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AstraZeneca Admits for First Time in Court Documents Its COVID Vaccine Can Cause Rare Side Effect
AstraZeneca has admitted for the first time in court documents that its COVID vaccine can cause a rare side effect, in an apparent about-turn that could pave the way for a multi-million pound legal payout.
The pharmaceutical giant is being sued in a class action over claims that its vaccine, developed with the University of Oxford, caused death and serious injury in dozens of cases.
Lawyers argue the vaccine produced a side effect that has had a devastating effect on a small number of families. The first case was lodged last year by Jamie Scott, a father of two, who was left with a permanent brain injury after developing a blood clot and a bleed on the brain that prevented him from working after he received the vaccine in April 2021. The hospital called his wife three times to tell her that her husband was going to die.
AstraZeneca is contesting the claims but has accepted, in a legal document submitted to the High Court in February, that its COVID vaccine “can, in very rare cases, cause TTS.”
Wiping Out Polio ‘Not Guaranteed’, Support Needed, Bill Gates Says
Success in the fight to wipe out polio is not guaranteed, according to tech billionaire turned philanthropist Bill Gates, whose foundation has poured billions into the effort.
Gates warned against complacency in tackling the deadly viral disease as he welcomed a $500 million pledge from Saudi Arabia on Sunday to fight polio over the next five years, bringing it in line with the U.S. as one of the biggest national donors.
However, there is still a $1.2 billion dollar funding gap in the $4.8 billion budget for the Global Polio Eradication Initiative (GPEI) up to 2026, a spokesperson said. The new money from Saudi Arabia will go some way towards closing that.
“It’s not guaranteed that we will succeed,” Gates told Reuters in an online call last week. “I feel very strongly that we can succeed, but it’s been difficult.”
The first missed target for eradicating polio was in 2000, and the Bill and Melinda Gates Foundation is the largest donor trying to realize that goal. “If we’re still here 10 years from now, people might be urging me to give up,” Gates said. “But I don’t think we will be. If things go well, we’ll be done in three years,” he said.
As Autism Cases Rise, Biopharma Springs Into Action
With the prevalence of autism on the rise in the U.S., the biopharma industry is making a concerted effort to develop new treatments to alleviate the challenges associated with the neurological condition.
Diagnoses of autism spectrum disorder (ASD) rose from 1 in 54 in 2016 to 1 in 36 in 2020, according to the Centers for Disease Control and Prevention. However, efforts by the biopharma industry to find treatments have also accelerated; more than 100 drugs are in trial or have completed studies, according to the autism news site Spectrum.
But despite this significant push, challenges remain when it comes to developing a successful treatment for ASD.
One large pharma bucking this trend is Roche. The company is investigating the small molecule alogabat, a highly selective positive allosteric modulator of the GABAA α5 receptor, which is expressed in brain regions that are key to ASD. Roche is investigating the molecule’s efficacy, safety and tolerability in an ongoing Phase II study for patients aged 15–45, a company spokesperson told BioSpace in an email, adding that alogabat has been safe and well tolerated so far.
Risk of Uveitis Recurrence Higher in Year After COVID Vaccination
The incidence of uveitis in the year after COVID-19 was 17% among nearly 474,000 Korean adults with a history of the inflammatory eye condition, according to a report in JAMA Ophthalmology.
The patients had previously had uveitis and had received at least one dose of an mRNA (Pfizer/BioNTech or Moderna) or adenovirus vector–based (AstraZeneca or Johnson & Johnson) COVID-19 vaccine. The average patient age was 58.9 years, 51.3% were women, and none tested positive for COVID-19 during the study period.
Uveitis is a potentially serious inflammation of the eye’s middle layer of tissue that can cause symptoms such as pain, redness, and blurry vision.
The incidence of uveitis was 8.6% at 3 months, 12.5% at 6 months, and 16.8% at 1 year. The odds of uveitis were increased among recipients of all four vaccines, including Pfizer (hazard ratio [HR], 1.68), Moderna (HR, 1.51), AstraZeneca (HR, 1.60), and Johnson & Johnson (HR, 2.07). The risk was highest in the first 30 days after vaccination and peaked between the first and second doses (HR, 1.64).
Can Neosporin Protect You From Getting COVID?
For years, researchers have been working on vaccines that aim to prevent viral infections by strengthening immune defenses at viruses’ doorway to the body: the nose.
A small study recently published in PNAS presents a similar, if lower-tech, idea. Coating the inside of the nose with the over-the-counter antibiotic ointment Neosporin seems to trigger an immune response that may help the body repel respiratory viruses like those that cause COVID-19 and the flu, the study suggests.
The research raises the idea that Neosporin could serve as an “extra layer” of protection against respiratory illnesses, on top of existing tools like vaccines and masks, says study co-author Akiko Iwasaki, an immunobiologist at the Yale School of Medicine and one of the U.S.’ leading nasal vaccine researchers.
They found that Neosporin — and specifically one of its active ingredients, the antibiotic neomycin sulfate — seems to stimulate receptors in the nose that “are fooled into thinking there’s a viral infection” and in turn create “a barrier that’s put up against any virus,” Iwasaki explains. In theory, she says, that means it could protect against a range of different infections.
WHO: Antibiotics Overused in COVID Patients During Pandemic
U.S. News & World Report reported:
The World Health Organization on Friday reported “extensive” overuse of antibiotics during the COVID-19 pandemic that could have increased the spread of antimicrobial resistance.
The organization found that only 8% of patients hospitalized with COVID-19 needed antibiotics for bacterial co-infections. However, about 75% of patients were treated with antibiotics. The highest rate of use was among people with severe or critical COVID-19 at 81% on average.
Additionally, the use of antibiotics did not improve overall clinical outcomes for COVID-19 patients, according to WHO.
Antimicrobial resistance is an “urgent global public health threat” that killed at least 1.27 million people worldwide in 2019, according to the Centers for Disease Control and Prevention.
Pfizer Scores FDA Nod for Hemophilia B Gene Therapy, Will Charge $3.5 Million per Dose
Ten years after dipping its toes into the gene therapy pool in a licensing deal with Spark Therapeutics, Pfizer has gained FDA approval for the acquired treatment.
The U.S. regulator has endorsed Beqvez (fidanacogene elaparvovec-dzkt) for adults with the bleeding disorder hemophilia B. It becomes the first FDA-approved gene therapy for Pfizer and the second in the indication following CSL and uniQure’s hemophilia B treatment Hemgenix, which became the world’s most expensive drug at $3.5 million when it was approved in 2022.
Pfizer had the chance to undercut its rival on price but decided to charge the same $3.5 million for Beqvez. The therapy will be available to patients this quarter, a spokesperson confirmed on Friday to Fierce Pharma.
Heard on the Street: Bristol-Myers Goes From Big Pharma to Little Pharma
The Wall Street Journal reported:
Bristol-Myers Squibb’s market capitalization has dropped so much over the past year that it is now arguably no longer part of the big pharma club.
After reporting disappointing earnings figures on Thursday, the company’s shares fell sharply, giving it a market capitalization of about $95 billion. That makes it smaller than biotechs like Regeneron and Vertex, both of which are worth around $100 billion. Merck is worth about $330 billion, while similarly struggling Pfizer still is worth around $150 billion.
The problem for Bristol-Myers is that its older blockbuster products, cancer drug Revlimid and blood thinner Eliquis, are expected to decline in the coming years and investors aren’t convinced that the company has enough growth drivers in the near term.
‘Real Hope’ for Cancer Cure as Personal mRNA Vaccine for Melanoma Trialed
Doctors have begun trialing in hundreds of patients the world’s first personalized mRNA cancer vaccine for melanoma, as experts hailed its “game-changing” potential to permanently cure cancer. Now experts are testing new jabs that are custom-built for each patient and tell their body to hunt down cancer cells to prevent the disease ever coming back.
A phase 2 trial found the vaccines dramatically reduced the risk of the cancer returning in melanoma patients. Now a final, phase 3, trial has been launched and is being led by University College London Hospitals NHS Foundation Trust (UCLH).
Known as mRNA-4157 (V940), the vaccine targets tumor neoantigens, which are expressed by tumors in a particular patient. These are markers on the tumor that can potentially be recognized by the immune system. The jab carries coding for up to 34 neoantigens and activates an anti-tumor immune response based on the unique mutations in a patient’s cancer.
The phase 3 global trial will now include a wider range of patients and aims to recruit about 1,100 people. The U.K. arm aims to recruit at least 60 to 70 patients across eight centers, including in London, Manchester, Edinburgh and Leeds.
Acuitas, CureVac Settle Lawsuit Over COVID Vaccine Patent Rights
Biotech company Acuitas Therapeutics and Germany-based CureVac (5CV.DE) have settled Acuitas’ lawsuit demanding credit for inventions related to COVID-19 vaccines, according to a filing on Thursday in Virginia federal court.
Acuitas sued CureVac last year in the U.S. District Court for the Eastern District of Virginia, claiming its scientists should have been named as co-inventors of CureVac patents covering technology used in messenger RNA (mRNA)-based shots. CureVac told the court on Thursday that they had settled their dispute and will ask to dismiss the case.
Canada-based Acuitas said in the lawsuit, filed last November, that CureVac omitted Acuitas scientists from its patent applications after they collaborated to develop lipid nanoparticle mRNA-delivery technology during the COVID-19 pandemic.
Acuitas separately licensed the lipid nanoparticle technology used in Pfizer and BioNTech’s COVID-19 shots. CureVac has accused Pfizer and BioNTech of infringing its patents, including the patents at issue in the Acuitas case, in an ongoing lawsuit in Virginia.
Insulin Shortages ‘Causing Stress and Anxiety’ for UK Diabetes Patients
People with type 1 diabetes are being forced to endure the “stress and anxiety” of insulin shortages, patients, pharmacists and health campaigners have warned.
The “distressing” drug scarcity, the latest to affect the U.K., is sowing uncertainty for the 400,000 people with the condition, with some products not available again until next year amid global manufacturing shortages.
Britain is already contending with record numbers of medicines becoming hard or impossible to obtain, including those for attention deficit hyperactivity disorder and epilepsy.
