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BioMarin Phase 3 Study of Pegvaliase for Phenylketonuria (PKU) Meets Primary Endpoint of Blood Phenylalanine (Phe) Reduction

TrendBioMarin2016-03-22 13:43 Read   433

BioMarin announced today that the pivotal Phase 3 PRISM-2 study (formerly referred to as 165-302) of pegvaliase met the primary endpoint of change in blood Phe compared with placebo (p<0.0001) in preliminary results.

Valeant turns crisis into farce

TrendEP Vantage2016-03-22 13:26 Read   83

with Valeant’s stock off 60% over the past five days and its business in tatters you might have been excused for thinking that things couldn’t get much worse. You’d have been wrong.

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.

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.

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.

Chimerix shares crash as antiviral flops and deaths spike in first PhIII challenge

TrendChimerix2015-12-29 14:03 Read   206

 High hopes for Chimerix's antiviral turned into a bad case of data shock Monday morning after the biotech revealed that brincidofovir had failed its first Phase III study.

CHMP recommends EU approval for UCB’s new drug brivaracetam for people with epilepsy

TrendUCB2015-11-23 14:04 Read   515

CHMP recommendation based on Phase 3 data showing brivaracetam significantly reduced the frequency of seizures in patients aged 16 years and older with uncontrolled partial-onset seizures.

UCB receives positive EU CHMP opinion for CIMZIA® (certolizumab pegol) to treat severe, active and progressive rheumatoid arthritis in DMARD-naïve patients

TrendUCB 2015-11-23 12:41 Read   615

UCB has announced that the EMA’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending extending the European Union marketing authorization for the use of CIMZIA® in the treatment of severe, active and progressive RA in DMARD-naïve adult patients.

Aeterna Zentaris Announces First Patient Enrolled for Confirmatory Phase 3 Trial of Macrilen™ for the evaluation of AGHD

TrendAeterna Zentaris 2015-11-20 15:50 Read   414

Aeterna Zentaris Inc.announced today that the first patient has been enrolled for the Company's confirmatory Phase 3 clinical study to demonstrate the efficacy of Macrilen™ (macimorelin), a novel orally-active ghrelin agonist for use in evaluating adult growth hormone deficiency ("AGHD").

PTC Completes Enrollment of Phase 3 Clinical Trial of Translarna™ for Patients with Cystic Fibrosis

TrendPTC 2015-11-20 14:59 Read   361

PTC Therapeutics, Inc. today announced that it has completed enrollment of ACT CF, the company's second Phase 3 clinical trial of Translarna™ (ataluren) for patients with nonsense mutation cystic fibrosis (nmCF).

Teva Reports Positive Top-Line Results from Phase III Trials Evaluating Fluticasone Propionate/Salmeterol and Fluticasone Propionate Multidose Dry Powder Inhalers (MDPIs) in Patients with Asthma

TrendTeva2015-11-20 14:25 Read   352

Studies demonstrate greater efficacy with lower doses delivered via multidose dry-powder inhaler (MDPI) compared to placebo .Results showcase Teva’s expanding respiratory R&D capabilities and support advancement of core, breath-actuated MDPI platform.

Dermira Completes Patient Enrollment for Second CIMZIA(R) (certolizumab pegol) Phase 3 Clinical Trial in Psoriasis Program

TrendDermira2015-11-20 10:18 Read   391

Enrollment Continues for Third and Final CIMZIA Phase 3 Trial in Patients With Moderate-to-Severe Plaque Psoriasis