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"Mr. Reddy has been a key member of Aurobindo leadership and has played a pivotal role in the Company’s growth journey since inception. A veteran of the pharma industry, he has expertise in manufacturing technology and has been actively involved in the overall affairs and the strategic decision making of the Company," Aurobindo said in a regulatory filing.
The approval by the US Food & Drug Administration for the generic Pimavanserin capsules is for the strength of 34 mg, Cadila Healthcare said in a regulatory filing. "The drug will be manufactured at the group's formulation manufacturing facility at SEZ Ahmedabad," it said.
"As expected, T cell immunity holding up better against #Omicron. This will protect us against severe disease. Please get vaccinated if you have not," said Swaminathan in a tweet on Wednesday. Either vaccines or prior infections with COVID-19 trigger human T cell response.
"The larger mandate of the NPPA was to seal the MRP keeping in view the margins allowed under the Drug Price Control Order to the wholesalers and retailers," Rakesh Gupta, president of the Jammu Pharmaceutical Distributors Association said in Srinagar. He was accompanied by Naveen Kumar Bali, president of Jammu Chemists Association.
Mankind Pharma on Wednesday said it has joined hands with BDR Pharmaceuticals to launch oral anti-COVID-19 pill Molulife (Molnupiravir) in the country. The tie-up is a licensing arrangement where production is by BDR Pharma and marketing, selling, promotion, distribution is by Mankind Pharma, the company said in a statement.
Ahmedabad-based Hester Biosciences is a part of Gujarat Covid Vaccine Consortium (GCVC), which in May this year signed an agreement with Bharat Biotech for manufacture of the latter’s drug substance for its Covid-19 vaccine.
Union health minister Mansukh Mandaviya said 13 companies in India will manufacture the drug approved for restricted use under emergency situation for treatment of adult patients who have high risk of progression of Covid-19.
Cipla plans to launch Molnupiravir under the brand name Cipmolnu. Molnupiravir is the first oral antiviral approved by the UK Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of mild-to-moderate Covid-19 at high risk of developing severe disease.
The US Food & Drug Administration (USFDA) granted approval to the abbreviated new drug application (ANDA) filed by Granules Pharmaceuticals, Inc (GPI) -- a wholly owned foreign subsidiary of the company -- for Prazosin Hydrochloride capsules, of strengths 1mg, 2mg and 5mg, Granules India Limited said in a statement.
Union Health Minister Mansukh Mandaviya on Tuesday said that the Central Drug Authority CDSCO has approved the Serum Institute of India's COVID-19 vaccine Covovax, Biological E's jab Corbevax and anti-Covid pill Molnupiravir for restricted use in emergency situation.
The SEC on COVID-19 of the CDSCO, which reviewed the emergency use authorisation (EUA) applications of Serum Institute of India (SII) for the second time on Monday, after detailed deliberation has recommended granting EUA to Covovax.
"The Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO) reviewed the emergency use authorisation (EUA) application for the second time on Monday and after detailed deliberation recommended granting emergency use authorisation to Covovax," an official source said.
On vaccination of children, the guidelines said, "For such beneficiaries, option for vaccination would only be available for Covaxin as this is the only vaccine with EUL (emergency use listing) for the age-group 15-17." The ministry said that as a matter of abundant precaution, for those HCWs FLWs, who have received two doses, another dose of COVID-19 vaccine would be provided from January 10.
Zydus Cadila's vaccine ZyCoV-D has not yet been introduced in the country's inoculation programme, even for adults, though it had received emergency use authorisation from the drug regulator on August 20, making it the first vaccine that could be administered in the age group of 12-18 years in the country.
The subject experts committee (SEC), a body under India's drug regulator, will meet on Monday to review the applications for granting approval to the new vaccines and the antiviral drug, people in the know told ET.
Dubai-based Aster DM Healthcare is increasing its focus on India with a target of netting half of the revenue from here over the next five years and plans to hive off its GCC operations into a separate entity, the chairman has said
The company had planned to export from its manufacturing plant near Madurai in Tamil Nadu, where it has invested Rs 600 crore. "It has started exporting now to South East Asian nations. We have started even exporting Glister herbal toothpaste to Indonesia and we are looking at Thailand and other countries for that," Pant told PTI.
In October 2021, the Subject Expert Committee of the Central Drugs Standard Control Organisation (CDSCO), which evaluates vaccine applications, had recommended granting an approval for Covaxin for children aged between 2 and 18 years. However, the regulator has decided to restrict the approval to only teens, instead of the younger age group.
Prime Minister Narendra Modi addressed the nation on Christmas on Saturday night and announced two big changes in the vaccination policy. "We will introduce vaccination for children between 15 and 18 years of age from January 3. This will help in protecting children going to schools and colleges," said the prime minister.
The Subject Expert Committee (SEC) under the drug regulator of India has asked manufacturers in India to specify the category of Covid patients that are likely to receive the greatest benefit of the treatment from the drug be indicated.
The Tocilizumab drug may be considered for use in the presence of severe disease (preferably within 24 to 48 hours of onset of severe disease/ICU admission), according to the guidelines.
Three private equity-led investment platforms have been created specifically targeting the API space, while at least half a dozen transactions are in various stages of negotiations, according to bankers and fund managers.
Three private equity– led investment platforms have been created specifically targeting the API space, while at least half a dozen transactions are in various stages of negotiations, according to bankers and fund managers.
The USFDA also said the drug should be given for whom alternative COVID-19 treatment options authorized by the FDA are not accessible or clinically appropriate. The regulatory agency said molnupiravir should be initiated as soon as possible after diagnosis of COVID-19 and within five days of symptom onset.
Biocon's partner US-based Equillium Inc has expanded its 'EQUALISE' study in Systemic Lupus Erythematosus (SLE) and Lupus Nephritis for Itolizumab to clinical centers in India, Biocon Ltd said in a regulatory filing.
The company has begun investing $1 billion, at risk, in the manufacture of its potential Covid-19 oral antiviral drug with the goal of making treatment courses available as quickly as possible, pending authorisation.
Data from Pfizer's clinical trial showed its two-drug antiviral regimen was 90% effective in preventing hospitalizations and deaths in patients at high risk of severe illness. Recent lab data suggests the drug retains its effectiveness against Omicron.
The news comes days after Reuters reported https://ift.tt/3eedQLK that tens of millions of migrants may be denied COVID-19 vaccines from the vaccine-sharing programme COVAX because of concerns over who would be liable in the event of harmful side-effects.
Biologics capabilities can be synergistic with the company's anti-body drug conjugation capabilities; specifically, for customers who prefer the speed and simplicity benefits of an integrated program that involves development, manufacturing, conjugation, and fill finish. PPS currently offers integrated payload, conjugation, fill finish services, and the addition of anti-body capabilities enhances that offering.
