Fujifilm announced Tuesday it is putting approximately $850 million in cash into its CDMO arm, Fujifilm Diosynth Biotechnologies, to boost biologics capacity in Britain and the United States—joining a multibillion-dollar CDMO investment spree among companies worldwide.

In the U.S., the investment will double cell culture production for recombinant vaccines. Across the Atlantic, the money will triple cell culture capacity (and will…

Long-acting oral drug specialist Lyndra Therapeutics has raised $60.5 million in Series C financing, the Massachusetts-based company announced last week.

Lyndra’s pipeline includes a weekly formulation of an HIV medication, a biweekly formulation of the antimalarial ivermectin, and a monthly oral contraceptive. Endpoints News reported that the new funding will back a Phase 3 study of the company’s lead candidate, a weekly form of…

The string of good news for Sanaria’s PfSPZ-CVac malaria vaccine candidate continued Wednesday with promising Phase 1 data based on human challenges.

The research, published in the journal Nature, found that two versions of the chemoprophylaxis-attenuated whole-organism vaccine regimen protected volunteers three months following dosing, according to a press release from the U.S. National Institutes of Health, which helped conduct the…

Mentions: Sanaria, malaria, vaccines, NIH

South Dakota-based SAB Biotherapeutics announced Tuesday that it has dosed the first participant in a Phase 2a study of its SAB-176 novel anti-influenza human IgG intravenous immunotherapy designed to treat or prevent type A and B seasonal influenza (including emerging and mutating strains) and pandemic flu.

The company appears to hope the multivalent polyclonal antibody will rival Roche’s blockbuster antivirals Tamiflu and Xofluza in…

Mentions: SAB, flu, drugs, Roche

Corporate restructuring, clinical trial results, and a new business investment kept Sanofi in the news this week.

First, the company announced Monday that as part of its “ongoing efforts to reduce the complexity of its Consumer Healthcare portfolio and accelerate its growth trajectory,” it will offload 16 products to Germany’s STADA Arzneimittel. Neither firm disclosed deal terms.

The same day, Sanofi announced that its…

The state of the hunt: 

  • Gavi plans new terms and conditions for self-financing COVAX participants.
     
  • Cuba’s three-dose Abdala vaccine candidate proved 92.3% effective in Phase 3.
     
  • The U.S. halted distribution of two monoclonal antibodies from Eli Lilly.

 

Approved or authorized vaccines

Bharat Biotech submitted final Phase 3 data to Indian regulators showing 77.8% efficacy…

The U.S. Biomedical Advanced Research and Development Authority will add more than $12 million to an existing contract with Massachusetts-based Public Health Vaccines LLC to advance its Marburg candidate into clinical trials, the company announced Wednesday.

The deal extends an original $10 million award for the recombinant vesicular stomatitis virus (rVSV)-based candidate, according to the press release. The contract also includes an…

Health science conglomerate Danaher will acquire North Dakota-based CDMO Aldevron for approximately $9.6 billion in cash, the former announced last week. Aldevron, which manufactures plasmid DNA, mRNA and recombinant proteins for companies including Moderna, will operate as a standalone business within Danaher’s Life Sciences segment, the press release said. Danaher’s holdings include diagnostics specialists Cepheid and Beckman Coulter as…

Amid pressure from activist investors, GSK on Wednesday offered details on longstanding plans to “demerge” its consumer healthcare arm into a separately listed company. Set for mid-2022, the spinoff will include a one-time dividend paid to the parent entity—restyled as a growth-focused drugs and vaccines behemoth dubbed “New GSK”—of up to $11.2 billion.

Flush with funds, New GSK will concentrate on R&D and commercial investments…

Promising mRNA vaccines made news again last week as the U.S. Walter Reed Army Institute of Research announced that its investigational shot against P. falciparum malaria achieved “high levels of protection” in mice. NPJ Vaccines published the study on the jab (PfCSP mRNA-LNP), co-developed with Acuitas Therapeutics and other collaborators.

In other malaria news, Life Science Alliance published details last week on a method developed by…

San Diego-based Qpex Biopharma announced last week that it has begun a Phase 1 study of QPX9003, its next-generation intravenously administered synthetic polymyxin for infections caused by drug-resistant gram-negative pathogens (including Acinetobacter species and P. aeruginosa).

In other AMR news, the U.S. National Institutes of Health has awarded HelixBind $3.3 million to support testing of its RaPID/BSI diagnostic platform for sepsis…

Sanofi and Massachusetts-based Translate Bio have launched a Phase 1 trial of an mRNA-based seasonal flu vaccine candidate targeting influenza A/H3N2, the companies announced Tuesday. The study will evaluate two formulations of the vaccine (MRT5400 and MRT5401) in up to 280 healthy adults, per the press release. The collaborators also have a Covid-19 vaccine candidate in Phase 1/2 and plan to develop mRNA shots for up to three additional…

SK Bioscience signed a deal on Monday to invest $132 million by 2024 to boost vaccine production at its L House facility in Andong, according to local media and Reuters. The South Korean company will reportedly use the funds to buy land and equip the site with expanded capabilities for vaccine platforms including mRNA and viral vectors.

The Andong plant currently produces both the AstraZeneca and Novavax Covid-19 vaccines and recently…

WHO announced Monday that the COVAX partnership’s first Covid-19 mRNA vaccine technology transfer hub will launch with a South African consortium comprising Biovac, Afrigen Biologics and Vaccines, a “network of universities,” and the Africa Centres for Disease Control and Prevention.

A press release quoted WHO Director-General Tedros Adhanom Ghebreyesus as saying Covid-19 had “highlighted the importance of local production to address…

GSK subsidiary ViiV will pay Halozyme Therapeutics $40 million upfront (plus milestones) for rights to develop HIV medicines with dosing intervals of three months or longer using Halozyme’s rapid drug delivery technology, the companies announced jointly on Tuesday.

According to the press release, ViiV plans to launch trials in 2021 with its drug cabotegravir, which is currently administered every two months for prevention of HIV.

The state of the hunt: 

  • The vaccine candidate from Novavax demonstrated 90.4% overall efficacy in Phase 3—and 93% against “key variants.”
     
  • CureVac’s mRNA vaccine candidate performed poorly, missing the primary endpoint in a Phase 3 trial riddled with variant infections.
     
  • The U.S. launched a $3 billion program to stimulate antiviral drug R&D.
Approved or authorized vaccines

The Access to Medicine (AtM) Foundation released a new report last week highlighting some biotechs that are finding novel ways to get badly needed antibiotics to patients in low- and middle-income countries despite notoriously difficult market conditions.

Drawing on “new data and discussions with stakeholders,” the report said that small- and medium-sized companies (SMEs) now account for 75% of all late-stage antimicrobials in the R…

Bayer announced last week that it is investing a total of $303 million to build a new pharmaceutical facility and modernize an existing plant, both in Finland.

The expansion will help Bayer meet its goal of providing 100 million women in low- and middle-income countries with access to family planning and modern contraception by the end of 2030, the press release said.

Portland-based Hemex Health announced Monday a software-based upgrade that expands the age range for sickle cell disease (SCD) tests on its portable, low-cost Gazelle platform from 6 months and up to all ages, including newborns.

In other SCD news, San Francisco’s Global Blood Therapeutics said Monday that voxelotor—its oral, once-daily treatment for the disease—has notched Promising Innovative Medicine designation from British…

Mentions: Hemex, SCD, diagnostics, GBT, drugs

The International AIDS Vaccine Initiative (IAVI) announced Monday $27.4 million in additional funding to conduct Phase 2b trials of its recombinant vesicular stomatitis virus (rVSV) vector-based Lassa fever vaccine (rVSVΔG-LASV-GPC) in Liberia, Nigeria and Sierra Leone.

According to the press release, the European & Developing Countries Clinical Trials Partnership and the Coalition for Epidemic Preparedness Innovations (CEPI)…

Mentions: IAVI, Lassa, vaccines, EDCTP, CEPI