Aims to track the progress of the infection across the UK

Experts says $20bn needed to vaccinate global population

AbbVie may be working through COVID-19, but it's pressing ahead with its Allergan merger, too—and taking stock of products hit by pandemic lockdowns. That puts Allergan’s aesthetics business top of mind, but AbbVie CEO Rick Gonzalez figures customers are ready and able to return quickly for treatment.

Indonesia reported on Saturday 533 new coronavirus infections, the biggest daily increase, taking the total number to 13,645, health ministry official Achmad Yurianto said.

The Department issued a statement today after JBS and National Beef announced the abandonment of the JBS/National Beef transaction, which the Department had filed suit to block in October.

Soripada Lubis, a naturalized American citizen originally from Indonesia, pleaded guilty today to harboring illegal aliens for commercial advantage and private financial gain. Lubis’ wife, Siti Chadidjah Siregar, a citizen of Indonesia, pleaded guilty to making false statements to federal agents who were investigating the scheme.

A federal grand jury in Fort Smith, Ark., has indicted five men from the Donaldson, Ark., area on federal civil rights charges as well as charges of making false statements to the FBI.

Dustin I. Nix, 21, of Donaldson, Ark., pleaded guilty today in federal court in Hot Springs, Ark., to two federal civil rights charges for his role in a conspiracy to force a woman and her young children from their home in Donaldson because she associated with African Americans.

The Department announced a settlement agreement to make Donna’s, a café and restaurant located in the Mt. Vernon neighborhood of Baltimore accessible to people with disabilities.

The lawsuit alleges that the Valley Club adopted a racially-discriminatory policy to bar summer camps from using its facilities after a group of predominantly African-American school children visited the facility.

Blue Cross Blue Shield of Michigan abandoned its attempt to purchase Physicians Health Plan of Mid-Michigan after the Department informed the companies that it would file an antitrust lawsuit to block the acquisition.

Today President Barack Obama granted pardons to nine individuals.

API Healthcare Corporation has abandoned its merger plans with Kronos Inc. after the Department of Justice expressed concerns that the acquisition would have reduced competition and increased prices in healthcare-specific workforce management technology.

The NASDAQ OMX Group Inc. and IntercontinentalExchange Inc. abandoned their joint bid to acquire NYSE Euronext after the Department of Justice informed the companies that it would file an antitrust lawsuit to block the deal.

Today President Barack Obama granted pardons to eight individuals.

VeriFone Systems Inc., Hypercom Corp. and Ingenico S.A. have abandoned plans for Hypercom to divest its U.S. point-of-sale business to Ingenico.

Attorney General Eric Holder today welcomed Denise O'Donnell as the Justice Department's Director of the Bureau of Justice Assistance.

Attorney General Eric Holder today welcomed Donald B. Verrilli Jr. as the next Solicitor General of the United States.

Thirteen individuals, including five doctors, one pharmacist and one chiropractor, were charged today for their participation in the illegal distribution of pain killers, steroids and human growth hormones through “pill mills” operating in Broward, Palm Beach and Martin Counties in Florida, and through the internet, respectively.

Today President Barack Obama granted pardons to five individuals and commutation of sentence to one individual.

"Nearly half a century has passed since a national tragedy catapulted Lyndon Johnson to the Presidency, and at the same time 'launched a new chapter in America’s story. Those of us who lived through those painful days will never forget LBJ’s first Presidential speech – to a nation in mourning, and in desperate need of strong and steady leadership," said Attorney General Holder.

“This result is a victory for the millions of Americans who use mobile wireless telecommunications services,” said Deputy Attorney General Cole.

"Although we have come together in a time of loss, it is clear that we are bound by more than grief. We are united by our gratitude – for Congressman Payne’s enduring contributions, his many sacrifices, and his inspiring achievement," said Attorney General Holder.

Deryl Paul Dedmon, John Aaron Rice and Dylan Wade Butler, all from Brandon, Miss., pleaded guilty today in U.S. District Court in Jackson to federal hate crime charges in connection with an assault culminating in the death of James Craig Anderson.

Barclays Bank PLC, a financial institution headquartered in London, has entered into an agreement with the Department of Justice to pay a $160 million penalty to resolve violations arising from Barclays’s submissions for the London InterBank Offered Rate (LIBOR) and the Euro Interbank Offered Rate (EURIBOR), which are benchmark interest rates used in financial markets around the world.

Former Alabama Governor Don Siegelman was resentenced today to serve 78 months in prison for his role in bribery, conspiracy, fraud and obstruction of justice charges involving former HealthSouth CEO Richard M. Scrushy.

3M Co. abandoned its plan to acquire Avery Dennison Corp.’s Office and Consumer Products Group, its closest competitor in the sale of adhesive-backed labels and sticky notes, after the Department of Justice informed the companies that it would file a civil antitrust lawsuit to block the deal.

Today President Barack Obama granted pardons to the following seventeen individuals.

Over the course of a remarkable and highly-varied career – spanning more than two decades of service to the legal profession – Zach Fardon has demonstrated his commitment to the cause of justice, and to the highest ideals of America’s legal system.

Today President Barack Obama granted clemency to 21 individuals, consisting of eight commutations and 13 pardons.

A campaign worker was indicted yesterday by a federal grand jury in the Southern District of Texas for allegedly paying voters to vote in a Donna, Texas school board election. Two other campaign workers were indicted on similar charged last week for alleged vote-buying in the election.

A campaign worker pleaded guilty today for paying voters to vote in the November 2012 school board election in Donna, Texas.

Louisiana-Pacific Corp. (LP) abandoned its plan to acquire Ainsworth Lumber Co. Ltd., its close competitor in the sale of a type of manufactured wood-based panel called oriented strand board (OSB), after the Department of Justice expressed concerns about the transaction’s likely anticompetitive effects.

Guadalupe Escamilla, 72, of Weslaco, Texas, pleaded guilty to one count of vote-buying before Chief U.S. District Judge Ricardo Hinojosa in the Southern District of Texas, McAllen Division.

DB Group Services (UK) Limited, a wholly owned subsidiary of Deutsche Bank AG (Deutsche Bank), has agreed to plead guilty to wire fraud for its role in manipulating the London Interbank Offered Rate (LIBOR), a leading benchmark interest rate used in financial products and transactions around the world

As a sponsor or CRO, you understand the importance of a thorough site selection process. A site needs to be able to meet enrollment targets and time frames, protect the rights and safety of study participants, execute the protocol, deliver quality data, and maintain GCP compliance. That’s what your site feasibility surveys and pre-study visits are designed to evaluate. And as you’re assessing a site’s abilities, the site is conducting its own feasibility process. They’re mining their patient database and assessing inclusion/exclusion criteria. They’re reviewing staff credentials and ensuring they have adequate resources to manage the number of subject visits and collect the data the protocol requires.

But when we conduct GCP audits, we find there’s one perspective that is sometimes overlooked by both sides: the needs of the study drug itself.




Study Drug Attributes Affecting Site Selection Process

IP Environment.  Aside from needing sufficient storage space, many drugs have special storage requirements. Does the site have the equipment and resources needed to maintain and adequately monitor and record environmental conditions such as temperature or humidity? Do they have agreements with their vendors that guarantee a specific response time for repairing or replacing faulty equipment? If they lose electricity, do they have back up power, or at least provisions to move the IP off-site? (This is a common auditor question in hurricane-prone areas.)


Preparation of Study Drug.  Does your investigational product need to be reconstituted in a liquid? Do doses need to be compounded in different concentrations? Does the protocol require that an IV solution be prepared, filtered, and sterilized? These activities take time, specially trained personnel, and sometimes specialized equipment such as ventilation hoods. If your protocol demands an involved IP prep, your feasibility survey must include questions that allow you to assess these site capabilities and your pre-study visit should definitely include some time in the pharmacy. 

Drug Administration. Handing over a bottle of capsules to a study participant is one thing; inserting a butterfly catheter into an antecubital vein is something else again. If drug administration is very invasive, you’ll want to verify that the site has taken this into account when providing you enrollment projections. During subject visits, staff members may have to calculate doses, give intramuscular injections, perform infusions, or conduct sterilization procedures. You’ll want to verify that site staff has this expertise if required. Some clinical trials require a blinded dispenser who cannot be involved in any other study procedure or activities. If so, does the site have the resources for this?

Site Selection: it’s not just the PI, it’s the IP too
The study success and patient safety are jeopardized when a site can’t meet its enrollment target or doesn’t have the resources to execute the protocol. IP requirements can affect a site’s ability to do both. It’s critical that your site selection process – both your feasibility questionnaire and your pre-study visit – evaluate how well the site can meet the storage, preparation, and administration requirements of the study drug.

__________________________________________________________________________
A version of this article originally appeared in InSite, the Journal of the Society for Clinical Research Sites.

Photo Credit: By Harmid (Own work) [Public domain], via Wikimedia Commons

With the overwhelming vote in the Parliament in favor of the Commission proposal to amend the MDR it is politically basically a done deal now that the MDR will be amended. After the vote there were people that immediately stated that the amendment was formally approved – not so. We are looking at law making […]

For goodness sake, if you're going to hike, wear a mask.

The daft showdown over coronavirus masks wouldn't matter if we didn't live in the political tinderbox that is Trump's America.

Older people who are more at risk of dying from COVID-19 contribute immeasurably to society, but they should not have to prove their worth.

By Sara W. Koblitz —

In March 2019, Yokogawa completed a demonstration project for the Optimization of the Operation Control of Oil Refining Plants in Indonesia. The New Energy and Industrial Technology Development Organization (NEDO) awarded this project to Yokogawa in 2013.

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.

Former CEO Achmad Zaky stepped down from his position, in a surprise move, in December 2019.

The post Indonesian unicorn Bukalapak’s co-founder & CTO Herucahyono exits appeared first on DealStreetAsia.

Ruangguru CEO Adamas Belva Syah Devara has resigned from its role as the government's special staff.

The post Indonesia Digest: Ruangguru CEO quits govt role; Gojek partners Paxel appeared first on DealStreetAsia.

Wihardja’s appointment comes nine months after his predecessor, former MDI Ventures CEO Nicko Widjaja, quit to join BRI Ventures.

The post Indonesia’s MDI Ventures appoints former AC Ventures partner Donald Wihardja as CEO appeared first on DealStreetAsia.

Indogen is working with its portfolio firms to explore opportunities in Greater China and Japan.

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ESB claims to be enabling restaurants to transition to the cloud-kitchen model amid the COVID-19 outbreak.

The post AC Ventures leads seed round of Indonesian restaurant ERP startup ESB appeared first on DealStreetAsia.