Te­va spin­out rais­es $85M in IPO; No­var­tis beefs up gener­ics unit with $440M deal

→ Af­ter Te­va spin­out 89bio re­cent­ly an­nounced that its IPO was be­ing held up, the com­pa­ny is back in the game of­fer­ing 5,304,687 shares at a price of $16 per share. The com­pa­ny has raised $84.9 mil­lion IPO in gross pro­ceeds and will be list­ed un­der the tick­er sym­bol $ETNB. Bo­fA Se­cu­ri­ties, SVB Leerink and RBC Cap­i­tal Mar­kets are the joint book-run­ning man­agers for the of­fer­ing. Op­pen­heimer & Co is the co-man­ag­er for the of­fer­ing.

→ Look­ing to amp up its pres­ence in Japan’s hos­pi­tals, No­var­tis has struck a deal to buy out As­pen’s port­fo­lio of gener­ics in the world’s third largest health­care mar­ket. The phar­ma gi­ant is pay­ing $440 mil­lion for As­pen’s Japan­ese sub­sidiary.

No­var­tis said tropifex­or, a non-bile acid FXR ag­o­nist, has scored on sev­er­al key bio­mark­ers of NASH in a Phase IIb tri­al, in­clud­ing re­duc­tions in he­pat­ic fat, ala­nine amino­trans­ferase and body weight com­pared to a place­bo at 12 weeks.

Daré Bio­science has ac­quired Gates-Foun­da­tion-backed Mi­crochips Biotech, which is de­vel­op­ing an im­plant en­gi­neered to de­liv­er hun­dreds of ther­a­peu­tic dos­es over months or years. The tech­nol­o­gy, first cre­at­ed in the lab of pro­lif­ic MIT sci­en­tist Bob Langer, has been val­i­dat­ed in os­teo­poro­sis pa­tients and is be­ing eval­u­at­ed for use as a re­versible con­tra­cep­tive. “The ad­di­tion of this user-con­trolled, long-act­ing re­versible con­tra­cep­tive op­por­tu­ni­ty to Daré’s pipeline, which al­ready in­cludes the nov­el month­ly, hor­mone-free con­tra­cep­tive Ovaprene, will unique­ly po­si­tion Daré with two of the po­ten­tial­ly most dis­rup­tive in­no­va­tions in the con­tra­cep­tive cat­e­go­ry, said Daré chief Sab­ri­na Mar­tuc­ci John­son. Daré is prep­ping to re­port the da­ta from the ovaprene post­coital test clin­i­cal tri­al and a pre-piv­otal study to sup­port prod­uct reg­is­tra­tion.

→ The tide of an­tibi­ot­ic re­sis­tance shows no signs of stop­ping, and the FDA is re­ward­ing the com­pa­nies that are still in the field. A Phase III in­tra­venous com­bi­na­tion an­tibi­ot­ic, ATM-AVIfrom Al­ler­gan and Pfiz­er has scored the FDA’s QIDP des­ig­na­tion and fast track sta­tus. The drug, de­signed to tar­get Gram-neg­a­tive pathogens, is in de­vel­op­ment com­pli­cat­ed in­tra-ab­dom­i­nal in­fec­tions (cIAI), com­pli­cat­ed uri­nary tract in­fec­tions, and hos­pi­tal-ac­quired bac­te­r­i­al pneu­mo­nia,  and ven­ti­la­tor-as­so­ci­at­ed bac­te­r­i­al pneu­mo­nia.

→ On the heels of pos­i­tive da­ta un­veiled at ES­MO, Chi-Med has se­cured a place in line at Chi­na’s drug reg­u­la­to­ry agency for su­r­u­fa­tinib. The Na­tion­al Med­ical Prod­ucts Ad­min­is­tra­tion is re­view­ing an NDA for the ki­nase in­hibitor in ad­vanced non-pan­cre­at­ic neu­roen­docrine tu­mors, which would be Chi-Med’s sec­ond prod­uct on the mar­ket. The Lon­don-list­ed biotech re­port­ed last month in the SANET-ep tri­al, su­r­u­fa­tinib ex­tend­ed me­di­an pro­gres­sion-free sur­vival to 9.2 months com­pared to 3.8 months on place­bo.

No­vo Nordisk is tak­ing an­oth­er care­ful step in­to the NASH space by li­cens­ing a pre­clin­i­cal com­pound from Japan’s UBE. UD-014 is a semi­car­bazide-sen­si­tive amine ox­i­dase/vas­cu­lar ad­he­sion pro­tein-1 in­hibitor that is be­lieved to have both an­ti-in­flam­ma­to­ry and an­tiox­ida­tive ef­fects. The Dan­ish drug­mak­er, known for its di­a­betes fran­chise, has col­lab­o­rat­ed with Gilead to test its GLP-1 drug semaglu­tide as part of a triple NASH com­bo.

Ab­cam signed off a cash pay­ment of €120 mil­lion to pur­chase Ex­pe­deon AG‘s pro­teomics and im­munol­o­gy busi­ness ac­tiv­i­ties. The agree­ment is still sub­ject to a share­hold­er ap­proval at a meet­ing held next month by Ex­pe­deon.

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)

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

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)

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

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)

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

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

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

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.

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An ex­pe­ri­enced biotech is stitched to­geth­er from transpa­cif­ic parts, with 265 staffers and a fo­cus on ‘new bi­ol­o­gy’

Over the past few years, different teams at a pair of US-based biotechs and in labs in Japan have labored to piece together a group of cancer drug programs, sharing a single corporate umbrella with research colleagues in Japan. But now their far-flung operations have been knit together into a single unit, creating a pipeline with 10 cancer drug development programs — going from early-stage right into Phase III — and a host of discovery projects managed by a collective staff of some 265 people.

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New stan­dard of care? FDA hands Pfiz­er, Mer­ck KGaA an OK for Baven­cio in blad­der can­cer

The breakthrough therapy designation Pfizer and Merck KGaA notched for Bavencio in bladder cancer has quickly paved way for a full approval.

The PD-L1 drug is now sanctioned as a first-line maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma, applicable in cases where cancer hasn’t progressed after platinum-containing chemotherapy.

Petros Grivas, the principal investigator of the supporting Phase III JAVELIN Bladder 100, called the approval “one of the most significant advances in the treatment paradigm in this setting in 30 years.”

Covid-19 roundup: Vac­cines will need to beat place­bo by 50% to qual­i­fy for FDA OK; UK tri­al drops Kale­tra

The FDA will set the bar for approving a Covid-19 vaccine at 50% efficacy, the Wall Street Journal reported, meaning any successful candidate will have to reduce the risk of coronavirus disease by at least half compared to placebo.

That requirement is part of guidance that the agency is set to release later today, laying out detailed criteria for vaccine developers — some of whom are eyeing an OK by the end of the year, in line with expectations at Operation Warp Speed.

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Joseph Kim, Inovio CEO (Andrew Harnik, AP Images)

Pos­i­tive Covid-19 vac­cine da­ta? New mouse study? OWS in­clu­sion? Yep, but some­how, the usu­al tid­bits from In­ovio back­fire

You don’t go more than 40 years in biotech without ever getting a product to market unless you can learn the art of writing a promotional press release. And Inovio captures the prize in baiting the hook.

Tuesday morning Inovio, which has been struggling to get its Covid-19 vaccine lined up for mass manufacturing, put out a release that touched on virtually every hot button in pandemic PR.

There was, first and foremost, an interim snapshot of efficacy from their Phase I program for INO-4800.