The Access to Medicine (AtM) Foundation has released its 2021 antimicrobial resistance benchmark report evaluating 17 of the industry’s most active players in the AMR space.

GSK maintained its lead among multinational corporations, although Pfizer leaped from sixth to a close second place after making “significant strides” in stewardship, waste management, drug access, R&D and data sharing. The AtM Foundation praised Pfizer as the…

The Lancet published Phase 3 data on Monday showing that co-administration of ivermectin and albendazole had higher efficacy against T. trichiura than albendazole alone in two of the three regions in the study.

Compared to albendazole monotherapy (the current standard of care), the combination outperformed in Laos (66% vs. 8%) and on Tanzania’s Pemba Island (49% vs. 6%) against the roundworm, but yielded no added benefit in Côte d’…

GSK on Tuesday announced Phil Dormitzer as its new global head of vaccines R&D.

Dormitzer joins the multinational from Pfizer, where he was vice president and chief scientific officer for RNA and viral vaccines—and a key figure behind Pfizer's Covid-19 shot. He will report to GSK CSO Hal Barron starting this week.

FierceBiotech said the move is a boost to GSK after a "mini exodus" from the company that included losing former…

Several manufacturers expanded their operations in the United States, per announcements and media reports last week.

First, U.S. multinational BD plans to boost its San Diego presence with a new 220,000-square-foot biosciences R&D facility, expected to open by end-2023, Fierce Biotech reported. Also, Chinese cancer specialist BeiGene said it is expanding its New Jersey footprint with a 400,000-square-foot, “state-of-the-art”…

Merck has halted development of its MK-8507 investigational HIV drug after seeing a decrease in certain white blood cells in Phase 2 participants who took the non-nucleoside reverse transcriptase inhibitor in combination with islatravir, another Merck HIV drug candidate, the company announced in November.

A press release said Merck “remains confident in islatravir’s overall profile” and will continue development of the nucleoside drug…

The U.S. FDA has granted priority review to Merck’s 15-valent pneumococcal conjugate vaccine (PCV) as the agency evaluates the shot for children and adolescents ages 6 weeks to 17 years, the company announced Wednesday.

Marketed as Vaxneuvance, the jab won FDA approval for use in adults in July, just weeks after Pfizer’s 20-valent vaccine became the first next-gen PCV to cross the finish line.

Novo Nordisk will swallow up Massachusetts-based drugmaker Dicerna for $3.3 billion in cash, the Danish company announced in November.

The companies partnered in 2019 to develop RNA interference (RNAi) therapies using Dicerna’s proprietary technology, which Novo will acquire as part of the deal, according to its press release.

The acquisition is the latest in a slew of big-ticket purchases for Novo Nordisk, including a $1.35…

A new Phase 1 trial in Mali of Sanaria’s PfSPZ malaria shot showed a three-dose regimen was well-tolerated and conferred 51% vaccine efficacy against intense natural P. falciparum transmission, according to a Lancet Infectious Diseases article published in mid-November.

The results are in line with earlier studies using the five-dose regimen, per the authors.

VBI Vaccines has secured a U.S. FDA nod for what the company calls the “only” approved three-antigen adult hep B shot in the country, according to a Wednesday press release.

Marketed as PreHevbrio, the recombinant vaccine elicited higher rates of seroprotection in Phase 3 than GSK’s single-antigen Engerix-B in all adults (91.4% vs. 76.5%) and adults ages 45 and older (89.4% vs. 73.1%), the Massachusetts-based company said.

The…

The state of the fight: 

  • U.S. regulators signed off on boosters for all adults.
     
  • India raised a syringe export limit to allow supplies to reach PAHO and UNICEF.
     
  • Pfizer will let Medicines Patent Pool sublicense its oral antiviral to manufacturers in 95 countries.

AUTHORIZED VACCINES  
 

Pfizer/BioNTech’s shot generated stronger antibody responses than three rival…

Public agencies in over 100 LMICs will be able to buy SD Biosensor’s STANDARD Q HIV/Syphilis Combo test for less than $1 through a collaboration between the company, the Clinton Health Access Initiative (CHAI) and Britain’s MedAccess, the partners announced Monday.

A volume guarantee agreement between MedAccess and the South Korean manufacturer will make the WHO-prequalified diagnostic available to a cohort of countries bearing 98% of…

Baxter International’s CDMO unit plans a $100 million expansion to its sterile fill-finish manufacturing facility in western Germany, the company announced last week. The investment adds to a multibillion-dollar investment spree among manufacturers worldwide.

In related news, Samsung Biologics has bought land in Incheon, South Korea, where it plans a $259 million genetic medicines facility, the Korea Herald reported in early November.…

What role can vaccines play in combatting antimicrobial resistance? A public-private partnership seeks to answer that question through an open-source, web-based analytic platform, Germany’s European Vaccine Initiative (EVI) announced last week.

The PrIMAVeRa project—coordinated by EVI and backed by $10.3 million from the Brussels-based Innovative Medicines Initiative—joins GSK, Janssen and Pfizer with 16 academic and SME partners across…

Mentions: vaccines, mAbs, AMR, EVI, IMI, GSK, J&J, Janssen, Pfizer

Johnson & Johnson will spin off its consumer health assets as a new standalone company, the pharma giant announced last week.

Its remaining business segments (including pharmaceutical and medical device units) are expected to gross about $77 billion in 2021, while segments belonging to the “New Consumer Health Company” would gross around $15 billion, according to the press release.

J&J’s move follows similar plays by GSK,…

Mentions: J&J, consumer health

The University of Oxford has launched a Phase 1 trial of a multivalent Ebola vaccine candidate targeting both the Zaire and Sudan strains of the filovirus, the university announced last week.

The ChAdOx1 biEBOV vaccine uses the same adenovirus vector platform as the AstraZeneca/Oxford Covid-19 shot, whose storage conditions are “amenable to use in the developing world,” the trial’s chief investigator noted. By contrast, Merck’s Ebola…

Merck KGaA announced positive results this week from Phase 3 trials in Kenya and Côte d’Ivoire of the pediatric schistosomiasis treatment arpraziquantel. The orally dispersible pill is more child-friendly than current standard of care praziquantel and cured “close to or above” 90% of participants ages 3 months to 6 years after three weeks of treatment, according to the press release.

The German multinational now plans to apply for…

The state of the fight: 

  • More European countries cautioned against Moderna’s vaccine for younger people over concerns about side effects.
     
  • Generics companies are preparing to roll out their versions of Merck’s molnupiravir oral antiviral.
     
  • Pfizer is in talks with 90 countries over supply deals for its antiviral candidate.

 

AUTHORIZED VACCINES  


France and…

, CARB-X, antibiotics, AMR, Acurx, CDI, drugs, clinical trials

November 10, 2021 — India’s Bugworks Research announced Monday that it administered doses in the first human trial of its novel broad-spectrum antibiotic against multidrug-resistant Gram-negative bacteria. Bugworks is one of four CARB-X grantees conducting Phase 1 studies this year, the Bugworks press release noted. Boston University-led CARB-X has supported the company’s…

Mentions: Bugworks

GE plans to spin off its healthcare business into a separate public company as part of a broader restructuring, the conglomerate announced Tuesday. Targeted for early 2023, the transaction would create a freestanding diagnostics specialist. GE Healthcare had $18 billion in 2020 revenue and about 47,000 employees, according to a company presentation.

GE also intends to launch its energy business as a separate entity in 2024, leaving the…

Japan’s Global Health Innovative Technology (GHIT) Fund will invest $6.6 million in diagnostics, drugs and vaccines development, the nonprofit announced last week.

One award will advance an ongoing Chagas disease drug development project by the Drugs for Neglected Diseases Initiative (DNDI). The five other are new projects: a TB diagnostic, a placental malaria vaccine, a malaria drug, and two separate Chagas drugs (by DNDI/Takeda and…