Day: January 25, 2019

FDA: More Blood Pressure Drugs May Have Shortages After Recalls

Additional shortages of blood pressure drugs in the United States are possible following recent recalls related to traces of a probable carcinogen found in some versions a particular class of hypertension medicines, the U.S. Food and Drug Administration said Friday.

The drugs, including valsartan, belong to a class of widely-used medicines for treating high blood pressure called angiotensin II receptor blockers, or ARBs. Valsartan is the generic of Novartis’ Diovan.

The FDA also said it may have identified the root cause of the potentially cancer-causing impurities but that it is still investigating.

The recalls began last summer after the FDA was informed that ingredients used by Chinese manufacturer Zhejiang Huahai Pharmaceuticals Co (Huahai) to produce valsartan contained the impurities. The FDA later halted all imports from one of Huahai’s factories.

Other manufacturers have also had to recall valsartan after the impurities were found in their versions of the drug.

It is currently listed as in shortage by the FDA.

Generic drugs

Some generic versions of other ARBS, such as losartan and irbesartan, have also been recalled. The most recent recall was announced earlier this week.

The agency said that it determined that the impurities “may be generated when specific chemicals and reaction conditions are present in the manufacturing process” and “may also result from the reuse of materials, such as solvents.”

The reuse of solvents is an accepted practice in the industry, but manufacturers are generally expected to ensure that reused materials meet certain safety standards.

more

Sundance Is Homecoming for Julianne Moore and Husband

For director Bart Freundlich and Julianne Moore, having their film “After the Wedding” premiere opening at the Sundance Film Festival holds a special significance. Moore and Freundlich came to the festival 22 years ago with another film, “The Myth of Fingerprints,” before marriage, children and everything else.

“In between there have been a ton of movies, mainly by her, but some by me,” Freundlich said. “This is something that is really special to me.”

The family drama “After the Wedding” kicked off the 2019 Sundance Film Festival Thursday night in the Eccles Theater. The film is a remake of an Oscar-nominated Danish film from Susanne Bier, and stars Moore as a wealthy businesswoman looking to donate money to an Indian orphanage run by Michelle Williams’ character, while also planning her daughter’s wedding with her husband, played by Billy Crudup.

Things get a little more complicated than that, but the developments are better left seen for oneself.

There was at least one significant change, however. In the original Danish film, Moore’s character was a man, but she gave her husband the idea to flip the gender.

Moore said the switch “deepened” the story for her.

Sundance founder Robert Redford started off the evening reflecting on the origins of the festival, 34 years ago. He recalled a quainter Park City, with only one theater, the Egyptian and just a few restaurants and a library. In the early years, he remembered standing outside the theater, “Trying to hustle people in.”

“People were just wondering why I was there,” Redford laughed. “But finally, slowly things developed.”

Indeed, Redford hardly has to hustle people into theaters anymore at Sundance. Every one of the half dozen opening night films were sold out Thursday.

“Without you there’s nothing,” Redford told the audience. “Thank you for being part of the equation.”

more

For 25 Years, SAG Awards Have Been ‘the Actors’ Party’

The Screen Actors Guild turns 25 years old Sunday, and executive producer Kathy Connell has shaped every one.

And while the milestone anniversary offers a chance to reflect on the show’s growth and impact, Connell says not to expect too many flashbacks on the telecast, which will be broadcast on TNT and TBS beginning at 8 p.m. Eastern.

“We’re going to have some lookbacks but we only have two hours, our show is very tight,” Connell said.

Connell has produced every SAG Awards, which honors the top performances in film and television each year. Tom Hanks and Jodie Foster were the top film actor winners in 1995, while this year the Bradley Cooper and Lady Gaga-led A Star Is Born is the top film nominee.

Cooper and Gaga, along with actors Chadwick Boseman from Black Panther and Constance Wu from Crazy Rich Asians will be among the presenters Sunday.

Unlike other awards ceremonies that also honor directors, writers and other artists, the SAG Awards are solely focused on actors and the craft of acting.

“It’s really a peer award and it’s very meaningful because to become a union member is one milestone and then to be nominated and awarded by your peers is another major milestone I think for actors,” Connell said during a recent interview. “It’s very personal. The room has fun. Our show is different because the room has fun. We consider it the actors’ party at the actors’ house.”

‘Wonderful moments’

The ceremony also showcases the guild’s Life Achievement Award, which predates the awards show and has been bestowed since 1962.

This year’s recipient is Alan Alda, whom Connell calls a “true TV icon and a wonderful man.”

Previous recipients include Morgan Freeman, Carol Burnett, Betty White, Elizabeth Taylor, Sidney Poitier and George Burns.

Connell’s hands-on approach — she and her team meticulously craft the seating chart — has led to many special memories, including one with 2014 honoree Debbie Reynolds.

The actress wasn’t feeling well, so her daughter Carrie Fisher took her place during rehearsals. Fisher and Connell shared a few moments together.

“My parents had just passed, so I knew what it was like and the concern that she had for Debbie’s health, and so she and I had a couple of wonderful moments together,” Connell said. “Then Carrie and Debbie had a great time onstage, and I think it was the last time they were both onstage together.”

Evolution of SAG awards

Connell has presided over numerous changes to the awards over the years. The inaugural ceremony, for instance, did not include the outstanding film ensemble, added in the second year. The category has become a key bellwether for whether a film will be nominated for best picture at the Academy Awards.

Last year, Kristen Bell served as the show’s first ever host. Megan Mullally, a three-time TV comedy actress SAG winner for Will & Grace, will host this year’s show.

Connell said there’s still at least one awards show mainstay the SAGs hasn’t used: “They still haven’t let me do a song and dance, I don’t know why.”

Above all, she says she tries to keep the show fun.

“It’s a work day for these actors. People don’t understand it. It is really a workday for them,” she said. “Just like any contest, some people are going to go home without a statue. So how do I make it as enjoyable as I can possibly make it for people? That’s my job.”

more

Judge Approves Changes to Weinstein’s Legal Team

A judge signed off Friday on changes to the legal team representing Harvey Weinstein in his rape and sexual assault case, allowing the film producer to swap out his bulldog New York City defense attorney for a four-person team that’s full of courtroom star power.

The disgraced Hollywood mogul was in court in Manhattan —along with new lawyers Jose Baez, Ronald Sullivan and Duncan Levin, and former lawyer Benjamin Brafman — as Judge James Burke approved the switch.

“Welcome to the New York State Supreme Court,” Burke told Weinstein’s new lawyers.

Weinstein, 66, and Brafman, 70, announced last week that they had “agreed to part ways amicably.” The move came a month after they lost a hard-fought bid to get the case thrown out.

Weinstein’s trial is tentatively scheduled for May.

He is charged with raping a woman in 2013 and performing a forcible sex act on a different woman in 2006. He denies all allegations of nonconsensual sex.

Weinstein’s other new lawyer, Pamela Robillard Mackey, didn’t attend Friday’s hearing because she was out of the country.

Baez is perhaps the best-known name of the four. He first gained fame for representing Casey Anthony, the Florida mom whose televised trial in 2011 ended in an acquittal on charges of killing her young daughter.

Baez and Sullivan, a 52-year-old Harvard law professor, teamed up to successfully defend New England Patriots tight end Aaron Hernandez against murder charges in 2017. Hernandez, in prison for a 2015 murder conviction, killed himself five days later.

Mackey, who’s based in Denver, represented Kobe Bryant when the former basketball star was accused of raping a 19-year-old at a Colorado resort in 2003. The charges were dismissed when prosecutors said the accuser was no longer interested in testifying.

Levin is a former top deputy under Manhattan District Attorney Cyrus Vance Jr.

Weinstein announced the new legal team on Wednesday.

Actress Rose McGowan, one of the first of dozens of women to accuse Weinstein of sexual misconduct, blasted Baez and Sullivan for agreeing to represent Weinstein after they defended her in a drug case last year. She called it a “major conflict of interest.”

Baez and Sullivan said in a statement that McGowan’s case had nothing to do with Weinstein and that they were certain there was no conflict.

 

more

At Davos, Nearly half WTO Members Agree to Talks on new e-Commerce Rules

Impatient with the lack of World Trade Organization rules to cover the explosive growth of e-commerce, 76 countries and regions agreed on Friday to start negotiating this year on a set of open and predictable regulations.

The WTO’s 164 members were unable to consolidate some 25 separate e-commerce proposals at the body’s biennial conference at Buenos Aires in December, including a call to set up a central e-commerce negotiating forum.

In a gathering on the sidelines of the World Economic Forum in Davos, ministers from a smaller group of countries including the United States, the European Union and Japan, agreed to work out an agenda for negotiations they hope to kick off this year on setting new e-commerce rules.

“The current WTO rules don’t match the needs of the 21st century. You can tell that from the fact there are no solid rules on e-commerce,” Japan’s trade minister Hiroshige Seko told reporters in Davos.

Asked whether China could join the negotiations, Seko said: “What’s very important is to first set high-standard rules. If China could join, we would welcome that.”

The WTO failed to reach any new agreements at a ministerial conference in December, which ended in discord in the face of stinging U.S. criticism of the group. The stalemate dashed hopes for new deals on regulating the widening presence of e-commerce.

The emergence of the coalition willing to press ahead with new e-commerce rules, despite others’ reservations, reinforces a trend toward the fragmentation of WTO negotiations and away from global “rounds” of talks that have run out of steam.

“We will seek to achieve a high-standard outcome that builds on existing WTO agreements and frameworks with the participation of as many WTO members as possible,” members of the coalition said in a joint statement issued on Friday.

“We continue to encourage all WTO members to participate in order to further enhance the benefits of electronic commerce for businesses, consumers and the global economy.”

E-commerce, which developed largely after the WTO’s creation in 1995, was not part of the Doha round of talks that began in 2001 and eventually collapsed more than a decade later.

Many countries insist that Doha-round development issues must be dealt with before new issues can be tackled. But other countries say the WTO needs to move with the times, and note that 70 regional trade agreements already include provisions or chapters on e-commerce, according to a recent study.

U.S. President Donald Trump’s administration says the WTO is dysfunctional because it has failed to hold China to account for not opening up its economy as envisaged when Beijing joined in 2001.

To force reform at the WTO, Trump’s team has refused to allow new appointments to the Appellate Body, the world’s top trade court, a process which requires consensus among member states. As a result, the court is running out of judges, and will be unable to issue binding rulings in disputes.

 

more

Microsoft’s Bing Blocked in China for Two Days

Chinese internet users lost access to Microsoft’s Bing search engine for two days, setting off grumbling about the ruling Communist Party’s increasingly tight online censorship.

Microsoft Corp. said Friday that access had been restored. A brief statement gave no reason for the disruption or other details.

Comments on social media had accused regulators of choking off access to information. Others complained they were forced to use Chinese search engines they say deliver poor results.

“Why can’t we choose what we want to use?” said a comment signed Aurelito on the Sina Weibo microblog service.

Government censorship

Bing complied with government censorship rules by excluding foreign websites that are blocked by Chinese filters from search results. But President Xi Jinping’s government has steadily tightened control over online activity.

The agency that enforces online censorship, the Cyberspace Administration of China, didn’t respond to questions sent by fax.

China has by far the biggest population of internet users, with some 800 million people online, according to government data.

Foreign sites blocked

The Communist Party encourages internet use for business and education but blocks access to foreign websites run by news organizations, human rights and Tibet activists and others deemed subversive.

Since coming to power in 2012, Xi has promoted the notion of “internet sovereignty,” or the right of Beijing and other governments to dictate what their publics can do and see online.

Chinese filters block access to global social media including Twitter, Facebook and YouTube. Officials argue such services operating beyond their control pose a threat to national security.

Xi’s government also has tightened controls on use of virtual private network technology that can evade its filters.

Alphabet Inc.’s Google unit operated a search engine in China until 2010 that excluded blocked sites from results. The company closed that after hacking attacks aimed at stealing Google’s source code and breaking into email accounts were traced to China.

That has helped Chinese competitors such as search engine Baidu.com to flourish. But Baidu has been hit by repeated complaints that too many search results are irrelevant or are paid advertising.

more

US House Republican Introduces Bill to Grant Trump More Tariff Power

A Republican U.S. representative on Thursday introduced White House-drafted legislation that would give President Donald Trump more power to levy tariffs on imported goods in an effort to pressure other countries to lower their duties and other trade barriers.

The measure offered by Representative Sean Duffy, which has been touted by Trump administration officials, has already been declared unacceptable by some Republican senators, including Senate Finance Committee Chairman Chuck Grassley.

Democrats, who control the House of Representatives and its legislative agenda, are unlikely to grant Trump more executive authority, especially as a standoff over the partial government shutdown drags on. A spokesman for House Speaker Nancy Pelosi could not immediately be reached for comment.

The Reciprocal Trade Act, which Trump was expected to highlight in his now-delayed State of the Union address, would give him authority to levy tariffs equal to those of a foreign country on a particular product if that country’s tariffs are determined to be significantly lower than those charged by the United States.

It would also allow Trump to take into account non-tariff barriers when determining such tariffs.

Trump has invoked trade laws passed in the 1960s and 1970s to levy tariffs on steel and aluminum on national security grounds and has applied tariffs on imports from China based on U.S. findings that Beijing is misappropriating U.S. intellectual property through forced technology transfers and other means.

The United States has lower tariffs than many other countries, such as its 2.5 percent levy on imported passenger vehicles compared with the European Union’s 10 percent tariff.

But increasing them and applying them in a country-specific manner would effectively be a violation of the World Trade Organization’s most fundamental rule, that tariffs must be applied globally and cannot be raised unilaterally except in anti-dumping and anti-subsidy cases.

“The goal of the U.S. Reciprocal Trade Act is not to raise America’s tariffs but rather to encourage the rest of the world to lower theirs,” Duffy said in a statement, adding that the authority would be a negotiating tool to pressure other countries to lower their tariffs.

more