The wave of CDMO capacity expansions continued into the new year with contract manufacturer ZhenGe Biotech raising $100 million in series C funding to build “multiple” 15,000-liter production lines, according to its press release last week.

Founded in 2017, the Shanghai-based company—which also has facilities in Maryland—claims expertise in monoclonal and bispecific antibodies, antibody-drug conjugates, fusion proteins and vaccines.…

Mentions: CDMOs, mAbs, gene therapy

Current winners of the Covid-19 vaccine race previewed plans for their windfalls at last week’s 40th J.P. Morgan Healthcare Conference, which took place virtually for the second consecutive year.

Moderna trumpeted $17.5 billion in 2021 Covid-19 product sales and sounded an optimistic note about the year ahead, claiming $18.5 billion in advance purchase agreements for vaccine or booster doses for delivery in 2022. Also, CEO Stéphane…

GSK Chief Scientific Officer Hal Barron will depart in August to head San Francisco-based startup Altos Labs, the multinational announced Wednesday. He will be succeeded by Senior VP of Medicinal Science and Technology Tony Wood, a longtime Pfizer veteran.

The press release said Barron will remain on GSK’s board as he transitions to the $3 billion-funded biotech focused on cellular rejuvenation and reversing disease.

Barron’s move…

Decreased Shigella prevalence may “partly explain the mortality benefit” observed in children under age 5 who received azithromycin in the Africa-based MORDOR trial, according to a study published last week in Clinical Infectious Diseases.

The new study analyzed samples from child participants in 30 villages in Niger and found a 64% reduction in Shigella infections after two years in those who received Pfizer’s Zithromax tablet…

Vir Biotechnology announced last week that the Gates Foundation is giving the San Francisco-based biotech $10 million in grant funding and a $40 million equity investment to back the development of platform technologies that can produce broadly neutralizing antibodies to treat HIV and prevent malaria.

The new initiative will trial the “potential impact of broadly neutralizing antibodies engineered to inhibit viral replication and spread…

The state of the fight: 

  • A booster dose of Bharat Biotech’s Covaxin increased neutralizing antibodies up to 265-fold.
     
  • WHO added therapies from Eli Lilly and GSK/Vir to its list of recommended Covid-19 treatments.
     
  • Novartis will pay over $162 million to in-license Molecular Partners’ ensovibep antiviral candidate.

 

AUTHORIZED VACCINES

Two doses of Pfizer/BioNTech’s…

A battery-operated TB test designed for low-resource, high-burden settings has earned a nod from the Global Fund’s Expert Review Panel for Diagnostics, the test’s co-developer announced Monday.

Qiagen’s QIAreach QuantiFERON-TB test, co-developed with Australia-based Ellume, offers “ultrasensitive digital detection” of latent tuberculosis infection, according to an Ellume press release. The approval clears the way for the test’s…

Merck KGaA will bolster its mRNA contract manufacturing business with the $780 million acquisition of Exelead, an Indiana-based CDMO, the multinational announced last week.

Exelead’s specialties include lipid nanoparticle-based drug delivery technology used in mRNA-based therapeutics, according to a Merck press release.

Mentions: M&A, Merck KGaA, CDMOs, mRNA, drugs

Ghana-based pharmaceutical supply chain startup mPharma has locked up $35 million in Series D funding, TechCrunch reported last week.

A portion of the funds will fuel the expansion of mPharma’s Mutti pharmacies in eight African markets, per the article, which said the pharmacies will offer a first point of care for patients, with services including medical consultations and diagnostics.

The new investments bring mPharma’s total…

Dosing has begun in a British Phase 1 trial of a lymphatic filariasis and onchocerciasis drug candidate, AWZ1066S, the Liverpool School of Tropical Medicine (LSTM) announced last week.

Developed through a partnership between Japan’s Eisai, LSTM and the University of Liverpool, the therapy targets symbiotic Wolbachia bacteria in adult worms rather than killing the worms themselves, an approach that may reduce treatment time and…

Sanofi is backing out of a collaboration with Sangamo Therapeutics to develop a gene-edited sickle cell disease therapy, California-based Sangamo announced last week.

The news came weeks after Sangamo touted favorable proof-of-concept data on SAR445136 from a Phase 1/2 trial. In the press release, Sanofi’s R&D chief attributed the move to a strategic focus on “universal genomic medicine approaches.” But BioPharma Dive noted that…

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,”…