hang un­til re­solved,” SVB Leerink an­a­lysts wrote in a note.

→ With the brief stint at Ac­celeron be­hind him, Robert Zeldin has found his next CMO role at Roivant’s new au­toim­mune-fo­cused off­shoot, Im­muno­vant. The ap­point­ment brings Zeldin back to his roots in im­munol­o­gy and lever­ages his more re­cent ex­pe­ri­ence with clin­i­cal de­vel­op­ment to ad­vance IMVT-1401, an an­ti­body that fa­cil­i­tates the degra­da­tion of path­o­gen­ic IgG. Brad­ford Mid­dlekauff, a Medarex alum and biotech vet, is al­so join­ing Pe­te Salz­mann’s team as gen­er­al coun­sel.

→ Rare dis­ease drug de­vel­op­er Akari Ther­a­peu­tics has won fast track sta­tus from the FDA for its lead ex­per­i­men­tal drug, no­ma­co­pan, for hematopoi­et­ic stem cell trans­plant-as­so­ci­at­ed throm­bot­ic mi­croan­giopa­thy (HSCT-TMA) in pe­di­atric pa­tients. The con­di­tion, for which there are no ap­proved ther­a­pies, has an es­ti­mat­ed 80% mor­tal­i­ty rate. Akari’s shares $AK­TX jumped about 34% to $2.41 in ear­ly trad­ing. The com­pa­ny has re­cent­ly un­der­gone a pe­ri­od of up­heaval — last year, Nas­daq threat­ened to scrap its po­si­tion on the ex­change af­ter Akari failed to file its an­nu­al re­port on time, days af­ter the New York City biotech oust­ed its for­mer CEO David Horn Solomon for al­leged­ly abus­ing the com­pa­ny cred­it card.

Regeneron CEO Leonard Schleifer speaks at a meeting with President Donald Trump, members of the Coronavirus Task Force, and pharmaceutical executives in the Cabinet Room of the White House (AP Photo/Andrew Harnik)

OWS shifts spot­light to drugs to fight Covid-19, hand­ing Re­gen­eron $450M to be­gin large scale man­u­fac­tur­ing in the US

The US government is on a spending spree. And after committing billions to vaccines defense operations are now doling out more of the big bucks through Operation Warp Speed to back a rapid flip of a drug into the market to stop Covid-19 from ravaging patients — possibly inside of 2 months.

The beneficiary this morning is Regeneron, the big biotech engaged in a frenzied race to develop an antibody cocktail called REGN-COV2 that just started a late-stage program to prove its worth in fighting the virus. BARDA and the Department of Defense are awarding Regeneron a $450 million contract to cover bulk delivery of the cocktail starting as early as late summer, with money added for fill/finish and storage activities.

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Boehringer In­gel­heim ties the knot with Num­ab on new an­ti­bod­ies; Ca­balet­ta inks pact with Ar­ti­san

→ Switzerland’s Numab Therapeutics has added Boehringer Ingelheim to its roster of collaborators. And they will start with two projects aiming at developing new drugs for difficult-to-treat lung and gastrointestinal cancers and patients with geographic atrophy. “Numab’s technology platform fits well with our internal antibody discovery and engineering capabilities and will enhance our efforts to deliver transformative antibody-based therapeutics to patients,” said Paige Mahaney, an SVP at Boehringer Ingelheim.

Noubar Afeyan, Flagship CEO and Tessera chairman (Victor Boyko/Getty Images)

Flag­ship ex­ecs take a les­son from na­ture to mas­ter ‘gene writ­ing,’ launch­ing a star-stud­ded biotech with big am­bi­tions to cure dis­ease

Flagship Pioneering has opened up its deep pockets to fund a biotech upstart out to revolutionize the whole gene therapy/gene editing field — before gene editing has even made it to the market. And they’ve surrounded themselves with some marquee scientists and execs who have crowded around to help shepherd the technology ahead.

The lead player here is Flagship general partner Geoff von Maltzahn, an MIT-trained synthetic biologist who set out in 2018 to do CRISPR — a widely used gene editing tool — and other rival technologies one or two better. Von Maltzahn has been working with Sana co-founder Jake Rubens, another synthetic biology player out of MIT who he describes as his “superstar,” who’s taken the CSO role.

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Covid-19 roundup: Squab­bles with gov­ern­ment de­lay Mod­er­na’s PhI­II — re­ports; No­vavax se­cures largest Warp Speed deal yet: $1.6B

A much-anticipated Phase III trial for Moderna’s Covid-19 vaccine is being held up as the company delayed submitting trial protocols and sparred with government scientists on how to run the study and even what the benchmark for success should be, Reuters reported.

Moderna, the first US company to put their vaccine into human testing, was supposed to enter a 30,000-person study this month in partnership with the NIH to determine whether it can prevent infection. STAT reported last week that the trial was facing delays over the protocol, but that a July start was still possible. Neither the NIH nor Moderna ever disclosed a specific date the trial should start, but Reuters reported that the agency had hoped to begin on July 10.

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Donald and Melania Trump watch the smoke of fireworks from the South Lawn of the White House on July 4, 2020 (via Getty)

Which drug de­vel­op­ers of­fer Trump a quick, game-chang­ing ‘so­lu­tion’ as the pan­dem­ic roars back? Eli Lil­ly and Ab­Cellera look to break out of the pack

We are unleashing our nation’s scientific brilliance and will likely have a therapeutic and/or vaccine solution long before the end of the year.

— Donald Trump, July 4

Next week administration officials plan to promote a new study they say shows promising results on therapeutics, the officials said. They wouldn’t describe the study in any further detail because, they said, its disclosure would be “market-moving.”

— NBC News, July 3

Something’s cooking. And it’s not just July 4 leftovers involving stale buns and uneaten hot dogs.

Over the long weekend observers picked up signs that the focus in the Trump administration may swiftly shift from the bright spotlight on vaccines being promised this fall, around the time of the election, to include drugs that could possibly keep patients out of the hospital and take the political sting out of the soaring Covid-19 numbers causing embarrassment in states that swiftly reopened — as Trump cheered along.

So far, Gilead has been the chief beneficiary of the drive on drugs, swiftly offering enough early data to get remdesivir an emergency authorization and into the hands of the US government. But their drug, while helpful in cutting stays, is known for a limited, modest effect. And that won’t tamp down on the hurricane of criticism that’s been tearing at the White House, and buffeting the president’s most stalwart core defenders as the economy suffers.

We’ve had positive early-stage vaccine data, most recently from Pfizer and BioNTech, playing catchup on an mRNA race led by Moderna — where every little sign of potential trouble is magnified into a lethal threat, just as every advance excites a frenzy of support. But that race still has months to play out, with more Phase I data due ahead of the mid-stage numbers looming ahead. A vaccine may not be available in large enough quantities until well into 2021, which is still wildly ambitious.

So what about a drug solution?

Trump’s initial support for a panacea focused on hydroxychloroquine. But that fizzled in the face of data underscoring its ineffectiveness — killing trials that aren’t likely to be restarted because of a recent population-based study offering some support. And there are a number of existing drugs being repurposed to see how they help hospitalized patients.

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Cel­lec­tis slammed af­ter pa­tient dies and FDA slaps a hold on their tri­al for an off-the-shelf CAR-T for mul­ti­ple myelo­ma

Cellectis was slammed after the market close on Monday as the biotech reported that the FDA demanded it hit the brakes on their MELANI-01 trial for their off-the-shelf cell therapy UCARTCS1A after one of the patients in the study died of treatment-related cardiac arrest.

The multiple myeloma patient had previously been treated unsuccessfully with various therapies, noted the biotech, and had been given dose level two (DL2) of their allogeneic CAR-T.

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Shoshanna Shendelman, Applied Therapeutics CEO (Applied Therapeutics)

A lit­tle biotech slaps back at a 'crim­i­nal' short at­tack, vow­ing to pur­sue a pros­e­cu­tion of their case

As short attacks go, Biotech Research Partners’ assault on Applied Therapeutics’ “cherry picked” data and a variety of so-called red flags didn’t cause a whole lot of damage. Ahead of the July 4 holiday, its shares $APLT were dinged and showed signs of quick recovery.

But that didn’t stop an incendiary response, as the biotech swung into action bright and early Monday morning.

Applied Therapeutics accused the authors of the short report of manipulating graphs and figures, misrepresenting data and included factual misrepresentations — all of which added up, in their view, to fraud.

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Bill Haney, Dragonfly CEO (Dave Pedley/Getty Images for SXSW)

A boom­ing Drag­on­fly is tak­ing its TriN­KETs to Copen­hagen as the lat­est Bris­tol My­ers pact spurs ex­pan­sion plans — out­side the US

Bristol Myers Squibb is making a habit out of collaborating with the crew at Dragonfly, adding their 3rd deal in a series that now will take them into newly charted R&D territory. And the fast-growing team at the Cambridge-based biotech is adding a facility in Copenhagen for its next growth spurt, where the government is making it easy to recruit scientists internationally as the U.S. throttles back.

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Covid-19 roundup: Teamed up with NIH, Re­gen­eron launch­es PhI­II pre­ven­tion tri­al for an­ti­body cock­tail

As Regeneron moves its antibody cocktail into Phase II/III trials testing REGN-COV2 as a treatment for both hospitalized and non-hospitalized patients with Covid-19, the biotech is also starting a Phase III in the prevention setting.

The National Institute of Allergy and Infectious Diseases — which orchestrated the large, randomized study for remdesivir that produced positive results — will jointly run the study.

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