WHO has established a “global biomanufacturing training hub” in South Korea that will serve LMICs aspiring to manufacture their own vaccines and therapies, according to a joint announcement Wednesday from the U.N. health agency, the South Korean government and the WHO Academy.
The selected facility outside Seoul has already been training domestic biomanufacturing companies, and will now work with the WHO Academy to expand its…
WHO reportedly added two vaccines to its prequalification list in recent weeks.
Sanofi’s meningococcal ACYW tetanus toxoid-based conjugate vaccine, MenQuadfi, notched PQ status last month, according to WHO records.
Meanwhile, a CNBG announcement last week on Chinese social media stated that its Sabin-based inactivated polio vaccine (sIPV) had won the designation. With this approval, CNBG’s shot beats out Sinovac’s product to…
The state of the fight:
Bavarian Nordic’s RSV vaccine candidate (MVA-BN RSV) has notched U.S. FDA Breakthrough Therapy designation for adults age 60 and older on the strength of preliminary clinical evidence, the Denmark-based company announced Monday. The news follows earlier Phase 2 data showing the candidate resulted in a “statistically significant” reduction of viral load and up to 79% efficacy in preventing symptomatic RSV infections in adults ages 18-50.
…BioNTech on Wednesday introduced the modular mRNA vaccine manufacturing platform it plans to deploy in Africa. But the fanfare was overshadowed by allegations—published last week in The BMJ—that a consultancy in the pay of the German company has sought to “undermine” a WHO-managed initiative for a multilateral mRNA technology transfer hub in South Africa. According to the BMJ article, the Malta-based Kenup Foundation circulated a report last…
Centauri Therapeutics has raised over $32.6 million in Series A financing to support the development of novel antibacterial candidates for difficult-to-treat infections, the company announced Wednesday. Investors in the round include Boehringer Ingelheim Venture Fund, Evotec and Novo Holdings REPAIR Impact Fund.
The London-based biotech won CARB-X backing in 2020 for its ABX01 dual-acting immunotherapy to treat serious infections caused…
CureVac has dosed the first participant in a Phase 1 trial of its multivalent mRNA-based seasonal influenza vaccine candidate (CVSQIV) developed with GSK, CureVac announced last week. The companies inked an mRNA collaboration deal in 2020 when GSK invested in the German biopharma.
In other flu news, Cidara Therapeutics announced Monday that the U.S. FDA has accepted its Investigational New Drug (IND) application for the company’s…
The state of the fight:
AUTHORIZED VACCINES
J&J’s single-dose shot was only 53%…
BioMarin Pharmaceutical has sold a U.S. FDA priority review voucher (PRV) to an undisclosed buyer for $110 million, the California-based rare disease specialist announced Wednesday.
The price represents a decrease from BioMarin’s last PRV sale, a $125 million deal with Novartis in 2017.
Bugworks Research has secured $18 million in Series B financing, the biopharma announced Wednesday. The funds will support the clinical development of BWC0977, the India-based company’s novel broad-spectrum antibiotic against multidrug-resistant Gram-negative bacteria, among other projects.
Currently in Phase 1, BWC0977 has had CARB-X backing since 2017.
Public Health Vaccines (PHV) has launched a Phase 1 trial of its PHV02 single-dose, recombinant vesicular stomatitis virus (rVSV)-based vaccine candidate against Nipah virus, the biotech announced Wednesday.
PHV is developing the shot with fellow Massachusetts-based company Crozet BioPharma. In 2019, the project secured up to $43.6 million in funding from the Coalition for Epidemic Preparedness Innovations to bring it through Phase 2…
The state of the fight:
REGULATORY UPDATES
Pfizer and BioNTech have begun rolling data submission for authorization of their…
Eli Lilly will invest $1 billion to build a new manufacturing facility for injectable products and devices in North Carolina, creating nearly 600 jobs in the process, the company announced last week.
In other Lilly news, the company on Wednesday announced a commitment of $14.4 million to UNICEF’s work to improve health outcomes in 10 million children and adolescents with noncommunicable diseases in Bangladesh, Malawi, Nepal, the…
Moderna and the International AIDS Vaccine Initiative (IAVI) have dosed the first participants in a Phase 1 trial of an experimental mRNA-based HIV vaccine (mRNA-1644) and boost candidate (mRNA-1644v2-Core), according to a joint press release issued last week.
The trial builds off a previous proof-of-concept study showing that a compound (developed by IAVI and Scripps Research) in mRNA-1644 generated a B-cell response in 97% of…
The U.S. FDA gifted Moderna a Priority Review Voucher (PRV) when it approved the Massachusetts-based company’s Covid-19 vaccine on Monday, according to an agency letter.
Moderna has yet to disclose plans for its voucher. On the resale market, PRV values have fallen sharply from their 2015 high of $350 million, with more recent sales coming in around $100 million.
Oxford Biomedica and Homology Medicines last week launched a U.S.-based adeno-associated virus (AAV) CDMO offering clients “innovative manufacturing expertise” in AAV and lentiviral-based cell and gene therapies, according to a joint press release. Under the deal, Oxford Biomedica will pay Massachusetts-based Homology $130 million upfront and pump $50 million more into the joint entity—dubbed Oxford Biomedica Solutions—in exchange for an 80%…
Pfizer has named William Pao to succeed Rod MacKenzie as its chief development officer, the multinational announced Tuesday. Pao joins from Roche, where he's overseen research and development since 2018.
MacKenzie is retiring after 35 years at Pfizer, per the company's press release.
Washington D.C. lobby group Pharmaceutical Research and Manufacturers of America (PhRMA) is "attacking the WHO" and several governments it accuses of "harming biopharma innovation," Endpoints News reported Wednesday.
In its annual update to the U.S. Trade Representative on the state of IP protection, PhRMA singled out a WHO roadmap for access to medicines and vaccines, faulting the document for urging technical support to countries…
Samsung Biologics is buying out Biogen's nearly 50% stake in their Samsung Bioepis biosimilars joint venture for $2.3 billion, the companies announced last week.
The JV has launched five biosimilars to date, with four more currently in Phase 3, according to a Samsung press release.
The Wall Street Journal said Massachusetts-based Biogen might use the proceeds for new acquisitions "as it grapples with the fallout over Aduhelm,"…
Gilead will pay rival ViiV $1.25 billion upfront and a 3% royalty on future U.S. sales (through 2027) of its once-daily single-tablet Biktarvy regimen—bictegravir, emtricitabine and tenofovir alafenamide—as part of a patent infringement settlement, ViiV’s parent company announced Monday.
The GSK subsidiary filed suit against Gilead in 2018, claiming that the bictegravir component of Biktarvy infringed on ViiV’s patents relating to its…