EC grants marketing authorisation for Takeda’s Ninlaro capsules
The European Commission (EC) has granted conditional marketing authorisation for Takeda Pharmaceutical’s Ninlaro capsules. The oral proteasome inhibitor is indicated in combination with lenalidomide and dexamethasone for adult patients with multiple myeloma who have previously received at least one therapy. The EC’s decision was based on data from the pivotal Phase III Tourmaline-MM1 trial, which showed that the capsule with lenalidomide and dexamethasone increased the length of progression-free survival by about 40% in patients with relapsed and refractory multiple myeloma.
Pfizer cuts €400M plant expansion after dumping cholesterol-lowering drug program
Pfizer is dumping much of the €400 million plant expansion in Ireland it was planning to support it. With the decision not to proceed with the pro-protein convertase subtilisin/kexin type 9 inhibitor (PCSK9i) bococizumab, the New York drug maker will not need the 371,300-square-foot expansion of its Grange Castle biologics manufacturing unit or the 300 or so jobs that would have brought. Following the decision to discontinue the development of bococizumab, part of the potential expansion for which the planning permission was sought will not go ahead. Expansion in relation to other incoming products will continue as planned, involving investment, recruitment and new technology.
Drug regulation: 27 medicines sold by top firms ‘fail’ quality tests
In a major crackdown since March this year, drug regulators of seven states have alleged that 27 medicines — sold by 18 major drug companies in India — are of “substandard” quality, citing grounds such as false labelling, wrong quantity of ingredients, discoloration, moisture formation, failing dissolution test and failing disintegration test. Some of the key brands which were alleged to be substandard are: antipsychotic drug Stemetil and antibiotic drug Pentids from Abbott India; anti-bacterial medicine Althrocin by Alembic Pharma; migraine medication Vasograin by Cadila Pharma; popular cough syrup Ascoril by Glenmark Pharma; worm infection drug Zentel by GSK India; arthritis medication Hydroxychloroquine (HCQS) by Ipca Labs; anti-inflammatory medication Myoril by Sanofi Synthelabo; and Torrent Pharma’s hypertension drug Dilzem.
Merck’s Keytruda nabs FDA’s ‘priority’ tag in microsatellite instability-high cancer
The immuno-oncology med has taken the spotlight back with a priority review tag from the FDA. Merck’s Keytruda isn’t letting rival Opdivo from Bristol-Myers Squibb soak up all the November regulatory attention. The agency doled out the distinction to Keytruda for the treatment of previously treated patients with advanced microsatellite instability-high cancer, the New Jersey pharma giant said on Monday, and it should speed the med’s path down the regulatory pathway. If Keytruda ultimately snags an approval, Merck will add it to the list of indications its budding star already boasts in melanoma, non-small cell lung cancer and head-and-neck cancer. Microsatellite instability-high cancer is an area where Merck’s competitors haven’t yet hit the market, meaning it’s an opportunity to build a lead.