Bushu plans $100 mil­lion ex­pan­sion for phar­ma­ceu­ti­cal in­spec­tion fa­cil­i­ty; RUC­DR breaks away from Rut­gers Uni­ver­si­ty, re­launch­es as IBX

In an ef­fort to be­come an “Asia hub” for phar­ma­ceu­ti­cal in­spec­tion and dis­tri­b­u­tion, con­tract man­u­fac­tur­er Bushu Phar­ma­ceu­ti­cals is pour­ing $100 mil­lion in­to the ex­pan­sion of its Mis­ato, Japan plant over the next 5 years.

Bushu is near­ly done build­ing its 42,000-square-foot cold chain ware­house in Mis­ato. Up­grades in­clude 8 new pack­ag­ing lines, new in­spec­tion sta­tions, and IT im­prove­ments to its pro­duc­tion au­toma­tion and lab­o­ra­to­ry in­for­ma­tion man­age­ment sys­tems. When con­struc­tion is com­plete, the com­pa­ny will have 12 in­spec­tion sta­tions for pre-filled sy­ringes, and 7 sta­tions each for liq­uid vials and lyophilized vials. In to­tal, 23 sta­tions will be “sup­port­ed by cam­eras.”

“We are ex­cit­ed about our cap­i­tal ex­pan­sion plans,” Bushu COO Tadao Takano said in a pre­pared state­ment. “Our Asia hub strat­e­gy is com­ing to life. The added space and ad­di­tion­al in­spec­tion lines will al­low us to bring more of our client’s bulk prod­ucts in­to the coun­try, which will make their lo­gis­tics and sup­ply chain sys­tems much more ef­fi­cient.” — Nicole De­Feud­is 

In­fin­i­ty Bi­ologiX spins off from Rut­gers Uni­ver­si­ty

RUC­DR In­fi­nite Bi­o­log­ics broke away from Rut­gers Uni­ver­si­ty on Wednes­day, and re­launched as In­fin­i­ty Bi­ologiX (IBX). The com­pa­ny will still con­duct re­gen­er­a­tive med­i­cine and on­col­o­gy re­search at the Rut­gers cam­pus — but it’s now fi­nan­cial­ly in­de­pen­dent.

Rut­gers Uni­ver­si­ty ap­proved the sale of RUC­DR in June. An­drew Brooks, an ad­junct pro­fes­sor at Rut­gers and for­mer RUC­DR COO, will re­main at the helm as IBX CEO and CSO. RUC­DR alums Robin Grim­wood and Rus­sell Hager will serve as pres­i­dent and COO, and ex­ec­u­tive VP of strate­gic op­er­a­tions, re­spec­tive­ly. Viking Glob­al In­vestors con­tributed a “sig­nif­i­cant in­fu­sion of growth cap­i­tal,” ac­cord­ing to the com­pa­ny.

In May, RUC­DR be­came the first to get a EUA for a sali­va-based Covid-19 test — a method that Brooks tout­ed as “quick­er and more scal­able” than nasal swab­bing. The com­pa­ny has since de­vel­oped an at-home sali­va-based test with part­ners Spec­trum So­lu­tions and Ac­cu­rate Di­ag­nos­tic Labs.

“The tran­si­tion to IBX en­ables us to scale and in­no­vate at a pace which will in­crease our foot­print both here in the U.S. and abroad. RUC­DR has made a pro­found im­pact in acad­e­mia and in­dus­try in the ar­eas of ge­nomics, bi­o­log­i­cal sci­ences, and med­i­cine. We now look for­ward to the im­mense op­por­tu­ni­ty ahead as an or­ga­ni­za­tion in­de­pen­dent from Rut­gers while main­tain­ing our core aca­d­e­m­ic dri­ve and mis­sion,” Grim­wood said in a pre­pared state­ment. — Nicole De­Feud­is 

Rakuten ac­quires catheter pro­duc­er to shore up sup­ply chain

Rakuten Med­ical, a biotech fo­cus­ing on a form of can­cer ther­a­py known as pho­toim­munother­a­py, has ac­quired a com­pa­ny that pro­duces and com­mer­cial­izes a large range of catheters.

The biotech an­nounced the ac­qui­si­tion of Med­light SA on Wednes­day morn­ing, em­pha­siz­ing the need to en­sure ac­cess to a sup­ply chain vi­tal to the de­vel­op­ment of di­ag­nos­tics and ther­a­peu­tic light tech­nolo­gies. Fi­nan­cial terms of the deal were not dis­closed.

Wednes­day’s deal al­so brings Med­light’s net­work of sub­con­trac­tors for op­ti­cal de­vices on board and gives Rakuten more com­pre­hen­sive over­sight of its de­vel­op­men­tal sup­ply chain.

Rakuten’s lead pro­gram is dubbed ASP-1929, which re­ceived fast track des­ig­na­tion from the FDA. The can­di­date is an an­ti­body-drug con­ju­gate com­prised of the an­ti­body ce­tux­imab, which binds to epi­der­mal growth fac­tor re­cep­tors, and a dye that lo­cal­ly ac­ti­vates the an­ti­body through a non-ther­mal red light emit­ted via laser. ASP-1929 is cur­rent­ly in Phase III for the treat­ment of re­cur­ring head and neck can­cers. — Max Gel­man

Im­ple­ment­ing re­silience in the clin­i­cal tri­al sup­ply chain

Since January 2020, the clinical trials ecosystem has quickly evolved to manage roadblocks impeding clinical trial integrity, and patient care and safety amid a global pandemic. Closed borders, reduced air traffic and delayed or canceled flights disrupted global distribution, revealing how flexible logistics and supply chains can secure the timely delivery of clinical drug products and therapies to sites and patients.

News brief­ing: Gilead part­ner Gala­pa­gos sells off CRO for $37M; Polyphor bags $3.3M from CF Foun­da­tion

Close Gilead ally Galapagos is selling off one of its contract research organizations to a Polish pharma company.

Galapagos has agreed to sell 100% of the outstanding shares in the CRO Fidelta to Selvita, in a deal worth roughly $37 million expected to close in the first week of January. The acquisition is expected to nearly double Selvita’s revenues, the company says, as well as expand its drug discovery efforts.

Gen­mab ax­es an ADC de­vel­op­ment pro­gram af­ter the da­ta fail to im­press

Genmab $GMAB has opted to ax one of its antibody-drug conjugates after watching it flop in the clinic.

The Danish biotech reported Tuesday that it decided to kill their program for enapotamab vedotin after the data gathered from expansion cohorts failed to measure up. According to the company:

While enapotamab vedotin has shown some evidence of clinical activity, this was not optimized by different dose schedules and/or predictive biomarkers. Accordingly, the data from the expansion cohorts did not meet Genmab’s stringent criteria for proof-of-concept.

Michelle Longmire, Medable CEO (Jeff Rumans)

Med­able gets $91M for vir­tu­al clin­i­cal tri­als, bring­ing to­tal raise to $136M

As biotechs look to get clinical studies back on track amid the pandemic, Medable returned to the venture well for the second time this year, bagging a $91 million Series C to build out its virtual trial platform.

The software provider recently launched three new apps for decentralizing clinical trials, and saw a 500% revenue spike this year. And it isn’t alone. Back in August, Science 37 secured a $40 million round for its virtual trial tech, with support from Novartis, Sanofi Ventures and Amgen. Patients and researchers are taking a liking to the online approach, suggesting regulators could allow it to become a new normal even after the pandemic is over.

PhRMA sues Trump gov­ern­ment over drug im­por­ta­tion rule — days be­fore it's set to be ef­fec­tive

Ever since President Donald Trump floated the idea of using state-sponsored importation to lower drug prices, PhRMA has made its opposition abundant. Not only is the proposal dangerous and futile,  but the trade group has also argued that it may even be illegal.

Now that the FDA has issued its final rule permitting states to bring certain drugs from Canada, PhRMA is taking the government to court — just a few days before the rule is slated to take effect.

The ad­u­canum­ab co­nun­drum: The PhI­II failed a clear reg­u­la­to­ry stan­dard, but no one is cer­tain what that means any­more at the FDA

Eighteen days ago, virtually all of the outside experts on an FDA adcomm got together to mug the agency’s Billy Dunn and the Biogen team when they presented their upbeat assessment on aducanumab. But here we are, more than 2 weeks later, and the ongoing debate over that Alzheimer’s drug’s fate continues unabated.

Instead of simply ruling out any chance of an approval, the logical conclusion based on what we heard during that session, a series of questionable approvals that preceded the controversy over the agency’s recent EUA decisions has come back to haunt the FDA, where the power of precedent is leaving an opening some experts believe can still be exploited by the big biotech.

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In fi­nal days at Mer­ck, Roger Perl­mut­ter bets big on a lit­tle-known Covid-19 treat­ment

Roger Perlmutter is spending his last days at Merck, well, spending.

Two weeks after snapping up the antibody-drug conjugate biotech VelosBio for $2.75 billion, Merck announced today that it had purchased OncoImmune and its experimental Covid-19 drug for $425 million. The drug, known as CD24Fc, appeared to reduce the risk of respiratory failure or death in severe Covid-19 patients by 50% in a 203-person Phase III trial, OncoImmune said in September.

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Pascal Soriot (AP Images)

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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Feng Tian, Ambrx CEO (Ambrx)

Af­ter 5 qui­et years, a for­mer Scripps spin­out rais­es $200M and an­nounces plans to try again at an IPO

The first time San Diego biotech Ambrx tried to go public in 2014, they failed and the company’s board switched to a radically different strategy: They sold themselves for an undisclosed amount to a syndicate of Chinese investors and pharma companies.

Now, after 5 quiet years, that syndicate has raised a mountain of cash and indicated they’ll soon make another bid to go public.

Earlier this month, Ambrx raised $200 million in what they billed as a crossover round financed by Fidelity, BlackRock, Cormorant Asset Management, HBM Healthcare Investments, Invus, Adage Capital Partners and Suvretta Capital Management. It’s the largest amount they’ve ever raised and, according to Crunchbase figures, more than doubles the total amount of VC capital collected since their launch 17 years ago.