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Justice Department Sues to Stop Florida Tax Return Preparer

The United States has asked a federal court in Tampa, Florida, to stop Octavio Cruz and his company, Advantage Accounting Corp., from preparing federal income tax returns for others, the Justice Department announced today



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Grand Rapids Landlords to Pay $550,000 and Terminate Manager’s Responsibilities to Settle Sexual Harassment Lawsuit Filed by Justice Department

The Justice Department announced today that the owners and operators of the Alger Meadows Apartments in Grand Rapids, Michigan, have agreed to pay $550,000 in damages and civil penalties and to terminate property manager Dale VanderVennen’s role in managing the complex to settle a lawsuit alleging that VanderVennen sexually harassed female tenants in violation of the Fair Housing Act (FHA).



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Justice Department Sues to Stop South Florida Tax Return Preparer Engaged in Fraud and Earned Income Credit Schemes

The United States has asked a federal court in Miami to permanently bar a South Florida man and his two Miami businesses, Ebenezer Tax Services Inc. and Primo Tax Service Inc., from preparing federal income tax returns for others, the Justice Department announced today. He is alleged to have defrauded the government out of more than $20 million



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Justice Department Reaches Agreement with the City of Baltimore to Prevent Disability Discrimination

The Justice Department today announced that it has reached an agreement with the city of Baltimore, Maryland, to end hiring practices that discriminate against people with disabilities. The agreement, filed as a consent decree along with a complaint in the U.S. District Court for the District of Maryland, resolves allegations by the department that the city engaged in a pattern or practice of discrimination under the Americans with Disabilities Act (ADA). Title I of the ADA prohibits employers from discriminating against individuals on the basis of disability in various aspects of employment, including hiring



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Bank of America to Pay $16.65 Billion in Historic Justice Department Settlement for Financial Fraud Leading up to and During the Financial Crisis

Attorney General Eric Holder and Associate Attorney General Tony West announced today that the Department of Justice has reached a $16.65 billion settlement with Bank of America Corporation – the largest civil settlement with a single entity in American history ­— to resolve federal and state claims against Bank of America and its former and current subsidiaries, including Countrywide Financial Corporation and Merrill Lynch. As part of this global resolution, the bank has agreed to pay a $5 billion penalty



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Federal Court Bars Missouri Man from Preparing Federal Tax Returns

A federal court has permanently barred William Naes of St. Charles, Missouri, from preparing federal tax returns for others, the Justice Department announced today. The permanent injunction order, to which Naes consented, was entered by U.S. District Judge E. Richard Webber of the U.S. District Court for the Eastern District of Missouri



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Justice Department Announces Successful Resolution of Consent Judgment Involving Detroit Police Department

The Justice Department today announced the U.S. District Court for the Eastern District of Michigan’s termination of the consent judgment relating to the Detroit Police Department’s (DPD) use of force and arrest and witness detention practices. The Justice Department and the city of Detroit jointly sought the termination of the consent judgment and approval of a Transition Agreement maintaining federal oversight of the DPD for an additional 18 months. The transition agreement starts a new chapter of reform and accountability for the DPD as it works in collaboration with the Justice Department to better ensure constitutional policing, promote community confidence, and improve public safety in the city of Detroit. The Justice Department’s Civil Rights Division and the U.S. Attorney’s Office for the Eastern District of Michigan have worked cooperatively throughout the duration of this matter



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Sixteen Former Puerto Rico Police Officers Plead Guilty to Running Criminal Organization from the Police Department

Sixteen former Puerto Rico police officers have pleaded guilty for their roles in a criminal organization run out of the police department. The officers used their affiliation with law enforcement to commit robbery and extortion, to manipulate court records in exchange for bribes, and to sell illegal narcotics



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Justice Department Sues to Stop Chicago-Area Woman and Her Businesses from Preparing Tax Returns

The United States filed a complaint in federal court in Chicago to bar Laurie G. Helfer, aka Laurie G. Powell, individually and through her businesses Laurie’s Freelance & Tax Preparation Services and Tax Lady Laurie Inc., from preparing federal tax returns for others, the Justice Department announced today



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Department of Justice Releases Second Report to Congress on Indian Country Investigations and Prosecutions

The Department of Justice released today its second report to Congress entitled Indian Country Investigations and Prosecutions, which provides a range of enforcement statistics required under the Tribal Law and Order Act of 2010, as well as information about the progress of the Attorney General’s initiatives to reduce violent crime and strengthen tribal justice systems



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Justice Department Requires Divestiture in Tyson Foods Inc. Acquisition of the Hillshire Brands Company

The Department of Justice announced today that it will require Tyson Foods Inc. to divest Heinold Hog Markets, its sow purchasing business, in order to proceed with its $8.5 billion acquisition of The Hillshire Brands Company. The department said that, without the required divestiture, the transaction would have combined companies that account for more than a third of sow purchases from U.S. farmers, thereby likely reducing competition for purchases of sows from farmers.



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Justice Department Files Suit Against City of St. Anthony Village Over Denial of Permit for Mosque

Acting Assistant Attorney General Molly Moran for the Justice Department’s Civil Rights Division and U.S. Attorney Andrew M. Luger for the District of Minnesota today announced the filing of a lawsuit against the city of St. Anthony Village for an alleged violation of the Religious Land Use and Institutionalized Persons Act of 2000 (RLUIPA). Specifically, the lawsuit seeks injunctive relief requiring St. Anthony Village to allow the Abu Huraira Islamic Center to maintain a worship space in the basement of the St. Anthony Business Center.



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Justice Department Asks Court to Dismiss Saint Elizabeths Hospital Case After Conditions Improved Under Consent Decree

Today, the Justice Department asked a federal court to dismiss the injunction to address civil rights violations at Saint Elizabeths Hospital in Washington, D.C., because the District of Columbia and the Department of Behavioral Health have significantly improved the care and treatment of persons confined to Saint Elizabeths Hospital. Saint Elizabeths is the district’s facility for treating individuals with mental health conditions. The reforms, which were implemented following requirements under a court order, have ensured that persons at Saint Elizabeths Hospital are discharged to the community with adequate supports to live in integrated settings. Further, the reforms resulted in important improvements in integrated treatment planning, psychological and psychiatric services, nursing care and protection from assault.



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Justice Department Files Lawsuit Against Louisiana Crane Company Alleging Discrimination Against Work-authorized Immigrants

The Justice Department announced today the filing of a lawsuit with the Executive Office for Immigration Review against Louisiana Crane Company LLC (Louisiana Crane), which is headquartered in Eunice, Louisiana.



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Justice Department Settles Immigration-Related Employment Discrimination Claim Against a Restaurant Management Company

The Justice Department announced today that it reached an agreement with Culinaire International, a catering and restaurant management company headquartered in Houston, Texas, resolving a claim that Culinaire engaged in citizenship discrimination during the employment eligibility reverification process in violation of the Immigration and Nationality Act (INA).



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Justice Department Seizes an Additional $500,000 in Corrupt Assets Tied to Former President of Republic of Korea

The Department of Justice has seized approximately $500,000 in assets traceable to corruption proceeds accumulated by Chun Doo Hwan, the former president of the Republic of Korea. This seizure brings the total value of seized corruption proceeds of President Chun to more than $1.2 million.



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Attorney General Holder Statement on the Planned Departure of Associate Attorney General Tony West

Attorney General Eric Holder released the following statement Wednesday on the departure, effective September 15, of Associate Attorney General Tony West:



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Attorney General Holder Announces Next Steps to Address Concerns Regarding the City of Ferguson and St. Louis County Police Departments

Attorney General Eric Holder announced today that the Justice Department has launched two initiatives to address concerns about police services in the city of Ferguson and in St. Louis County, Missouri.



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Attorney General Holder Delivers Remarks at Press Conference Announcing Pattern or Practice Investigation into Ferguson Police Department

"These anecdotal accounts underscored the history of mistrust of law enforcement in Ferguson that has received a good deal of attention. As a result of this history – and following an extensive review of documented allegations and other available data – we have determined that there is cause for the Justice Department to open an investigation to determine whether Ferguson Police officials have engaged in a pattern or practice of violations of the U.S. Constitution or federal law."




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Justice Department Participates in Child Cyber Safety Night at Nationals Park, Saturday, September 6th

Child Cyber Safety Night at the Ballpark is the latest effort by the Justice Department and its law enforcement and community partners to encourage parents to speak with their children about online and cell phone safety and provide prevention materials.



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Justice Department Files Fair Housing Lawsuit Against Kent State University for Discrimination Against Students with Disabilities in University Housing

The Justice Department today filed a lawsuit against the Kent State University, the Kent State University Board of Trustees and university officials for violating the Fair Housing Act by discriminating against students with disabilities in student housing.



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Justice Department Settles Religious Discrimination Lawsuit Against School District of Philadelphia

The Department of Justice announced today that it has entered into a settlement agreement with the School District of Philadelphia that resolves a religious accommodations lawsuit filed in March 2014. In its lawsuit, the United States alleged that the school district violated Title VII of the Civil Rights Act of 1964 (Title VII) by failing to accommodate the religious beliefs, observances and/or practices of Siddiq Abu-Bakr, a school police officer who is Muslim, and similarly-situated employees who maintain a beard longer than one-quarter inch for religious purposes.



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Justice Department Sues to Shut Down Mississippi Tax Return Preparer

The United States has requested that the U.S. District Court for the Northern District of Mississippi permanently bar Nathaniel Kimble, Greenville, Mississippi, man from preparing federal income tax returns for others, the Justice Department announced today.



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Owner of Tax Return Preparation Franchise and Health Provider Business Sentenced to Prison for Tax Fraud, Healthcare Fraud and Money Laundering

Claude Arthur Verbal II, formerly of Raleigh, North Carolina, and now of Miami, was sentenced today to serve 135 months in prison for tax fraud, healthcare fraud and money laundering crimes in two separate cases in federal court



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Statement by the U.S. Department of Justice and the Office of the Director of National Intelligence on the Declassification of Documents Related to the Protect America Act Litigation

On January 15, 2009, the U.S. Foreign Intelligence Surveillance Court of Review (FISC-R) published an unclassified version of its opinion in In Re: Directives Pursuant to Section 105B of the Foreign Intelligence Surveillance Act, 551 F.3d 1004 (Foreign Intel. Surv. Ct. Rev. 2008). The classified version of the opinion was issued on August 22, 2008, following a challenge by Yahoo! Inc. (Yahoo!) to directives issued under the Protect America Act of 2007 (PAA). Today, following a renewed declassification review, the Executive Branch is publicly releasing various documents from this litigation, including legal briefs and additional sections of the 2008 FISC-R opinion, with appropriate redactions to protect national security information. These documents are available at the website of the Office of the Director of National Intelligence (ODNI), www.dni.gov; and ODNI’s public website dedicated to fostering greater public visibility into the intelligence activities of the U.S. Government, IContheRecord.tumblr.com. A summary of the underlying litigation follows.



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Federal Court Bars Louisiana Woman from Preparing Federal Tax Returns

A federal court in New Orleans has permanently barred Shawanda Nevers, of La Place, Louisiana, from preparing federal income tax returns for others, the Justice Department announced today.



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Justice Department and CNCS Announce $1.8 Million in Grants to Enhance Immigration Court Proceedings and Provide Legal Assistance to Unaccompanied Children

The Department of Justice and the Corporation for National and Community Service (CNCS), which administers AmeriCorps national service programs, has awarded $1.8 million in grants to increase the effective and efficient adjudication of immigration proceedings involving certain children who have crossed the U.S. border without a parent or legal guardian.



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Department of Justice and Federal Trade Commission Sign Cooperation Agreement with Colombian Antitrust Agency

Assistant Attorney General Bill Baer of the Department of Justice’s Antitrust Division has signed an antitrust cooperation agreement with the Colombian antitrust agency on behalf of the Department of Justice. The agreement also was signed by Federal Trade Commission Chairwoman Edith Ramirez, and went into effect today with the signature of Pablo Felipe Robledo, Colombia’s Superintendent of Industry and Commerce.



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Attorney General Holder Announces Partnership with Department of Housing and Urban Development to Improve Civil Legal Aid for Juveniles

Attorney General Eric Holder is set to announce a partnership between the Department of Justice’s Office of Juvenile Justice and Delinquency Prevention (OJJDP) and the Department of Housing and Urban Development (HUD). HUD will offer new grants to support collaborations between HUD-funded organizations, and civil legal aid programs and public defender offices. The grant funded collaborations will focus on expunging and sealing juvenile records – improving the chances that reentering youth will be able to obtain degrees, find work and secure housing. The announcement is set to be made this evening during the Attorney General’s remarks to the Legal Services Corporation 40th anniversary celebration.



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Court Bars Florida Tax Return Preparer from Preparing Returns for Others

A federal district judge in the U.S. District Court for the Middle District of Florida has permanently barred Jeanne Covington, of Tampa, Florida, and her company, Jeanne’s Tax Preparation and Bookkeeping Inc., from preparing federal income tax returns for others.



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Justice Department Announces National Effort to Build Trust Between Law Enforcement and the Communities They Serve

Attorney General Eric Holder announced today the launch of the Justice Department’s National Initiative for Building Community Trust and Justice.



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Justice Department and State Partners Secure $1.375 Billion Settlement with S&P for Defrauding Investors in the Lead Up to the Financial Crisis

Attorney General Eric Holder announced today that the Department of Justice and 19 states and the District of Columbia have entered into a $1.375 billion settlement agreement with the rating agency Standard &s Financial Services LLC, along with its parent corporation McGraw Hill Financial Inc., to resolve allegations that S&s 2013 lawsuit against S& true credit risks. Other allegations assert that S&s business relationships with the investment banks that issued the securities.



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Justice Department Reaches $470 Million Joint State-Federal Settlement with HSBC to Address Mortgage Loan Origination, Servicing and Foreclosure Abuses

The Justice Department, the Department of Housing and Urban Development (HUD) and the Consumer Financial Protection Bureau, along with 49 state attorneys general and the District of Columbia’s attorney general, have reached a $470 million agreement with HSBC Bank USA NA and its affiliates (collectively, HSBC) to address mortgage origination, servicing and foreclosure abuses



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DSM Insight Series: 1 in 4 Consumers Prepare, Consume Breakfast in Less Than 5 Minutes

DSM today published the first part of a new report in its Global Insight Series, focused on breakfast habits and behavior in Europe and the US.




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Preparing for Pricing in DTC TV

UPDATE 2: On August 21, 2019, the government filed a notice of appeal in this case.

UPDATE: On July 8, 2019, the judge in the pending litigation described below issued an order setting aside the CMS rule. The full opinion is available here.

If nothing changes, the new rule about including drug pricing in TV ads from CMS will go into effect one week from today on July 9, 2019.

There are a few wrinkles to keep in mind as we approach this deadline. First, there's a lawsuit pending that could delay the rule's implementation. Second, the operational challenges of abiding by the rule are the biggest hurdle including the expanded 2253 filing requirements. Third, the rule's scope is still unclear. Fourth, the rule doesn't preclude or preempt the PhRMA Principles change from April. Finally, the overlapping but non-identical scope of the rules could lead to some confusion and compliance hiccups. This post addresses each of these points in turn.

Pending Litigation

As I noted in a previous post, several pharmaceutical companies along with the Association of National Advertisers filed a complaint seeking to overturn the CMS rule. The full complaint is available here. The plaintiffs have filed a motion to stay the rule's implementation, and the judge has set a date of July 8 for issuing a decision. So, it is possible that companies will not actually be required to include their drug pricing in TV spots on July 9; however, as a practical matter, companies airing spots on July 9 and soon thereafter have most likely already developed them with the required pricing information included. 

All promotional materials for prescription drugs, biologics, and vaccines must be submitted to the FDA at time of initial dissemination or publication, so the FDA has most likely already begun receiving submissions of TV spots that include the information, and it is unlikely that a company would go to the time and expense of producing two versions of their TV spots (one with the pricing and one without) and submit both the FDA, only to determine on July 8 which spot to air the next day. Consequently, even if the judge issues a stay on the rule, there's a good chance that you'll see at least a few TV spots featuring pricing on July 9.

And that points to one of the issues the rule raises: operational challenges.

Operational Challenges 

Adding a line of copy to a TV ad is not a massive creative endeavor, and because the rule only requires the copy to appear on screen for a long enough time to be read, there are no audio implications, but the CMS rule requires that the pricing information presented is kept up to date. Specifically, the new rule requires that the pricing information provided be:
"as determined on the first day of the quarter during which the advertisement is being aired or otherwise broadcast." 42 CFR 403.1202 (not yet live on the code of federal regulations itself).

That means the pricing information must potentially be updated every quarter. Of course, most companies don't change their drug pricing quarterly, but it is common to have pricing updates twice per year. So, every time a company changes its pricing, it will have to determine what ads are currently airing and whether the pricing updates affect those ads. If the pricing changes affect the ads, then the ads will have to be updated. An updated TV ad both means an expense for the advertiser, but it also means a new 2253 filing with the FDA because updated materials must be resubmitted to the Agency.

And that means that the media buyers placing the ads will have one additional wrinkle to keep in mind as they manage the ad placements. They'll need to make sure that as new pricing comes into affect and ads are updated that the old ads are removed from the rotation, lest they be placed on CMS's naughty list.

That operational challenge is compounded by the fact that the scope of the rule is unclear, so it's not currently possible to say exactly what ads must include drug pricing.

Rule Scope Unclear

As I noted in a previous post, CMS made it clear that the requirement to include pricing does not apply to ALL direct to consumer (DTC) ads, but only to a limited subset of DTC ads. Specifically, the new requirement applies to only ads that appear on broadcast, cable, satellite, and streaming television. Unfortunately, CMS never explained what "streaming television" is. I tried to find a definition somewhere but wasn't able to do so. This matters because there are tons of DTC video ads that MIGHT be considered subject to the rule that are definitely not presented on "broadcast, cable, or satellite television."

Because of this scope unclarity, the operational challenges of managing ad inventory is compounded, and of course, companies must decide how to handle ads that are used on television when they appear in places where the pricing information is not required. It would certainly be easier to develop a version of the ad that doesn't require quarterly updates, but it also is easier to traffic fewer total ad units.

CMS Rule Adds to (Doesn't Replace) PhRMA's Pricing Requirements

The Pharmaceutical Research and Manufacturers of America (PhRMA) updated its Guiding Principles on Direct to Consumer Advertisements about Prescription Medicines in October of 2018. The most significant change was the addition of a requirement for television ads to include a destination where people can find pricing information about the prescription drug being advertised. This requirement became operative in April of 2019. All members of PhRMA are obligated to follow the PhRMA guiding principles, and most companies that are not members of PhRMA also abide by the guiding principles. Consequently, almost all television commercials currently airing include a link to a webpage with pricing information.

Adhering to the CMS rule does NOT meet the PhRMA guiding principles. Consequently, most companies will be providing both a link to a page with additional information and the pricing information required by CMS. We'll see how companies execute this, but my expectation is that a single screen at the end of a television commercial will accommodate both pieces of information.

Of course, not all ads are required to include both pieces (or even either piece!) of information.

Non-identical Overlapping Scopes

The new CMS rule applies to all advertised indications of a pharmaceutical product that are reimbursed via Medicare or Medicaid and whose cost is at least $35 per month (or for a typical course of treatment). 42 CFR 403.1200. Note that some drugs have multiple indications, where only some of the indications are reimbursed by CMS. For those products, only the ads that promote an indication reimbursed by CMS are required to include the pricing information; and only if the drug's list price is at least $35 per month (or for a typical course of treatment).

By contrast, the PhRMA guiding principles apply to all ads for prescription medicines regardless of whether the drug is reimbursed by CMS and regardless of the cost. Of course, the guiding principles are only binding on members of PhRMA and any non-member companies that have chosen to abide by the guiding principles.

TL;DR

Some commercials (but we don't know exactly which ones) might start having pricing information in one week. The addition of this information is allegedly going to address the allegedly high price of prescription drugs. The only guaranteed aspect of the recent changes from PhRMA and CMS is that marketing and regulatory operations groups are going to have challenges ensuring ongoing compliance, and the FDA is about to start getting more 2253 filings, including a likely surge of revised television spots in the next few days.




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Repairing spinal cord injuries with a protein that regulates axon regeneration

Temple University researchers discovered that boosting levels of a protein called Lin28 in injured spinal cords of mice prompts the regrowth of axons and repairs communication between the brain and body. They believe the discovery could be used to develop new treatments for both spinal cord and optic nerve injuries.




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Despite sales bump, brands that are not preparing for stormy seas ahead could struggle, consultant says

The dietary supplement industry as a whole is enjoying booming sales as consumer stock up on products to support optimum health. But an industry strategist warns that that sales bump is likely to be ephemeral, and brands that are not strategizing vigorously now may be caught out in the near future.




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Editorial: California was ready for a recession, but nothing could have prepared it for coronavirus

The good news: The state is far better prepared to meet this challenge than it was a decade ago. The bad news: It will need help from the feds, and a lot of it.




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Hong Kong stock exchange CEO to depart after 10 years at helm




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ASEAN banks prepare for flood of bad loans amid coronavirus havoc






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Bank Exam Preparation Tips 2020 at Home: IBPS PO, IBPS Clerk, IBPS RRB, SBI Clerk, RBI, LIC

Bank Exams Preparation Tips 2020: Have a look at important Tips and Strategies for bank exam preparation to fetch recruitment in banks as PO/Clerk/SO. Know details of SBI Clerk 2020, IBPS RRB 2020, IBPS PO 2020, IBPS Clerk 2020, RBI Assistant 2020, LIC AAO/ADO 2020 and other bank exams. 




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Igniting autophagy through the regulation of phase separation




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MACROD2 deficiency promotes hepatocellular carcinoma growth and metastasis by activating GSK-3β/β-catenin signaling




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California NICU disaster preparedness




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Biomimetic niches reveal the minimal cues to trigger apical lumen formation in single hepatocytes




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A methylation functional detection hepatic cell system validates correlation between DNA methylation and drug-induced liver injury




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The sustained undermining of science by the EPA’s leaders is a travesty




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Composition-dependent thermodynamics of intracellular phase separation