New IPO BioNTech (NASDAQ:BNTX) is up 11% premarket on modest volume as it tries to recoup yesterday’s 5% dip from its $15 offering price in its first day of trading.
https://seekingalpha.com/news/3505220-ipo-biontech-11-percent-premarket
Friday, October 11, 2019
RedHill Bio up 7% premarket on positive data on RHB-104 in Crohn’s
Thinly traded micro cap RedHill Biopharma (NASDAQ:RDHL) is up 7% premarket on light volume in response to 52-week results from a Phase 3 clinical trial, MAP US, evaluating RHB-104 in patients with Crohn’s disease.
The study continued to meet the primary endpoint
of clinical remission achieved at week 26, showing a rate of 22.4%
compared to 36.7% at the earlier time point (p=0.0048). Key secondary
endpoints were also sustained.
On the safety front, there was a cardiac
abnormality, progressive prolongation of the QTcF interval (heart rhythm
disorder that can lead to serious arrhythmias), observed at week 52 but
none resulted in serious adverse cardiac events.
Results from an open-label extension study, MAP US2, in patients with persistently active Crohn’s, showed a clinical remission rate of 27.8% at week 16 and 22.2% at week 52.
https://seekingalpha.com/news/3505261-redhill-bio-7-percent-premarket-positive-data-rhbminus-104-crohnsFlight Attendants Union Asks FAA To Ban E-Cigarettes On Airplanes
At least 265 incidents in the air or at airports have involved lithium-ion batteries since 1991, according to the FAA.
Out of those 265, a minimum of 48 smoke or fire incidents were from lithium batteries in e-cigarettes, which is more than the number caused by cell phones, laptops, battery chargers, tablets or spare batteries.
The vaping devices often contain cheaper batteries that are more likely to fail and start a fire, and the nation’s largest flight attendant union is calling on the Federal Aviation Administration to ban all e-cigarettes from airplanes, according to CBS News.
“A lithium-ion battery fire on a plane can be catastrophic,” Sara
Nelson, president of the Association of Flight Attendants, told CBS.
Flight attendants have turned into de facto firefighters, and this means the FAA needs to do more, she said.
Even though flight attendants are trained to take care of fires by placing flaming devices in special fire-resistant bags, Nelson said it would be better if they didn’t have to manage those situations at all.
“How about we just not have these e-cigarettes on the plane at all?”
Mark Millam of the Flight Safety Foundation told CBS that a ban requires more information.
“A ban could happen when there is the right information that’s understood about it,” he said.
The FAA responded that it has “clear regulations” on the safe transport of lithium-ion batteries, and said vape pens, e-cigarettes and spare batteries must be put in carry-on bags.
https://www.benzinga.com/markets/cannabis/19/10/14575157/flight-attendants-union-asks-faa-to-ban-e-cigarettes-on-airplanes
Out of those 265, a minimum of 48 smoke or fire incidents were from lithium batteries in e-cigarettes, which is more than the number caused by cell phones, laptops, battery chargers, tablets or spare batteries.
The vaping devices often contain cheaper batteries that are more likely to fail and start a fire, and the nation’s largest flight attendant union is calling on the Federal Aviation Administration to ban all e-cigarettes from airplanes, according to CBS News.
Flight attendants have turned into de facto firefighters, and this means the FAA needs to do more, she said.
Even though flight attendants are trained to take care of fires by placing flaming devices in special fire-resistant bags, Nelson said it would be better if they didn’t have to manage those situations at all.
“How about we just not have these e-cigarettes on the plane at all?”
Mark Millam of the Flight Safety Foundation told CBS that a ban requires more information.
“A ban could happen when there is the right information that’s understood about it,” he said.
The FAA responded that it has “clear regulations” on the safe transport of lithium-ion batteries, and said vape pens, e-cigarettes and spare batteries must be put in carry-on bags.
https://www.benzinga.com/markets/cannabis/19/10/14575157/flight-attendants-union-asks-faa-to-ban-e-cigarettes-on-airplanes
Thursday, October 10, 2019
Improving nature’s own ability to kill dangerous bacteria
The Centers for Disease Control and
Prevention considers antibiotic resistance one of the most urgent public
health threats, one that affects communities worldwide. The
ramifications of bacteria’s ability to become resistant to antibiotics
can be seen in hospitals, public places, our food supply, and our water.
In their search for solutions, researchers at Rensselaer Polytechnic
Institute have been looking to nature. In a paper recently published in Biomacromolecules,
the team demonstrated how it could improve upon the ability of nature’s
exquisitely selective collection of antimicrobial enzymes to attack
bacteria in a way that’s much less likely to cause bacterial resistance.
“The idea is that we could take nature’s approach and just make it better,” said Jonathan Dordick, a chaired professor of chemical and biological engineering and a member of the Center for Biotechnology and Interdisciplinary Studies (CBIS), who led this research at Rensselaer with postdoctoral researcher Domyoung Kim and Senior Research Scientist Seok-Joon Kwon.
In order for bacteria to grow and live, they naturally produce autolysin enzymes that can break down their own cell walls, allowing those cells to divide and multiply.
In attacking one another, bacteria take advantage of a similar process, using an antibacterial protein known as a bacteriocin to kill a bacterium. Bacteria can also be attacked by bacteriophages, which are viruses that infect bacteria. They produce phage endolysin enzymes, which attack the bacterial cell from the inside. All three types of enzymes are broadly known as cell lytic enzymes, as they catalyze the breakdown of the bacterial cell wall.
“It’s very difficult for bacteria to become resistant to the action of these enzymes,” Dordick said. “For example, if they became resistant to an autolysin, they wouldn’t divide.”
Like building blocks, most cell lytic enzymes are modular. They’re made up of one binding domain which attaches to the cell wall, and a catalytic domain that breaks holes in the cell wall — effectively destroying the targeted bacteria.
These enzymes are very specific, Dordick said, targeting one or only a few bacteria. In this paper, the researchers set out to see if they could improve the combinations nature has created.
“The idea was: Could we use a Lego-like approach here? Could we take a binding domain from one enzyme and can we mix it with a binding domain or catalytic domain of another one?” Dordick said.
More specifically, the team took the protein streptavidin, which acts as an effective template to which the researchers could attach a binding domain from one organism and a catalytic domain from another. The modularity approach allows them to make new combinations quickly in order to determine which work best.
They found that in targeting Staphylococcus aureus — commonly known as staph — their combinations were very effective, at times even better than what occurs in nature.
“We genetically expressed the binding domains or the catalytic domains from several different organisms,” Dordick said. “We identified some that worked better than what nature provided. So that opens up an entirely new way of developing antimicrobial enzyme systems.”
“This research has the potential to improve human health,” said Deepak Vashishth, director of CBIS, a research center that brings faculty of multiple disciplines together to solve complex challenges. “It is emblematic of the innovative solutions that are needed to advance medical care.”
These findings lay the groundwork for further research and for improving the team’s creation of paints or coatings that could be applied to surfaces in order to seek out and kill targeted bacteria; to control and re-engineer various microbiomes found in nature; and potentially to be used clinically, for example, to control skin and intestinal infections.
This work was done in collaboration with a group led by Jungbae Kim, professor of chemical and biological engineering from Korea University. It was supported by a grant from the Global Research Laboratory Program through the National Research Foundation of Korea.
“The idea is that we could take nature’s approach and just make it better,” said Jonathan Dordick, a chaired professor of chemical and biological engineering and a member of the Center for Biotechnology and Interdisciplinary Studies (CBIS), who led this research at Rensselaer with postdoctoral researcher Domyoung Kim and Senior Research Scientist Seok-Joon Kwon.
In order for bacteria to grow and live, they naturally produce autolysin enzymes that can break down their own cell walls, allowing those cells to divide and multiply.
In attacking one another, bacteria take advantage of a similar process, using an antibacterial protein known as a bacteriocin to kill a bacterium. Bacteria can also be attacked by bacteriophages, which are viruses that infect bacteria. They produce phage endolysin enzymes, which attack the bacterial cell from the inside. All three types of enzymes are broadly known as cell lytic enzymes, as they catalyze the breakdown of the bacterial cell wall.
“It’s very difficult for bacteria to become resistant to the action of these enzymes,” Dordick said. “For example, if they became resistant to an autolysin, they wouldn’t divide.”
Like building blocks, most cell lytic enzymes are modular. They’re made up of one binding domain which attaches to the cell wall, and a catalytic domain that breaks holes in the cell wall — effectively destroying the targeted bacteria.
These enzymes are very specific, Dordick said, targeting one or only a few bacteria. In this paper, the researchers set out to see if they could improve the combinations nature has created.
“The idea was: Could we use a Lego-like approach here? Could we take a binding domain from one enzyme and can we mix it with a binding domain or catalytic domain of another one?” Dordick said.
More specifically, the team took the protein streptavidin, which acts as an effective template to which the researchers could attach a binding domain from one organism and a catalytic domain from another. The modularity approach allows them to make new combinations quickly in order to determine which work best.
They found that in targeting Staphylococcus aureus — commonly known as staph — their combinations were very effective, at times even better than what occurs in nature.
“We genetically expressed the binding domains or the catalytic domains from several different organisms,” Dordick said. “We identified some that worked better than what nature provided. So that opens up an entirely new way of developing antimicrobial enzyme systems.”
“This research has the potential to improve human health,” said Deepak Vashishth, director of CBIS, a research center that brings faculty of multiple disciplines together to solve complex challenges. “It is emblematic of the innovative solutions that are needed to advance medical care.”
These findings lay the groundwork for further research and for improving the team’s creation of paints or coatings that could be applied to surfaces in order to seek out and kill targeted bacteria; to control and re-engineer various microbiomes found in nature; and potentially to be used clinically, for example, to control skin and intestinal infections.
This work was done in collaboration with a group led by Jungbae Kim, professor of chemical and biological engineering from Korea University. It was supported by a grant from the Global Research Laboratory Program through the National Research Foundation of Korea.
Story Source:
Materials provided by Rensselaer Polytechnic Institute. Note: Content may be edited for style and length.
Materials provided by Rensselaer Polytechnic Institute. Note: Content may be edited for style and length.
Journal Reference:
- Domyoung Kim, Seok-Joon Kwon, Jessica Sauve, Keith Fraser, Leighann Kemp, Inseon Lee, Jahyun Nam, Jungbae Kim, Jonathan S. Dordick. Modular Assembly of Unique Chimeric Lytic Enzymes on a Protein Scaffold Possessing Anti-Staphylococcal Activity. Biomacromolecules, 2019; DOI: 10.1021/acs.biomac.9b01134
FDA guidance aims for loophole to avoid rebates
The FDA has completed a draft guidance that would create a legal
loophole for drug companies to bypass legal commitments to pay rebates
to PBMs and payers. The guidance, which is under review at the Office of
Management and Budget, is intended to allow companies to sell drugs at
net prices that don’t include rebate payments.
If and when it is implemented, HHS believes the
guidance would enable drug companies to create a parallel market that
would function alongside regular supply chains. In this separate
channel, imported drugs could be sold at lower list prices to patients
who are uninsured or who have large deductibles.
The guidance could also give companies the ability
to free themselves from long-term contracts and negotiate new contracts
for distributing drugs through conventional supply chains.
The scheme, first announced by HHS in a plan
released in July, rests on FDA giving the green-light to a sleight of
hand trick involving National Drug Codes (NDCs), codes that FDA assigns
to drugs so it can track them throughout the supply chain.
Drug manufacturers would be permitted to obtain a new NDC for imported drugs.
While the imported products would be designated with
different NDCs, manufacturers would be required to ensure that the
imported drugs are identical to those produced for the U.S. market. The
imported drugs would be manufactured in the same factories as those
intended for the U.S. market.
Because contracts identify drugs by NDC, according
to HHS, the manufacturers would be able to sell the imported drugs
without regard to long-term contracts they had entered into for the U.S.
market.
In its plan outlining the proposal, HHS said
“multiple manufacturers have stated (either publicly or in statements to
the Administration) that they wanted to offer lower cost versions but
could not readily do so because they were locked into contracts with
other parties in the supply chain. This pathway would highlight an
opportunity for manufacturers to use importation to offer lower-cost
versions of their drugs.”
The HHS plan downplayed safety concerns, stating
that because drugs would “imported through conventional supply channels,
this pathway generally would rely on applicable existing safeguards to
ensure supply chain integrity.”
The proposal is, however, likely to raise safety concerns.
Beyond the potential for counterfeit or adulterated
drugs entering the supply chain, there will be concerns that having
identical products on the market with different NDCs could interfere
with FDA’s ability to track drugs.
The scheme is also certain to face criticism — and
possibly litigation — from PBMs and insurers who will argue that the
government is inappropriately allowing drug manufacturers to slip out of
legal commitments.
The FDA draft guidance on “Importation of Certain
FDA-Approved Human Prescription Drugs, Including Biological Products”
was sent Monday to the Office of Management and Budget for review. There
is no deadline for OMB to complete the review.
https://www.biocentury.com/bc-extra/politics-policy/2019-10-08/fda-guidance-aims-loophole-avoid-rebatesPain relief: When to use cold, when to use heat
Sore from a workout? You don’t have to reach for pain relief medicine
when ice or heat will help. But when should you go cold and when should
you go warm?
Ice is the go-to therapy when an injury first happens. It can stop the swelling of a sprained ankle, for instance, and numb the pain. The traditional approach is 20 minutes on, 20 minutes off at first. You might step this down to 20 minutes every two or three hours on the second and third days. If you have a long-term injury, icing the area for 10 to 20 minutes after a workout can be soothing.
Ice options include a plastic bag of crushed ice, a reusable ice pack or even a bag of peas that can be refrozen for use again—label it so no one eats them. Whatever you use, always place a thin towel between the ice and your skin to prevent skin damage.
Once the swelling of an injury is gone, you can switch to heat. Heat eases discomfort and promotes healing. With a chronic condition like arthritis, it can soothe achy joints and lessen your pain. You can follow the same type of schedule you would when icing.
Just as you don’t want to freeze your skin with ice, you don’t want to burn it with heat. So watch the settings on a heating pad. You want warmth, but you don’t want it to feel hot. Another choice is a reusable heat pack that you warm in the microwave. You can find versions that come shaped for the body part needing treatment. Even just a warm shower or bath can help. The water should be between the high 90s and 100 degrees.
Although these are considered safe at-home remedies, talk to your doctor first if your injury could be serious—for instance, you notice a lot of swelling and pain—or if you have any chronic health conditions, including any that prevent you from feeling hot and cold, like neuropathy, often from diabetes.
https://medicalxpress.com/news/2019-10-pain-relief-cold.html
Ice is the go-to therapy when an injury first happens. It can stop the swelling of a sprained ankle, for instance, and numb the pain. The traditional approach is 20 minutes on, 20 minutes off at first. You might step this down to 20 minutes every two or three hours on the second and third days. If you have a long-term injury, icing the area for 10 to 20 minutes after a workout can be soothing.
Ice options include a plastic bag of crushed ice, a reusable ice pack or even a bag of peas that can be refrozen for use again—label it so no one eats them. Whatever you use, always place a thin towel between the ice and your skin to prevent skin damage.
Once the swelling of an injury is gone, you can switch to heat. Heat eases discomfort and promotes healing. With a chronic condition like arthritis, it can soothe achy joints and lessen your pain. You can follow the same type of schedule you would when icing.
Just as you don’t want to freeze your skin with ice, you don’t want to burn it with heat. So watch the settings on a heating pad. You want warmth, but you don’t want it to feel hot. Another choice is a reusable heat pack that you warm in the microwave. You can find versions that come shaped for the body part needing treatment. Even just a warm shower or bath can help. The water should be between the high 90s and 100 degrees.
Although these are considered safe at-home remedies, talk to your doctor first if your injury could be serious—for instance, you notice a lot of swelling and pain—or if you have any chronic health conditions, including any that prevent you from feeling hot and cold, like neuropathy, often from diabetes.
https://medicalxpress.com/news/2019-10-pain-relief-cold.html
Rotavirus infection may turn on type 1 diabetes
Rotavirus infection may play a role in the development of type 1
diabetes, according to a front matter article published October 10 in
the open-access journal PLOS Pathogens by Leonard C. Harrison of the University of Melbourne in Australia, and colleagues.
Rotavirus remains the major cause of infantile gastroenteritis worldwide, although the advent of vaccination has substantially decreased associated mortality. Following the recent introduction of rotavirus vaccination, there has been a 15% decrease in the incidence of type 1 diabetes in Australian children under four years of age, suggesting that rotavirus vaccination could contribute to the primary prevention of this autoimmune disease. This finding complements human and animal studies implicating rotavirus in the development of type 1 diabetes in genetically susceptible children.
In the article, Harrison and colleagues begin by reviewing molecular evidence supporting their hypothesis and point out the association between rotavirus infection and serum islet autoantibodies. They also discuss results indicating that rotavirus infection induces pancreatic pathology, as well as environmental factors that promote the rise in incidence of type 1 diabetes. Finally, they review population-level data suggesting that rotavirus vaccination may be associated with a decrease in the incidence of type 1 diabetes. According to the authors, it will be important to identify which children are most likely to be protected by rotavirus vaccination. Moreover, future studies should aim to reveal disease mechanisms and directly demonstrate whether rotavirus infects the human pancreas prior to the onset of islet autoimmunity or type 1 diabetes.
Harrison concludes, “Vaccination against rotavirus may have the additional benefit in some children of being a primary prevention for type 1 diabetes.”
Rotavirus remains the major cause of infantile gastroenteritis worldwide, although the advent of vaccination has substantially decreased associated mortality. Following the recent introduction of rotavirus vaccination, there has been a 15% decrease in the incidence of type 1 diabetes in Australian children under four years of age, suggesting that rotavirus vaccination could contribute to the primary prevention of this autoimmune disease. This finding complements human and animal studies implicating rotavirus in the development of type 1 diabetes in genetically susceptible children.
In the article, Harrison and colleagues begin by reviewing molecular evidence supporting their hypothesis and point out the association between rotavirus infection and serum islet autoantibodies. They also discuss results indicating that rotavirus infection induces pancreatic pathology, as well as environmental factors that promote the rise in incidence of type 1 diabetes. Finally, they review population-level data suggesting that rotavirus vaccination may be associated with a decrease in the incidence of type 1 diabetes. According to the authors, it will be important to identify which children are most likely to be protected by rotavirus vaccination. Moreover, future studies should aim to reveal disease mechanisms and directly demonstrate whether rotavirus infects the human pancreas prior to the onset of islet autoimmunity or type 1 diabetes.
Harrison concludes, “Vaccination against rotavirus may have the additional benefit in some children of being a primary prevention for type 1 diabetes.”
More information: Leonard C. Harrison et al, Does rotavirus turn on type 1 diabetes?, PLOS Pathogens (2019). DOI: 10.1371/journal.ppat.1007965
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