Connect with us


Sage drug for depression gets lift in phase III trial





vitaminsSage’s new antidepressant is being called a “blockbuster” depression drug for good reason: It’s the first federally-approved drug to significantly differ from nearly a half century’s worth of antidepressants.Shutterstock
  • On Monday, a new drug for depression got a big lift from positive clinical trial results. Stocks surged on the news.
  • The drug is made by Sage Therapeutics, a Cambridge-based pharmaceutical company that focuses on brain disorders.
  • Nearly all existing antidepressants, from Celexa to Zoloft, work on the brain’s serotonin network. But the drugs fail for as many as 1 in 3 people and take 4-6 weeks to have an effect.
  • Sage’s new drug targets a different brain system than these antidepressants. As a result, it appears to work faster and last longer.

A drug that works differently than all existing antidepressants just got a big boost. 

In results from its latest clinical trial on Monday, the drug, called Sage 217, appeared to relieve symptoms of post-partum depression in a sample of roughly 150 women. Made by pharmaceutical company Sage Therapeutics, the new drug candidate acts on the brain’s gaba system, in stark contrast to all current medications for depression. Those drugs are called SSRIs (selective serotonin reuptake inhibitors) and effect the brain’s serotonin network.

Sage’s stock surged accordingly, rising from roughly $97 per share to almost $150 per share.

Some early research suggests it may even be possible for patients to go several weeks without taking the drug — as opposed to being tied to a daily pill. And analysts say the results suggest the drug would also be a good candidate for people with regular depression, also known as major depressive disorder, as well as those with post-partum depression or PPD.

Experts who study depression told Business Insider they’d been cheered by earlier study results on the drug, which suggested it could offer patients relief in a different way from current treatments.

Read More: The biggest healthcare investor conference starts on Monday — here are the top 5 areas we’re keeping an eye on

The latest results bolster that analysis, they say, making the new drug potentially appealing for many patients.

However, although the drug appears to be a big innovation in several ways, those experts say it’s worth noting that it would likely not work as a sort of one-and-done treatment in the way Sage CEO Jeff Jonas described over the summer

Why Sage’s new drug could be a game changer for people with depression

man silhouette alone sunrise sunsetSage-217 may not require patients to take the drug daily as they would with current antidepressants.Daiana Lorenz/YoutubeAnalysts, scientists, and clinicians agree that Sage’s new drug could be a game-changer for the millions of people who live with depression and don’t get results with current treatments.

For its latest study, researchers concluded that Sage-217 worked fast and well, noting that most patients observed a relief in symptoms as early as three days into the treatment. Those results were maintained for at least a month.

“In our view, these data not only provide a more commercially viable product for post-partum depression, but should also further increase investor confidence in the ongoing Phase 3 trial in the broader population of patients [with major depression],” JPMorgan analyst Cory Kasimov wrote in a note

A drug that works fast and lasts is something that most patients with depression have never seen. For all of the hope that drugs like Celexa and Prozac have inspired, they don’t work for as many as one in every three patients. 

In addition, the drugs — which target the brain’s serotonin system and are thus known as SSRIs (selective serotonin reuptake inhibitors) — take roughly 4-6 weeks to work.

That’s not quick enough for patients with severe depression and suicidal thoughts, according to Cristina Cusin, a psychiatrist at Massachusetts General Hospital and an assistant professor at Harvard University who specializes in severe depression. 

By contrast, Sage’s drug appears to take an effect as quickly as two weeks into treatment — not as fast as rapid-fire anesthetic drug ketamine, but significantly quicker than all existing approved antidepressants.

Read more: A ‘party drug’ with potential to be the next blockbuster antidepressant is edging closer to the mainstream, but it could set you back $9,000

Wall Street analysts say they see a huge market potential for the new drug.

Latest results are ‘a best case scenario’ for the new drug

The results the company released this morning “represent essentially a best case scenario,” for the drug, wrote JPMorgans’ Kasimov.

Others agreed.

“The possibility of having something that impacts the Gaba system is attractive because if you were to launch it tomorrow, there’s likely going to be lots of patients who’ve failed with anything that’s available,” Paul Matteis, the managing director of biotech research with brokerage firm Stifel, told Business Insider in December.

Plus, the drug may not require patients to take it daily, at least according to both the latest study and a series of preliminary results from the company’s clinical trials.

That’s something that Matteis said sounds like it would be “preferred by most patients than having to take something indefinitely.”

That optimism is what Sage CEO Jonas was likely alluding to when he made his comments about Sage-217 over the summer, Matteis said. 

In June, Jonas said Sage-217 had the potential for patients with depression “to feel well within days, with just a two week course of treatment — similar to how antibiotics are used today.”

Shortly after he made that statement, the company’s stock surged.

Yet instead of taking the drug only once, most experts say patients would likely need to take it “episodically” — meaning as frequently as once a month. That’s still a big change from the way current antidepressants are administered, and could be a significant boost for patients, said Matteis.

“Any paradigm-shifting drug is going to have some nuances that, I don’t wanna say are scary, but are counterintuitive to the current therapy model.”

Wenn ihr mit jemandem sprechen wollt, erreicht ihr die Telefon Seelsorge unter 0800/111 0 111 oder 0800/111 0 222, kostenfrei und rund um die Uhr. Sorgen wiegen schwer und sie richten sich nicht nach Tages- oder Öffnungszeiten. Da ist es gut, wenn auch mitten in der Nacht jemand ein offenes Ohr hat.
Die Mitarbeiter sind sich ihrer verantwortungsvollen Aufgabe bewusst und nehmen Ihren Anruf ernst – egal, ob um acht Uhr morgens oder um Mitternacht.


Source link

قالب وردپرس


Wedding attack and tech: How OpenText’s investigations service beats the traditional approach





At its heart, an investigation is a hunt for relevant facts in order to tell a story — a story that drives strategies for organizations, including law firms.

Tracy Drynan, head of OpenText Recon Investigations — a seamless end-to-end service that helps companies and law firms find evidence for all types of investigations including internal investigations, litigation assessments, compliance and regulatory investigations, c-suite vetting and more — says these stories are a more powerful tool than most people think.

The team led by Drynan arms both in-house and external counsel with the information needed to guide their corporate and outside lawyers with the information needed to guide their clients: an investigation empowers them. What differentiates OpenText Recon is the speed with which the team utilizes specialized tools and workflows to efficiently locate evidence. This approach gains insights into patterns, gaps and relationships in a fraction of the cost of a traditional eDiscovery review, and more quickly gathers the relevant facts to create that critical story.

“Whether it be litigation or a regulatory investigation or an internal audit, often time is of the essence,” Drynan says. “Being able to make decisions that affect your bottom line, your liability, your risks which ultimately challenge your resources, even public opinion, is critical.”

Too often, an archaic model is applied to investigations — one derived when we still existed in a paper society — that analyzes all available information but doesn’t actively hunt for relevant facts, and that produces a disconnect. An efficient model does not need to analyze every piece of information.

“It’s flawed for this reason,” Drynan says. “When you review a set of information, even when you apply advanced analytics and information retrieval science, it is still at the end bucketed for a team to analyze it contiguously. In a way, we are still following the pre-electronic paradigm — we are reviewing almost paper documents one by one, and that unfortunately is handicapping both the talent and the technology in the hunt for the facts.”

While lawyers may make a living hunting facts and building narratives, Drynan would argue their approach could be improved and points out that many of the companies hired by firms to help out during an investigation still apply that outdated model. OpenText Recon breaks that pattern and approaches the hunt differently — they don’t compartmentalize anything, which means the team can identify patterns more easily. Those patterns become the clues, which become the facts, that become the story that allow lawyers to make those critical decisions. The result is not a stack of documents, but a more nuanced report outlining the important facts to analyze.

Continue Reading


Canada takes aim at Netflix, Airbnb in $6.5B big-tech tax plan





Canada’s federal government is planning to force foreign-based technology firms such as Netflix Inc. and Airbnb Inc. to charge their users a sales tax in a move aimed at boosting the government’s coffers by as much as $6.5 billion over the next five years. 

The new taxation plans, outlined in the government’s Fall Economic Statement, attempt to level the playing field between Canadian companies and foreign-based digital corporations that were largely exempt from paying federal sales taxes. Some provinces — such as Saskatchewan, British Columbia, and Quebec — introduced taxes on streaming services like Netflix earlier this year. 

The government announced Monday that any foreign-based company selling digital products or services to consumers in Canada will be required to collect and remit the Goods and Services Tax or Harmonized Sales Tax. The new tax changes are proposed to begin on July 1, 2021. 

“Canadians want a tax system that is fair, where everyone pays their fair share, so the government has the resources it needs to invest in people and keep our economy strong. That is why we are moving ahead with implementing GST/HST on multinational digital giants and limiting stock option deductions in the largest companies,” said Finance Minister Chrystia Freeland, in prepared remarks. 

“And Canada will act unilaterally, if necessary … to apply a tax on large multinational digital corporations, so they pay their fair share just like any other company operating in Canada.”

Those taxes will include any sales on products or services made through digital marketplace platforms, sales to Canadians of goods that are located in Canadian fulfillment warehouses, as well as any companies whose platforms help to facilitate short-term rental accommodations in Canada. 

However, the new taxation moves wouldn’t see streaming services such as Netflix, Inc.’s Prime Video, Walt Disney Co.’s Disney+, and Spotify Technology SA meet certain Canadian-content requirements, something the Canadian Radio-television and Telecommunications Commission​ recommended be adopted rather than introduce new tax measures in a wide-ranging report released earlier this year. 

The CRTC estimates that those streaming services record annual revenue of roughly $5 billion, according to its most recent financial data. The federal broadcast regulator said in January that Ottawa should require foreign streaming services to invest in local programming rather than “digital taxes” that would likely get passed down to consumers. 

“It is more appropriate to establish a regime that requires such online streaming services that benefit from operating in Canada to invest in Canadian programming that they believe will attract and appeal to Canadians,” the report said. 

Ottawa will also consider new corporate-level taxes for foreign-owned digital corporations and is working with the Organisation for Economic Co-operation and Development to develop a framework it expects to provide further details on in the next budget. It expects the new measure will result in $3.4 billion in new tax revenue over the next five years once it is introduced sometime in 2022. 

Continue Reading


RevoluGROUP Canada Inc. RevoluPAY To Pursue Dubai Financial Services Authority PSP License





VANCOUVER, British Columbia(GLOBE NEWSWIRE) — RevoluGROUP Canada Inc. (TSX-V: REVO), (Frankfurt: IJA2) (the “Company”) is pleased to announce that it has dispatched Company advisor Erik A. Lara Riveros to pursue the petition of a Payment Service Provider (“PSP”) Money Service Business License in the Dubai International Financial Centre (“DIFC”) from the Dubai Financial Services Authority.

Corporate Rational For a PSP License in Dubai

In May 2020, RevoluPAY was granted the European PSD2 license. In September, RevoluPAY received Pan-European passporting approval to operate in 27 E.U. countries. The Company has further expanded its international open banking reach through definitive agreements (“DA”) with BBVA, Flutterwave, and Thunes. Additionally, via direct PSD2 SEPA passporting, the Company added sixty-eight countries and territories to its financial operations roster. In November, the Company submitted petitions for both the analogous United States MSB licenses and the Canadian FINTRAC license. The MEASA region of the Middle East, Africa, and South Asia is a significant financial hub that necessitates exposure for both financial operations and a strategic base for the region’s operations. The Company considers the DIFC an excellent regional hub, having introduced robust legislation for payment services providers (“PSP”) like RevoluPAY.

Furthermore, DIFC conveniently fills the timezone gap for a global financial center between London and New York’s leading financial centers in the West and Hong Kong and Tokyo in the East. Company advisor Erik A. Lara Riveros is duly accredited with the Dubai Financial Services Authority, which should aid the Company’s plans to obtain the Dubai PSP license and establish a corporate financial hub in the region. The Company has diligently prepared all required documentation, and Mr. Lara Riveros arrives in Dubai on the 4th of December 2020 to initiate the license petition process. The global operations of RevoluPAY expect to benefit from the multi timezone capability garnered from a supplementary and PSP licensed subsidiary domiciled in the MEASA region.

License Sought in Dubai

The Company intends to pursue the Category 3D license, which covers the following activities, “Providing or Operating a Payment Account, executing Payment Transactions or Issuing Payment Instruments, including creating and maintaining accounts for executing payment transactions, issuance of personalized sets of procedures agreed upon by the users and the provider, for initiation or execution of payment instructions.”

Continue Reading