Tablet Manufactured – Tenil http://www.tenil.net/ Sun, 16 Jan 2022 05:19:54 +0000 en-US hourly 1 https://wordpress.org/?v=5.8 https://www.tenil.net/wp-content/uploads/2021/05/tenil-icon-150x150.png Tablet Manufactured – Tenil http://www.tenil.net/ 32 32 Sun Pharma and Lupine recall products in the US market https://www.tenil.net/sun-pharma-and-lupine-recall-products-in-the-us-market/ Sun, 16 Jan 2022 05:19:54 +0000 https://www.tenil.net/sun-pharma-and-lupine-recall-products-in-the-us-market/

Major drugmakers Sun Pharma and Lupin are recalling products in the United States, the world’s largest drug market, for different reasons. According to the latest US Food and Drug Administration (USFDA) law enforcement report, Sun Pharma is recalling 696 bottles of pregabalin capsules (50mg), used for the treatment of epilepsy, anxiety and nerve pain, in the US market. According to the US health regulator, the Mumbai-based major pharmaceutical company is recalling the affected lot due to “tablet/capsule specification failure: out-of-specification results for particle size distribution and bulk density of the active pharmaceutical ingredient”. New Jersey-based Sun Pharmaceutical Industries Inc, a unit of the company, initiated the nationwide (US) Class II recall of the affected lot on October 22 last year. According to the USFDA, a Class II recall is initiated in a situation where use of or exposure to an offending product may result in temporary or medically reversible adverse health consequences or when the likelihood of serious adverse health consequences health is low. Lupine, meanwhile, is recalling 50,832 bottles of gatifloxacin ophthalmic solution, an antibiotic used to treat bacterial eye infections. According to the USFDA, the company’s U.S.-based unit is recalling the affected lot due to “out of specification stability: out-of-specification results observed in a water loss test that may affect assay contents.” and change the concentration of the drug”. the affected batch was manufactured at the Lupin factory in Pithampur, Madhya Pradesh. The batch was distributed in the United States by Baltimore-based Lupine Pharmaceuticals Inc, according to the report. The drugmaker launched a voluntary Class III recall in the United States and Puerto Rico on December 22 last year. Lupine is also recalling 23,965 bottles of oxycodone hydrochloride tablets, used for the treatment of moderate to severe pain. According to the USFDA, the company is recalling the lot due to an “out-of-specification impurity test result observed at an 18-month long-term stability time point.” The company’s US subsidiary launched a Class III recall on December 29. year. A Class III recall is initiated in a “situation in which use of or exposure to an infringing product is not likely to cause adverse health consequences”. The US generic drug market was estimated at around $115.2 billion in 2019. It is the largest market for pharmaceuticals.

(This story has not been edited by the Devdiscourse team and is auto-generated from a syndicated feed.)

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Anti-vax doctor claims to have found ‘strange object’ in Covid-19 recipient https://www.tenil.net/anti-vax-doctor-claims-to-have-found-strange-object-in-covid-19-recipient/ Fri, 14 Jan 2022 03:19:44 +0000 https://www.tenil.net/anti-vax-doctor-claims-to-have-found-strange-object-in-covid-19-recipient/

A doctor on Thursday called for a halt to vaccination against Covid-19, claiming to have found a “strange object” in a person inoculated with the Moderna vaccine.

Earlier, the same doctor claimed to have found an “unidentified organism” in Covid-19 vaccines. Lee Young-mi, an obstetrician-gynecologist who made such claims, also revealed that she was being sued by the Central Ethics Committee of the Korean Medical Association.

Lee Young-mi, an obstetrician-gynecologist in a white coat, speaks at a press conference in Seoul on Thursday.

At a press conference held Thursday by the Corona Truth-finding Medical Society in Seoul, Lee said she also found questionable floating material while analyzing the object in a person vaccinated against Covid-19.

“A victim who had suffered general paralysis after receiving a Moderna jab reported finding a discharged ‘strange object’ with air bubbles in the water,” Lee said. “The victim retained the foreign object which was discharged from the body using duct tape and wrapping paper from October to December 15 and submitted it to the Corona Truth-finding Medical Society for investigation.”

Lee went on to say that she used a microsurgical tool to separate the object from the tape and paper and cultured it using physiological saline solution.

“I found ‘floating stuff’ through microscopic examination,” she says.

Another doctor who attended the press conference said Pfizer’s Covid-19 treatment pill, Paxlovid, contained a “microchip” and patients should not take it.

Jeon Gi-yeop, an internal medicine specialist and member of the society, pointed out that the government had told people to “swallow, not chew, Paxlovid”.

“It’s because there’s a chance that the oral medication will contain a microchip,” he said. “So people shouldn’t be taking government-provided Covid-19 treatment.”

However, these claims have no scientific evidence.

The Paxlovid dosage guidelines state that Paxlovid should be swallowed and not chewed as the drug has been manufactured in a tablet form considering the concentration of the drug absorbed by the human body.

It is important to strictly adhere to dosage guidelines to avoid over-absorption of the drug.

Lee Hyuk-min, professor of laboratory medicine at Severance Hospital, said antiviral drugs should be taken according to expert advice in an interview with YTN.

“These drugs should not be chewed,” he said.

If a patient bites and chews the tablet, the medicine may be absorbed too quickly, which can cause problems. “That’s why you shouldn’t chew Paxlovid when you take it.”

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Novartis CEO: We are moving towards filing Covid drugs with molecular partners with the FDA https://www.tenil.net/novartis-ceo-we-are-moving-towards-filing-covid-drugs-with-molecular-partners-with-the-fda/ Wed, 12 Jan 2022 17:31:04 +0000 https://www.tenil.net/novartis-ceo-we-are-moving-towards-filing-covid-drugs-with-molecular-partners-with-the-fda/ Below is the unofficial transcript of an exclusive CNBC interview with Novartis (NYSE:NVS) CEO Dr. Vas Narasimhan on CNBC’s “Squawk on the Street” (MF 9AM – 11AM ET) today. , Wednesday 12 Januaryand. Here is a link to the video on CNBC.com:

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Novartis CEO: We are moving towards filing Covid drugs with molecular partners with the FDA

CARL QUINTANILLA: Day three of the JPMorgan Healthcare conference. Meg Tirrell joins us with a special guest. Hi Meg.

MEG TIRRELL: Hi Carl. Joining us now is Dr. Vas Narasimhan, CEO of Novartis. Come on, it’s great to see you. Thanks to be here. You know, I want to start with the news you had this week about a potential COVID drug that you licensed from Molecular Partners. The data looks really good, somewhat similar to antibody drugs. How quickly do you think this might be able to go through regulators and get to patients?

DR. VAS NARASIMHAN: Yes, thank you Meg. Great to be here as always with you. This drug ensovibep is quite exciting. It’s a new technology called DARPin. It is an engineered anchor and repeat protein that can target the COVID spike protein to three different locations. And what that allows this drug to do in all the in vitro tests that we’ve done so far is be able to neutralize all the COVID virus strains of concern quite consistently. Now, this is the first data we have clinically showing that the drug is able to reduce viral load, speed up recovery time and reduce hospitalizations and deaths by 79%. So right now, we’re moving towards filing with the FDA for emergency use authorization. Our goal is to increase manufacturing to start having supplies in the first half of this year with more scale for the second half of this year. And the real vision here is to have a drug that can be used, hopefully, regardless of the strain of COVID that might mutate in the future.

TIRRELL: And I understand that because of the way this drug is made, you might be able to make it faster in larger quantities, what kinds of doses do you expect in terms of the number of courses that might be available?

NARASIMHAN: You know, it’s a unique manufacturing process compared to antibodies. So rather than using mammalian cells, it uses bacterial production which allows us to increase the production of bacterial cells, which allows us to scale production faster to much larger volumes, also has higher yields. I think it’s too early to say exactly how much we could produce this year but we certainly think we’ll be in the millions of doses and over a million doses and really now the question is how fast can we tell us that. Again, assuming we get regulatory approvals and any other necessary support from the US government as well as other governments, but we’re certainly doing everything we can to ramp up manufacturing as quickly as possible.

TIRRELL: And I understand Novartis is also working on an oral pan-coronavirus drug, which may be in clinical trials this year. Just tell us how you view COVID and what solutions will be needed for the future? It doesn’t sound like you think this is something we’re going to get over soon.

NARASIMHAN: Well, we have certainly learned that pandemics are likely to be with us in one form or another and certainly coronaviruses. And the idea here is that one of the critical proteins for a coronavirus that is independent of the type of coronavirus is called the main protease and our hope is that by designing a drug for this main protease inhibitor it would be effective regardless the strain of coronavirus that may come in the future. So whether it’s SARS, MERS, COVID, anything else down the line, we’ve been working on this for about 18 months. We have identified a development candidate. We’re working now to bring that into the clinic and then hopefully we’ll have data over the next year, years, I would say, to really get something out of it, but it would give us an option to future pandemics. And I think with the first ensovibep drug like this, we’re trying to take a longer-term view to bring solutions to the world.

TIRRELL: Well, a longer term view is something that I think a lot of people would appreciate, especially as we see what’s happening with testing right now. I also want to ask you about some other news of the day, namely the Centers for Medicare & Medicaid Services coverage decision on amyloid antibody drugs for Alzheimer’s disease. You know, I wanted to ask you about this because you and I talked after Biogen got this fast-track approval in June and you noted, okay, there’s this pathway, maybe for drugs in neurology and maybe that’s something everyone in the industry should be looking at. Does CMS’s strict coverage decision change the opportunity you think you’ve seen from the FDA in neurology?

NARASIMHAN: Well, I think we have a unique set of circumstances here, which people who have been in the industry for a long time certainly haven’t really seen before, where you have a set of trials that weren’t always going in the same direction and some data a little difficult to interpret. I think what this indicates is that even in neuroscience we need strong studies that demonstrate not only a biomarker benefit but also a clinical benefit for patients, for payers to want to cover, cover a medication. I think it also highlights the challenge we face that there are times when the regulator has one point of view and then the reimbursement bodies have a different point of view. This is a problem we have faced in Europe for many years. In general, we would be in favor of regulators and reimbursement bodies trying to align their views. I think that’s a pretty unique circumstance in terms of data and of course now CMS output.

TIRRELL: All right, Go, we have to leave it at that. But we’d love to see you again because there’s a lot more to talk about with Sandoz, the proceeds of your Roche stake sale, so much more Vas, thanks for being with us.

NARASIMHAN: Thank you Meg.

Updated

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iPad Pro 2022 – first rumors and what we want to see https://www.tenil.net/ipad-pro-2022-first-rumors-and-what-we-want-to-see/ Mon, 10 Jan 2022 17:30:36 +0000 https://www.tenil.net/ipad-pro-2022-first-rumors-and-what-we-want-to-see/

We expect there will be a 2022 iPad Pro, given that Apple has revised its premium tablet every year since its introduction (excluding 2019). With last year’s iPad Pro being one of the most important updates of all time, we’re excited to see what Apple has in store this year.

Rumors are currently rare. However, with the likely launch date fast approaching, we hope to hear more about the new iPad Pro in the near future.