pharma news

Jul 11, 2017

Gilead faces revived lawsuit claiming it sidestepped FDA with HIV drug imports Gilead Sciences thought it had prevailed in a whistleblower lawsuit alleging it circumvented FDA rules to use a China-made active ingredient in three top HIV meds, rather than a higher-priced version from South Korea that the agency had a...

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 20, 2017

Johnson & Johnson nabs another combo approval for myeloma star Darzalex Late last year, Johnson & Johnson widened Darzalex’s reach with some combo approvals. And now, it’s adding to that roster. The medication has snagged a green light for use in tandem with chemo drug dexamethasone and Celgene’s Pomalyst fo...

Jun 13, 2017

J&J's Invokana matches Jardiance's 14% reduction in major CV events There’s officially another heart-helping SGLT2 on the block. But this one brings some varied benefits—and amputation risks—along with it. In a cardiovascular outcomes trial, Johnson & Johnson's Invokana matched up to Eli Lilly and Boehringer...

Jun 06, 2017

Dendreon touts T-cell response data for prostate cancer vaccine Provenge Dendreon has had no shortage of challenges with Provenge since winning FDA approval for the groundbreaking prostate cancer vaccine back in 2010. Years later, the company has unveiled new data showing the med generates a killer T-cell response—a...

May 23, 2017

AstraZeneca's new benralizumab helps severe asthma patients cut back on steroids AstraZeneca's respiratory candidate benralizumab can help some severe asthma patients cut down on—or even stop—the unsavory steroid pills they use daily to stave off attacks, a new study showed. Dubbed Zonda, the phase 3 trial found tha...

Apr 25, 2017

Samsung biosim nod sets J&J's Remicade up for tough fight Samsung Bioepis won FDA approval late Friday for its Remicade substitute, Renflexis (infliximab-abda), becoming the the second biosimilar to threaten that brand in the U.S. Not an unexpected event, and the launch isn’t expected until October because of bi...

Apr 18, 2017

Novartis gets second CAR-T candidate FDA ‘breakthrough’ tag As the battle between Swiss major Novartis and biotech rival Kite Pharma heats up to be the first to market a CAR-T cancer med, the Big Pharma has been handed its second FDA ‘breakthrough’ tag for its eagerly awaited JULIET trial. This latest label, which c...

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,...