💊 Third time’s a charm for Sanofi and Pompe disease; Medtronic’s next-gen pacemakers get FDA green light; No mo’ mpox in the US

#331 | The evolution of the dengue virus in India; Covid wavelets to stay; Love Vaccines in the time of cholera

Hello, and welcome back to The Kable this fine Tuesday.

Sanofi already has two therapies for the rare metabolic disorder Pompe disease. But what’s better than two? Three. The pharma giant is shelling out $150 million to acquire the rights to Maze Therapeutics’ drug candidate MZE001 for the disease after a phase 1 study showed positive data in February this year. Maze could also make up to $600 million in milestone payments depending on the drug’s progress in clinical trials.

While Novo Nordisk is shelling out $15 million on 2seventy bio’s preclinical gene therapy candidate for haemophilia A, Bristol Myers Squibb is shelling out the same amount in a separate deal for Immatics’ solid tumour-targeting T cell therapy candidate. These milestone payments are a continuation of years-long partnerships between the two sets of companies.

After prior agreements making Ossis their partner in Asia Pacific, and then Europe, the Middle East and Africa, Zimmer Biomet is now acquiring the manufacturer of personalised 3D-printed implants.

New York-based Ovid Therapeutics is partnering with biotech Graviton Bioscience in a $10 million deal to develop treatments for rare brain disorders.

As part of the US FDA’s initiative to enhance mRNA production, Arranta Bio, a part of Recipharm’s biologics unit, is collaborating with MIT on a three-year project to develop a continuous manufacturing technology for mRNA therapeutics.

But enough from the US. European Big Pharma companies are suggesting that we might see more M&A activity soon.

Coming to FDA approvals, yesterday, Medtronic announced that it has received a green light for its next-gen Micra AV2 and Micra VR2 miniaturised leadless pacemakers.

India’s Concept Medical received its third Investigational Device Exemption (IDE) approval from the US FDA for its Sirolimus-Coated Balloon (SCB) for the treatment of small vessels in coronary arteries. The IDE approval permits Concept to conduct studies to gather safety and effectiveness data for the SCB. This makes Concept the first Indian company to receive IDE approval for an intervention of this kind in the US.

Uzedy, Teva and MedinCell’s long-acting injection for the treatment of schizophrenia in adults also got a thumbs up from the FDA.

Meanwhile, BMS has announced that its CAR-T Breyanzi met primary and secondary endpoints in two clinical trials for the lymphoma treatment.

And dreading the loss of patent protection for cancer drug Xtandi, Astellas, and Pfizer have unveiled new data about the drug. Xtandi added to the hormone therapy Leuprolide was effective in preventing tumour metastasis or death by 58% compared to the hormone therapy alone in men with non-metastatic hormone-sensitive prostate cancer. This is a greater reduction than even Xtandi alone. If approved, this could potentially be Xtandi’s fourth approved indication in the US.

Meanwhile, the World Bank has approved $100 million in financing for the Nepal Quality Health Systems Programme to improve healthcare quality, coverage and capacity in the Koshi and Gandaki provinces.

Have you been using the stimulants Nose Slap or Soul Slap for some alertness and energy? Maybe you should just stick to caffeine, as the US FDA is warning that these over-the-counter products primarily contain ammonia which can result in a range of adverse events. If you ask us, the product’s name didn’t inspire much confidence in the first place.

The FDA has also asked India’s Sun Pharma to put its tests of a particular dose of an experimental drug for alopecia areata on hold. This is due to the potential of blood clots. Tests of the 12 mg dose are affected, but trials for the 8 mg dose are proceeding as per plan.

In India, experts are all for immunising both young girls and boys with the HPV vaccine as HPV infections have been implicated in not only cervical cancer but also vulvar cancer, penile cancer, and oropharyngeal cancer, among others.

Wonder what mpox has been up to these days? Not much, at least in the US. For the first time since the outbreak began in May last year, US CDC data shows no new cases in over a week.

Things aren’t looking as rosy in Madagascar, where Doctors Without Borders teams are seeing appalling rates of malnutrition as the country struggles through the consequences of food insecurity, extreme weather events and malaria all at once.

If you’ve been celebrating the lull in layoff news, we’re here to throw a wet blanket on those celebrations. In yet another round of goodbyes, Thermo Fisher is letting go of 218 employees in San Diego.

No lull in bird flu news either, as 20 California condors not in California have died since March, with half of them testing positive for avian influenza. This is particularly sad as the bird species is already endangered, with only 334 condors in the wild before this outbreak.

Australia has, so far, been able to enjoy its chicken without any cares. But it seems the continent is not as well prepared for a potential bird flu outbreak in wildlife as it is for one in poultry.

And finally, after the approval of a global roadmap on meningitis in November 2020, the WHO is developing guidelines for the diagnosis, treatment and care of those with meningitis and has released a list of experts it is considering to join its Guideline Development Group.