Efficacy News and Research

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Merck KGaA initiates Phase 3 START2 study of MUC1 antigen-specific cancer immunotherapy tecemotide

Oncothyreon Inc. today announced that Merck KGaA, Darmstadt, Germany, has initiated the international Phase 3 START2 study, which is designed to assess the efficacy and safety of the investigational MUC1 antigen-specific cancer immunotherapy tecemotide (also known as L-BLP25) in patients with unresectable, locally advanced Stage III non-small cell lung cancer (NSCLC).

7 Apr 2014

Deciphera Pharmaceuticals initiates Phase 1 clinical trial of pan-RAF inhibitor LY3009120

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7 Apr 2014

Santen announces Phase III results of sirolimus intravitreal injections in non-infectious posterior segment uveitis patients

Santen Inc., the U.S. subsidiary of global ophthalmic pharmaceutical company Santen Pharmaceutical Co., Ltd. (Osaka, Japan), today announced that SAKURA (Study Assessing double‐masKed Uveitis tReAtment) Study 1, the first of two Global Phase III studies evaluating intravitreal injections of sirolimus in patients with non-infectious posterior segment uveitis (NI-PSU), met its primary endpoint.

From Santen Pharmaceutical Co., Ltd. 7 Apr 2014

A novel device for inhalation drug delivery

Inhalation is an increasingly important route for non-invasive drug delivery for both systemic and local applications. Control of particle size and output plays a critical role in the efficient and effective delivery of oft en expensive medications to the lung.

4 Apr 2014

Novartis to present early stage data on 19 investigational compounds at AACR annual meeting

Novartis announced today that early stage data on 19 investigational compounds in its oncology pipeline will be presented at the annual meeting of the American Association of Cancer Research, April 5-9, 2014 in San Diego, CA.

4 Apr 2014

FDA approves expanded use Dyax’s KALBITOR in treatment of acute hereditary angioedema

Dyax Corp. today announced that the U.S. Food and Drug Administration (FDA) has approved an expansion of the indication for KALBITOR (ecallantide), a peptide inhibitor of plasma kallikrein used in the treatment of acute hereditary angioedema (HAE) attacks, to include patients 12 years of age and older.

4 Apr 2014

Harvard stem cell scientists discover potential treatment for amyotrophic lateral sclerosis

Harvard stem cell scientists have discovered that a recently approved medication for epilepsy may possibly be a meaningful treatment for amyotrophic lateral sclerosis (ALS)-Lou Gehrig's disease, a uniformly fatal neurodegenerative disorder. The researchers are now collaborating with Massachusetts General Hospital to design an initial clinical trial testing the safety of the treatment in ALS patients.

4 Apr 2014

Neurovance closes $6.3M extension to its series A1 financing round to advance development of EB-1020 SR

Neurovance, Inc. today announced that it has closed a $6.3 million extension to its series A1 financing round to further advance development of EB-1020 SR, a non-stimulant, for the treatment of all subtypes of adult ADHD (attention deficit hyperactivity disorder).

3 Apr 2014

FDA clears Omeros' OMS721 IND for inhibition of complement‑mediated TMAs

Omeros Corporation today announced that its Investigational New Drug Application (IND) to evaluate OMS721 for the inhibition of complement‑mediated thrombotic microangiopathies (TMAs) has been cleared by the U.S. Food and Drug Administration.

3 Apr 2014

BDSI enrolls first patient in Clonidine Topical Gel Phase 3 trial for treatment of painful diabetic neuropathy

BioDelivery Sciences International, Inc. announced today the enrollment of the first patient in the RHAPSODY Study, a Phase 3 clinical trial of Clonidine Topical Gel for the treatment of painful diabetic neuropathy.

3 Apr 2014

Janssen begins Phase 3 OPTIMIST trials for treatment of chronic Genotype 1 HCV infection

Janssen R&D Ireland (Janssen) announced today that two Phase 3 trials are recruiting patients to examine the efficacy and safety of the NS3/4A protease inhibitor simeprevir in combination with the nucleotide inhibitor sofosbuvir for the treatment of chronic genotype 1 hepatitis C virus (HCV) infection in treatment-naive and treatment-experienced patients with and without cirrhosis.

3 Apr 2014

CardioCell receives IND approval for Phase IIa clinical study of itMSC therapy to treat heart failure

CardioCell LLC has just received the FDA's investigational new drug (IND) approval for a United States-based, Phase IIa clinical study using its allogeneic stem-cell therapy to treat subjects with chronic heart failure (CHF), which generates more than 1 million hospitalizations annually.

3 Apr 2014

Gilead reports topline results from sofosbuvir Phase 3 trial in Japan for treatment of HCV infection

Gilead Sciences, Inc. today announced topline results from a Phase 3 clinical trial (Study GS-US-334-0118) in Japan evaluating the once-daily nucleotide analog polymerase inhibitor sofosbuvir in combination with ribavirin (RBV) for the treatment of genotype 2 chronic hepatitis C virus (HCV) infection.

3 Apr 2014

FDA grants Fast Track designations for IV and oral formulations of Tetraphase's eravacycline

Tetraphase Pharmaceuticals, Inc. today announced that the U.S. Food & Drug Administration has granted Fast Track designations for both the intravenous (IV) and oral formulations of the company's lead antibiotic candidate, eravacycline.

3 Apr 2014

JPIAMR outlines steps to minimise antimicrobial resistance

Antibiotics have saved millions of lives from once deadly infectious diseases. But, misuse of antibiotics and other antimicrobials in humans and animals has led to bacteria evolving resistance.

3 Apr 2014

Sanaria receives 2014 Vaccine Industry Excellence Award for "Best Prophylactic Vaccine"

Sanaria received the 2014 Vaccine Industry Excellence Award for the "Best Prophylactic Vaccine" at a ceremony held March 25 in Washington DC during the 14th World Vaccine Congress.

3 Apr 2014

FDA allows CryoLife to begin PerClot clinical trial in the U.S.

CryoLife, Inc., a leading medical device and tissue processing company focused on cardiac and vascular surgery, announced today that it has received approval of its Investigational Device Exemption (IDE) for PerClot from the United States Food and Drug Administration.

2 Apr 2014

ANP reports positive results from chronic toxicity study of ATL1102 in multiple sclerosis

Antisense Therapeutics Limited is pleased to advise that results from a chronic toxicity study in monkeys indicate that ATL1102, an antisense oligonucleotide currently under development for the treatment of multiple sclerosis (MS), was well-tolerated when given subcutaneously for a 6-month dosing period at the 2 dose levels tested (1.5 and 3mg/kg/dose).

2 Apr 2014

FDA approves ORALAIR sublingual allergy immunotherapy tablet

GREER Laboratories, Inc., a leading developer and provider of allergy immunotherapy products and services, today announced that the U.S. Food and Drug Administration has approved ORALAIR (Sweet Vernal, Orchard, Perennial Rye, Timothy and Kentucky Blue Grass Mixed Pollens Allergen Extract) sublingual allergy immunotherapy tablet.

2 Apr 2014

Boston Scientific presents new data on cardiology-related clinical trials at ACC 2014

Reinforcing its position as a global leader in bringing new therapies to patients with heart and cardiovascular disease, Boston Scientific Corporation (NYSE: BSX) reported favorable results in studies related to cardiac resynchronization therapy (CRT), platinum chromium stent platforms and transcatheter aortic valve replacement (TAVR).

2 Apr 2014

Efficacy News and Research

Merck KGaA initiates Phase 3 START2 study of MUC1 antigen-specific cancer immunotherapy tecemotide

Deciphera Pharmaceuticals initiates Phase 1 clinical trial of pan-RAF inhibitor LY3009120

Santen announces Phase III results of sirolimus intravitreal injections in non-infectious posterior segment uveitis patients

A novel device for inhalation drug delivery

Novartis to present early stage data on 19 investigational compounds at AACR annual meeting

FDA approves expanded use Dyax’s KALBITOR in treatment of acute hereditary angioedema

Harvard stem cell scientists discover potential treatment for amyotrophic lateral sclerosis

Neurovance closes $6.3M extension to its series A1 financing round to advance development of EB-1020 SR

FDA clears Omeros' OMS721 IND for inhibition of complement‑mediated TMAs

BDSI enrolls first patient in Clonidine Topical Gel Phase 3 trial for treatment of painful diabetic neuropathy

Janssen begins Phase 3 OPTIMIST trials for treatment of chronic Genotype 1 HCV infection

CardioCell receives IND approval for Phase IIa clinical study of itMSC therapy to treat heart failure

Gilead reports topline results from sofosbuvir Phase 3 trial in Japan for treatment of HCV infection

FDA grants Fast Track designations for IV and oral formulations of Tetraphase's eravacycline

JPIAMR outlines steps to minimise antimicrobial resistance

Sanaria receives 2014 Vaccine Industry Excellence Award for "Best Prophylactic Vaccine"

FDA allows CryoLife to begin PerClot clinical trial in the U.S.

ANP reports positive results from chronic toxicity study of ATL1102 in multiple sclerosis

FDA approves ORALAIR sublingual allergy immunotherapy tablet

Boston Scientific presents new data on cardiology-related clinical trials at ACC 2014

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

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