A storm of scrutiny relating to Johnson & Johnson’s pricing and patenting of its tuberculosis med bedaquiline (branded as Sirturo) is clearing up after reaching a fever pitch last year.
It took many years, but Johnson & Johnson’s tuberculosis med Sirturo can finally claim full approvals in the U.S. and Europe following initial conditional nods. nnRegulators on both sides of the Atlantic granted the full approvals based on data from a phase 3 study showing that a Sirturo-containing regimen delivered a “significant improvement” in treatment outcomes compared to other, injectable-containing regimens, according to a recent company press release. The STREAM Stage 2 study was the first large-scale trial to evaluate an all-oral Sirturo-based regimen.
Janssen Submits Phase 3 Study Data to the European Medicines Agency and U.S. Food and Drug Administration for SIRTURO® (bedaquiline)
After allowing generic competition and slashing the price of its multidrug-resistant tuberculosis (MDR-TB) med Sirturo (bedaquiline) in low- and middle-income countries, Johnson & Johnson has taken its access efforts a step further by committing to not enforce secondary patents on the treatment in 134 countries.
Seven weeks after saying it would allow generic competition for drug-resistant tuberculosis (TB) treatment Sirturo (bedaquiline) in low- and middle-income countries (LMICs), Johnson & Johnson has slashed its own drug's price in those markets.
India’s patent office denied Johnson & Johnson’s attempt to extend the company’s patent on a formulation of bedaquiline, which is used to treat drug-resistant tuberculosis, until 2027.
Indian Patent Office (IPO), Mumbai, will be holding a final hearing tomorrow on a patent opposition filed by two tuberculosis (TB) survivors against the US drugmaker Johnson & Johnson (J&J)'s secondary patent application on the TB drug bedaquiline. The primary patent of the drug is set to expire in July this year.
Prices of several anti-diabetes drugs, patented antivirals used in the treatment of tuberculosis, HIV and hepatitis C are set to get cheaper with their inclusion in the latest edition of National List of Essential Medicines, 2022, released on Tuesday.
We have one more startup to add to the list before we call it a day. ATAI Life Sciences, which likes to dabble with psychedelics in developing new therapies, has another mind bender in the works. They’ve kickstarted a new company to delve into formulations of N,N-dimethyltryptamine (DMT) —the active ingredient in ayahuasca — for new drugs to use in the mental health field. DMT acts as a partial agonist on a variety of 5-HT receptors, they say, which makes it a good candidate for patients not attracted to the potent brew featured on certain South American journeys. “These novel products are expected to simplify in-clinic administration and allow greater pharmacokinetic control of the psychedelic experience and its overall duration,” said Srinivas Rao, chief scientific officer of ATAI. “Patients may even be able to attend psychotherapy sessions later the same day.”
(Reuters) - Johnson & Johnson (JNJ.N) said on Monday it was slashing the price of its version of tuberculosis drug bedaquiline to $340 from $400, for a six-month treatment, in low- and middle-income countries, to scale up its use during the COVID-19 pandemic.