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: 

  • Merck will allow Medicines Patent Pool to sublicense its oral antiviral to manufacturers in 105 LMICs.
     
  • The Access to COVID-19 Tools Accelerator released a new strategic plan and budget through September 2022.
     
  • Antidepressant fluvoxamine reduced the risk of hospitalization for high-risk Covid-19 patients by about 32%.
Approved or authorized vaccines

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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…

Mentions: Evotec, CAPRISA, Kenup, VRC, HIV, drugs, IPOs

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.…

Novartis has begun a “strategic review” of its Sandoz subsidiary that will “explore all options, ranging from retaining the business to separation,” the Basel-based company announced Tuesday alongside its quarterly earnings statement. While the generic business accounted for around 20% of total company sales last year, the Swiss pharma giant expects the unit’s core operating income to decline more than previously expected, the press release…

Mentions: Novartis, Sandoz, generics

Teva announced Wednesday a $4 billion “sustainability-linked financing framework” that the company will use to refinance its debt while incentivizing its efforts to increase access to medicines in LMICs by 150%.

The Access to Medicine Foundation has independently validated the Tel Aviv-based company’s framework, which also includes a goal to reduce Scope 1 and 2 greenhouse gas emissions by 25% by 2025, the press release said.

The state of the fight: 

  • The Bill & Melinda Gates Foundation will invest up to $120 million to accelerate access to Merck’s molnupiravir for lower-income countries.
     
  • Valneva’s inactivated vaccine candidate generated superior neutralizing antibody titer levels to those induced by the AstraZeneca/Oxford shot, according to a Phase 3 readout.
     
  • U.S. regulators cleared booster shots of the J&…

Emergent BioSolutions has launched a U.S.-based Phase 3 trial of its CHIKV VLP single-dose chikungunya virus-like particle vaccine in healthy people ages 12-64, the Maryland-based company announced last week.

The announcement follows Phase 2 persistence data that showed people who received a dose of the adjuvanted candidate maintained neutralizing antibody titers for two years at levels 19 times higher than pre-vaccination.

Rivals…

Entasis Therapeutics’ investigational sulbactam-durlobactam (SUL-DUR) antibiotic was non-inferior versus standard colistin at preventing 28-day all-cause mortality in people with carbapenem-resistant A. baumannii infections, the Massachusetts-based biotech announced Monday, citing new Phase 3 data. The topline results also showed that SUL-DUR patients had higher clinical cure rates and lower rates of nephrotoxicity compared to those receiving…

GSK has launched a Phase 1/2 trial of a Shigella vaccine candidate against S. sonnei and S. flexneri serotypes 1b, 2a and 3a, the company announced Tuesday.

According to ClinicalTrials.gov, the company will first study its altSonflex1-2-3 vaccine candidate in adults ages 18-50 in Europe before trialing the shot in a shigellosis-endemic population in Africa.

The shot uses the Generalized Modules for Membrane Antigens (GMMA)…

A new J&J subsidiary established by the pharma giant to hold its cosmetic talc litigation liabilities has filed for voluntary Chapter 11 bankruptcy, Johnson & Johnson announced last week.

J&J’s press release said the filing is intended to resolve claims “in a manner that is equitable to all parties, including any current and future claimants” and is “not a concession of liability.” Nevertheless, J&J will provide…

Mentions: J&J, litigation

Regulators delivered good news to Merck last week.

Firstly, the EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended approval of the company’s 15-valent pneumococcal conjugate vaccine in adults. The U.S. FDA approved the shot in July.

Meanwhile, the FDA approved Merck’s blockbuster cancer immunotherapy, Keytruda, to be used in combination with chemotherapy, with or without bevacizumab (Roche’s Avastin), for the…

Three pharmas published environmental, social and governance commitments this week.

First, BD released its 2021 Together We Advance strategy, promising to achieve carbon neutrality across direct operations by 2040, to work with supply chain partners on labor and environmental practices, and to improve ethnic and gender diversity at its management and executive levels by 1% year over year, among other measures.

Next up, GSK’s HIV…

Mentions: GSK, ViiV, BD, BMS, CSR, ESG, DEI, governance