The BJP leaders waged a social media war against the Bengal government by accusing the state of hiding Covid-19 figures and also complaining the Centre that TMC-led government in Bengal has completely failed in handling the coronavirus crisis.

UFC returns to action this weekend with an action-packed card of action from Florida.The mixed martial arts organisation comes back after a coronavirus-enforced hiatus on Saturday night in Jacksonville with a 11-fight bill headlined by Tony Ferguson’s clash against Justin Gaethje for the interim lightweight title.

ESPN+ subscribers can get a great deal on the Saturday PPV event.

The Cleveland Cavaliers overcame the absence of LeBron James to earn a 97-95 victory over the San Antonio Spurs on Monday.

When David Haye agreed to swap the boxing gym for a poker table and challenge the world's best, the former heavyweight and cruiserweight world champion admits he did not know what he was letting himself in for.

Kate and William have thanked the public for Prince Louis's birthday wishes by sharing an adorable behind the scenes photograph of the young royal, who turns two today.

Kevin Love's Cavs became one of the first teams in the NBA to reopen their practice facility for voluntary individual workouts, a process that Love described as "weird" but also "pretty uplifting."

While this drama set in a shadowy San Francisco tech start-up is wonderful to look at, its plot and character development are a little shaky

Garland says sci-fi show is 'companion piece' to 2014 film Ex Machina

With comedy festivals cancelled around the world, Amazon Prime is releasing 10 original Australian standup specials to tide you over. Filmed at Melbourne's Malthouse theatre during the Before Times, the biweekly series has featured names like Celia Pacquola, Zoë Coombs Marr and Dilruk Jayasinha – with Tom Gleeson, Anne Edmonds and Tom Walker coming up soon. A few minutes of each is being published exclusively on Guardian Australia, and this week we have Judith Lucy, from her 2019 tour Judith Lucy vs Men

• Two Amazon Original standup specials will be released each week from 10 April. Amazon Prime is offering a 30-day free trial here

Continue reading...

Paul Pogba vs Graeme Souness is the feud that keeps on giving after the two exchanged barbs again on Tuesday.

Football has been suspended for the foreseeable future due to the coronavirus pandemic.

Suggestions that the staging of Liverpool's Champions League clash with Atletico Madrid may have led to a spike in coronavirus cases in the city have today been described as 'an interesting hypothesis' by a scientific advisor to the government.

The government have been urged to conduct an investigation into links between Liverpool hosting a Champions League meeting with Atletico Madrid and a spike in cases of coronavirus in the city.

Football fans will finally have some live action to watch on Friday, when the South Korean K-League returns from its coronavirus shutdown.

Welcome to Standard Sport's LIVE coverage of the K-League openers between Jeonbuk Hyundai Motors and the Suwon Samsung Bluewings

A social media influencer who led police on a chase with a child in the car has been jailed, but not before she posted videos and selfies on her way to court.

While potential for finishing the 2019-2020 NBA season remains in doubt, the folks at NBA 2K have moved forward with simulating the results. The 2K Sim playoffs have completed their conference championships and are ready to “play” the final round. In...

The story of Kobe Bryant and Michael Jordan sharing the court the last time on March 28, 2003, when the kid scored 55 points and the G.O.A.T. had 23.

Chargers open NFL season on road against Cincinnati Bengals and then make SoFi Stadium debut in Week 2 against defending Super Bowl champion Kansas City Chiefs.

THEY didn’t exactly steal a firetruck, but Cleveland fans have made good use of it as part of their celebrations of the Cavaliers’ first NBA title.

Tony Ferguson and Justin Gaethje clash for the interim lightweight title tonight in Florida while Dominick Cruz takes on bantamweight champion Henry Cejudo in the co-main event

(MedPage Today) -- Study Authors: Robert Zeiser, Nikolas von Bubnoff, et al.; Nelson Chao Target Audience and Goal Statement: Oncologists, hematologists The goal of this study was to determine the benefit/risk profile of the Janus kinase (JAK...

Four veteran GOP campaign managers gathered—virtually—to predict an unprecedented race that’s been blindsided by a pandemic and an economic collapse.

The senior senator faces an especially difficult reelection challenge. Did she change or did her voters?

When evaluating public cloud providers on pricing, it is easy to get hung up on the differences. AWS and Google Cloud each have their own service catalog, terminology and purchasing variations. But do these differences actually impact the final bill?

Keep on reading: Google Cloud vs. AWS: Who Has The Best Pricing?

This week, I’m rerunning some popular posts while I prepare for this Friday’s video webinar: Industry Update and COVID-19 Impact: PBMs & Payers.

Today's rerun highlights one of the most effective tactics that PBMs have developed to extract deeper discounts from brand-name drug makers. COVID-19 seems likely shift the U.S. payer mix away from commercial health plans. Expect even tighter formulary management and more restrictions as PBMs work even harder to cut costs for their plan sponsor clients.

Click here to see the original post and comments from January 2020.

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For 2020, the two largest pharmacy benefit managers (PBMs)—Express Scripts and the Caremark business of CVS Health—have again increased the number of drugs they have excluded from their standard formularies. The 2020 formulary exclusion lists are available below for your downloading pleasure.

Below, I highlight my key takeaways from the 2020 lists:

• The number of exclusions

• Management of specialty drugs

• Indication-based formularies

• The slow adoption of biosimilars

• The PBMs’ patient-unfriendly exclusions in the hepatitis C category

Formulary exclusions have emerged as a powerful tool for PBMs to gain additional negotiating leverage against manufacturers. The prospect of exclusion leads manufacturers to offer deeper rebates to avoid being cut from the formulary. Exclusions are therefore a key factor behind falling brand-name net drug prices.

Read on for a look at this year’s exclusions along with some closing thoughts on what exclusions mean for patients.
Read more »

CVS Pharmacy Inc., the retail pharmacy division of CVS Caremark Corporation that operates more than 7,000 retail pharmacies in 41 states and the District of Columbia, has agreed to pay the United States and 10 states $17.5 million to resolve False Claims Act allegations.

In one of the first False Claims Act settlements involving Medicare’s Prescription Drug Program, known as Part D, RxAmerica LLC. has entered into a civil settlement agreement with the United States in which it has agreed to pay the government $5.25 million to resolve allegations that it made false submissions to the Centers for Medicare & Medicaid Services (CMS), the Justice Department announced today. RxAmerica, a wholly-owned subsidiary of CVS Caremark Corporation, provides prescription drug benefits to Medicare beneficiaries pursuant to a prescription drug plan.

Caremark LLC, a pharmacy benefit management company (PBM), will pay the government and five states a total of $4.25 million to settle allegations that it knowingly failed to reimburse Medicaid for prescription drug costs paid on behalf of Medicaid beneficiaries, who also were eligible for drug benefits under Caremark-administered private health plans.

Today's Daily Dose brings you news about Bristol-Myers' CheckMate -743 study results; Cyclacel Pharma's entry into COVID-19 drug bandwagon; Exelixis touching a new 52-week high and Novartis exploring anti-malaria drug for COVID-19.

From : Communities>>Regulatory Open Forum
This message was posted by a user wishing to remain anonymous Dear RAPS members, I am preparing a submission for a device that has no special controls and we have identified the following standards to name a few. 62304-  ANSI AAMI IEC   62304:2006/A1:2016 62366-1:2015-  Medical Devices - Part 1: Application Of Usability Engineering To Medical Devices 14971- Medical Devices - Applications Of Risk Management To Medical Devices I am trying to see what approach will be good. Should I prepare a DOC or [More]

From : Communities>>Regulatory Open Forum
This message was posted by a user wishing to remain anonymous I'd recommend a statement that you are using these standards as general use. A Declaration of Conformity allows you to submit less testing information, but FDA still may request it. In the case of the standards you mentioned, FDA will require that information (e.g. software documentation, risk management, etc). So I would not bother with the DoC as you still have to submit all that material. Here was a nice thread discussing the topic [More]

From : Communities>>Regulatory Open Forum
Hello Anonymous  You will be generating software documents (which is data of a sort), in accordance  with  ANSI-AAMI IEC 62304, and there is output from ISO 14971 which goes into the submission.   I just think DoCs are wasteful busy time and would do as few as possible. Regarding IEC 62366-1, maybe if you want mention it and do a DoC, but if the device  usability  study is not required in a submission don't  put it in there unless asked.  Just my opinion. Biocompatibility if used, is generating test [More]

From : Communities>>Regulatory Open Forum
This message was posted by a user wishing to remain anonymous For device-lead drug combination products, is there any difference in the quality (grade) of API used compared to a pure drug product? The cGMP guidance for combination products does not seem to specify, and since drug claims cannot be made on device-lead drug combination products, it was not clear what quality of drug is required. Thank you!

From : Communities>>Regulatory Open Forum
​I doubt FDA would have any willingness to change the requirements or expectations for a drug product based on whether it is in a strictly drug product versus in a combination product.  The fact also that there is not a published allowance for this is further evidence that FDA expects that the drug will meet the requirements as expected for drug products without providing any allowed changes or classes of changes.  Remember, FDA expects that drug products meet specific requirements.  Things like [More]

From : Communities>>Regulatory Open Forum
Hello, I agree with Ginger, when you look at standards there will most likely be an output of documents from following those standards, i.e. risk management file, usability report, all the software documentation.  These would be included in the different sections of the 510(k) so you can claim them as recognised standards you are following.  I have mentioned in previous posts, we take a simple approach for the declaration of conformity to standards that is a small table describing what we are complying, [More]

The carrier strike group is expected to be deployed in the US Central Command region, where the US Navy currently has no aircraft carrier stationed.

Nov 24, 2019

How do the two major approaches to carbon pricing compare on relevant dimensions, including efficiency, cost-effectiveness, and distributional equity? This paper addresses this question by drawing on theories of policy instrument choice pertaining to the attributes — or merits — of the instruments.

Nov 24, 2019

How do the two major approaches to carbon pricing compare on relevant dimensions, including efficiency, cost-effectiveness, and distributional equity? This paper addresses this question by drawing on theories of policy instrument choice pertaining to the attributes — or merits — of the instruments.

Jan 15, 2020

The events surrounding the US assassination of Iranian Quds Force leader Major General Qassem Soleimani brought to the surface the two main ideological forces that now battle each other across the Middle East - the anti-imperial "resistance" of Iran and its Arab allies, and the freedom "revolution" of domestic protesters in the same lands. 

Jan 15, 2020

The events surrounding the US assassination of Iranian Quds Force leader Major General Qassem Soleimani brought to the surface the two main ideological forces that now battle each other across the Middle East - the anti-imperial "resistance" of Iran and its Arab allies, and the freedom "revolution" of domestic protesters in the same lands. 

Jan 15, 2020

The events surrounding the US assassination of Iranian Quds Force leader Major General Qassem Soleimani brought to the surface the two main ideological forces that now battle each other across the Middle East - the anti-imperial "resistance" of Iran and its Arab allies, and the freedom "revolution" of domestic protesters in the same lands. 

Jan 15, 2020

The events surrounding the US assassination of Iranian Quds Force leader Major General Qassem Soleimani brought to the surface the two main ideological forces that now battle each other across the Middle East - the anti-imperial "resistance" of Iran and its Arab allies, and the freedom "revolution" of domestic protesters in the same lands. 

Jan 15, 2020

The events surrounding the US assassination of Iranian Quds Force leader Major General Qassem Soleimani brought to the surface the two main ideological forces that now battle each other across the Middle East - the anti-imperial "resistance" of Iran and its Arab allies, and the freedom "revolution" of domestic protesters in the same lands. 

Jan 15, 2020

The events surrounding the US assassination of Iranian Quds Force leader Major General Qassem Soleimani brought to the surface the two main ideological forces that now battle each other across the Middle East - the anti-imperial "resistance" of Iran and its Arab allies, and the freedom "revolution" of domestic protesters in the same lands.