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Updated: 2 years 24 weeks ago

FDA approves first cancer drug through new oncology review pilot that enables greater development efficiency

Wed, 07/18/2018 - 21:41
The U.S. Food and Drug Administration today approved Kisqali (ribociclib) in combination with an aromatase inhibitor for the treatment of pre/perimenopausal or postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer, as initial endocrine-based therapy.
Categories: Category 2

Sanofi and REVOLUTION Medicines launch global partnership to develop potential first-in-class targeted treatments for multiple cancers

Wed, 07/18/2018 - 10:00
Sanofi and REVOLUTION Medicines, Inc. today announced an exclusive worldwide partnership to develop and commercialize targeted therapies, based on the biology of the cellular enzyme SHP2, for patients with non-small lung cancer and other types of cancer carrying certain mutations. This collaboration builds on precision oncology discoveries by REVOLUTION Medicines and preclinical development of RMC-4630,
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Lyophilization USA Conference 2018

Tue, 07/17/2018 - 12:00
15 - 16 November 2018, New Jersey, USA.
16% of the top 100 pharmaceutical drugs and 35% of biologic drugs are lyophilized. With more than 30% of the FDA-approved parenterals lyophilized and soon more than half injectable drugs to require lyophilization there is ample room for standardization and expansion of the lyophilization process in pharmaceuticals.
Categories: Category 2

New findings suggest allergic responses may protect against skin cancer

Tue, 07/17/2018 - 10:00
The components of the immune system that trigger allergic reactions may also help protect the skin against cancer, suggest new findings. The research, led by Imperial College London, highlights previously unknown skin defences - and could open avenues for developing new skin cancer treatments.
Categories: Category 2

Pfizer initiates pivotal Phase 3 program for investigational hemophilia B gene therapy

Mon, 07/16/2018 - 12:00
Pfizer Inc. (NYSE:PFE) and Spark Therapeutics (NASDAQ:ONCE) announced today that Pfizer initiated a Phase 3 open-label, multi-center, lead-in study (NCT03587116) to evaluate the efficacy and safety of current factor IX prophylaxis replacement therapy in the usual care setting. The factor IX prophylaxis efficacy data obtained in the lead-in study will serve as the within-subject control group for
Categories: Category 2

The immune system: T cells are built for speed

Mon, 07/16/2018 - 10:00
Without T cells, we could not survive. They are a key component of our immune system and have highly sensitive receptors on their surface that can detect pathogens. The exact way that these receptors are distributed over the surface of the T cells is still not completely understood, but the analyses by TU Wien show that previous ideas are no longer tenable.
Categories: Category 2

FDA warns of imposters sending consumers fake warning letters

Fri, 07/13/2018 - 22:08
The U.S. Food and Drug Administration is warning consumers about criminals forging FDA warning letters to target individuals who tried to purchase medicines online or over the phone. Based on the agency's experience with criminals posing as FDA employees, the FDA is concerned that these fake warning letters are linked to an international extortion scam. The FDA generally does not issue warning letters to individuals who purchase medicines online.
Categories: Category 2

Amgen and MBC Biolabs announce winners of the Amgen Golden Ticket

Thu, 07/12/2018 - 12:00
Amgen (NASDAQ:AMGN) and MBC BioLabs (formerly QB3@953) announced that Delve Therapeutics and Mitokinin have won the Amgen Golden Ticket at MBC BioLabs. Each company receives one year of lab bench space and access to core facilities at the MBC BioLabs life sciences incubator, as well as connections to Amgen's scientific and business leaders to help advance its scientific programs.
Categories: Category 2

Bioengineers create pathway to personalized medicine

Thu, 07/12/2018 - 10:00
Engineering cellular biology, minus the actual cell, is a growing area of interest in biotechnology and synthetic biology. It's known as cell-free protein synthesis, or CFPS, and it has potential to provide sustainable ways to make chemicals, medicines and biomaterials. Unfortunately, a long-standing gap in cell-free systems is the ability to manufacture glycosylated proteins - proteins with a carbohydrate attachment.
Categories: Category 2

SMi presents the 13th annual industry leading conference: Cold Chain Distribution

Wed, 07/11/2018 - 12:00
10 - 11 December 2018, London, UK.
The 13th annual event will specifically focus on recent advances in temperature-controlled logistic solutions and the impact of regulatory changes on this multi-billion-dollar industry. The event will also address the impact of the overwhelming digitalisation of the industry and how companies, from biotech’s to pharma, need to adapt, as well as the crucial challenges of supply chain visibility and data integrity in the cold chain industry.
Categories: Category 2

Pfizer to organize for future growth

Wed, 07/11/2018 - 10:00
Pfizer Inc. (NYSE:PFE) today announced it will organize the company into three businesses: a science-based Innovative Medicines business which will now include biosimilars and a new hospital business unit for anti-infectives and sterile injectables; an off-patent branded and generic Established Medicines business operating with substantial autonomy within Pfizer and a Consumer Healthcare business.
Categories: Category 2

Short-term improved vascular function after consuming red raspberries

Tue, 07/10/2018 - 12:00
A recent randomized controlled trial, published in the Archives of Biochemistry and Biophysics, provides insights on the promising outcomes of short-term improvements in blood vessel function among healthy males who consumed dietary achievable amounts of red raspberries. The subjects - ten healthy males aged 18 to 35 - consumed drinks prepared with 200g and 400g of frozen raspberries containing 201 or 403 mg of total polyphenols, or a matched control drink in terms of macro and micronutrient content, color, and taste.
Categories: Category 2

XANTUS programme confirms low bleeding and low stroke rate with Xarelto® in 11,121 prospectively investigated patients with atrial fibrillation

Tue, 07/10/2018 - 10:00
Results from an analysis of Bayer's XANTUS programme were recently published in the Journal of the American College of Cardiology (JACC)(1). The data confirm the safety profile of the oral Factor Xa inhibitor Xarelto® (rivaroxaban) in routine clinical practice. The analysis highlighted low bleeding and low stroke rates in patients with atrial fibrillation (AF) treated with Xarelto, as well as low rates of treatment discontinuation.
Categories: Category 2

Orphan Drugs and Rare Diseases Conference 2018

Mon, 07/09/2018 - 12:00
17 - 18 October, London, UK.
Patients with rare diseases cannot continue to be overlooked because of costly therapies and have the same rights to treatment as any other patient. At this year's Orphan Drugs and Rare Diseases conference, organised by SMi Group and taking place in London, industry experts will address the opportunities and challenges within the rare disease treatment field.
Categories: Category 2

Human clinical trial reveals verapamil as an effective type 1 diabetes therapy

Mon, 07/09/2018 - 10:00
Researchers at the University of Alabama at Birmingham Comprehensive Diabetes Center have discovered a safe and effective novel therapy to reduce insulin requirements and hypoglycemic episodes in adult subjects with recent onset Type 1 diabetes by promoting the patient's own beta cell function and insulin production - the first such discovery to target diabetes in this manner.
Categories: Category 2

FDA takes steps to encourage more informative labeling on prescription drug and biological products' indications and usage

Fri, 07/06/2018 - 02:14
Today, the U.S. Food and Drug Administration issued a draft guidance to provide recommendations for consideration when drafting the Indications and Usage section of human drug and biological product labeling. The FDA regulations require the Indications and Usage section of drug labeling to state that the drug is indicated for the treatment, prevention, mitigation, cure or diagnosis of a disease or condition, or for the relief of the disease or condition’s symptoms.
Categories: Category 2

Researchers develop a new method for turning skin cells into pluripotent stem cells

Thu, 07/05/2018 - 12:00
Our bodies consist of many different kinds of cells, each with their own role. The Japanese scientist Shinya Yamanaka had made earlier the discovery, earning the Nobel Prize in 2012, that cells from adult skin can be converted to cells typical of early embryos, so-called induced pluripotent stem cells (iPSC). This process is called reprogramming.
Categories: Category 2

Data-sharing website may speed the response to new illegal drugs

Thu, 07/05/2018 - 10:00
The drug overdose epidemic currently gripping the nation is so tenacious in part because it's being driven by fentanyl, a synthetic opioid that comes in many forms. Each form has a slightly different chemical structure, and clandestine chemists are constantly cooking up new ones. From a law-enforcement perspective, this makes fentanyl a moving target and very difficult to control.
Categories: Category 2

New small molecules pave the way for treating autoinflammatory disease

Wed, 07/04/2018 - 12:00
The innate immune system is the first line of defense, with cells that quickly identify "foreign" motifs from viruses and bacteria and mount up a counterattack to eliminate them. As a key strategy to sense the presence of pathogens, the cells of the innate immune system use receptors that can identify microbial DNA and in turn activate a protein called STING (STimulator of Interferon Genes). Once activated, STING turns on genes that help cells fight off the infecting pathogen.
Categories: Category 2

Bayer expands strategic alliance with Broad Institute of MIT and Harvard

Wed, 07/04/2018 - 10:00
Bayer and the Broad Institute of MIT and Harvard announced the launch of the joint Precision Cardiology Laboratory, which will pursue novel scientific insights to enable the development of new therapies for patients with cardiovascular diseases such as heart failure. Heart failure - a general diagnosis given when the heart doesn’t pump effectively - is a composite of multiple factors, and as such requires new tools and methods to gain deeper knowledge to benefit patients.
Categories: Category 2
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