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Researchers engineer three cell lines to produce nonproprietary versions of NISTmAb

When the National Institute of Standards and Technology issued the world's first standardized monoclonal antibody in July 2016, the exhaustively analyzed protein known as NISTmAb was intended as a valuable tool for biopharmaceutical companies.

1 Aug 2018

New guidelines provide framework for responding to drug shortages and to improve patient care

Healthcare teams in patient care settings can develop policies and procedures to minimize the impact of drug shortages by incorporating new guidelines published today by ASHP (American Society of Health-System Pharmacists).

31 Jul 2018

European Commission approves Pfizer’s first oncology biosimilar

Pfizer Inc. today announced the European Commission has approved TRAZIMERA, a biosimilar to Herceptin (trastuzumab), for the treatment of human epidermal growth factor overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

31 Jul 2018

FDA approves first ever non-surgical treatment for rare neuroendocrine cancers

The U.S. Food and Drug Administration has approved the first ever non-surgical treatment for the rare neuroendocrine cancers pheochromocytoma and paraganglioma.

31 Jul 2018

New method to evaluate drug benefits may reduce health care costs

With the cost of drugs a critical issue in health care, health insurance companies and government payers need to understand how new and existing drugs compare in terms of benefits and risks.

31 Jul 2018

Researchers investigate potential of injectable trace minerals to keep dairy cows healthier

When dairy cattle consume aflatoxin-contaminated feed, they are lethargic, their appetite wanes, they produce less milk, and their immune system goes awry.

31 Jul 2018

FDA approves first therapy for patients with rare tumors of the adrenal gland

The U.S. Food and Drug Administration today approved Azedra (iobenguane I 131) injection for intravenous use for the treatment of adults and adolescents age 12 and older with rare tumors of the adrenal gland (pheochromocytoma or paraganglioma) that cannot be surgically removed (unresectable), have spread beyond the original tumor site and require systemic anticancer therapy.

31 Jul 2018

Ivosidenib receives FDA approval to treat acute myeloid leukemia patients with IDH1 mutation

Clinical trials at University of Colorado Cancer Center and elsewhere now result in the drug ivosidenib earning approval from the U.S. Food and Drug Administration for the treatment of adult patients with relapsed or refractory acute myeloid leukemia with a susceptible isocitrate dehydrogenase-1 mutation.

30 Jul 2018

New findings suggest opportunity to focus on safe opioid use and disposal among older adults

Nearly a third of older adults have received a prescription for an opioid pain medicine in the past two years, but many of them didn't get enough counseling about the risks that come with the potent painkillers, how to reduce their use, when to switch to a non-opioid option, or what to do with leftover pills, a new poll finds.

30 Jul 2018

New study provides insight into how stimulant treatments for ADHD work

Stimulant medications are an effective treatment for Attention-Deficit/Hyperactivity Disorder. In the classroom, parents and teachers say that medications like methylphenidate can reduce symptoms and improve behavior.

28 Jul 2018

Drug that treats diabetes found to exert powerful check on macrophages in controlling inflammation

When tissue is damaged, one of the body's first inflammatory immune-system responders are macrophages, cells which are commonly thought of as "construction workers" that clear away damaged tissue debris and initiate repair.

28 Jul 2018

Pairing online patient dashboard with 'nudges' to doctors triples statin prescribing rates

Pairing an online patient dashboard with "nudges" to doctors tripled statin prescribing rates in a clinical trial led by Penn Medicine researchers.

27 Jul 2018

Cannabis appears to have no effect on breathlessness during exercise in advanced COPD patients

Inhaled vaporized cannabis does not appear to improve or worsen exercise performance and activity-related breathlessness in patients with advanced chronic obstructive pulmonary disease, according to a randomized controlled trial published online in the Annals of the American Thoracic Society.

27 Jul 2018

Novartis' new drug combination receives positive CHMP opinion for treating stage III BRAF mutant melanoma

Novartis today announced the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending approval of Tafinlar® in combination with Mekinist® for the adjuvant treatment of adult patients with stage III melanoma with a BRAF V600 mutation, following complete resection.

27 Jul 2018

Alnylam’s patisiran receives positive opinion from CHMP for treating hATTR amyloidosis

Alnylam Pharmaceuticals, Inc., the leading RNAi therapeutics company, announced today that the Committee for Medicinal Products for Human Use has adopted a Positive Opinion recommending marketing authorization of patisiran for the treatment of hereditary transthyretin-mediated amyloidosis in adults with stage 1 or stage 2 polyneuropathy.

27 Jul 2018

Newer version of ALS drug may effectively treat inherited form of the disease

NIH-funded researchers delayed signs of amyotrophic lateral sclerosis in rodents by injecting them with a second-generation drug designed to silence the gene, superoxide dismutase 1.

27 Jul 2018

Study shows spillover effect of evidence-based opioid prescribing for major procedures

To curb the use of opioids after major elective operations and prevent these pain relievers from falling into the wrong hands, surgeons at the University of Michigan developed prescribing recommendations based on published medical evidence for one operation, gall bladder removal, and then discovered a spillover effect that led them to prescribe roughly 10,000 fewer pills for other major operations, according to study results appearing as an "article in press" on the website of the Journal of the American College of Surgeons ahead of print.

27 Jul 2018

Preoperative opioid consumption is strongest risk factor for prolonged opioid use, shows study

Patients taking opioids for at least three months before spinal fusion surgery in the lower spine are much more likely to continue taking opioids one year after surgery, reports a study in Spine .

27 Jul 2018

NGI assistant boosts precision of inhaler testing

The upgraded NGI Assistant is a labour-saving device that boosts the precision and productivity of inhaler testing to unprecedented levels.

From Copley Scientific Limited 26 Jul 2018

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

Pharmaceutical News

Researchers engineer three cell lines to produce nonproprietary versions of NISTmAb

New guidelines provide framework for responding to drug shortages and to improve patient care

European Commission approves Pfizer’s first oncology biosimilar

FDA approves first ever non-surgical treatment for rare neuroendocrine cancers

New method to evaluate drug benefits may reduce health care costs

Researchers investigate potential of injectable trace minerals to keep dairy cows healthier

FDA approves first therapy for patients with rare tumors of the adrenal gland

Ivosidenib receives FDA approval to treat acute myeloid leukemia patients with IDH1 mutation

New findings suggest opportunity to focus on safe opioid use and disposal among older adults

New study provides insight into how stimulant treatments for ADHD work

Drug that treats diabetes found to exert powerful check on macrophages in controlling inflammation

Pairing online patient dashboard with 'nudges' to doctors triples statin prescribing rates

Cannabis appears to have no effect on breathlessness during exercise in advanced COPD patients

Novartis' new drug combination receives positive CHMP opinion for treating stage III BRAF mutant melanoma

Alnylam’s patisiran receives positive opinion from CHMP for treating hATTR amyloidosis

Newer version of ALS drug may effectively treat inherited form of the disease

Study shows spillover effect of evidence-based opioid prescribing for major procedures

Preoperative opioid consumption is strongest risk factor for prolonged opioid use, shows study

NGI assistant boosts precision of inhaler testing

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

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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