FDA

Jun 27, 2017

With patent loss looming, Takeda knocks proposed Velcade copycats in FDA petition Takeda’s multiple myeloma blockbuster Velcade is quickly running out of patent protection, but the drug maker has filed a citizen petition it hopes can stave off competition for a little while longer. The Japanese pharma giant asked th...

Jun 22, 2017

Novartis takes on Regeneron with AMD drug that needs fewer doses than Eylea Last year, U.S. sales of Regeneron’s drug to treat age-related macular degeneration (AMD) came in at $3.3 billion—68% of the company’s total revenues—so it’s no wonder investors have been expressing some concerns about potential rivals movin...

May 26, 2017

Steele-Richardson-Olszewski syndrome, commonly known as Progressive Supranuclear Palsy, is an uncommon brain disorder that causes serious problems for patients in terms of walking, balance and eye movements. The disorder arises as a result of deterioration of cells in areas of the brain that control body movement an...

May 02, 2017

FDA Approves Alunbrig (brigatinib) for Rare Lung Cancer Takeda Pharmaceuticals announced the FDA approved Alunbrig (brigatinib) to treat patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib. Brigatinib is a kinas...

Apr 12, 2017

Malaysia calls for phase 4 Dengvaxia study before considering full approval Already struggling to meet initial expectations, Sanofi Pasteur's dengue vaccine Dengvaxia will have to undergo phase 4 testing in Malaysia before the endemic country agrees to sign off on a full approval. Malaysia’s National Pharmaceutical ...

Mar 28, 2017

Tesaro puts AstraZeneca on notice with early FDA nod for Lynparza rival niraparib Tesaro’s closely watched ovarian cancer drug niraparib—now dubbed Zejula—won an FDA nod on 27th March, months before its scheduled decision date. Apart from getting approval, Zejula also got a broader label than its head-to-head rival,...

Feb 28, 2017

Prosecutors rope Pfizer into fast-growing copay assistance probe After first focusing on biotech and speciality pharma, the feds have made their way to Big Pharma, with the New York drug giant joining a group that includes Gilead Sciences, Biogen, Valeant Pharmaceuticals and others about ties to copay assistance pro...

Jan 27, 2017

Payers block Kaléo's expensive EpiPen challenger Kaléo reintroduced its Auvi-Q last week at a list price of $4,500 for a two-pack in an effort to capture some market share from Mylan’s EpiPen, which is listed at about $600 for a two-pack. Auvi-Q is set to launch next month. Under Kaléo’s pricing strategy, Auvi-Q wil...

Dec 20, 2016

US drug approvals are on track to drop by more than half in 2016 compared to 2015. The agency had approved 19 new drugs this year as of 9 December, putting it on track for its lowest yearly tally since 2007. The decline is made more dramatic by 2015’s bumper crop of approvals. The FDA approved 45 new drugs last year...

Nov 29, 2016

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 mye...