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…

Washington state-based startup Inventprise revealed Wednesday that it has won up to $90 million from the Gates Foundation to advance its pediatric 25-valent pneumococcal conjugate vaccine candidate (IVT-25) through Phase 2.

The company will make IVT-25 “available and accessible at an affordable price” to LMICs and make its proprietary “linker” platform technology available for future global health vaccine development, the press release…

The Lancet Microbe published results last week from a Phase 1b study evaluating the safety and tolerability of U.K.-based Vaccitech’s ChAdOx1 MERS vaccine candidate.

The results—from Saudi Arabia’s first clinical trial—showed the simian adenovirus-vectored shot was safe and well-tolerated at all dosage levels while a single high-dose jab improved immunogenicity through six months.

The vaccine uses the same platform as the…

Mentions: Vaccitech

Moderna “does not have plans” to advance its chikungunya antibody candidate to Phase 2, the company revealed last week in its third-quarter earnings press release. The Massachusetts-based mRNA specialist said it had completed a Phase 1 study of mRNA-1944 and would publish full results soon. Moderna also deprioritized a chikungunya vaccine candidate (mRNA-1388) in January 2020.

In other news, the New York Times reported Tuesday on an…

After more than 20 years as a shareholder, Novartis has agreed to sell its 33% stake in Roche to its Basel-based cross-town rival for $20.7 billion, the companies separately announced last week.

“We concluded that now is the right time to monetize our investment,” Novartis CEO Vas Narasimhan said in a press release. Meanwhile, Roche’s press release claimed the move disentangles the two competitors and enables it to regain “full…

Mentions: Novartis, Roche, M&A

Chinese CDMO WuXi Biologics launched its new 12,000-square-meter facility in its eponymous hometown last week. The plant will produce monoclonal antibodies, bispecifics and fusion proteins, among other drug products, with up to 60 million vials per year in capacity, the press release said.

The investment delivers an eighth global facility to the company.

Mentions: Wuxi, drugs, mAbs, CDMOs

The state of the fight: 

  • WHO issued an Emergency Use Listing for Bharat Biotech’s Covaxin vaccine.
     
  • Kenya’s Revital Healthcare will more than triple its annual syringe production amid a “looming shortfall” in LMICs.
     
  • Pfizer’s Paxlovid antiviral slashed Covid-19 hospitalizations or death by 89%.

 

AUTHORIZED VACCINES

 
WHO listed Bharat Biotech’s Covaxin vaccine…

Fueled by its fill-finish contract for J&J’s Covid-19 vaccine, South Africa’s Aspen Pharmacare last week opened a general anesthetics manufacturing line at its Gqeberha facility. Part of a $222 million expansion, the line is the southern hemisphere’s largest for general anesthetics, according to Bloomberg.

Aspen noted on social media that South Africa to date has “imported the general anaesthetics needed in our healthcare system.”…

The International AIDS Vaccine Initiative (IAVI) has entered another agreement to use Batavia Biosciences’ novel HIP-Vax platform to manufacture doses for clinical trials, the Dutch CDMO announced last week. This time around, the vaccine candidate is IAVI’s Sudan ebolavirus shot.

Batavia is already using the high-volume, low-cost, small-footprint technology to produce doses for Phase 1 trials of IAVI’s Lassa fever vaccine candidate.…

As world leaders descended on the COP26 climate change conference in Glasgow this week, several pharma companies promoted their own ESG pledges.

First, Moderna on Monday outlined a commitment to achieve net-zero carbon emissions globally by 2030. The announcement touted a plan to use renewable or offset energy in all U.S. facilities starting this year and to implement sustainable construction for new plants in Africa and Canada. CEO…