Johnson & Johnson starts phase 3 trial of vaccine; could be available for use by early 2021
US drugmaker Johnson& Johnson says the vaccine could be available for use by early 2021 if proven safe, effective. In the next phase J&J will enroll up to 60,000 volunteers across three continents and study safety and efficacy of a single vaccine dose. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - September 23, 2020 Category: Pharmaceuticals Source Type: news

Biocon appoints Anupam Jindal as new CFO
He will report to the Chief Executive Officer and Managing Director Siddharth Mittal. Jindal will take over from Indranil Sen who was the interim CFO and he will continue as Vice-President for Finance. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - September 22, 2020 Category: Pharmaceuticals Source Type: news

Kool-ex and IndoSpace to jointly develop warehouses for COVID-19 vaccine
As part of the asset-light deal, Kool-ex and IndoSpace will jointly design and set-up 10-11 warehouses by 2023, making it the largest Pharma storage footprint in the country. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - September 22, 2020 Category: Pharmaceuticals Source Type: news

Remdesivir batch withdrawn due to inferior quality: Maharashtra government
Seeking to allay concerns over shortage of Remdesivir, the minister said the government held talks with pharma companies and ensured sufficient supply of the medicine for COVID-19 patients. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - September 22, 2020 Category: Pharmaceuticals Source Type: news

Sun Pharma arm launches plaque psoriasis treatment drug in Japan
In a regulatory filing, Sun Pharmaceutical Industries said its "wholly-owned Japanese subsidiary has launched Ilumya Subcutaneous Injection 100 mg Syringe in Japan for the treatment of plaque psoriasis in adult patients who have an inadequate response to conventional therapies". (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - September 22, 2020 Category: Pharmaceuticals Source Type: news

Pfizer is on track to be first to find out if its Covid vaccine works
A wide range of symptoms and severity makes the evaluation of Covid-19 vaccines tricky. The U.S. Food and Drug Administration has said that to be approved, vaccines should cut the number of symptomatic cases by half. Yet documents released by the drugmakers show each has its own approach to defining which symptoms count, and when to count them. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - September 22, 2020 Category: Pharmaceuticals Source Type: news

Bharat Biotech inks pact with WU's School of Medicine for COVID-19 intranasal vaccine
According to a press release issued by the city-based vaccine maker, Bharat Biotech owns the rights to distribute the vaccine in all markets except the US, Japan and Europe. While the Phase I trials will take place in St Louis University's Vaccine and Treatment Evaluation Unit, Bharat Biotech, upon obtaining the required regulatory approval, will pursue further stages of clinical trials in India. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - September 22, 2020 Category: Pharmaceuticals Source Type: news

Most people infected with novel coronavirus develop symptoms: Study
The latest study, published in the journal PLOS Medicine, suggests that true asymptomatic cases of SARS-CoV-2 comprise a minority of infections. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - September 22, 2020 Category: Pharmaceuticals Source Type: news

China hikes prices of key drug ingredients
While increased prices will put cost pressure on the domestic industry over the next few months, more importantly it has sparked speculation that this could be a potential ploy by China to scupper efforts of India ’s drug industry to be self-reliant, or ‘Atmanirbhar’. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - September 21, 2020 Category: Pharmaceuticals Source Type: news

Strides Pharma Science arm gets USFDA nod for tension headache tablets
Strides Pharma Global Pte Ltd, Singapore, has received approval for Butalbital, Acetaminophen, and Caffeine tablets USP in the strengths of 50 mg/325 mg/40 mg from the United States Food and Drug Administration (USFDA), Strides Pharma Science said in a regulatory filing. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - September 21, 2020 Category: Pharmaceuticals Source Type: news

Bayer's Aflibercept injection gets DCGI nod for Diabetic Macular Edema indication
Diabetic Macular Edema occurs when high blood sugar levels damage capillaries that leak fluid into the retina, resulting in swelling and blurred vision. The approval of Aflibercept injection for intravitreal use presents a new and alternative treatment option to currently available therapies, for patients with DME, Bayer in India said in a statement. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - September 21, 2020 Category: Pharmaceuticals Source Type: news

India trials for Russia's 'Sputnik-V' vaccine could start in next few weeks: Executive
Indian trials of the Sputnik-V vaccine candidate, being developed by Russia's sovereign wealth fund, will enroll 1,000-2,000 participants and be conducted at multiple government and private hospitals across the country, Deepak Sapra, CEO for API and pharmaceutical services at Dr. Reddy's, told Reuters. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - September 21, 2020 Category: Pharmaceuticals Source Type: news

Sterling Biotech case reassigned to same judge who recused earlier
ASJ Rana on Monday had recused himself from hearing the matter, saying he was "shocked" as he was approached by one of his classmates on behalf of the accused, while terming the incident as "unfortunate". (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - September 21, 2020 Category: Pharmaceuticals Source Type: news

India's Serum Institute starts manufacturing Codagenix's potential COVID-19 vaccine
Serum Institute, the world's largest vaccine maker by the number of doses produced, will develop Codagenix's CDX-005, which is delivered intranasally rather than via injection. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - September 21, 2020 Category: Pharmaceuticals Source Type: news

India needs to invest Rs 5K cr to give all Indians Covid vaccine: Zydus Cadila Chairman
Given the fact almost all vaccines are going to work at least two doses, if we look at India's population and decide to immunise 50 per cent of the population, we would require over 130 crore doses and that's not the capacity anybody has, Zydus Cadila Chairman Pankaj R Patel said (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - September 20, 2020 Category: Pharmaceuticals Source Type: news

Natco Pharma aims to diversify product portfolio in domestic market
Informing shareholders, the drug maker said its oncology segment suffered in the last financial year due to pricing controls from the government, and its Hepatitis-C business continued to decline due to reduction in market size. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - September 20, 2020 Category: Pharmaceuticals Source Type: news

BDR Pharma launches 80 mg version of prostate cancer drug at Rs 24,480 per pack in India
The company had earlier received approval from the Drugs Controller General of India (DCGI) to manufacture 40 mg enzalutamide in 2017 to treat men with metastatic castration-resistant prostate cancer (mCRPC) under the brand name Bdenza, BDR Pharma said in a statement. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - September 20, 2020 Category: Pharmaceuticals Source Type: news

AstraZeneca, under fire for coronavirus vaccine safety, releases trial blueprints
Polls are finding Americans increasingly wary of accepting a coronavirus vaccine. And scientists inside and outside the government are worried that regulators, pressured by the president for results before Election Day on Nov. 3, might release an unproven or unsafe vaccine. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - September 19, 2020 Category: Pharmaceuticals Source Type: news

Tata Group officially ventures into the medical devices with Tata Medical and Diagnostics
Officially incorporated in July 2020, the company manufactures medical appliances and instruments and appliances for measuring, checking, testing, navigating and other purposes; it has launched Tata CRISPR test, powered by CSIR-IGIB FELUDA for detecting the novel coronavirus. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - September 19, 2020 Category: Pharmaceuticals Source Type: news

DCGI approves commercial launch of Tata Group's low cost Covid-19 test 'Feluda'
The Tata CRISPR test achieves accuracy levels of traditional RT-PCR tests with quicker turnaround time, less expensive equipment and better ease of use. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - September 18, 2020 Category: Pharmaceuticals Source Type: news

Where are we with coronavirus vaccines? Here are the promising nine
There were several developments regarding vaccines and drugs this week, including the tie-up between the makers of Russia ’s Sputnik V vaccine and Dr Reddy’s. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - September 18, 2020 Category: Pharmaceuticals Source Type: news

NPPA asks state drug controllers to prevent hoarding , black marketing of medical oxygen
In the letter, NPPA Chairperson Shubhra Singh said the increase in number of COVID-19 cases in the country has resulted in surge of demand for medical oxygen. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - September 18, 2020 Category: Pharmaceuticals Source Type: news

Kochi-based company to start phase 2b trials of COVID drug next week
PNB Vesper Life ’s chief executive PN Balaram is upbeat the company’s experimental drug PNB-001 will be effective in treating symptoms of Covid-19. The Kochi-based pharma company is set to begin clinical trials on patients suffering from the disease next week. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - September 17, 2020 Category: Pharmaceuticals Source Type: news

Moderna, Pfizer blueprints revealed: Vaccine frontrunners bow to public pressure, abandon secrecy
Companies typically share these documents after their studies are complete. The disclosures while the trials are still underway, a rare move, are aimed at addressing growing suspicion among Americans that President Donald Trump ’s drive to produce a vaccine before the election on Nov. 3 could result in a product that was unsafe. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - September 17, 2020 Category: Pharmaceuticals Source Type: news

Zydus Cadila gets American health regulator's approval to market mineral supplement
Zydus Cadila has received final approval from the US Food and Drug Administration (USFDA) to market Potassium Chloride extended release tablets in the strengths of 10 mEq (750 mg) and 20 mEq (1,500 mg), Zydus Cadila, part of Cadila Healthcare group. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - September 17, 2020 Category: Pharmaceuticals Source Type: news

Dr Reddy's Laboratories launches over-the-counter eye allergy drop in US
Dr Reddy's said Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2 per cent and 0.1 per cent, are indicated for the temporary relief of itchy eyes due to pollen, ragweed, grass, animal hair and dander. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - September 16, 2020 Category: Pharmaceuticals Source Type: news

Maharashtra's private hospitals, district Covid centres battle heavy staff attrition
At a parallel level, Covid care centres of different districts are also engaged in active poaching of healthcare personnel from other districts, luring them with higher pay and additional facilities like food and lodging. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - September 15, 2020 Category: Pharmaceuticals Source Type: news

View: India should take the lead on vaccine delivery
One critical challenge will be storage and transportation. Some of the vaccines that use the new messenger RNA technology will need to be stored at subzero temperatures, as low as minus-70 or minus-80 degrees Celsius. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - September 15, 2020 Category: Pharmaceuticals Source Type: news

RDIF and Dr Reddy's tie up to manufacture coronavirus vaccine Sputnik V for India
Adding that the platform of human adenoviral vectors, which is the core of the Russian vaccine, has been tested in more than 250 clinical studies over decades, and it has been found safe with no potential negative long-term consequences. ” (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - September 15, 2020 Category: Pharmaceuticals Source Type: news

India to be a big hub for production of Russian vaccines: Kirill Dimitriev, CEO, RDIF
Upon successful trials the Russian vaccine can be available in India by end of 2020, said Kirill Dmitriev in an exclusive interview with ET. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - September 15, 2020 Category: Pharmaceuticals Source Type: news

Aurobindo ties up with Biotechnology Industry Research Assistance Council for COVID-19 vaccine
Aurobindo Pharma said it is developing a vaccine for COVID-19 through its wholly-owned US subsidiary, Auro Vaccines. The vaccine candidate is based on a proprietary vaccine delivery platform of the company. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - September 14, 2020 Category: Pharmaceuticals Source Type: news

Govt has prepared 2 schemes to promote bulk drugs manufacturing in India: Gowda
As per the data from various Port Offices of the Central Drugs Standard Control Organization (CDSCO), the percentage of raw materials imported from China in terms of value stood at 72.40 per cent for 2019-20, Union Minister D V Sadananda Gowda said in reply to a question in the Lok Sabha. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - September 14, 2020 Category: Pharmaceuticals Source Type: news

Saptagir Laboratories signs deal with Jubilant Generics to manufacture 'Remdesivir'
Remdesivir is an experimental antiviral drug developed by Gilead Sciences, Inc. as a course of treatment for Covid-19. Gilead entered into a non-exclusive licensing agreement with Jubilant Life Sciences for distribution to 127 countries. Following this, Jubilant Life Sciences through its subsidiary Jubilant Generics has entered an exclusive agreement with Saptagir Laboratories to manufacture Remdesivir. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - September 13, 2020 Category: Pharmaceuticals Source Type: news

Centre introduced Assisted Reproductive Technology (Regulation) Bill in Lok Sabha to map the fertility industry
The Bill states that assisted reproductive technologies can be availed of by any woman above marriageable age but less than 50 years and any man above marriageable age but less than 55 years. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - September 13, 2020 Category: Pharmaceuticals Source Type: news

We will be focusing on a three-pronged strategy to drive growth, says Zydus Wellness
As a part of the strategy, the company would accelerate growth of core brands with innovations to focus on portfolio diversification and expansion with an aim to recruit new customers. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - September 12, 2020 Category: Pharmaceuticals Source Type: news

Will resume COVID-19 vaccine trials after DCGI nod: Serum Institute
Pharma giant AstraZeneca on Saturday said that clinical trials for the AstraZeneca Oxford coronavirus vaccine, AZD1222, have resumed in the UK following confirmation by the Medicines Health Regulatory Authority (MHRA) that the trials were safe. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - September 11, 2020 Category: Pharmaceuticals Source Type: news

DGCI directs Serum Institute to suspend any new recruitment in phase 2, 3 COVID-19 vaccine clinical trials
On 9 September ANI first reported that DCGI issued a show-cause notice to Serum Institute for not pausing the ongoing clinical trial of the COVID-19 vaccine. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - September 11, 2020 Category: Pharmaceuticals Source Type: news

Drug regulator asks Serum Institute to increase safety monitors of Covid drug trials
A day after the company halted the trial of the AstraZeneca-Oxford University Covid vaccine in the country. The Drug controller has asked the Pune based company to suspend any new recruitment in the Phase II/III trial till further orders. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - September 11, 2020 Category: Pharmaceuticals Source Type: news

PNB Vesper gets nod to begin phase-2 clinical trials for COVID-19 drug
The molecule was initially developed for lung cancer, the company's promoter and chief executive P N Balaram told . The firm's labs are located in Britain. He said the company on Thursday received permission from the Central Licensing Authority under the Central Drugs Standard Organisation for the second phase of clinical trials. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - September 10, 2020 Category: Pharmaceuticals Source Type: news

Taking the good with the bad: How potential Covid-19 vaccines offered hope and disappointment
​​This week the trial results on a few treatment options offered hope and disappointment. Vaccine developers also gave a realistic launch deadline for their vaccines. Divya Rajagopal reports on this week’s update. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - September 10, 2020 Category: Pharmaceuticals Source Type: news

Covid testing strategy revised for Bengaluru; more focus on RT-PCR test
Covid test data shows that Bengaluru has struggled to meet the antigen-testing target. In the last seven days, the BBMP could only achieve 11% of the RAT target. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - September 10, 2020 Category: Pharmaceuticals Source Type: news

AstraZeneca trials only after review by UK ’s Drug and Safety Monitoring Board: Serum Institute
The decision to put the trials on hold was taken by the members of the DSMB after they were informed about the serious adverse events reported in Phase II/III trials in UK. “The subject has been diagnosed with neurological disorder,” it has informed the the Drug controller General Of India (DCGI). (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - September 9, 2020 Category: Pharmaceuticals Source Type: news

Serum Institute of India officially halts the trial of Astrazeneca-Oxford vaccine in India
"We are reviewing the situation and pausing India trials till AstraZeneca restarts the trials. We are following DCGI's instructions and will not be able to comment further on trials", said Adar Poonawala, CEO of Serum Institute of India in a statement. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - September 9, 2020 Category: Pharmaceuticals Source Type: news

Serum Institute gets DCGI notice over Oxford COVID-19 vaccine trial suspension by AstraZeneca
The Drugs Controller General of India, Dr V G Somani, in his show-cause notice has asked SII as to why the permission granted for conducting phase 2 and 3 clinical trials of the vaccine candidate in the country be not suspended till patient safety is established. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - September 8, 2020 Category: Pharmaceuticals Source Type: news

Serum Institute gets DCGI notice over Oxford COVID-19 vaccine trial suspension by AstraZeneca abroad
The Drugs Controller General of India, Dr V G Somani, in his show-cause notice has asked SII as to why the permission granted for conducting phase 2 and 3 clinical trials of the vaccine candidate in the country be not suspended till patient safety is established. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - September 8, 2020 Category: Pharmaceuticals Source Type: news

Serum Institute of India to also halt trial of the Oxford-AstraZeneca vaccine candidate
AZ on Wednesday morning said that it was temporarily halting the trial of the vaccine candidate after one of the participants developed "unexplained illness" in the UK. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - September 8, 2020 Category: Pharmaceuticals Source Type: news

Restrict use of pain reliever Tapentadol: Child rights panel urges government
“The chairperson, NCPCR recommended to examine the issue to notify the drug under Schedule H 1 of Drugs and Cosmetics Rules, 1945,” another official said. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - September 8, 2020 Category: Pharmaceuticals Source Type: news

Dr Reddy's launches Remdesivir under brand name 'Redyx' for Covid-19 treatment in India
According to a press release from the drug maker, the launch is part of the licensing agreement with Gilead Sciences, Inc. (Gilead) that grants Dr Reddys the right to register, manufacture and sell Remdesivir, a potential treatment for Covid-19, in 127 countries including India. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - September 8, 2020 Category: Pharmaceuticals Source Type: news

Dr Reddy's launches generic arthritis drug in US market
"The launch of product is an important addition to our pain/analgesics portfolio of over-the-counter (OTC) products, and represents our continued commitment to the private label OTC space," Dr Reddy's Laboratories North America Generics CEO Marc Kikuchi said in a statement. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - September 8, 2020 Category: Pharmaceuticals Source Type: news

India scaling up production of active pharmaceutical ingredients: Amitabh Kant
Speaking at the 14th Annual BioPharma and Healthcare Summit, the NITI Aayog CEO said India is now gearing up for innovation in its pharmaceutical ecosystem focusing on speedy and scaled up delivery of new vaccines and personalised medicines. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - September 7, 2020 Category: Pharmaceuticals Source Type: news