News in Numbers

10.24bn

The cumulative number of total Covid-19 vaccination doses administered globally has crossed exceeded 10.24bn

$952m

Merck reported $952m in sales for its Covid-19 antiviral molnupiravir in Q4 last year and expects to sell the treatment courses worth $5-6bn this year

70%

As per the American Cancer Society, 70% of the 10 million cancer-related deaths worldwide were in low-middle income countries

5

Novavax’s Nuvaxovid became the fifth Covid-19 vaccine authorized by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) in early February

200m

Over 200 million people are at risk of contracting a neglected infectious disease like leprosy, dengue, rabies and leishmaniasis among others, as per the Pan American Health Organization

Approvals

FLEQSUVY

Weeks after Saol Therapeutics won approval for its strawberry-flavored oral granules, Azurity Pharmaceuticals has received FDA authorization for an oral suspension aimed at the same piece of the market.

Source: Fierce Pharma

S-217622

The Japanese Prime Minister says the government would consider granting conditional early approval for the oral COVID-19 treatment being developed by Shionogi, as the firm prepares to start a late-stage global trial.

Source: Reuters

Nuvaxovid

The UK has authorised the Novavax Covid-19 vaccine for use as a two-dose primary shot in adults. It will be the UK’s fifth vaccine. Nuvaxovid, already approved by the European Medicines Agency and the World Health Organization last year, was shown in trials to be up to 90.4 per cent effective against Covid-19

Source: Financial Times

Enjaymo

Anemia caused by the autoimmune disorder cold agglutin disease now has its first approved treatment, a Sanofi drug designed to block a pathway key to the progression of this condition. The FDA gave a regulatory nod for the drug, sutimlimab, an infusion given every two weeks.

Source: MedCity News

Kimmtrak

The US FDA has approved Immunocore’s Kimmtrak (tebentafusp-tebn) a bispecific gp100 peptide-HLA-directed CD3 T cell engager, for HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma. The approval is based on results from the IMCgp100-202 study.

Source: FDA

Clinical Trials

PAREXEL AND MEDIDATA EXTEND ALLIANCE TO BOOST DECENTRALISED TRIAL DELIVERY

Medidata and clinical research organisation (CRO) Parexel have expanded their 15-year international strategic collaboration to boost the delivery of decentralised clinical trials. In June last year, Medidata unveiled a suite of technologies under its DCT Program.

Source: Clinical Trials Arena

PFIZER STARTS CLINICAL TRIAL FOR OMICRON-SPECIFIC COVID VACCINE

The study will look at how well the modified vaccine works in unvaccinated people, as well as people who are already vaccinated and boosted. The drugmakers said they aim to enroll up to 1,420 healthy adults ages 18 to 55 in the trial.

Source: NBC News

UROGEN COMMENCES PHASE III NON-MUSCLE INVASIVE BLADDER CANCER TRIAL

UroGen Pharma has commenced the Phase III ENVISION clinical trial of its investigational treatment UGN-102 (mitomycin) for intravesical solution, to treat low-grade, intermediate-risk non-muscle invasive bladder cancer (NMIBC) patients.

Source: Clinical Trials Arena

AARDVARK STARTS ENROLMENT IN THREE PHASE II TRIALS OF TAS2R AGONIST

Aardvark Therapeutics has commenced subject enrolment in three Phase II clinical trials of its oral drug ARD-101. The three trials are in obesity, in post-gastrectomy or gastric bypass surgery, and in Prader-Willi Syndrome.

Source: Clinical Trials Arena

MODERNA LAUNCHES CLINICAL TRIAL FOR HIV VACCINE THAT USES MRNA TECHNOLOGY

The biotech has teamed up with the nonprofit International AIDS Vaccine Initiative to develop the shot, which uses the same technology as Moderna's successful COVID-19 vaccine. The first participants were given doses of the vaccine Thursday.

Source: ABC News

UNIVERSITY OF MINNESOTA IVERMECTIN TRIAL NEARING COMPLETION

University of Minnesota researchers expected to finish enrollment toward the end of January in the nation's first clinical trial of ivermectin to treat COVID-19, and the study's highly anticipated results could be available around February end.

Source: Star Tribune