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Halozyme initiates Ultrafast Insulin combination Phase 2 studies with rHuPH20

Halozyme Therapeutics, Inc. today announced the initiation of two Phase 2 Ultrafast Insulin treatment studies that utilize its rHuPH20 hyaluronidase enzyme (PH20) in combination with the two leading commercially available mealtime analogs: insulin aspart, the active ingredient in NovoLog®, and insulin lispro, the active ingredient in Humalog®.

2 Sep 2010

PolyMedix's PMX-60056 Phase 1B/2 dose-ranging clinical study for heparin reversal meets study endpoints

PolyMedix, Inc., an emerging biotechnology company focused on developing new therapeutic drugs to treat acute cardiovascular disorders and infectious diseases, has successfully completed a Phase 1B/2 dose-ranging clinical study with PMX-60056, a synthetic small-molecule designed to reverse heparin and low molecular weight heparin anticoagulants.

11 Aug 2010

Morphine plus oxycodone IV combination exhibits improved analgesia, tolerability compared to IV morphine

QRxPharma Limited announced today positive results of its Phase 2 comparative proof-of-concept study to evaluate the efficacy and safety of its IV (intravenous) formulation of morphine plus oxycodone versus IV morphine alone for the treatment of moderate to severe post-operative pain in patients following hip replacement surgery. The main findings demonstrated that QRxPharma's formulation of MoxDuo IV resulted in fewer side effects and offered better pain relief than morphine alone.

9 Aug 2010

Studies on VIAject and Vialog presented at 70th American Diabetes Association sessions

Studies of a more-rapid-acting injectable human insulin formulation (VIAject®) in the treatment of type 1 and type 2 diabetes and of a novel insulin analog formulation (Vialog™) in an animal model of diabetes were reported this week in three poster presentations at the 70th Scientific Sessions of the American Diabetes Association in Orlando, Florida. The findings are based upon results from recent clinical and preclinical studies sponsored by Biodel Inc..

1 Jul 2010

Chelsea initiates NORTHERA Phase III trial for symptomatic NOH associated with PD

Chelsea Therapeutics International, Ltd. announced the initiation of Study 306, a pivotal Phase III trial evaluating the efficacy of NORTHERA™, an oral synthetic precursor of norepinephrine, for the treatment of symptomatic neurogenic orthostatic hypotension (NOH) associated with Parkinson's disease.

29 Jun 2010

AFREZZA provides long-term glucose control in Type 2 diabetics: Study

AFREZZA (insulin human [rDNA origin]) Inhalation Powder, a well-tolerated, investigational ultra rapid acting mealtime insulin, as part of a diabetes treatment regimen, provides long-term glucose control comparable to usual insulin therapy but with a significantly reduced incidence of hypoglycemia and less weight gain in patients with Type 2 diabetes, according to a two-year study presented today at the American Diabetes Association's 70th Scientific Sessions.

29 Jun 2010

First placebo-controlled clinical study results of BYETTA injection with Lantus presented at ADA 2010

Amylin Pharmaceuticals, Inc. and Eli Lilly and Company today announced results from the first double-blind, placebo-controlled clinical study to evaluate BYETTA (exenatide) injection added to Lantus (insulin glargine), which showed patients with type 2 diabetes achieved glucose targets without weight gain or increasing their risk of hypoglycemia. These findings were presented at the 70th Annual Scientific Sessions of the American Diabetes Association in Orlando, Fla.

28 Jun 2010

Relypsa commences enrollment for RLY5016 Phase 2 study in heart failure patients with chronic kidney disease

Relypsa, Inc., today announced the initiation of patient enrollment in a Phase 2, open-label titration clinical study of the company's lead drug candidate, RLY5016, in heart failure patients with chronic kidney disease. RLY5016 is a novel non-absorbed oral potassium binder intended to prevent and treat hyperkalemia, a serious condition characterized by elevated serum potassium levels.

16 Jun 2010

UCB announces availability of Vimpat oral solution formulation

UCB today announced the availability of an oral solution formulation of Vimpat- (lacosamide) C-V, an antiepileptic drug (AED) for add-on treatment of partial-onset seizures in people with epilepsy age 17 years and older. Vimpat 10 mg/mL solution is now available in U.S. pharmacies.

14 Jun 2010

Phase II study results of riociguat for CTEPH and PAH published online

Bayer HealthCare Pharmaceuticals, Inc. today announced that the study "Riociguat for chronic thromboembolic pulmonary hypertension and pulmonary arterial hypertension: a phase II study" was published online this week by the European Respiratory Journal. Results of this study to assess the safety, tolerability and the feasibility of individual dose titration of riociguat were previously presented at the 2009 International Conference of the American Thoracic Society.

11 Jun 2010

AFREZZA non-inferior to standard therapy insulin lispro in reducing HbA1c levels of Type 1 diabetics

MannKind Corporation today announced that results of a new 16-week trial show that the investigational ultra rapid acting mealtime insulin, AFREZZA™ (insulin human [rDNA origin]) Inhalation Powder, combined with basal insulin, is clearly non-inferior to standard therapy insulin lispro, a rapid acting insulin, also combined with basal insulin, in reducing HbA1c levels in subjects with inadequately controlled Type 1 diabetes.

11 Jun 2010

LifeWatch Services to unveil advanced AF TeleClinic service at HRS Annual Meeting

LifeWatch Services, Inc., a subsidiary of LifeWatch AG, will unveil its advanced AF TeleClinic service offering this week at the Heart Rhythm Society (HRS) Annual Meeting taking place in Denver, Colorado. The AF TeleClinic service, empowered with the latest communication, IT and medical technologies, ensures physicians are well equipped to deliver optimal diagnostic and treatment options to their patients.

11 May 2010

S2S hosts students from Newark Science Park High School for a day of hands-on science

Students 2 Science, Inc. hosted students from Newark Science Park High School for a day of hands-on science as part of its year-long "Supercharged Science" program.

7 May 2010

Update on ICA-105665 clinical development plans for treatment of epilepsy and pain

Icagen, Inc. today provided an update on clinical development plans for ICA-105665, the Company's novel drug candidate for the treatment of epilepsy and pain.

28 Apr 2010

Aton Pharma acquires the U.S. marketing rights to LODOSYN tablets from BMS

Aton Pharma, Inc., a diversified specialty pharmaceutical company, today announced that it has acquired the U.S. marketing rights to LODOSYN (carbidopa) tablets from Bristol-Myers Squibb Company.

26 Apr 2010

Study finds AFREZZA comparable to standard of care insulin therapy

Pulmonary function test results (PFTs) in patients treated with AFREZZATM (insulin human [rDNA origin]) Inhalation Powder, a well-tolerated, ultra rapid acting insulin, at follow-up measurements were similar to PFT results observed in patients receiving standard antidiabetic therapy, according to data presented today at the American Association of Clinical Endocrinologists 19th Annual Meeting (Poster #267).

24 Apr 2010

AFREZZA Inhalation Powder reduces incidence of hypoglycemia in patients with Type 1 diabetes

Diabetes treatment regimens containing AFREZZATM (insulin human [rDNA origin]) Inhalation Powder, a well-tolerated, ultra rapid acting insulin, provide glucose control similar to standard insulin therapy along with weight loss and reduced incidence of hypoglycemia in patients with Type 1 diabetes and poorly controlled blood sugar levels, according to a two-year study presented today at the American Association of Clinical Endocrinologists 19th Annual Meeting (Poster #283).

24 Apr 2010

Patients with RLS using rotigotine achieve sustained improvements

New data presented at the 62nd American Academy of Neurology annual meeting in Toronto, Canada, showed that patients with moderate to severe Restless Legs Syndrome using rotigotine achieved sustained improvements in symptoms over 5 years of treatment.

15 Apr 2010

AED Vimpat to be the subject of numerous studies and analyses at AAN meeting

The antiepileptic drug Vimpat- (lacosamide) (C-V) will be the subject of numerous studies and analyses-both UCB-sponsored and independent-at the 62nd annual American Academy of Neurology meeting, taking place at the Metro Toronto Convention Centre in Toronto from April 10-17.

9 Apr 2010

Request for lift of full clinical hold on Proellex program

Repros Therapeutics Inc. today announced that the Company has requested a lift of the full clinical hold on its oral drug Proellex® being developed for the treatment of uterine fibroids and endometriosis. On August 4, 2009, the FDA noted that further testing of Proellex® was placed on full clinical hold due to findings of serious adverse events associated with liver toxicity.

5 Apr 2010