FDA

Oct 03, 2017

Strategic Immunology Alliance partners Nimbus Therapeutics and Celgene to develop therapies for Autoimmune Disorders A biotechnology company involved in the development of drugs and therapies through computational expertise announced on October 3 that they are entering into a long-term strategic alliance with Celgen...

Sep 28, 2017

Another flop for Alzeimer’s as Late Stage drug of AxovantSciences fails in trial Axovant Sciences has reported the failure of their late-stage trial involving the testing of its pill Intepirdinecould not suppress Alzheimer's symptoms in participants of the trail. The news had plunged the Wall Street into another wav...

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...