💊 Kenya's Universal Corporation plots a lifeline against malaria; AbbVie, GSK, others under FTC fire; Bayer's incubator network expands
#467 | Programming cancer cell death; Drugging undruggable proteins; Obesity's links to neurodegeneration
Hello, and welcome back to The Kable, dear reader. After a long time, it’s a long day in the life sciences. And amidst all the deal-making and drug-approving, not all looks pretty for Big Pharma. Before we get there, though, there are some promising updates from the regions of our interest.
First, the Saudi Ministry of Health has inked an MoU with the medtech giant Becton Dickinson Saudi Arabia. This partnership for digital transformation aims to strengthen healthcare infrastructure, focusing on automation, digitisation, and patient and health worker safety. All the activities under this agreement align with the Kingdom’s Vision 2030, including the aim to digitise 70% of patient activities by 2030.
Oman’s Ministry of Health and the Saudi Food and Drug Authority have agreed to cooperate in ensuring the safety, reliability, and efficiency of medical devices and supplies.
China-headquartered commercial-stage biotech Clover Biopharmaceuticals has completed its Biological License Application (BLA) submission for its seasonal flu vaccine to the Brazilian Health Regulatory Agency. If approved, Clover will get access to the world’s second-largest seasonal flu vaccine market.
But coming to the avian variety, Brazil has detected more cases of bird flu in wild birds. The virus has not yet reached commercial flocks. This is great for the country, the world’s top chicken exporter, which can retain its avian influenza-free status before the World Organization for Animal Health (WOAH). Nonetheless, caution is always good – the agriculture ministry has extended a national health emergency for another 180 days.
Futura Medical is expanding its presence in LatAm. Going beyond its current presence in Mexico and Brazil, the developer of sexual health products is extending M8 Pharmaceuticals’ licensing agreement to 14 more countries. By exercising its option, M8 will now exclusively develop and commercialise MED3000, marketed as Eroxon, for the treatment of erectile dysfunction in Central and South America.
Over in Asia, the Korea Health Industry Development Institute (KHIDI) is recruiting companies to participate in the Korea Startup/Biopharma Acceleration Programme 2023. This programme will give Korean startups or biopharma companies research funding and opportunities to collaborate with Takeda, the Japanese pharma giant. The programme is focused on the areas of oncology and neuroscience.
Meanwhile, South Korea’s GC Biopharma has sought marketing approval from the Korean Ministry of Food and Drug Safety for its anthrax vaccine GC1109. The shot has been co-developed with the Korea Disease Control and Prevention Agency, with whom GC has been collaborating since 2002. If approved, the shot will be the first recombinant anthrax vaccine globally.
The Bill & Melinda Gates Foundation is providing more support for AI-powered ultrasound for pregnancy exams. With new grant funding, Philips has now received a total of $60 million for its AI ultrasound project from the Foundation. The project has already seen positive impacts in a pilot in Kenya. The new funding will help it expand to more countries and support the tech’s eventual commercial launch.
In India, the Central Drugs Standard Control Organisation (CDSCO) has set the ball rolling on a new Digital Drugs Regulatory System (DDRS). The DDRS will be a single-window unified digital ecosystem for all regulatory activities in the country. A much-needed initiative for a country that needs to build back the trust and confidence of the global pharma market.
American life sciences venture capital company Flagship Pioneering is on a trip around the world. After setting up shop in London earlier this year, Flagship is now establishing a regional hub in Singapore. The venture firm, with portfolio companies like Moderna, hopes to scale its companies and sign new partnerships in the region from this hub.
And now that not-so-pretty Big Pharma news we promised you. Well, the Federal Trade Commission (FTC), the guardian of consumer rights in the US, has been scrutinizing the build-up of patents that has prevented generic competition from emerging. Yesterday, the FTC challenged over 100 patents, claiming that they were improperly or inaccurately listed in the FDA’s Orange Book. AbbVie, AstraZeneca, Boehringer Ingelheim, GSK, Teva, and five other manufacturers are under fire for improper listings in the Orange Book, which is the registry of patents on approved medicines. Such improper listings – over asthma inhalers, epinephrine autoinjectors, and other drugs – can stall drug development, stifle innovation, and trigger regulatory delays for potential generics challengers by throwing up legal hurdles. The pharma companies concerned have 30 days to withdraw or amend their patent listings unless they want to certify that their patents are proper.
That’s not all the bad news for Big Pharma. In France, the Parquet National Financier (PNF) has initiated a preliminary investigation into the country’s very own Sanofi. The allegations? Potential stock price manipulation and the dissemination of misleading or false financial communications, especially concerning the launch of its star product, the antibody Dupixent, in 2017. The national prosecutor had opened the probe in March this year. Sanofi has not been contacted by the prosecutor, but it stands by the accuracy of its accounts.
Gilead Sciences has unveiled positive trial data for a potential first-line adenocarcinoma treatment. The combination treatment – with the only Fc-silent anti-T-cell immunoreceptor with Ig and ITIM domains (TIGIT) – could be the first to market for upper gastrointestinal tract adenocarcinomas.
Pfizer’s cost cuts have made the journey to Ireland. 100 employees at its manufacturing plant in Newbridge, Kildare, will say bye-bye to the company.
The CDMO Fujifilm Diosynth Biotechnologies has its first tenant. J&J’s Janssen has committed to a large-scale manufacturing suite at the CDMO’s biopharma manufacturing facility in Holly Springs, North Carolina, set to be fully operational in 2025.
Bayer yesterday announced the global expansion of its life science incubator network, Bayer Co.Lab. With a new presence in Shanghai, China and Kobe, Japan, Bayer has strategically widened its external innovation network, with a particular focus on early-stage incubation. The new site in China will prioritise oncology and cell and gene therapy innovations. In Japan, the focus will be on multiple therapy areas, including cell and gene therapy-based innovations.
Evotec SE and Dewpoint Therapeutics have entered a strategic R&D collab. The partners will advance Dewpoint’s lead oncology pipeline of condensate modifying therapeutics (c-mods) using Evotec’s data-driven platform INDiGO.
In a phase 3 trial, Akeso’s bispecific antibody met primary endpoints, improving overall survival in first-line patients with severe gastric cancer or gastroesophageal junction adenocarcinoma.
Regarding the pandemic accord, conversations concerning intellectual property (IP) protections and waivers have appeared to go nowhere so far. Now, it appears they do have some direction: towards the World Trade Organisation (WTO). Several European countries are asserting that the controversial IP rights conversation is a problem for the WTO, not the WHO.
Speaking of the WHO, the agency’s 2023 global tuberculosis (TB) report is out. While it underlines the global recovery in the scale-up of TB diagnosis and treatment services post-Covid, it highlights the crisis of multidrug-resistant TB and the need for increased investment and concerted action.
Yesterday, the WHO also published the second edition of the classification of digital interventions, services, and applications in health. This taxonomy helps all concerned sectors to precisely document and describe the use of digital technology in pursuit of health goals.
Also, the WHO launched a guide on using whole genome sequencing as a tool for foodborne disease surveillance and response.
And finally, October was hot. So hot that EU scientists are quite certain that 2023 will go down in history as the warmest in 125,000 years.