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Novimmune's NI-0501 Granted Breakthrough Therapy Designation by US FDA for Treatment of Patients With Primary Hemophagocytic Lymphohistiocytosis (HLH)

EVENTSNovimmune2016-03-21 14:19 Read   136

Novimmune, a Swiss biotech company, today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to NI-0501 for the treatment of patients with primary HLH with refractory disease, or with recurrent or progressive disease during conventional therapy.

What's next for Gilead in oncology?

EVENTSGilead2016-03-21 14:01 Read   234

As competition for its hepatitis C drugs intensifies, Gilead Sciences ($GILD) has been working to build up in other therapeutic areas, especially cancer. And while a painful clinical failure for the blockbuster hopeful Zydelig and the high-profile departure of oncology head Philippe Bishop have hamstrung those efforts, Gilead is bullish about its future in the field.

STELARA® Induced Clinical Response And Remission In Phase 3 Study For The Treatment Of Patients With Moderate To Severe Crohn's Disease Who Had Previously Failed Or Were Intolerant To Anti-TNF-Alpha Therapy

TrendJanssen2016-03-21 13:57 Read   118

Phase 3 data presented at the 11th Congress of the European Crohn's and Colitis Organisation (ECCO) showed that treatment with STELARA® (ustekinumab) induced clinical response and clinical remission in adult patients with moderate to severe Crohn's disease who had previously failed or were intolerant to treatment with one or more anti-tumor necrosis factor (TNF)-alpha therapies.

Hutchison China MediTech Limited Announces Pricing of U.S. Public Offering of ADSs

EVENTSChi Med2016-03-18 14:56 Read   122

Hutchison China MediTech Limited (“Chi Med”) (AIM: HCM) announces the pricing of its U.S. public offering of American depositary shares (“ADSs”) (the “Offering”), raising gross proceeds of approximately US$101.25 million.

Study: The FDA's 'breakthrough' program is speeding up cancer approvals

CommentsFriends of Cancer Research2016-03-15 14:50 Read   168

Since the FDA unveiled its breakthrough therapy designation in 2012, cancer drugs brought into the program won approval roughly three months faster than other oncology therapies, according to a new study.

GW Pharma soars as its cannabis-derived drug aces Phase III

TrendGW Pharma2016-03-15 09:29 Read   127

London's GW Pharmaceuticals ($GWPH) said its cannabis-based treatment for epilepsy came through in a late-stage trial, sending the biotech's share price skyrocketing and improving its odds of FDA approval.

Roche receives China Food and Drug Administration (CFDA) approval for the CINtec(R) PLUS Cytology test to help prevent women from developing cervical cancer

EVENTSRoche2016-03-13 07:28 Read   242

Roche announced the China Food and Drug Administration (CFDA) approval of the CINtec(R) PLUS Cytology test, designed to improve the detection and early intervention of pre-cancerous cervical disease.

The CRISPR patent fight pits Broad against Berkeley, with three biotechs in the middle

FrontierStat story2016-03-10 15:45 Read   317

The ongoing dispute over who owns the rights to a potentially revolutionary gene editing technology is finally headed to court, as the U.S. Patent and Trademark Office prepares to weigh in on a dispute with major implications for biotech.

Reeling from an FDA rejection, Telesta sheds 15% of its staff

TrendTelesta2016-03-10 13:16 Read   93

 Montreal biotech Telesta Therapeutics is cutting 15% of its payroll to conserve cash as the company works to get its once-rejected cancer drug back on track.

Medivation's mystery cancer drug gets out from an FDA hold

RegulatorMedivation2016-03-10 10:43 Read   120

Medivation ($MDVN) alarmed regulators earlier this year with the revelation that its mid-stage cancer drug, purported to block the protein PD-1, didn't do that at all, leading the FDA to put the program on hold.

Baxalta makes $1.7bn play for slice of CAR-T market

CommentsBaxalta2016-03-01 15:05 Read   156

Baxalta has made a play for a stake of the emerging CAR-T immunotherapy market with a $1.7bn, three-year alliance with Precision BioSciences.

FDA designated a record number of orphan drugs last year

CommentsSTAT2016-02-16 17:05 Read   148

ophan drugs may target small patient populations, but they are racking up big numbers at the Food and Drug Administration.