New this week:
Generic Sayana Press alternative prequalified
WHO has granted its first prequalification for a generic subcutaneous depot medroxyprogesterone acetate (DMPA-SC), issuing the designation to Incepta Pharmaceuticals’ Medogen SubQ contraceptive.
The Children’s Investment Fund Foundation (CIFF) welcomed the milestone early this month, saying prequalifying the generic alternative to Pfizer’s Sayana Press would “give countries another trusted supplier and help make the product more affordable for health systems.”
CIFF and the Gates Foundation supported the Bangladesh-based manufacturer in developing the three-month, self-injectable contraceptive, per the press release.
PRIOR COVERAGE:
MCRI, Incepta team up on rota (June 5, 2024)
Pfizer, partners expand Sayana Press access in LMICs (August 9, 2023)
Self-injecting Sayana Press helps women continue contraception (April 18, 2018)
Pfizer announces Sayana Press price reduction (May 10, 2017)
Vaccine R&D: Group A Strep, pneumo and other shots advance
Notwithstanding vaccine funding setbacks (and vaccine policy setbacks) in the U.S., recent updates from manufacturers and clinical trial databases show a slew of new progress in vaccines addressing global health priorities.
GSK Group A Strep vaccine enters clinic: The CARB-X-funded Phase 1 trial for GSK’s four-component Group A Streptococcus candidate is now underway. GSK global health lead Thomas Breuer announced the development last week on LinkedIn.
- The first-in-human study will evaluate two formulations of the jab—one adjuvanted with alum and another using GSK’s AS37 adjuvant—in healthy adults ages 18-25, per ClinicalTrials.gov.
- Collaborators include BARDA, the German government, the U.K.’s Global AMR Innovation Fund, and Wellcome Trust.
GSK’s next-gen pneumo jab is also recruiting a Phase 1 trial: The Pn-MAPS30plus candidate “aims to broaden protection by covering more serotypes than currently licensed pneumococcal vaccines,” per ClinicalTrials.gov.
SII studies whole-cell pneumo jab: Recruitment is underway for a Phase 2 trial of a whole-cell pneumococcal (wSp) vaccine candidate in children ages 5-7 months, per ClinicalTrials.gov data.
- The “low cost-to-produce, serotype-independent” vaccine candidate won a 2024 grant from the U.S. National Institute of Allergy and Infectious Diseases (NIAID), according to the grant record.
- Sponsored by Serum Institute of India’s European subsidiary, the study’s collaborators include SII, NIAID, and Rochester General Hospital.
Shigella shot enters Phase 1: A quadrivalent conjugate Shigella vaccine from Washington state’s Inventprise has entered first-in-human trials in the U.S., according to ClinicalTrials.gov and a trial recruitment platform.
- The double-blind trial will compare varying dose formulations of IVT Shigella-04 (with and without adjuvant) to placebo in healthy adults ages 18-49.
VLP-based RSV jab enters Phase 2: Recruitment is set to commence for the mid-stage trial of China-based Patronus Biotech’s LYB005 in adults ages 60 and older, per ClinicalTrials.gov.
- The randomized, observer-blinded trial will compare three dose levels of the Luye Life Sciences subsidiary’s LYB005 (with and without the A01B adjuvant) to placebo in adults ages 60 and older.
Other vaccine news of note:
- An inactivated West Nile vaccine candidate is currently in Phase 1 in the U.S., per Clinical Trials.gov. The HydroVax-001B vaccine from Oregon Health & Science University spinout Najit Technologies is being evaluated by the Infectious Diseases Clinical Research Consortium (IDCRC) in collaboration with NIAID, according to an IDCRC update.
- GSK’s Shingrix has won expanded approval in China for adults ages 18 and older at increased risk from immunodeficiency or immunosuppression—bringing the shot’s indications in the country in line with those in the U.S.
- South Korea’s GC Biopharma will produce a portion of the commercial supply of Curevo’s recombinant shingles vaccine candidate “for global markets” under a new manufacturing deal. Seattle-based Curevo’s CRV-101 (amezosvatein) is currently in an expanded Phase 2 study, with a late-stage trial targeted for next year.
PRIOR COVERAGE:
Curevo shingles jab succeeds in Phase 2 (January 10, 2024)
CARB-X backs two GSK vaccines (March 3, 2021)
Europe pumps $110M more into BioNTech Rwanda site
BioNTech has won additional support for its mRNA manufacturing site in Kigali, Rwanda. The European Investment Bank and the European Commission (EC) have committed up to $110 million in financing for the project, according to a joint press release Monday.
These funders join CEPI, which in 2024 committed up to $145 million, and BioNTech itself, which estimated its investment at about $150 million in a 2023 fact sheet about the facility.
Aspirations run high for the site, made of modular units (dubbed “BioNTainers”) that can be quickly set up and adapted to produce different mRNA-based vaccines, per the press release. The facility is expected to produce vaccines “for widespread use” and clinical trial materials for local partners.
The new funding, including a $40.5 million Commission grant and a loan option of up to $69 million from EIB, reflects a changing landscape for Africa-based mRNA production. Having fallen under criticism during the Covid pandemic for refusing to share its Pfizer-partnered Comirnaty jab with the WHO-backed mRNA tech transfer in South Africa—and even being accused of undermining the hub—BioNTech is emerging as a prominent player in Africa-based manufacturing.
The company’s Kigali site “could become the first commercial mRNA vaccine facility on the continent,” as the European agencies’ press release notes.
PRIOR COVERAGE:
WHO mRNA tech transfer hub enters new phase (June 17, 2025)
CEPI, BioNTech expand mRNA vaccines partnership (May 29, 2024)
BioNTech to launch Rwanda mRNA vaccine plant this month (December 6, 2023)
BioNTech’s African vaccine production plans change tack (September 27, 2023)
BioNTech firms up African production plans (October 27, 2021)
Long-acting drugs in the spotlight at EACS 2025
As the 20th European AIDS Conference (EACS) got underway Wednesday in Paris, Gilead and ViiV showcased competing HIV treatment and prevention data.
Gilead presented new safety findings for lenacapavir, reporting data suggesting the long-acting PrEP injectable can be co-administered with statins and PDE-5 inhibitors with “appropriate monitoring and dose adjustment,” according to a company release. The firm also unveiled late-breaking Phase 2 results for its once-weekly oral regimen combining lenacapavir with Merck’s islatravir: people living with HIV who switched to the weekly combo maintained viral suppression through two years of follow-up, Gilead said.
ViiV Healthcare, meanwhile, released results from its CLARITY study showing that 90% of participants preferred its long-acting cabotegravir (CAB-LA) to Gilead’s lenacapavir after one injection. The company omitted to mention that CAB-LA requires dosing every two months, compared with twice-yearly administration for lenacapavir.
Not to be left out, Merck presented new Phase 3 data on adults living with HIV-1 who switched from Gilead’s Biktarvy to Merck’s once-daily oral combination of islatravir and doravirine. Across clinical trials, the switch to the Merck regimen—currently under review for U.S. FDA approval—was associated with minimal changes in weight and body composition and no clinically meaningful effects on fasting lipids or insulin resistance.
The conference runs through Saturday.
PRIOR COVERAGE:
Funding cuts loom over AIDS Society Conference (July 16, 2025)
Merck’s islatravir sees late-stage HIV success (January 8, 2025)
Gilead, Merck offer updates at CROI (March 13, 2024)
Chinese manufacturing projects advance in Africa
The first part of Fosun Pharma’s three-phase $58 million facility in Côte d’Ivoire is set for completion by year-end.
That’s according to a South China Morning Post overview last week of China’s “health silk road” initiative in Africa.
Fosun plans to produce antimalarials and antibiotics at the plant, whose capacity will reportedly reach 5 billion tablets annually when fully complete.
Meanwhile, a $100 million Fidson Healthcare facility in Nigeria is expected to reach completion by early 2027, the article said. With a focus on HIV drugs, the project stems from a 2024 agreement with Aidea Pharma, PharmaBlock Sciences and the China-Africa Development Fund.
Other initiatives from Chinese firms include Jijia’s plans to construct an oral cholera vaccine plant in Zambia and a Shanghai Haiqi project for insulin production in Nigeria.
PRIOR COVERAGE:
IVI, Zambia team up on vaccine manufacturing (September 3, 2025)
Moderna axes another overseas mRNA investment (July 30, 2025)
Africa’s Dek to manufacture PCV13 (January 15, 2025)
Fosun to build West African drugs plant (June 7, 2023)
Roche asks Indian high court to stop generic drug sales
An intellectual property fight in India over Roche’s spinal muscular atrophy (SMA) drug Evrysdi (risdiplam) has reached a new phase.
As reported by Mint on Tuesday, Roche is appealing last week’s judgment from the Delhi High Court, which upheld an earlier ruling that cast doubts on Roche’s patent claims. The two courts underscored public interest concerns while allowing generic manufacturer Natco to produce its own version, per the article.
The case will now advance to the Supreme Court.
The drug costs $81,000 per year for an adult in India, according to the Third World Network (TWN), an advocacy organization that supported SMA patients with their legal representation in the case. Natco’s version may cost as little as $179 per bottle, versus $6,982 per bottle from Roche, TWN said.
PRIOR COVERAGE:
J&J dealt new patent setback for TB drug (July 17, 2024)
India rejects IP provisions in EFTA trade talks (February 21, 2024)
J&J stands down on TB drug patent enforcement (October 4, 2023)
India nixes J&J patent extension on bedaquiline (March 29, 2023)
CEPI backs SII’s pandemic ‘pressure test’
Serum Institute of India will develop an H5N1 vaccine candidate “as a prototype for a potential disease X.”
Per a joint press release Tuesday, CEPI will provide up to $16.4 million for the initiative—an effort to “supercharge” pandemic preparedness by testing the ability of SII’s baculovirus-based platform to quickly produce new antigens against H5 viruses.
SII will produce and compare two H5 antigens for a recombinant protein vaccine: a wild-type antigen and an AI-optimized, broad-spectrum version from Houston Methodist Research Institute, the announcement said.
In other CEPI news, the organization last week announced up to $18 million in funding for a Stanford School of Medicine effort to design and test broadly protective filovirus vaccines. The research will combine immunogens, designed with the help of AI, with a ferritin-based protein-nanoparticle vaccine platform, aiming for “all-in-one protection” against Marburg, Ebola Sudan, Ebola Zaire, “and even filoviruses that we don’t yet know about.”
PRIOR COVERAGE:
SII to manufacture Valneva chikungunya vaccine (January 8, 2025)
CEPI recruits SII for manufacturing network (January 24, 2024)
Aspen secures $30M for African vaccine manufacturing (December 14, 2022)
Egypt’s Minapharm in vaccine and mAb collab
A three-way tie-up between IAVI, Cairo’s Minapharm and Berlin-based CDMO ProBioGen aims to advance the end-to-end development and manufacturing of priority vaccines and biologics in Africa.
Announcing their new memorandum of understanding last week, the partners said they would accelerate the development of ProBioGen´s modified vaccinia Ankara jab against mpox, seeking to overcome “cost, supply, and implementation barriers that have severely restricted access.”
In addition, building on Minapharm’s monoclonal antibody (mAb) production capabilities “to further expand the existing regional manufacturing hub for affordable mAbs,” the initiative includes a technology transfer of IAVI’s portfolio of antibody-based products for HIV prevention, per the joint press release.
PRIOR COVERAGE:
African biotech inks biosimilar deal (July 9, 2025)
At 100 years, IPD expands ambitions (December 18, 2024)
IAVI partnership targets pediatric HIV mAbs (February 7, 2024)
VitriVax wins scale-up funds
A new award from the Gates Foundation will help VitriVax scale up its platform—designed to condense multiple vaccine doses into one thermostable, controlled-release shot—for GMP manufacturing in preparation for Phase 1 trials.
Announcing the funding on Tuesday, the Colorado-based company said the two-year, $9.9 million grant will help it work with a CDMO in support of future clinical development of a vaccine based on its Atomic Layering Thermostable Antigen and Adjuvant (ALTA) platform.
The company’s backers include Adjuvant Capital, CEPI, and the U.S. Defense Threat Reduction Agency.
PRIOR COVERAGE:
CEPI funds single-shot vaccine platform (April 30, 2025)
Vaccine developers score BMGF grants (December 4, 2024)
Single-shot vaccine platform wins BMGF backing (December 6, 2023)
U.S. awards $29M for single-dose infectious disease jab (July 26, 2023)
Adjuvant funds vaccine tech platform (July 7, 2021)
WHO Foundation partners with MNCs
The WHO Foundation this week announced a pair of collaborations with drugmakers.
On Monday, the foundation said it would join forces with Lilly “to financially support” the aims of WHO’s global action plan on the public health response to dementia. The support—of unspecified monetary value—aims to strengthen efforts on dementia risk reduction, early detection, diagnosis and care, per the foundation’s press release.
On Tuesday, the foundation announced a wide-ranging collaboration with Bayer “to resource WHO's efforts to eliminate neglected tropical diseases, promote self-care, and gain insights into the impact of climate changes on sexual and reproductive health.” No financial terms were disclosed.
Established in 2020 as “an independent grant-making entity” supporting WHO’s global health efforts, the WHO Foundation has faced criticism over transparency. A July analysis in BMJ Global Health said the foundation had levels of donor transparency “akin to oft-criticised free market think tanks, with attendant risks for both undue influence and/or reputational damage.”
PRIOR COVERAGE:
Lilly, Max Foundation to boost NCD treatment access (January 10, 2024)
Lilly adds $50M to ‘social impact’ portfolio (May 9, 2023)
Bayer shifts focus from women’s health (March 29, 2023)
AtM publishes 2026 Access to Medicine Index Methodology
The 2026 Access to Medicine (AtM) Index will add mpox, noma and kidney cancer to its disease scope and update a handful of performance indicators. That’s according to the 2026 Index Methodology, unveiled last week.
Unchanged since the 2024 Index will be the 20 research-based pharma players evaluated. The biannual exercise selects companies for inclusion based on factors such as revenue, market capitalization, and “the size and relevance of their product portfolios and pipelines” for diseases and countries in scope, according to the Index Methodology.
Among the updated performance indicators, AtM has retired ad hoc donations from its product delivery technical area. The Methodology notes that most companies have a policy “that aligns with the expectations of this indicator”—suggesting that its purpose has been achieved; but the document also cautions that ad hoc donations, while a meaningful path to access in some circumstances, “are not a sustainable solution for long-term access.”
Other indicator changes include an updated definition of inclusive business models and refinements to patient reach parameters, per AtM.
PRIOR COVERAGE:
AtM report: insulin access initiatives ‘falling short’ (May 14, 2025)
AtM Index: LMIC access efforts stagnate (November 20, 2024)
AtM analyzes generics access in LMICs (September 27, 2023)
AtM Index sees access progress, gaps (November 16, 2022)
Q3 2025 earnings: J&J severs orthopedics unit
J&J on Tuesday reported $24 billion in third-quarter sales—a 4.4% improvement (excluding currency and portfolio effects) that “modestly” beat expectations, per Bloomberg.
Oncology drove the results, with sales leaping 19.2% to $6.5 billion. Infectious disease sales continued to shrink—albeit at a slower pace than Q2—bringing in $829 million (a 4.3% drop) in the third quarter.
Coinciding with its earnings release, J&J announced the planned separation of its orthopedics business. Known as DePuy Synthes, the unit brought in about $9.2 billion in 2024 sales.
PRIOR COVERAGE:
J&J drops dengue prevention drug (October 9, 2024)
J&J looks to narrow Dutch vaccines operations (August 23, 2023)
J&J overhauls infectious disease R&D (February 8, 2023)
J&J to jettison consumer health (November 17, 2021)
Lab-free test detects asymptomatic malaria
For the first time, a diagnostic used outside a lab has proven sensitive enough to detect low-level malaria infections in people without symptoms.
That’s according to an article last week from Imperial College London, whose ProtonDX spinout co-created the test, known as Dragonfly.
Using blood from a finger prick, the test can be processed without specialized laboratory equipment. It then requires 30-minute incubation at a constant temperature, after which results can be read.
The research validating Dragonfly was published in Nature Communications last week.
The team behind the test is working with Africa CDC to explore production and scale-up opportunities with manufacturers in the region, according to Imperial College London.
PRIOR COVERAGE:
African manufacturing gets $50M Unitaid boost (August 27, 2025)
African-made diagnostics efforts advance (May 7, 2025)
Revital cuts ribbon on Kenyan diagnostic facility (May 22, 2024)
Quick hits
- Product development partnerships contributed to the development of 42% of the 57 new global health medicines approved by WHO-listed authorities and the WHO prequalification program between 2005 and 2024, per a recent landscape analysis. Such systematic obstacles as reduced commercial incentives, scientific knowledge gaps and regulatory barriers led to lagging drug R&D for diseases endemic to LMICs. – Nature Reviews Drug Discovery
- Blacksmith Medicines has won U.S. FDA Fast Track and Qualified Infectious Disease Product designations for FG-2101, the San Diego-based company’s novel antibiotic for serious Gram-negative infections. CARB-X and Lilly are among the firm’s backers. – Blacksmith press release
- Novo Nordisk will acquire metabolic disease specialist Akero Therapeutics for at least $4.7 billion. – Novo Nordisk press release
- The latest Global Burden of Disease study found life expectancy 20 years higher in 2023 than in 1950. But the world faces “an emerging crisis of higher death rates in adolescents and young adults” due to suicide and drug and alcohol consumption (in North America and Latin America) and infectious diseases and unintentional injuries (in sub-Saharan Africa). Noncommunicable diseases account for nearly two-thirds of the world’s total mortality and morbidity. – IHME press release
- A new WHO report on AMR found resistance varying widely among regions in 2023, with about one in three common bacterial infections resistant to antimicrobials in WHO’s Southeast Asian and Eastern Mediterranean regions, one in five in Africa, and only 1 in 10 in Europe. – CIDRAP
- Seattle’s Monod Bio will develop a next-gen preeclampsia diagnostic—using what it calls its “AI-powered” protein design technology—with the help of a $750,000 Grand Challenges grant from the Gates Foundation. – Monod Bio press release
- Following Pfizer’s lead, AstraZeneca has announced a “historic agreement” (those were Pfizer’s exact words, too) with the U.S. government to “lower the cost of prescription medicines for American patients.” – AstraZeneca press release
- The Kenya Medical Research Institute has launched a $4 million women’s health R&D initiative. By 2033, the LEA-WH program aims to bring five to 10 innovative products to market testing, help create five to 10 startups, facilitate five to 10 patent applications, and catalyze $3 million-$5 million in follow-on funding. – KEMRI press release
