🗞 Indian drugmakers on the backfoot; Indonesia’s Bio Farma launches a Covid shot
Hello and welcome back to The Friday Kable, your round-up of the most interesting life science stories this week. This has been an eventful week all around the world. Uganda is dealing with an Ebola outbreak, while 26 other countries are grappling with cholera outbreaks. India took a big hit on the world stage with an Indian drugmaker's drugs being held to account by the WHO for paediatric deaths in The Gambia. Indonesia launched a homegrown Covid vaccine. Indonesia also launched China's first mRNA Covid vaccine. Japan pumped in more money into pandemic prep. Lots of news, good and bad, from Africa.
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In a major blow to India's image as the pharmacy to the world, the death of 66 children in The Gambia is now linked to four cough syrups made by Indian company Maiden Pharmaceuticals. The report suggests the presence of the toxic chemical Diethylene Glycol (DEG) in the syrups, which caused kidney failure and eventual death in the kids. While the Indian government has launched a probe, the WHO issued a medical product alert to stop sales of these cough syrups until investigated by national regulators.
Our friends at Pharmexcil have asked us to share this refresher about a program conducted by the US FDA earlier this year on generic drugs.
Liver cancer is among the top five causes of cancer deaths in nearly 100 countries, including developed nations. And what worries experts is that if the trend continues, primary liver cancer diagnoses and fatalities could increase by more than 55% annually by 2040. So again, the need is to incorporate national-level policies to achieve at least a 3% annual decline through immunisation, testing, and treatment, especially in Eastern Asia, Northern Africa, and South-Eastern Asia, where the liver cancer burden is higher.
(Big News Network)
Cholera, a disease that can kill within hours if left untreated, is brewing in 26 countries, most of which are already reeling under poverty, conflicts, and weather disasters. The WHO warns it may run out of vaccines for acute outbreaks and immunisation camps by the year's end.
Vedanta's medical arm Balco Medical Centre (BMC), is inching towards becoming India's cancer care destination. The company ties up with the UK hub-backed Anuva to build a Cancer Genomics Biobank for cancer research, bridging the gap between bench to bedside precision treatment for cancer patients.
Glenmark brings good news to insulin-resistant type-2 diabetes patients in India by launching LOBG (Thiazolidinedione Lobeglitazone). The ₹10 per tablet drug aims to improve sugar levels and create a new pathway to treat insulin resistance in India, affecting almost 45 million diabetic patients.
Indian drugmaker Lupin has been in the bad books of the US FDA recently, but that has not stopped the agency from giving a green signal to launch Lupin's generic HIV drug, Darunavir tablets, in the US. Maybe because it's manufactured at Lupin's facility in Nagpur and not Tarapur.
India may have wasted over 100 million doses of Covid vaccines (Covishield and Covaxin), costing around Rs 2,250 crore, with the bulk of wastage coming from Covishield. One can blame the dip in demand and low shelf life. And the vaccine manufacturers are in no hurry to seek an extension to their supply contracts since next-gen vaccines are expected to be intranasal or Omicron-focussed.
India may be winning hearts for its vaccine contribution on the global forum. Still, back home, a delayed cancer diagnosis is causing early childhood deaths. While the five-year survival rate in India is just over 40%, the number is nearly double in developed countries. Moreover, the government focuses more on adult cancer, causing a worrisome 49% of pediatric cancer to remain undiagnosed. The need of the hour is a national-level childhood cancer plan linking primary and tertiary cancer care.
(New Indian Express)
Zydus Lifesciences is in for double delight after receiving two approvals from the USFDA in a week. The first is Sildenafil oral suspension to treat pulmonary hypertension manufactured at its Himachal Pradesh manufacturing plant. The second nod is for the generic version of Mirabegron tablets for bladder treatment to be manufactured at the Gujarat plant.
Antibiotic resistance (ABR) is a global problem, and Bangladesh is a major contributor. But not anymore. The country is prescribing some hard laws for pharmaceutical companies and has banned physicians and pharmacies, and primary hospitals from selling antibiotics without a prescription, failing which licenses will be revoked.
(The Daily Star)
Indonesian vaccine maker Bio Farm-a signs a global deal with British company Pro Factor Pharma to co-develop and sell recombinant factor VIII products to treat Hemophilia A in ASEAN 6 and India. With the recombinant technology, the company hopes to offer treatment at an affordable price, usually considered expensive and out of reach for 75% of haemophilia patients globally.
Indonesia wants to move into the endemic stage of the pandemic phase of COVID-19 but is not happy with the booster shot coverage, one of the WHO requirements, which is still looming at 23.13%. However, a booster may be a good idea with economic and community activities back to normalcy.
Indonesia is in the news for vaccines. First, it gets a EUA for its homegrown Covid vaccine; Indovac then approves China's first mRNA vaccine (unapproved by China) for home use. Now it secures a contract from UNICEF to supply its WHO-approved polio vaccine, nOPV2, for 2022 & 23 to the global OPV stockpile.
Japan's struggle for a homegrown vaccine is finally making some headway. The $2 billion earmarked in the 2021 fiscal budget for vaccine subsidy and research programmes is finally being used by offering $1.6 billion to 17 projects by universities and companies. Beneficiaries also include pharma firm Daiichi Sankyo and Hiroshima University, to upgrade their facilities that can switch from producing biopharmaceuticals during disease-free periods to vaccines and materials during disease outbreaks.
Moderna could not enter the Chinese market with its Covid-19 vaccine, and we now know why. The company was not ready to give away its vaccine recipe, a prerequisite by China for approving it, citing safety concerns. But as they say, never say never; Moderna still hopes for a collaboration.
Once a global frontrunner in Covid vaccines, AstraZeneca meets the Valvneva vaccine fate in Japan. After shaking hands for 120 million vaccine doses, the government cancelled a contract for 62.3 million while discarding 13.5 million doses.
MENA & GCC
Saudi's Al-Rajhi bank collaborates with Qassim Health Cluster as part of the bank's social responsibility projects to establish a fully guaranteed $3.6 million diabetes centre in Buraidah. The hospital is expected to treat nearly 20,000 diabetic patients in the Qassim region with expansion plans for later years.
Qatar's healthcare leader, Estithmar Holding, signs an MoU with Algeria to establish the Qatari-Algerian Hospital, a 400-bed medical facility in Algiers through Elegancia Healthcare. This deal offers better healthcare to Algerians and is part of Estithmar's expansion strategy.
Egypt is offering the disability health card to 2.7 million severely disabled people by 2030. It has roped in Red Crescent Society volunteers and doctors to facilitate the registration process. In addition, a disabled person can now produce medical reports from certified hospitals not older than March 2019 to avail of this card.
The government of Abu Dhabi has launched a new funding program to support research and innovation in life-threatening diseases. The program will see selected applicants with clinical research projects in cardio-metabolic and vascular disorders, cancer, Alzheimer's disease, rare diseases, emerging infectious disease, and antimicrobial resistance get grants and mentoring from the government. If you have a tie-up with a health facility based in Abu Dhabi, apply for a grant here.
(DoH, Abu Dhabi)
It's a good week for the South African vaccine regulator, South African Health Products Regulatory Authority (SAHPRA), which attained an ML3 (maturity level 3)(ML3) authority for vaccines. The country now joins Tanzania, Ghana, Nigeria and Egypt as the only countries from Africa to have achieved this rating.
And in Botswana, the government has launched the Public Health Institute (BPHI) to strengthen R&D and laboratory and diagnostic capabilities to quickly detect and respond to infectious disease threats before they become epidemics.
Afreximbank has signed a host country agreement worth $300 million with Nigeria for its ambitious African Medical Centre of Excellence (AMCE). AMCE Abuja will be a first-of-its-kind quaternary-level medical facility in West Africa, also serving as headquarters for other AMCEs to be launched across Africa.
Ghana College of Physicians and Surgeons (GCPS) receives a £10 million 5-year grant from the UK to conduct in-depth research on NCDs in three West African countries; Ghana, Burkina Faso and Niger. The goal is to improve health in West Africa with applied research on the prevention, diagnosis and management of three connected NCDs - hypertension, diabetes and common mental disorders.
Over 67% of women in Nigeria are anaemic, and it's not surprising since the country ranks second in the global malnutrition burden. What's disturbing is that the health sector still remains underfunded, and investment in nutrition is minimal. Pregnant women are at risk after childbirth, and so are 17 million impoverished children suffering from life-threatening diseases. What Nigeria needs is prayers and a multisectoral nutrition investment at the national level.
A food crisis, exacerbated by climate change, Covid and the Ukraine war, has left the world reeling. But Kenya's new president has a plan. He has lifted the ban on the cultivation of GMO crops in place since 2012 for plantation and import. And with 23 of Kenya's 47 counties facing drought and the need to feed a 50 million population, GMO crops may also be the way forward.
(Business Daily Africa)
Liberia thinks big to win big. The country is among the 100 shortlisted NDC for the $3 trillion green investment award by the African Green Infrastructure Investment Bank (AfGIIB). What helped Liberia is revising its Nationally Determined Contribution (NDC) to cut greenhouse gas emissions from 15% to 64% below the projected business by 2030 in line with Paris Agreement.
(Front Page Africa)
Surrozen scores a sizzling deal with Boehringer Ingelheim to research and develop SZN-413 to treat retinal diseases using Surrozen's SWAP technology. Boehringer will offer $12.5 million in upfront payment and up to $586.5 million in milestone biobucks and, on completion of joint research, will assume development and commercial responsibilities.
Equashield, an Israeli medtech company, is now a unicorn after raising $300 million from Nordic Capital for a 25% stake. No surprise here since Israel's medtech companies are known for their technological breakthroughs. Equashield's manual and automated solutions for the compounding and administration of hazardous drugs by health workers in hospitals have recorded sales in the hundreds of millions of dollars.
Apollo Hospitals has acquired a 60% stake in AyurVAID hospitals under the flagship of Kerala First Health Services Private Ltd (KFHSL) for Rs 26.4 crore. The investment will be used for upgradation, acquisitions and strengthening digital health initiatives.
Big pharma is keeping Singapore's vaccine manufacturing sector robust, which wasn't the case before the pandemic. While the island state saw investments from Sanofi and BioNTech post-pandemic, the latest entrant is Merck which opened a vaccine and biologics plant and broke ground for a new plant to produce inhalers as part of its $500 million, five-year expansion plan announced in 2020.
AstraZeneca's rare disease unit Alexion will acquire gene editing specialist LogicBio Therapeutics at a premium of 660% for $68 million. While this buyout expands Alexion's foothold in gene editing, for LogicBio, the deal came at a perfect time as it was all set to be delisted from the Nasdaq due to a steady stock price decline.
Halma, a life-saving technology company, acquired IZI Medical Products, a consumable medical device, to expand into minimally invasive diagnostic products, especially for cancer. The initial payment of $153.5 million will be funded from Halma's existing facilities on a cash- and debt-free basis.
Israeli AI-based clinical assistant, Kahun raised $ 8 million in fresh funding for its AI-enabled clinical reasoning chatbot, offering gold-standard clinical assessment to physicians. The funds will be utilised for services and market expansion.
R & D
Lumpy Skin Disease (LSD), caused by the Capripoxvirus virus, has killed more than 60,000 cattle in India already this year. So the question remains, will the infected meat or milk infect humans too? While the disease does not seem zoonotic, scientists at the Indian Council of Medical Research (ICMR) have launched a study to discover more since the infection is new to India.
International researchers have identified a technique to mass produce 100 biodegradable microrobots per minute, which is about 10,000 times faster than the current medicinal microrobots manufacturing technology. The technology is likely to improve the efficacy of regenerative medicine such as stem cell therapy.
Dutch vaccine maker Intravacc has received a $14 million grant from the US NIH to develop an intranasal vaccine for gonorrhoea. The vaccine is based on Intravacc's outer membrane vesicles (OMV) platform and has been proven effective in animal models.
The US NIH grants a $19 million TB vaccine project to Sydney Univerity, Centenary Institute and international collaborators. Long overdue, we say, since even now, the world uses a 100-year-old TB vaccine for a disease that kills almost 1.5 million people annually. Researchers are optimistic about developing the next-gen vaccine using the antigen and adjuvant combination in the next five years.
The next time you test positive for Covid, flush your nose twice daily with a saline solution within 24 hours of testing. This simple technique can stop the virus from entering your lungs, says a new study. In fact, nasal wash trial participants were eight times less likely to be hospitalised, highlighting that countries with nasal wash as a cultural practice had lower fatalities than developed countries like the US.
(Ear, Nose & Throat Journal)
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