The state of the fight: 

  • Regeneron and Roche’s REGEN-COV became the first antibody drug to score U.S. FDA clearance for post-exposure prophylaxis of Covid-19.
     
  • Six-month data on Pfizer/BioNTech’s vaccine showed continuing high efficacy against severe disease.
     
  • Antibody levels induced by Sinovac’s vaccine dropped sharply six months after completion of a two-dose regimen, according to new data.…

Germany’s BioNTech announced Monday that it is “evaluating sustainable mRNA vaccine production capacities in Africa” for a candidate malaria shot and other vaccines.

The company said in a press release it would select promising candidates for clinical development from “multiple vaccines featuring known [m]alaria targets” (such as the circumsporozoite protein) while also evaluating new antigens. First trials are planned for year-end 2022…

GSK used its second-quarter 2021 results, released Wednesday, to announce the abandonment of a Phase 2 pediatric RSV vaccine candidate after results showed the shot (GSK3389245A/ChAd155-RSV) was unlikely to meet target efficacy. The company also has adult and maternal immunization candidates for RSV in Phase 3.

Nonetheless, the U.S. FDA did hand GSK a good start to the week: on Monday, the agency expanded the market for Shingrix,…

Mentions: GSK, RSV, vaccines, FDA, shingles

BMJ Open published findings last week showing only 26% of pharmaceutical products had publicly available results for all clinical trials supporting their U.S. FDA approvals. Large companies were “significantly more transparent” than non-large companies, driven by better data sharing procedures and the implementation of reporting requirements, the researchers found.

Otsuka announced last week that the EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended approval of Deltyba, the Japanese firm’s dispersible delamanid tablet, for multidrug-resistant pulmonary tuberculosis in patients of all ages weighing at least 10 kilograms (22 pounds).

Mentions: Otsuka, EMA, MDR-TB, TB, drugs

University of Oxford researchers on Wednesday launched a Phase 1 trial of an adenoviral-vectored vaccine candidate for human plague. Forty healthy adults ages 18-55 will receive the new shot, which is based on the same ChAdOx1 platform used for the AstraZeneca/Oxford Covid-19 vaccine, according to a press release from the university.

Mentions: plague, Oxford, vaccines

Arvinas and Pfizer announced last week that they will collaborate on ARV-471, an investigational estrogen receptor-targeting breast cancer therapy, currently in Phase 2.

Pfizer will pay the Connecticut-based biotech $650 million upfront (plus up to $1.4 billion in milestones) and separately make a $350 million equity investment. Both will share development costs and profits equally, according to the press release.

The move follows…

Mentions: Arvinas, Pfizer, cancer, drugs

Moderna announced last week its launch of a foundation to promote “public health, healthcare and educational opportunities,” with an initial endowment of $50 million. The Moderna Charitable Foundation is the first public social good commitment for the maker of the blockbuster Covid-19 vaccine.

Meanwhile, Novartis last week announced a 10-year collaboration with multiple U.S.-based historically Black colleges and universities (HBCUs) and…

Mentions: Moderna, Novartis, CSR, DEI

The state of the fight: 

  • South Africa’s Biovac will fill-finish the Pfizer/BioNTech vaccine.
     
  • The U.S. will give $200 million to South Africa’s Aspen Pharmacare to boost vaccine capacity.
     
  • CEPI and IVI are backing new vaccine trials in Africa.

 

Regulatory updates

Sanofi’s “Vidprevtyn” under rolling review: The EMA announced Tuesday it has begun reviewing the recombinant…

Gilead, Merck and the TB Alliance were among the players touting new data at the 11th International AIDS Society Conference on HIV Science (IAS 2021), held in a virtual format July 18-21.

Gilead on Saturday offered promising Phase 2/3 news on lenacapavir, its investigational, long-acting HIV-1 capsid inhibitor, which it said achieved “high rates of virologic suppression” at week 26 in people living with HIV whose virus was no longer…

Batavia Biosciences announced last week that it has successfully manufactured shots for Phase 1 trials in Africa and the U.S. of the recombinant vesicular stomatitis virus (rVSV) vector-based Lassa fever vaccine being developed by the International AIDS Vaccine Initiative (IAVI).

The Dutch company, which initially partnered with IAVI in 2018, said it manufactured rVSVΔG-LASV-GPC using its HIP-Vax platform, which “enables the production…

Sinovac announced last week that China’s National Medical Products Administration has approved its Sabin-based inactivated polio vaccine (sIPV).

In its press release, the Chinese biotech said that WHO accepted its prequalification materials in early 2020 and completed site inspections this February. If prequalified, Sinovac’s sIPV would become the second Sabin-based product to gain the status after LG Chem’s in January 2021.

The…

Local media reported Monday that Mumbai-based TechInvention has struck an import deal with EuBiologics to market the South Korean company’s oral cholera vaccine (OCV) in India.

Business Standard quoted TechInvention CEO Syed Ahmed as saying the move fills a market gap resulting from Sanofi’s OCV production pause at its Shantha subsidiary. TechInvention is targeting a price range for Euvichol-Plus of $8-$10 per single dose in India’s…

Merck’s next-generation 15-valent pneumococcal conjugate vaccine (PCV) earned U.S. FDA approval in adults last week, crossing the finish line for people age 18 and older nearly six weeks after rival Pfizer’s 20-valent shot.

Even so, Merck’s Vaxneuvance seems poised to beat Pfizer in the race for the lucrative pediatric market. Merck said in May that it plans to seek FDA approval for the shot’s use in children this year.

Mentions: Merck, FDA, pneumo, PCV, Pfizer, vaccines

Sanofi announced Monday that the U.S. FDA has approved its oral sleeping sickness treatment, fexinidazole, in patients age 6 and older and weighing at least 20 kilograms. According to the press release, the approval also nets a tropical disease Priority Review Voucher for Sanofi’s co-developer, the Drugs for Neglected Diseases Initiative. Sanofi and DNDI will share the PRV benefits.

The EMA approved the drug in 2018.

Europe’s public-private Innovative Medicines Initiative (IMI) announced last week the launch of UNITE4TB—a $218 million, seven-year project to accelerate and improve the clinical evaluation of combinations of existing and novel drugs as treatment regimens for drug-resistant and drug-sensitive tuberculosis. UNITE4TB is the newest project of IMI’s AMR Accelerator.

The consortium—which involves 30 partners including academic institutions,…

Mentions: IMI, AMR, UNITE4TB, TB, drugs, GHIT

J&J will pay up to $5 billion over nine years under a settlement over its role in the U.S. opioid epidemic, media reported Tuesday. The agreement with U.S. states, cities and counties will also cost three U.S. drug distributors a combined $21 billion, according to The Washington Post.

J&J said in a press release that the settlement is designed to resolve “the vast majority of litigation-based claims” over its opioid sales.

Mentions: J&J

Merck KGaA announced last week a contract with Strides Pharma’s Nairobi subsidiary Universal to manufacture the German multinational’s new pediatric schistosomiasis formulation, arpraziquantel.

Undergoing Phase 3 trials in Kenya and Côte d’Ivoire, the candidate is orally dispersible and more child-friendly than praziquantel, its precursor and the current standard of care, according to the press release.

Merck KGaA said the…

British diagnostics developer Mologic announced Monday that it plans to transform from a for-profit company into a social enterprise through an acquisition worth at least $41 million. The Soros Economic Development Fund is leading the takeover with support from the Gates Foundation, according to Mologic’s press release.

Under a new name—Global Access Health—the firm aims to expand affordable access to medical technology in LMICs,…

Regeneron will invest $1.8 billion over six years to expand its existing Westchester County, New York campus—boosting its research, preclinical manufacturing and support facilities at the site, the state’s governor announced last week. The project is expected to be completed in 2027, according to the press release.

Mentions: Regeneron