Tag Archives: commission

S.Korea set to curb Google, Apple commission dominance

SEOUL, Aug 24 (Reuters) – South Korea is likely to bar Google and Apple from requiring software developers to use their payment systems, effectively stopping them from charging commissions on in-app purchases, the first such curbs on the tech giants by a major economy.

The parliament’s legislation and judiciary committee is expected on Tuesday to approve the amendment of the Telecommunications Business Act, dubbed the “Anti-Google law,” that takes aim at app store operators with dominant market positions.

If the bill gets the committee’s approval, it will be put to a final vote on Wednesday. Lawmakers in South Korea have pushed the issue of the commission structure since mid last year.

Alphabet Inc’s (GOOGL.O) Google and Apple Inc (AAPL.O) were not immediately available for comment.

Both companies have faced global criticism because they require software developers using their app stores to use proprietary in-app payment systems that charge commissions of up to 30% on in-app purchases.

“For gaming apps, Google has been forcing app developers to use its own payment system … and it wants to expand its policy to other apps like music or webtoon,” said Kwon Se-hwa, a general manager at the Korea Internet Corporations Association, a nonprofit group representing Korean IT firms.

“If the new bill becomes the law, developers will have options to use other independent payment systems,” Kwon said.

The European Union last year proposed the Digital Markets Act, taking aim at app store commissions. The rules are designed to affect large companies, but some European lawmakers are in favour of tightening them to specifically target American technology giants, Reuters reported in June. read more

Earlier this month in the United States, a bipartisan trio of senators introduced a bill that would rein in app stores of companies that they said exert too much market control, including Apple and Google. read more

In South Korea, the home market of Android phone maker Samsung Electronics Co Ltd (005930.KS), Google Play Store earned revenue of nearly 6 trillion won ($5.29 billion) in 2019, according to a government report published last year.

Earlier this year, Google said it will lower the service fee it charges developers on its app store from 30% to 15% on the first $1 million they earn in revenue in a year. Apple has made similar moves. read more

For Apple too, commissions from in-app purchases are a key part of its $53.8 billion services business, and are a major expense for some app developers.

In May, an antitrust lawsuit filed by the maker of the popular game “Fortnite” against Apple revealed that the game maker paid $100 million in commissions to Apple over two years. read more

Reporting by Heekyong Yang in Seoul, Additional reporting by Stephen Nellis in San Francisco
Editing by Shri Navaratnam

Our Standards: The Thomson Reuters Trust Principles.

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Clark County Commission unanimously votes in favor of new mask mandate

LAS VEGAS (KTNV) — The Clark County Commission held an emergency meeting today in response to the rising number of COVID-19 cases in the county and unanimously voted in favor of an employee mask mandate.

The meeting started with passionate pleas from community members on both sides of the debate, followed by testimony from the Southern Nevada Health District.

RELATED: Clark County commissioners discuss COVID mitigation amid rising case numbers

After commissioners asked questions of the SNHD representative they debated the options available to them before voting on a motion brought by Commissioner Jim Gibson.

The motion stated that all employers in Clark County must mandate their employees to wear a mask when in public spaces of the building. Those in enclosed offices or cubicles do not have to wear a mask when in their enclosed areas but must wear a mask when out in the public spaces.

This new mandate will take effect at 11:59 p.m. on July 21 and run through August 17 when the commissioners will meet again.

REPLAY THE FULL MEETING HERE:

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McCarthy threatens to strip GOP members of committee assignments if they accept an offer from Pelosi to serve on 1/6 commission

McCarthy’s threat comes after the House voted to establish the committee. Reps. Liz Cheney of Wyoming and Adam Kinzinger of Illinois were the only two Republican members to vote in favor of its formation. Pelosi, who can appoint eight members to the committee, announced Thursday that Cheney will serve on the committee.

Two GOP sources told CNN McCarthy’s threat speaks to one thing — that the GOP leader is threatened by the select committee and once again is doing everything he can to try to kill it.

Punchbowl News was first to report McCarthy’s threat.

Pelosi made the move to establish the committee after Senate Republicans blocked the formation of a bipartisan commission to investigate the attack on the US Capitol.

After Wednesday’s vote, McCarthy refused to say if he will cooperate and offer up members to serve on the committee, telling CNN, “It seems pretty political to me.” He did not respond when CNN asked if that meant he would not appoint anyone.

Under the House’s resolution, Pelosi will appoint eight members to the commission and McCarthy has five slots he can fill “in consultation” with Pelosi — meaning the House speaker could veto his selections.

Pelosi announced her picks Thursday, saying that in addition to Cheney, Democratic Reps. Bennie Thompson of Missouri; Zoe Lofgren, of California; Adam Schiff, of California; Pete Aguilar, of California; Stephanie Murphy, of Florida; Jamie Raskin, of Maryland; and Elaine Luria of Virginia. would serve on the committee.

Asked Tuesday if she would consider vetoing McCarthy’s selections if they had voted to overturn President Joe Biden’s electoral win, Pelosi said, “We’ll see. We’ll see who they nominate.”

Reacting to the news of McCarthy’s threat, Kinzinger, who said he didn’t hear it directly from McCarthy, told reporters, “Who gives a sh*t?”

“When you’ve got people that say crazy stuff and you’re not gonna make that threat, to make the threat the truth tellers, you’ve lost, you know any credibility and then so that’s all I’m gonna say on it.”

Kinzinger said Wednesday if he was asked to serve on the committee, he would consider it.

“It’s not necessarily anything I look forward to doing, but if I thought my voice was needed to get to the bottom of it, it would be something I would be open to,” he told a local TV station.

Cheney, the former No. 3 House Republican, told CNN Wednesday, “Our nation, and the families of the brave law enforcement officers who were injured defending us or died following the attack, deserve answers. I believe this select committee is our only remaining option.”

CNN’s Chandelis Duster, Manu Raju, Jeremy Herb, Ryan Nobles, Alex Rogers and Annie Grayer contributed to this report.

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German vaccine commission says people under 60 shouldn’t receive AstraZeneca second dose

A German vaccine commission is advising people under the age of 60 that have received their first dose of AstraZeneca’s COVID-19 vaccine to not receive their second dose.

Reuters reported that the committee, called STIKO, recommended that people receive a dose of an mRNA-based vaccine, such as those from Pfizer/BioNTech or Moderna, 12 weeks after receiving their first AstraZeneca dose.

“Until the appropriate data is available, STIKO recommends for people under 60 years old that instead of the second AstraZeneca dose, a dose of an mRNA-vaccine should be given 12 weeks after the first vaccine,” STIKO said, according to Reuters.

STIKO noted that here was no scientific evidence on the safety of a mixed series of vaccines, according to the wire service. 

The recommendation comes after Germany suspended the use of AstraZeneca’s vaccine for those under the age of 60 over concerns of a rare occurrence of blood clots found in a small number of people that received the vaccine.

STIKO at the time planned on releasing recommendations for those who had received their first dose by the end of April.

A handful of countries have paused or suspended the use of AstraZeneca’s COVID-19 vaccine amid reports of blood clots in a small percentage of patients. 

Canada’s National Advisory Committee on Immunization recommended on Monday against using the vaccine in adults under age 55 while it investigated concerns over clotting.

The European Medicines Agency said Wednesday that there was a remote possibly of blood clots, but there was no evidence that the vaccine was linked to an increased risk of clotting.

AstraZeneca said in late March that its vaccine was 76 percent effective against symptomatic COVID-19, and that it planned on filing for an emergency use authorization from the U.S. Food and Drug Administration.



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Threats but few details as European Commission demands vaccine ‘reciprocity’ – POLITICO

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European Commission officials on Monday reiterated a barrage of vague threats about blocking coronavirus vaccine exports but could not explain what precisely they planned to do, when they planned to do it or how it would actually lead to more doses injected into EU citizens’ arms.

So after yet another day of far more questions than answers about the EU’s slow-rolling vaccine campaign, only this much was clear: the continued stumbling in Brussels was not going to stop the grumbling among citizens and EU national leaders ahead of a virtual European Council summit on Thursday.  

The Commission’s threats, which President Ursula von der Leyen first articulated last week, are nominally directed at the U.K. — the one vaccine-producing nation that has been receiving doses produced on the European Continent, but, by all accounts, is not exporting any doses produced domestically.

The British government — and the British people — have reacted angrily to the EU’s sabre-rattling, and Prime Minister Boris Johnson has reached out to European counterparts trying to head off any new restrictive measures that could bring pressure on him to respond. Some allies are already urging him to hold his fire, even if the EU takes action, to avoid setting off a trade war that could disrupt delicate supply chains.

But, for the moment at least, the Commission held its fire.

“Look, we are not going to speculate on the tools or the actual details of what it is that we could suggest in order to achieve the objectives,” the Commission’s chief spokesman, Eric Mamer, said. “Our issue indeed is with the underperformance, under-delivery of vaccines compared to what is in our contracts with these companies and that is the issue that we want to solve — how to make sure that companies deliver to the EU as per contract.”

But while Mamer, speaking at the regular midday news conference, referred to multiple companies, the Commission’s wrath right now is directed only at one: AstraZeneca, which is tens of millions of doses behind what it promised to deliver.

As one way to potentially redress that shortfall, the Commission is looking at the possibility of restricting AstraZeneca vaccine exports manufactured at a plant in the Netherlands run by a subcontractor, Halix. And on Monday, Dutch officials indicated they would cooperate with a Commission decision to ban such exports.

But it is unclear if that would even help. Internal Market Commissioner Thierry Breton, the EU’s point-man on increasing vaccine production, previously said the Halix factory had not been shipping doses to the U.K., though that may have changed.

As a separate complication, the European Medicines Agency has not yet authorized the Halix factory to manufacture vaccines for the EU. The snafu appears to be a technical oversight that was as much the Commission’s fault for not insisting that AstraZeneca seek such authorization as it was the company’s fault for not doing so. That approval is now in process, Mamer said.

Mamer insisted repeatedly throughout Monday’s news conference that the Commission’s goals were simply to force vaccine manufacturers to follow the EU’s purchase agreements and to achieve “reciprocity” from other vaccine-producing countries getting EU-made doses — again, namely the U.K.

He defined reciprocity as the export of either finished vaccine doses, or of raw materials needed to make vaccines.

At the same time, he confirmed that even if the Commission were to block exports, it did not currently have legal authority to seize unshipped vaccines and repurpose them for EU countries. Such a move would require additional emergency measures and could risk violating World Trade Organization rules, as well as further undermine the EU’s reputation as a champion of international rules-based free trade.

“This is not about banning vaccine exports,” Mamer said. “It’s about making sure that we are in a position to receive the vaccines that are foreseen for Europe.”

Journalists and some national officials were still left wondering how the Commission would actually guarantee delivery of the expected vaccines, something it has yet to be able to do with AstraZeneca. So far, the Commission has blocked just one shipment with Italy’s support — of AstraZeneca vaccines intended for Australia. On Monday, Mamer said the Commission did not know what happened to the stymied 250,000 doses and referred questions to the company.

EU leaders are due to discuss the vaccine export issue during their videoconference summit on Thursday. But because they are not meeting in person, they cannot take any immediate, formal decision.

There has been some speculation that leaders, who are under increasing political pressure over the slow pace of vaccinations, may want to broaden the export bans to focus not just on AstraZeneca but also on BioNTech/Pfizer, Moderna and potentially other producers who so far have met their contractual commitments to the EU.

Such a move would not only draw the ire of the companies but also of other countries, including partners like Canada, Australia and Mexico, which are purchasing vaccines from EU manufacturers.

In issuing her new threats last week, von der Leyen offered a rationale for blocking exports more widely — a move that while controversial might actually lift vaccination rates in the EU. Coincidentally, it might also give a boost to Germany’s governing Christian Democratic Union party in a super election year.

But other EU countries said they would oppose such an aggressive move, warning that von der Leyen’s incendiary approach was risking the EU’s reputation in an attempt to play to a German audience.

“I’m increasingly feeling like a we’re all just part … of a German election play,” said one EU diplomat.

Two EU diplomats said only France and Italy were clearly in support of a broader export ban, while Germany’s position remained unclear. And France was the only country to openly back that new high-risk approach.

“I support the announcements made by the president of the Commission … in particular to require reciprocity,” President Emmanuel Macron said last week.  

Officials from countries including Spain, Sweden and the Netherlands said they were against blocking exports of vaccines from companies that were fulfilling their contracts.

With EU countries divided and leaders meeting virtually, it seemed unlikely there would be a resolution of the debate this week.

Meanwhile, European Council President Charles Michel’s previous effort to challenge the U.K. to reveal how many doses it has exported seemed forgotten amid the noise of the Commission’s threats — not to mention London’s warnings about the possibility of a damaging trade war.

Emilio Casalicchio and Anna Isaac and contributed reporting.

This article is part of POLITICO’s premium policy service: Pro Health Care. From drug pricing, EMA, vaccines, pharma and more, our specialized journalists keep you on top of the topics driving the health care policy agenda. Email [email protected] for a complimentary trial.

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McConnell throws cold water on Dems’ proposed 1/6 Commission

McConnell indicated that he would be open to a commission narrowly focused on security on the Hill.

“We could do something narrow that looks at the Capitol, or we could potentially do something broader to analyze the full scope of the political violence problem in this country,” McConnell added. “We cannot land at some artificial, politicized halfway point.”

McConnell’s comments underscore the steep challenge Democrats face if they hope — as Pelosi suggests — to recreate the spirit of the 9/11 Commission, a bipartisan review of the 2001 terrorist attacks that’s considered a model for intensive after-action reviews of nationally significant moments. Lawmakers have proposed similar “9/11 commissions” for the onset of Covid in America.

McConnell’s remarks come as two Senate committees are pressing on with a joint bipartisan investigation into the security failures that allowed a pro-Trump mob to breach the Capitol while lawmakers were certifying Joe Biden’s Electoral College victory.

The Senate Homeland Security and Rules committees will hold a hearing next week with officials from the Pentagon, the Department of Homeland Security and the FBI — three entities that came under heavy criticism during the panels’ first hearing on Tuesday.

Former Capitol Police Chief Steven Sund and acting D.C. Police Chief Robert Contee told senators that the Pentagon slow-walked their urgent pleas for assistance from the National Guard. They also indicated they were not informed about intelligence reports suggesting that extremist groups were gearing up for violence.

The next hearing, scheduled for next Wednesday, will feature testimony from Robert Salesses, assistant secretary of defense for homeland defense and global security; Jill Sanborn, assistant director of the FBI’s counterterrorism division; and Melissa Smislova, who leads the Department of Homeland Security’s Office of Intelligence and Analysis.

In addition, senators are expected to be briefed on Capitol security measures later Wednesday by the acting Capitol Police chief and the acting Senate sergeant-at-arms.

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European Commission Grants Ocugen Orphan Medicinal Product Designation for Gene Therapy Product Candidate, OCU400, For the Treatment of Both Retinitis Pigmentosa and Leber Congenital Amaurosis

MALVERN, Pa., Feb. 23, 2021 (GLOBE NEWSWIRE) — Ocugen, Inc., (NASDAQ: OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19, today announced that on the recommendation of the European Medicines Agency (EMA), the European Commission has granted orphan medicinal product designation for OCU400 (AAV5-hNR2E3), for the treatment of both retinitis pigmentosa (RP) and Leber Congenital amaurosis (LCA).

The prevalence of RP in Europe is estimated at approximately 165,000 patients and the prevalence of LCA in Europe is estimated at approximately 40,000 patients. Globally, the number of people suffering from RP and LCA is estimated to be around 2.0 million and 0.2 million, respectively.

“We believe the granting of this designation by the European Commission validates the potential of our modifier gene therapy platform to treat many inherited retinal diseases (IRDs). IRDs associated with RP and LCA diseases are caused by mutations in over 175 genes, and it is impractical to develop therapies that are specific to each gene. OCU400 has the remarkable potential to address a significant number of patients globally who are in desperate need of rescue from these blindness diseases and we are working diligently to move this program to clinic,” said Dr. Shankar Musunuri, Chairman of the Board, Chief Executive Officer, and Co-founder of Ocugen.

“RP and LCA are chronically debilitating groups of IRDs characterized by severe impairment in visual functions starting as young as infancy, often progressing into night blindness and tunnel vision and eventually causing total blindness as early as the patient’s mid-40s. Since the existing approved therapy only addresses a small percentage of this population, there is an unmet need for new treatment options addressing a wider population of patients with IRDs,” said Dr. Mohamed Genead, Chair of Retina Scientific Advisory Board and Acting Chief Medical Officer of Ocugen.

Nuclear Hormone Receptors such as NR2E3 are important modulators of retinal development and function acting as “master genes” in the retina. NR2E3 is delivered to target cells in the retina using an adeno-associated viral (AAV) vector. As a potent modifier gene, expression of NR2E3 within the retina may help reset retinal homeostasis, potentially stabilizing cells and rescuing photoreceptor degeneration. Preclinical results published in Nature Gene Therapy demonstrate the potency of modifier gene therapy to elicit broad-spectrum therapeutic benefits in early and advanced stages of RP including vision rescue in early and advanced stages of the disease.

Orphan medicinal product designation in Europe offers certain benefits to drug developers while they develop drugs intended for safe and effective treatment, diagnosis, or prevention of rare diseases or conditions that impact fewer than 5 in 10,000 patients in the European Union. Benefits include protocol assistance, reduced regulatory fees, research grants, and 10 years of market exclusivity following regulatory approval.

About Retinitis Pigmentosa
Retinitis pigmentosa is a clinically and genetically heterogeneous group of IRDs characterized by diffuse progressive dysfunction of predominantly rod photoreceptors, with subsequent degeneration of cone photoreceptors, and retinal pigment epithelium (RPE). Visual impairment usually manifests as night blindness and progressive visual field loss. Its prevalence is 1 in 3,000 to 1 in 5,000. RP may be seen in isolation (typical RP) or in association with systemic disease. Over 150 gene mutations have been associated with RP and this number represents only 60% of the RP population. The remaining 40% of RP patients cannot be genetically diagnosed, making it difficult to develop individual treatments.

About Leber Congenital Amaurosis
Leber congenital amaurosis is a family of congenital retinal dystrophies that results in severe vision loss at an early age. Patients present usually with nystagmus, sluggish or near-absent pupillary responses, severely decreased visual acuity, photophobia and high hyperopia. It is the most severe retinal dystrophy causing blindness by the age of 1 year. This dystrophy is a genetically heterogeneous recessive disease affecting 1 in 30,000 to 1 in 81,000 subjects. Mutations in one of more than two dozen genes can cause LCA.

About OCU400
OCU400 is a novel gene therapy product candidate with the potential to be broadly effective in restoring retinal integrity and function across a range of genetically diverse IRDs. OCU400 is the first program that Ocugen is advancing based on its breakthrough modifier gene therapy platform developed by Dr. Neena Haider, Associate Professor of Ophthalmology at Harvard Medical School and Associate Scientist at the Schepens Eye Research Institute (SERI) of Massachusetts Eye and Ear. Ocugen obtained an exclusive worldwide license from SERI to develop and commercialize ophthalmology products based on specified nuclear hormone receptor genes, including NR2E3. Consisting of a functional copy of the nuclear hormone receptor gene NR2E3, OCU400 is delivered to target cells in the retina using an AAV vector. As a potent modifier gene, expression of NR2E3 within the retina may help reset retinal homeostasis, stabilizing cells and potentially rescuing photoreceptors from degeneration.

About Ocugen, Inc.
Ocugen, Inc. is a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with one drug – “one to many” and our novel biologic product candidate aims to offer better therapy to patients with underserved diseases such as wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy. We are co-developing Bharat Biotech’s COVAXIN™ vaccine candidate for COVID-19 in the U.S. market. For more information, please visit www.ocugen.com.

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from our current expectations. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events or otherwise, after the date of this press release.

Ocugen Contact:
Ocugen, Inc.
Sanjay Subramanian
Chief Financial Officer and Head of Corporate Development
ir@ocugen.com

Media Contact:
For Ocugen:
LaVoieHealthScience
Emmie Twombly
etwombly@lavoiehealthscience.com
+1 857-389-6042

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Pelosi announces plans for ‘9/11-type commission’ to investigate Capitol attack

“To protect our security, our security, our security, our next step will be to establish an outside, independent 9/11-type Commission to ‘investigate and report on the facts and causes relating to the January 6, 2021 domestic terrorist attack upon the United States Capitol Complex,'” Pelosi wrote.

Pelosi has previously called for the formation of such a commission and said she believes there is a need for it.

A commission of this nature would be established by a statute, passed by both chambers and signed into law by the President. The commission members would not be elected leaders and would be outside the government.

In a separate letter to House Democrats earlier this month, Pelosi wrote that it is “clear that we will need to establish a 9/11-type Commission to examine and report upon the facts, causes and security relating to the terrorist mob attack on January 6.”

The deadly attack prompted House Democrats to move swiftly to impeach former President Donald Trump in January. The Senate impeachment trial of the former President concluded over the weekend, and ended in Trump’s acquittal on a single charge of incitement of insurrection.

Efforts to shore up security at the Capitol and shed light on what led to its breach by a violent, pro-Trump mob on January 6 are still ongoing, however.

In mid-January, Pelosi announced that retired Lt. General Russel Honoré will lead a review of the “security infrastructure” of Capitol Hill in the wake of the attack.

“For the past few weeks, General Honoré has been assessing our security needs by reviewing what happened on January 6 and how we must ensure that it does not happen again,” Pelosi wrote in her letter on Monday.

“He has been working with Committees of Jurisdiction and will continue to make proposals. It is clear from his findings and from the impeachment trial that we must get to the truth of how this happened,” she said.

Earlier this month, Pelosi told reporters as she left a news conference that a 9/11-style commission to investigate the insurrection would look “different” than the one formed following the September 11, 2001, terror attack — and would have a greater emphasis on diversity.

“Different from 9/11. What were there, nine people? All white, one woman. It will look different,” she said at the time.

Although Pelosi complimented the 9/11 commission, she said that now “it’s a different world.”

Asked then about who she had in mind to serve on the commission, Pelosi confirmed that members would not be serving on it, saying, “It’s an outside commission.”

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