The impacts of the COVID-19 pandemic bring change shifts the status quo on a daily basis with both breadth and depth. Everything we as individuals and as a society would normally do is undergoing change. FDA regulatory oversight is one … Continue reading →

Earlier this month I published a blog posting that raised questions related to the potential for disruption of approvals in the wake of FDA actions to limit inspections due to the COVID-19 pandemic. Subsequently I had the opportunity to pose … Continue reading →

With the COVID-19 impact making itself apparent on a daily basis as the numbers climb and organizations respond, the effects on the pharma and biotech sector also shifts. Yesterday FDA announced a new concentration of agency assets to be focused … Continue reading →

In response to written questions submitted last month regarding the potential for delays, FDA had stated that “CDER remains fully capable to continue daily activities, while responding to the public needs of the current COVID-19 outbreak.” In a subsequent blog … Continue reading →

April 27, 2020 – As the COVID-19 pandemic continues, the Food and Drug Administration (FDA) must balance safeguarding public health with the desire for timely product reviews. Staff members at the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research are working diligently to keep all of these balls in […]

The European Medicines Agency has begun a rolling review of data on Gilead’s remdesivir, positioning it to cut the time it takes to decide whether to approve the drug in COVID-19 patients.

The FDA has delayed its decision on whether to approve Bristol Myers Squibb’s CAR-T cell therapy by three months. Bristol Myers attributed the delay to its submission of additional information upon the request of the FDA.

The U.S. Food and Drug Administration has approved the first genetically engineered animal for human consumption.

Appeals court calls EPA approval of bee-threatening sulfoxaflor “based on flawed and limited data.”

The agro giant made contradictory claims to the government about the herbicide Enlist Duo, the EPA isn’t happy.

And the company that makes the chemical, Bayer CropScience, refuses to agree.

As we wait for President Obama and the State Department to make a decision on the proposed Keystone XL pipeline, talk seems to have shifted away from why the pipeline should be rejected to what should be done in the event the project is approved.

Elliott Vichinsky, MD, University of California, San Francisco (UCSF) Benioff Children's Hospital Oakland

A Technology Development Story: meet the SYNERGY™ Stent System engineers

Several big firms, including Danish wind turbine manufacturer Vestas, are involved in the project.

Moderna has received FDA approval for the company's Covid-19 vaccine to continue into the second phase. CNBC's Meg Tirrell reports.

Experts warn that vaccine timelines look ambitious and argue more thought is needed on manufacturing.

Dr. Scott Gottlieb, member of the boards of Pfizer and biotech company Illumina and former FDA commissioner, tells "Squawk Box" that a Covid-19 vaccine could be made available for use in "selected circumstances" before it receives official approval for wider distribution.

The Indian Institute of Technology (IIT), Delhi has developed a COVID-19 test kit, which has got the approval of Indian Council of Medical Research (ICMR). "We started working on it by the end of January and got it ready in three months. We wanted to contribute to affordable low-cost diagnostics that could be used in large numbers," V Perumal, Professor at IIT-Delhi, told ANI.

Perumal said that it is a swab testing kit. "Testing will be cheaper than all existing devices," he said, adding that the device is affordable for commercial production. ICMR had on Thursday approved detection assay for COVID-19, which has been developed by researchers at IIT-Delhi's Kusuma School of Biological Sciences (KSBS).

"The assay has been validated at the ICMR with a sensitivity and specificity of 100 per cent. This makes IIT-Delhi the first academic institute to have obtained ICMR approval for a real-time PCR-based diagnostic assay," read a statement from IIT-Delhi.

This is the first probe-free assay for COVID-19 approved by the ICMR and it will be useful for specific and affordable high throughput testing. It can easily be scaled up as it does not require fluorescent probes. The team is targeting large-scale deployment of the kit at affordable prices with suitable industrial partners as soon as possible.

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Switzerland's country-by-country reporting regime meets international standards and the country effectively exchanges the reports it receives with other countries, an OECD peer review has concluded.

The Indian Council of Medical Research (ICMR) will conduct trial in 21 hospitals to assess safety and efficacy of convalescent plasma on COVID-19 patients.

Mortgage Approvals in the United Kingdom decreased to 56.16 Thousand in March from 73.67 Thousand in February of 2020. Mortgage Approvals in the United Kingdom averaged 83.91 Thousand from 1986 until 2020, reaching an all time high of 151.80 Thousand in May of 1988 and a record low of 26.36 Thousand in November of 2008. Mortgage approvals for house purchase refers to the firm offers of lenders to advance credit secured on specific dwellings to their customers. It covers approvals that are fully secured on residential property by a first mortgage. It includes existing borrowers transferring their existing mortgage to another property, lending to first-time purchasers and lending for buy-to-let purposes. This page provides the latest reported value for - United Kingdom Mortgage Approvals - plus previous releases, historical high and low, short-term forecast and long-term prediction, economic calendar, survey consensus and news.

Building Permits in Australia decreased to -4 percent in March from 19.90 percent in February of 2020. Building Permits in Australia averaged 0.33 percent from 1983 until 2020, reaching an all time high of 31.70 percent in May of 2012 and a record low of -21.90 percent in November of 2002. In Australia, Building Permits show the monthly change in the number of total dwelling units approved, including building activity carried out on existing buildings. This page provides the latest reported value for - Australia Building Permits - plus previous releases, historical high and low, short-term forecast and long-term prediction, economic calendar, survey consensus and news.

Mortgage Approvals in Oman increased to 1348 in February from 1087 in January of 2020. Mortgage Approvals in Oman averaged 1485.61 from 2011 until 2020, reaching an all time high of 2595 in March of 2016 and a record low of 139 in July of 2017. This page provides - Oman Mortgage Approvals- actual values, historical data, forecast, chart, statistics, economic calendar and news.

Mortgage Approvals in Spain decreased to 36050 Units in February from 39314 Units in January of 2020. Mortgage Approvals in Spain averaged 52140.30 Units from 2003 until 2020, reaching an all time high of 129128 Units in September of 2005 and a record low of 12146 Units in August of 2013. This page provides - Spain Mortgage Approvals- actual values, historical data, forecast, chart, statistics, economic calendar and news.

Building Permits in Sri Lanka decreased to 2491 in the second quarter of 2019 from 2685 in the first quarter of 2019. Building Permits in Sri Lanka averaged 2866.83 from 1996 until 2019, reaching an all time high of 4505 in the second quarter of 2006 and a record low of 1638 in the second quarter of 2009. This page provides - Sri Lanka Housing Approvals- actual values, historical data, forecast, chart, statistics, economic calendar and news.

At a time when more transactions than ever are happening online, payments behemoth Stripe is announcing three new features to continue expanding its reach. The company today announced that it will now offer card issuing services directly to businesses to let them in turn make credit cards for customers tailored to specific purposes. Alongside that, it’s going […]

Nadine Goncalves is dating model Tiago Ramos and posted a loving photo of the couple on Instagram, despite Ramos being six years Neymar's junior.

Cody Simpson's mother Angie appears to have given her tick of approval on her son's new love Miley Cyrus.

Donald Trump attributed his Wednesday approval rating boost to the recent controversy with Alexandria Ocasio-Cortez and the rest of the freshmen 'squad' of congresswomen.

She recently brought her hilarious Kath & Kim character Sharon Strzelecki back to life, appearing in a series of UberEats commercial with Kim Kardashian.

Top White House officials shelved expert guidance to reopening America from the Centers for Disease Control and Prevention, despite the report being greenlit by the CDC director, the Associated Press reported.The first 17 pages of the report — which spanned more than 60 pages — was initially released by the AP on May 7, after the White House killed its release on April 30, the day federal social distancing guidelines were set to expire.Following the AP report on Thursday, the White House subsequently fast-tracked the approval for release of the guidance.White House spokeswoman Kayleigh McEnany told reporters Friday that the report was not released because CDC director Robert Redfield had not approved of it. However, internal emails obtained by the AP suggest a different timeline.Visit Business

According to another report in the magazine, the duo 'have discussed plans for kids, with Seal meeting Delta's mother Lea to get her tick of approval'.

Arnold Schwarzenegger tweeted a video on Tuesday deriding Donald Trump in the wake of the president's latest approval rating, which Gallup reported on Sunday as being at 39%.

President Trump's attention turned back to his poll numbers Saturday, as he arrived at his Trump International Golf Club in West Palm Beach.

Joe Biden downplayed Donald Trump's approval rating boost during the coronavirus outbreak, claiming all president's have seen a surge during times of crisis in the U.S.

Swiss drug maker Roche says its coronavirus antibody blood test has a specificity rate of 99.8% and a sensitivity of 100%, meaning it would show very few false positives and no false negatives

International Football Association Board's Lukas Brud has revealed that Wenger's proposed major overhaul of the law is not an option and the offside rule will remain the same.

The Bank of England's latest credit conditions survey revealed lenders believe the availability of household unsecured credit will decrease between April and June amid coronavirus.

Many of the institutions or departments who have sent in applications for IPR consideration to the NBA are also represented on the committee which evaluates the applications, reports Kanchi Kohli.

The SC orders the government to constitute an independent environmental regulatory authority. While the flaws in the current arrangement are plain, it is not clear if independence of the regulator alone can address these, writes Kanchi Kohli.

The private sector Baspa II hydel power project went live over two and half years ago and has been selling power to the Himachal Pradesh State Electricity Board. Lack of regulatory approvals and determination of final wholesale tariff has not deterred the company from raising money in capital markets. Himanshu Upadhyaya finds out more.

As the coronavirus pandemic continued sweeping across the globe, NASA put a halt on its usual space-related activities and began developing a prototype ventilator to help combat the deadly virus. The newly developed ventilator has just received emergency approval from the

The Indian auto industry is slowly working its way to restart operations in India, after being shut down for over 40 days. Automobile companies are currently preparing to resume production in accordance with the government's guidelines for ensuring all safety and social distancing norms are followed.

ECB/FCCB approvals decline 31 per cent to $5,564 million during Q1

Delays in environment clearances needs to be addressed on a fast-track basis for achieving coal production target of 795 MT during the current five year plan (2012-17), the Economic Survey said today.

Chris Baker got Angry and Nerdy about Zynga making board games out of online games out of board games. Commenters commented. Baker defends his purchase of said games. And gets Angry.