FDA approves Gilead’s Veklury for Covid-19 in paediatric patients


The US Food and Drug Administration (FDA) has granted approval to Gilead Sciences’ supplemental new drug application (sNDA) for Veklury (remdesivir) to treat paediatric Covid-19 patients aged over 28 days. Previously, Veklury obtained sNDA approval to treat adult and adolescent patients in the non-hospitalised setting. The approval is based on findings from the open-label, single-arm Phase II/III CARAVAN clinical trial of Veklury. Results from CARAVAN showed that Veklury was well-tolerated in hospitalised Covid-19 paediatric patients while an increased proportion of subjects demonstrated clinical improvement and recovery. A three-day treatment course of Veklury is advised for paediatric patients in the non-hospital setting under the latest expanded indication.


Pfizer to recall batches of Accupril due to presence of nirtrosamine

Pfizer has announced plans to voluntarily recall five batches of its hypertension treatment, Accupril (Quinapril HCl) tablets, after finding increased levels of a nitrosamine, N-nitroso-quinapril. The move comes after the levels of N-nitroso-quinapril were found to be above the Acceptable Daily Intake (ADI) level in recent testing. Nitrosamines could raise the risk of cancer if individuals are exposed to them over the suitable levels for a longer duration. Nitrosamines could raise the risk of cancer if individuals are exposed to them over the suitable levels for a longer duration. Pfizer noted that the hypertension therapy has a safety profile that is established over three decades.

11 May | DEALS

Pfizer to acquire Biohaven Pharmaceutical for $11.6bn in cash 

Pfizer has signed a definitive agreement for the acquisition of all outstanding shares of Biohaven Pharmaceutical in a deal totalling nearly $11.6bn, or for $148.50 for each share in cash. A commercial-stage biopharmaceutical firm, Biohaven has a portfolio of therapies for debilitating neurological and neuropsychiatric ailments. The Neuroinnovation portfolio of the company comprises FDA-approved dual-acting therapy, NURTEC ODT (rimegepant), indicated for use in adults for acute treatment and episodic prevention of migraine. According to the deal, Pfizer will acquire CGRP programmes of Biohaven, including rimegepant, zavegepant and five pre-clinical assets. The acquisition was unanimously approved by the boards of directors of Pfizer and Biohaven.

29 April | COVID-19

API enters partnership to develop antivirals for SARS-CoV-2 variants

Applied Pharmaceutical Innovation (API) has entered a collaboration with the University of Saskatchewan, Canada, for the discovery and development of new antivirals against emerging variants of the SARS-CoV-2 virus. Under the partnership, a high-throughput drug screening platform will be developed to detect new therapies, as well as drug targets that demonstrate a potential to become new antivirals for all rampant and emerging coronavirus variants. This system will boost capacity for the number of compounds that are screened daily and aid in the detection of lead compounds by leveraging genetic and compound library screening. 

5 May | COVID-19

Novavax seeks expanded authorisation for Covid-19 vaccine in Great Britain

Novavax has sought expansion of the authorisation from the Medicines and Healthcare products Regulatory Agency (MHRA) for its Covid-19 vaccine, Nuvaxovid (NVX-CoV2373), for use in adolescents of the age 12 to 17 years in Great Britain. In February this year, the vaccine obtained conditional marketing authorization (CMA) from MHRA for use in people aged 18 years and above. The vaccine is administered in two doses at a gap of 21 days as the initial vaccination regimen.  

This CMA expansion request is based on the entirety of pre-clinical, clinical and manufacturing-related (CMC) data submitted to the regulatory authority.  

6 May | COVID-19

FDA limits usage of Janssen’s Covid-19 vaccine in adults 

The US FDA has limited the authorised use of the Janssen’s Covid-19 vaccine to people aged 18 years and above. With the US COVID-19 Vaccine Fact Sheet update, the vaccine is intended for use in people for whom no other authorised or approved Covid-19 vaccines are available or clinically appropriate.The latest move comes after the regulatory agency carried out an updated assessment and evaluation of cases reported and concluded that the thrombosis risk with thrombocytopenia syndrome (TTS) warrants limited usage of the shot. TTS causes rare blood clots along with reduced blood platelet levels.

In Brief

Gilead reports 3% revenue growth in Q1 2022

Gilead Sciences has reported a 3% rise in revenue to $6.6bn in the first quarter (Q1) of 2022 as against $6.4bn in the year-ago quarter. The revenue growth was attributed to the improved demand for Biktarvy and Veklury (remdesivir).  This was partially offset by the impact of Truvada’s loss of exclusivity in the US and adverse pricing dynamics for hepatitis C virus (HCV) therapies. 

Orion and Jemincare sign deal to develop non-opioid drug for pain

Orion Corporation has signed an agreement to obtain exclusive international development and marketing rights for Chinese Jemincare’s non-opioid drug, JMKX000623, to treat acute and chronic pain. The commercialisation rights exclude the Greater China region. JMKX000623 is a selective inhibitor of NaV 1.8, a key sodium channel subtype that regulates the pain fibres’ excitability.

Janssen ends vaccine development partnership with Bavarian Nordic

The Janssen Pharmaceutical Companies of Johnson & Johnson has discontinued the partnership and licence agreements with Bavarian Nordic for developing vaccines against the hepatitis B virus and human papillomaviruses (HPV). The partnership intended to use Modified Vaccinia Ankara – Bavarian Nordic (MVA-BN) technology of Bavarian Nordic to develop the vaccines.

Advanz Pharma to acquire Intercept’s subsidiaries and operations

Advanz Pharma has entered an agreement for the acquisition of the majority of subsidiaries and operations of Intercept Pharmaceuticals in Canada, Europe and all other markets that are outside of the US. With the takeover, Advanz will also gain the ex-US rights to market Intercept’s Ocaliva (obeticholic acid) to treat primary biliary cholangitis (PBC).

Novavax seeks CMA expansion for Covid-19 vaccine in EU for adolescents

Novavax has sought an expansion for the conditional marketing authorization (CMA) from the European Commission (EC) for its recombinant, adjuvanted Covid-19 vaccine, Nuvaxovid (NVX-CoV2373), for use in adolescents of the age 12 to 17 years. In December last year, the vaccine obtained CMA from the EC for active immunisation to prevent Covid-19 in people aged 18 years and above.

8 April | DEALS

FDA extends review period for Pfizer-Myovant’s sNDA for Myfembree 

The FDA has extended the review period for Pfizer and Myovant Sciences’ supplemental New Drug Application (sNDA) for Myfembree to manage moderate to severe pain linked to endometriosis. Myfembree comprises 40mg relugolix, 1mg estradiol and 0.5mg norethindrone acetate. The regulatory agency needs additional time for reviewing further data on bone mineral density. Relugolix lowers the amount of oestrogen and other hormones produced by ovaries, estradiol is an oestrogen that could cut down bone loss risk and norethindrone acetate is a progestin needed when women with a uterus take oestrogen. With the latest development, the FDA has set an extended Prescription Drug User Fee Act (PDUFA) goal date of 6 August this year. 

3 February | Regulatory


The FDA has granted orphan drug designation to Inhibrx’s INBRX-101 to treat alpha-1 antitrypsin deficiency (AATD).

INBRX-101 is a recombinant human AAT-Fc fusion protein.

It can safely attain and preserve AAT levels observed in healthy people with a favourable safety profile and the possibility of dosing once a month.

In brief

ICR researchers find drug combination to treat brain cancer in children

Researchers from the Institute of Cancer Research, UK, have identified a new combination of two approved cancer drugs that can be used to treat children suffering from incurable brain cancer.

Ocugen seeks FDA EUA for Covid-19 vaccine use in children

Ocugen has sought EUA from the US FDA for its Covid-19 vaccine candidate, BBV152, for use in children in the age group of two to 18 years.

Developed by Ocugen’s partner, India-based Bharat Biotech, and the Indian Council of Medical Research – National Institute of Virology, the whole-virion, inactivated vaccine is called Covaxin.

FDA declines to grant EUA for NRx’s Zyesami to treat Covid-19 patients

The US FDA has declined to grant an EUA for NRx Pharmaceuticals’ therapy, Zyesami (aviptadil), to treat critical Covid-19 patients who have respiratory failure.

In a letter to the company, the agency noted that its decision comes due to inadequate evidence on the known and possible benefits of the treatment and its risks in critical Covid-19 patients with respiratory failure.

Novartis and Dunad sign deal to develop protein degrader drugs

Novartis and UK-based company Dunad Therapeutics have signed a strategic partnership and licence agreement to develop oral targeted protein degrader small molecule therapies.

EMA stops rolling review of Lilly’s antibodies for Covid-19

The EMA has ended the rolling review of the marketing authorisation application for Eli Lilly Netherlands’ antibodies, bamlanivimab and etesevimab, to treat Covid-19.