As world leaders descended on the COP26 climate change conference in Glasgow this week, several pharma companies promoted their own ESG pledges.
First, Moderna on Monday outlined a commitment to achieve net-zero carbon emissions globally by 2030. The announcement touted a plan to use renewable or offset energy in all U.S. facilities starting this year and to implement sustainable construction for new plants in Africa and Canada. CEO…
A polyvalent inactivated coxsackievirus B (CVB) vaccine candidate met the primary endpoint in a first-in-human trial, its New Jersey-based developer announced last week.
Citing interim results, Provention Bio said in a press release that its PRV-101—a shot targeting “all five key CVB strains associated with type 1 diabetes (T1D) autoimmunity”—was well-tolerated and induced high titers of viral-neutralizing antibodies against all…
Merck KGaA’s MilliporeSigma subsidiary will help Saudi Arabia-based SaudiVax design and launch a new biologics and vaccine manufacturing facility serving the Middle East and North Africa, MilliporeSigma announced Wednesday.
The collaboration aims to “localize” the production of “high-quality, Halal, and affordable vaccines and biotherapeutics” in Saudi Arabia, according to MilliporeSigma’s press release.
Gilead’s once-daily single-tablet Biktarvy regimen (bictegravir, emtricitabine and tenofovir alafenamide) showed high effectiveness and high levels of adherence in interim results from an ongoing “real-world” study, the California-based company announced last week at the 18th European AIDS Conference.
Conducted at sites in Canada, Europe and Israel, the BICSTaR study in adults living with HIV found that 97% of treatment-naïve…
Ten pharma companies have joined a U.S. FDA and U.S. National Institutes of Health initiative to streamline the gene therapy development process for rare diseases.
Armed with $76 million from the NIH and private partners, the Bespoke Gene Therapy Consortium will pursue a standardized therapeutic development model based on the adeno-associated virus (AAV) vector. The initiative will support four to six clinical trials, each focused on a…
Vaxess has opened a new facility in Woburn, Massachusetts, to manufacture its MIMIX smart release microneedle patch for clinical trials, the company announced last week. Looking ahead, a planned expansion at the facility will provide additional space for developing the patch, according to a company press release.
Vaxess has several deals in the works for the platform, including with South Korea’s GC Pharma and Taiwan’s Medigen Vaccine…
Venatorx Pharmaceuticals announced Monday that it has entered into a licensing agreement with Roche to advance drug treatments for infections caused by carbapenem-resistant Enterobacterales (CRE) bacteria.
Boston University-led nonprofit CARB-X gave the Pennsylvania-based company $15 million between 2019 and 2020 to develop a new class of oral antibiotics to treat infections caused by multidrug-resistant N. gonorrhoeae.
Wellcome Leap announced new grantees last week for its R3 (“RNA readiness and response”) program.
Co-founded in July by the Wellcome Trust spinout and the Coalition for Epidemic Preparedness Innovations (CEPI), the $60 million R3 initiative aims to increase the number of RNA-based biologic products on the market (thereby driving down production costs) and create a self-sustaining network of manufacturing facilities for surge capacity.…
Thirteen leading pharma companies released third-quarter 2021 financial results in October, while one Japanese firm reported first-half 2021 results for the fiscal year ending in March. (Figures exclude exchange rate and portfolio changes where applicable.)
South Korea’s LG Chem saw its third-quarter numbers soar 70.7% over the same period last year, delivering $9.1 billion in sales. However, operating profit tumbled 20%, mainly due to…
Breakthrough research in TB treatment, testing and transmission took center stage at this year’s 52nd Union World Conference on Lung Health, held virtually between October 19-22.
First, Médecins Sans Frontières (MSF) researchers presented new data from a Phase 2/3 trial showing that an investigational, all-oral, six-month regimen is safer and more successful at treating rifampicin-resistant TB than the current options. According to an…
The state of the fight:
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The Gates Medical Research Institute (Gates MRI) has entered into a licensing agreement with Atreca to develop a novel monoclonal antibody (mAb) for the prevention of malaria, the California-based biotech announced last week.
MAM01/ATRC-501 is an engineered version of a human mAb that’s generated following vaccination with GSK’s RTS,S shot. The mAb targets the malaria circumsporozoite protein (CSP) and has been shown to protect animals…
The U.S. Biomedical Advanced Research and Development Authority (BARDA) has made two recent Sudan ebolavirus and Marburg virus vaccine awards.
Firstly, the International AIDS Vaccine Initiative (IAVI) said Wednesday that BARDA has given it up to $126 million to help develop its two recombinant vesicular stomatitis virus (rVSV)-vectored candidates.
Meanwhile, Sabin Vaccine Institute announced last week that BARDA has released a…
BioNTech on Tuesday touted plans to start construction of an mRNA vaccine manufacturing plant in Africa in mid-2022, part of an agreement with Institut Pasteur de Dakar, Rwanda Biomedical Centre and other collaborators to establish “end-to-end manufacturing capacities for mRNA-based vaccines in Africa,” according to a BioNTech press release.
The agreement was formalized in a memorandum of understanding, the company said.
The…
Catalent is investing an additional $230 million to expand viral vector manufacturing capacity at its Maryland gene therapy campus, the company announced Tuesday. The U.S. CDMO already pumped $130 million into the plant last year for Covid-19 vaccine production.
CDMOs have been expanding globally to keep up with demand for their products.
Germany’s Evotec will collaborate with the Centre for the AIDS Programme of Research in South Africa (CAPRISA) to develop CAP256, a broadly neutralizing antibody against HIV, according to a Monday announcement from the Kenup Foundation, which brokered the deal.
The antibody—the result of a collaboration with the U.S. National Institutes of Health’s Vaccine Research Center (VRC)—demonstrated a “good safety profile” in Phase 1, per the…
Shanghai’s Fosun Pharma is racking up majority ownership of Antejin Biotech through a $628 million deal combining Fosun’s vaccine unit with the Chengdu-based biopharma, Bloomberg reported Tuesday.
Antejin has a 13-valent pneumococcal vaccine in early-stage trials, according to Bloomberg, and a 24-valent pneumococcal conjugate shot in an earlier stage of development, according to Endpoints News. Fosun will have the option to boost its…
Both Pfizer’s and Merck’s next-generation pneumococcal conjugate vaccines (PCVs) got the nod for routine use from the U.S. CDC’s Advisory Committee on Immunization Practices (ACIP) last week.
The decision surprised Wall Street analysts, who had expected ACIP to favor Pfizer’s single-dose 20-valent Prevnar “one-and-done” vaccine over Merck’s 15-valent Vaxneuvance (which requires the company’s 23-valent polysaccharide Pneumovax as a…
Merck’s investigational HIV drug islatravir succeeded as part of a daily oral combination in two Phase 3 trials and has entered Phase 2 as part of a weekly regimen, the company announced this week.
In the Phase 3 studies, virologically suppressed adults with HIV-1 switched from other regimens to islatravir (a nucleoside reverse transcriptase translocation inhibitor) in combination with Merck’s Pifeltro (doravirine). At 48 weeks, those…
The Lancet Infectious Diseases on Tuesday published first-in-human studies on a novel antimalarial compound that Merck KGaA is developing with the Medicines for Malaria Venture (MMV). The ascending-dose and volunteer infection studies support the development of M5717—a plasmodium eukaryotic translation elongation factor 2 inhibitor—as a component of a single-dose antimalarial combination therapy or for malaria prophylaxis, the article said.…