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UCB, Dermira enter into licensing agreement for development, commercialization of Cimzia

UCB, a global biopharmaceutical leader, and Dermira, Inc., a privately held US-based dermatology company, announced today that they have entered into an exclusive licensing agreement for the development and future commercialization of Cimzia (certolizumab pegol) in dermatology.

3 Jul 2014

Functional status informs blood pressure risks in elderly

The functional status of elderly people modifies the association between their blood pressure and cardiovascular disease risk, a study shows.

23 Jun 2014

BioDelivery Sciences receives approval of NDA for BUNAVAIL from FDA

BioDelivery Sciences International, Inc. received approval of the New Drug Application (NDA) for BUNAVAIL™ (buprenorphine and naloxone) buccal film (CIII) from the U.S. Food and Drug Administration (FDA).

9 Jun 2014

Edge Therapeutics commences enrollment in second cohort of EG-1962 Phase 1/2 NEWTON study for aSAH

Edge Therapeutics, a clinical-stage biotechnology company that discovers, develops and seeks to commercialize novel, hospital-based therapies for acute, life-threatening neurological conditions, today announced that it has initiated patient enrollment in the second cohort of the NEWTON study, a multicenter, randomized, controlled, open-label, Phase 1/2 clinical trial of the company's lead product candidate, EG-1962.

5 Jun 2014

Experts from ProfNet network available to discuss timely issues in coverage area

Below are experts from the ProfNet network that are available to discuss timely issues in your coverage area. If you are interested in interviewing any of the experts, please contact them via the contact information at the end of the listing.

31 May 2014

Inotropic agents support epoprostenol initiation in severe PAH

Researchers have published a protocol for use of inotropic agents during initiation of epoprostenol therapy in patients with severe pulmonary arterial hypertension.

14 May 2014

FDA approves Bayer's Kogenate FS antihemophilic factor VIII to prevent bleeding episodes in adults with hemophilia A

Bayer HealthCare announced today that the U.S. Food and Drug Administration (FDA) has approved a new indication for Bayer's Kogenate® FS antihemophilic factor VIII (recombinant), for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults with hemophilia A.

12 May 2014

Bristol-Myers Squibb to present new immunotherapy study data at ASCO Annual Meeting

Bristol-Myers Squibb Company today announced that new data from studies investigating its immunotherapies in adjuvant and advanced melanoma, non-small cell lung cancer (NSCLC) and metastatic renal cell carcinoma (mRCC) will be presented at the 50th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago from May 30-June 3.

6 May 2014

UCB announces results from PRECiSE clinical trial of Cimzia in patients with Crohn's disease

UCB announced today results from the PRECiSE 3 7-year open label extension clinical trial of Cimzia (certolizumab pegol), the longest continuous trial of an anti-TNF therapy evaluating long-term safety in Crohn's disease.

6 May 2014

Genmab/GSK receive FDA sBLA approval for Arzerra in combination with chlorambucil for treatment of CLL

GlaxoSmithKline plc and Genmab A/S announced today that the U.S. Food and Drug Administration (FDA) has approved a Supplemental Biologic License Application (sBLA) for the use of Arzerra® (ofatumumab), a CD20-directed cytolytic monoclonal antibody, in combination with chlorambucil for the treatment of previously untreated patients with chronic lymphocytic leukaemia (CLL) for whom fludarabine-based therapy is considered inappropriate.

21 Apr 2014

Pradaxa receives FDA approval for treatment and reduction of risk of recurrence of DVT and PE

Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved Pradaxa® (dabigatran etexilate mesylate) for the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in patients who have been treated with a parenteral anticoagulant for five to 10 days, and to reduce the risk of recurrent DVT and PE in patients who have been previously treated. DVT and PE are collectively referred to as venous thromboembolism (VTE).

8 Apr 2014

Clonidine increases hypotension and non-fatal cardiac arrest after noncardiac surgery

Clonidine - a drug that reduces blood pressure and heart rate - increased rates of clinically concerning hypotension and non-fatal cardiac arrest after noncardiac surgery, according to the POISE-2 trial presented at the American College of Cardiology's 63rd Annual Scientific Session.

1 Apr 2014

rEVO Biologics commences ATryn Phase 3 clinical program for treatment of preeclampsia in pregnant women

rEVO Biologics Inc., a subsidiary of LFB SA, today announced the initiation of the Phase 3 clinical program for ATryn for the treatment of preeclampsia in pregnant women during the 24th to 28th week of pregnancy.

31 Mar 2014

SEATTLE II study confirms safety and efficacy of thrombolytic therapy for acute PE

EKOS Corporation, a BTG International group company, notes the presentation of the results of the SEATTLE II trial this afternoon at ACC.14, the 63rd Annual Scientific Session and Exposition of the American College of Cardiology in Washington, DC in the United States.

31 Mar 2014

Study of astronauts show heart becomes more spherical when exposed to microgravity in space

New findings from a study of 12 astronauts show the heart becomes more spherical when exposed to long periods of microgravity in space, a change that could lead to cardiac problems, according to research to be presented at the American College of Cardiology's 63rd Annual Scientific Session.

31 Mar 2014

Biogen Idec's ALPROLIX receives FDA approval for hemophilia B treatment

Today Biogen Idec announced that the U.S. Food and Drug Administration has approved ALPROLIX [Coagulation Factor IX (Recombinant), Fc Fusion Protein], the first recombinant, DNA derived hemophilia B therapy with prolonged circulation in the body.

29 Mar 2014

Kessler Foundation receives grant to supports variety of rehabilitation research projects in spinal cord injury

Kessler Foundation has received more than $718,000 in grant funding from the Craig Neilsen Foundation. The funding, comprised of five grants, supports a variety of rehabilitation research projects in spinal cord injury (SCI), including pain management, functional outcomes, quality of life, and factors affecting cognitive function.

18 Mar 2014

Pierre Fabre Dermatologie receives FDA marketing authorization for pediatric drug Hemangeol

Pierre Fabre Dermatologie has obtained marketing authorization from the FDA for the pediatric drug Hemangeol (propranolol hydrochloride), which is the first and only approved treatment for "proliferating infantile hemangioma requiring systemic therapy".

18 Mar 2014

CSI's new Diamondback Peripheral 60cm systems receive FDA clearance for PAD treatment

Cardiovascular Systems, Inc., announced today it has received FDA clearance of its new Diamondback 360 60cm Peripheral Orbital Atherectomy Systems (OAS) for the treatment of peripheral arterial disease (PAD).

10 Mar 2014

Cedars-Sinai neurosurgeon successfully performs CSF repair surgery on patient

When Elizabeth "Beth" Johnson stood up from working at her computer Oct. 28, she noticed "a kind of funny feeling" in the back of her neck. By Nov. 2, the sensation had become an excruciating headache that came on whenever she tried to stand or sit upright.

28 Feb 2014

Hypotension News and Research

UCB, Dermira enter into licensing agreement for development, commercialization of Cimzia

Functional status informs blood pressure risks in elderly

BioDelivery Sciences receives approval of NDA for BUNAVAIL from FDA

Edge Therapeutics commences enrollment in second cohort of EG-1962 Phase 1/2 NEWTON study for aSAH

Experts from ProfNet network available to discuss timely issues in coverage area

Inotropic agents support epoprostenol initiation in severe PAH

FDA approves Bayer's Kogenate FS antihemophilic factor VIII to prevent bleeding episodes in adults with hemophilia A

Bristol-Myers Squibb to present new immunotherapy study data at ASCO Annual Meeting

UCB announces results from PRECiSE clinical trial of Cimzia in patients with Crohn's disease

Genmab/GSK receive FDA sBLA approval for Arzerra in combination with chlorambucil for treatment of CLL

Pradaxa receives FDA approval for treatment and reduction of risk of recurrence of DVT and PE

Clonidine increases hypotension and non-fatal cardiac arrest after noncardiac surgery

rEVO Biologics commences ATryn Phase 3 clinical program for treatment of preeclampsia in pregnant women

SEATTLE II study confirms safety and efficacy of thrombolytic therapy for acute PE

Study of astronauts show heart becomes more spherical when exposed to microgravity in space

Biogen Idec's ALPROLIX receives FDA approval for hemophilia B treatment

Kessler Foundation receives grant to supports variety of rehabilitation research projects in spinal cord injury

Pierre Fabre Dermatologie receives FDA marketing authorization for pediatric drug Hemangeol

CSI's new Diamondback Peripheral 60cm systems receive FDA clearance for PAD treatment

Cedars-Sinai neurosurgeon successfully performs CSF repair surgery on patient

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