August 30, 2019 10:14 AM EDTUpdated 11:00 AM
Protocols

Paratek pub­lish­es pos­i­tive PhI­II da­ta on ap­proved Nuzyra; Al­ler­gan set­tles opi­oid law­suits in two Ohio coun­ties

Endpoints Staff

→ Paratek Phar­ma­ceu­ti­cals‘ $PRTK Nuzyra (omada­cy­cline) has met all pri­ma­ry and sec­ondary clin­i­cal study end­points in their OA­SIS-2 Phase III clin­i­cal tri­al, ac­cord­ing to re­sults pub­lished in The Lancet In­fec­tious Dis­eases. In the study, in­volv­ing 735 adults with AB­SS­SI, Nuzyra was shown to be as ef­fec­tive as Pfiz­er‘s $PFE twice-dai­ly oral-on­ly Zyvox (line­zol­id). Nuzyra is cur­rent­ly avail­able in the US as a once-dai­ly oral and in­tra­venous an­tibi­ot­ic for the treat­ment of adults with com­mu­ni­ty-ac­quired bac­te­r­i­al pneu­mo­nia and AB­SS­SI. The drug is al­so be­ing stud­ied for the treat­ment of uri­nary tract in­fec­tions.

→ Wrap­ping a week of big opi­oid law­suit news, Al­ler­gan $AGN dis­closed that it’s set­tled with two Ohio coun­ties, avoid­ing a mul­ti-de­fen­dant tri­al sched­uled for Oc­to­ber. The drug­mak­er — which con­tends that it has not ac­tive­ly mar­ket­ed or pro­mot­ed any opi­oid prod­ucts since 2013 and that it does not have li­a­bil­i­ty for gener­ic claims — said it’s seek­ing in­dem­ni­fi­ca­tion from oth­er par­ties in the fed­er­al lit­i­ga­tion. Per the set­tle­ment, Al­ler­gan is pay­ing $1.9 mil­lion to Sum­mit Coun­ty and $3.1 mil­lion to Cuya­hoga Coun­ty.

→ On the heels of a fast track des­ig­na­tion, Akari Ther­a­peu­tics has added or­phan sta­tus to its lead drug no­ma­co­pan’s cre­den­tials. The C5 in­hibitor is be­ing po­si­tioned as a treat­ment for hematopoi­et­ic stem cell trans­plant-as­so­ci­at­ed throm­bot­ic mi­croan­giopa­thy in pe­di­atric pa­tients. The biotech plans to com­mence a piv­otal tri­al in the fourth quar­ter this year, said COO Clive Richard­son, who was in­stalled as in­ter­im CEO more than a year ago af­ter David Horn was oust­ed amid a scan­dal.

AUTHOR

Endpoints Staff

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Tesla and SpaceX founder Elon Musk gestures to the audience after being recognized by President Trump following the successful launch of a Falcon 9 rocket at the Kennedy Space Center. (via Getty Images)
July 2, 2020 06:30 AM EDTUpdated 10:07 AM
People
Coronavirus

Tes­la chief Elon Musk teams up with Covid-19 play­er Cure­Vac to build 'R­NA mi­cro­fac­to­ries'

John Carroll

Editor & Founder

Elon Musk has joined the global tech crusade now underway to revolutionize vaccine manufacturing — now aimed at delivering billions of doses of a new mRNA vaccine to fight Covid-19. And he’s cutting right to the front.

In a late-night tweet Wednesday, the Tesla chief announced:

Tesla, as a side project, is building RNA microfactories for CureVac & possibly others.

That’s not a lot to go on. But the tweet comes a year after Tesla’s German division in Grohmann and CureVac filed a patent on a “bioreactor for RNA in vitro transcription, a method for RNA in vitro transcription, a module for transcribing DNA into RNA and an automated apparatus for RNA manufacturing.” CureVac, in the meantime, has discussed a variety of plans to build microfactories that can speed up the whole process for a global supply chain.

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George Yancopoulos (Regeneron)
July 1, 2020 08:28 AM EDTUpdated 14 hours ago
People

UP­DAT­ED: Re­gen­eron co-founder George Yan­copou­los of­fers a com­bat­ive de­fense of the po­lice at a high school com­mence­ment. It didn’t go well

John Carroll

Editor & Founder

Typically, the commencement speech at Yorktown Central School District in Westchester — like most high schools — is an opportunity to encourage students to face the future with confidence and hope. Regeneron president and co-founder George Yancopoulos, though, went a different route.

In a fiery speech, the outspoken billionaire defended the police against the “prejudice and bias against law enforcement” that has erupted around the country in street protests from coast to coast. And for many who attended the commencement, Yancopoulos struck the wrong note at the wrong time, especially when he combatively challenged someone for interrupting his speech with a honk for “another act of cowardness.”

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Elias Zerhouni (Photo by Vincent Isore/IP3/Getty Images)
June 30, 2020 09:39 AM EDT
People
R&D
Pharma

Elias Zer­houni dis­cuss­es ‘am­a­teur hour’ in DC, the de­struc­tion of in­fec­tious dis­ease R&D and how we need to prep for the next time

John Carroll

Editor & Founder

Elias Zerhouni favors blunt talk, and in a recent discussion with NPR, the ex-Sanofi R&D and ex-NIH chief had some tough points to make regarding the pandemic response.

Rather than interpret them, I thought it would be best to provide snippets straight from the interview.

On the Trump administration response:

It was basically amateur hour. There is no central concept of operations for preparedness, for pandemics, period. This administration doesn’t want to or has no concept of what it takes to protect the American people and the world because it is codependent. You can’t close your borders and say, “OK, we’re going to be safe.” You’re not going to be able to do that in this world. So it’s a lack of vision, basically just a lack of understanding, of what it takes to protect the American people.

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June 29, 2020 05:59 AM EDTUpdated 10:34 AM
R&D
Cell/Gene Tx

Sec­ond death trig­gers hold on Astel­las' $3B gene ther­a­py biotech's lead pro­gram, rais­ing fresh con­cerns about AAV

John Carroll

Editor & Founder

Seven months after Astellas shelled out $3 billion to acquire the gene therapy player Audentes, the biotech company’s lead program has been put on hold following the death of 2 patients taking a high dose of their treatment. And there was another serious adverse event recorded in the study as well, with a total of 3 “older” patients in the study affected.

The incidents are derailing plans to file for a near-term approval, which had been expected right about now.

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July 2, 2020 10:37 AM EDTUpdated 11:00 AM
China

Look­ing for 'ex­ter­nal in­no­va­tion,' Boehringer In­gel­heim re­serves $500M+ for new Shang­hai hub

Amber Tong

Editor

Now that Boehringer Ingelheim’s bet on contract manufacturing in China has paid off, the German drugmaker is anteing up more to get into the research game.

Boehringer has set aside $507.9 million (€451 million) for a new External Innovation Hub to be built in Shanghai over five years. The site will become one of its “strategic pillars” as the team strives to get 71 approvals — either for new products or indications — by 2030, said Felix Gutsche, president and CEO of Boehringer Ingelheim China.

Vas Narasimhan, Novartis CEO (Patrick Straub/​EPA-EFE/​Shutterstock)
July 2, 2020 10:31 AM EDTUpdated 11:26 AM
Pharma

No­var­tis pays $678M for kick­back scheme as Vas Narasimhan tries to dis­tance phar­ma gi­ant from shady be­hav­ior

Jason Mast

Associate Editor

Novartis has reached another large settlement to resolve misconduct allegations, agreeing to pay more than $678 million to settle claims that it had spent hundreds of millions of dollars on lavish dinners, so-called speaking fees and expensive alcohol “that were nothing more than bribes” to get doctors to prescribe Novartis medications.

The top-shelf alcohol and lavish meals included a $3,250 per person night at Nobu in Dallas, a $672-per person dinner at Washington DC’s Smith & Wollensky and a $314 per person meal at Sushi Roku in Pasadena, according to the Justice Department complaint. There were at least 7 trips to Hooters and fishing trips in Alaska and off the Florida coast. Each of these events were supposed to be “speaker programs” where doctors educated other doctors on a drug, but the DOJ alleged many were “bogus” wine-and-dine events where the drug was barely mentioned, if at all.  (“Nobody presented slides on the fishing trips,” the complaint says.)

July 2, 2020 08:48 AM EDT
Peer Review

No­vavax snags Ben Machielse for CMC and pro­motes a trio of staffers; Mar­ty Du­vall lands an­oth­er CEO post at On­copep­tides

Alex Hoffman

Assistant Editor

Kathy Wong

Assistant Editor

→ Novavax has been making waves recently by securing a $384 million commitment from CEPI to cover R&D and manufacturing for its Covid-19 vaccine while also spending $167 million on a 150,000 square-foot facility. The Maryland biotech continues to shore up its leadership team as well, bringing in Ben Machielse as their EVP of CMC just a couple weeks after nabbing AstraZeneca vet Filip Dubrovsky as their new CMO. Machielse was president and CEO of Vtesse from 2014-17, and before that, he also spent more than 11 years at MedImmune and was EVP of operations for the back half of his tenure.

Endpoints News

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Dan Gold, MEI Pharma CEO
July 2, 2020 08:30 AM EDT
R&D

De­vel­op­ment part­ners at MEI, Helsinn dump a high-risk PhI­II AML study af­ter con­clud­ing it would fail sur­vival goal

John Carroll

Editor & Founder

Four years after Switzerland’s Helsinn put $25 million of cash on the table for an upfront and near-term milestone to take MEI Pharma’s drug pracinostat into a long-running Phase III trial for acute myeloid leukemia, the partners are walking away from a clinical pileup.

The drug — an HDAC inhibitor — failed to pass muster during a futility analysis, as researchers concluded that pracinostat combined with azacitidine wasn’t going to outperform the control group in the pivotal.

July 1, 2020 09:37 AM EDTUpdated 09:53 AM
R&D
Coronavirus

Pfiz­er shares surge on pos­i­tive im­pact of their mR­NA Covid-19 vac­cine — part­nered with BioN­Tech — in an ear­ly-stage study

John Carroll

Editor & Founder

Pfizer and their partners at the mRNA specialist BioNTech have published the first glimpse of biomarker data from an early-stage study spotlighting the “robust immunogenicity” triggered by their Covid-19 vaccine, which is one of the leaders in the race to vanquish the global pandemic.

Researchers selected 45 healthy volunteers 18-55 years of age for the study. They were randomized to receive 2 doses, separated by 21 days, of 10 µg, 30 µg, or 100 µg of BNT162b1, “a lipid nanoparticle-formulated, nucleoside-modified, mRNA vaccine that encodes trimerized SARS-CoV-2 spike glycoprotein RBD.” Their responses were compared against the effect of a natural, presumably protective defense offered by a regular infection.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 84,700+ biopharma pros reading Endpoints daily — and it's free.

Paratek pub­lish­es pos­i­tive PhI­II da­ta on ap­proved Nuzyra; Al­ler­gan set­tles opi­oid law­suits in two Ohio coun­ties

Tes­la chief Elon Musk teams up with Covid-19 play­er Cure­Vac to build 'R­NA mi­cro­fac­to­ries'

UP­DAT­ED: Re­gen­eron co-founder George Yan­copou­los of­fers a com­bat­ive de­fense of the po­lice at a high school com­mence­ment. It didn’t go well

Elias Zer­houni dis­cuss­es ‘am­a­teur hour’ in DC, the de­struc­tion of in­fec­tious dis­ease R&D and how we need to prep for the next time

Sec­ond death trig­gers hold on Astel­las' $3B gene ther­a­py biotech's lead pro­gram, rais­ing fresh con­cerns about AAV

Look­ing for 'ex­ter­nal in­no­va­tion,' Boehringer In­gel­heim re­serves $500M+ for new Shang­hai hub

No­var­tis pays $678M for kick­back scheme as Vas Narasimhan tries to dis­tance phar­ma gi­ant from shady be­hav­ior

No­vavax snags Ben Machielse for CMC and pro­motes a trio of staffers; Mar­ty Du­vall lands an­oth­er CEO post at On­copep­tides

De­vel­op­ment part­ners at MEI, Helsinn dump a high-risk PhI­II AML study af­ter con­clud­ing it would fail sur­vival goal

Pfiz­er shares surge on pos­i­tive im­pact of their mR­NA Covid-19 vac­cine — part­nered with BioN­Tech — in an ear­ly-stage study