Emergent BioSolutions has dosed the first participant in an Australia-based Phase 1 trial of its nanoparticle-based universal flu vaccine candidate, the Maryland company announced last week.

The study will evaluate the influenza virus A component of EBS-UFV-001. Emergent plans future studies of additional components that would protect against all influenza A and B strains, according to its press release.

Emergent licensed the…

Two pharmas closed out 2021 with large M&As.

In the biggest deal of the year, Melbourne-based CSL announced last week an all-cash acquisition of Swiss specialty pharma Vifor worth $11.7 billion. The purchase will help “expand our presence in the rapidly growing nephrology market,” CSL’s CEO said in a press release.

Next, Sanofi struck a billion-dollar deal with California-based Amunix, the French company announced Tuesday. The…

Mentions: CSL, Sanofi, M&A, drugs, cancer

The U.S. FDA has awarded Orphan Drug Designation to Zydus Cadila’s malaria therapeutic, the company announced last week.

The status gives the Ahmedabad-based drugmaker eligibility for “certain development incentives, including tax credits for qualified clinical testing, prescription drug user fee exemptions and seven-year marketing exclusivity upon FDA approval,” the press release said.

Zydus Cadila is developing the potential…

Nigeria’s May & Baker is set to expand in West Africa by partnering with companies in Ghana and Senegal, local media said Monday.

CEO Patrick Ajahn was quoted at a media event as saying that his company has decided to “pick a few companies that we can partner with so that issues of registration do not arise.”

May & Baker is recertifying GMP at its Ogun State Pharmacentre as part of its expansion, Ajahn added.

The EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended approval of Pfizer’s 20-valent pneumococcal conjugate vaccine in adults, the company announced last week. Prevnar 20—to be marketed in Europe as Apexxnar—scored its U.S. FDA nod in June.

Pfizer remains locked in a next-gen PCV race with Merck, whose 15-valent shot crossed the regulatory finish line after Pfizer’s in the U.S. but took first place in the E.U.

The state of the fight: 

  • WHO issued an Emergency Use Listing for Serum Institute of India’s version of Novavax’s vaccine.
     
  • The U.S. CDC recommended mRNA-based vaccines over J&J’s.
     
  • Data on the effectiveness of monoclonal antibody therapies against the Omicron variant began pouring in.

AUTHORIZED VACCINES  

A U.S. CDC advisory panel recommended mRNA-based vaccines…

The Access to Medicine (AtM) Foundation announced Tuesday that it will expand its biannual ranking of the 20 largest pharmas to include monitoring of the world’s most important generic, vaccine, diagnostics, and medical gas companies.

Citing an “unacceptable gap between the ‘haves’ and the ‘have-nots,’” an AtM press release said the Covid-19 pandemic had revealed “acute issues of access,” not only to medicines and vaccines but to…

Merck has issued a $1 billion sustainability bond, the company announced Monday. The instrument will fund environmental, social and governance (ESG) projects and “contribute to the advancement of the United Nations Sustainability Development Goals,” according to a press release.

Merck said proceeds from the bond—part of an $8 billion debt offering—will support access to essential healthcare services, infectious disease R&D,…

Moderna plans to set up an mRNA vaccine manufacturing facility in Australia capable of producing up to 100 million doses per year, the Massachusetts-based biotech announced Monday. The new facility, in the state of Victoria, will make shots against respiratory viruses including Covid-19, seasonal influenza and RSV, the press release said. The company did not disclose financial terms, but Reuters reported Monday that the deal could be worth up…

Moderna’s mRNA-1010 quadrivalent seasonal influenza vaccine candidate boosted antibody titers against all four strains in both younger and older adults, according to interim Phase 1 data the Massachusetts-based biotech shared last week. The company also revealed that it is developing two “beyond quadrivalent” seasonal flu vaccine candidates—mRNA-1011 and mRNA-1012—that it believes will “expand strain coverage and enhance tools available to…

Novo Nordisk will pour nearly $2.6 billion into three new manufacturing facilities and one existing plant at its production site in Denmark, the company announced Monday. The “vast majority” of the investment will go toward increasing production of active pharmaceutical ingredients, the press release said.

Meanwhile, Fujifilm Diosynth Biotechnologies will allocate $300 million—of a previously announced $850 million investment to boost…

Reportedly flush with Covid-19 vaccine revenues, Pfizer will shell out approximately $6.7 billion in cash to buy San Diego-based Arena Pharmaceuticals, the companies announced Monday. The acquisition will boost Pfizer’s Inflammation and Immunology program, the press release said.

Pfizer will also invest $68.5 million to build a gene therapy manufacturing facility in North Carolina, the New York-headquartered company announced Wednesday…

Mentions: Pfizer, M&A, gene therapy

The African Union and Africa Centres for Disease Control and Prevention convened regional and international stakeholders in Rwanda last week to discuss progress on boosting vaccine manufacturing on the continent.

A joint communiqué underscored successes to date, saying the Partnership for Africa Vaccine Manufacturing (PAVM) had struck deals between multinational and local companies and established WHO training and manufacturing “hubs.”…

Bluebird Bio’s gene therapy for sickle cell disease led to complete resolution of severe vaso-occlusive events and reduced hemolysis in a Phase 1/2 study, the Massachusetts company announced Sunday.

Bluebird presented the data on lovo-cel (formerly LentiGlobin) at the 63rd American Society of Hematology Annual Meeting (ASH) and in the New England Journal of Medicine. The company noted that cases of acute myeloid leukemia in two people…

The state of the fight: 

  • New studies supported heterologous primary regimens and heterologous boosters.
     
  • Serum Institute of India is weighing slashing Covishield production by 50%.
     
  • The U.S. FDA OK’d AstraZeneca’s Evusheld long-acting monoclonal antibody therapy as PrEP for certain groups.

 

AUTHORIZED VACCINES  

Mixing the AstraZeneca/Oxford or Pfizer/BioNTech…

Boston University has published the last of its annual reports evaluating the progress of Access Accelerated, the industry-led initiative to address noncommunicable disease burdens in LMICs.

The 2021 Access Observatory identified 61 active access programs, with a majority focused on cancer. That number represents a decline from 75 active programs in 2019 and 73 in 2018. The report cited the “unprecedented” challenge of Covid-19 as…

India’s Hilleman Laboratories is setting up in Singapore, a company press release said Monday. The Merck and Wellcome joint venture is investing $58 million over the next five years to develop a 30,000-square-foot facility focused on R&D and clinical trials “up to Phase II stage.” Expected to be fully operational by early 2023, the site will develop “affordable, high-value vaccines and biologics for Singapore as well as low- and middle-…

China again exacted concessions from drugmakers, with pharmas agreeing to price cuts averaging 62% in exchange for adding 67 branded drugs to its national medical insurance program, per a Reuters article last week.

Additions to the national reimbursement drugs list included J&J’s cancer drug Darzalex and three new indications for Eli Lilly’s sintilimab, a monoclonal antibody.

Lilly appeared eager to comply with what Reuters…

Mentions: drug pricing, drugs, China

Three major pharmas have shared end-of-year environmental, social and governance announcements over the past weeks.

Merck invested a new round of $150 million in essential maternal and reproductive health services funding for 25 million women by 2025 through its Merck for Mothers program.

Meanwhile, Takeda launched a new U.S. corporate social responsibility program with a first-year commitment of $20 million for “health equity,…

SAB Biotherapeutics’ novel anti-influenza fully human IgG intravenous immunotherapy succeeded in Phase 2a, the South Dakota-based company announced last week.

The SAB-176 polyclonal antibody—for moderate to severe seasonal flu A and B—significantly reduced viral load and clinical symptoms compared to placebo in adults challenged with a pandemic flu strain, the press release said.