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Telesta Therapeutics receives FDA BLA Filing Notification for MCNA

Telesta Therapeutics Inc. announced today that it has received its BLA Filing Notification for MCNA from the U.S. Food and Drug Administration. This formal letter communicates that the FDA has completed its initial review of Telesta's Biologics License Application (BLA) submitted on June 29, 2015 and has accepted it for filing.

29 Aug 2015

AMCP issues statement in response to FDA’s draft guidance requiring nonproprietary names for biological products

The Academy of Managed Care Pharmacy (AMCP) is disappointed in the Food and Drug Administration's (FDA's) draft guidance and proposed rule that calls for biologics, including reference products and biosimilars, to bear a nonproprietary name with an FDA-designated suffix.

28 Aug 2015

Researchers identify drugs that may enhance ability of TKI dasatinib to kill human cancer cells

Researchers have discovered how a common mutation in a high-risk leukemia subtype drives the cancer's aggressiveness and have identified drugs that may work with existing precision medicines to improve survival. St. Jude Children's Research Hospital scientists led the study, which was published online today in the journal Cancer Cell.

28 Aug 2015

New study provides framework for establishing value-based pricing for new cancer drugs

At a time when cancer drug prices are rising rapidly, an innovative new study provides the framework for establishing value-based pricing for all new oncology drugs entering the marketplace. Using a highly sophisticated economic model, researchers from Winship Cancer Institute of Emory University and Georgia Institute of Technology used an example of a new lung cancer drug.

28 Aug 2015

Researchers find way to trigger 'virus alert' that may help boost drug's ability to prevent cancer cells

Working with human cancer cell lines and mice, researchers at the Johns Hopkins Kimmel Cancer Center and elsewhere have found a way to trigger a type of immune system "virus alert" that may one day boost cancer patients' response to immunotherapy drugs. An increasingly promising focus of cancer research, the drugs are designed to disarm cancer cells' ability to avoid detection and destruction by the immune system.

27 Aug 2015

Health providers still prescribing expensive malaria drugs in Nigeria to patients who do not have malaria

Health providers trained to perform malaria rapid diagnostic tests (RDT) are still prescribing valuable malaria medicines to patients who do not have malaria, according to new research published in PLOS ONE.

27 Aug 2015

Nitroglycerin can be repurposed to treat cancer, researchers find

For over a century, nitroglycerin has been used medically - particularly in the treatment of angina, or chest pain. It is a safe, cheap and effective treatment. Now, according to the latest study in ecancermedicalscience, researchers find that nitroglycerin is the latest in a series of medicines that could be repurposed to treat cancer.

27 Aug 2015

Soligenix obtains additional funding from NIAID to advance development of OrbeShield for GI ARS treatment

Soligenix, Inc., a late-stage biopharmaceutical company developing products that address unmet medical needs in the areas of inflammation, oncology and biodefense, announced today that the National Institute of Allergy and Infectious Diseases has exercised its option to advance preclinical development of OrbeShield (oral beclomethasone 17,21-dipropionate or oral BDP).

27 Aug 2015

Founder of ACPA discusses how patient with chronic pain can tackle their NSAID usage

When a patient with chronic pain is experiencing symptoms, relief is only thing on their mind. NSAIDs, or nonsteroidal anti-inflammatory drugs, can often provide that relief, however it's important to balance the potential benefits with the potential risks of these drugs.

27 Aug 2015

Single dose of oral cholera vaccine could save more lives in crisis situations

An oral cholera vaccine that is in short supply could treat more people and save more lives in crisis situations, if one dose were dispensed instead of the recommended two, new Johns Hopkins Bloomberg School of Public Health research suggests.

27 Aug 2015

Symic receives $1.5M NIH Phase II SBIR grant to develop AVF therapeutic candidate

Platform therapeutic company Symic Biomedical, Inc. announced today that it has received a $1.5M Phase II SBIR grant from the National Institutes of Health to further develop its therapeutic agent to reduce arteriovenous fistula (AVF) failures, a significant unmet clinical need in end stage renal disease (ESRD) patients undergoing hemodialysis.

27 Aug 2015

Antiviral-based therapies have potential to protect humans from deadly Ebola virus

For the first time, UK physicians have demonstrated that antiviral-based therapies have the potential to protect humans from the deadly Ebola virus. The report, published in The Lancet Infectious Diseases journal, describes a case-series of eight British health-care workers who were evacuated to the Royal Free Hospital in London, UK after possible accidental exposure to Ebola virus in Sierra Leone between January and March 2015.

26 Aug 2015

Novartis receives FDA approval for expanded use of Promacta for younger children with rare blood disorder

Novartis announced today that the US Food and Drug Administration has approved an expanded use for Promacta to include children 1 year of age and older with chronic immune thrombocytopenia who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy.

26 Aug 2015

New research could potentially yield novel platform for cancer vaccines

New research led by Wyss Core Faculty member David Mooney, Ph.D., in collaboration with researchers at the Dana-Farber Cancer Institute could potentially yield a new platform for cancer vaccines. Leveraging a biologically inspired sponge-like gel called "cryogel" as an injectable biomaterial, the vaccine delivers patient-specific tumor cells together with immune-stimulating biomolecules to enhance the body's attack againstcancer.

26 Aug 2015

Epinephrine delay decreases survival for children with in-hospital, nonshockable cardiac arrest

Among children with in-hospital cardiac arrest with an initial nonshockable heart rhythm who received epinephrine (adrenaline), delay in administration of epinephrine was associated with a decreased chance of 24-hour survival and survival to hospital discharge, according to a study in the August 25 issue of JAMA.

26 Aug 2015

FDA, EMA accept filing applications for Boehringer Ingelheim's afatinib to treat patients with advanced SCC of the lung

Boehringer Ingelheim today announced that both the U.S. Food and Drug Administration and the European Medicines Agency have accepted filing applications for afatinib for the treatment of patients with advanced squamous cell carcinoma (SCC) of the lung progressing after treatment with first-line chemotherapy.

26 Aug 2015

Elite CBD Remedy Tincture now available through Mary's Nutritionals

Elite Botanicals, the leading cultivator of CBD-rich hemp in Colorado, today announced that it's Elite CBD Remedy Tincture is now available through medical and recreational dispensaries in Colorado, as well as online through Mary's Nutritionals.

26 Aug 2015

Tocagen's Toca 511 & Toca FC receives FDA orphan drug designation for treatment of glioblastoma

Tocagen Inc., a clinical-stage immuno-oncology company, today announced that the U.S. Food and Drug Administration has granted orphan drug designation to the company's lead immuno-oncology product candidate, Toca 511 & Toca FC, for the treatment of glioblastoma.

26 Aug 2015

Mylan releases generic version of Zosyn Injection in the U.S.

Mylan N.V. today announced the U.S. launch of Piperacillin and Tazobactam for Injection USP, 3.375g Single-dose Vials, which is the generic version of Pfizer's Zosyn Injection.

26 Aug 2015

Shire enters into agreement with Sanquin for CINRYZE

Shire plc announced today it has entered into an agreement with Sanquin Blood Supply, the manufacturer of CINRYZE (C1 esterase inhibitor [human]), providing Shire access to its manufacturing technology and allowing Shire to source additional manufacturers to meet the growing demand for CINRYZE.

25 Aug 2015

Pharmaceutical News

Telesta Therapeutics receives FDA BLA Filing Notification for MCNA

AMCP issues statement in response to FDA’s draft guidance requiring nonproprietary names for biological products

Researchers identify drugs that may enhance ability of TKI dasatinib to kill human cancer cells

New study provides framework for establishing value-based pricing for new cancer drugs

Researchers find way to trigger 'virus alert' that may help boost drug's ability to prevent cancer cells

Health providers still prescribing expensive malaria drugs in Nigeria to patients who do not have malaria

Nitroglycerin can be repurposed to treat cancer, researchers find

Soligenix obtains additional funding from NIAID to advance development of OrbeShield for GI ARS treatment

Founder of ACPA discusses how patient with chronic pain can tackle their NSAID usage

Single dose of oral cholera vaccine could save more lives in crisis situations

Symic receives $1.5M NIH Phase II SBIR grant to develop AVF therapeutic candidate

Antiviral-based therapies have potential to protect humans from deadly Ebola virus

Novartis receives FDA approval for expanded use of Promacta for younger children with rare blood disorder

New research could potentially yield novel platform for cancer vaccines

Epinephrine delay decreases survival for children with in-hospital, nonshockable cardiac arrest

FDA, EMA accept filing applications for Boehringer Ingelheim's afatinib to treat patients with advanced SCC of the lung

Elite CBD Remedy Tincture now available through Mary's Nutritionals

Tocagen's Toca 511 & Toca FC receives FDA orphan drug designation for treatment of glioblastoma

Mylan releases generic version of Zosyn Injection in the U.S.

Shire enters into agreement with Sanquin for CINRYZE

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