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CHMP issues positive opinion supporting use of Trelegy Ellipta in broader group of COPD patients

GlaxoSmithKline plc and Innoviva, Inc. announced that the European Medicines Agency's Committee for Medicinal Products for Human Use has issued a positive opinion today supporting the use of Trelegy Ellipta in a broader group of patients with moderate to severe chronic obstructive pulmonary disease and that labeling, if approved, will be updated to further reflect its effect on exacerbations of COPD.

21 Sep 2018

As states try to rein in drug spending, feds slap down one bold Medicaid move

States serve as “laboratories of democracy,” as U.S. Supreme Court Justice Louis Brandeis famously said. And states are also labs for health policy, launching all kinds of experiments lately to temper spending on pharmaceuticals.

21 Sep 2018

CHMP provides positive opinion to Cabometyx for previously-treated patients with hepatocellular carcinoma

Ipsen announced today that the Committee for Medicinal Products for Human Use, the scientific committee of the European Medicines Agency, provided a positive opinion for Cabometyx (cabozantinib) as a monotherapy for the treatment of hepatocellular carcinoma in adults who have been previously treated with sorafenib.

21 Sep 2018

UAB researchers study dysfunction of the immune system associated with NSAID carprofen

Non-steroidal anti-inflammatory drugs, or NSAIDs, are commonly used as inflammation blockers worldwide. However, recent clinical data show these painkillers can have serious side effects that create some risk of heart attacks, strokes, and kidney or heart failure.

21 Sep 2018

New naturally occurring antibiotic found effective against Mycobacterium tuberculosis

A naturally occurring antibiotic called kanglemycin A is effective against Mycobacterium tuberculosis, the bacteria that cause tuberculosis, even in drug-resistant strains, according to an international team of researchers who used chemistry, molecular biology, microbiology, and X-ray crystallography to show how the compound maintains its activity.

21 Sep 2018

Pfizer’s 20vPnC vaccine receives Breakthrough Therapy designation from FDA

Pfizer Inc. announced today that its 20-Valent Pneumococcal Conjugate Vaccine candidate, PF-06482077, received Breakthrough Therapy designation from the US Food and Drug Administration for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes in the vaccine in adults aged 18 years and older. Pfizer expects to start Phase 3 trials in a few months.

20 Sep 2018

LineaRx signs agreement with Takis/Evvivax to develop linear-DNA based anti-cancer vaccines

Applied DNA Sciences Inc. announced today that LineaRx, Inc., its wholly-owned subsidiary focused on next-generation biotherapeutics, has signed a Joint Development Agreement with Takis S.R.L. and Evvivax S.R.L., biotechnology companies focused on the discovery and development of DNA based anti-cancer vaccines for the human and animal markets, respectively.

20 Sep 2018

Vax-Hub to influenze radical change in development and manufacturing of vaccines

Vax-Hub, a new Future Vaccine Manufacturing Research Hub, will bring together academia, industry and policy makers to affect radical change in the development and manufacturing of vaccines and improve responses to outbreaks of deadly pandemics such as Swine Flu and Ebola.

20 Sep 2018

ALSAM Foundation invests additional $2 million for drug discovery and development projects

The ALSAM Foundation recently invested an additional $2 million to continue the Therapeutic Innovation Grants Program at the CU Skaggs School of Pharmacy and Pharmaceutical Sciences.

20 Sep 2018

Celltrion and Emory University sign 'Incubation' agreement to develop new drug candidates for atherosclerosis

Celltrion, Inc. signed an 'Incubation' agreement with Emory University in Atlanta to support the research and development of new drug candidates for atherosclerosis.

20 Sep 2018

Cannabinoid drugs reduce perceived unpleasantness of painful stimuli and increase tolerance

Researchers in the College of Arts and Sciences have determined that cannabinoid drugs do not appear to reduce the intensity of experimental pain, but, instead, may make pain feel less unpleasant and more tolerable.

19 Sep 2018

Study: Infants using popular anti-reflux medicines are not at increased risk of lung infections

New University of Otago research shows infants using popular anti-reflux medicines like omeprazole are not at increased risk of pneumonia or other lower respiratory tract infections, contrary to findings from other international studies.

19 Sep 2018

Ipsen receives approval from Health Canada for CABOMETYX tablets for treating renal cell carcinoma

Exelixis, Inc. today announced that its partner Ipsen Biopharmaceuticals Canada Inc. received approval from Health Canada of CABOMETYX® tablets for the treatment of adults with advanced renal cell carcinoma who have received prior vascular endothelial growth factor targeted therapy.

19 Sep 2018

UTILITY receives FDA approval for Investigational New Drug applications

UTILITY therapeutics Ltd, a pharmaceutical company focused on developing and commercializing antibiotics in the US, today announces that the US Food and Drug Administration has approved the Investigational New Drug applications for mecillinam and pivmecillinam.

19 Sep 2018

Analysis does not find any safety concerns of bivalent HPV vaccine

Infection with human papillomavirus can cause certain cancers in women and men, but HPV vaccines are highly effective in preventing infection with oncogenic HPV types.

19 Sep 2018

Researchers harness Zika virus vaccine under development to target glioblastoma

Researchers at The University of Texas Medical Branch at Galveston have successfully harnessed a Zika virus vaccine under development to target and kill the brain cancer known as glioblastoma.

19 Sep 2018

FDA takes new steps to address opioid crisis by approving Opioid Analgesic Risk Evaluation and Mitigation Strategy

Today, the U.S. Food and Drug Administration took new steps as part of its broader efforts to address the opioid crisis by approving the final Opioid Analgesic Risk Evaluation and Mitigation Strategy.

19 Sep 2018

New Crest Gum & Enamel Repair toothpaste may boost enamel repair and reverse gingivitis

According to data from the Centers for Disease Control and Prevention, nearly half of U.S. adults have gum disease. Harmful plaque bacteria can hide in crevices below the gum line.

18 Sep 2018

New compound could prevent malaria parasites from maturing inside mosquito

Researchers have identified compounds that could prevent malaria parasites from being able to infect mosquitoes, halting the spread of disease.

18 Sep 2018

Muscle relaxants used during general anesthesia can increase risk of pulmonary complications

Muscle relaxants that are used during general anesthesia increase the risk of pulmonary complications after surgery, according to the European milicenter study POPULAR, in which Karolinska Institutet researchers are involved. The study is published in the journal Lancet Respiratory Medicine.

18 Sep 2018

Pharmaceutical News

CHMP issues positive opinion supporting use of Trelegy Ellipta in broader group of COPD patients

As states try to rein in drug spending, feds slap down one bold Medicaid move

CHMP provides positive opinion to Cabometyx for previously-treated patients with hepatocellular carcinoma

UAB researchers study dysfunction of the immune system associated with NSAID carprofen

New naturally occurring antibiotic found effective against Mycobacterium tuberculosis

Pfizer’s 20vPnC vaccine receives Breakthrough Therapy designation from FDA

LineaRx signs agreement with Takis/Evvivax to develop linear-DNA based anti-cancer vaccines

Vax-Hub to influenze radical change in development and manufacturing of vaccines

ALSAM Foundation invests additional $2 million for drug discovery and development projects

Celltrion and Emory University sign 'Incubation' agreement to develop new drug candidates for atherosclerosis

Cannabinoid drugs reduce perceived unpleasantness of painful stimuli and increase tolerance

Study: Infants using popular anti-reflux medicines are not at increased risk of lung infections

Ipsen receives approval from Health Canada for CABOMETYX tablets for treating renal cell carcinoma

UTILITY receives FDA approval for Investigational New Drug applications

Analysis does not find any safety concerns of bivalent HPV vaccine

Researchers harness Zika virus vaccine under development to target glioblastoma

FDA takes new steps to address opioid crisis by approving Opioid Analgesic Risk Evaluation and Mitigation Strategy

New Crest Gum & Enamel Repair toothpaste may boost enamel repair and reverse gingivitis

New compound could prevent malaria parasites from maturing inside mosquito

Muscle relaxants used during general anesthesia can increase risk of pulmonary complications

Transforming Lab Workflows with Cell Culture Automation

Building Bridges to Scalable Allogeneic Cell Therapy

Edoardo Fabini

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