Thermo Fisher wrapped up 2021 by buying bioscience reagents specialist PeproTech for $1.9 billion in cash, the Massachusetts-based behemoth announced last week.

The deal gives Thermo Fisher access to New Jersey-based PeproTech’s recombinant proteins portfolio, “an excellent strategic fit within our biosciences business,” per the press release.

Mentions: Thermo Fisher, M&A

The state of the fight: 

  • India granted Biological E’s Corbevax—a low-cost, patent-free vaccine—its first regulatory authorization.
     
  • A J&J booster was 85% effective against hospitalization in South Africa during the Omicron wave.
     
  • India authorized molnupiravir but omitted the antiviral from its recommended clinical protocol on safety concerns.

 

AUTHORIZED VACCINES…

RNA therapeutics specialist Sirnaomics wrapped up 2021 with a $64 million IPO on the Hong Kong stock exchange, Clarivate BioWorld reported Tuesday.

Based in Maryland and Suzhou, the company’s pipeline includes influenza A and Covid-19 therapies and a Covid-19 vaccine. Its lead candidate is a Phase 2 oncology and dermal fibrosis treatment, per a press release.

Meanwhile, Israel’s BiondVax announced on December 23 a $9.8 million…

Pfizer and BioNTech will jointly develop a third mRNA-based vaccine using Pfizer’s antigen technology and BioNTech’s mRNA platform—this time against shingles.

Under deal terms announced Wednesday, BioNTech will lock up $75 million in cash and an equity investment of $150 million from Pfizer. The German company could also earn milestone payments worth up to $200 million and a share of the profits, according to a joint press release.…

Quidel Corporation will buy New Jersey in-vitro diagnostic specialist Ortho Clinical for $6 billion in cash and newly issued shares, per a late December announcement from the San Diego-based company.

Expected to close in the first half of 2022, the deal will allow for “top-tier R&D capabilities, a more diverse product pipeline, and broader geographic footprint,” Quidel’s CEO said in the press release.

Mentions: Quidel, Ortho, diagnostics, M&A

The state of the fight: 

  • Oral antivirals from Pfizer and Merck notched U.S. FDA authorizations.
     
  • Earlier use of remdesivir cut the risk of death or hospitalization by 87% in a new study.
     
  • The Novavax vaccine secured a second WHO Emergency Use Listing.

AUTHORIZED VACCINES  

The AstraZeneca/Oxford vaccine starts waning in protection against serious illness within three months…

ViiV has won U.S. FDA approval for Apretude, the first long-acting injectable for pre-exposure prophylaxis of HIV, the GSK subsidiary announced Monday.

The cabotegravir-based shot can be administered as few as six times per year after the first two 600-mg doses, per the press release. In clinical trials, Apretude offered 69%-90% lower incidences of HIV when compared to daily oral emtricitabine/tenofovir disoproxil fumarate (TDF/FTC)…

Mentions: ViiV, GSK, HIV, PrEP, drugs, FDA, regulatory

Médecins Sans Frontières (MSF) and Human Rights Watch (HRW) are lobbying the U.S. government to force Pfizer and Moderna to share their Covid-19 mRNA technology with developing country vaccine manufacturers, the organizations said last week.

In an open letter, the activist groups quoted a December report by researchers from MSF and AccessIBSA that identified 100 manufacturers across Africa, Asia and Latin America with the “technical…

Promising C. difficile drug ridinilazole has failed in Phase 3, CARB-X grantee Summit Therapeutics announced Monday.

The Massachusetts-based company said the study showed that the investigational drug resulted in a higher observed Sustained Clinical Response rate than current standard-of-care vancomycin “but did not meet the study’s primary endpoint for superiority.”

The company did see a “meaningful reduction in recurrence,”…

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…