drugs

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.   Approved or authorized vaccines

New, six-month Pfizer/BioNTech vaccine…

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 an $830 million deal between the two on general…

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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).

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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 protein Covid-19 vaccine candidate, which uses a GSK adjuvant. Sanofi also expects real…

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 effectively responding to therapy. A company press…

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, GSK, J&J’s Janssen subsidiary, KNCV…

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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 agreement will build up “extensive production capacities…

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.

The state of the fight: 

Gavi inked a 550-million-dose supply deal with China’s CNBG and Sinovac.
  Bharat Biotech applied for WHO Emergency Use Listing of its inactivated vaccine.
  Cuba authorized BioFarmaCuba’s Abdala vaccine.

 

Approved or authorized vaccines

The U.S. FDA granted Priority Review to Pfizer/BioNTech’s Comirnaty vaccine in the companies’ bid for full licensure, the companies announced Friday.
 
While the press release noted a…

J&J last week launched a research center hosted at the London School of Hygiene & Tropical Medicine (LSHTM) that will focus on antimicrobial resistance (AMR) and next-generation TB drug regimens. The J&J Satellite Center for Global Health Discovery at LSHTM marks the first in a planned series of academic research centers, according to a company press release.

Each center will partner with academic institutions to focus on threats with high unmet need, including AMR,…

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