Fortress Biotech sells bro­ker­age firm fol­low­ing Reuters ex­posé; Tra­con con­tends with an­oth­er set­back in brain can­cer

→ In the af­ter­math of a Reuters re­port shin­ing a light on its ques­tion­able re­la­tion­ship with Na­tion­al Hold­ings, Fortress Biotech an­nounced it is sell­ing con­trol of the bro­ker­age firm that’s pro­vid­ed con­sid­er­able — if in­con­spic­u­ous — fundrais­ing sup­port for its biotech ven­tures. In a deal reg­is­tered at $22.9 mil­lion, Fortress Bio will trans­fer its ma­jor­i­ty stake — 56.1% — to B. Ri­ley Fi­nan­cial, giv­ing the fi­nan­cial ser­vices com­pa­ny ac­cess to 700 bro­kers, 90,000 cus­tomer ac­counts and $12 bil­lion-plus in client’s as­sets, the com­pa­nies say.

→ Tiny Tra­con $TCON has suf­fered an­oth­er brain can­cer set­back. Last year, its lead drug TRC105 failed in a Phase III NCI study in pa­tients with re­cur­rent glioblas­toma. On Mon­day, it re­port­ed dis­ap­point­ing ini­tial da­ta from a Phase II NCI study eval­u­at­ing its ex­per­i­men­tal drug, TRC102, in com­bi­na­tion with Mer­ck’s $MRK Temodar, in the same pa­tient pop­u­la­tion. TRC102 plus Temodar did not meet the main goal of re­sen­si­tiz­ing pa­tients to Temodar treat­ment in the ini­tial 19 en­rolled pa­tients, al­though two pa­tients met the sec­ondary end­point of pro­gres­sion-free sur­vival be­yond 6 months, the com­pa­ny said. The drug con­tin­ues to be eval­u­at­ed in four on­go­ing NCI tri­als.

→ Af­ter years of see­ing its stock in the gut­ters, RXi Phar­ma­ceu­ti­cals $RXII has de­cid­ed to op­er­ate un­der a new ban­ner: Phio Phar­ma­ceu­ti­cals $PHIO. The name change re­flects its de­ci­sion to con­cen­trate on im­muno-on­col­o­gy ap­pli­ca­tions for its RNA tech, the com­pa­ny says, some­thing it’s sig­naled with a T-cell re­search pact with Medi­gene an­nounced late last year.

Har­vard spin­out QurAlis has brought its to­tal amount of seed fund­ing to $5.5 mil­lion by adding BioIn­no­va­tion Cap­i­tal and Vi­va Biotech Lim­it­ed to the fold. The mon­ey, as well as a sec­ond year of spon­sored lease at Lab­Cen­tral and a new res­i­den­cy at JLABS, will sup­port QurAlis’ in ad­vanc­ing its treat­ments for amy­otroph­ic lat­er­al scle­ro­sis (ALS) and fron­totem­po­ral de­men­tia to the clin­ic. “My part­ners and I have fol­lowed QurAlis’ progress close­ly dur­ing its time at Lab­Cen­tral,” said Jo­hannes Frue­hauf, pres­i­dent of Lab­Cen­tral and gen­er­al part­ner at BioIn­no­va­tion Cap­i­tal. “We be­lieve their nov­el ap­proach has the po­ten­tial to change the tra­jec­to­ry of the dis­ease, just as the an­tivi­ral ther­a­pies did for HIV in the late 1990s; we are ex­cit­ed to pro­vide our sup­port and ex­per­tise to help pro­pel the com­pa­ny for­ward.”

Covid-19 roundup: Eu­rope pur­chas­es 80M dos­es of Mod­er­na's vac­cine; CO­V­AXX se­cures $2.8B in emerg­ing mar­ket pre-or­ders

With the announcement of its vaccine efficacy data last week, Moderna is starting to line up customers for its Covid-19 mRNA jabs.

The Massachusetts-based biotech announced Wednesday it has agreed to sell an initial round of 80 million doses to the European Commission, with the option to double the amount to 160 million. Once the member states rubber stamp the approval, the deal will be finalized.

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UP­DAT­ED: As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

Af­ter Ko­dak de­ba­cle, US lends $1.1B to a syn­thet­ic bi­ol­o­gy com­pa­ny and their big Covid-19, mR­NA plans

In mid-August, as Kodak’s $765 million government-backed push into drug manufacturing slowly fell apart in national headlines, Ginkgo Bioworks CEO Jason Kelly got a message from his company’s government liaison: HHS wanted to know if they, too, might want a loan.

The government’s decision to lend Kodak three quarters of a billion dollars raised eyebrows because Kodak had never made drugs before. But Ginkgo, while not a manufacturing company, had spent the last decade refining new ways to produce materials inside cells and building automated facilities across Boston.

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News brief­ing: FDA re­quests new tri­al for Reata's Friedre­ich's atax­ia pro­gram; J&J's Trem­fya picks up ex­pand­ed la­bel in Eu­rope

Three months after Reata Pharmaceuticals suggested its Friedreich’s ataxia program omaveloxolone could be delayed, the company revealed that is indeed going to be the case.

Reata $RETA shares took a nosedive Wednesday after the biotech revealed that the FDA said supplemental data for its pivotal trial did not strengthen the case for approval. As a result, the drug is likely to need another study before the FDA takes up the case.

FDA hands Liq­uidia and Re­vance a CRL and de­fer­ral, re­spec­tive­ly, as Covid-19 cre­ates in­spec­tion chal­lenge

Two biotechs said they got turned away by the FDA on Wednesday, in part due to pandemic-related travel restrictions.

North Carolina-based Liquidia Technologies was handed a CRL for its lead pulmonary arterial hypertension drug, citing the need for more CMC data and on-site pre-approval inspections, which the FDA hasn’t been able to conduct due to travel restrictions. The agency also deferred its decision on Revance Therapeutics’ BLA for its frown line treatment, because it needs to inspect the company’s northern California manufacturing facility. The action, Revance emphasized, was not a CRL.

Jef­frey Hat­field takes over from Diego Mi­ralles as CEO of Vi­vid­ion; Drag­on­fly scores a new ex­ec with COO Alex Lu­gov­skoy

→ San Diego protein degradation startup Vividion Therapeutics has made a change at the top with Jeffrey Hatfield taking the helm as CEO, replacing Diego Miralles six months after Roche forked over $135 million to collaborate with Vividion on their small molecule degraders. Hatfield is chairman of the board at miRagen Therapeutics and previously held the CEO job at Zafgen and Vitae Pharmaceuticals. He also had a series of leadership roles at Bristol Myers Squibb from 1996-2004, including SVP, immunology and virology divisions.

Chi­na opens the door for biotech in­vestors in Hong Kong to buy Shang­hai stocks, and vice ver­sa

When Shanghai’s STAR board began opening its doors to biotech, it was considered not just a rival to Nasdaq but also the stock exchange in Hong Kong. Those perceptions may take an amicable turn as China expands a mutual access program with the city.

The changes mean investors in mainland China will be able to own Hong Kong biotech chapter stocks, while those in Hong Kong — a much more internationally connected group — would have access to those listed on STAR. In effect, it turns the Shanghai market into a globally accessible exchange overnight while also broadening a key source of revenue for HKEX.

Bax­ter con­tin­ues on-shoring push with $50M In­di­ana ex­pan­sion

It’s been a banner year for the once humdrum business of manufacturing drugs, particularly vaccines. Billions have been spent ramping up facilities for Covid-19 jabs, while individual CDMOs have expanded their facilities, apparently anticipating demand or responding to a government-led push to onshore drug manufacturing.

Now Baxter Biopharma Solutions, the CDMO wing of the many-armed healthcare giant Baxter, is getting in on the game. On Tuesday, they announced plans to spend $50 million to expand their flagship, 600,000 square-foot facility in Bloomington, IN.

Eu­ro­pean Union aims to es­tab­lish patent workaround in case of emer­gen­cies while try­ing to strength­en its own IP

The European Union is looking at ways to bypass patent protections and make it easier to make generic drugs in cases of emergency such as the Covid-19 pandemic, a new document says.

Normally, under WTO regulations, the practice known as “compulsory licensing” is allowed in exceptional circumstances and could be applied as a waiver to bypass patent holders. Wednesday’s document was published as part of the EU’s plan to shore up the intellectual property rights of its member states.