News in Numbers

96% 

The percentage of the population in low-income countries remain unvaccinated against COVID-19, as per IMF

5

The FDA amended the EUA for Pfizer/BioNTech’s Covid-19 shot to reduce the time between the completion of the initial dosing regimen and booster shot from six to five months.

290m

The number of confirmed COVID-19 cases crossed the 290 million mark in early January as per the World Health Organization

50%

Biogen is cutting the wholesale acquisition cost of its controversial Alzheimer’s disease drug Aduhelm by 50% to $28,000

5

The CDC made a controversial decision to issue a guidance that recommended an isolation period from 10 to five days after testing positive for COVID-19

Approvals

MOLNUPIRAVIR

The US FDA granted an EUA for Merck-Ridgeback’s oral Covid-19 antiviral molnupiravir based on positive results from the Phase III MOVe-OUT trial

Source: Pharmaceutical Technology

ORENCIA

Bristol Myers Squibb’s Orencia (abatacept) became the first drug approved by the FDA to prevent acute graft versus host disease (aGVHD), where the donor bone marrow or stem cells attack the graft recipient.

Source: MedPage Today

NVX-CoV2373

The Drugs Controller General of India granted an emergency use authorization (EUA) to Novavax’s Covid-19 vaccine. Serum Institute will produce and supply it as Covovax in India.

Source: Pharmaceutical Technology

REZVOGLAR

The US FDA approved Eli Lilly’s insulin glargine biosimilar Rezvoglar which references Sanofi’s Lantus. This is the second FDA approved insulin biosimilar.

Source: New York Times

TEZSPIRE

Amgen and AstraZeneca’s Tezspire (tezepelumab) got an FDA nod to treat people with asthma who are ages 12 or older as an add-on maintenance treatment.

Source: Fierce Pharma

Clinical Trials

GILEAD AND MERCK TO TRIAL TRODELVY-KEYTRUDA COMBO FOR LUNG CANCER

Gilead Sciences and Merck (MSD) have signed two clinical trial partnerships and supply agreements to assess the antibody-drug conjugate Trodelvy (sacituzumab govitecan-hziy) plus Keytruda (pembrolizumab) for first-line metastatic non-small cell lung cancer (NSCLC).

Source: ClinicalTrialsArena

PFIZER STUDY SHOWS COVID-19 BOOSTER CAN BE GIVEN ALONG WITH PNEUMONIA SHOT

Pfizer says booster doses of its COVID-19 vaccine can be administered along with its pneumonia vaccine and produced strong safety and immune responses in people aged 65 and above in a late-stage study. This is based on a study that evaluated Prevnar 20 with a third dose of the Pfizer/BioNTech Covid-19 vaccine

Source: Reuters

NOVARTIS AND MOLECULAR PARTNERS REPORT POSITIVE ANTIVIRAL TRIAL DATA

Novartis and Molecular Partners have announced positive results with the antiviral ensovibep to treat Covid-19. An overall decline of 78% in the risk of hospitalisation and/or ER visits or death was observed across all ensovibep groups versus placebo.

Source: ClinicalTrialsArena

ASTRAZENECA SAYS EARLY TRIAL DATA INDICATES THIRD DOSE HELPS AGAINST OMICRON

AstraZeneca says that preliminary data from a trial showed that its COVID-19 shot, Vaxzevria, generated an increase in antibodies against the Omicron and other variants like Delta, when given as a third booster dose.

Source: Reuters

MEDICARE WILL COVER ALZHEIMER’S DRUG ADUHELM ONLY FOR PATIENTS IN A CLINICAL TRIAL

CMS announced that it will cover Biogen’s Alzheimer‘s disease drug, which targets amyloid build-ups in the brain, only if patients are enrolled in a clinical trial. The treatment was FDA approved in June.

Source: Politico

MYRTELLE CONCLUDES PRELIMINARY STAGE OF CANAVAN DISEASE GENE THERAPY TRIAL

Three children from Cohort 1 of the first-in-human Phase I/II clinical trial of gene therapy, codeveloped by Pfizer and Myrtelle, for Canavan disease (CD) have been successfully treated. The companies signed this agreement last year.

Source: ClinicalTrialsArena