Bomb squad called to As­traZeneca vac­cine plant; Lu­men nabs CARB-X award for low-cost an­tidiar­rheal

A plant lo­cat­ed in Wrex­ham, Wales that is pack­ing the Ox­ford/As­traZeneca Covid-19 vac­cine in­to vials was sur­round­ed by a bomb squad af­ter of­fi­cials called po­lice to re­port a sus­pi­cious pack­age.

The alert caused a par­tial evac­u­a­tion of the plant, the BBC was among those to re­port Wednes­day. The own­er of the plant, British drug­mak­er Wock­hardt UK, said it was co­op­er­at­ing with lo­cal au­thor­i­ties and that there were no re­ports of any in­juries.

“Wock­hardt UK in Wrex­ham this morn­ing re­ceived a sus­pi­cious pack­age to site,” the com­pa­ny said in a state­ment to BBC. “All rel­e­vant au­thor­i­ties were im­me­di­ate­ly no­ti­fied and en­gaged. Up­on ex­pert ad­vice we have par­tial­ly evac­u­at­ed the site pend­ing a full in­ves­ti­ga­tion.”

The British gov­ern­ment is al­so mon­i­tor­ing the sit­u­a­tion.

An in­di­vid­ual who works next door to the plant told BBC he heard a “big bang” around 11:35 a.m. lo­cal time. He went out­side with two oth­ers to see what caused the noise but couldn’t de­ter­mine where it had come from. The po­lice then quick­ly closed off the road.

The Welsh plant has the ca­pa­bil­i­ty to pro­duce about 300 mil­lion dos­es of the vac­cine per year. It’s the same plant that last week saw mas­sive flood­ing near­by, though the worst of the storm ap­peared to spare the plant.

Lu­men to earn up to $14.5 mil­lion from CARB-X for an­tidiar­rheal

Lu­men Bio­science and CARB-X are work­ing on a new project to­geth­er, one that could pro­vide Lu­men with some cash.

The pair are work­ing to de­vel­op an oral mon­o­clon­al an­ti­body cock­tail to pre­vent se­ri­ous di­ar­rheal dis­eases caused by Campy­lobac­ter je­ju­ni and en­tero­tox­i­genic E. coli. CARB-X is putting up an ini­tial fund­ing com­mit­ment of $5.2 mil­lion, and the project is el­i­gi­ble for an ad­di­tion­al $8.26 mil­lion in mile­stones, sub­ject to avail­able funds at CARB-X.

Com­mon­ly re­ferred to as trav­el­er’s di­ar­rhea, the dis­eases are a ma­jor cause of death and sick­ness in the de­vel­op­ing world, par­tic­u­lar­ly in in­fants and chil­dren. The in­tend­ed prod­uct is a low-cost, ed­i­ble an­ti­body cock­tail that can be eas­i­ly shipped, stored, and used world­wide, in­clud­ing in re­gions that lack cold-chain dis­tri­b­u­tion.

Lu­men’s pro­gram has com­plet­ed Phase I and should en­ter Phase II in ear­ly 2021, CEO Bri­an Fin­row told End­points News in Sep­tem­ber. The pro­gram is al­so part­ly fund­ed by the Bill and Melin­da Gates Foun­da­tion.

CARB-X is a glob­al non-prof­it part­ner­ship that works on ac­cel­er­at­ing ear­ly an­tibac­te­r­i­al R&D to com­bat drug-re­sis­tant bac­te­ria. This deal brings the num­ber of ac­tive projects in the CARB-X port­fo­lio to 50.

Qual­i­ty Con­trol in Cell and Gene Ther­a­py – What’s Re­al­ly at Stake?

In early 2021, Bluebird Bio was forced to suspend clinical trials of its gene therapy for sickle cell disease after two patients in the trial developed cancer. As company scientists rushed to assess whether there was any causal link between the therapy and the cancer cases, Bluebird’s stock value plummeted – as did those of multiple other biopharma companies developing similar therapies.

While investigations concluded that the gene therapy was unlikely to have caused cancer, investors and the public may be more skittish regarding the safety of gene and cell therapies after this episode. This recent example highlights how delicate the fields of cell and gene therapy remain today, even as they show great promise.

Chris Gibson (Photo By Vaughn Ridley/Sportsfile for Web Summit via Getty Images)

Re­cur­sion founders gin for­tunes as IPO back­ers show­er $436M on one of the biggest boasts in AI -- based on some very small deals

In the AI drug development world, boasting often comes with the territory. Yet few can rival Recursion when it comes to claiming the lead role in what company execs like to call the industrialization of drug development, with promises of continued exponential growth in the number of drugs it has in the pipeline.

On Friday, the Salt Lake City-based biotech translated its unicorn-sized boasts into a killer IPO, pricing more than 24 million shares at the high end of its range and bringing in $436 million — with a large chunk of that promised by some deep-pocket backers.

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Seagen gets Au­gust PDU­FA for Pad­cev ex­pan­sions; Adap­tate pulls in new cash for gam­ma delta T cell an­ti­bod­ies

Seagen is riding the wave of two new priority reviews straight to the FDA.

The Bothell, WA-based biotech and their partners at Astellas announced Monday that two supplemental BLAs for Padcev had been accepted by US regulators. FDA has set Aug. 17 as the PDUFA date for the reviews.

“With our recent regulatory submissions, we intend to provide the highest level of clinical evidence supporting Padcev use — overall survival data from a randomized Phase III trial — and expand availability in multiple countries where there is unmet medical need,” said Astellas oncology chief Andrew Krivoshik.

UP­DAT­ED: New Kaiser analy­sis shows how lim­it­ing price ne­go­ti­a­tions to tar­get­ed drugs may bet­ter fo­cus up­com­ing leg­is­la­tion

As Congress considers whether to adopt sweeping new legislation to lower prescription drug prices across the board, the Kaiser Family Foundation is out with a new report on Monday showing how a more targeted approach on a subset of drugs might be a more efficient way to save government funds.

“This analysis shows that Medicare Part D and Part B spending is highly concentrated among a relatively small share of covered drugs, mainly those without generic or biosimilar competitors,” wrote Juliette Cubanski, deputy director of the program on Medicare policy at KFF, and Tricia Neuman, SVP of KFF. “Focusing drug price negotiation or reference pricing on a subset of drugs that account for a disproportionate share of spending would be an efficient use of administrative resources, though it would also leave some potential savings on the table.”

Tillman Gerngross (Adagio)

Till­man Gern­gross' Covid-19 an­ti­body moon­shot scores $336M with the help of new ace CFO. Is an IPO next?

Less than a year into its existence, serial biotech entrepreneur Tillman Gerngross’ antibody play Adagio has raced ahead into a pivotal trial for its lead drug for Covid-19 on the back of some very promising preclinical data. Now, crossover investors led by Peter Kolchinsky at RA are rolling up the Brinks truck — and that could spell an IPO in the offing for Adagio.

Adagio has bagged $336 million as part of a Series C round led by RA Capital to advance lead single-shot antibody ADG20 through a pivotal Phase I/II/III trial for the treatment of mild to moderate Covid-19 patients at high risk of infection, the biotech said Monday.

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When is a drug re­al­ly a de­vice? Court knocks down FDA ap­peal in try­ing to sort that grey area

It’s always a surprise when a court has to step in to tell the FDA that it erred in performing one of its main duties: classifying whether a medical product is drug or a device.

But that’s what the US Court of Appeals for the District of Columbia did on Friday, making clear to the world’s top drug regulator that Genus Medical Technologies’ contrast agent barium sulfate (also known as Vanilla SilQ) should not be considered a drug, as the FDA had said, but a medical device.

Q1: A flood of in­vestor cash drove biotech's num­bers to new record highs, and the tor­rent of cash is mov­ing up­stream fast

If you thought biotech was booming last year, wait until you get a load of the numbers from Q1 2021.

On virtually every level, with one exception, the money engine was working around the clock in the first 3 months of this year. Venture capital has reached such a fever peak that the average B round now weighs in at an average mega-weight value of $100 million. The money flow is also finding its way to the mouth of the R&D river, where discovery work now merits the big bucks instead of cautionary seed funds.

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Jami Rubin (EQRx)

Ja­mi Ru­bin, once fa­bled for grilling bio­phar­ma ex­ecs, de­camps to head fi­nance at drug pric­ing dis­rupter

As Goldman Sachs’ top pharmaceutical analyst, Jami Rubin was known for asking the tough questions. Now, as she takes the lead on EQRx’s mission to rewrite the rules of drug pricing, we’ll see how good her answers are.

Rubin made the jump to biotech on April 5, becoming EQRx’s new CFO, the company said Monday. She’s coming from PJT Partners, where she’s been a partner providing strategic guidance for biotech and pharmaceutical companies for the last couple years. With EQRx’s recent $500 million Series B round in the books, it wouldn’t be a surprise if she was already lining up a public debut.

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Ben Carson (Evan Vucci, AP Images)

UP­DAT­ED The doc­tor is in: Trump in­sid­er Ben Car­son joins NASH play­er Galectin as a 'spe­cial con­sul­tant,' part-time spokesman

In the few short months since President Donald Trump left office, his former department heads are reportedly having a difficult time finding employment. But for Ben Carson, Trump’s former housing secretary, that’s not a problem anymore after biotech came calling.

Carson, a former GOP presidential candidate and erstwhile HUD head, has joined Galectin Therapeutics as a “special consultant” the biotech hopes will help raise its profile and provide an entrée to key business partnerships, the company said Monday.