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China Warns Spread of An ‘Unknown Pneumonia’ Deadlier Than COVID-19

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Unknown pneumonia in Kazakhstan
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Unknown pneumonia in Kazakhstan – Chinese Embassy Warns Citizens.

A warning about unknown pneumonia has been issued by the Chinese embassy in Kazakhstan, which says pneumonia has caused more than 600 deaths in the central Asian country in June.

The Chinese embassy said the new disease has a fatality rate much higher than Covid-19, in an advisory issued for its citizens living in the former Soviet Bloc country.

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China’s northwest Xinjiang Uyghur Autonomous Region borders with Kazakhstan.

In the first six months of the year, the ‘unknown pneumonia’ caused 1,772 deaths, of which 628 deaths occurred in June alone. A statement issued by the embassy on its WeChat platform said these deaths included those of Chinese citizens also.

The embassy added that the fatality rate of this unknown pneumonia in Kazakhstan is much higher than Covid-19.

However, it’s not clear if the Chinese officials have any more information about this particular pneumonia or if there is any specific reason to call it unknown.

And there isn’t any clarity if the World Health organization is informed about this “unknown pneumonia.”

The Chinese embassy reminded the Chinese nationals in Kazakhstan to be aware of the situation and increase prevention strategies to lower the infection risks.

The number of patients infected with the new pneumonia is two to three times higher than that of Covid-19, Kazakhstan’s healthcare minister said on Wednesday.

To contain the spread of novel coronavirus, Kazakhstan had implemented a lockdown on March 16, which was later lifted in May. Due to an increase in the number of cases, the restrictions were reimposed again.

The country could be facing a second wave of infections, president Kassim-Jomart Tokayev said. According to the Hong Kong-based South China Morning Post, Kazakhstan’s President Kassym-Jomart Tokayev said on Wednesday that it was too early to relax restrictions as the situation was still serious.

In fact, the country was facing a second wave of Covid-19 coupled with a huge uptick in pneumonia cases, he added.

Nearly 300 people diagnosed with the unknown pneumonia are being hospitalized every day in Kazakhstan, the health care department chief in the capital Nur-Sultan, Saule Kisikova, told the news agency Kazinform.

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Source: https://www.biotecnika.org/2020/07/unknown-pneumonia-in-kazakhstan-chinese-embassy-warns-citizens/

Biotechnology

Perceptive debuts LianBio with cancer and heart disease programs from BridgeBio, MyoKardia

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After working in stealth since October, Perceptive Advisors is unveiling its latest biotech: LianBio, which serves the dual mission of bringing much-needed new drugs to China and helping U.S. biotech companies expand their operations into Asia.

LianBio launches with a trio of assets licensed from MyoKardia and BridgeBio Pharma companies Navire Pharma and QED Therapeutics. LianBio is handing over more than $60 million upfront in exchange for development and commercialization rights to the programs in China and “selected Asian markets.” BridgeBio and MyoKardia will pick up equity in the LianBio, too.

And that’s not all—LianBio has a “strategic relationship” with BridgeBio that gives it first dibs on the 20 programs already in the latter’s pipeline, as well as any assets it may bring under its umbrella in the next four years, said Konstantin Poukalov, a managing director at Perceptive Advisors and executive chairman of LianBio. The company will be on the hook for up to $505 million in milestone payments to BridgeBio and $147.5 million to MyoKardia.

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LianBio’s pipeline includes mavacamten—a treatment for hypertrophic cardiomyopathy (HCM), an inherited disorder that causes the muscle walls of the heart to thicken, potentially to the point where they can obscure blood flow. MyoKardia plans to submit the drug for FDA approval for obstructive HCM in early 2021 and continue to develop it for patients with the non-obstructive form of HCM and those with a specific kind of heart failure, in which the left ventricle can’t properly fill with blood and pumps less blood to the body than normal.

RELATED: GlaxoSmithKline veteran Zhi Hong launches Brii Biosciences with $260M

LianBio has also licensed infigratinib, QED Therapeutics’ EGFR inhibitor that’s in a phase 3 study for bile duct cancer, and a SHP2 inhibitor that Navire Pharma is developing for drug-resistant tumors and other hard-to-treat cancers. LianBio hands over $26.5 million upfront

The company views these as more than just licensing deals, Debra Yu, LianBio’s chief business officer said. It plans to pitch in and run clinical trials in China and other parts of Asia where appropriate.

“It isn’t just like we get mavacamten and we go wherever we want with it and pay them the royalties,” Yu said.

“In the case of mavacamten, MyoKardia already got it all the way through for the obstructive HCM indication and we’ll take it into China,” she added. “But for the other indications, in nonobstructive HCM and (heart failure with preserved ejection fraction), we will work side by side with them.”

As for infigratinib, that could mean testing the drug in cancers that QED is not yet looking at, but that are prevalent in China, such as gastric cancer, she added.

It’s part of Perceptive and LianBio’s bid to bring cutting-edge medicines to China and address what CEO Bing Li calls the gap between global innovation and the China market.

“China has predominantly been a generics market for most of its time,” Yu said. “Even today, there is still a very limited number of innovative drugs and certainly not those we would call ‘paradigm-shifting.”

As it advances its pipeline, LianBio aims to double its team by the end of the year. It will be on the hunt for more assets that it might want to pursue in China, both through its deal with BridgeBio and other potential partners.

When asked if LianBio would ever dive into in-house discovery and development, Poukalov said “nothing is ever off the table,” but that the core focus of the company’s model is “high-quality assets that are highly significantly derisked.”

“But once our therapeutic areas of focus are established, we are certainly willing to move to earlier stages of development,” Poukalov added. That could include putting together novel cancer-fighting combinations based on Navire’s SHP2 inhibitor.

“In the near-term, I don’t think we are going to be doing true benchwork—there are plenty of people who are good at doing that—but we will be utilizing what we know and the access we have to be creative and do early-stage development work,” he said.

Editor’s note: This story has been updated to remove the dollar amount of LianBio’s funding as it was incorrect.

Source: https://www.fiercebiotech.com/biotech/perceptive-debuts-lianbio-cancer-and-heart-disease-programs-from-bridgebio-myokardia

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Biotechnology

Medtronic snaps up smart insulin pen maker Companion Medical in a ‘bold move’

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Medtronic is buying up leading smart insulin pen and phone app maker Companion Medical as it looks to shore up its growing weakness in the pump market.

The med tech major gets access to Companion’s InPen, a so-called smart insulin pen that not only delivers insulin, but also tracks insulin on board, provides an meal bolus calculator and shares information with connected systems.

The InPen last for around a year and works with short-acting insulins, although work is being done on long-acting insulins. The company made around $11 million in 2019 sales and was looking to triple that this year, after launching in late 2017, though its market penetration is pretty low.

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“This acquisition is an ideal strategic fit for Medtronic as we further simplify diabetes management and improve outcomes by optimizing dosing decisions for the large number of people using multiple daily injection (MDI),” said Sean Salmon, EVP and president of the Diabetes Group at Medtronic.

“We look forward to building upon the success of the InPen by combining it with our intelligent algorithms to deliver proactive dosing advice personalized to each individual. This smart CGM system can help people think less about diabetes and be able to live life with more freedom, on their own terms.

”Our goal is to become a trusted partner that offers consistent support whether an individual wants to stay on MDI, transition to automated insulin delivery or take a break from their pump.”

Analysts at Jefferies said the buyout was a “bold move” and a “source of growth” for Medtronic, and could add $200 million in incremental revenue.  

It points out that Medtronic has “been floundering in diabetes,” losing around a point of share a month in the pump market. The Companion deal will help offset this, and allows Medtronic to serve not only the current and future pump market, but also those that chose to stay on pens, Jefferies said in a note the clients.

The plan now is to combine its diabetes tools (from its Nutriono and Klue buyouts) with InPen and integrate its own continuous glucose monitoring (CGM) system.

Jefferies notes however that the future of insulin delivery “remains a debate.” They firm muses whether smart pens “provide enough of a clinical leap for patients such that pumps prove too much of a relative burden for their benefits.”

Financial details of the deal were not made public. Medtronic’s shares were up nearly 2% Tuesday.

Source: https://www.fiercebiotech.com/medtech/medtronic-snaps-up-smart-insulin-pen-maker-companion-medical-a-bold-move

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Fulcrum’s losmapimod fails interim analysis in muscle wasting trial 

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Fulcrum Therapeutics’ losmapimod has performed no better than placebo in an interim analysis of data from a phase 2 clinical trial in patients with facioscapulohumeral muscular dystrophy (FSHD). Despite the setback, Fulcrum hailed the data as “very encouraging,” zeroing in on results from a pre-specified sensitivity analysis to make its case for an upbeat reading of the interim analysis.

Losmapimod is a p38α/β mitogen activated protein kinase inhibitor that Fulcrum picked up from GlaxoSmithKline last year. GSK developed the drug in cardiovascular disease, without success, but Fulcrum’s analysis of the pathogenesis of progressive muscle wasting disorder FSHD led it to spy a different application for the molecule. Fulcrum committed to pay up to $37.5 million in clinical and regulatory milestones for the asset in the belief it may block expression of DUX4.

The phase 2 trial is the first big clinical test of that hypothesis. So far, losmapimod is coming up short. After 16 weeks, subjects who received losmapimod twice daily experienced a 3.7-fold rise in DUX4 expression as measured in skeletal muscle biopsies, compared to a 2.8-fold increase in the placebo arm. Numerically, placebo performed better than losmapimod.

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That headline finding of the interim analysis of the primary endpoint data sent shares in Fulcrum down 29% at points in premarket trading. Fulcrum CEO Robert Gould took a different view than investors, pointing to the results in a subgroup of eight subjects with the highest baseline levels of DUX4 expression to make his case.

In that subgroup analysis, the three patients on losmapimod experienced a 38-fold decrease in DUX4 expression, compared to a 5.4-fold decline in the five subjects on placebo. Fulcrum said the results indicate “muscle biopsies within the higher levels of DUX4-driven gene expression may be needed to observe a reduction from baseline.”

Fulcrum will need more data to validate that hypothesis. Work to gather the data is underway. The phase 2 enrolled 80 subjects and was due to evaluate DUX4 activity in all of them at 16 weeks. That plan changed when COVID-19 prevented researchers from taking muscle biopsies, leading Fulcrum to extend the study and take samples from some people at 36 weeks. In changing the protocol, Fulcrum chose to use biopsies already taken at 16 weeks for an interim analysis.

Topline primary endpoint results from the other subjects are due in the first quarter of next year. Fulcrum plans to follow up with a fuller dataset featuring secondary and exploratory endpoint results in the second quarter.

Those other endpoints may provide a clearer picture of whether losmapimod is improving the lives of FSHD patients, rather than just acting on a biomarker. The full list of outcomes evaluated in the phase 2 include muscle strength, motor function and quality of life. 

Source: https://www.fiercebiotech.com/biotech/fulcrum-s-losmapimod-fails-interim-analysis-muscle-wasting-trial

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