Shasun got US regulatory nod for dementia | WeForNews | Latest News, Blogs Shasun got US regulatory nod for dementia – WeForNews | Latest News, Blogs
Connect with us


Shasun got US regulatory nod for dementia




Bengaluru, May 25: Indian drug-maker Strides Shasun Ltd has got approval for its Memantine Hydrochloride tablets to treat Alzheimer’s-type dementia from the US regulator,said the company.

The 5mg and 10mg Memantine Hydrochloride tablets for treating moderate to severe Alzheimer’s-type dementia has been approved by US Food & Drug Administration (USFDA).

“The US market for Memantine Hydrochloride tablets is about $60 million. The product will be manufactured at our flagship facility in Bengaluru and marketed by Strides Pharma Inc in the US at the earliest,” said the filing.

Shasun has four business verticals, viz. Regulated Markets, Emerging Markets, Institutional Business and Active Pharmaceutical Ingredients.

The company has eight manufacturing footprint plants across three continents and three R&D facilities in India.
Wefornews Bureau


Opportunity for India as Russia ready to produce Covid vax at foreign sites of partners

Putin also slammed the Western vaccines saying they were made from monkey and chimpanzee adenovirus.




COVID-19 Vaccine

New Delhi: India has a huge opportunity to be the next big hub for vaccine production after Russia announced that it will manufacture Covid-19 vaccines at foreign sites with partners.

Amir Ullah Khan, economist at MCRHRDI of the Government of Telegana, and former senior advisor for Bill and Melinda Gates Foundation, said, “As Russia is keen to work with other countries, including India, this is a huge opportunity for us to be the next big hub for vaccine production. India has played an important role with the most prominent partnership of Dr. Reddy’s lab with the Russian Development Investment Fund. The lab will conduct clinical trials and provide Sputnik V for coronavirus in India.”

Russia has recently expressed the willingness to produce vaccines at foreign sites. It is very encouraging and a huge opportunity for India which is among the largest manufacturers of generic drugs and vaccines in the world. It is home to half a dozen major vaccine makers which are developing vaccines against the virus that causes Covid-19.

“With India’s increasing experience in manufacturing vaccines and crucial role in product innovation that is affordable, the country is foreseen as a growing vaccine hub. About 60 per cent of all vaccines worldwide are manufactured in India and it can be world’s door to vaccines,” said Gajendra Singh, a public health expert.

Russian President Vladimir Putin said on Thursday that Russia is ready to produce Covid-19 vaccines at the sites of foreign partners.

“Most importantly, we are ready to agree to produce this vaccine or these vaccines at the production sites of our foreign partners. They have this equipment, and I want to emphasise this, not to the detriment of vaccination in Russia itself, since we still have to purchase or develop this equipment, we are ready to work with our foreign partners,” Putin said.

“I just want to remind you that we are generally ready to work more closely with our colleagues in science than we have done so far. We know that many European countries have already signed contracts for the supply of vaccines from the UK,” Putin said.

Putin also slammed the Western vaccines saying they were made from monkey and chimpanzee adenovirus.

“Unfortunately, our colleagues there have experienced some malfunctions, they make their vaccine based on monkey and chimpanzee adenovirus, and our specialists at the Gamaleya Institute make it based on human adenovirus in order to deliver the necessary components to the cells in the human body. And it works effectively. Thank God, without glitches,” Putin said.

Putin added that mass vaccination will start by the end of the year.

“We do not have a single serious glitch in this area. Both the vaccines by Vector and the Gamaleya Institute work effectively. The question is how to mass produce it. The vaccine has already been delivered to all the regions of Russia. I hope that we will be able to start mass vaccination at the end of the year,” Putin said.

Continue Reading


Sanofi, GSK to supply COVAX with 200 mn doses of COVID-19 vaccine

Translate Bio has established mRNA manufacturing capacity and Sanofi expects to be able to supply annual capacity of 90 to 360 million doses.



COVID-19 Vaccine

New Delhi, Oct 29 : Sanofi and GSK have signed a Statement of Intent with Gavi, the legal administrator of the COVAX Facility, a global risk-sharing mechanism for pooled procurement and equitable distribution of eventual COVID-19 vaccines.

Sanofi and GSK intend to make available 200 million doses of their adjuvanted recombinant protein-based COVID-19 vaccine, if approved by regulatory authorities and subject to contract, to the COVAX Facility.

Both Companies intend to contribute to COVAX’s ambition to ensure successful COVID-19 vaccines reach those in need, whoever they are and wherever they live, once they obtain appropriate approvals.

“To address a global health crisis of this magnitude, it takes unique partnerships. The commitment we are announcing today for the COVAX Facility can help us together stand a better chance of bringing the pandemic under control,” said Thomas Triomphe, Executive Vice President and Global Head of Sanofi Pasteur.

“This moment also reflects our long-term commitment to global health and ensures our COVID-19 vaccines are affordable and accessible to those most at risk, everywhere in the world.”

Roger Connor, President of GSK Vaccines added, “Since we started working on the development of COVID-19 vaccines, GSK has pledged to make them available to people around the world. We are proud to be working with Sanofi to make this adjuvanted recombinant protein-based vaccine available to the countries signed up to the COVAX Facility as soon as possible – this has the potential to be a significant contribution to the global fight against COVID-19.”

The COVAX Facility is part of COVAX, a global collaboration of governments, global health organisations, businesses and philanthropic organisations working to accelerate development, production, and equitable access to COVID-19 vaccines. COVAX is co-led by Gavi, the Coalition for Epidemic Preparedness Innovations (CEPI) and WHO and forms the vaccines pillar of the Access to COVID-19 Tools (ACT) Accelerator. More than 180 countries and economies have signed onto the COVAX Facility to get timely and cost-effective access to vaccines to meet the global scale of the COVID-19 pandemic.

Through the COVAX Facility’s efforts, vaccines will be distributed in participating countries through the WHO’s recently published Allocation Framework, and the WHO’s Strategic Advisory Group of Experts on Immunization (SAGE) Values Framework which has begun to frame future guidance on vaccine use. These allocation principles aim to ensure that people in all parts of the world will get access to COVID-19 vaccines once they are available.

Sanofi and GSK initiated a Phase 1/2 study on September 3 with a total of 440 subjects enrolled, and anticipate first results in early December 2020, to support the initiation of a pivotal Phase 3 study before the end of the year. If these data are sufficient for licensure application, it is planned to request regulatory approval from the first half of 2021. In parallel, the Companies are scaling up manufacturing of the antigen and adjuvant respectively.

In addition to the recombinant protein-based vaccine in collaboration with GSK, Sanofi is developing a messenger RNA vaccine in partnership with Translate Bio. With several innovative vaccine platforms currently being investigated across the industry, mRNA is considered among the most promising.

Preclinical data showed that two immunizations of the mRNA vaccine induced high neutralizing antibody levels that are comparable to the upper range of those observed in infected humans. Sanofi expects the Phase 1/2 study to start in the fourth quarter of 2020, with earliest potential approval in the second half of 2021. Translate Bio has established mRNA manufacturing capacity and Sanofi expects to be able to supply annual capacity of 90 to 360 million doses.

Continue Reading


Covid Vaccine: Infections reported among Sputnik V trial volunteers

On August 11, Russia became the first country in the world to register the vaccine against coronavirus which was named Sputnik V.




Vaccine Covid

Moscow: There have been instances of infection among volunteers of Sputnik V trials, the world’s first registered vaccine against Covid-19 virus, according to a top official of the developer of the Russian vaccine, said a media report.

This is the reason why the developer of the vaccine, the Gamaleya National Research Center for Epidemiology and Microbiology of the Russian Healthcare Ministry, is considering the possibility of disclosing the data on who among the volunteers were administered the vaccine, before summing up the results of the study, Russian news agency TASS reported on Wednesday.

Earlier, Deputy Research Director of the Gamaleya National Research Center, and Associate Member of the Russian Academy of Sciences, Denis Logunov, reported that trial participants will find out whether they received the vaccine or the placebo only after the end of tests.

The center’s director Alexander Gintsburg reported that the last group of volunteers out of the total of 40,000 may be inoculated by the end of January 2021.

“…Apparently, there are (coronavirus) infections (among the post-registration trials participants). At some point in mid-November the provisional results will be summed up, then we will find out the difference between the placebo and the test samples,” Gintsburg was quoted as saying to TASS.

In response to a question on how the results can be obtained before the end of the study if the data can be disclosed only after its completion, the director said that currently the center is thinking of introducing relevant amendments to the legislation.

The center’s director also explained that coronavirus infections among the volunteers may be related to the fact that an individual wasn’t vaccinated, that is, received the placebo.

On August 11, Russia became the first country in the world to register the vaccine against coronavirus which was named Sputnik V.

Russia faced criticism for approving a vaccine before conducting crucial phase-3 trials.

Post-registration trials of the preparation started in Moscow on September 7, with the first volunteers receiving the vaccine on September 9.

In all, 40,000 people participate in the program, 10,000 of whom will receive a placebo instead of the vaccine, TASS reported.

Earlier, the Janssen-Cilag company, the pharmaceutical division of US multinational Johnson & Johnson, temporarily suspended clinical trials in Brazil of a vaccine against Covid-19.

Before that, the Oxford Covid-19 vaccine trial was temporarily paused as one of the participants reported a suspected severe adverse reaction. The trial resumed after a safety review.

Continue Reading

Most Popular

Corona Virus (COVID-19) Live Data

COVID-19 affects different people in different ways. Most infected people will develop mild to moderate illness and recover without hospitalization.