Pharma News

The World Health Organization (WHO) has updated its patient care guidelines to include interleukin-6 receptor blockers, a class of medicines that are lifesaving in patients who are severely or critically ill with COVID-19, especially when administered alongside corticosteroids.

These were the findings from a prospective and a living network meta-analysis initiated by WHO, the largest such analysis on the drugs to date. Data from over 10 000 patients enrolled in 27 clinical trials were considered.

Amgen announced that the U.S. Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) and granted Priority Review for tezepelumab in the treatment of asthma. Tezepelumab is being developed by Amgen in collaboration with AstraZeneca.

The goal of the trial, known as HIV-CORE 0052, is to evaluate the safety, tolerability, and immunogenicity of the HIVconsvX vaccine – a mosaic vaccine targeting a broad range of HIV-1 variants, making it potentially applicable for HIV strains in any geographical region.

Thirteen healthy, HIV-negative adults, aged 18-65 and who are considered not to be at high risk of infection, will initially receive one dose of the vaccine followed by a further booster dose at four weeks.

AstraZenecas proposed acquisition of Alexion Pharmaceuticals, Inc.has achieved an important step towards completion by having cleared the European Commission review.

The clearance follows competition clearances in the United States, Japan and other countries globally, with a complete list available on astrazeneca.com. Regulatory clearance in the UK is pending and remains a requirement to complete the deal.

Merck known as MSD outside the United States and Canada, announced that the U.S. Food and Drug Administration (FDA) has approved an expanded label for KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the treatment of patients with locally advanced cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation.

Alvotech, the Iceland-based biosimilar company, announced that the first patient has been dosed in the comparative, confirmatory efficacy and safety clinical study (AVT04-GL-301) for AVT04, Alvotech‘s proposed biosimilar to the reference product Stelara®. The objective of the study is to demonstrate therapeutic equivalence between AVT04 and Stelara® in terms of safety, efficacy and immunogenicity in patients with moderate-to-severe chronic plaque psoriasis.

A connective tissue protein known to support the framework of organs also encourages immune responses that fight bacterial infections, while restraining responses that can be deadly in the condition called sepsis, a new study finds.

In the wake of the COVID-19 pandemic, and considering the enhanced production of COVID Vaccines, the Government proactively took the decision of setting up additional laboratories,to facilitate expedited testing / pre-release certification of the  vaccines.

National Pharmaceutical Pricing Authority (NPPA) allows price hikes of essential medicines like Carbamazepine, Ranitidine and ibuprofen by 50 percent. They have included 9 strengths of these medicines and allows manufacturers to increase pricing after being advised by the Standing Committee on Affordable Medicines and Health Products (SCAMHP), Niti Aayog, Government of India.