KGaA reported fourth-quarter and full-year 2020 financials last week. (Figures exclude exchange rate and portfolio changes where applicable.)

For the quarter, group sales jumped 11% to $5.2 billion, 1.6% above analyst consensus estimates.

For the full year, group sales increased by 6% to $20 billion, in line with consensus estimates. The German company attributed the hike to a 71% jump in sales of multiple sclerosis drug Mavenclad…

Mentions: Merck KGaA

Serum Institute of India (SII) wrote Prime Minister Narendra Modi’s office last week proposing reforms to India’s regulatory systems, saying the government should extend certain coronavirus-specific vaccine rules to all vaccines.

As reported in local media, the March 2 letter from SII’s government and regulatory affairs director noted that the company produced 50 million Covishield doses last year while awaiting emergency use…

Johannesburg’s University of the Witwatersrand will collaborate with Cape Town’s Biovac, helping the South African government-backed biopharma “build specialist skills capacity” to produce viral-vectored vaccines, the university announced last week.

Through Wits Enterprise—a private company owned by the university—an academic team specializing in adenovirus-vectored vaccines will train Biovac to generate engineered viruses for possible…

The state of the hunt:

  • Serum Institute of India will export Covishield doses to the United Kingdom.
     
  • COVAX unveiled initial vaccine allocations, and numerous COVAX participants received their first shipments and began administering jabs.
     
  • Bharat Biotech’s Covaxin demonstrated 81% efficacy against symptomatic disease in an interim Phase 3 analysis.

 

Vaccines


CARB-X announced two awards on Monday to GSK Biologicals and the GSK Vaccines Institute for Global Health to fund two vaccines currently in preclinical development: one to prevent Group A Streptococcus infections and the other targeting Salmonella enterica. The awards are potentially worth more than $18 million, according to a CARB-X press release.

GSK also received up to $7.5 million from CARB-X in September 2020 to fund a Phase 1…

Inovio announced Monday that its VGX-3100 DNA-based HPV immunotherapy has met primary and secondary endpoints among all evaluable subjects in Phase 3 trials.

Administered using the Pennsylvania-based biotech’s proprietary Cellectra 5PSP “smart device,” VGX-3100 reduced cervical high-grade squamous intraepithelial lesions caused by HPV-16 and HPV-18 and cleared infection in 23.7% of people with endpoint data.

However, those results…

Merck announced last week that it is buying Massachusetts-based immune diseases specialist Pandion Therapeutics for $1.85 billion. The deal hands Merck the biotech’s “robust pipeline” of precision immune modulators, the joint press release said.

The transaction is expected to close in the first half of 2021, per the press release.

Merck announced Tuesday the fifth round of global grants in its Merck for Mothers program, which funds organizations working to increase health equity in maternity care and support, according to its press release.

New grantees include a UNICEF program in Argentina focused on adolescents from indigenous communities and a Save the Children-backed project to support pregnant teenagers and young mothers in rural Moldova.

While…

Rapidly rising Moderna used its most recent quarterly report to disclose that chief medical officer Tal Zaks will leave in September.

Credited with helping to build the vaccine manufacturer’s pipeline of mRNA jabs over the past six years (including its successful Covid-19 shot), Zaks made large, frequent sales of Moderna stock last year, behavior that STAT said in an October 2020 article would violate insider trading rules at most major…

Takeda continued its ongoing business restructuring on Friday, announcing that it will transfer four of its Type 2 diabetes medications for the Japanese market to Teijin Pharma for $1.2 billion. Takeda will continue to manufacture and supply the drugs but will hand off marketing authorization to the Tokyo-based drugmaker, the press release said.

The deal is the latest noncore asset sell-off for the Japanese company as it seeks to…

GSK subsidiary ViiV asked the U.S. FDA last week to expand the label of Cabenuva—its long-acting injectable combination HIV regimen (containing ViiV’s cabotegravir and J&J’s rilpivirine)—to allow dosing once every two months in addition to the monthly regimen the regulator approved earlier this year.

The move follows The Lancet’s publication in December 2020 of data supporting bimonthly shots.

Mentions: GSK, ViiV, J&J, FDA, HIV, drugs

Twelve leading pharma companies released fourth-quarter and full-year 2020 financial results in February. (Figures exclude exchange rate and portfolio changes where applicable.)

Leading the round, Gilead’s fourth-quarter revenue soared 26% over last year to $7.4 billion, beating consensus estimates by 4%. Veklury (remdesivir) drove the surge with $1.9 billion in quarterly sales: the antiviral now treats one in two hospitalized Covid-…

The state of the hunt:

  • J&J’s single-dose vaccine scored unanimous endorsement from a U.S. FDA advisory committee, clearing the way for a likely EUA.
     
  • The COVAX Facility made its first shipments, sending vaccine doses to Ghana and Ivory Coast.
     
  • Moderna and Pfizer made progress toward clinical trials of modified, variant-specific vaccines.

 

Vaccines


Adjuvant Capital announced last week a $300 million Global Health Technology Fund focused on accelerating the development of medical innovations for “historically overlooked public health challenges.”

The New York-based social impact investor noted in its press release that it has already backed 14 companies, requiring each to make products broadly accessible to people in low- and middle-income countries. Adjuvant’s “young portfolio”…

The industry-backed AMR Action Fund announced new investments last week totaling more than $140 million from the Boehringer Ingelheim Foundation, the European Investment Bank and Wellcome Trust. It also appointed Henry Skinner—a venture capitalist and microbiologist who once served as a managing director of Novartis Venture Fund—as its CEO.

Skinner told STAT that the billion-dollar fund, which seeks to bring two to four new antibiotics…

CARB-X announced on Tuesday up to $2.2 million in funding for the University of Queensland’s octapeptin potentiator research program, which aims to develop a new drug that disables the protective cell membrane of drug-resistant Gram-negative bacteria.

Low- and middle-income countries could use engineered octapeptin peptides to “breathe new life” into old antibiotics, according to the press release.

Mentions: CARB-X, AMR, drugs, antibiotics

The European Union launched last week a biodefense preparedness program modeled on the U.S. Biomedical Advanced Research and Development Authority.

The Health Emergency Preparedness and Response Authority (HERA) will begin with a coronavirus-specific initiative, the HERA Incubator, committed to detecting and analyzing SARS-CoV-2 variants, developing new or updated vaccines to address those variants, and producing vaccines “at scale and…

Mentions: BARDA, HERA, EC, Covid-19, vaccines

Inovio announced Tuesday that it has dosed the first participant in a West Africa-based Phase 1b trial of its INO-4500 DNA vaccine against Lassa fever.

The Pennsylvania-based company said it hopes to make the shot available for emergency use “as [a] stockpile product following Phase 2.” The candidate—delivered through Inovio’s Cellectra “smart device”—generated robust antibody and T cell immune responses in previous U.S.-based Phase 1…

Mentions: Inovio, Lassa, vaccines, CEPI, NTDs

WHO announced Tuesday that it has sent Guinea 11,000 doses of Merck’s Ebola vaccine to help combat the West African country’s new outbreak.

Earlier this year, the International Federation of Red Cross and Red Crescent Societies, Médecins Sans Frontières, UNICEF and WHO launched a global stockpile of the shot. Managed by UNICEF and allocated by WHO’s International Coordinating Group on Vaccine Provision, the Switzerland-based reserve…

Mentions: WHO, Merck, Ebola, vaccines

The state of the hunt:

  • Two versions of the AstraZeneca/Oxford vaccine secured EUL from the World Health Organization.
     
  • J&J has applied for both WHO and EMA authorization for Janssen’s Covid-19 vaccine.
     
  • The Pfizer/BioNTech shot remains stable at higher temperatures than previously believed.

 

Vaccines


Approved or authorized vaccines
 
Pfizer…