News for 'FDA'

Can Ranbaxy recover from its US debacle?

Can Ranbaxy recover from its US debacle?

Rediff.com2 Feb 2012

USFDA consent decree reveals that firm will have to forego huge short-term opportunities for its generics.

Ranbaxy Lipitor rights: Mylan challenge dismissed

Ranbaxy Lipitor rights: Mylan challenge dismissed

Rediff.com4 May 2011

Mylan had sued the United States Food and Drugs Administration for providing the exclusive right to Ranbaxy, alleging the permission was given on the basis of 'falsified data'.

Using blood banks in Maharashtra to cost more

Using blood banks in Maharashtra to cost more

Rediff.com4 Mar 2012

At present, the service charge for one unit (bag) of blood is Rs 850.

Cipla recalls asthma drugs in US

Cipla recalls asthma drugs in US

Rediff.com21 May 2015

Cipla is recalling the drug for failed impurities and degradation specifications.

Oxford vaccine doing 'everything expected': Study

Oxford vaccine doing 'everything expected': Study

Rediff.com22 Oct 2020

A team at Bristol University used recently developed techniques to validate that the vaccine accurately follows the genetic instructions programmed into it by the Oxford University team.

Oxford jabs effective against severe Covid: US trial

Oxford jabs effective against severe Covid: US trial

Rediff.com22 Mar 2021

The Oxford/AstraZeneca vaccine is also being produced as part of a tie-up by the Serum Institute of India.

How India's pharma growth story fizzled out

How India's pharma growth story fizzled out

Rediff.com5 Jul 2017

Once tipped to emerge as the biggest exporter, the pharmaceutical industry is yet to acquire the scale of those in software services, says Krishna Kant.

Indian companies not singled out for inspections: USFDA

Indian companies not singled out for inspections: USFDA

Rediff.com18 Mar 2015

A global policy would reward firms which strive for higher quality.

New hopes for Ranbaxy to grab Lipitor pie

New hopes for Ranbaxy to grab Lipitor pie

Rediff.com8 Apr 2011

Ranbaxy's hope of a windfall from the $7-billion Lipitor market in the US is shining again. The US Food and Drugs Administration (USFDA) has taken a strong stance against US-based Mylan, which had opposed FDA's decision to allow approval to Ranbaxy's generic version of Lipitor.

ICMR plans to scale-up testing capacity to 1 lakh/day

ICMR plans to scale-up testing capacity to 1 lakh/day

Rediff.com6 Apr 2020

The ICMR has approved over 200 labs (both public and private) for COVID-19 testing through-PCR machines.

Natco challenges Gilead's patent on Tamiflu

Natco challenges Gilead's patent on Tamiflu

Rediff.com9 Feb 2011

The company has sought the United States Food and Drug Administration (FDA)'s approval to market a generic version of Tamiflu (oseltamivir phosphate), said Gilead Sciences, the US company that owns the Tamiflu patent. Natco officials declined to comment on the development.

US allows 'game-changer' saliva-based Covid test

US allows 'game-changer' saliva-based Covid test

Rediff.com16 Aug 2020

The new test it will enable rapid testing amongst more people easily.

Zydus infringed Takeda's patent, rules US court

Zydus infringed Takeda's patent, rules US court

Rediff.com20 Jun 2013

Takeda had filed a case of patent infringement in response to Zydus' abbreviated new drug application.

'Ham-handed' action against Snapdeal to hurt business: Pilot

'Ham-handed' action against Snapdeal to hurt business: Pilot

Rediff.com3 May 2015

He said action was akin to holding highway builders responsible for lane violations

Indian pharma remains top in US generics

Indian pharma remains top in US generics

Rediff.com3 Jan 2011

But the newer entrants prove nimbler than the slowing pioneers.

US justices block generic drug liability lawsuits

US justices block generic drug liability lawsuits

Rediff.com25 Jun 2013

Generic drugmakers cannot be sued under state law for adverse reactions to their products.

Covid-19: How the testing infrastructure is struggling

Covid-19: How the testing infrastructure is struggling

Rediff.com25 Mar 2020

'India is too large a place to have just 10 labs performing these Covid-19 tests.'

Moderna says its COVID-19 vaccine is 94.5% effective

Moderna says its COVID-19 vaccine is 94.5% effective

Rediff.com16 Nov 2020

Cambridge, Massachusetts-based Moderna's announcement comes just a week after Pfizer and Biontech said their COVID-19 vaccine candidate was found to be more than 90 per cent effective in preventing COVID-19 in participants.

Wockhardt launches prostate drug in US market

Wockhardt launches prostate drug in US market

Rediff.com28 Apr 2010

Pharma major Wockhardt on Wednesday said it has launched Tamsulosin capsules, indicated for problem of prostate enlargement, in the US market on the day one of the expiry of patent covering the drug.

Investors concerned about Wockhardt

Investors concerned about Wockhardt

Rediff.com17 Oct 2013

The rap from both the US and UK drug regulators, including the latest one from the latter, has hit the scrip.

What the future holds for Biocon

What the future holds for Biocon

Rediff.com6 May 2018

'The obvious opportunity is biosimilars, which are simpler but more expensive,' says Kiran Mazumdar-Shaw, founder of Biocon.

Ranbaxy gets USFDA nod for generic Serzone

Ranbaxy gets USFDA nod for generic Serzone

Rediff.com28 Apr 2003

The United States Food and Drugs Administration has granted Ranbaxy Laboratories a tentative approval to market a generic form of Bristol-Myers' anti-depressant Serzone, US FDA's web site said.

Sun Pharma's US subsidiary to cut jobs

Sun Pharma's US subsidiary to cut jobs

Rediff.com30 Jul 2009

Earlier last month US FDA officials had seized drug products manufactured by Caraco Pharmaceutical at its Michigan facilities in Detroit, Farmington Hills, and Wixom, alleging violation in good manufacturing practice.

India's pharma cos can now invest more in R&D

India's pharma cos can now invest more in R&D

Rediff.com7 Jul 2009

Reduction in customs duty on certain bulk drugs used in making life saving drugs to 5% is a positive for companies having product pipeline catering to these segments.

'Made in India' dominates US AIDS scheme

'Made in India' dominates US AIDS scheme

Rediff.com16 Oct 2009

Indian drug companies have cornered an overwhelming majority of drug approvals under the US President's Emergency Plan for AIDS Relief.

Pfizer says its Covid vaccine is 95% effective in final trials

Pfizer says its Covid vaccine is 95% effective in final trials

Rediff.com18 Nov 2020

Pfizer and BioNTech said they have concluded phase 3 study of their mRNA-based COVID-19 vaccine candidate BNT162b2, meeting all primary efficacy endpoints.

US drug regulator raps Sun Pharma unit

US drug regulator raps Sun Pharma unit

Rediff.com5 Nov 2008

The US subsidiary of Sun Pharmaceuticals, Caraco Pharmaceutical Laboratories, has received a warning letter from the Food and Drug Administration.

Ranbaxy forged data, says US drug regulator

Ranbaxy forged data, says US drug regulator

Rediff.com26 Feb 2009

India's largest drug manufacturer, Ranbaxy Laboratories, had falsified data and test results of medicines manufactured at its Himachal Pradesh facility to obtain marketing approval in the United States, says the US Food and Drug Administration.

Wockhardt's Shendra unit set for key US test

Wockhardt's Shendra unit set for key US test

Rediff.com7 Jan 2014

If the company manages to get a go-ahead from the regulator for this plant, it might result in resumption of supplies of several of their products, barred from the US last year.

Parkinson's medicine in patent tangle

Parkinson's medicine in patent tangle

Rediff.com4 Nov 2008

Drug major Wockhardt has challenged the US patent of Stalevo, a new generation combination drug for the treatment of Parkinson's disease, originated by Finland-based Orion Corporation and marketed by Novartis.

Indian pharma companies bullish in the US

Indian pharma companies bullish in the US

Rediff.com6 Mar 2009

Despite the ongoing trouble India's largest drug maker, Ranbaxy, is facing in the United States, domestic pharmaceutical companies are betting high on the world's largest drug market with added vigour.

US drops legal action against Ranbaxy

US drops legal action against Ranbaxy

Rediff.com10 Oct 2008

Ranbaxy's shares jumped almost 10 per cent, having long been depressed by escalating investigations from the US Food and Drug Administration, triggering a ban, which is still in place, that stops the US importing or purchasing the company's drugs. Daiichi Sankyo, the Japanese drugmaker, reiterated on Wednesday that it would stick to its June offer to buy Ranbaxy in spite of its recent troubles.

Maharashtra government bans Maggi

Maharashtra government bans Maggi

Rediff.com6 Jun 2015

Maharashtra government on Friday decided to put a ban on Maggi noodles after some samples were found to contain lead above the permissible limit.

Issues with USFDA to take long to resolve: Ranbaxy

Issues with USFDA to take long to resolve: Ranbaxy

Rediff.com9 Nov 2009

Last year, the USFDA had banned 30 generic drugs produced at Ranbaxy's plants at Poanta Sahib.

'Ranbaxy got USFDA nod with no data or fraudulent data'

'Ranbaxy got USFDA nod with no data or fraudulent data'

Rediff.com7 Nov 2013

In May this year, Ranbaxy had pleaded guilty to 'felony charges' for violating manufacturing norms and agreed to pay $500 million penalty to US authorities.

Why heating food in microwave is bad for your health

Why heating food in microwave is bad for your health

Rediff.com12 May 2018

Heating plastic containers in the microwave releases chemicals that can cause cancer, obesity and infertility.

Pharma sector can be a good bet

Pharma sector can be a good bet

Rediff.com17 Nov 2015

Analysts say those taking exposure through stocks could look at firms focused on domestic business

Does US face agricultural terrorism?

Does US face agricultural terrorism?

Rediff.com10 Mar 2008

US experts were pondering on the safety of food imported into US from developing countries. In lieu of this thought process, a new trend has emerged in America of preferring locally produced food. This trend is affecting Wal Mart and Whole Foods too. It has been observed that when food travels far, the local community are the least benefitted out of the exports. But the trend to grow more locally will seriously affect nations that depend largely on agricultural exports.

Now, Pfizer, Novartis, GSK under USFDA scanner

Now, Pfizer, Novartis, GSK under USFDA scanner

Rediff.com19 Jul 2008

Amid reports of a US Congress probe against India's largest drug maker Ranbaxy Laboratories, data show that many leading multinational companies such as Pfizer, GlaxoSmithKline, Novartis and Merck are also under the scanner of the US drug regulator, for more or less similar violations as Ranbaxy is alleged to have committed.

GSK withdraws sale of Zinetac after health alert

GSK withdraws sale of Zinetac after health alert

Rediff.com26 Sep 2019

GSK is continuing with investigations into the potential source of the NDMA, which is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.