๐ WHO prequalifies conjugate meningitis shot; Boehringer Ingelheim to supply France with bird flu shots; Novartis violates UK marketing standards
#383 | The world gets hungrier; Bird flu gets scarier; The ocean gets greener
Hello, reader. Welcome back to The Kable. Howโs your week been so far? We have lots to make it better today, especially if youโre looking to get in on the action in Africa.
But first, we have news of a group of scientists led by Singaporeโsย Nanyang Technological Universityย who have found that Ponatinib, an existing cancer drug, can potentially beย repurposed to target certain aggressive cancersย - like those of bones and the brain - which currently lack targeted treatments.
Theย WHO has prequalified MenFive, the first-ever conjugate vaccine which protects against the five predominant causes of meningococcal meningitis in Africa. With funding from the UK government, this shot has been developed by PATH and the Serum Institute of India. It is the only vaccine which works against meningitis caused by meningococcal group X. Prequalification means the MenFive can now be procured by UN agencies and Gavi. Initially, it will be available for use in reactive vaccine campaigns for meningitis outbreaks.
We canโt wait for the day when we can stop writing about potential ethylene or diethylene glycol (EG and DEG) contamination. Today is not that day. The US FDA has issued aย warning letter to California-based NeilMed Pharmaceuticals, a manufacturer of OTC nasal and ear care products. The FDAโs grouse is issues with cleaning and sterilisation, in addition to the companyโs failure to adequately test components like glycerin for potential DEG or EG presence.
Lupin has had its fair share ofย run-insย with the FDA, and the latest is a Form 483 withย two observations for its Nagpur, India facilityย which makes oral solid dosages. Lupin has also received the Establishment Inspection Report (EIR) with aย Voluntary Action Indicated (VAI) classificationย for its Pithampur Unit-2 facility, which produces oral solids and ophthalmic dosage forms, in India.
Novartis is in breach of the UK drug marketing authorityโs rules, with the issues relating to the companyโs promotional website for their heart drug Entresto. PMCPA indicated thatย Novartisโ violationsย included โproviding misleading informationโ, โfailing to maintain high standardsโ, and the most serious Clause 2, โbringing discredit upon, and reducing confidence in the pharmaceutical industryโ.
Meanwhile, Sanofi is getting lighter as itย hands several consumer brands to STADAย in some European countries. This comes after STADA already acquired 16 Sanofi products in 2021 and entered a deal to distribute and market Sanofiโs portfolio in 20 European countries, and later in 10 Central Asian countries as well. Pain medicines, allergy eye drops, and vitamins are some of the products being subjected to the latest change of guard.
France needs 80 million bird flu vaccine doses for its poultry vaccination campaign which starts in October. The country has chosen Germanyโsย Boehringer Ingelheim to supply the shots.
In Colombia,ย deforestation fell 29.1% in 2022, marking the lowest level since 2013.
And finally, Abu Dhabiโsย Burjeel Holdings is partnering with the USโ BridgeBio Pharmaย on a multi-phase project to identify rare diseases in the MENA region.
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