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Biogen, Sage face uphill battle with postpartum depression pill – Yahoo Canada Shine On

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By Bhanvi Satija and Mariam Sunny

(Reuters) – The U.S. drug regulator’s approval of Biogen and Sage Therapeutics’ first-of-its-kind postpartum depression (PPD) pill is unlikely to allay the drugmakers’ growth concerns, analysts said on Monday.

Adverse commentary after their PPD drug was approved by the U.S. Food and Drug Administration (FDA) on Friday sent Sage shares tumbling 40%, while Biogen dropped 3% in premarket trading.

At least four brokerages cut price targets on Biogen, while two downgraded Sage.

Their drug, Zurzuvae, became the first oral treatment for a common complication that impacts one in eight women during and after pregnancy, and affects their ability to return to normal functioning.

The FDA’s decision to decline the drug’s approval for a much larger cohort of patients with clinical depression, along with strict safety warnings for its use in PPD, is still a “strike against (Biogen’s) management”, Baird analyst Brian Skorney said.

“We think this is going to be a tough indication to build a big market out of, even at a high premium price,” Skorney said in a research note.

There is a major need for PPD drugs as existing treatments include general anti-depressants that take up to six weeks to show effect, Biogen said in February. Zurzuvae improved symptoms of PPD after 15 days in a late-stage trial.

Zurzuvae’s use as a clinical depression treatment represents a more than $1 billion sales opportunity compared with $250 million to $500 million potential for postpartum depression, said Jefferies analyst Michael Yee.

“Postpartum depression is not necessarily where a big commercial opportunity is,” Biogen CEO Christopher Viehbacher said last month.

The U.S. FDA said last week that additional studies might be required to support the drug’s approval for major depressive disorder (MDD), or clinical depression.

Biogen is unlikely to “quickly move forward on another late-stage study for MDD”, given its focus on saving costs and its recent announcement of job cuts, Yee said.

(Reporting by Mariam Sunny and Bhanvi Satija in Bengaluru, writing by Manas Mishra, editing by Vinay Dwivedi)

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Health-care announcements expected with two weeks to go in N.B. election race

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New Brunswick‘s Liberal and Green parties are set to make announcements about health care on the campaign trail today as the provincial election race enters its second half.

Liberal leader Susan Holt is scheduled to hold her announcement this morning in Saint John, N.B., followed by lunch at the city’s market.

A spokesperson with the Progressive Conservative party shared few details about the event scheduled for leader Blaine Higgs in Fredericton this morning.

Green Party Leader David Coon will hold a news conference this morning about “local health-care decision-making” alongside deputy leader Megan Mitton in her Sackville, N.B. riding.

On Saturday, Coon said he was proud to put forward a gender-balanced slate among the party’s 46 candidates.

While the Liberals and Progressive Conservatives are running with full slates, the Greens are three candidates short and will not have full representation when the province’s residents go to the polls on Oct. 21.

This report by The Canadian Press was first published Oct. 7, 2024.

The Canadian Press. All rights reserved.

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Alberta Health Services’ snag leads to potential delay of patient referrals

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EDMONTON – The Health Quality Council of Alberta is investigating how some medical referrals weren’t properly processed, potentially affecting 14,000 patients over the last five years across the province.

The referrals were made to specialists outside of Alberta Health Services, such as physiotherapists and dietitians.

The health authority’s CEO, Athana Mentzelopoulos, says it does an average 100,000 referrals per year, but in some cases it can’t confirm if patients received referral services.

She says the problem was flagged in late September, and a preliminary estimate suggests 31 patients may have experienced a potential negative outcome due to the delays.

The provincial government requested the investigation, and the quality council is to find out how the snag occurred and how it can be prevented in the future.

The health authority says it has begun notifying patients who may have been affected by the disruption, and the cases could date back to 2019.

This report by The Canadian Press was first published Oct. 4, 2024.

The Canadian Press. All rights reserved.

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Don’t fall for fake dentists offering veneers and other dental work on social media

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WASHINGTON (AP) — If you have stained or chipped teeth, you might be considering veneers, customized teeth coverings that can restore a photogenic smile without more extensive dental work.

But dentists warn that these pricey cosmetic enhancements are at the center of a worrisome online trend: unlicensed practitioners without proper training or supervision offering low-cost veneers.

These self-described “veneer techs” often promote themselves on Instagram and TikTok, promising a full set of veneers for less than half of what dentists typically charge. Some also market their own training courses and certifications for people looking to get into the business.

It’s misleading, health professionals warn — and illegal. All states require dental work, including veneers, to be performed under the supervision of a licensed dentist.

On Thursday, Georgia law enforcement officials arrested Brandon Diller, who promoted himself to 158,000 Instagram followers as “Atlanta’s top veneer specialist and trainer.” Diller practiced dentistry without a license and sold “training and certificates, which were worthless” and “provided no legitimate or legal credentials,” according to an arrest warrant from Fulton County’s District Attorney’s office.

Here’s what to know about veneers and how to avoid bogus providers and services:

What are dental veneers?

Veneers are thin, custom-made dental coverings used to hide minor imperfections or to fill in gaps between teeth. Unlike crowns or more invasive dental implants, veneers are almost always considered cosmetic dentistry and generally aren’t covered by insurance.

Dentists usually charge between $1,000 and $2,000 per tooth for veneers, with higher prices for those made from porcelain compared with lower-grade materials.

Placing veneers involves stripping some of the natural enamel from the tooth and bonding the new covering into place. Because of that process, getting veneers is considered an irreversible procedure, according to the American Dental Association. They are not permanent, and can be expected to last between 5 to 15 years before they degrade and need to be replaced.

In recent months the ADA has been stepping up warnings about the risks of veneer procedures done by unlicensed individuals.

“Quality control is lost without the involvement of a licensed dentist,” said Dr. Ada Cooper, a New York-based dentist and ADA spokesperson. “We undergo years of education and training and need to be licensed by various regulatory bodies before we can practice.”

What are the risks of getting veneers from someone who isn’t licensed?

Improper veneer procedures can cause a range of health problems, including severe pain, nerve damage and tooth loss.

Patients need to be anesthetized before the enamel is removed from their teeth.

“It could be incredibly painful if they’re not anesthetized correctly,” said Dr. Zach Truman, who runs an orthodontics practice in Las Vegas. “You can also go too deep into the tooth and penetrate what’s called the pulp chamber, which contains blood vessels and nerves.”

One of the biggest problems Truman sees with unregulated veneer work is that customers aren’t getting screened for existing dental problems, such as gum disease and cavities.

“If you put a veneer on a tooth that has an active cavity, you’re just going to seal it in there and eventually it’s going to progress to tooth loss,” Truman said.

Dental veneers aren’t the only option for improving the appearance of teeth. Over-the-counter whitening kits can help with minor stains and discoloration. And dentists can sometimes use composite materials to reshape chipped or uneven teeth. But Truman says those fillings are prone to crack and won’t last as long as veneers.

How can I spot bogus veneer providers online?

One clue: Many individuals performing unlicensed dental work promote themselves on social media as “veneer technicians.”

Instead of working out of a dental office they often perform treatments at beauty salons, hotel rooms or private homes. Some advertise multi-city tours and encourage clients to message them to book an appointment in advance.

Much of the appeal of the services is in their pricing, with some offering a full set of veneers for a flat fee of $4,000 or $5,000. That’s less than half of what patients can generally expect to pay at a dental office.

Performing dental work without an appropriate license is illegal, the ADA notes.

Dentists and hygienists are licensed by state governments, who also define the work dental assistants can perform. But in all cases, veneers and other dental procedures must be supervised by a licensed dentist.

Earlier this year, Illinois law enforcement officials arrested a woman running a business called the Veneer Experts after she posted videos of herself fitting braces, veneers and other dental products without a license. She was previously arrested in Nevada on similar allegations of practicing dentistry without a license.

What are the best ways to find legitimate dental providers?

The ADA maintains a website detailing the training and licensing requirements for dentists across the U.S. Most states also maintain websites where you can lookup and verify licensure information and find any past disciplinary actions for dentists and other health professionals.

“It’s really critical to understand that dentistry is a regulated health care profession that requires formal educations and licensure,” Cooper said.

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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.

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