Biocon Limited has launched its GLP-1 peptide, liraglutide, for the treatment of diabetes and obesity in the Netherlands, as the biopharmaceutical firm positions itself as a global player in the fast-growing diabetes and obesity market currently dominated by the likes of Novo Nordisk and Eli Lilly.
The UK's medicines regulator on Thursday approved a new antibody treatment against COVID-19, which it believes will also be effective against new variants such as Omicron.
The Medicines and Healthcare Products Regulatory Agency said in its latest Yellow Card monitoring of the coronavirus vaccine programme this week that of the 18.1 million people who had the Oxford vaccine in the UK, 30 people developed blood clots and seven had died as of March 24.
The UK's medicines regulator on Friday approved the Pfizer/BioNTech coronavirus vaccine for 12 to 15 year olds.
The United Kingdom on Wednesday became the first country to approve the Pfizer/BioNTech vaccine against COVID-19, paving the way for mass vaccinations against the deadly novel coronavirus.
The warning comes after two National Health Service (NHS) workers experienced 'anaphylactoid reaction' symptoms shortly after being injected, but are now said to be recovering well.
AstraZeneca and the University of Oxford, as the trial sponsor, said that they cannot disclose further medical information but confirmed that independent investigations concluded that the trials were safe to restart.
The British-Swedish pharmaceutical major and the UK's medicines regulator said that the vaccines produced by Oxford University in collaboration with AstraZeneca to protect against COVID-19 are safe.
Adar Poonawalla said he was hopeful that Covovax, the Novavax vaccine made by SII, will be launched around October this year for adults and for children by the first quarter of next year, depending on DCGI approvals.
The rap from both the US and UK drug regulators, including the latest one from the latter, has hit the scrip.
An expert committee of the Central Drugs Standard Control Organisation (CDSCO) on Wednesday sought additional safety and efficacy data for COVID-19 vaccine candidates of Serum Institute and Bharat Biotech, after deliberating upon their applications seeking emergency use authorisation for the shots, official sources said.
The crackdown also targeted 10,603 websites, leading them to be closed down or suspended through having their domain name or payment facilities removed.
'Once DCGI will give us the permission to restart the trials in India, we will resume the trials,' Serum Institute of India (SII) said in a statement.
The UK's National Health Service was already lining up thousands of medics and volunteers to be ready to deliver jabs up and down the country.
In 2009, Ranbaxy had to recall about 4,000 cartons of Sotret Isotretinoin through its US-based subsidiary.
According to the chairman, there will be an annual loss of Rs 100 crore due to the MHRA alert on Waluj plant
Its Waluj manufacturing facility in Maharashtra failed to meet the good manufacturing norms prescribed by the UK drug regulator.
As for Bharat Biotech, the Subject Expert Committee (SEC) on COVID-19 of the CDSCO asked the firm to expedite volunteer recruitment for the ongoing clinical trial and said it may conduct interim efficacy analysis for further consideration of restricted emergency use approval for its vaccine Covaxin, they stated.
Indian drug firms get a shot in the arm in the $12 bn Australian drug market as the Therapeutic Goods Administration (TGA), Australia agrees to accelerate the drug approval process in that country for Indian players who already have an approved plant and product from one of the stringent regulatory authorities like US, EU or Canada. From current sales of $340 mn, the Indian firms can see a significant upside in sales; felt Dinesh Dua, former chairman of the Pharmaceutical Exports Promotion Council of India (Pharmexcil), and the MD of Nectar Lifesciences. He highlighted that only 12 percent of the Australian drug market is generic, as against 80-90 per cent in the US or EU. Of this $1.5 bn generic drug market in India, Indian companies have a small share.
The central government is importing COVID-19 vaccines and is in talks with COVID-19 vaccine manufacturers Pfizer and Johnson & Johnson, Union Minister of State for Home Affairs G Kishan Reddy said.
According to officials, an additional dose of vaccine is different from a booster dose.
Frontline healthcare staff, people over the age of 80 and care home workers will be among the first to get the vaccine as part of Phase 1 of the programme from Tuesday, which was approved for rollout by the UK's independent regulator earlier this week.
The UK government is under increasing pressure on Monday to review its COVID-19 vaccine protocol in place for travellers from India, after its updated rules effective from next month failed to recognise Indian vaccines under an expanded list of countries.
The expert committee sought more information from Serum Institute regarding the Oxford-AstraZeneca vaccine.
Earlier in April, Pfizer said that it had offered a not-for-profit price for its vaccine for the government immunisation programme in India and it remains committed to continuing engagement with the government to make the vaccine available in India.
India's drug regulator Drugs Controller General of India has granted permission to Mumbai-based pharmaceutical company Cipla to import Moderna's COVID-19 vaccine for restricted emergency use in the country, official sources said on Tuesday.
Once the UK drug regulator gives its approval to the Oxford vaccine, the expert committee on COVID-19 at the Central Drugs Standard Control Organisation (CDSCO) will hold its meeting and thoroughly review the safety and immunogenicity data from the clinical evaluations conducted abroad and in India before granting any emergency authorisation for the vaccine here, official sources said.
The Oxford vaccine, which also has a tie-up with the Serum Institute of India, is expected to win approval in the UK before Thursday, speeding up the provision of the jab to the most vulnerable groups.
The Union health ministry said in a statement on Monday that over 23,000 adverse events have been reported since the vaccination drive involving Covishield and Covaxin vaccines started in the country and of these 700 cases were reported to be serious.
Calling for 'equal recognition of vaccines', COVAX on Thursday urged all governments to recognise as 'fully vaccinated' those people who have received COVID-19 vaccines deemed safe by World Health Organisation, saying any move that restricts travel of people based on the vaccines they have received is 'counter-effective, both in spirit and outcome'.
Sputnik V is the third vaccine India has given the go-ahead to after 'Covishield', developed by Oxford University and AstraZeneca and 'Covaxin', the indigenous vaccine manufactured by Bharat Biotech. Covishield is manufactured by the Serum Institute of India.
Wockhardt MD Murtaza Khorakiwala said his firm had responded to the FDA's observations but declined to give details.
"Vaccination is our big weapon in the fight against COVID-19," he said. He added that India is the fastest country globally to reach the landmark of 17 crore doses in 114 days and thanked all the states and UTs for their contribution in achieving this feat.
Facing accusations of delay in placing orders for vaccines, the government on Thursday defended its vaccine procurement policy saying it has been pursuing Pfizer, J&J and Moderna since mid-2020 for the earliest possible imports, and has even waived local trials for well-established foreign vaccine makers.
The Medicines and Healthcare Regulatory Agency, which had been formally tasked by the UK government last month with the process of clearance after the jab emerged "safe and effective" against the novel coronavirus in human trials, is expected to authorise the vaccine by December 28 or 29 after the final data is provided on Monday, 'The Daily Telegraph' quoted senior government sources as indicating.
Senior Congress leader Anand Sharma on Sunday raised concerns over India's drugs regulator granting permission for restricted use of Bharat Biotech's COVID-19 vaccine and asked the government to explain why mandatory protocols and verification of data has been dispensed with.
Hari Shukla from Tyne and Wear said he feels it is his duty to receive his first of the two-dose vaccine, a moment UK Prime Minister Boris Johnson hailed as a "huge step forward" as Tuesday was dubbed "V-Day" or Vaccine Day in the UK.
The European Medicines Agency's review is the second setback to Alkem Laboratories
Wockhardt is recalling select drugs in the US, which were under import restrictions from the USFDA.
Maggie is among the first set of people contacted in advance by the NHS for the jab based on a pre-determined health risk criteria and will include 87-year-old British Indian grandfather of nine Hari Shukla, who will get his first dose at a hospital in Newcastle.
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