💉 Investigating India’s Galentic Pharma; Ending AIDS by 2030; Making generic TB drugs
#384 | Continue to drink your diet cola; Stay away from deer; Paint the town white
Hello and welcome back to The Kable for the last time this week. As always, today’s edition is packed with all things research, regulation and investment from the life sciences world. And as with all Fridays, today’s Kable is free. So send it to all your colleagues and friends who haven't realised what a brilliant resource we are; show them what they’re missing.
One million. That’s how many people Pfizer wants to enrol for its new clinical trial registry, PfizerLink. The pharma biggie is going all out, advertising on social media and elsewhere, to convince both healthy volunteers and those with medical conditions to sign up. If you’ve always wanted to be a guinea pig for science, this is your chance.
At MIT, faculty lead a three-year pilot-scale research programme to design the world’s first fully integrated, continuous mRNA manufacturing platform. The US FDA supports this endeavour with $82 million in funding from its Centre for Biologics Evaluation and Research.
Pharma has kept things interesting lately with all its courtroom drama. CureVac has already been at loggerheads with Pfizer and BioNTech in the US and German courts over Covid vaccine patent infringement cases. Now in the US, CureVac has added its tenth patent claim to the mix; in Germany, the number has expanded from five to 8.
Layoffs also continue. This time it is Haleon, which spun off from GSK last year, looking to cut costs by cutting jobs worldwide.
In a deal that could be worth upwards of $7 billion, Roivant Sciences is in talks with Roche to sell its experimental drug for ulcerative colitis and Crohn’s disease. Roivant had acquired the bowel disease drug in a deal with Pfizer. An official announcement about the drug’s new change of guard could be announced in the coming days.
The European Commission and the European Investment Bank have inked an agreement to establish HERA Invest, a €100 million guarantee to support R&D in pressing cross-border health threats in the region. This funding instrument will prioritise small- and mid-sized companies which tackle antimicrobial resistance, pathogens with pandemic potential, chemical threats and more.
The US FDA has released two new draft guidance documents on manufacturing cell and gene therapies. One of them provides manufacturers with recommendations to carry out adequate risk assessments before modifying manufacturing practices. The other one outlines the consequences of sponsors not complying with FDA-mandated post-marketing studies.
Over in Africa, the CDC has launched its revamped Advisory and Technical Council.
The Egyptian Drug Authority is in talks about future collaborations with South Africa’s Afrigen Biologics and Vaccines, potentially related to vaccines and laboratory reagents.
And finally, with a total investment of $850 million, GSK’s facility in Tuas is now Singapore’s largest vaccine production site.
The Week That Was
The week started with news from the Middle East, where the Sultanate of Oman is the latest country to prioritise indigenous production. Human influenza and insulin shots will be produced in the country for the first time in Khazaen Economic City.
The UK’s Medicines and Healthcare Products Regulatory Agency approved GSK’s Arexvy shot against RSV for use in adults 60 years and over. This vaccine already has the go-ahead from regulators in the US and EU.
California-based startup Varda Space Industries hitched a ride aboard a SpaceX Falcon 9 rocket and successfully grew crystals of the HIV drug Ritonavir in a space trial.
Based on three cases reported by the Icelandic Medicines Agency, the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) began investigating whether people taking Novo Nordisk’s diabetes and obesity drugs Ozempic and Saxenda have a higher risk of developing suicidal or self-harm ideation.
After the WHO, in March, issued a safety alert concerning the dangers of Pholcodine, an ingredient commonly found in cough and cold remedies, India is the latest country whose drug regulatory authority is mulling issuing a warning regarding the cautious use of Pholcodine-containing cold and cough remedies.
A Bloomberg report covered how despite being subject to intense heat waves, the perception of Africa as a “hot continent” has led to such incidents being overlooked and under-reported.
We worry about what the situation has been so far, considering that India only this week demanded that small- and medium-sized drugmakers achieve higher standards. The country’s Health Minister called for self-regulation in the sector and making Schedule M compulsory for pharma MSMEs in a phased manner.
In the Americas, the National Regulatory Authorities of Regional Reference sat down to develop a joint action plan to strengthen the regulation of medical products in the region.
The WHO prequalified MenFive, the first-ever conjugate vaccine which protects against the five predominant causes of meningococcal meningitis in Africa.
Three UN agencies – the WHO, the Food and Agriculture Organization (FAO), and the World Organisation for Animal Health (WOAH) – raised an alarm over the increasing avian flu outbreaks across the globe. They fear that the virus could potentially adapt to infect humans more easily, with a new H5N1 strain that spread rapidly among wild birds earlier this year. The threat of a potential pandemic still exists.
The UN's annual State of Food Security and Nutrition in the World report suggested that about 122 million more people were hungry in 2022 than in 2019, making it unlikely that the UN's Sustainable Development Goal to end hunger by 2030 will be met.
And finally, the 3rd International Conference on Public Health in Africa (CPHIA 2023), organised by the Africa CDC and the African Union, is taking place in Zambia in November this year. Of particular interest to organisations looking to ride the self-reliance wave in Africa will be this call for side events from the conference. A great opportunity for organisations looking to work in Africa on health equity, disease control, strengthening health systems, environmental health, health policy, digital health, and pharma manufacturing. Applications close August 11, 2023.
Newsworthy
Regulatory scrutiny goes AWOL in “the world’s pharmacy”. A fascinating investigation by Scroll into Indian pharmaceutical manufacturer, Galentic Pharma. Galentic is the subject of an international health alert raised by the WHO due to quality defects in multiple batches of its eye medicine, tetracycline hydrochloride ophthalmic ointment. The alerts are issued in rare cases when a significant public health threat is perceived to extend beyond a single country. Two out of the three medical alerts issued by WHO this year are related to drugs manufactured in India.
Large international organisations like United Nations Children’s Fund (UNICEF) and Médecins Sans Frontières (MSF) have halted their purchases from Galentic Pharma and initiated a joint audit of the manufacturing plant. The company, which exports ophthalmic and dermatological products to over 45 countries, has been forced to recall all its tetracycline hydrochloride ointment batches from 2020 to February 2023 following complaints from at least five international buyers.
Indian authorities, however, have only suspended production of Galentic Pharma's ointment for 25 days, a move that will come only into effect in September, seven months after the WHO alert. The leniency of Indian authorities has drawn criticism from experts, given the severity of the violations.
Quality issues with the ointment included particles of different colours and sizes in the tube, cap and nozzle, black and brown splotches on the inner foil, and ingredients separating from each other. Inspections at the company's manufacturing plant revealed 24 violations under the Drugs and Cosmetics Act. These violations included skipping essential quality tests, poor standards in packaging, and continued purchase of active pharmaceutical ingredients from a supplier without checking for their audit report.
The WHO is now calling for “increased surveillance and diligence within the supply chains of countries and regions likely to be affected by the affected batches of this product”. The fallout could significantly impact the Indian pharmaceutical industry, which has faced recent international scrutiny due to other cases of quality lapses.
(Scroll)
Go on, drink (some of) that diet soda. The WHO has announced that while aspartame, a common artificial sweetener, has been categorised as a "possible carcinogen," it remains safe for consumption at currently approved levels. The classification, made by the International Agency for Research on Cancer (IARC), means there is limited evidence that aspartame can cause cancer, but it doesn't consider the amount one would need to consume to be at risk. This aspect was reviewed by another panel, the Joint Committee on Food Additives (JECFA), who found no compelling evidence of harm caused by aspartame at consumption levels below 40mg/kg a day. Despite these findings, the WHO suggested that consumers opt for water over artificially sweetened or sugary beverages. Other scientists and industry associations argue that the evidence linking aspartame to cancer is weak, and maintain that it remains a safe alternative for individuals looking to reduce their sugar intake. Our First Kabler is most pleased.
(WHO)
Ending AIDS this decade. The United Nations (UN) has stated that the goal of ending AIDS by 2030 is achievable if nations are willing to invest in prevention, treatment, and the adoption of non-discriminatory laws. According to the UN's AIDS program, UNAIDS, approximately 39 million people worldwide were living with HIV in 2022. The UNAIDS report highlighted the need for strong political commitment towards evidence-based HIV prevention and treatment programs, as well as the empowerment of community networks. The report revealed that progress has been most notable in regions with significant financial investment, such as eastern and southern Africa, where new HIV infections have fallen by 57% since 2010. However, the report also notes an increase in new infections in Eastern Europe, central Asia, the Middle East, and North Africa, attributed to inadequate HIV prevention services for marginalised populations and challenges posed by punitive laws and social discrimination.
(UN News)
Stopping TB in its tracks. The Stop TB Partnership has opened tenders for the generic production of key tuberculosis (TB) drug, Bedaquiline, to reduce costs and improve access in lower- and middle-income countries (LMICs). Bedaquiline is the first new TB therapy introduced in the last 40 years. Following negotiations, pharmaceutical company Johnson & Johnson has granted licenses to the Stop TB Partnership's Global Drug Facility, allowing it to tender, procure, and supply generic versions of the drug, even in countries where patents are still valid. The partnership has called this agreement significant in supporting the common goal of ending TB, inviting all Bedaquiline suppliers that meet the Global Drug Facility's quality criteria to participate in the tender.
(The Economic Times)
Keeping personal health data private in India. In March 2023, privacy concerns were raised when a researcher discovered that personal health information was easily accessible on the Indian government's health insurance program's website. This echoed earlier incidents during the pandemic where local authorities and government websites posted private health information, including names, addresses, quarantine durations, and COVID-19 test results. This violation of privacy extended to the physical realm with signs posted outside the homes of COVID-19-positive individuals until court intervention in December 2020.
Paradoxically, while personal health information was unintentionally made public, researchers struggle to access vital data for studies due to an incomplete and slow-to-update civil registration system and the unavailability or difficulty in interpreting certain datasets. The process is further complicated by the government's reluctance to share unflattering data, cultural sensitivities, privacy concerns, and the heavy workload of healthcare workers. Experts suggest clearer decisions on what data to collect, a more focused allocation of resources, the use of data registries, and the need for better coordination between central and state governments in building health information systems.
(The BMJ)
R&D
Adios to ALS. Amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease, affects nerve cells in the brain and spinal cord. Most of the time, the neurodegenerative disease is sporadic, which means that it occurs without any family history of the disease. Sporadic ALS has been classified as an inflammatory disease, with immune cells like cytotoxic T cells, mast cells and inflammatory macrophages, in a case of mistaken identity, attacking neurons in the central nervous system.
Researchers from the University of California in Los Angeles set out to find treatments for sporadic ALS. They treated ALS patients’ immune cells using dimethyl fumarate, or DMF (already approved to treat MS) and molecule H-151 (which blocks autoimmunity in lab models). They found that these substances reduced the expression of enzymes involved in inflammation; they concluded that both DMF and H-151 are candidate drugs to target the autoimmunity which results in ALS. The researchers now intend to seek approval for a clinical trial after a bit more snooping around in immune cells.
(The FASEB Journal)
The flexibility of cell therapy. Cell therapies have shown encouraging results in treating several diseases. For Parkinson’s, dopamine replacement therapy is the current standard of care. But most transplanted dopamine cells don’t survive long enough to carry out their good work; needle trauma from the transplant triggers the immune response which results in dopamine neuron death. But researchers from Mass General Brigham are not having it. Their research has uncovered that supplementing neuronal cell therapy with host regulatory T cells could suppress needle trauma. As a result, grafts could survive and thrive a lot more easily. Considering that needle trauma is a universal issue in nervous system cell therapies, the principles these researchers used could be translated to the treatment of Alzheimer’s, ALS, and Huntington’s as well.
(Nature)
Sayonara to solid tumours. Cancer immunotherapy has been a game-changer in treating different blood cancers. When it comes to solid tumours, however, it has its fair share of challenges. And considering 90% of all tumours are solid tumours, some scientists from Harvard have aptly focused their efforts on addressing this issue.
Conducting their study in mice with melanomas, immune engineers have developed a new biomaterials-based immunotherapy approach. Called SIVET, this approach facilitates the local delivery of antigen-specific, adoptively-transferred T cells directly to tumour sites. It also enables their prolonged activation and broader engagement of the host immune system. Thus, they allow for a long-lasting effect against tumours carrying new antigens.
(Nature Communications)
Humans are quite the hazard. To the poor animals in our labs. To the planet. To each other. And apparently, also to deer. A new study from the Animal and Plant Health Inspection Service of the US Department of Agriculture claims that people spread the SARS-CoV-2 virus to wild-tailed deer in the US at least 100 times in late 2021 and early 2022. Even after viral lineages like Alpha, Delta and Omicron had left the human population, they continued to circulate in deer. Obviously, this isn’t good news: it means that the virus, in its many forms, has found a long reservoir in these creatures, a place to hide out and mutate into more dangerous forms before it’s time for them to attack again.
The virus can jump back into the human population and instigate another severe wave. The study suspects that in at least three instances, humans likely caught the virus from deer. But let’s not blame it all on deer. The Covid virus is still very much still circulating in humans. As preferred hosts, our bodies still give it space and time to mutate. The severity of the risk posed by deer is uncertain. The US government intends to continue and extend its survey of animals to study viral transmission.
(USDA, Nature Communications)
The Kibble
Paint the town red white. In the most creative solution to climate change yet, scientists are suggesting that painting 2% of the Earth white – not just any white, but the whitest white paint developed by Purdue researchers in 2021 – could fix global warming. This special paint is so white that it reflects over 98% of light. Pour it over your building, and it would make the Sun’s light bounce back into space, keeping surfaces cool since they wouldn’t absorb as much heat as they do now.
Now 2% doesn’t seem like a lot. But it would be the entire area of the United States and some more. And how exactly we’re going to paint rivers, forests and deserts is an inconvenience we can delay thinking about. All said and done, painting the world white definitely beats blocking out the Sun. Pick up your paintbrushes, friends. Let’s get to work.
(Business Insider)
Bottom line
Making insects buzz less. A study conducted by researchers from the University of Melbourne, Beijing Forestry University, and the University of California Davis found that particulate air pollution from industry, transport, and bushfires could hinder an insect's ability to find food and mates. Airborne particulates can accumulate on insects' antennae, obstructing their capacity to detect odours. The team conducted several experiments, observing that exposure to air pollution led to collecting more particulate material on the houseflies' antennae, impacting their odour-related neural responses and decision-making in a Y-shaped tube 'maze'. The study also found that smoke particles from bushfires could contaminate the antennae of various insects, including bees, wasps, moths, and flies, even at considerable distances from the fire. These findings raise concerns about potential threats to insect populations, which play vital roles in pollination and nutrient recycling.
(Nature Communications)
Heating up the seas. A study led by researchers at UC Santa Barbara, published in Global Change Biology, has found that marine protected areas (MPAs), which are vital for conserving marine ecosystems, are not resilient to ocean warming. Using data from a decade of monitoring 13 MPAs during a record-breaking marine heatwave, the team found that despite providing benefits like increased fish diversity and biomass, MPAs do not facilitate resistance or recovery from such climate events. In contrast, marine heatwaves significantly impact these protected ecosystems similarly to unprotected areas, causing shifts in community structures and population balances. This research highlights that while MPAs offer valuable insights into the impact of climate change on marine ecosystems, they alone cannot buffer against the effects of global warming, pointing to a need for additional climate action and nature-based solutions.
(Global Change Biology)
Oh, and Gopal Nair doesn't want you to see this.