💊 US FDA says no to homoeopathic eyedrops; MSD says yes to DACs; Scientists say maybe to wet-bulb thresholds

#492 | Critical medicines list for Europe; Zika vaccine for Brazil; Form 483 for Torrent

Hello, and welcome back to The Kable. During a mission to transfer critically ill patients and deliver supplies to a hospital in northern Gaza, the WHO says that military checkpoints caused delays. Health partners were detained, and bullets were fired at an aid truck and an ambulance. During the transfer process, one patient reportedly died of untreated wounds. The humanitarian support system is on the verge of falling apart. The WHO is reiterating its call for the protection of healthcare and humanitarian assistance in Gaza. A sustained ceasefire is the only way to go.

In Burundi, as in the rest of Africa, budgets allocated to the health sector are short of the massive investments needed to develop pharmaceutical infrastructure, manufacture vaccines, and diagnose and treat diseases. To plug this gap, officials from Burundi and the African Development Bank have been working on the Bank Group’s Strategy for Quality Health Infrastructure in Africa 2020-2030.

In Brazil, the São Paulo state government-owned research facility, the Butantan Institute, has announced that it is developing a Zika virus vaccine to prevent microcephaly in babies(microcephaly = a birth defect in which babies are born with smaller heads than expected). This update comes about 7 years after an outbreak in the country caused long-term developmental damage in children.

In the UAE, the Cabinet has decided to form a new board of directors for the Emirates Drug Establishment. The newly appointed board will steer the Establishment as it fosters R&D, creates an enabling environment for pharma investments, and boosts production and export of pharma products.

In Bangladesh, the Chinese company Crescent Hi Tech intends to establish an API manufacturing industry in the Bangladesh Export Processing Zones Authority (BEPZA) Economic Zone. Setting it up will involve an investment of $7.6 million. This will be the first API factory in the Zone. The APIs produced here are intended for export to the USA.

In India, the Organisation of Pharmaceutical Producers of India (OPPI) has urged the country’s drug controller to make public new launches and new drug permissions of Indian pharma companies to help them to track down potential infringers. The OPPI has said that the Central Drugs Standard Control Organisation (CDSCO) and state FDAs have refused to provide this information under the Right to Information Act, on the grounds that it is commercially sensitive. Indian pharma companies believe that this proposal, if implemented, could hurt them.

Also in India, Torrent Pharmaceuticals has received a Form 483 from the US FDA. The Form lists five procedural observations concerning its oral manufacturing facility in the state of Gujarat.

In Pakistan, the government has ordered Pharmix Laboratories’ factory shut. This move comes as reports from the Maldives and other countries suggest that Pharmix products are contaminated with diethylene glycol (DEG) and ethylene glycol (EG). The Maldives Health Ministry has also banned the import, sale, and use of 27 medicines manufactured by the Pakistani company.

Sun Pharma is raising its offer to acquire additional shares of Israeli Taro Pharmaceutical Industries.

Meanwhile, RNA partnerships abound. Paris-based Depixus has entered a collab with Japan’s Daiichi Sankyo; the latter will use Depixus’ novel MAGNA technology to accelerate RNA-targeted drug discovery. Also, as part of the 100 Days Mission, CEPI is partnering with Korea’s Chungbuk National University (CBNU) to advance the development of CBNU’s self-amplifying mRNA vaccine technology; CEPI will provide CBNU with up to $1 million in seed funding for preclinical research.

Now for Big Pharma. AstraZeneca is deepening its engagement in the RSV space. The pharma giant is acquiring US-based clinical-stage biopharma Icosavax and its late-stage RSV vaccine candidate for $800 million upfront.

Merck (MSD) is deepening its engagement in the ADC space. It is paying C4 Therapeutics $10 million upfront to work on degrader-antibody conjugates (DACs). The partners will initially focus on one oncology target.

Addressing concerns from US antitrust regulators by agreeing to donate royalty rights from the sales of cancer drug Bavencio to the American Association for Cancer Research, Pfizer is finally looking forward to closing its $43 billion acquisition of Seagen later this week.

Not all is well for Sanofi in France, where its epilepsy drug-producing manufacturing facility is under scrutiny after a recent leak caused the release of large amounts of the neurotoxin bromopropane. Five years ago, the same facility had been temporarily closed for a similar lapse.

In the US, the FDA has been busy. The Agency is establishing a new advisory committee to evaluate genetic metabolic disease treatments and has also unveiled draft guidance for pharma companies keen to use advanced manufacturing technology (ATM) in drug development.

As zoonotic disease threats grow globally, G20 countries will host a high-level meeting on One Health in October 2024.

At COP28, representatives from nearly 200 countries agreed yesterday to begin reducing global fossil fuel consumption. This is a first-of-its-kind deal, but as the COP28 President said, “we are what we do, not what we say.” So we guess we’ll have to wait and see.

And finally, in the last bit of activity the US FDA has been up to, the agency has asked consumers not to use ophthalmic products labelled as homoeopathic, among other tips to keep in mind.