UPDATE: HOLDEN will review its sponsorship deal with Collingwood after president Eddie McGuire’s radio attack on female football writer Caroline Wilson.

Netflix's new documentary, "Becoming," a companion to Michelle Obama's memoir of the same name, is unlikely to change one's view of its subject.

Rapman moves from YouTube to feature films with "Blue Story," a tale of two South-East London friends living in different neighborhoods torn apart by gang violence.

Veteran character actor Peter Gerety has a meaty role in Richard Jury's "Working Man" even as the movie shifts from quiet dignity into melodrama.

Andrew Ahn's lovely second feature "Driveways" also stars Hong Chau and Lucas Jaye.

The feature directing debut for actor Clark Duke, "Arkansas" amiably places Liam Hemsworth in a dangerous world of low-level criminals.

Beanie Feldstein stars

In "Becoming Kim Jong Un," former CIA officer expands our understanding of North Korea's dangerous, precarious regime by taking its leader seriously

Amy Jo Burns' novel, "Shiner," illuminates an Appalachia whose men "pray for God to show Himself while our wives wash their husbands' underpants."

More pensive than lively fun, Christophe Honoré's "On a Magical Night" casts Chiara Mastroianni as a woman rethinking her marriage after 20 years of her own infidelity.

Coronavirus muted the hype of Microsoft's Xbox Series X reveal. But there was "Assassin's Creed Valhalla" excitement and a "Madden NFL 21" end run.

In Netflix's "The Eddy," "La La Land" director Damien Chazelle returns to the musical — this one starring Andre Holland and Amandla Stenberg.

Matt Wolf's latest documentary, "Spaceship Earth," is a layered and absorbing account of a widely dismissed but remarkable scientific study.

Veteran Times journalist Jim Newton's graceful "Man of Tomorrow: The Relentless Life of Jerry Brown" doubles as a history of postwar California.

Georgia lifts many coronavirus-related restrictions, allowing gyms, hair salons, tattoo parlors and bowling alleys to reopen Friday.

First up: monthly depot formulation from Indivior

Braeburn Pharmaceuticals' CAM2038 gets positive FDA review

Kura Oncology is discontinuing development of one of its three clinical-stage cancer drug candidates amid pandemic-related impacts to its clinical trial plans. The decision to end work on the drug, KO-947, comes after San Diego-based Kura (NASDAQ: KURA) was successful in lifting a partial clinical hold placed on a Phase 1 trial of the drug […]

A new report based on a survey of ACRO members reveals that Risk-Based Monitoring (RBM) makes clinical trial quality review more efficient...

Firm’s recent success could have been very different had it been bought out by Pfizer in 2014

It’s perhaps not surprising that the worth of healthcare companies should emerge during a global pandemic, but we should offer thanks for the UK’s big pharma twins – AstraZeneca and GlaxoSmithKline.

The former, with its share price at all-time high, is now jostling with Shell and Unilever for the title of biggest company in the FTSE 100 index. Successful research bets, especially on cancer drugs, have transformed Astra.

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.

New crop of data suggests drug can speed recovery from COVID-19

The United States filed two major Clean Air Act settlements to reduce air emissions from container glass and Portland cement plants throughout the country.

Attorney General Eric Holder today announced the appointment of Juan Osuna as Acting Director for the Executive Office for Immigration Review (EOIR).

Attorney General Eric Holder announced today the creation of a new Professional Misconduct Review Unit to handle disciplinary actions for career attorneys at the Department of Justice that arise from Office of Professional Responsibility (OPR) investigations and appointed Kevin Ohlson to be its Chief.

The FBI and Department of Justice response to the National Research Council of the National Academy of Sciences report, "Review of the Scientific Approaches Used During the FBI’s Investigation of the 2001 Anthrax Letters."

Attorney General Eric Holder today announced the appointment of Juan Osuna as the permanent Director for the Executive Office for Immigration Review at the Department of Justice.

The Department of Justice, Federal Trade Commission (FTC) and the European Commission today issued an updated set of “best practices” that they use to coordinate their merger reviews.

A former CIA officer, John Kiriakou, was charged today with repeatedly disclosing classified information to journalists, including the name of a covert CIA officer and information revealing the role of another CIA employee in classified activities.

"This training could not be more timely. The tragic events in Oak Creek, Wisconsin just last month are a chilling reminder of the need to do all we can to foster tolerance, understanding, and respect among the diverse faiths, communities and peoples that make up America," said Deputy Attorney General Cole.

"We hope the training will inspire even broader collaborations in communities across the nation and forge lasting partnerships among law enforcement, elected officials, non-Sikh communities, and their Sikh neighbors," said Acting Associate Attorney General West.

The U.S. Department of Justice Office of Community Oriented Policing Services (COPS) today announced the completion and delivery of an eight-month review of the Las Vegas Metropolitan Police Department’s use of force policies and practices. The report, funded by a grant from the COPS Office, lists 75 findings and recommendations regarding officer-involved shootings and other use-of-force issues.

The Department of Justice filed a civil antitrust lawsuit today against Bazaarvoice Inc. challenging the company’s June 2012 acquisition of PowerReviews Inc.

The Department of Justice today declined to state its enforcement intentions regarding the implementation of a proposal submitted by IPXI Holdings LLC and its wholly-owned subsidiary Intellectual Property Exchange International Inc. (IPXI) to develop an exchange for the trading of unit license rights (ULRs) to sets of patents.

The government has intervened in a lawsuit filed under the False Claims Act against United States Investigations Services LLC (USIS) in the U.S. District Court for the Middle District of Alabama, alleging that USIS, located in Falls Church, Va., failed to perform quality control reviews in connection with its background investigations for the U.S. Office of Personnel Management (OPM).

"We are pleased that the court, after carefully weighing all of the evidence, agreed with the Justice Department that Bazaarvoice’s acquisition of PowerReviews was likely to extinguish price competition and substantially diminish the pace of innovation in the market for product ratings and reviews platforms," said Assistant Attorney General Baer.

The Department of Justice today submitted to the court a proposed remedy to address Bazaarvoice Inc.’s unlawful acquisition of PowerReviews Inc., following the Jan. 8, 2014, U.S. District Court for the Northern District of California finding that Bazaarvoice violated Section 7 of the Clayton Act when it acquired PowerReviews, its closest and only serious competitor.

The Department of Justice, the Federal Trade Commission (FTC), and the Competition Bureau Canada today issued a set of “best practices” to make more transparent how they coordinate merger reviews that affect the United States and Canada.

The calculus that many businesses make today is similar to the decisions that the mom and pop stores had to make several decades ago: Does the cost of paying out – that is, failing to tell the authorities about cyber attacks – outweigh the costs of potential retaliation?

The Department of Justice and Bazaarvoice Inc. have agreed on a remedy that will address Bazaarvoice’s illegal acquisition of PowerReviews Inc. by requiring Bazaarvoice to divest the assets it acquired from PowerReviews and adhere to other requirements to fully restore competition in the provision of online product ratings and reviews platforms.

A true cooperator – whether a mobster or a company – must forthrightly provide all the available facts and evidence so that the most culpable individuals can be prosecuted. If a corporation wants credit for cooperation, it must engage in comprehensive and timely cooperation; lip service simply will not do. Corporations do not act criminally, but for the actions of individuals. The Criminal Division intends to prosecute those individuals, whether they’re sitting on a sales desk or in a corporate suite.

It’s that time of year again when we pause to reflect on the state of the industry – and there’s more to focus on in biopharma today than just the drug pricing debate. As I described last year, we host

The post Our 2019 Year In Review: Macro, Biotech, and Atlas appeared first on LifeSciVC.

From : Communities>>Regulatory Open Forum
Hello Anon, In the version, I usually put the last year or the year generally recognised, e.g. ISO 14971 being 2007.  Then for the publication date, I do put the latest version when published so would be April 2010.  Because of the way standards are amended and revised, it can be quite difficult to determine what to put on the cover sheet.  I would also rely a bit on the Recognized Standards list the FDA publishes:  https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm  to list [More]

All the most important developments in the COVID-19 pandemic for pharmacists and their teams, as they happen.

To read the whole article click on the headline

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.