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FDA's Advisory Committee recommends approval of Praluent (alirocumab) Injection

Sanofi and Regeneron Pharmaceuticals, Inc. today announced that the Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration recommended the approval of the investigational therapy Praluent (alirocumab) Injection.

9 Jun 2015

Apitope's ATX-F8-117 granted FDA Orphan Drug Designation for treatment of haemophilia A patients

Apitope, the drug discovery and development company focused on disease-modifying treatments that reinstate immune tolerance, announced today that pre-clinical product candidate ATX-F8-117 has been granted Orphan Drug Status by the US Food and Drug Administration for the prevention or treatment of inhibitors in haemophilia A patients with inhibitors or at the risk of producing inhibitors.

9 Jun 2015

Study shows how GLP-1 receptor agonists modify the brain's response to food

Gut hormone-based medications used to treat diabetes, such as GLP-1 receptor agonists, have also been shown to reduce body weight. Researchers have been working to understand how. This study, presented today at the American Diabetes Association's 75th Scientific Sessions, sheds light on how GLP-1 receptor agonists alter the brain's response to food, possibly reducing cravings and increasing satisfaction while eating.

9 Jun 2015

Sanofi announces results from Phase IIIb ELIXA study of Lyxumia in adults with diabetes and high CV risk

Sanofi announced today the presentation of full results of the Phase IIIb ELIXA study, which was designed to assess the cardiovascular (CV) safety of Lyxumia (lixisenatide) in adults with type 2 diabetes and high CV risk.

8 Jun 2015

Braeburn reports positive topline results from Probuphine Phase 3 study for treatment of opioid addiction

Braeburn Pharmaceuticals, an Apple Tree Partners company, today reported positive topline results from the Phase 3 double-blind, double-dummy clinical study of Probuphine, the investigational subdermal implant containing buprenorphine HCl for the long-term maintenance treatment of opioid addiction.

8 Jun 2015

New statistics show oesophageal cancer rates increase by 50% in men

Oesophageal cancer rates in men have increased by 50 per cent since the early 1980s, with new cases reaching almost 6,000, according to new statistics from Cancer Research UK.

8 Jun 2015

More young children being exposed to marijuana, reveals Nationwide Children's study

Debates about legalizing marijuana have focused on crime rates, economic benefits, and health effects among adults. But a study published today from researchers at Nationwide Children's Hospital shows that the risk to young children of swallowing, breathing in or otherwise being exposed to marijuana also needs to be considered.

8 Jun 2015

Janssen begins rolling submission of daratumumab BLA to FDA for treatment of patients with multiple myeloma

Janssen Research & Development, LLC has initiated the rolling submission of its Biologic License Application (BLA) for daratumumab to the U.S. Food and Drug Administration (FDA) for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD), or who are double refractory to a PI and an IMiD.

7 Jun 2015

Once-weekly Trulicity 0.75 mg shows promising results in Japanese patients with type 2 diabetes

Results from a new study of Japanese patients with type 2 diabetes showed once-weekly Trulicity 0.75 mg provided greater hemoglobin A1c (A1C) reduction compared to once-daily Victoza 0.9 mg after 52 weeks of treatment. Eli Lilly and Company will present these data at the 75th American Diabetes Association Scientific Sessions in Boston.

7 Jun 2015

Bio-Techne to acquire 100% ownership of Cliniqa

Bio-Techne Corporation announced today that it has agreed to acquire 100% ownership of Cliniqa Corporation. Cliniqa specializes in the manufacturing and commercialization of quality controls and calibrators as well as bulk reagents used in the clinical diagnostic market.

From CLINIQA - Diagnostics Division 5 Jun 2015

Food labels effective in helping people make healthier food choices, shows study

A Cornell study of food labels in dining halls shows that when people know the calories and fat content in foods, they lean toward healthier fare.

5 Jun 2015

Women contribute around $3 trillion to global health care, but almost half of this is unpaid, unrecognised

A major new Commission on women and health has found that women are contributing around $3 trillion to global health care, but nearly half of this (2.35% of global GDP) is unpaid and unrecognised.

5 Jun 2015

Tentative FDA approval of lopinavir/ritonavir oral pellet formulation closes treatment gap for children with HIV

Infants and young children living with HIV will finally have access to an improved formulation of an antiretroviral (ARV) treatment, following the U.S. Food and Drug Administration's tentative approval last week of lopinavir/ritonavir (LPV/r) oral pellets developed by the Indian generic company Cipla.

5 Jun 2015

Eating less late at night may help reduce effects of sleep deprivation

Eating less late at night may help curb the concentration and alertness deficits that accompany sleep deprivation, according to results of a new study from researchers at the Perelman School of Medicine at the University of Pennsylvania that will be presented at SLEEP 2015, the 29th annual meeting of the Associated Professional Sleep Societies LLC.

5 Jun 2015

Seattle Children's opens enrollment for first clinical trial of Tumor Paint BLZ-100 for children with brain tumors

Seattle Children's today announced the opening of patient enrollment for the first clinical research trial of the drug Tumor Paint BLZ-100, which is designed to improve surgical outcomes in children with brain tumors – the most common solid tumor cancer in kids.

5 Jun 2015

Ibrutinib (IMBRUVICA) improves survival in treatment-naïve patients with chronic lymphocytic leukemia

Today, Pharmacyclics LLC, an AbbVie company, announced that ibrutinib (IMBRUVICA) improved progression-free survival (PFS; primary endpoint) and multiple secondary endpoints including overall survival (OS) and overall response rate (ORR) in treatment-naïve patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL, respectively) in the final analysis of the Phase III RESONATE™-2 (PCYC-1115) trial.

5 Jun 2015

Volunteer double act are ‘still game’ after 10 years

The Golden Jubilee’s very own ‘Jack and Victor’ have been honoured for serving Scotland’s national hospital for over a decade.

5 Jun 2015

Actavis receives FDA approval to market NATRELLE INSPIRA round gel-filled textured breast implants

Actavis plc, which recently completed the acquisition of Allergan, Inc., today announced that the company has received approval from the U.S. Food and Drug Administration to market NATRELLE INSPIRA round gel-filled textured breast implants, offering women undergoing reconstruction, augmentation or revision surgery another breast shaping option for a customized result.

5 Jun 2015

Rhythm announces initiation of two setmelanotide Phase 2 trials for treatment of PWS, POMC-null obesity

Rhythm announced today the initiation of two Phase 2 clinical trials focused on evaluating the safety and effectiveness of setmelanotide (RM-493), the company's novel melanocortin 4 receptor (MC4R) agonist, for the treatment of Prader-Willi Syndrome (PWS) and POMC-null obesity.

4 Jun 2015

CASI files application with CFDA to conduct ENMD-2076 Phase 2 trial in fibrolamellar carcinoma patients

CASI Pharmaceuticals, Inc., a biopharmaceutical company dedicated to the acquisition, development and commercialization of innovative therapeutics addressing cancer and other unmet medical needs for the global market with a commercial focus on China, announced today that it has filed an application with China's Food and Drug Administration to conduct a Phase 2 clinical trial in fibrolamellar carcinoma (FLC) patients in China for its proprietary drug candidate, ENMD-2076.

4 Jun 2015

Food News and Research

FDA's Advisory Committee recommends approval of Praluent (alirocumab) Injection

Apitope's ATX-F8-117 granted FDA Orphan Drug Designation for treatment of haemophilia A patients

Study shows how GLP-1 receptor agonists modify the brain's response to food

Sanofi announces results from Phase IIIb ELIXA study of Lyxumia in adults with diabetes and high CV risk

Braeburn reports positive topline results from Probuphine Phase 3 study for treatment of opioid addiction

New statistics show oesophageal cancer rates increase by 50% in men

More young children being exposed to marijuana, reveals Nationwide Children's study

Janssen begins rolling submission of daratumumab BLA to FDA for treatment of patients with multiple myeloma

Once-weekly Trulicity 0.75 mg shows promising results in Japanese patients with type 2 diabetes

Bio-Techne to acquire 100% ownership of Cliniqa

Food labels effective in helping people make healthier food choices, shows study

Women contribute around $3 trillion to global health care, but almost half of this is unpaid, unrecognised

Tentative FDA approval of lopinavir/ritonavir oral pellet formulation closes treatment gap for children with HIV

Eating less late at night may help reduce effects of sleep deprivation

Seattle Children's opens enrollment for first clinical trial of Tumor Paint BLZ-100 for children with brain tumors

Ibrutinib (IMBRUVICA) improves survival in treatment-naïve patients with chronic lymphocytic leukemia

Volunteer double act are ‘still game’ after 10 years

Actavis receives FDA approval to market NATRELLE INSPIRA round gel-filled textured breast implants

Rhythm announces initiation of two setmelanotide Phase 2 trials for treatment of PWS, POMC-null obesity

CASI files application with CFDA to conduct ENMD-2076 Phase 2 trial in fibrolamellar carcinoma patients

The future is bioengineered: Synthetic biology and global sustainability eBook

Improving healthcare sustainability through carbon data

A New Approach to Preventing Bladder Cancer Recurrence

Bringing real-time analytics to downstream bioprocess monitoring

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