Mod­er­na looks to the West Coast for lat­est ex­pan­sion

Mod­er­na’s phys­i­cal pres­ence in the US has main­ly been con­fined to the East Coast. But now it will be plant­i­ng its flag on the West Coast.

Brad Miller

The mR­NA biotech an­nounced Fri­day that it will be open­ing two new of­fices in South San Fran­cis­co and Seat­tle this year. Mod­er­na chief in­for­ma­tion of­fi­cer Brad Miller told End­points News the Seat­tle of­fice is slat­ed to open April 4.

The Seat­tle lo­ca­tion will be hous­ing Mod­er­na’s ef­forts in tech­nol­o­gy and im­ple­men­ta­tion of AI and cloud tools across its plat­form. Miller said that Seat­tle is home to a rich mar­ket of tech tal­ent, which makes it an at­trac­tive choice for an of­fice. Mod­er­na will look to hire around 100 em­ploy­ees but has room to bring that num­ber up to around 220.

“It’s no­to­ri­ous for hav­ing very en­tre­pre­neur­ial, very tech-deep. All the skills that we need at Mod­er­na to scale out our ca­pa­bil­i­ties to con­tin­ue to serve our cus­tomers with med­i­cines,” Miller said.

Mod­er­na Ge­nomics will be ex­pand­ing to the South San Fran­cis­co lo­ca­tion. How­ev­er, not many de­tails have emerged about the head­count or the open­ing at that lo­ca­tion. Miller stat­ed that hav­ing a pres­ence in the Bay Area will al­so get the com­pa­ny clos­er to more tech tal­ent as well.

Mod­er­na’s west­ward ex­pan­sion comes as it’s look­ing to boost its head­count by 2,000. Miller said that em­ploy­ee growth is chart­ed across the board, but a lot of the new em­ploy­ees will be spe­cif­ic to man­u­fac­tur­ing, in an at­tempt to pro­duce vac­cines and ther­a­peu­tics at “a greater out­put.”

“We need to en­able the man­u­fac­tur­ing (and) en­able the com­mer­cial­iza­tion of these ther­a­peu­tics and vac­cines, and so we’re go­ing to be fo­cused on mak­ing sure that we un­lock the po­ten­tial of the com­pa­ny,” he said.

The boost in head­count comes at a time when many in the biotech scene are trim­ming pipelines and staff, but Miller states that Mod­er­na is in an ex­pan­sion pe­ri­od, as it ex­pe­ri­enced a “fast amount of growth” dur­ing the Covid-19 pan­dem­ic. Miller not­ed that the com­pa­ny has an op­por­tu­ni­ty to scale its sys­tems and feels that it is a ripe time to scale up.

Mod­er­na will be ex­pand­ing across the At­lantic as well, open­ing a new re­search and man­u­fac­tur­ing site in Ox­ford­shire in the UK.

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.

Lu­pus drug de­vel­op­ment mar­ket heat­ing up, while FDA links with ad­vo­ca­cy group to fur­ther ac­cel­er­ate re­search

The long-underserved systemic lupus erythematosus (SLE) market is suddenly buzzing with treatment possibilities. Less than two years after AstraZeneca’s approval for Saphnelo — the first new SLE drug in a decade and joining just one other approved in GSK’s Benlysta – the pipeline of potential drugs numbers in the dozens.

Although most are very early stage — Spherix Global Insights estimates five in Phase II/III — the pharma R&D enthusiasm is catching on among doctors, patients and advocacy groups. On Wednesday, the Lupus Research Alliance and the FDA formed a novel private-public partnership called Lupus Accelerating Breakthroughs Consortium (Lupus ABC) to help advance lupus clinical trial success.

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Stéphane Bancel, Moderna CEO (AP Photo/Markus Schreiber)

Mod­er­na so­lid­i­fies deal with Kenya to build mR­NA man­u­fac­tur­ing fa­cil­i­ty

The mRNA player Moderna is further cementing its presence on the African continent.

Moderna announced on Thursday that it has finalized an agreement with Kenya’s government to partner up and bring an mRNA manufacturing facility to the east African nation. The new facility aims to manufacture up to 500 million doses of vaccines annually. Moderna also said the new facility will have the ability to spike its production capabilities to respond to public health emergencies on the continent or globally.

Ribbon cutting ceremony for Thermo Fisher's new cell therapy manufacturing site in San Francisco

Ther­mo Fish­er moves on cam­pus with new cell man­u­fac­tur­ing site in San Fran­cis­co

Thermo Fisher Scientific is putting down more roots in the Bay Area.

The manufacturer opened the doors to a new cell therapy manufacturing facility next to the University of California-San Francisco Medical Center’s Mission Bay campus and on the university’s campus.

UCSF and Thermo Fisher have had a partnership since 2021, with the new site focusing on manufacturing cell therapeutics for certain cancers, including glioblastoma and multiple myeloma. The new site plans to use Thermo Fisher’s expertise in manufacturing services to help UCSF accelerate the development of cell therapies and eventually get them into the clinic, said Dan Herring, the general manager of cell therapy services at Thermo Fisher, in an interview with Endpoints News.

Mass­a­chu­setts judge dis­miss­es law­suit against Bio­gen over failed launch of Alzheimer's drug Aduhelm

A Massachusetts federal judge on Wednesday dismissed a class action lawsuit filed by investors against Biogen and several of its current and former executives over the company’s failed Alzheimer’s drug, Aduhelm (aducanumab).

The investors argued that Biogen’s contact with the FDA was unlawful and that the company made 25 false and misleading statements, including statements about the rollout and price of the drug.

Af­ter safe­ty re­view, EMA mir­rors FDA with up­dat­ed rec­om­men­da­tions for JAK in­hibitors

The EMA released updated recommendations today for the use of JAK inhibitors (JAKi) after reviewing data from several clinical trials that showed increased incidents of issues in certain patients who have rheumatoid arthritis and other risk factors.

The EMA noted malignancy, major adverse cardiovascular events (MACE), serious infections, venous thromboembolism (VTE) and mortality in some patients.

Luke Miels, GSK chief commercial officer

GSK picks up Scynex­is' FDA-ap­proved an­ti­fun­gal drug for $90M up­front

GSK is dishing out $90 million cash to add an antifungal drug to its commercial portfolio, in a deal spotlighting the pharma giant’s growing focus on infectious diseases.

The upfront will lock in an exclusive license to Scynexis’ Brexafemme, which was approved in 2021 to treat a yeast infection known as vulvovaginal candidiasis, except in China and certain other countries where Scynexis already out-licensed the drug.

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Man­u­fac­tur­ing roundup: Catal­ent to pro­duce low-cost ver­sion of nalox­one; CSL opens R&D site

Catalent will be manufacturing a low-cost version of the opioid overdose treatment naloxone as part of a contract with Harm Reduction Therapeutics.

Catalent plans to manufacture the treatment at its facility in Morrisville, NC. No financial details on the deal were disclosed.

Harm Reduction was granted priority review status for the NDA on its spray last year. The company has been working on a naloxone product since 2017. It is anticipating approval in July of this year and a US launch in early 2024.

As­pen looks to re­bound in pro­duc­tion and rev­enue af­ter Covid-19

Last year, South African-based vaccine manufacturer Aspen Pharmacare was facing reports that it had not received a single order for its manufactured Covid-19 shots and that manufacturing lines were sitting idle. But now the vaccine producer is looking to turn things around.

Aspen’s disclosure of its financial results in March unveiled that manufacturing revenue had decreased by 12% to R 603 million ($33.8 million), which Lorraine Hill, Aspen Group’s COO, said is attributable to lower Covid vaccine sales.