Zydus Cadila to commence phase II clinical trials of COVID-19 vaccine ZyCoV-D from Aug 6
"The company reports that the doses of the vaccine administered to healthy volunteers in the phase I clinical trial, which began on July 15, 2020, has been well tolerated," Cadila Healthcare, the listed entity of the group, said in a regulatory filing. Zydus Cadila Chairman Pankaj R Patel said the phase I dosing to establish the safety of ZyCoV-D is an important milestone. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - August 5, 2020 Category: Pharmaceuticals Source Type: news

Lupin launches coronavirus drug Favipiravir in India at Rs 49 per tablet
Favipiravir has received authorisation from the Drug Controller General of India (DCGI) for emergency use, Lupin said in a regulatory filing. Its Covihalt dosage strength has been developed keeping in mind convenience of administration. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - August 5, 2020 Category: Pharmaceuticals Source Type: news

IHH to continue to execute Fortis plan: Koji Nagatomi, India Chairperson Mitsui
IHH Healthcare Berhad ’s acquisition of Fortis Healthcare has been caught in a logjam since December 2018 after the Supreme Court put the sale on hold. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - August 4, 2020 Category: Pharmaceuticals Source Type: news

Sun Pharma latest to sell COVID-19 drug favipiravir in India, to cost Rs 35 per tablet
Favipiravir, along with another antiviral, remdesivir, has emerged as one of the most sought-after drugs at hospitals fighting COVID-19 in India, which saw a surge of 50,000-plus infections for the sixth straight day on Tuesday. Sun's version of favipiravir, to be called FluGuard, will cost 35 rupees per 200 mg tablet, making it the cheapest version available. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - August 4, 2020 Category: Pharmaceuticals Source Type: news

Will continue to focus on growing businesses faster than market: Sun Pharma
Drug major Sun Pharma will remain focussed on growing its businesses faster than the market in which it operates, the company said in its Annual Report 2019-20. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - August 4, 2020 Category: Pharmaceuticals Source Type: news

Cipla witnesses 3 senior-level exits including India biz CEO
Drug firm Cipla has witnessed three senior-level exits, including that of the company's Executive Vice-President and CEO for India business Nikhil Chopra. The other two executives are Nikhil Lalwani, head of India prescription business, and Kunal Khanna, cluster head of chronic and emerging business development and portfolio. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - August 4, 2020 Category: Pharmaceuticals Source Type: news

India is in talks with Russia over anti covid vaccine production
Earlier, Deputy Prime Minister Tatyana Golikova announced that mass production of the vaccine developed by the Gamaleya National Research Center for Epidemiology and Microbiology of the Russian Healthcare Ministry is expected to start in September 2020. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - August 4, 2020 Category: Pharmaceuticals Source Type: news

Jubilant Life Sciences arm launches Remdesivir injection in the Indian market
Jubilant Generics will make the drug available to over 1,000 hospitals providing Covid-19 treatment in India through its distribution network, the company said in a release. Jubilant had entered into a non-exclusive licensing agreement with US Gilead Sciences, Inc. In May, which that granted it the right to register, manufacture and sell Gilead ’s investigational drug Remdesivir in 127 countries including India. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - August 3, 2020 Category: Pharmaceuticals Source Type: news

Pricing Covid-19 vaccines too high could backfire on big pharmaceutical companies
A world without global intellectual property would be one of constant electronic warfare. State-backed hacking, such as China apparently tried with Moderna this week, would be a constant threat. Nor would companies enjoy a comfortable relationship with their own governments, who would see them less as engines of growth and more as storehouses of national wealth. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - August 3, 2020 Category: Pharmaceuticals Source Type: news

Wockhardt snags Covid-19 vaccine manufacturing deal from the UK govt
This deal by Wockhardt entails only manufacturing the vaccine only for the United Kingdom. The government has reserved one fill and finish production line for its exclusive use for the next 18 months in order to guarantee the supply of vaccines required to fight COVID-19 in the UK, Wockhardt said in a statement. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - August 3, 2020 Category: Pharmaceuticals Source Type: news

US generics business to continue its growth momentum: Pharma firm Cadila Healthcare
According to the Cadila Healthcare's annual report for fiscal year 2019-20, the company is planning to introduce additional "topical, transdermal and injectable products" in coming years. The US was the largest contributor to the consolidated revenues of the company with 45 per cent share, it said. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - August 2, 2020 Category: Pharmaceuticals Source Type: news

Lupin recalls 35,928 bottles of generic antibiotic drug 'Cefdinir' in the US market
As per the latest Enforcement Report of the US Food and Drug Administration (USFDA), the Mumbai-based company is recalling Cefdinir for oral suspension USP, 250 mg/5mL, packaged in 60 ml bottles. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - August 2, 2020 Category: Pharmaceuticals Source Type: news

BCG shots could slow down Covid-19 spread in first thirty days, says study
The paper published in Science Advances, a peer-reviewed medical journal brought out by the American Association for the Advancement of Science, said that countries with mandatory Bacillus Calmette-Gu érin (BCG) vaccination showed “slower infection and death rates” during the first 30 days of the Covid-19 outbreak in their country. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - August 2, 2020 Category: Pharmaceuticals Source Type: news

With trials just starting, Adar Poonawalla gets a front-row seat to the global vaccine race
The Serum Institute, which is exclusively controlled by a small and fabulously rich Indian family and started out years ago as a horse farm, is doing what a few other companies in the race for a vaccine are doing: mass-producing hundreds of millions of doses of a vaccine candidate that is still in trials and might not even work. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - August 2, 2020 Category: Pharmaceuticals Source Type: news

Serum Institute of India gets approval to start human trials for Oxford vaccine
Earlier this week, a committee of experts had deferred a decision on the request of SII to start trials and asked the company to amend its protocol for the clinical study. The subject expert committee (SEC) had recommended eight amendments to be made to the firm's proposal to conduct Phase-II and -III trials. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - August 1, 2020 Category: Pharmaceuticals Source Type: news

Zydus Cadila gets tentative nod from USFDA to market Parkinson's disease drug
The company has received tentative approval from the United States Food and Drug Administration (USFDA) to market the capsules in the strengths of 23.75 mg/95 mg, 36.25 mg/145 mg, 48.75 mg/195 mg, and 61.25 mg/245 mg, Zydus Cadila said in a statement. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - August 1, 2020 Category: Pharmaceuticals Source Type: news

Panel recommends Serum Institute's name for phase 2, 3 human clinical trials of Oxford vaccine candidate
The recommendations of the committee at the Central Drugs Standard Control Organisation have been sent to the Drugs Controller General of India for approval. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - July 31, 2020 Category: Pharmaceuticals Source Type: news

India part of international alliance Gavi's new coronavirus global vaccine access drive
The COVAX Advance Market Commitment (AMC) forms part of the COVAX Facility, a mechanism hosted by Gavi, the Vaccine Alliance, designed to guarantee rapid, fair and equitable access to COVID-19 vaccines for every country in the world. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - July 31, 2020 Category: Pharmaceuticals Source Type: news

Sikkim drug manufacturing units halt operations due to Covid, raising supply concerns
While Sikkim is still under lockdown, the state government has allowed pharma units outside containment zones to operate with minimum staff, subject to strict adherence to social distancing norms and regulation of movement of people and goods. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - July 31, 2020 Category: Pharmaceuticals Source Type: news

No justification to deny drug cos deduction of expenses incurred on freebies to doctors: ITAT
A bench comprising judicial member Ravish Sood and accountant member G Manjunatha ruled that a Central Board of Direct Taxes circular and the IMC ’s regulations could not be relied upon to disallow a drug company’s expenditure claims. The IMC’s code of conduct applies only to medical practitioners and doctors and not to pharmaceutical companies and the healthcare sector, it said. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - July 30, 2020 Category: Pharmaceuticals Source Type: news

PE fund Advent International buys controlling stake in API manufacturer RA Chem Pharma
The US private equity fund is understood to have pipped a rival offer from a consortium consisting another PE fund Carlyle Group and former Mylan Labs CEO Hari Babu. Bangalore-based Microlabs controls the entity currently. An official announcement is expected soon. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - July 30, 2020 Category: Pharmaceuticals Source Type: news

Remdesivir sells at 10x prices, NPPA unable to regulate as it's not notified as a 'drug'
The NPPA can only control prices of devices and products that are defined as drugs under the Drugs and Cosmetics Act. A product or device that is not notified as a drug goes out of the NPPA's purview. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - July 30, 2020 Category: Pharmaceuticals Source Type: news

Hetero launches Favipiravir in India under the brand ‘Favivir’ to treat Covid-19
This is the second drug developed by Hetero after Covifor, the generic version of Remdesivir injection to be administered intravenously in a hospital for treatment of severe Covid-19, under the license from Gilead Sciences. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - July 29, 2020 Category: Pharmaceuticals Source Type: news

COVID-19 fatality rate declining progressively, total recoveries 9.88 lakh: Health ministry
India's COVID-19 case fatality rate (CFR) is lower than what it is globally. On Wednesday, the CFR stood at 2.23 per cent, the lowest since April 1, the health ministry said in a statement. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - July 29, 2020 Category: Pharmaceuticals Source Type: news

Indian API makers benefit as global buyers ditch China
Price sensitivity among formulation companies is declining amid a receding threat of supply chain disruptions from Chinese suppliers, which had also occurred in the past, he said. Considering that India has the highest number of API facilities approved by the US Food and Drug Administration, it will remain a critical part of the global supply channel, Munde noted. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - July 28, 2020 Category: Pharmaceuticals Source Type: news

India-UK tie up for new 8 million pounds medicinal research
India and the UK will be enhancing their science and research collaboration with five new projects worth 8 million pounds to tackle anti-microbial resistance, which could lead to important advances in the global fight against antibiotic-resistant bacteria and genes. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - July 28, 2020 Category: Pharmaceuticals Source Type: news

Coronavirus Vaccine Race: Most of the Covid-19 vaccines are already reserved
ET takes a look at how the European Union, the Unites States, other OECD nations, and, more importantly, India are placed in the race to secure vaccine supplies. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - July 27, 2020 Category: Pharmaceuticals Source Type: news

Govt should grant infrastructure status to API industry: IPA President Satish Reddy
The IPA wants the government to accord infrastructure status to the Active Pharmaceutical Ingredients (API) industry, and provide a boost to innovation through tax incentives on patent income, streamlined pathways for testing and approval of experimental therapies, its president, Satish Reddy told ET. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - July 27, 2020 Category: Pharmaceuticals Source Type: news

Dr Reddy's Laboratories gets USFDA nod for Xeglyze lotion, used for lice treatment
Dr Reddy's Laboratories said it is working to commercialise this product through partners. In a regulatory filing, Dr Reddy's Laboratories announced it has received "approval of Xeglyze (abametapir) lotion... by the US Food and Drug Administration (USFDA)". (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - July 27, 2020 Category: Pharmaceuticals Source Type: news

Govt releases guidelines for schemes to boost domestic manufacturing of bulk drugs, med devices
The objective is to make India self-reliant in production of 53 critical (active pharmaceutical ingredients) APIs or Key Starting Materials (KSMs), and in production of medical devices, for which India is crucially dependent upon imports," Sadananda Gowda, the federal minister for chemicals and fertilisers, tweeted on Monday. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - July 27, 2020 Category: Pharmaceuticals Source Type: news

Lupin, Granules India recall around 9.71 lakh bottles of diabetes drug in the US market
As per the latest Enforcement Report of the US Food and Drug Administration (USFDA), Lupin is recalling 4,92,858 bottles of Metformin Hydrochloride extended-release tablets in 500 mg and 1,000 strengths. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - July 26, 2020 Category: Pharmaceuticals Source Type: news

Health ministry decides against including Itolizumab in clinical management protocols for COVID-19
The permission to market the drug was granted for the treatment of cytokine release syndrome in 'moderate' to 'severe' Acute Respiratory Distress Syndrome patients due to COVID-19. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - July 26, 2020 Category: Pharmaceuticals Source Type: news

Innovations can help India's biotechnology economy to hit USD 100 billion by 2025: Amitabh Kant
Addressing a webinar titled 'Global Perspective on India's Biotech Potential: Manufacturing Hub& Foreign Investment', Kant said India is working to boost the biotechnology sector under the flagship programmes like 'Make in India' and 'Startup India'. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - July 24, 2020 Category: Pharmaceuticals Source Type: news

Sun Pharma's arm Taro resolves all cases with United States Department of Justice
Under a deferred prosecution agreement reached with the DOJ, it said, adding that the dept will file an information for conduct that took place between 2013 and 2015. Taro Pharmaceutical said, if the company adheres to the terms of the agreement, including the payment of USD 205.7 million, the DOJ will dismiss the information at the end of a 3-year period. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - July 24, 2020 Category: Pharmaceuticals Source Type: news

Mumbai-based Vishat Diagnostics gets ICMR nod to supply COVID-19 antigen testing kit
"With COVID-19 Ag Respi-Strip, we are bringing CE certified and ICMR approved kits at affordable prices, which is also our company's driving force for all other product lines," Vishat Diagnostics MD Pratik Chaitala said. At a time when India is touching its peak in daily numbers of cases, it becomes critical to rapidly increase testing, he added. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - July 24, 2020 Category: Pharmaceuticals Source Type: news

Chemists procure over 1000 vials of Remdesivir to fight Covid-19 crisis in Kashmir
The administration maintains that the health infrastructure in Valley is equipped enough to deal with the crisis, however, the scenes at the hospitals and complaints of patients belie the official claims. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - July 23, 2020 Category: Pharmaceuticals Source Type: news

Cipla all set to launch Favipiravir drug for treatment of COVID patients: CSIR
An off-patent anti-viral drug, Favipiravir, originally discovered by Fuji Pharma in Japan, has shown promise in clinical trials for treatment of COVID-19 patients, especially in mild and moderate cases. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - July 23, 2020 Category: Pharmaceuticals Source Type: news

Piyush Goyal calls for removing hurdles in access to medicines at affordable prices
"The minister called for removing multiple hurdles in access to medicines at affordable prices created by the lopsided WTO rules for protecting intellectual property," a ministry statement said. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - July 23, 2020 Category: Pharmaceuticals Source Type: news

Trial results show significant faster time to clinical improvement with Favipiravir: Glenmark
Results from the Phase 3 trial showed numerical improvements for the primary efficacy endpoint with 28.6 per cent faster viral clearance in the overall population in the Favipiravir plus standard supportive care compared to those in the standard supportive care alone (control arm) , Glenmark said in a statement. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - July 22, 2020 Category: Pharmaceuticals Source Type: news

Piramal Critical Care partners with Medivant Healthcare to supply injectable drugs in US
Piramal Critical Care on Wednesday said it has partnered with US-based pharmaceutical outsourcing facility Medivant Healthcare to address severe shortage of injectable drugs in hospitals across the United States. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - July 22, 2020 Category: Pharmaceuticals Source Type: news

Unichem Laboratories gets USFDA nod for drug to treat irregular heartbeat
Drug firm Unichem Laboratories on Wednesday said it has received approval from the US health regulator for its Amiodarone tablets used to treat irregular heartbeat. The approved product is a generic version of Wyeth Pharmaceuticals Inc's Cordarone tablets. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - July 22, 2020 Category: Pharmaceuticals Source Type: news

Mylan gets DCGI nod for anti-tuberculosis drug Pretomanid for conditional access
The Drug Controller General of India (DCGI) has approved Pretomanid for conditional access under the National Tuberculosis Elimination Program (NTEP), Mylan said in a statement. Through the conditional access approval from DCGI, Mylan will initially make its Pretomanid available in India through a donation of 400 treatment courses to the NTEP, it added. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - July 22, 2020 Category: Pharmaceuticals Source Type: news

Covid-19 vaccine by October-November: Adar Poonawala to Odisha CM Naveen Patnaik
Serum Institute of India CEO Adar Poonawalla, during an interaction with Odisha Chief Minister Naveen Patnaik through a video conference, expressed optimism that the COVID-19 vaccine could be ready by October-November this year and the next phase of the trial can start in mid-August in India. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - July 22, 2020 Category: Pharmaceuticals Source Type: news

Glenmark defends price of its COVID-19 drug favipiravir version after DCGI sends notice
“Compared to other therapies approved for emergency use in COVID-19, FabiFlu is much more economical and an effective treatment option,” the company said in a statement. The company said that Favipiravir in India when launched was at the lowest market cost (Rs 103/tab) as compared to its cost in other countries where it was approved like Russia, Japan, Bangladesh and China. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - July 21, 2020 Category: Pharmaceuticals Source Type: news

Possible but not certain COVID-19 vaccine rolled out this year: Oxford developer
"The end of the year target for getting vaccine rollout, it's a possibility but there's absolutely no certainty about that because we need three things to happen," said Sarah Gilbert, adding it needed to be shown to work in late stage trials, there needed to be large quantities manufactured and regulators had to agree quickly to licence it for emergency use. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - July 21, 2020 Category: Pharmaceuticals Source Type: news

Biocon partners with Voluntis to develop digital therapeutics for diabetes patients
The licensing agreement, signed between Biocon Biologics ’ subsidiary Biocon Sdn. Bhd., Malaysia and Voluntis, would make Biocon Biologics one of the first insulin companies to offer a US Food and Drug Administration-cleared and CE-marked, digital therapeutic product - Insulia - to Type 2 diabetes patients, said Biocon in a press release. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - July 21, 2020 Category: Pharmaceuticals Source Type: news

Novartis turning to technology to manage business: Bertrand Bodson, Chief Digital Officer
Swiss drugmaker Novartis is turning to tech to deal with the pharma business in times of pandemic, as companies go virtual. Bertrand Bodson, chief digital officer, Novartis, in an interview shares how the company is innovating its business in the time of pandemic. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - July 21, 2020 Category: Pharmaceuticals Source Type: news

Airborne transmission of Covid possible, wear masks in enclosed spaces, cautions CSIR
Amid recent acknowledgement from the World Health Organisation (WHO) over emerging evidence of airborne spread of the novel coronavirus, the head of India ’s premier R&D body has said that airborne transmission of SARS-CoV-2 is indeed a “distinct possibility” and suggested wearing masks even in “enclosed” spaces. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - July 21, 2020 Category: Pharmaceuticals Source Type: news

AstraZeneca vaccine's success in early human trials bodes well for Adar Poonawalla and Serum Institute
Adar Poonawalla's Serum Institute of India is one of Astra Zeneca's partners in the search for the vaccine and will potentially be responsible for the mass manufacture of the final product. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - July 20, 2020 Category: Pharmaceuticals Source Type: news

Coronavirus cure: Human clinical trials for Covaxin begins at NIMS in Hyderabad
The company has developed the vaccine in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV). (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - July 20, 2020 Category: Pharmaceuticals Source Type: news