Amgen's new 245,000 square-foot R&D lab in San Francisco's Oyster Point

R&D ac­cel­er­a­tion: Am­gen opens its sec­ond largest re­search site, with lab and of­fice space for 650 staff

Am­gen has fa­mous­ly been called a law firm with a biotech com­pa­ny at­tached to it. And now that biotech at­tach­ment will have sig­nif­i­cant­ly more room to de­vel­op and grow.

Right next to Genen­tech’s 1 DNA Way in south San Fran­cis­co, Am­gen on Thurs­day opened the doors to a new 245,000-square-foot build­ing that will be filled with about 650 staff work­ing to dis­cov­er drugs to treat can­cer, in­flam­ma­to­ry dis­eases and car­diometa­bol­ic dis­or­ders.

Con­struc­tion on the nine-sto­ry fa­cil­i­ty, which is right on the ma­ri­na at Oys­ter Point, be­gan in 2019 and was ini­tial­ly ex­pect­ed to open in ear­ly 2022. Now the space will of­fer a num­ber of perks to at­tract top tal­ent, like dif­fer­ent din­ing op­tions, a health club and out­door recre­ation ar­eas.

Robert Brad­way

“This new state-of-the-art fa­cil­i­ty fur­ther demon­strates our com­mit­ment to dis­cov­er­ing and de­vel­op­ing treat­ments for some of the world’s most se­ri­ous and wide­spread dis­eases,” Am­gen chair­man and CEO Robert Brad­way said in a state­ment.

Since an­nounc­ing its de­ci­sion to pull out of neu­ro­science R&D in 2019, Am­gen has con­sol­i­dat­ed its US-based re­search to South San Fran­cis­co and Thou­sand Oaks, where it’s head­quar­tered. But in ad­di­tion to the 149 jobs they axed in Cam­bridge — where the neu­ro­science team was large­ly based — Am­gen al­so laid off 172 staffers na­tion­wide in 2019 as part of an ef­fort to cut op­er­a­tions, R&D and field-based com­mer­cial po­si­tions.

More re­cent­ly in the Bay Area, Am­gen is pay­ing $4 bil­lion for Chemo­Cen­tryx, a San Car­los-based biotech fo­cused on oral­ly ad­min­is­tered ther­a­peu­tics to treat au­toim­mune dis­eases, in­flam­ma­to­ry dis­or­ders and can­cer. That deal is ex­pect­ed to close this quar­ter.

In ad­di­tion to Genen­tech, Ab­b­Vie al­so has built new space at Oys­ter Point in re­cent years, near a few of its part­ners like Cal­i­co, Cy­tomX and Alec­tor.

In ad­di­tion to the open­ing of its site, Am­gen this week al­so scored a new $290 mil­lion sup­ply deal with the US gov­ern­ment for its drug for use in ra­di­o­log­i­cal and nu­clear emer­gen­cies.

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Who’s spend­ing and who’s cut­ting from Big Phar­ma’s $127B R&D bud­get? Here are the top 15 play­ers

A couple of the Big 15 biopharma companies in R&D hit the gas on research spending last year. Merck and Sanofi still have lots to prove in the pipeline, and they’re willing to gamble large sums to make a better future for themselves.

Doing nothing would be infinitely worse.

But collectively, the top players rang up a modest 2.4% increase in spending in 2022, which didn’t cover inflationary pressures. And that set the tone for an extraordinarily cautious year for the industry — even as it laid out about $127 billion to advance new drugs or up the ante on approved therapies.

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Jeff Bluestone (R), Sonoma Biotherapeutics CEO

Jef­frey Blue­stone brings his start­up haul to $400M+, join­ing forces with Re­gen­eron on cell ther­a­pies

These days, when Jeffrey Bluestone gets together with his contemporaries in science, the conversation often turns to retirement plans.

But a little more than three years ago, Bluestone reached a momentous turning point in his career, exiting a prestigious post at UCSF, where he had spent decades in the scientific pursuit of new therapies. And it had nothing to do with retirement anytime in the near future.

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Gun­ning for 2023 ap­proval, GSK de­tails PhI­II da­ta for Jem­per­li in front­line en­dome­tri­al can­cer

GSK has a new slate of data to offer on its PD-1 inhibitor, Jemperli — data that the pharma giant hopes will cement one of the four drug approvals it’s expecting this year.

While Jemperli (dostarlimab) is already approved for a subset of patients with second-line endometrial cancer, GSK set out in the Phase III RUBY trial to test it as an earlier line of treatment while also enrolling a broader group of patients. In an interim analysis, Jemperli was shown to extend progression-free survival for both the subset and the overall trial population when added to chemotherapy.

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Mihael Polymeropoulos, Vanda Pharmaceuticals CEO

Van­da wins court case against FDA over dis­clo­sure of CRL de­tails for sleep drug

DC District Court Judge Christopher Cooper today granted Vanda Pharma’s request to require the FDA to disclose more info on the complete response letter for its sleep disorder drug Hetlioz.

The melatonin receptor agonist is approved by the FDA to treat non-24-hour sleep-wake disorder, a circadian rhythm disorder. But in 2018 Vanda filed a supplemental application to market Hetlioz as a treatment for jet lag, which the FDA rejected in August 2019, with few details on what Vanda needed to correct course, according to the company.

Sally Susman, Pfizer EVP and chief corporate affairs officer

Q&A: Pfiz­er cor­po­rate com­mu­ni­ca­tions chief Sal­ly Sus­man dis­cuss­es book craft­ed in pan­dem­ic and per­son­al lessons

From the political arena to the finance and beauty industries to pharmaceuticals, Pfizer’s Sally Susman has broken barriers, stereotypes and conventions. And now the chief communicator is “Breaking Through,” the title of her first book about effective and innovative communications launching today. The full official title is “Breaking Through: Communicating to Open Minds, Move Hearts, and Change the World.”

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Es­pe­ri­on sues Dai­ichi Sankyo, de­mand­ing pay­ment of $300M mile­stone for car­dio drug

Esperion is suing its business partner Daiichi Sankyo, saying the Japanese drugmaker is improperly refusing to pay a $300 million milestone that the biotech company will be owed after reporting positive data from a large trial of its cardiovascular drug Nexletol.

The 2019 deal between the companies had Daiichi Sankyo pay $150 million upfront plus another $150 million after the first sales of the drug. But another major payout was tied to an outcomes study reported this month, known as CLEAR. Esperion, in its suit against Daiichi, argues that the drug’s more than 20% reduction of heart attack risk is enough to trigger a $300 million payout from Daiichi once it’s added to the drug’s label.

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Eli Lil­ly to in­crease in­vest­ment to $1B in­to new Irish man­u­fac­tur­ing fa­cil­i­ty — re­port

The US pharma giant Eli Lilly will be increasing its financial commitment to a manufacturing site in Ireland.

According to a release from Ireland’s Industrial Development Agency (IDA) on Monday, Lilly will be investing another $500 million in its manufacturing facility in Limerick, Ireland — bringing the total investment into the facility to approximately $1 billion.

In January of last year, Lilly announced it was placing a $446 million investment into the site to expand active pharmaceutical ingredient and monoclonal antibody production.

Uğur Şahin, BioNTech CEO (Andreas Arnold/picture-alliance/dpa/AP Images)

BioN­Tech read­ies for plunge in Covid sales, will boost mR­NA and on­col­o­gy pipelines

BioNTech is estimating €5 billion (nearly $5.4 billion) in Covid-19 vaccine sales this year, a marked drop from €17.1 billion ($18.5 billion) in 2022 — and way off analysts’ expectations of around €8 billion ($8.6 billion).

In BioNTech’s year-end earnings call on Monday, it reported a total of €17.3 billion ($18.7 billion) in 2022 revenue, almost all from vaccine sales, which include those via its Pfizer deal and direct sales.

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