Alembic Pharma gets USFDA nod for bipolar disorder treatment drug
In a regulatory filing, Alembic Pharmaceuticals said it has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Asenapine Sublingual Tablets in the strengths of 5 mg and 10 mg. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 11, 2020 Category: Pharmaceuticals Source Type: news

Sanofi-GlaxoSmithKline's experimental Covid vaccine fails in some older patients
Instead, the companies said they planned to test a modified version of their vaccine in a smaller trial beginning in February. Rather than compare their candidate with a placebo, they said, it could be tested against a vaccine expected to be authorized by regulators for emergency use soon. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 11, 2020 Category: Pharmaceuticals Source Type: news

ADB launches USD 9 billion COVID-19 vaccine initiative for its developing member economies
"As ADB's developing members prepare to vaccinate their people as soon as possible, they need financing to procure vaccines as well as appropriate plans and knowledge to be able to safely, equitably, and efficiently manage the vaccination process," ADB President Masatsugu Asakawa said. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 11, 2020 Category: Pharmaceuticals Source Type: news

AstraZeneca to test combining COVID-19 vaccine with Russian shot
The developers of Sputnik V suggested on Twitter last month that AstraZeneca try the combination. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 11, 2020 Category: Pharmaceuticals Source Type: news

Scientists develop new inhalation delivery system for vaccines
The findings, published in the journal Med, suggests that a safe and effective lung delivery system could be developed for vaccines and therapeutics against pathogens such as the novel coronavirus. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 11, 2020 Category: Pharmaceuticals Source Type: news

Country's first mRNA vaccine candidate by Gennova gets nod for conducting human trials: DBT
The novel mRNA vaccine candidate, HGCO19, is supported with seed grant under the Ind-CEPI mission of the Department of Biotechnology. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 11, 2020 Category: Pharmaceuticals Source Type: news

Covid-19: India's first indigenous mRNA vaccine gets DCGI nod for human trial
(Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 11, 2020 Category: Pharmaceuticals Source Type: news

Single Covid-19 vaccine dose or double? Data put regulators in a fix
The US Food and Drug Administration has released its findings on the Pfizer/BioNtech efficacy data where it suggested that the vaccine at a single dose with 67% efficacy would work. Pfizer has said its vaccine efficacy is 97% when two doses are given at an interval of 30 days. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 11, 2020 Category: Pharmaceuticals Source Type: news

Kazakhstan, European nations keen to buy vaccines from India
Kazakhstan, Central Asia ’s biggest state and India’s largest trade partner in the region, is open to the idea of both purchasing vaccines from India as well as entering into joint collaboration, ambassador Yerlan Alimbayev, who was part of the team, told ET. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 11, 2020 Category: Pharmaceuticals Source Type: news

Viveo health to expand its operations in India
The expansion was prompted by the current situation in India that was preventing patients from seeking access to health, owing to fear of getting infected with the coronavirus in overcrowded hospitals and clinics, Viveo Health India business director Prasant Kumar Mohanty said. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 11, 2020 Category: Pharmaceuticals Source Type: news

COVID-19: Randomised clinical trial on efficacy of Siddha medicine completed
Nine other clinical trials involving Siddha medicine either as stand-alone or adjunct with allopathic medicine that were taken up throughout Tamil Nadu are in various stages of completion. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 10, 2020 Category: Pharmaceuticals Source Type: news

Not without India: World's biggest medicine maker gears up for coronavirus vaccine race
India manufactures more than 60% of all vaccines sold across the globe, and while its $40 billion pharmaceutical sector is not yet involved in the production of the expensive Pfizer Inc and Moderna shots, the nation will play a pivotal role in immunizing much of the world. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 10, 2020 Category: Pharmaceuticals Source Type: news

Indian pharma industry's Covid-19 vaccine plans
Serum Institute of India (SII) - The world's largest vaccine producer will manufacture AstraZeneca Plc's Covishield and another formulation developed by U.S. rival Novavax Inc . Organizations such the GAVI vaccine group and the Bill& Melinda Gates Foundation are backing both candidates for large-scale distribution around the globe. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 10, 2020 Category: Pharmaceuticals Source Type: news

SeQuent Scientific launches Citramox LA injection in 10 European countries
SeQuent said the new approval builds on the recent approvals of Tulazzin (Tulathromycin) and Halofusol (Halofuginone) in Europe. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 10, 2020 Category: Pharmaceuticals Source Type: news

Zydus Cadila gets USFDA Fast Track Designation for Saroglitazar
Drug firm Zydus Cadila on Wednesday said it has received Fast Track Designation from the US health regulator for its investigational drug candidate Saroglitazar Mg, indicated for the treatment of a liver disease - primary biliary cholangitis (PBC). (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 9, 2020 Category: Pharmaceuticals Source Type: news

Gennova Biopharmaceuticals granted conditional permission for human clinical trial of its COVID-19 vaccine
The recommendations of the Subject Expert Committee (SEC) on COVID-19, which deliberated upon the proposal submitted by the firm for grant of permission to conduct phases 1 and 2 clinical trials along with animal toxicity study data, has been approved by DCGI. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 9, 2020 Category: Pharmaceuticals Source Type: news

Pfizer promises tiered pricing for its Covid-19 vaccine
“We will have tiered pricing for middle-income countries (India is considered a middle-income country) and we will give it for free in Africa,” Albert Bourla, CEO of Pfizer, said at a press conference organised by the International Federation of Pharmaceutical Manufacturers and Associations. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 9, 2020 Category: Pharmaceuticals Source Type: news

AZ-Oxford vaccine safe & efficacious: Interim analysis
“ChAdOx1 nCoV-19 has an acceptable safety profile and has been found to be efficacious against symptomatic Covid-19 in this interim analysis of ongoing clinical trials,” the Lancet said. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 9, 2020 Category: Pharmaceuticals Source Type: news

Pfizer vaccine moves closer to getting the OK in the United States
The encouraging developments come as the coronavirus continues surging across much of the world. The scourge has claimed more than 1.5 million lives, including over 285,000 in the US, the highest toll of any country. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 9, 2020 Category: Pharmaceuticals Source Type: news

Bharat Biotech's intranasal vaccine to enter phase I/II trials by month-end
Vaccine producer Bharat Biotech International (BBIL) could begin phase I/II human clinical trials for its single-dose intranasal vaccine candidate for Covid-19 by the end of December or early next month, its chairman, Krishna Ella, said on Tuesday. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 9, 2020 Category: Pharmaceuticals Source Type: news

Aurobindo Pharma gets USFDA nod for sedative drug
Drug major Aurobindo Pharma On Wednesday said it has received final approval from the US health regulator for generic of Precedex injection, used for sedation of patients. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 9, 2020 Category: Pharmaceuticals Source Type: news

Roche links with Moderna to include antibody test in COVID-19 vaccine trial
Roche said the test can provide quantitative evidence of the presence and levels of antibodies that develop in response to the vaccine candidate. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 9, 2020 Category: Pharmaceuticals Source Type: news

Serum Institute likely to supply Covid vaccine at Rs 250 a dose to the government: Media reports
The government is pinning its hopes for mass supply on Serum Institute, which lodged the first formal application for emergency-use approval of AstraZeneca's shot on Monday. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 8, 2020 Category: Pharmaceuticals Source Type: news

Nations must address barriers against access to affordable medicines, new technologies: India at UN
The 193-member General Assembly decided by consensus to proclaim December 27 as the 'International Day of Epidemic Preparedness' - a day to highlight the importance of the prevention of, preparedness for and partnerships against epidemics such as COVID-19. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 8, 2020 Category: Pharmaceuticals Source Type: news

Indoco Remedies wins tenders worth Rs 140 crore for supply of kidney stones treatment drug in Germany
Aditi Kare Panandikar, Managing Director - Indoco Remedies said: "This is Indoco's first own label product in Europe. Germany is totally tender business and Indoco has won almost 80 - 85 per cent tenders for Allopurinol. This is a tender order for supplies spread over two years". (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 8, 2020 Category: Pharmaceuticals Source Type: news

Piramal Pharma Solutions invests around USD 32 mn to expand Michigan facility
The expansion is planned to be ready for customers beginning summer 2022. It is expected that the expansion will add around twenty new hires to the site, bringing the total headcount to more than 180 employees and further benefiting the local economy, it added. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 8, 2020 Category: Pharmaceuticals Source Type: news

India may authorise some COVID-19 vaccines in weeks, says health secretary
Six vaccines, including Astra Zeneca's Covidshield and Bharat Biotech's Covaxin, are in trial stages, Federal health secretary Rajesh Bhushan told a press conference. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 8, 2020 Category: Pharmaceuticals Source Type: news

COVID vaccines in India: 6 candidates in different trial stages, 3 may get licensed in 'next few weeks'
(Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 8, 2020 Category: Pharmaceuticals Source Type: news

Bharat Biotech's intranasal COVID-19 vaccine to enter phase 1 trials next month
Replying to a query on the probable pricing of Covaxin, he said Indian vaccines will be much cheaper when compared to other countries. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 8, 2020 Category: Pharmaceuticals Source Type: news

Covid-19: India pins hopes on 4 vaccines to inoculate 30 crore by July
While Covishield, according to a PTI report late on Sunday evening, sought emergency approval, Covaxin is expected to be approved for emergency use by the end of January or early February, if the shots clear scrutiny. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 7, 2020 Category: Pharmaceuticals Source Type: news

Covid-19: Serum Institute seeks emergency authorisation for Oxford vaccine Covishield in India
(Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 7, 2020 Category: Pharmaceuticals Source Type: news

Zydus Cadila gets permission from DCGI for phase-1 clinical trial of novel molecule ZYIL1
Drug firm Zydus Cadila on Monday said it has received permission from Drugs Controller General of India (DCGI) to initiate phase-1 clinical trial of its novel molecule ZYIL1, indicated for use as an inhibitor for inflammation condition 'NLRP3'. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 7, 2020 Category: Pharmaceuticals Source Type: news

COVID-19 vaccine clinical trials: 17 volunteers given doses of Russia's Sputnik V in Pune
Sputnik V vaccine has been developed by the Gamaleya National Research Center of Epidemiology and Microbiology and Russian Direct Investment Fund (RDIF). As per reports, India has purchased 100 million doses of the candidate from Russia. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 6, 2020 Category: Pharmaceuticals Source Type: news

Medicine traders flag crisis of essential medicines due to farmers' agitation
Amid the siege on the capital by farmers protesting against the newly-formed agrarian laws by the Centre on its various borders, the All India Organisation of Chemists and Druggists (AIOCD) has expressed concerns about the possibility of a shortage of essential medicines as the road transportation has been hampered in north India. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 6, 2020 Category: Pharmaceuticals Source Type: news

After Haryana's Anil Vij tests positive, Bharat Biotech says COVAXIN efficacious, safe
"COVAXIN clinical trials are based on a two-dose schedule, given 28 days apart. The vaccine efficacy will be determined 14 days after the second dose. COVAXIN has been designed to be efficacious when subjects receive both the doses," Bharat Biotech said in a statement. The Haryana minister tested positive for novel coronavirus, around two weeks after he was administered the first trial dose of Bharat biotech vaccine candidate, COVAXIN. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 5, 2020 Category: Pharmaceuticals Source Type: news

COVID-19: Zydus Cadila gets DGCI nod for phase 3 clinical trials with biological therapy
The company had completed the phase 2 clinical trials with PegiHep last month. In a regulatory filing, Zydus Cadila said it has received approval from the DCGI to start the phase 3 clinical trials in COVID-19 patients with its biological therapy Pegylated Interferon alpha-2b or PegiHep. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 4, 2020 Category: Pharmaceuticals Source Type: news

Important to have large basket of COVID-19 vaccine candidates: DBT Secretary
Department of Biotechnology secretary Renu Swarup said the vaccines that are being developed indigenously are on different platforms and each has its own benefits and challenges. "It is not necessary that the first one is the best, you may have one coming later which is going to be better but it is difficult to say right now," she said. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 4, 2020 Category: Pharmaceuticals Source Type: news

Price of Remdesivir injection fixed at Rs 2,360 in Maharashtra
The government has also put together a list of 59 pharmaceutical outlets where it can be purchased, covering all the major cities, towns and districts, said Dr Pradeep Vyas, principal secretary, public health and family welfare. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 4, 2020 Category: Pharmaceuticals Source Type: news

India biggest buyer of COVID-19 vaccine with 1.6 bn doses, experts say this could cover 60% population
India has purchased 500 million doses of the Oxford University-AstraZeneca vaccine candidate, one billion from the US company Novavax and 100 million doses of the Sputnik V candidate from Russia's Gamaleya Research Institute, according to the US-based Duke University Global Health Innovation Center. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 4, 2020 Category: Pharmaceuticals Source Type: news

India will wait for Oxford and Bharat Biotech shots
The government is keenly watching developments in Oxford-AstraZeneca candidate for which Serum Institute is the local partner and has said it will apply for emergency use authorisation in next few days. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 3, 2020 Category: Pharmaceuticals Source Type: news

5 Covid vaccines undergoing trial in India logistically feasible for distribution in both urban, rural areas: AIIMS director
Dr Guleria expressed hope that by the end of this month or early next month, at least one of the five vaccines being locally-tested should get emergency use authorisation from the drug regulator to be administered to the public starting with priority groups. According to sources, global pharma giant Pfizer had talks with the Indian government late August, but since then there has been no development. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 3, 2020 Category: Pharmaceuticals Source Type: news

Committed to engaging with Indian govt to make vaccine available in country: Pfizer
The UK on Wednesday became the first country to approve the Pfizer/BioNTech vaccine against COVID-19 with the UK regulator Medicines and Healthcare products Regulatory Agency (MHRA)granting a temporary authorisation for its emergency use. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 3, 2020 Category: Pharmaceuticals Source Type: news

India will wait for Oxford and Bharat Biotech shots
The Pfizer-BioNTech Covid-19 vaccine is not available for India at present and its requirement for ultra-cold temperature — minus 70 degree Celsius (minus 94 degrees Fahrenheit) — for storage is a serious hurdle as the vaccine will need to be distributed in remote areas and even urban centres lack such facilities. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 3, 2020 Category: Pharmaceuticals Source Type: news

Alembic Pharma receives USFDA approval for Metolazone tablets
The approved product is therapeutically equivalent to the reference listed drug product Zaroxolyn Tablets 2.5 mg, 5 mg and 10 mg of Lannett Company, Inc. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 3, 2020 Category: Pharmaceuticals Source Type: news

Phase-3 clinical trial of Covaxin commences in Kolkata
The governor further said that the Centre's Ayushman Bharat scheme, which provides free healthcare services, has provided succour to many amid the crisis. Notably, the scheme has not been implemented in West Bengal so far. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 2, 2020 Category: Pharmaceuticals Source Type: news

Rhizen Pharmaceuticals gets USFDA approval for phase one clinical trials for Covid-19 drug
The Switzerland-based firm, which is a clinical-stage oncology-focussed biopharmaceutical company, has received approval for its investigational new drug (IND) application from the US Food and Drug Administration (FDA) to study its oral Dihydroorotate dehydrogenase (DHOHD) inhibitor for SARS-CoV-2 infection, Rhizen Pharmaceuticals S A said in a statement. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 2, 2020 Category: Pharmaceuticals Source Type: news

Pfizer/BioNTech's Covid-19 vaccine: How the mRNA technology works
The UK health secretary, Matt Hancock, tweeted that the NHS stands ready to start vaccinating early next week. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 2, 2020 Category: Pharmaceuticals Source Type: news

Who will get COVID-19 vaccine first in the world
(Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 2, 2020 Category: Pharmaceuticals Source Type: news

Dr Reddy's Labs begins phase 2/3 trials for Russia's Sputnik V COVID-19 vaccine
JSS Medical Research was roped in as clinical partner to conduct the multi-centre and randomised controlled study that includes safety and immunogenicity study, Dr Reddy's& RDIF said in a joint statement. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 2, 2020 Category: Pharmaceuticals Source Type: news

When and which COVID-19 vaccines are likely to be available in Asia
Trial data from Pfizer Inc with partner BioNTech SE, Moderna Inc and AstraZeneca Plc has shown their experimental vaccines are effective in preventing the coronavirus. If regulators approve any in coming weeks, the companies have said distribution could begin almost immediately. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 1, 2020 Category: Pharmaceuticals Source Type: news