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FDA approves Galderma's Mirvaso topical gel for facial erythema of rosacea

Galderma Laboratories, L.P. announced that the U.S. Food and Drug Administration has approved Mirvaso (brimonidine) topical gel, 0.33% for the topical treatment of the facial erythema (redness) of rosacea in adults 18 years of age or older. Applied once daily, Mirvaso works quickly to reduce the redness of rosacea and lasts up to 12 hours. Galderma expects Mirvaso to be available in pharmacies September 2013.

27 Aug 2013

Nuvo: FDA accepts to review New Drug Application for PENNSAID 2%

Nuvo Research Inc., a specialty pharmaceutical company dedicated to building a portfolio of products for the topical treatment of pain and the development of its immune modulating drug candidate WF10 today announced that its U.S. licensee for PENNSAID (diclofenac sodium topical solution) 1.5% w/w and PENNSAID 2% (diclofenac sodium topical solution) 2% w/w, Mallinckrodt has advised that the U.S. Food and Drug Administration has accepted for filing and review the New Drug Application for PENNSAID 2% submitted by Mallinckrodt on August 7, 2013.

22 Aug 2013

Novartis starts shipment of 2013-2014 seasonal influenza vaccines to US customers

Novartis announced today that it has begun shipment of its seasonal influenza vaccines to customers in the US market for the 2013-2014 season. Novartis plans to ship a minimum of 30 million doses of its influenza vaccines to the US market, including Fluvirin (Influenza Virus Vaccine), approved for use in people 4 years of age and older, and Flucelvax (Influenza Virus Vaccine), approved for use in adults 18 years of age and older.

22 Aug 2013

First lots of 2013-2014 seasonal influenza vaccine released for U.S. distribution

Sanofi Pasteur, the vaccines division of Sanofi, announced today that the first lots of Fluzone (Influenza Virus Vaccine) for the 2013-2014 season have been released by the U.S. Food and Drug Administration for U.S. distribution and were shipped July 24.

25 Jul 2013

Clinical trial finds that sleep quality impacts skin function and aging

In a first-of-its-kind clinical trial, physician-scientists at University Hospitals (UH) Case Medical Center found that sleep quality impacts skin function and aging.

24 Jul 2013

FDA approves Novartis' Exelon Patch for treatment of severe Alzheimer's disease

The US Food and Drug Administration has expanded the approved indication for Exelon Patch (rivastigmine transdermal system) to include the treatment of people with severe Alzheimer's disease with Exelon Patch 13.3mg/24h.

28 Jun 2013

Ustekinumab doses improve signs and symptoms of PsA with favourable safety profiles

New PSUMMIT 2 data first presented at EULAR 2013, the Annual Congress of the European League Against Rheumatism, further demonstrate the efficacy of ustekinumab in Psoriatic Arthritis (PsA).

13 Jun 2013

Solid formulations of the recombinant anthrax vaccine: an interview with Dr Mark Carnegie-Brown, CEO, Glide Pharma

Anthrax vaccines have a prominent place in the history of medicine. This goes back to, Pasteur, who while everybody associates with the milk treatment process, also worked on rabies and Anthrax vaccines in cattle.

6 Jun 2013

Bayer HealthCare to present new data on oncology portfolio at ASCO meeting

Bayer HealthCare announced today that new data on the oncology portfolio, including Nexavar (sorafenib) tablets, Stivarga (regorafenib) tablets and the recently U.S. Food and Drug Administration approved product Xofigo (radium Ra 223 dichloride) injection will be presented at the 49th Annual Meeting of the American Society of Clinical Oncology, May 31 – June 4, in Chicago, IL (USA).

16 May 2013

Bayer HealthCare: Patient enrollment underway in Phase III trial of Stivarga tablets for treatment of HCC

Bayer HealthCare announced today that patient enrollment is underway for RESORCE (Regorafenib after Sorafenib in Patients with Hepatocellular Carcinoma), an international Phase III trial to evaluate the efficacy and safety of Stivarga (regorafenib) tablets for the treatment of patients with hepatocellular carcinoma who have progressed on Nexavar (sorafenib) tablets, an anticancer medicine for the treatment of patients with unresectable HCC.

15 May 2013

Peripheral neuropathic pain patch treatments: an interview with Anne Hodgkins, Astellas Pharma

Peripheral neuropathic pain is caused by lesion or disease to the peripheral somatosensory nervous system. Nerve damage that can lead to peripheral neuropathic pain can happen as a result of a range of different diseases, medications or traumatic injuries.

8 May 2013

Martindale Pharma announces UK launch of Prenoxad Injection for opioid overdose

Martindale Pharma, a leader in the manufacture and supply of specialty pharmaceuticals, is pleased to announce the UK launch of Prenoxad Injection, the world's first licensed emergency treatment for acute opioid related overdose for use at home or other non-medical settings.

3 May 2013

FDA grants orphan-drug designation to XEN402 for treatment of pain associated with EM

Teva Pharmaceutical Industries Ltd. and Xenon Pharmaceuticals Inc. announced today that the US Food and Drug Administration has granted orphan-drug designation to the investigational drug XEN402 being developed for the treatment of pain associated with erythromelalgia.

24 Apr 2013

Nuvo Research reaches another milestone with the launch of Pliaglis in Europe

Nuvo Research Inc., a specialty pharmaceutical company dedicated to building a portfolio of products for the topical treatment of pain and Galderma Pharma, S.A., today announced the European launch of Pliaglis (lidocaine and tetracaine) Cream 7%/7%.

23 Apr 2013

New study to discover preventive use of antibiotics for Lyme disease

At the start of the "Tick Week", the Netherlands National Institute for Public Health and the Environment and Wageningen University are commencing a large-scale study to discover whether preventive use of antibiotics can stop Lyme disease developing after a tick bite.

16 Apr 2013

Regeneron, Sanofi announce pooled data from Phase 1b trials with dupilumab for atopic dermatitis

Sanofi and Regeneron Pharmaceuticals, Inc. announced that pooled data from two Phase 1b trials with dupilumab (REGN668/SAR231893), an investigational, high-affinity, subcutaneously administered, fully-human antibody targeting the alpha subunit of the interleukin 4 receptor (IL-4R alpha), were presented at the 71st Annual Meeting of the American Academy of Dermatology (AAD) in Miami.

4 Mar 2013

FDA approves Genzyme’s KYNAMRO to treat homozygous familial hypercholesterolemia

Genzyme, a Sanofi company, and Isis Pharmaceuticals Inc., today announced that the U.S. Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for KYNAMROTM (mipomersen sodium) injection.

30 Jan 2013

Celgene announces results from REVLIMID plus VIDAZA phase II study on AML

Celgene International Sàrl today announced that results from a study evaluating the combination of REVLIMID (lenalidomide) plus VIDAZA (azacitidine) in patients 60 years or older with untreated acute myeloid leukemia (AML) were presented at the American Society of Hematology annual meeting in Atlanta, GA.

11 Dec 2012

CSL, PharmaJet partner for needle-free delivery of Afluria influenza vaccine

PharmaJet Inc. has entered into a collaboration with CSL Limited to enable Afluria influenza vaccine to be delivered with the PharmaJet Stratis needle-free jet injector, as soon as the 2013-2014 flu season.

30 Nov 2012

UCB to sponsor key sets of VIMPAT C-V data at 66th American Epilepsy Society annual meeting

UCB, a global biopharmaceutical company focusing on CNS and immunology treatment and research, is sponsoring key sets of VIMPAT® (lacosamide) C-V data at the 66th Annual Meeting of the American Epilepsy Society (AES) in San Diego, Calif., November 30 - December 4.

29 Nov 2012