Apple’s battery replacement program cut into iPhone sales

Apple may have shot itself in the foot with its $ 29 iPhone battery replacement program as 10 million more users than anticipated opted to swap out their old batteries rather than pony up for a new phone. The Cupertino, Calif.-based company has replaced 11 million batteries under the program, according to Daring Fireball’s John Gruber,…
Business | New York Post

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Here Are the Winners of the Google Podcasts Creator Program

Previously, BLACK ENTERPRISE reported that Google and PRX, a leader in podcast content, training, and technology were looking for multicultural podcast creators to participate in the accelerator portion of the Google Podcasts creator program. Well, it seems they are locked and loaded. Here are the participating teams:

AfroQueer, Nairobi, Kenya

Google Podcasts

AfroQueer, Maeve Francis, Aida Holly-Nambi, Selly Thiam (Image: Google)

A reported, narrative-driven podcast about queer Africans living, loving, surviving and thriving on the African continent and in the diaspora.

Las Raras, Santiago, Chile

Google Podcasts

Las Raras, Martin Cruz, Catalina May (Image: Google)

This Spanish-language, non-fiction podcast tells stories of “The Weird Ones,” the people who live on the margins of society because of their background or life choices, and how these stories challenge social norms.

Timestorm, Bloomfield, New Jersey

Google Podcasts

Timestorm, Michael Aquino, Dania Ramos (Image: Google)

This audio fiction series tells the story of 12-year-old twins, Alexa and Beni Ventura, who travel through time to uncover hidden moments in the history of Puerto Rican culture.

Long Distance, Los Angeles, California

Google Podcasts

Long Distance, Patrick Epino, Paola Mardo (Image: Google)

This reported, narrative podcast uncovers unknown histories and present-day realities about life in the Filipino diaspora.

The Colored Girl Beautiful, Baltimore, Maryland

Google Podcasts

The Colored Girl Beautiful, Baltimore, Maryland (Image: Google)

Explores black women’s concepts of beauty, then and now, using Emma Azalia Hackley’s 1916 book The Colored Girl Beautiful as a framework.

Who Taught You How To Drive?! Philadelphia, Pennsylvania

Google Podcasts

Who Taught You How To Drive?!, Tanikka Charraé, Melissa Tsuei, Tezarah Wilkins (Image: Google)

A humorous interview podcast about how we get around told through the stories of drivers, walkers, riders, and bikers and their habits on the road.

“The teams selected for the first round show incredible promise, and we couldn’t be more excited to help these producers develop and grow their shows,” said Zack Reneau-Wedeen, Product Manager of Google Podcasts which launched in June 2018. “This program is one of the ways we hope to ensure that our millions of listeners have access to a variety of content for all types of global audiences.”

The program is funded by Google and run independently by PRX. The creator program aims to remove barriers to podcasting, increase the diversity of voices in the industry, and make sure content is available for all audiences through a series of educational programs, including a 20-week podcast training and accelerator program.

The post Here Are the Winners of the Google Podcasts Creator Program appeared first on Black Enterprise.

Lifestyle | Black Enterprise

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CRH 9-month EBITDA Rises; Commences Phase 3 Of Share Buyback Program

CRH Plc. (CRH, CRH.L), a building materials group, reported Tuesday that for the nine-month period ended 30 September 2018, EBITDA, a key earnings metric, rose 8 percent to 2.5 billion euros from 2.3 billion euros in the year-ago period. Like-for-like EBITDA rose 2 percent.
RTT – Earnings

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Government Investigation Finds Flaws In the FDA’s Orphan Drug Program

The Food and Drug Administration has failed to ensure that drugs given prized rare-disease status meet the intent of a 35-year-old law, federal officials revealed in a report Friday.

The Government Accountability Office, which spent more than a year investigating the FDA’s orphan drug program, said “challenges continue” in the program that was created to spur development of drugs for diseases afflicting fewer than 200,000 patients.

The investigation began after a request from three high-profile Republican senators last year, in the wake of a KHN investigation. KHN found that the program was being manipulated by drugmakers to maximize profits and to protect niche markets for medicines being taken by millions.

The GAO uncovered inconsistent and often incomplete reviews early in the process of designating medicines as orphan drugs and recommended “executive action” to fix the system. In some cases, FDA reviewers failed to show they had checked how many patients could be treated by a drug being considered for orphan drug status; instead, they appeared to trust what drugmakers told them.

In response to GAO’s probe, the FDA issued a statement saying it agreed with the report recommendations regarding documentation and that the agency is “streamlining our processes.” The agency declined requests for interviews. In a comment included with the report, Matthew Bassett, assistant secretary for legislation at the Department of Health and Human Services, said HHS agreed with GAO’s recommendations.

John Dicken, director of the GAO’s health care team, said the focus of the report is “ensuring that the intent of the law is being met.”

The FDA’s rare-disease program began after Congress overwhelmingly passed the 1983 Orphan Drug Act to motivate pharmaceutical companies to develop drugs for people who lacked treatments for their conditions. Rare diseases had been ignored by drugmakers because treatments for them weren’t expected to be profitable. The law provides fee waivers, tax incentives for research and seven years of marketing exclusivity for any drug the FDA approves as an “orphan.”

The incentives, though, have proven to be more powerful and highly coveted than expected, said Avik Roy, president of the Foundation for Research on Equal Opportunity, a conservative think tank.

Many people are “starting to wonder whether or not the Orphan Drug Act over-corrected for the problem,” Roy said, noting that a third of all pharmaceutical spending in the U.S. will be on so-called rare-disease medicines in 2020.

GAO analysts examined FDA records for 148 applications submitted by drugmakers for orphan drug approval in late 2017. FDA’s reviewers are supposed to apply two specific criteria — how many patients would be served and whether there is scientific evidence the drug will treat their disease.

In nearly 60 percent of the cases, the FDA reviewers did not capture regulatory history information, including “adverse actions” from other regulatory agencies. The FDA uses experienced reviewers, Dicken noted, who may already know the history of certain submitted drugs and not see the need to document it.

And 15 percent of the time FDA reviewers failed to independently verify patient estimates provided by the drugmaker.

Of the 148 records the GAO reviewed, 26 applications from manufacturers were granted orphan status even though the initial FDA staff review was missing information.

“It is tempting to think that perhaps those approvals were sort of granted routinely without sufficient scrutiny,” said Bernard Munos, senior fellow at FasterCures and the Milken Institute.

By contrast, early Orphan Drug Act advocate Abbey Meyers said she was not concerned about the lack of population estimates because many rare diseases lack population studies that show how common a disease is.

Rather, Meyers said, she’s “disappointed that there is no government-funded agency that is willing to finance” such research.

The GAO investigation began after Scott Gottlieb, who took over as FDA commissioner in May 2017, announced a “modernization” of the rare-disease program.

Critics have long complained that drugmakers game the FDA’s approval process for orphan drugs. In January 2017, the KHN investigation, which was co-published and aired by NPR, revealed that many orphan drugs aren’t entirely new and don’t always start as treatments for rare diseases.

The GAO report, while not analyzing the same years, found that 38.5 percent of orphan drug approvals from 2008 to 2017 were for drugs that had been previously approved either for mass-market or rare-disease use. About 71 percent of the drugs given orphan status were intended to treat diseases affecting fewer than 100,000 people.

KHN’s investigation found that popular mass-market drugs such as cholesterol blockbuster Crestor, Abilify for psychiatric conditions, cancer drug Herceptin and rheumatoid arthritis drug Humira, the best-selling medicine in the world, all won orphan approval yet were already on the market to treat common conditions.

In addition, more than 80 orphan drugs won FDA approval for more than one rare disease — or several — each one with its own bundle of rich incentives.

Genentech’s Avastin, a cancer treatment approved for mass-market use in 2004, won three more orphan-designated approvals this year for the treatment of three rare forms of cancer. It now has 11 approved orphan uses in all, and exclusive protections that keep generics at bay won’t run out until 2025.

Sens. Orrin Hatch (R-Utah), Chuck Grassley (R-Iowa) and Tom Cotton (R-Ark.) sent a letter in March 2017 asking the GAO to investigate the program and find out whether Congress’ original intent for it was still being followed.

“Despite the success of the Orphan Drug Act, 95 percent of rare diseases still have no treatment options,” Hatch said in a statement Friday. “I hope that my colleagues will utilize this [GAO] report as they work to strengthen the accomplishments of the Orphan Drug Act and encourage developers to continue their investment in this patient population.” The GAO report also mentioned concerns about prices, noting that “the ability to command high prices” was one reason the rare-disease market was growing so rapidly.

The average cost per patient for an orphan drug was $ 147,308 in 2017 compared with $ 30,708 for a mass-market drug, according to a 2018 EvaluatePharma report on the 100 top-selling drugs in the United States. Celgene’s chemotherapy drug Revlimid was the top-selling orphan with $ 5.4 billion in sales and $ 184,011 in revenue per patient.

“We have accepted culturally that it’s OK for a company to charge high prices for [orphan] drugs,” said Roy. “The end result is that a lot of these orphan drugs are $ 10 billion drugs, even though they are for rare diseases.”

From 2008 to 2017, more than half of the drugs granted orphan status were for cancer or blood disorders, according to the GAO report. And nearly two-thirds of drugs approved in the program were given expedited review processes, such as accelerated approval or fast-track designation.

Prior to announcing Gottlieb’s modernization plan, the FDA had a backlog of 138 drug applications for orphan status that had been waiting more than 120 days. The backlog was cleared in August 2017 after staff from across the agency stepped in to help.


KHN’s coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation.

Kaiser Health News

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NASA selects nine U.S. companies to vie for moon program funding

NASA on Thursday named nine U.S. companies, including Lockheed Martin Corp, that will compete for funding under the space agency’s renewed long-term moon program, a private-public undertaking to develop technology that will explore the lunar surface.


Reuters: Science News

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Spire.io – Over 50 Million Minutes of Calm Discovered!

Uber’s new rewards program offers significant perks for frequent riders

Uber Rewards Program

If you’re a frequent Uber rider and Uber Eats user, you’ll be pleased to learn that the company has launched the equivalent of a frequent flyer program for its services. The more money you spend on Uber and Uber Eats, the better and more interesting perks you’ll get, which, in turn, will motivate you to spend even more cash on Uber. Bikes and scooters will also be included in Uber Rewards soon.

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Uber’s new rewards program offers significant perks for frequent riders originally appeared on BGR.com on Wed, 14 Nov 2018 at 17:02:48 EDT. Please see our terms for use of feeds.


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Apple launches repair program for iPhone X units with faulty displays

iPhone X

Though not a widespread problem by any means, some iPhone X users over the past few months have experienced issues with non-responsive and temperamental displays. In light of this, Apple today launched a new replacement program for iPhone X users who have encountered this particular touch issue.

Per an Apple support document, impacted devices tend to exhibit one or two behaviors. Specifically, impacted iPhone X units will either not respond to touch at all or will react even when not touched. Either way, it’s undoubtedly a frustrating usability issue, especially for a device that was priced in excess of $ 999.

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Apple launches repair program for iPhone X units with faulty displays originally appeared on BGR.com on Sat, 10 Nov 2018 at 20:10:50 EDT. Please see our terms for use of feeds.


BGR

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California’s Medi-Cal program paid $4B to recipients who may have been ineligible, audit shows

FOX News

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http://www.acrx.org -As millions of Americans strive to deal with the economic downturn,loss of jobs,foreclosures,high cost of gas,and the rising cost of prescription drug cost. Charles Myrick ,the President of American Consultants Rx, announced the re-release of the American Consultants Rx community service project which consist of millions of free discount prescription cards being donated to thousands of not for profits,hospitals,schools,churches,etc. in an effort to assist the uninsured,under insured,and seniors deal with the high cost of prescription drugs.-American Consultants Rx -Pharmacy Discount Network News

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Click today to request your free ACRX discount prescription card and save up to 80% off of your medicine!

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This Program Empowers Kids By Helping Them Create ‘Superhero’ Prosthetics | NBC Nightly News

NBC News

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http://www.acrx.org -As millions of Americans strive to deal with the economic downturn,loss of jobs,foreclosures,high cost of gas,and the rising cost of prescription drug cost. Charles Myrick ,the President of American Consultants Rx, announced the re-release of the American Consultants Rx community service project which consist of millions of free discount prescription cards being donated to thousands of not for profits,hospitals,schools,churches,etc. in an effort to assist the uninsured,under insured,and seniors deal with the high cost of prescription drugs.-American Consultants Rx -Pharmacy Discount Network News

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New Treasury program limits foreign investment in U.S. technology

The restrictions, which go into effect on Nov. 10, are part of a pilot program that aims to give the government more power to block foreign, non-controlling investments in companies involved in industries such as aircraft development and computer manufacturing, as well as chemical and weapons systems.
Business

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