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Three additional pharma companies released fourth-quarter and full-year 2021 financial results in March. (Figures exclude exchange rate and portfolio changes where applicable.)
Merck KGaA’s group net sales in the fourth quarter rose 9.9% to $5.7 billion, beating consensus estimates of $5.6 billion. The German company attributed the growth to its “Big 3” businesses—the process solutions business of its life sciences segment, new…
Hyderabad-based Aurobindo has put the Indian market in its sights with the $22.6 million acquisition of the domestic formulations business of Veritaz, Aurobindo announced Monday. Veritaz boasts around 40 brands in the acute and critical care therapeutic segments and is also headquartered in Hyderabad.
The acquisition will serve as a “launch pad for marketing biosimilar and other products in India,” Aurobindo said in its press release…
China’s National Medicinal Products Administration has approved Walvax’s bivalent HPV vaccine for the prevention of cervical cancer caused by HPV 16 and HPV 18, Chinese media sources reported last week.
The shot will compete for domestic market share against GSK, Merck, and China’s Xiamen Innovax.
A booster dose of Sanofi’s Dengvaxia tetravalent dengue vaccine “does not elicit a consistent, meaningful booster effect” against all dengue serotypes in people previously exposed to the virus, according to a Phase 2 non-inferiority study published Tuesday in The Lancet Infectious Diseases.
The Sanofi-funded study—conducted in Colombia and the Philippines—tested an additional dose of the live attenuated shot administered one or two…
A long-lasting insecticidal net (LLIN) treated with chlorfenapyr generated a 44% reduction in malaria incidence in children ages 6 months to 10 years and provided “significantly better protection” compared to a standard pyrethroid-only LLIN, according to 24-month data from a Tanzania-based trial published last week in The Lancet.
The study underscored the value of BASF’s dual-ingredient Interceptor G2, according to a press release from…
A new U.S. FDA approval adds adolescents to the population eligible for Cabenuva, the long-acting injectable HIV-1 treatment combining ViiV’s cabotegravir and Janssen’s rilpivirine, J&J announced Tuesday. Like adults, virologically suppressed adolescents age 12 and older can take the combo either monthly or every two months.
In related news, GSK subsidiary ViiV announced a Cabenuva label update last week. The FDA-approved update…
The U.S. FDA cleared the Investigational New Drug (IND) application for the intranasal RSV vaccine candidate (BLB-201) from Georgia-based CyanVac and its Californian subsidiary, Blue Lake Biotechnology, the companies announced Monday.
The move paves the way for Phase 1 trials, which will test BLB-201 in healthy adults ages 18-75, the press release said.
In other RSV news, Pfizer’s candidate shot (RSVpreF) won U.S. FDA Breakthrough…
The state of the fight:
- Moderna shared new Phase 2/3 data supporting the use of Spikevax in children under age 6.
- Pfizer will supply UNICEF with up to 4 million Paxlovid courses in 2022.
- Boosters of mRNA vaccines continued to offer strong protection against severe Covid-19 outcomes.
Moderna claimed clinical trial success for its vaccine in children…
Bavarian Nordic has entered into a licensing and supply agreement with Shanghai-based Nuance Pharma to develop and commercialize Bavarian’s RSV vaccine candidate (MVA-BN RSV) for adults in China and other Asian markets, the Danish company announced Monday. Under the deal, Nuance Pharma will pay $12.5 million upfront and up to $212.5 million in milestones.
Nuance will run Phase 1 and 3 trials in China and push Asian regulatory approval…
Serum Institute of India (SII) will boost its European presence through a vaccine manufacturing tie-up between its Serum Life Sciences subsidiary and Mumbai-based Wockhardt, the latter announced Sunday.
Wockhardt’s U.K. subsidiary will set up a new fill-finish facility in North Wales capable of producing 150 million doses of “multiple” SII vaccines, the press release said. Financial terms were not disclosed.
Pune-based SII…
Unitaid will fund “two large-scale operational projects” distributing long-acting injectable HIV pre-exposure prophylaxis (PrEP) to at-risk populations in Brazil and South Africa, the WHO-hosted agency announced last week.
ViiV Healthcare—recently under fire for its reluctance to pursue voluntary licensing for the cabotegravir-based shots—will donate supplies. But the donation didn’t exempt the GSK subsidiary from pricing scrutiny from…
A month after stepping down as president of Takeda’s global vaccine business, Rajeev Venkayya has been named CEO of Aerium Therapeutics, an antibody specialist that emerged from stealth mode on Tuesday. The Boston- and Lausanne-based biopharma’s pipeline includes two monoclonal antibodies against SARS-CoV-2 aimed at “vulnerable populations for which vaccines do not provide adequate protection,” according to a press release.
Leaving…
The state of the fight:
- Medicines Patent Pool sublicensed Pfizer’s Paxlovid to 35 generics manufacturers.
- Key WTO members reached a tentative agreement to waive some IP rights on Covid-19 vaccines.
- Moderna and Pfizer asked the U.S. FDA to authorize fourth doses of their respective jabs.
Medigen’s protein subunit vaccine (MVC-COV1901) offered…
GSK’s pediatric formulation of tafenoquine, its single-dose radical cure for P. vivax malaria, has scored its first approval. Australia cleared the drug for children ages 2-15 (for use in combination with chloroquine), the Medicines for Malaria Venture (MMV) announced Monday.
The decision was supported by Phase 2b trial data showing that tafenoquine was 95% efficacious at preventing disease recurrence in children ages 6 months to 15…
Venatorx Pharmaceuticals’ cefepime-taniborbactam was superior to standard of care meropenem for treating complicated urinary tract infections in Phase 3 trials, the Pennsylvania-based company announced last week.
The investigational antibiotic—which targets carbapenem-resistant Enterobacterales and P. aeruginosa—generated bacterial eradication in 70% of participants compared to 58% treated with meropene, and cefepime-taniborbactam’s…
Bayer will sell its pest control business to private equity player Cinven for $2.6 billion, the companies announced last week. Reuters noted that Bayer is seeking to pare debt in the wake of its $63 billion Monstanto acquisition in 2018.
Bharat Biotech will partner with Spain’s Biofabri to develop, manufacture and distribute a novel, live attenuated tuberculosis vaccine candidate, the companies announced Wednesday. The tie-up aims to guarantee the future supply of MTBVAC in over 70 countries, “especially in Southeast Asia, and sub-Saharan Africa,” according to a joint press release.
The shot originated at the University of Zaragoza. Additional collaborators include the…
The University of Oxford has started recruiting for a Phase 1/2 human challenge trial of a paratyphoid vaccine candidate, the university announced last week. The University of Maryland School of Medicine developed the oral candidate (CVD 1902) to protect against Salmonella Paratyphi infection, per the press release.
An Oxford researcher commented that a licensed paratyphoid vaccine is “desperately needed” due to “increasing antibiotic…
The University of Oxford and Ifakara Health Institute have dosed the first participants in a Tanzania-based Phase 1b/2 trial of Oxford’s single-dose rabies vaccine candidate, the university announced earlier this month.
The ChAdOx2 RabG vaccine uses the same adenovirus vector platform as the AstraZeneca/Oxford Covid-19 shot and would be a “game changer” if successful, according to Oxford’s chief trial investigator. The investigator…