Indian drugmaker Zydus Cadila said on Thursday it has applied for emergency use approval of its three-dose COVID-19 vaccine that showed efficacy of 66.6% in an interim study and could become the second home-grown shot if regulators consent.
Although coronavirus infections have dropped from a devastating peak in April and May that strained healthcare facilities, experts have warned of a third wave, saying widespread vaccination is one of the best pandemic defences.
Zydus' vaccine "will certainly help in ramping up India's overall vaccination drive as it would be the fifth approved," Prashant Khadayate, a pharmaceutical industry analyst at GlobalData said.
The drugmaker said it was evaluating a two-dose regimen for the shot.
If approved, ZyCoV-D will be the world's first DNA vaccine, Zydus said, as it makes use of a portion of the genetic code - DNA or RNA - in the SARS-CoV-2 virus to stimulate an immune response against its spike protein.
DNA vaccines differ from other approved COVID-19 shots, which are based on new mRNA technology such as in those from Pfizer and Moderna, and established technology like viral vectors, as with AstraZeneca.
Zydus, which aims to produce up to 120 million doses annually, said its study coincided with the peak of India's second wave of infections and affirmed its efficacy against new mutants, especially the Delta variant.
It did not, however, disclose its efficacy against those variants.
Swiss drugmaker Novartis could get into the hot field of messenger ribonucleic acid (mRNA) technology, which has come to the fore during the coronavirus pandemic, Chairman Joerg Reinhardt said in a newspaper interview.
"The mRNA technology has proven to be an attractive option in this situation and of course every research company is questioning whether they should invest more in this area," he told the Swiss paper Aargauer Zeitung.
"Novartis is doing the same and we are having the discussion this week in the executive committee and then in August in the board of directors," he added without being more specific.
Many companies, including Novartis, had withdrawn from antiviral and antibacterial research, figuring the probability of success was relatively low. "We are now reassessing that," he said.
Activist investor Elliott Management Corp. has called on U.K. pharmaceutical giant GlaxoSmithKline PLC to assess its board and management ahead of a long-planned separation of its consumer-healthcare business.
The investor criticized GlaxoSmithKline's "poor record of execution and value creation" in a letter published Thursday, its first public intervention over the FTSE 100 company since it built a significant stake. It said the company's combined businesses should be worth around 45% more than GlaxoSmithKline's current valuation.
Elliott urged the company's board to appoint nonexecutive directors with biopharma and consumer-health expertise prior to the separation and to run robust processes for selecting the best executive leadership for the two businesses, considering both internal and external candidates.
GlaxoSmithKline Chief Executive Emma Walmsley, who became CEO in 2017, has driven more investment into research as well as the separation of the consumer-healthcare business.
"Elliott is not advocating a specific outcome but is arguing for a robust process, because it is critical that the board assure current and future shareholders that the new leadership of both companies was selected through a credible process that conforms to corporate governance best practices," the investor said. It said existing management should remain in place until a decision is made on new leadership.
The investor also said GlaxoSmithKline should incentivize a stronger performance and greater ambition, improve profitability while investing more in research-and-development, display openness to value-maximizing pathways and preserve the nimbleness of its vaccines and pharma operations.
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Acumen Pharmaceuticals, Inc. (“Acumen” or “Acumen Pharmaceuticals”) (Nasdaq: ABOS), a clinical-stage biopharmaceutical company developing a novel disease-modifying approach to target what Acumen believes to be a key underlying cause of Alzheimer’s disease, today announced the pricing of its upsized initial public offering of 9,999,999 shares of common stock at a public offering price of $16.00 per share. The gross proceeds to Acumen, before deducting underwriting discounts and commissions and offering expenses, are expected to be approximately $160 million. All of the shares of common stock are being offered by Acumen. In addition, Acumen has granted the underwriters a 30-day option to purchase up to an additional 1,499,999 shares of common stock at the initial public offering price, less the underwriting discounts and commissions.
Acumen’s shares are expected to begin trading on the Nasdaq Global Select Market on Thursday, July 1, 2021 under the ticker symbol “ABOS.” The offering is expected to close on July 6, 2021, subject to customary closing conditions.
BofA Securities, Credit Suisse and Stifel are acting as joint lead book-running managers for the offering. UBS Investment Bank is also acting as a book-running manager.
Republicans in the House held a hearing Tuesday to discuss origins of the coronavirus pandemic and heard from experts that it is ‘highly likely’ the virus originated at the Wuhan Institute of Virology, and that the Chinese military was involved in running the lab much earlier than previously thought.
The hearing of the House Select Subcommittee on the Coronavirus Crisis went ahead without any Democrat involvement, and no appearance from either NIH director Dr. Francis Collins and NIAID director Anthony Fauci, who both declined to attend.
As Minority Whip Steve Scalise noted last week, Democrats have not held any hearings and without subpoenas it is near impossible to get health officials to turn up to any Republican led hearing.
During the hearing, Scalise declared “We have asked that question for more than a year and requested that the House majority hold hearings to investigate the origins of COVID. Perplexingly, Speaker [Nancy] Pelosi [(D-Calif.)] has refused to allow a single hearing — calling it a ‘diversion.’”
“As the American people will hear today from our expert witnesses, this is far from a diversion,” Scalise asserted.
During the hearing, which lasted three hours, Dr. Brett Giroir, who served as Assistant Secretary for Health in President Trump’s HHS, stated “This is a worldwide pandemic in which millions of people have died. It may have been the result of a lab-leak — and we think highly likely it is.”
When questioned on ‘gain of function’ research at the Wuhan lab, Giroir said “it’s unbelievable to me that coronavirus work wouldn’t even get into the process.”
“If you look at the abstract from the latest grant that was done to EcoHealth, it talks about using protein sequence data, infectious clone technology, in vitro and in vivo infection experiments. This is all gain-of-function. How this could not get into the P3 process is unbelievable,” Giroir continued, referencing the P3CO oversight board that decides on U.S. funding of the research.
Also appearing at the hearing were Dr. Steven Quay, founder of Atossa Therapeutics, and Richard Muller, a physics professor at the University of California at Berkeley.
The two recently authored a study that concluded “COVID-19 has a genetic footprint that has never been observed in a natural coronavirus.”
“A natural zoonosis has two processes,” Quay said, adding “It jumps into humans but it can’t do very well… but then it’s building up its repertoire, it’s learning how to infect humans. And then finally, and this takes a year to 18 months. So here, it was human-to-human from the get-go.”
“That simply indicated gain-of-function,” Muller explained, noting “The fact that it was human from the get-go implies gain-of-function. There’s no way that we know that could happen [naturally].”
The scientists also all noted that more within the scientific community didn’t speak out earlier because they feared being ostracised or labeled racist.
“Physicians who were on the task force, or who were around the task force, were under tremendous pressure from their scientific colleagues to not even show up with the president on stage,” said Giroir, referencing Trump’s repeated use of the phrase ‘China virus’.
“There was such bias against the president, that even thinking that you were helping the president, you were excommunicated from the scientific community,” Giroir added.
“They were working on a program related to synthetic biology and gain-of-function using serial passage revolutionary technology approaches quite publicly,” said Asher.
“Of course they were working on dual-use research of concerns, it’s called DURC. And the DURC, in this case, if it gets out of a lab and it’s not contained promptly, could result in a weapons-like release,” Asher added.
He continued, “Whether they deliberately did it, I have very little sense they did. But were they deliberately working on developing the capability to use advanced pathogen genetic capabilities for war in a way that no one has seen ever employed? Yeah they were. Of course they are.”
Representative Michael McCaul (R-Tx), ranking member of the House Foreign Affairs Committee and Head of the China Task Force, also announced that he has received intelligence indicating the Chinese Military may have taken over the Wuhan lab earlier than had previously been reported.
“New testimony now received by my committee reveals the Chinese military potentially took over this lab, not in January 2020 as was reported, but earlier in 2019,” McCaul said.
“The Chinese military were actually in the facility at the time of 2017. That signals the CCP was worried about something at the lab before the world even knew what COVID-19 was. Why else would they put the Chinese military in charge?” McCaul questioned.
The State Department Fact Sheet, released in January, previously noted that secret military research was being conducted at the lab, noting “Despite the WIV presenting itself as a civilian institution, the United States has determined that the WIV has collaborated on publications and secret projects with China’s military. The WIV has engaged in classified research, including laboratory animal experiments, on behalf of the Chinese military since at least 2017.”
McCaul proclaimed that “I believe it’s time to completely dismiss the wet market as a source of the outbreak,” adding “I would say this is a diversion by the CCP, and all roads point to the lab.”
he continued, “In a city five times larger than the City of Houston, the first signs of a new illness were all clustered around the old WIV facility — the Level 2 facility. Then on September 12, 2019, the WIV suddenly took their virus database offline. You have to ask the question: “Why? Why did they take this offline?” Removing the database would prevent hospitals in the city from comparing samples from sick patients to the lab’s library of viruses. If the CCP was attempting to cover up a leak of coronaviruses being studied at the WIV, this would remove the ability to link COVID-19 back to the WIV.”
Scientists explored a technique called 'neurofeedback,' which enables ADHD patients to train their attention, based on instant feedback from the level of their brain activity. The team of neuroscientists found that not only did the training have a positive effect on patients' concentration abilities, but also that the attention improvement was closely linked to an enhanced response from the brain -- the P3 wave -- which is known to reflect integration of information in the brain.
Attention Deficit Hyperactivity Disorder (ADHD) affects about 7% of children, with a two out of three chance of persisting into adulthood. This neurodevelopmental disorder is characterised by concentration difficulties, increased distractibility, impulsivity and hyperactivity. Today, ADHD is treated with pharmaceutical drugs that may have unwanted side effects. This is why scientists from the University of Geneva (UNIGE) and the University Hospitals of Geneva (HUG), Switzerland, explored a new technique called 'neurofeedback', which enables ADHD patients to train their attention, based on instant feedback from the level of their brain activity. The team of neuroscientists found that not only did the training have a positive effect on patients' concentration abilities, but also that the attention improvement was closely linked to an enhanced response from the brain- the P3 wave -- which is known to reflect integration of information in the brain, with higher P3 amplitudes indicating greater attention towards detected targets. The findings are open-access and have been published in the journal Clinical Neurophysiology.
Attention Deficit Hyperactivity Disorder (ADHD) develops in childhood and leads to numerous difficulties with attention, concentration and impulsiveness. It has genetic associated with environmental causes, and is characterised by a deficit in dopamine, a neurotransmitter involved in executive functions. "These disorders persist for the most part into adulthood and lead to problems in relational and socio-professional functioning, making it easier for people with this disorder to turn to alcohol or drugs," notes Marie-Pierre Deiber, a researcher in the Department of Psychiatry at UNIGE Faculty of Medicine and at the HUG Division of Psychiatric Specialties.
Today, ADHD is treated with medications that increase the concentration of dopamine, which improves the patient's attention. As the disorder is often accompanied by depression, anxiety or even bipolar disorders, treatment is generally combined with psychotherapy. "However, pharmaceutical treatments can be accompanied by significant side effects, such as nervousness, sleep disturbance, but also an increased risk of developing other psychiatric disorders or cardiovascular diseases," explains Roland Hasler, a researcher in the HUG Division of Psychiatric Specialties. "This is why we wanted to investigate a completely non-pharmacological and non-invasive treatment based on the principle of 'neurofeedback'."
Sending the brain its own signals
Neurofeedback is a type of neurocognitive intervention based on the training of "real-time" brain signals. Using an electroencephalogram (EEG) with 64 sensors, the scientists capture the electrical activity of cortical neurons and focus their analysis on the spontaneous Alpha rhythm (with frequency around 10 Hertz), coupling its amplitude fluctuation to a video game that the patients can control with the power of their attention. "The aim of neurofeedback is to make the patients aware of the moments when they are no longer attentive. With practice, brain networks then "learn" to reduce attentional lapses through neuroplasticity," explains Tomas Ros, researcher in the Department of Basic Neurosciences at UNIGE Faculty of Medicine and at the Centre for Biomedical Imaging (CIBM). To do this, the patient's EEG is connected to a computer that displays the image of a space shuttle. When the patient is in an attentive brain state (low Alpha rhythm), this makes the space shuttle move forward. But as soon as the patient is distracted or loses attention (high Alpha rhythm), this stops the space-shuttle movement instantly. Faced with the stopping of the space shuttle, the patient realizes that he/she was no longer paying attention and refocuses to restart the shuttle.
Training the brain to focus without medication?
To measure the effects of neurofeedback training, the Geneva team administered an attention test to 25 adults with ADHD, and 22 neurotypical adults. The results showed that, at baseline, ADHD patients made more mistakes and had a more variable reaction time than the control participants, in line with a signature of impaired attention. After 30 minutes of neurofeedback training, the participants took the attention test again.
"The first finding was that stimulus detection and response variability were improved, indicating attentional enhancement," says Marie-Pierre Deiber. "But what interested us most was the impact of the neurofeedback training on the P3 component, which has previously been shown to be reduced in ADHD, and directly linked to the neurocognitive processing of the stimulus." The higher the amplitude of the P3, the more efficient the processing of the stimulus is, and the more accurate the response to the attention task. "The amplitude of the P3 increased significantly after neurofeedback training, and was directly associated with a reduction in the number of errors made by the patients," reports Tomas Ros.
This study firstly shows that a single 30-minute session of neurofeedback can induce short-term plasticity in the brain and encourages attentional improvements in ADHD patients. Secondly, it supports the existence of an electro-physiological marker of attentional processing in ADHD. "Thus, the P3 could be a cerebral signature that would allow us to better understand the neurocognitive mechanisms of ADHD," continues Nader Perroud, professor in the Department of Psychiatry at UNIGE Faculty of Medicine and at the HUG Division of Psychiatric Specialties. Finally, as the effects are evident in the short term, the scientists plan to carry out a neurofeedback treatment based on multiple training sessions, in order to observe whether the brain's plasticity is strengthened over time. "The ultimate goal is to enable patients to learn to concentrate without medication and to be able to train their brain in the comfort of their home," concludes Tomas Ros.
Marie-Pierre Deiber, Camille Ammann, Roland Hasler, Julien Colin, Nader Perroud, Tomas Ros. Electrophysiological correlates of improved executive function following EEG neurofeedback in adult attention deficit hyperactivity disorder. Clinical Neurophysiology, 2021; 132 (8): 1937 DOI: 10.1016/j.clinph.2021.05.017
