Notizia

View All

Therapeutics and Celgene to develop therapies; Takeda’s expansion; J&J hopes to limit; Tech Prize for genome sequencing; Endocyte’s late-stage prostate cancer deal

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...

Find More

Notizia
Alzeimer’s drug; Guardant Health receives approval; First Patient Dosed in Phase 1 Clinical Trial; Sunny Pharmtech and Vitruvias Therapeutics Receive FDA Approval

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...

Find More

Cannabidiol trial; MyoKardia aims; LDL drug data

Failure of Phase II cannabidiol trial leads to loss for Zynerba Zynerba Pharmaceuticals’ phase II trial for transdermal cannabinoid candidate missed all its endpoints, as it failed to hit a single goal or show a dose response raises big doubts about the drug's prospects. This news eroded around 55% off Zynerba’s sto...

Find More

Takeda knocks Velcade; FDA nod awaited; Novartis gets approval; Astellas UK dodges; Haegarda set for launch

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...

Find More

J&J nabs; Clovis plots Rubraca; Novartis scores EU approval; Seattle Genetics stops trials

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...

Find More

Roche, Boehringer tout; Pfizer, Bristol-Myers got sued; FDA commissioner unveils; EpicGenetics expands

Roche, Boehringer tout new idiopathic pulmonary fibrosis analyses to boost their rival medications The idiopathic pulmonary fibrosis (IPF) market-share battle between Roche’s Esbriet and Boehringer Ingelheim’s Ofev hasn’t let up since the FDA green-lighted the medications in October 2014. And this week, both drugmak...

Find More

Samsung biosim nod sets; Lilly’s med hits; BioMarin sees pricing; Spinraza scores; Klick creates

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...

Find More

Tesaro puts AstraZeneca; XELJANZ® receives; Innovus nabs; Alexion brings

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,...

Find More

USFDA warns; Vit B3 prevents glaucoma; Zydus Cadila receives nod; U.S. experts soften on DNA editing

USFDA warns Bengaluru-based Resonance Labs of manufacturing norms violations US health regulator USFDA has red-flagged significant deviations from manufacturing norms at the Bengaluru-based API facility of Resonance Laboratories, including failure to have adequate cleaning procedures to prevent contamination of prod...

Find More

SEC scrutinizes; Acacia meets endpoint; Axovant’s dementia drug; Novartis expands; Aurobindo responds

In letter to Allergan, SEC says it will scrutinize industry's use of non-GAAP accounting When the SEC criticized Valeant Pharmaceuticals over its use of non-GAAP reporting, it seemed like a regulator barking at a company known for pushing the limits. But now the agency has fired a warning shot across the bow of the ...

Find More