More than 200 million Pfizer doses have been administered in the US, and hundreds of millions more worldwide, since December.
Cancer has no race, so why do new innovative cancer drugs discriminate based on race and ethnic groups, asks Digonto Chatterjee.
Drug major Sun Pharma is recalling over 34,000 bottles of a generic medication, used to treat high blood pressure, in the US market due to failed dissolution testing. As per the US Food and Drug Administration's Enforcement Report, the US-based arm of Sun Pharmaceutical Industries is recalling lots of Diltiazem Hydrochloride extended-release capsules which are used to treat angina, high blood pressure and some types of irregular heartbeats.
These four patients were given blood for the treatment of Thalassemia, post which they were found infected.
With all major US export-oriented drug manufacturing plants in the country up for inspection in 2022, some estimates peg that at least 20-30 per cent of the new product launches lined up for the US will be subject to on-site inspection by the US Food and Drug Administration (USFDA). The last two years saw limited physical inspections due to travel restrictions during the pandemic. "Pre-Covid, the frequency and number of inspections of manufacturing plants in India by USFDA had increased significantly," analysts from ICICI Securities Research noted. "With growing ANDA filings, especially for complex products. "We expect this trend to return with the environment normalising," analysts from ICICI Securities Research noted.
According to The New York Times, this move means that many highly vulnerable people will begin receiving the vaccine within days. It further called the authorisation by the FDA as a 'historic turning point' as the US death toll from the Wuhan-originated virus nears 300,000.
In a setback that could potentially delay the launch of Bharat Biotech's Covid-19 vaccine Covaxin in USA, the Food and Drug Administration there has "recommended" Ocugen Inc, the US partner of the Indian vaccine maker, to go for Biologics Licence Application (BLA) route with additional data, nixing hopes of Emergency Use Authorisation.
In a joint statement, the CDC and the FDA said they were investigating clots in six women in the days after vaccination, in combination with reduced platelet count.
Mutual funds (MFs) are betting on a turnaround in the healthcare sector to boost returns but are divided on the prospects of the information technology (IT) sector amid uncertain growth outlook. At the end of June, all of the top 20 fund houses were overweight on the healthcare sector vis--vis the sector's presence in the BSE 200 index, shows a report by Motilal Oswal Financial Services (MOFS). In the case of the IT sector, only six of the 20 fund houses had overweight positions.
Pfizer can show the FDA approval to the Indian regulator and present a case that based on whatever data submitted, the US regulator has granted a full marketing nod, says Sohini Das.
Global Pharma Healthcare is recalling entire lots of eye drop linked to vision loss in the US, according to the US Food and Drug Administration. The Chennai-based company is recalling all lots of artificial tears lubricant eye drops distributed by EzriCare, LLC and Delsam Pharma to the consumer level due to possible contamination, the US health regulator said in a statement. "The Centres for Disease Control and Prevention (CDC) alerted FDA to an investigation of a multi-state cluster of Verona Integron-mediated Metallo--lactamase (VIM)- and Guiana-Extended Spectrum--Lactamase (GES)- producing carbapenem-resistant Pseudomonas aeruginosa (VIM-GES-CRPA) infections possibly associated with the use of the artificial tears manufactured by Global Pharma Healthcare," USFDA said.
Indian-American multimillionaire biotech entrepreneur Vivek Ramaswamy's popularity rating and online fundraising have surged, a day after his impressive performance at the first Republican presidential primary debate.
According to an official statement, the FDA has determined that the Moderna COVID-19 vaccine has met the statutory criteria for issuance of an emergency use authorisation (EUA).
Alonso said he had huge respect for Hamilton and had no problems with him.
The US Food and Drug Administration said on Sunday that over 70,000 patients in the country had been treated with convalescent plasma, which is made using the blood of people who have recovered from coronavirus infections.
The US health regulator has pulled up drug major Sun Pharma for manufacturing lapses, including failure to follow appropriate written procedures designed to prevent microbiological contamination of drug products, at its Gujarat-based plant. In a warning letter, the US Food and Drug Administration (USFDA) pointed out various lapses at the Halol plant which produces finished pharmaceutical products. "This warning letter summarises significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals... Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated," the USFDA stated.
Nationalist Congress Party leader Ajit Pawar was given the finance and planning portfolio on Friday, nearly two weeks after he broke away from the original party and took oath as Maharashtra's deputy chief minister.
The regulator has also cancelled the licences of three packagers providing services to Subhiksha for violating the packaging rules. The warehouses are based in Bhiwandi, which is on the outskirts of Mumbai.
Even as most of its large-cap pharmaceutical peers have struggled to stay above water on the returns front, Zydus Lifesciences has been one of the big outperformers within the sector over the past year with a return of over 30 per cent. The gains have come on the back of multiple triggers such as the scaling up of new product launches in the US market, clearance for its Moraiya (Gujarat) facility and steady performance in the domestic market. Though it has been the top pharma gainer in the 2022-23 financial year (FY23), brokerages continue to maintain their 'buy' stance, given the strong visibility in the US market.
The Food and Drug Administration said its decision is based on new information, including clinical trial data results, that have led it to conclude that the drugs may not be effective to treat COVID-19 and that its potential benefits for such use do not outweigh its known and potential risks.
He is currently on a two-day swing to the crucial State of Iowa. On January 15, Iowa would kick off the 2024 Republican presidential primary season.
The Pfizer vaccine has already been approved for the public in the United Kingdom and, Canada.
Signalling pathways are complicated chain reactions which control many important human biological processes and in which certain proteins act as messenger molecules that promote or block the signals of other proteins.
In contrast with their strong performance in 2020 and 2021, pharmaceutical and healthcare funds experienced a decline in 2022, with returns plummeting by an average 9.8 per cent. This trend has continued in the current year, with year-to-date return remaining in the negative (-4.9 per cent). In the past three months, pharma funds have been hit hard, experiencing a 7.9 per cent decline.
Trump had said that he worked on removing a large number of bureaucratic obstacles to fast-track development and approval of a vaccine.
A vacation bench of Justices NJ Jamadar and Sharmila Deshmukh passed the decision on Wednesday while hearing a petition filed by the company challenging two orders of the state government.
Former New Jersey Governor Chris Christie and a Republican presidential aspirant have called his fellow rival Indian-American Vivek Ramaswamy a guy who sounds like ChatGPT and described him as an "amateur" Barack Obama.
Cadila Healthcare Ltd has received tentative approval from the USFDA to market Pravastatin Sodium Tablets in the US market.
If the actress fails to respond to the notice within the stipulated time frame, a case could be registered against her, Food Security Officer Mahimanand Joshi said.
The previous single-day record was on May 7 at 2,769 deaths.
Ferrari are planning to add female racers to their expanding young driver programme as they seek to develop talent for the future.
Maharashtra Food and Drug Administration has prohibited the sales of 'Red Bull', an energy drink, following complaints that the product's main ingredient Taurine is an animal derivative, which the company denies saying it is derived sythetically.
Alarmed by the growing number of advertisements on 'miracle' drugs being shown on television channels, Maharashtra Food and Drug Administration
Pfizer and BioNTech SE on Monday said trial results of COVID-19 vaccine showed that it is safe and produced robust neutralising antibody response in children aged five to 11 years, and they plan to seek regulatory approvals as soon as possible.
Vice President Mike Pence said Trump had authorised a ban on entry of foreign nationals who travelled to Iran in the last 14 days. The United States also advised its citizens not to travel to parts of South Korea and Italy, from where reports of coronavirus have appeared.
Ranbaxy Laboratories has received approval from the U.S. Food and Drug Administration to manufacture and market Clarithromycin XL 1,000 mg tablets.
The Maharashtra Food and Drug Administration on Monday ordered Parle Bisleri, manufacturer of Bisleri mineral water to stop production in its two units in Mumbai with immediate effect.
The new travel advisory came in the wake of the significant improvement in Covid situation in India.
Mick Schumacher, who will face intense scrutiny as embarks on his Formula One career, said for now he was simply overwhelmed to be following in his father's footsteps and called his promotion a dream come true.
The Johnson and Johnson vaccine, which works with one dose instead of two, got approval on Saturday, the third vaccine cleared in the country after emergency use authorisation (EUA) was given to two-dose shots from Pfizer and Moderna in December last year.
