The state of the fight: 

  • A U.S. regulatory committee endorsed booster doses for vulnerable people and those over age 65.
     
  • Kenya outlined plans to start fill-finish production of Covid-19 shots in early 2022.
     
  • An SII subsidiary scooped up a 15% stake in Biocon’s biologics unit as the companies launched a strategic alliance to produce and commercialize vaccines.
Approved or authorized…

Dhaka-based Beximco Pharmaceuticals will become the majority owner of Sanofi Bangladesh under a share purchase agreement announced Tuesday, per local media.

The parties provisionally agreed to a $49 million deal in January 2021, according to New Age.

Mentions: Beximco, Sanofi, M&A

The Clinton Health Access Initiative (CHAI), Hyderabad-based Laurus Labs and Unitaid announced a deal Monday to accelerate the development, commercialization and registration of a generic version of J&J/Janssen’s fixed-dose combination HIV treatment darunavir/ritonavir (DRV/r) for children.

Laurus Labs gets a “financial incentive” for a portion of the development and commercialization costs for the second- and third-line treatment,…

J&J touted positive Phase 3 data Monday showing that its Janssen subsidiary’s Zabdeno (Ad26.ZEBOV) and Mvabea (MVA-BN-Filo) Ebola vaccine regimen—co-developed with Bavarian Nordic—induced antibody responses against the Ebola Zaire virus in 98% of children and adults 21 days after the second dose.

In the adult cohort, immune responses persisted for at least two years, while a booster dose with Zabdeno after two years induced a strong…

Moderna last week used its annual R&D Day to reveal interim Phase 1 data on its RSV vaccine and tout other pipeline developments.

Three different dose levels of its RSV candidate (mRNA-1345) boosted neutralizing antibody titers in adults ages 65-79 against RSV-A “approximately 14-fold” and against RSV-B “approximately 10-fold,” with no significant difference between doses, the Massachusetts-based company said. Single injections of…

Following up on its March acquisition of GenMark, Roche last week announced the purchase of longtime partner TIB Molbiol for an undisclosed price. The Swiss company said the move would expand its molecular diagnostics portfolio with a wide range of assays for infectious diseases.

Touting a natural fit, the press release noted that the two companies have collaborated for over 20 years to address biological threats—including Ebola, MERS,…

Press Trust of India reported Tuesday that Serum Institute of India (SII) has replaced international rival Sanofi as India’s supplier of choice for inactivated polio vaccine (IPV). The news agency said SII has won a tender to provide the country’s Universal Immunisation Programme with 5.4 million IPV doses (with a first lot arriving this month), while Sanofi picked up a lesser 3.6 million-dose order.

SII is reportedly flush with…

Mentions: SII, Sanofi, IPV, Polio, vaccines

The state of the fight: 

  • AstraZeneca and the E.U. reached a settlement following a monthslong legal battle over vaccine delivery.
     
  • COVAX released an updated vaccine supply forecast that reduced the number of doses it expects to receive in 2021 by 25%.
     
  • Cuba began vaccinating children as young as age 2 with its homegrown Abdala and Soberana vaccines.
Approved or authorized vaccines…

HilleVax announced Wednesday that it has raised $135 million in financing—led by Frazier Healthcare Partners and joined by RA Capital Management, Deerfield Management Company, Abingworth and others.

The Boston-based biotech will use the funds to advance its Phase 2 virus-like particle norovirus vaccine candidate through further clinical development, the press release said. If approved, HIL-214 would become the first vaccine against the…

The TB Alliance has granted Lupin a non-exclusive license to manufacture the nonprofit drug developer’s pretomanid as part of the combination BPaL tuberculosis regimen (with J&J’s bedaquiline and linezolid).

The joint press release issued Monday said the Mumbai-based pharma intends to commercialize pretomanid “in approximately 140 countries and territories, including many of the highest TB burden countries around the world.”

Moderna will license a therapeutic candidate for an ultra-rare disease to a newly launched nonprofit “with no upfront fees” and “without any downstream payments,” the Massachusetts-based mRNA specialist announced Tuesday.

In a joint press release, Moderna said seeking a high price for this drug “is not aligned with our values”—effectively contrasting itself with other pharmas that have held on to unused intellectual property or sought…

The race to develop the world’s first RSV vaccine intensified last week on Pfizer’s announcement that it has dosed participants in a Phase 3 trial of its RSVpreF bivalent protein-based candidate.

The company is testing a single dose of the shot for prevention of moderate to severe lower respiratory tract illness in 30,000 adults age 60 and over, the press release said. The announcement comes several weeks after Pfizer touted positive…

Sanofi announced Wednesday that it will buy New York-based biotech Kadmon for approximately $1.9 billion in cash, bolstering the multinational’s transplant medicines portfolio.

The buyout also gives Sanofi access to Kadmon’s pipeline of drug candidates for immune and fibrotic diseases and immuno-oncology therapies, the press release said.

Sanofi has inked several billion-dollar-plus acquisitions this year, including a $3.2 billion…

Mentions: Sanofi, Kadmon, M&A, drugs

The state of the fight: 

  • The U.S. FDA set a September date to discuss Pfizer/BioNTech boosters while E.U. officials saw “no urgent need” for boosters in the already vaccinated.
     
  • Recruitment started in India for a late-stage trial of Serum Institute of India’s Covovax in children, and Biological E won approval to study its Corbevax in children.
     
  • Prehospital antiplatelet therapy (such as aspirin…

Bavarian Nordic announced Wednesday that its intranasal RSV vaccine candidate, MVA-BN RSV, showed a “statistically significant” reduction of viral load in a Phase 2 challenge trial, meeting the primary endpoint. The candidate also showed up to 79% efficacy in preventing symptomatic RSV, according to the press release. The company said it expects to announce next steps for the product later this year.

Other competitors in the race to…

France’s bioMérieux reported second-quarter 2021 financials Wednesday. (Figures exclude exchange rate and portfolio changes where applicable.)

Sales for the diagnostics firm grew 7.9% year-over-year to $864 million in the quarter, driven by double-digit boosts in immunoassay and reagent sales. In line with expectations, quarterly sales for its popular BioFire testing solution line softened to 5% due to lower demand in the United…

Following up on its previously announced ambitions to make mRNA vaccines in Africa, Germany’s BioNTech issued a joint communiqué last week with Institut Pasteur de Dakar and Rwanda Biomedical Centre outlining a potential—albeit “pre-contractual”—agreement.

If the deal gets formalized, BioNTech will pursue “end-to-end” manufacturing of mRNA-based malaria and tuberculosis vaccines (pending regulatory approval) in Rwanda and Senegal for…

The New England Journal of Medicine published Phase 3 results last week showing that seasonal vaccination with GSK’s RTS,S/AS01e malaria vaccine in combination with chemoprevention was superior to either intervention alone in children ages 5-17 months.

The trial—conducted in Burkina Faso and Mali—tested a regimen of three doses of the vaccine (followed by two annual boosters just before the peak of the malaria transmission season) and…

Mentions: GSK, malaria, vaccines, drugs

J&J announced Tuesday that it will discontinue the Imbokodo Phase 2b trial of its Janssen subsidiary’s HVTN 705/HPX2008 HIV-1 vaccine after a primary analysis showed that the regimen failed to provide “sufficient protection” against infection in women at high risk of acquiring HIV.

The investigational mosaic-based shot—tested in women ages 18-35 in five sub-Saharan African countries, with four doses given over one year—demonstrated…

Mentions: J&J, Janssen, HIV, vaccines

The Journal of Experimental Medicine published Phase 2 results last week showing that Novartis’ enzyme-blocking cancer drug imatinib cleared malaria parasites from 100% of treated adult Vietnamese men in three days when used in combination with standard of care (piperaquine plus dihydroartemisinin).

In contrast, 33% of trial participants who received only standard of care without the imatinib supplement experienced delayed parasite…

Mentions: Novartis, drugs, malaria