GSK gets Eu­ro­pean OK for HIV drug Ju­lu­ca; Akari dealt non-com­pli­ance no­tice from Nas­daq

→ GSK’s Vi­iV has snared a Eu­ro­pean ap­proval for Ju­lu­ca, which the phar­ma gi­ant touts as the first 2-drug, once-dai­ly, sin­gle pill reg­i­men OK’d for HIV. The drug is a com­bi­na­tion of Vi­iV’s do­lute­gravir 50mg with J&J’s rilpivirine 25mg. “The Eu­ro­pean Com­mis­sion De­ci­sion for Ju­lu­ca is very pos­i­tive news for peo­ple liv­ing with HIV (PL­HIV) across Eu­rope, who will now have the op­por­tu­ni­ty to main­tain their vi­ral sup­pres­sion with a com­plete treat­ment reg­i­men com­posed of on­ly two drugs with­in a sin­gle-pill,” said Vi­iV CEO Deb­o­rah Wa­ter­house.

Akari Ther­a­peu­tics is scram­bling to keep its po­si­tion on the Nas­daq $AK­TX af­ter fail­ing to file an an­nu­al re­port on time. The ex­change is giv­ing Akari 60 days to sub­mit a plan to re­gain com­pli­ance with Nas­daq’s fil­ing re­quire­ments for con­tin­ued list­ing, and the com­pa­ny says it plans to do so. If Nas­daq is hap­py with their com­pli­ance plan, it can grant an ex­ten­sion up un­til No­vem­ber 12 for Akari to re­file its Form 20-F. Akari has been us­ing a 20-F in lieu of a 10-K as it al­so has a foot in Lon­don. This comes just days af­ter the New York City-based biotech oust­ed its for­mer CEO David Horn Solomon for al­leged­ly abus­ing the com­pa­ny cred­it card — its sec­ond chief ex­ec­u­tive to step down amid scan­dal in a year.

No­vo Nordisk re­port­ed this morn­ing that adults with haemophil­ia B who re­ceived a sin­gle dose of their drug Re­fix­ia (nonacog be­ta pe­gol; N9-GP) “achieved greater to­tal fac­tor IX ex­po­sure than those treat­ed with rFIXFc (re­com­bi­nant fac­tor IX-Fc fu­sion pro­tein).”  The head-to-head par­a­digm7 tri­al re­sults were pre­sent­ed at the WFH 2018 World Con­gress in Glas­gow, UK.

Bioa­sis Tech­nolo­gies and WuXi Bi­o­log­ics have struck an ini­tial strate­gic col­lab­o­ra­tion deal for the de­vel­op­ment and man­u­fac­tur­ing of xB3-001, Bioa­sis’ lead in­ves­ti­ga­tion­al bi­o­log­i­cal can­di­date to treat brain can­cer.

Take­da swoops in to buy lit­tle biotech part­ner and its celi­ac drug poised to 'change stan­dard of care'

Having spent three years carefully grooming PvP Biologics and its drug for celiac disease, Takeda is happy enough with the proof-of-concept data to buy it all.

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Grow­ing ac­cep­tance of ac­cel­er­at­ed path­ways for nov­el treat­ments: but does reg­u­la­to­ry ap­proval lead to com­mer­cial suc­cess?

By Mwango Kashoki, MD, MPH, Vice President-Technical, and Richard Macaulay, Senior Director, of Parexel Regulatory & Access

In recent years, we’ve seen a significant uptake in the use of regulatory options by companies looking to accelerate the journey of life-saving drugs to market. In 2018, 73% of the novel drugs approved by the U.S. Federal Drug Administration (FDA) were designated under one or more expedited development program categories (Fast Track, Breakthrough Therapy, Priority Review, and Accelerated Approval).ᶦ

Mi­cro­bio­me Q&A: New study maps the vagi­na's 'op­ti­mal mi­cro­bio­ta' — and its im­pli­ca­tions for bio­phar­ma

The widely-held notion that the “optimal” vaginal microbiota is dominated by one strain of lactic-acid producing bacteria has now been challenged in a new paper, published in Nature Communications on Wednesday, which used advanced gene sequencing methods to map out the most comprehensive gene catalog of the human vaginal microbiome.

Things have changed in the more than 50 years since the concept of vaginal microbiota transplants was proposed and subsequently tainted by a Texas-based gynecologist who transplanted the vaginal fluid of women who had bacterial vaginosis into healthy females, suspecting he had isolated the bacteria responsible for the condition.

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Fol­low­ing US, Chi­na hos­pi­tal ef­forts, Gilead plots its own PhI­II tri­als for close­ly watched Covid-19 drug

Gilead is launching its own Phase III trials of remdesivir, the repurposed antiviral that a WHO official called the “one drug right now we think may have real efficacy” against Covid-19 as the novel coronavirus originating from Wuhan, China ravages the world.

Announced just a day after the NIH and the University of Nebraska Medical Center registered their US-based trial online, Gilead’s program will comprise two studies enrolling around 1,000 patients beginning in March. They will recruit primarily in Asian countries but will also include patients from other locations with “high numbers of diagnosed cases,” the company said.

Bio­gen touts new ev­i­dence from the gene ther­a­py com­pa­ny it wa­gered $800M on

A year ago, Biogen made a big bet on a small gene therapy company. Now they have new evidence one of their therapies could work.

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Anthony Fauci (AP Images)

UP­DAT­ED: NIH-part­nered Mod­er­na ships off its PhI-ready coro­n­avirus vac­cine can­di­date to a sea of un­cer­tain­ty

Off it goes.

Moderna has shipped the first batch of its mRNA vaccine against SARS-CoV-2 from its manufacturing facility in Norwood, Massachusetts, to the National Institute of Allergy and Infectious Diseases in Bethesda, Maryland, for a pioneering Phase I study.

It’s a hectic race against time. In the 42 days since Moderna selected the sequence they would use to develop their vaccine — a record time, no less — the number of confirmed cases around the world has surged astronomically from a few dozen to over 80,000, per WHO and Johns Hopkins estimates.

The candidate that they came up with, mRNA-1273, encodes for a prefusion stabilized form of the spike protein, which gives the virus its crown shape and plays a key role in transmission. The Coalition for Epidemic Preparedness Innovations, the Oslo-based group better known as CEPI, funded the manufacture of this batch.

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In at least one life-sci hub, gen­der and di­ver­si­ty ini­tia­tives haven’t made a dent

Gender and racial diversity at the top of UK life science companies has hardly budged over the last seven years despite repeated advocacy efforts, according to a new report.

The report, from the recruiting firm Liftstream, found that 14.8% of directors on life sciences boards were women and 21.1% of top executives were women. That’s a modest bump from the 9.8% of directors and 18.1% of executives Liftstream identified in their last report from 2014. The percentage of women CEOs moved from 8% to 9.8%.

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Will a 'risk-of­f' mind­set has­ten cell ther­a­py M&A? Io­vance surges on buy­out chat­ter

Is it time for some cell therapy M&A?

Investors of Iovance Biotherapeutics certainly thought so, sending its stock $IOVA up as much as 40% after Bloomberg reported that the cancer-focused biotech is talking to potential buyers.

While 2019 saw a number of high-profile gene therapy company takeovers — led by Roche’s $4.3 billion bid of Spark as Astellas went for Audentes, Biogen snapped up Nightstar and Vertex absorbed Exonics — large players appeared to prefer partnering on the cell therapy front, particularly when it comes to cancer. Hal Barron put his weight behind Rick Klausner’s startup as he rebuilt GlaxoSmithKline’s cancer pipeline. Takeda turned to MD Anderson to license their natural killer cell therapy.

One less ri­val for Im­muno­vant, as Alex­ion aban­dons FcRn in­hibitor

Less than one year after Alexion parted with $25 million upfront to secure access to a second anti-FcRn asset, it is abandoning the experimental drug. The discontinuation, disclosed at the SVB Leerink Global Healthcare Conference in New York during a fireside chat, bodes well for rival Immunovant.

The drug (ABY-039), partnered for development with Sweden’s Affibody, was forsaken on the basis of early-stage data that was not viewed favorably, Baird and SVB Leerink analysts noted.