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.
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.
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.
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.
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).
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.
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 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.
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.
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.
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.
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.
Trump had said that he worked on removing a large number of bureaucratic obstacles to fast-track development and approval of a vaccine.
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.
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.
Cadila Healthcare Ltd has received tentative approval from the USFDA to market Pravastatin Sodium Tablets in the US market.
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.
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.
Ferrari are planning to add female racers to their expanding young driver programme as they seek to develop talent for the future.
The previous single-day record was on May 7 at 2,769 deaths.
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.
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.
Alarmed by the growing number of advertisements on 'miracle' drugs being shown on television channels, Maharashtra Food and Drug Administration
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.
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.
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.
The new travel advisory came in the wake of the significant improvement in Covid situation in India.
The US will lift all restrictions for fully vaccinated international travellers, including from India, from November 8 but they will have to show proof of a negative coronavirus test before boarding a flight to the country, the White House has announced.
Pfizer Inc and its group companies filed a petition in a US court against Aurobindo Pharma Ltd and Dr Reddy's Laboratories alleging that the Indian drug-makers were planning separately to come out with generic versions of its blockbuster multi-billion dollar drug Ibrance (palbociclib) before expiration of its patent.
The drug controlling authority in Chhattisgarh on Thursday raided and sealed a unit of an antibiotic manufacturing company, whose product was used in sterilisation camps in Bilaspur district where 13 women died and several others fell ill.
USFDA issues Form 483 with as many as 14 observations that could impact ongoing operations at Aurobindo's Pashamailaram facility in Hyderabad.
Pharma major Ranbaxy Laboratories Ltd on Friday said it has received tentative approval from the US Food and Drug Administration to manufacture and market 25 mg, 100 mg and 200 mg Topiramate tablets.
The company has launched only 3 new products during 2015 when compared to 14 launches in 2014
Ranbaxy Laboratories has received tentative approval from the US Food and Drug Administration to manufacture and market Fosinopril Sodium and Hydrochlorothiazide tablets in 10 mg/12.5 mg and 20 mg/12.5 mg strengths
