According to a statement from the pharmaceutical company to the stock exchanges, the Import Alert implies that all future shipments of products manufactured at this facility are subject to refusal of admission to the US market until the facility becomes compliant with CGMP standards.

New Delhi [India], July 19 (ANI): Faced with rising prices of active pharmaceutical ingredients (APIs), and other key inputs coupled with a rise in freight and energy costs, the operating profitability of Indian pharmaceutical companies is expected to decline by 200-250 basis points (or 2.5 percentage points) in the financial year 2022-23, said a rating agency report.

The United States has given a nod to Pfizer and Moderna coronavirus vaccines for children as young as 6 months. The US FDA granted emergency authorization for the use of Pfizer and Moderna jabs in the youngest children. This age group is the final age group that was awaiting immunization against the deadly COVID-19. This implies […]

Mumbai (Maharashtra) [India], May 16 (ANI/NewsVoir): SkinGenious is on a mission to help Mumbai residents find the best skin specialists in Mumbai. As part of this quest, they have started an initiative to promote transparency and patient education about skin and hair treatments.

Ahmedabad (Gujarat) [India], March 15 (ANI): Zydus Lifesciences Ltd. has received final approval from the United States Food and Drug Administration (USFDA) to market Colestipol Hydrochloride Tablets in the strength of 1mg (US RLD: Colestid), said the pharmaceutical company on Monday.

A patient’s failing heart was replaced with the heart of a genetically engineered pig, known as the process of xenotransplantation, in a groundbreaking operation at the University of Maryland Medical Centre in Baltimore, United States. But he died two months later on Tuesday (March 8). On January 10, the successful transplantation procedure was in news, […]

New Delhi [India], March 9 (ANI): Zydus Lifesciences Ltd. has received final approval from the United States Food and Drug Administration (USFDA) to market Nitroglycerin Sublingual tablets used to relieve chest pain in people who have certain heart conditions, said the pharmaceutical company on Wednesday.

New Delhi Feb 19 PTI Bharat Biotech on Saturday said its Covaxin will be evaluated as a COVID-19 vaccine candidate in the US In a statement Ocugen Inc Bharat Biotechs partner in the US and Canada for Covaxin noted that the American health regulator -- the US Food and Drug Administration FDA -- has lifted its clinical hold to evaluate the COVID-19 vaccine candidate BBV152 known as Covaxin outside the US Covaxin BBVI52 which has been developed by Bharat Biotech in collaboration with the Indian Council of Medical Research ICMR is an investigational vaccine candidate product in the US Ocugen Inc is co-developing the Covaxin vaccine candidate for COVID-19 in the US and Canada We are pleased to be able to move our clinical program for Covaxin forward which we hope will bring us closer to offering an alternative COVID-19 vaccine Ocugen CEO and co-founder Shankar Musunuri said in a statement He further said We firmly believe that managing this pandemic requires more than one approach to vaccines so we are heartened to be able to continue developing our vaccine candidate With more than 200 million doses having been administered to adults outside the US Covaxin is currently authorised under emergency use in 20 countries Applications for emergency use authorisation are pending in more than 60 other countries The World Health Organisation WHO recently added Covaxin to its list of vaccines authorised for emergency use As many as 110 countries have agreed to mutual recognition of COVID-19 vaccination certificates with India that includes vaccination using Covaxin In a separate statement on Twitter Bharat Biotech noted that Covaxin is the only vaccine in India to have published clinical data for children 2-18 years of age while trashing few media reports which questioned the efficacy of the jab These trials were conducted based on regulatory approvals by the CDSCO and DCGI it said The vaccine was evaluated in 175 subjects in the 12-18 years age group and 350 subjects in children below 12 years of age it added It was one of the few vaccines to be evaluated in children with published data Overall Covaxin has more than 15 publications elucidating all aspects of the safety immunogenicity efficacy and effectiveness in adults and children This level of data transparency demonstrates a high degree of confidence in the product the company stated Every batch of Covaxin requires more than 250 quality control tests before it can be released for supplies it added The vaccine has been administered in more than 300 million subjects globally Bharat Biotech stated Since the start of the childrens vaccination program on January 3 2022 70 per cent of the children in the 15-18 years age group have received the first dose and more than 25 per cent of the children in the 15-18 years age group have also received their second doses it said Over 7 crore doses have been administered to children since January 2022 it added PTI MSS ABM ABM

A one-of-a-kind anti-viral COVID-19 pill, Molnupiravir was cleared in India for treating adults with coronavirus. Additionally, it is also approved for people “who have a high risk of progression of the diseases”. Read to know all about the COVID-19 pill. What is Molnupiravir? How does it work? Molnupiravir (MK-4482, EIDD-2801), initially made for treating influenza […]

New Delhi Dec 17 PTI Drug firm AstraZeneca on Friday said that a preclinical study has concluded that its antibody combination Evusheld for the prevention of coronavirus infection has been found to have retained neutralising activity against the Omicron variant The study was done independently by investigators at the US Food and Drug Administration USFDA Center for Biologics Evaluation and Research The work was supported by US government research funds Evusheld tixagevimab co-packaged with cilgavimab is a long-acting antibody combination for the prevention of COVID-19 In the study Evushelds Inhibitory Concentration 50 IC50 a measure of neutralising potency of an antibody was 171 ngml and 277 ngml in two confirmatory tests which is within the range of neutralising titres found in someone who has been previously infected with COVID-19 This study shows Evusheld retains neutralisation activity against the Omicron variant By combining two potent antibodies with different and complementary activities against the virus Evusheld was designed to evade potential resistance with the emergence of new SARS-CoV-2 variants Mene Pangalos Executive Vice President BioPharmaceuticals RD AstraZeneca said in a statement Evusheld is the first long-acting antibody to receive emergency use authorisation in the US for pre-exposure prophylaxis of COVID-19 in addition to authorisations in other countries and the drug firm is now working with regulators on applications for the use of Evusheld in treating COVID-19 he added The Omicron variant was not in circulation during the Evusheld clinical trials The company is continuing to collect further data to better understand the implications of this observation in clinical practice Additional analyses to evaluate Evusheld against the Omicron variant are being conducted by AstraZeneca and third-party laboratories with data anticipated very soon the drug maker notedPTI MSS ANS ANS