Scarcely a month after notching U.S. FDA approval of its 15-valent pneumococcal conjugate vaccine (PCV) in adults, Merck announced Wednesday that the shot has also met key immunogenicity and safety endpoints in a Phase 3 trial in infants.

Vaxneuvance had a safety profile “generally comparable” to PCV13, according to Merck’s press release. On immunogenicity, the shot was shown non-inferior to PCV13 for all 13 shared serotypes at two…

Mentions: Merck, PCV, pneumo, FDA, vaccines

Hot on the heels of record $19 billion second-quarter revenues (led by its Covid-19 shot), Pfizer announced Monday that it will buy Massachusetts-based immuno-oncology biotech Trillium Therapeutics for nearly $2.3 billion in cash.

The deal will boost Pfizer’s blood cancer pipeline and secure access to Trillium’s lead molecules (TTI-622 and TTI-621), according to the press release. The investigational therapies target the CD47 protein…

Samsung Biologics will expand its CDMO business with the construction of two new plants, South Korean media reported Wednesday, citing a company statement. Geared toward vaccines and cell and gene therapies, the new facilities at its Incheon hub are in addition to a previously announced “Super Plant” already under construction, according to FiercePharma.
 
The Wall Street Journal said the projects are part of a new, $205 billion…

A study in the August 21 issue of The Lancet supports Gavi and WHO efforts to immunize children with Bharat Biotech’s Typbar typhoid conjugate vaccine (TCV) in endemic settings, according to its authors.

Prior research on the vaccine—prequalified by WHO in 2017—was “not adequately powered” to evaluate clinical protection in children under age 2, the study said. But the new results showed “high-grade, significant protection” from the jab…

The state of the fight: 

  • Zydus Cadila’s three-dose, needle-free ZyCoV-D became the first authorized DNA-based Covid-19 vaccine.
     
  • AstraZeneca’s AZD7442 long-acting antibody reduced infection risk by 77% in Phase 3.
     
  • PAHO’s Revolving Fund will begin procuring Covid-19 vaccines for member states.
Approved or authorized vaccines

 
Assessing antibody levels to predict Moderna’s…

Basilea Pharmaceutica announced Monday that the U.S. Biomedical Advanced Research and Development Authority has increased its total investment in the Swiss company’s ceftobiprole antibiotic candidate to $134.2 million.

The new tranche of $4.3 million will support a Phase 3 trial to evaluate the intravenous drug as an S. aureus bacteremia treatment, the press release said.

The Basel-based company won funding from CARB-X in May to…

FierceBiotech reported Monday that CureVac quietly revealed in its latest financial report that Boehringer Ingelheim is walking away from its $600 million lung cancer deal inked with the German mRNA maker in 2014.

The new setback for CureVac comes just two months after its Covid-19 mRNA shot showed only 47% efficacy at preventing any severity of the disease, the news outlet said.

Eli Lilly announced Tuesday that its Lilly Bio-Medicines unit will split into separate neuroscience and immunology business units, effective September 5.

Lilly Neuroscience—to be led by current oncology chief Anne White—will manage the company’s Phase 3 portfolio in pain and neurodegeneration, including the “potential launch of donanemab,” its U.S. FDA Breakthrough Therapy candidate for Alzheimer’s disease, the press release said.

Mentions: Lilly, governance, mAbs, drugs

British researchers have identified a series of new drug compounds that could treat schistosomiasis, the London School of Hygiene & Tropical Medicine (LSHTM) announced on Wednesday.

LSHTM researchers and the nonprofit drug discovery company Salvensis screened more than 300,000 compounds—donated by the Medicines for Malaria Venture—to discover their ability to kill the three main species of parasitic worms.

In mouse models, the…

A literature review published in PharmacoEconomics last week found that the R&D costs of bringing a new molecular entity (NME) to market range immensely, from $161 million to more than $4.5 billion.

The researchers said their findings question the commonly cited $2.6 billion price tag to develop a new drug (calculated by the Tufts Center for the Study of Drug Development in 2016).

While estimates were highest for cancer (…

Mentions: R&D, drugs

Soligenix announced Wednesday positive preclinical data for its thermostable recombinant subunit vaccine candidates against Ebola Sudan, Ebola Zaire and Marburg viruses.

The shots—which use the novel CoVaccine HT adjuvant from BTG Specialty Pharmaceuticals—elicited “potent immune responses” that “suggest the feasibility” of formulating a multivalent filovirus vaccine to protect against all three pathogens, according to data published in…

Bharat Biotech’s Typbar-TCV typhoid conjugate vaccine remained stable for seven days at 45 degrees Celsius, according to an extended controlled-temperature conditions study published in Microorganisms on Wednesday.

The researchers from the Hyderabad-based company and Britain’s National Institute for Biological Standards and Control said that allowing the shot to leave the cold chain just prior to administration would “facilitate…

Mentions: BBIL, TCV, typhoid, vaccines, CTC, WHO, PQ

Bayer announced last week that it is acquiring drug discovery start-up Vividion Therapeutics for $1.5 billion upfront and up to $500 million more in potential milestone payments.

According to the press release, Bayer will gain full rights to the San Diego-based biotech’s chemoproteomic platform, which identifies “previously unknown binding pockets in undruggable targets” to generate novel compounds for oncology and immunology.

Mentions: Bayer, Vividion, R&D, drugs, cancer

Inovio announced last week that it has dosed the first participant in a Phase 2 study of its INO-4700 DNA vaccine against MERS. The multicenter trial—funded by the Coalition for Epidemic Preparedness Innovations (CEPI)—will involve approximately 500 healthy adults in Jordan and Lebanon.

According to the press release, Inovio and CEPI plan to make a stockpile of INO-4700 “available for emergency use as soon as possible following Phase 2…

Mentions: Inovio, MERS, vaccines, CEPI

The New England Journal of Medicine published Phase 1 results Wednesday from a small trial showing that a single infusion of an investigational antimalarial monoclonal antibody (CIS43LS) prevented infection for up to nine months in malaria-naïve adults exposed to P. falciparum.

The drug—developed by the U.S. National Institute of Allergy and Infectious Diseases—is also being tested in a larger Phase 2 trial in Mali to evaluate its…

Mentions: mAbs, drugs, malaria, NIAID

Moderna announced Tuesday that it will work with the Canadian government to build an mRNA vaccine manufacturing plant in the country to produce respiratory shots (including Covid-19, influenza and RSV) and boost the country’s pandemic rapid response capabilities.

The Massachusetts-based company said it intends to apply the same “sustainable national business model” to other geographies and is in discussion with other country governments…

Valneva reported positive Phase 3 results last week showing that its live attenuated, single-dose chikungunya shot produced neutralizing antibodies in 98.5% of subjects and was well-tolerated across age groups.

The company, which expects final results for VLA1553 within the next six months, is on course to be the first to win U.S. FDA approval and snag a Priority Review Voucher (PRV) for a chikungunya vaccine—ahead of rivals Emergent…

Vaxcyte announced last week an additional $3.2 million CARB-X grant to support the company’s Investigational New Drug (IND) application for its novel universal Group A Streptococcus vaccine VAX-A1. CARB-X awarded the company $2.7 million for its initial funding period, per Vaxcyte’s press release.

Including future milestone payments, CARB-X’s VAX-A1 funding is worth up to $29.7 million to the California biotech.

Mentions: Vaxcyte, CARB-X, GAS, vaccines

The state of the fight: 

  • Multiple wealthy countries outlined imminent booster dose plans, spurning a WHO plea for patience.
     
  • Novavax pushed back its timeline for seeking U.S. FDA authorization for its vaccine and said the U.S. had paused funding for the shot’s production.
     
  • The African Vaccine Acquisition Trust announced its first shipments of doses.

 

Approved or authorized…

Amgen will invest $550 million to build a new multi-product drug substance manufacturing facility in North Carolina, the company announced Tuesday.

Combined with a $365 million investment in an Ohio assembly and packaging site, announced in June, the project brings the cost of Amgen’s U.S. manufacturing push to over $900 million.

Mentions: Amgen, drugs