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Experts describe role of quantitative systems pharmacology in first-in-human clinical trials

Certara, the global leader in model-informed drug development, regulatory science, market access and real-world evidence services, announced today that Clinical Pharmacology & Therapeutics has published its "Letter to the Editor" describing the important role that quantitative systems pharmacology can play in defining dosing criteria for first-in-human clinical trials, together with the European Medicines Agency's response.

26 Jul 2018

CNDA approves KEYTRUDA for treatment of advanced melanoma

Merck, known as MSD outside the United States and Canada, today announced that KEYTRUDA, Merck's anti-PD-1 therapy, has been approved by the China National Drug Administration for the treatment of adult patients with unresectable or metastatic melanoma following failure of one prior line of therapy.

26 Jul 2018

Ciprofloxacin may disrupt normal functions of connective tissue

The use of ciprofloxacin and other antibiotics of the class of fluoroquinolones may be associated with disruption of the normal functions of connective tissue, including tendon rupture, tendonitis and retinal detachment

26 Jul 2018

Researchers find compounds that may pave way for new drugs against diabetes, obesity

A new study reveals that several drugs for treating hematological cancers are less effective than expected in inhibiting a special enzyme.

26 Jul 2018

Déjà voodoo: Pharma’s promises to curb drug prices have been heard before

Prescription drug prices were soaring. Angry policymakers swore they'd take action. Pharma giant Merck responded by promising to address the problem voluntarily, vowing to keep price increases under the overall rate of inflation.

25 Jul 2018

Omeros’ OMS721 receives positive opinion from EMA's COMP for treating hematopoietic stem cell transplant

Omeros Corporation announced today that the European Medicines Agency's Committee for Orphan Medicinal Products issued a positive opinion recommending orphan drug designation of OMS721 for treatment in hematopoietic stem cell transplantation.

25 Jul 2018

New opioid prescription control framework is a 'funhouse mirror image' of prior monopoly

A rise in addiction and overdose deaths involving opioids in the United States has spurred a series of initiatives focused on reducing opioid risks, including several related to prescription of opioids in care of pain.

25 Jul 2018

New protein complex may explain why patients develop resistance to novel anti-cancer drugs

A team of researchers at the University of Cambridge has identified a protein complex that might explain why some cancer patients treated with the revolutionary new anti-cancer drugs known as PARP inhibitors develop resistance to their medication.

25 Jul 2018

Depression, antidepressant use linked with higher risk of venous thromboembolism

In the first review of its kind, new research has found that depression and the use of antidepressants are each associated with an increased risk of venous thromboembolism.

24 Jul 2018

Common opioid-based painkillers increase harmful side effects in people with dementia

Commonly-prescribed opioid-based painkillers led to harmful side effects tripling in people with dementia.

24 Jul 2018

Outrage over China vaccines scandal

One of the largest vaccine manufacturers in China, Changchun Changsheng Bio-technology Ltd. was found to have falsified reports in connection with production and inspection of around 113,000 rabies vaccines.

23 Jul 2018

Long-term use of cannabis or cannabis-based drugs can impair memory, shows study

Long-term use of either cannabis or cannabis-based drugs impairs memory say researchers. The study has implications for both recreational users and people who use the drug to combat epilepsy, multiple sclerosis and chronic pain.

23 Jul 2018

Pfizer announces FDA approval of biosimilar to Neupogen

Pfizer Inc. today announced that the United States Food and Drug Administration has approved NIVESTYM (filgrastim-aafi), a biosimilar to Neupogen (filgrastim), for all eligible indications of the reference product.

23 Jul 2018

MOF vaccines could increase access to immunization and reduce the risk of global pandemics

Vaccinations are the safest way to protect against disease. However, many vaccines become ineffective when exposed to room temperature or heat.

23 Jul 2018

Former inmates more likely to die of opioid overdose after prison release

A recent study in North Carolina found that in the first two weeks after being released from prison, former inmates were 40 times more likely to die of an opioid overdose than someone in the general population.

23 Jul 2018

FDA approves first drug for treatment of adult AML patients with specific genetic mutation

The U.S. Food and Drug Administration today approved Tibsovo (ivosidenib) tablets for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who have a specific genetic mutation.

20 Jul 2018

Recovery United to launch pilot intervention program for patients who experienced opioid overdose

Today, Recovery United, Inc. announced the launch of a pilot intervention program at three Boise-area hospitals that will connect patients who have experienced an opioid overdose to certified peer recovery coaches

20 Jul 2018

Drug in clinical trials for Parkinson's disease offers hope for treating heart failure

A drug currently in clinical trials for treating symptoms of Parkinson's disease may someday have value for treating heart failure, according to results of early animal studies by Johns Hopkins Medicine researchers.

20 Jul 2018

New vaccine could protect unborn babies from Zika virus

Until recently, the Zika virus was not a priority since it affected relatively few people and the cost of creating a vaccine was estimated at EUR 149-468 million. But the spread of Zika in the Americas and discovery of a link with reduced head size and brain damage in babies of women infected while pregnant changed that.

20 Jul 2018

PureTech Health collaborates with Roche to advance oral administration of antisense oligonucleotides

PureTech Health plc, a clinical-stage biopharmaceutical company developing novel medicines focused on the Brain-Immune-Gut Axis, today announced that it has entered into a multiyear collaboration with F. Hoffmann-La Roche Ltd and Hoffmann-La Roche Inc., to advance PureTech's milk-derived exosome platform technology for the oral administration of Roche's antisense oligonucleotide platform.

20 Jul 2018

Pharmaceutical News

Experts describe role of quantitative systems pharmacology in first-in-human clinical trials

CNDA approves KEYTRUDA for treatment of advanced melanoma

Ciprofloxacin may disrupt normal functions of connective tissue

Researchers find compounds that may pave way for new drugs against diabetes, obesity

Déjà voodoo: Pharma’s promises to curb drug prices have been heard before

Omeros’ OMS721 receives positive opinion from EMA's COMP for treating hematopoietic stem cell transplant

New opioid prescription control framework is a 'funhouse mirror image' of prior monopoly

New protein complex may explain why patients develop resistance to novel anti-cancer drugs

Depression, antidepressant use linked with higher risk of venous thromboembolism

Common opioid-based painkillers increase harmful side effects in people with dementia

Outrage over China vaccines scandal

Long-term use of cannabis or cannabis-based drugs can impair memory, shows study

Pfizer announces FDA approval of biosimilar to Neupogen

MOF vaccines could increase access to immunization and reduce the risk of global pandemics

Former inmates more likely to die of opioid overdose after prison release

FDA approves first drug for treatment of adult AML patients with specific genetic mutation

Recovery United to launch pilot intervention program for patients who experienced opioid overdose

Drug in clinical trials for Parkinson's disease offers hope for treating heart failure

New vaccine could protect unborn babies from Zika virus

PureTech Health collaborates with Roche to advance oral administration of antisense oligonucleotides

How does norepinephrine influence anxiety-related behaviours?

Transforming Lab Workflows with Cell Culture Automation

Building Bridges to Scalable Allogeneic Cell Therapy

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