🗞 The African Medicines Agency takes one step closer to launch; Bayer sets up shop in Egypt

Hello and welcome back to The Friday Kable, your round-up of the most interesting life science stories this week.

The WHO's red-flagging of cough syrups made by India's Maiden Pharma continues to cause concern in India, Africa, and elsewhere. Saudi Arabia bets big, really big, on healthcare. Thailand is banking on medical tourism to recover its tourism dollars. Mexico is wooing European pharma to make it a manufacturing hub. An Israeli VC is looking to invest in Arab healthpreneurs. Astra Zeneca's intra-nasal Covid vaccine flunked its first test. The biggest news of the week though has to be Malawi's imminent rollout of the world's first malaria vaccine.

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Featured

In a major step forward, Africa's third-largest economy, South Africa, has become the 34th African nation to approve the African Medicines Agency (AMA) treaty, pending parliamentary ratification. Now we hope that with more than 20 countries ratified, AMA will soon become the apex medical regulatory body in the African Union.
(Health Policy Watch)

It's common practice to invest in biosafety labs following major epidemics. And the Covid-19 pandemic has not changed the trend. In fact, globally, plans are afoot to build more than 40 high-level biosafety laboratories, including in developing countries like India, which is currently building five BSL-3 facilities. But the question remains, will more bio labs help us fight outbreaks, or are we building too many labs in many places? Moreover, who will be responsible if labs are not well-run?
(Nature)


Asia

The state of Maharashtra in India has been proactively working towards controlling lumpy skin disease that has killed more than 1,00,000 cattle in India. After bearing the entire cost of cattle treatment, the state government is set to produce the vaccine once it pays Rs 70 lakh in royalty to the Indian Council of Agriculture Research (ICAR) for the vaccine technology.
(The Print)

India is home to a global pharma hub in Baddi, Himachal Pradesh catering to more than 700 pharmaceutical companies with an annual turnover of Rs 30,000 crore, of which Rs 9,500 crore involves exports. But the hub is running without a fully-equipped drug-testing lab. In fact, a Rs 30 crore project cleared in 2017 to set up a lab is yet to see the light of day, putting the focus back on quality drug manufacturing and how substandard medicines are exported without proper regulatory checks. In fact, the case of Maiden Pharma is not an isolated one. In 2021, 46 companies' licenses were cancelled due to quality issues. Only highlighting the urgent and imperative need for better quality compliance in Indian pharma.

Habitual offender Maiden Pharma finally came under the scanner after the World Health Organisation (WHO) red-flagged four of its products following the death of 66 children in The Gambia. And while Indian authorities have stopped production at Maiden Pharma's manufacturing plant after finding multiple quality lapses at the unit, states like Maharashtra and Kerala are either recalling or halting drugs by Maiden.

Indian Immunologicals is setting up a Rs 700 crore animal vaccine manufacturing facility in India's Genome Valley, Hyderabad, to address vaccine security for diseases like Foot Mouth Disease and other emerging diseases.
(Indian Immunologics Ltd)

A double whammy for Sri Lanka. The country has a stockpile of 6 million Pfizer vaccines worth $40 million that are expiring this year. Unfortunately, Sri Lankans are complacent about getting their booster shots, and the vaccines cannot be sold. So Sri Lanka is now donating the vaccines to Myanmar.
(Economy Next)

Indonesia is investigating the deaths of more than 20 children due to acute kidney injury, the same cause behind children's deaths in the Gambia. However, Indonesia clarified that cases in The Gambia are not connected to those in Indonesia since Maiden Pharma is not registered in the country.
(Reuters)

Aga Khan University is breaking ground by not only launching a new research centre in its facility to tackle non-communicable diseases (NCD), including mental illness, in Pakistan and Afghanistan, but it is also offering at least a 60% quota to women researchers. The five-year £7.6 million launch is a joint collaboration with the University of York funded by the UK's health department.
(University of York)


MENA & GCC

Reports of Egypt's exciting healthcare ventures and partnerships are mentioned every few days in The Kable. This week's big update is that Bayer is setting up a $12 million OTC production hub in Egypt to produce 60-70% OTC medicines locally. Bayer will also re-launch five new health products in Egypt by the end of 2025 and is looking for a local partner to collaborate with.

Egypt's B2B pharma platform, i'SUPPLY, is taking up the cause of problems faced by mid and small-sized wholesalers and pharmacies in supply chain disruptions. The company has raised $1.5 million in fresh funding led by Disruptech, offering a digitized one-stop-shop platform across all supply chain stages across Egypt and further expanding into the MENA region.
(Daily News)

Japan grants Syria $5 million to improve the healthcare system in the province of Homs, where 70% of the hospitals are functioning either partially or not at all. The aid will be extended through the Copenhagen-based United Nations Office for Project Services (UNOPS) for hospital restoration, including secondary medical care for the displaced Syrians.
(Arab News)

Saudi Arabia is expediting licencing and regulations to attract investors as it initiates 100 health projects worth $13 billion in a private-public partnership. The plan is to build two new medical cities, a 900-bed medical rehabilitation centre and 200 primary care centres.
(Zawya)


Africa

GSK is partially exiting commercial operations in Kenya as it moves to a third-party distribution model, causing several job losses.
(Reuters)

Worrying cholera outbreaks are being reported across Africa and the Middle East. Nairobi, Kenya is on high alert over fears of an outbreak in the neighbouring Kiambu county. On the other hand, with 4,420 cases and 128 casualties, Malawi is requesting more vaccines from the UN. Lebanon has reported its first cholera casualty after reporting an outbreak six days back, and Syria, with more than 13,000 cases, is living on a prayer. In addition, ongoing high outbreaks are reported from Afghanistan, Bangladesh, the Democratic Republic of Congo, Ethiopia and Nigeria.

Africa's first and only proton therapy centre has been set up in Kenya, a collaboration between the Kenyan government, Apollo Hospitals, India and Kenya's Balmer Healthcare. This will give Kenyans with advanced cancers who travel overseas otherwise, an affordable treatment alternative in the country.
(The Star)

Back in 2021, the nurses association appealed to the Tanzanian government to recruit nurses and midwives to address a staffing shortage. Well, they are still waiting. In fact, requirement for critical care nurses has now reached desperate levels where there are only 100 critical care nurses for about 65 million people, and the ratio of one nurse serving patients is 1:25 or worse, well below the WHO requirement of 1:4 to 6.
(The Citizen)

Experts fear that the lethal variant of monkeypox, Clade I suspected of killing more than 120 patients in the Democratic Republic of the Congo (DRC) this year alone, may follow its milder twin, Clade II and go global. Luckily, clinical trials of the antiviral Tecovirimat or TPOXX to treat monkeypox have already begun in DRC in a multi-agency collaboration led by USA's National Institute of Health (NIH) and DRC's National Institute for Biomedical Research (INRB)
(New Scientist, National Institute of Health)

Meanwhile, in some excellent news, Uganda and the WHO plan to jointly test not one but two Ebola vaccines as soon as next week to fight the Sudan and Zaire variants. The two vaccines developed by USA's Sabin and UK's Oxford are in phase 2 and 3 trials right now.
(Monitor)

Malawi is rolling out GSK's malaria vaccine next month for children below five after the completion of pilot trials. However, the Gates Foundation, backers of the vaccine, do not think the 30% effectiveness is worth the cost involved and will not offer financial support for the shot. But Malawi is optimistic that the vaccine can still save more than 400,000 deaths annually from mosquito-borne diseases.
(Voice Of America)

South Africa signed on with Pfizer to innoculate its population after what looked like a long wait due to delayed shipment from J&J Covid-19 vaccines. However, the country is now stuck with J&J vaccines that have no demand at home or in other countries, and the country's attempt to end the contract to pay for 11.4 million doses of J&J is in a quandary.
(Devex)


South & Central America

European pharma may say hola as soon as November or December as Mexico finalises companies to set up selected vaccine and medicine shops in Mexico in preparedness for the next pandemic.
(Yahoo News)

Colombia lawmakers have approved a bill to legalize and regulate cannabis nationwide, progressing it through a committee with nearly unanimous support. The newly elected President Gustavo Petro is also pushing for global drug policy reform.
(The Growth Op)

In a first, Israel is collaborating with a Latin American country, Argentina, to jointly sponsor research projects. Research topics range from medicine like retinal ageing, antifungal lung medicine, and non-invasive cancer diagnostics to green energy, like developing ion exchange membranes for hydrogen technologies.
(Business Standard)


Rest of the world

In a major blow to the Irish pharma industry, Novartis is once again sharpening its axe to chop off 400 jobs at its global service centre in Dublin by the end of 2024. The layoffs are in line with Novartis' plan of cutting 8,000 jobs worldwide to become a leaner company.
(MSN)


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Lifestores Healthcare, a Nigerian health tech startup, has raised $3 million to expand its pharmaceutical marketplace across Nigeria. The company offers two B2B products, a distribution platform, OGApharmacy, and ERP system making life simpler for pharmacies and hospitals. It plans to use the new funds to upgrade its platform and acquire new clients.
(Tech Crunch)

Bayer's recent acquisition, Vividion Therapeutics, continues on the mission to find new drug targets and biomarkers in oncology by collaborating with Tavros Therapeutics, a precision oncology platform. The deal includes finding four cancer targets with the option of five more, earning Tavros up to $930 million in bio bucks.
(Vividion)

The Nazareth-based NGT HealthCare II Impact Fund, created in 2021, announces approximately $92 million in commitments to promote the rapidly growing Arab medical innovators in Israel. The fund will focus on early-stage breakthrough technologies from academic and medical institutions.
(The Times Of Israel)

After generating over € 1.1 billion in the past, including 40 successful exits, Andrea Life Sciences, a Paris-based fund house, closed its BioDiscovery 6 fund for a massive $443 million. And with a balanced portfolio of innovative companies developing therapeutics and medical technology, the fund is ready for its biotech bets, which already include six companies, Evommune, Amolyt, TargED, Tubulis, Mineralys and Imcheck.
(Andrea Partners)


R & D

The 100-year-old BCG vaccine is proving why it's still in demand. While the vaccine offers protection against TB in infants, a team of Indian researchers demonstrated that affordable and globally available vaccines could increase the immune efficacy of the Covishield vaccine in young adults who are revaccinated with BCG for the second time.
(Frontiers In Immunology)

Nasal Covid vaccines are supposed to be the next big weapon against Covid-19, but it looks like AstraZeneca and Oxford have lost this battle, at least for now. The much-anticipated phase 1 trial of its nasal-spray vaccine candidate didn't show substantial evidence of mucosal immunity in participants.
(The Lancet)

In 2006, the USA's Homeland Security department identified Ebolavirus as a national threat. But it took an Ebola outbreak in 2022 to speed things up. And now, USA's Administration for Strategic Preparedness and Response (ASPR) is backing Mapp Biopharmaceutical with a $110 million contract to develop and eventually procure MBP134, a monoclonal antibody therapy to treat Sudan ebolavirus (SUDV).
(ASPR)


Nota Bene

In a first, Africa reports stunted growth in children due to extreme heat. In fact, a 95 degrees Fahrenheit temperature for about 12 days per month resulted in an increased prevalence of stunting by 18%. While we blame crop failure, malnutrition, climate change or developed countries, the urgent need is a climate action plan to improve child health in the region.
(Yale Climate Connections)

Victims of climate change are not just humans but wildlife, who are crying foul after losing 69% of their kind since 1970. The worst affected are freshwater species declining by 83% due to a 1.2°C rise in global temperatures since pre-industrial times. Latin America registered the most significant reduction of wildlife, with 94%.
(WWF)


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