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Adele's former personal trainer speaks about star's dramatic weight loss

The singer shared a post on Instagram to mark her 32nd birthday, revealing her slimmer frame




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Corrie star Colson Smith almost unrecognisable after incredible weight loss

The Corrie favourite has stunned fans with his new look after taking up running




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It’s Not Always Easy Being Green – Lawsuit Related to “Recyclable” Claims Highlights Risks Related to Environmental Benefit Claims

By: Jacqueline Chan and Vanessa Fulton Consumers are increasingly demanding environmentally-friendly products and packaging.  Driven by this increased demand and desire to create positive environmental change, companies are working hard to shift to more sustainable materials and packaging and seeking to communicate such efforts to consumers through product labels and advertising.  “Recyclable.”  “Biodegradable.”  “Made of

The post It’s Not Always Easy Being Green – Lawsuit Related to “Recyclable” Claims Highlights Risks Related to Environmental Benefit Claims appeared first on Kleinfeld Kaplan & Becker LLP.




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Potential of Ayurveda should not be ignored in the fight against COVID─19: Dr Saravadekar




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AIOCD urges govt to provide insurance cover to chemists to strengthen fight against COVID─19




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Q and A: How Protolabs and Essentium are helping fight Covid-19

MPN editor Laura Hughes reached out to Blake Teipel (BT), CEO and co-founder of Essentium, and Gurvinder Singh (GS), global product director, injection moulding at Protolabs, to find out how the companies were helping with the pandemic.




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How to ensure high quality plastics are delivered on time

During Covid-19, magnetic separation, metal detection, and conveying products are essential because they support the plastics processing industry and protect plastic from metal contamination.




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Greenlight Guru announces partnership to simplify global market access for medical device companies

Greenlight Guru, a Medical Device Quality Management Software (MDQMS) platform, has teamed up with Emergo by UL, a consulting firm specialising in global medical device regulatory compliance.




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Low-Dose Rivaroxaban Green-Lighted by FDA

For continued prevention of recurrent VTE




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Huffington Post: Data Exclusivity: Getting the Balance Right

Huffington Post: Data Exclusivity: Getting the Balance Right      A great article on the downsides of cutting or removing data exclusivity provisions for biologics.  The article points out that data protection is needed to enhance safety and create incentives to research and produce new innovative drugs that cost billions of dollars.  However, the author argues that the period must be […]




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Supreme Court Affirms: High Level of Proof Needed to Invalidate A Patent

Posted by Stephanie Fischer on June 10, 2011 at 3:29pm EDT on BIOtech Now The U.S. Supreme Court issued a favorable decision yesterday in the critical case of Microsoft v. i4i, in which Microsoft challenged the “clear and convincing evidence” standard traditionally used by courts in determining whether to invalidate an issued U.S. patent.   Microsoft argued for a lower “preponderance […]




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Ventus Launches With $60M to Shine Light on Innate Immune System Drugs

The innate immune system has become a hot area for drug development, and for good reason. As the body’s first line of defense, its function (or dysfunction) plays a role in many diseases. The problem, says Ventus Therapeutics CEO Marcelo Bigal, is that drug developers have been working in the dark. Scientists don’t know the […]




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Steven T Gill returns to Alimera as VP, Thought Leader Engagement

Ophthalmology specialist Alimera Sciences has announced that Steven T Gill is to return to the company in the newly created role of Vice President, Thought Leader Engagement.

Gill had previously served at Alimera as its Senior Director, Thought Leader Liaison, before leaving the company for Novartis, where he most recently held the position of Associate Director, Thought Leader Liaison at Novartis US.

read more




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ThoughtSphere lands patent for clinical trial data technology

The data management solution is designed to help sponsors and CROs manage data more effectively, increasing cost efficiency and effectiveness.




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Why Part D Plans Prefer High List Price Drugs That Raise Costs for Seniors (rerun)

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.

Part D reform has faded from the policy debate. This rerun explains why it is still needed. FYI, this is my favorite article from 2020 (so far).

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



Our high-list-price/high-rebate system remains a fundamental source of warped incentives and cascading problems within the Medicare Part D program.

For proof, check out the previously unpublished data below on market share for products that treat hepatitis C. Despite manufacturers offering products with lower list prices, Medicare Part D plans have rejected the therapeutically identical but lower-priced versions of these drugs.

List prices significantly affect seniors’ out of-pocket costs, so Part D plans are needlessly costing many of them thousands of dollars. The federal government's Medicare spending is also unnecessarily higher.

Anyone concerned about drug prices should pay close attention to this situation. Part D plans and seniors who don’t need specialty medications are benefiting, while seniors who need treatment with specialty medications are ripped off. Just another day inside the gross-to-net bubble!
Read more »
        




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Express Scripts vs. CVS Health: Five Lessons From the 2020 Formulary Exclusions and Some Thoughts on Patient Impact (rerun)

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.




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 »
        




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'Breakthrough' COVID-19 Tests Are Currently Cheap, Fast--and Not Very Accurate

Antigen-based assays could be used in the home, but critics say their error rates are still an issue

-- Read more on ScientificAmerican.com




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DIY Tool Lets High Schoolers Practice Gene Editing  

With a few dollars, researchers replicated an instrument that typically costs thousands 

-- Read more on ScientificAmerican.com




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ACRO Opposes Fatally-Flawed Right-To-Try Legislation

In May of 2017 the Board of Directors of the Association of Clinical Research Organizations, which represents the world’s leading clinical research...




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ACRO offers unique insights on risk-based monitoring of clinical trials, calls for adoption of RBM as a best practice

Following meetings with then-Commissioner Scott Gottlieb and senior leadership from the Center for Drug Evaluation and Research on the role of CROs and technology companies in designing and implementing risk-based monitoring (RBM) of clinical trials, ACRO this week submitted extensive comments on recent FDA Guidance.Increasing the use of innovative RBM technologies helps make clinical trials safer, more efficient and higher quality. ACRO’s comments offer unique insights into the recent expansion of RBM implementation and call for further increasing the use of these oversight technologies.




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“We’re active in the right businesses”

Coronavirus crisis: Employee safety at the top of the agenda / First DAX company to hold virtual stockholders’ meeting / Strategic and operational targets attained in 2019 / Dividend of 2.80 euros per share proposed / Good start to fiscal 2020 / Winkeljohann to succeed Wenning as Supervisory Board Chairman




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Covid-19 could mark a deadly turn in Ghana's fight against fake drugs

With substandard medicines already in wide circulation, fears are growing that coronavirus could create a lethal ‘parallel crisis’

When Joana Opoku-Darko’s daughter Anna was 18 months old, she came down with malaria, a disease common in Ghana and especially deadly for children.

She bought medication from a pharmacy in Ghana’s capital, Accra; when Anna’s fever didn’t subside she took her to a hospital, where they ran some tests.

The current focus on curbing Covid-19 spread means there is less focus on routine market surveillance

Related: Fight the fakes: how to beat the $200bn medicine counterfeiters | Helen Lock

Continue reading...




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European Medicines Agency’s review of Picato finds its risks outweigh its benefits

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has confirmed that the risks from using Picato are too high to end its suspension.




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‘Excess deaths’ in England among the highest in Europe

English excess deaths from the coronavirus are comparable to the worst hit countries in Europe, according to a Sky News analysis.




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UK contact-tracing app being tested on the Isle of Wight

The NHS’s coronavirus contract tracing app has been published to Apple and Google’s app stores with council staff and healthcare workers being invited to download it on the Isle of Wight today.




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First French case of COVID-19 occurred in December, a month earlier than previously thought

A French patient who suffered from pneumonia in December actually had COVID-19, it has been revealed.




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Coronavirus contact-tracing app trial to begin on the Isle of Wight

Initial roll-out will see key workers utilise the app




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Antibodies from llamas could help in fight against COVID-19

The hunt for an effective treatment for COVID-19 has led one team of researchers to find an improbable ally for their work: a llama named Winter. The team - from The University of Texas at Austin, the National Institutes of Health and Ghent University in Belgium - reports their findings about a potential avenue for a coronavirus treatment involving llamas on May 5 in the journal Cell.




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Ferring in sight of finish line with first microbiome-based drug

Swiss drugmaker Ferring and its Rebiotix subsidiary have announced a world first with a microbiome-based…



  • Antibiotics and Infectious diseases/Biotechnology/Drug Trial/Ferring Pharmaceuticals/Microbiomes/RBX2660/Rebiotix/Research/Switzerland

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An important option in the fight against antimicrobial resistance

Positive Phase III data for Recarbrio (imipenem/cilastatin/relebactam) have been announced by New Jersey,…



  • Antibiotics and Infectious diseases/Biotechnology/Drug Trial/Merck & Co/Recarbrio/Regulation/Research/US FDA/USA

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Global pharma and biotech’s fight against COVID-19: an investment perspective

Mark Brewer, who heads up the life sciences team at UK broker and M&A advisory company, finnCap, gives…



  • Actemra/Anti-virals/Avacta/Avigan/Biotechnology/Business Financing/Chloroquine/Coronavirus/Cytiva/Expert View/Faron Pharmaceuticals/favipiravir/Focus On/Fujifilm/Gilead Sciences/Hydroxychloroquine/In Depth/Medical Devices and Diagnostics/Novacyt/Remdesivir/Roche/SNG001/Synairgen/UK

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Can the price be right? With the world watching, Gilead faces a no-win decision on remdesivir

The world is waiting for Gilead Sciences to set a price tag for remdesivir, the first brand-new med authorized to treat COVID-19. Its choice will affect Gilead's reputation and bottom line, set a tone for follow-up meds—and either help polish up the pharma industry's image or create a new flashpoint for criticism.




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Federal agency finds 'reasonable grounds to believe' Rick Bright's whistleblower claims: NYT

Only days after former BARDA chief Rick Bright filed a whistleblower complaint alleging retaliation by the Trump administration, the U.S. Office of the Special Counsel has recommended his temporary reinstatement, the New York Times reports.




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Former Florida State Corrections Officer Convicted of Federal Civil Rights Crime

A federal jury in Jacksonville, Fla., found Paul Tillis, a former Florida Department of Corrections officer, guilty on Jan. 16, 2009, of a felony federal civil rights violation for an August 2005 assault on an inmate.



  • OPA Press Releases

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Chicago Police Officer Pleads Guilty to Violating Federal Civil Rights of a Man Beaten While Restrained in a Wheelchair

A Chicago police officer pleaded guilty today to violating the federal civil rights of a man whom the officer struck repeatedly with a dangerous weapon while the man was handcuffed and shackled in a wheelchair.



  • OPA Press Releases

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Eight Charged with Illegally Harvesting and Selling Striped Bass

Five commercial fishermen in St. Mary’s County, Md., a fish wholesaler, its owner and an employee have been charged in Maryland and Washington, D.C., for their role in the illegal harvest, sale, and purchase of hundreds of thousands of pounds of striped bass from the Chesapeake Bay and Potomac River from 2003 through 2007.



  • OPA Press Releases

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Two Oklahoma County Corrections Officers Indicted for Federal Civil Rights Violation in Death of Oklahoma City Man

A federal grand jury indictment was unsealed today in Oklahoma City charging corrections officers Gavin Littlejohn, 25, of Oklahoma City, and Justin Isch, 21, of Edmond, Okla., with a federal civil rights violation for the fatal assault of Christopher Beckman at the Oklahoma County Detention Center in May 2007.



  • OPA Press Releases

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Former Mississippi County Deputy Sheriffs Plead Guilty to Civil Rights Violations

Former Tippah County, Miss., Deputy Sheriff Jeffrey Rogers, 35, pleaded guilty today to a one-count information charging him and former Deputy Sheriff William Rogers with violating the civil rights of an arrestee. William Rogers, 56, who is Jeffrey Rogers’ father, pleaded guilty on Jan. 20, 2009, to the same charge of violating the civil rights of an arrestee.



  • OPA Press Releases

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Former Memphis Police Officer Found Guilty on 44 Counts of Civil Rights, Narcotics, Robbery and Firearms Charges

A federal jury in Memphis, Tenn., today found Arthur Sease IV, a former Memphis Police Department officer, guilty on forty-four counts of civil rights, narcotics, robbery and firearms offenses. The evidence at trial showed that from November 2003 through April 2006, Sease conspired with other Memphis police officers to use their authority as law enforcement officers, including their service weapons, to rob suspected drug dealers of cash, cocaine and marijuana. Sease and his co-conspirators would then resell the stolen drugs for their own profit.



  • OPA Press Releases

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Former Velda City, Mo., Reserve Police Officer Pleads Guilty to Civil Rights and Obstruction Charges

A former Velda City, Mo., auxiliary reserve police officer pleaded guilty today to violating the federal civil rights of a woman he sexually assaulted during a traffic stop and to concealing evidence of his crime from federal investigators. According to facts presented in court, on or about July 9, 2006, Joe Ernest Phillips, 38, then an auxiliary reserve police officer for the Velda City Police Department sexually assaulted a woman while acting under color of law and deprived her of her civil rights.



  • OPA Press Releases

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Justice Department Reaches Settlement with SmallTownPapers Inc., Regarding Employment Rights of Air Force Reservist

The Department has reached a settlement that, if approved by the court, will resolve a lawsuit the Department filed on behalf of Air Force Reservist Frank Bonnin against SmallTownPapers Inc., (SmallTownPapers). The complaint, filed in August 2008 in U.S. District Court in Seattle, alleged that SmallTownPapers violated the Uniformed Services Employment and Reemployment Rights Act of 1994 (USERRA) when it terminated Bonnin from his position as director of publisher relations due to his military obligation as an Air Force Reservist to attend active duty training.



  • OPA Press Releases

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APL Ltd. to Pay U.S. $26.3 Million to Resolve Fraud Allegations for Inflated Shipping Costs to Military in Iraq and Afghanistan

APL Limited has agreed to pay the government $26.3 million to resolve allegations that it submitted false claims to the United States in connection with contracts to transport cargo in shipping containers to support U.S. troops in Iraq and Afghanistan.



  • OPA Press Releases

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Justice Department Settles Lawsuit Against the City of Dayton, Ohio, Alleging Discrimination Against African Americans in the Hiring of Police Officers and Firefighters

The Department announced today that it has entered into a consent decree with the city of Dayton that, if approved by the court, will resolve the Department’s complaint that Dayton has been engaged in a pattern or practice of discrimination against African-Americans in its hiring of entry-level police officers and firefighters, in violation of Title VII of the Civil Rights Act of 1964 (Title VII).



  • OPA Press Releases

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Justice Department Files Lawsuit Against Wagner Industrial Electric Inc., to Enforce the Employment Rights of Indiana Army National Guardsman

The Department announced today that it has filed a lawsuit on behalf of Kevin Stenger, an Indiana National Guard member, against Wagner Industrial Electric Inc. (Wagner), alleging violations of the Uniformed Services Employment and Reemployment Rights Act of 1994 (USERRA). USERRA was enacted in 1994 to protect service members from being disadvantaged in their civilian careers due to serving in the uniformed services.



  • OPA Press Releases

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Justice Department Settles Lawsuit Against Ecolab Inc. to Enforce Employment Rights of Michigan U.S. Army Veteran

The Department announced today that it has entered into a consent decree with Ecolab Inc. (Ecolab) that will resolve the Department’s complaint, which was filed today, that Ecolab failed to reemploy Michigan veteran Stephen Alasin in violation of the Uniformed Services Employment and Reemployment Rights Act of 1994, as amended (USERRA). The consent decree was approved by the court today as well.



  • OPA Press Releases

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Justice Department Settles Lawsuit Against Stimson Lumber Company to Enforce the Employment Rights of Oregon Reservist

The Department announced today that it has entered into a consent decree with Stimson Lumber Company (Stimson) that, if approved by the court, will resolve the Department’s complaint, also filed today, that Oregon-based Stimson failed to reemploy Oregon reservist David Eckhardt in violation of the Uniformed Services Employment and Reemployment Rights Act of 1994 (USERRA).



  • OPA Press Releases

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Fairfield, Calif., Couple Indicted on Federal Civil Rights Charge for Alleged Bias-Motivated Assault

A Fairfield, Calif., couple was indicted today by a federal grand jury in Sacramento, Calif., on federal civil rights charges related to an alleged bias-motivated assault on an Indian-American couple. The two-count indictment alleges that on the evening of July 14, 2007, Joseph and Georgia Silva committed a bias-motivated assault on another couple at a public beach in South Lake Tahoe, Calif.



  • OPA Press Releases

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Former Lucas County, Ohio, Sheriff’s Office Corrections Officer Sentenced for Civil Rights Violations

A former corrections officer with the Lucas County, Ohio, Sheriff’s Office was sentenced today to four years in prison for violating the civil rights of inmates in his custody at the Lucas County jail, as well as private citizens on the streets of the greater Toledo area. Today in federal district court in Toledo, Ohio, Judge Jack Zouhary also sentenced the former corrections officer, Seth Bunke, to three years of supervised release following the prison term.



  • OPA Press Releases

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Justice Department Files Lawsuit Against Americraft Carton Inc., to Enforce the Employment Rights of Michigan Army National Guardsman

The Department today filed a lawsuit on behalf of David D. Sweatt, a Michigan Army National Guard member currently serving in Iraq, against Americraft Carton Inc. (Americraft), alleging violations of the Uniformed Services Employment and Reemployment Rights Act of 1994 (USERRA).



  • OPA Press Releases

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U.S. Border Patrol Agent Indicted on Federal Civil Rights Charge for Assault in Federal Detention Facility

A U.S. Border Patrol agent has been indicted by a federal grand jury in Tucson, Ariz., on federal civil rights charges related to an alleged assault on a detainee at a federal detention facility. The two-count indictment, returned on March 11, 2009, alleges that on May 10, 2006, Eduardo Moreno violated the civil rights of a federal detainee by assaulting and causing bodily injury to the individual while Moreno was on duty at the U.S. Border Patrol processing facility in Nogales, Ariz.



  • OPA Press Releases