News

EU Pharmacovigilance Risk Assessment Committee clears Diane 35 (Bayer) for Acne

During its meeting of 13 to 16 May 2013, the EMA Pharmacovigilance Risk Assessment Committee (PRAC) concluded that the benefits of Diane 35 (Bayer HealthCare) and other medicines containing cyproterone acetate 2 mg and ethinylestradiol 35 micrograms continue to outweigh their risks for the treatment of moderate to severe Acne related to androgen sensitivity and/or hirsutism (excessive unwanted growth ...

CHMP recommends Erivedge (Roche) for treatment of Basal Cell Carcinoma

Roche has announced that the European Union’s Committee for Medicinal Products for Human Use (CHMP) has recommended conditional approval of Erivedge (vismodegib) for the treatment of adult patients with symptomatic metastatic Basal Cell Carcinoma, or locally advanced Basal Cell Carcinoma inappropriate for surgery or radiotherapy. Conditional approval would make Erivedge the first licensed treatment for patients in Europe with ...

Picato(Leo Pharma) fails IQWiG assessment for Actinic Keratosis in Germany

In a preliminary assessment, the German Institute for Quality and Efficiency in Health Care ( IQWiG) has concluded that Leo Pharma's Picato gel (ingenol mebutate) for Actinic Keratosis, does not provide any added benefit over diclofenac/hyaluronic.

IQWiG commented that the drug manufacturer did not submit any relevant data: it did not cite any studies that directly compared ingenol ...

Positive Phase III results for tedizolid phosphate (Trius Therapeutics) for ABSSSI

Trius Therapeutics, Inc. has announced top-line results from its ESTABLISH 2 Phase III clinical trial of tedizolid phosphate (TR-701) for the treatment of Acute Bacterial Skin and Skin Dtructure Infections (ABSSSI), including methicillin resistant Staphylococcus aureus (MRSA). As in the ESTABLISH 1 study, which tested the oral dosage form of tedizolid, the ESTABLISH 2 intravenous to oral transition study ...

Phase IIa trial of AFN 1252 (Affinium Pharma) shows drug is effective and safe against Bacterial Infections

Results from a Phase IIa clinical trial evaluating oral AFN 1252, from Affinium Pharma, in acute Bacterial Skin and Skin Structure Iinfections (ABSSSI), demonstrates the drug offers excellent efficacy and safety. This study involved 103 patients with infections due to Staphylococcus, dosed twice daily for 5-14 days. The results show that Day 3 Improvement was achieved in 94% of patients ...

Study shows Picato (Leo Pharma) provides sustained clearance of Actinic Keratosis at 12 months

Results of long-term clearance rates of Actinic Keratosis lesions after treatment with Picato (ingenol mebutate gel), from Leo Pharma, demonstrated that patients showing sustained complete clearance at 12 months, was 46 per cent (n=108) on the face and scalp and 44 per cent (n=76) on the trunk or extremities.

The secondary outcome showed that patients in the overall population experienced ...

Phase III success for talimogene laherparepvec (Amgen) in Melanoma

Amgen has announced top-line results from the Phase III trial in Melanoma, which evaluated the efficacy and safety of talimogene laherparepvec for the treatment of unresected stage IIIB, IIIC or IV Melanoma compared to treatment with subcutaneous granulocyte-macrophage colony-stimulating factor (GM-CSF).

The study met its primary endpoint of durable response rate (DRR), defined as the rate of complete or ...

Study suggests omega-3 fish oil can help protect against Skin Cancer

Researchers have carried out the first clinical trial to examine the impact of the fish oils on the skin immunity. Results of the study found that taking a regular dose of fish oils boosted skin immunity to sunlight. Specifically, it also reduced sunlight-induced suppression of the immune system, which affects the body’s ability to fight Skin Cancer and infection. Volunteers ...

Dalbavancin (Durata Therapeutics) success in Phase III DISCOVER 2 trial for ABSSSI

Durata Therapeutics, Inc. has announced preliminary, top-line results for its DISCOVER 2 ("Dalbavancin for Infections of the Skin COmpared to Vancomycin at an Early Response") Phase III study of dalbavancin, which is under investigation for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible gram-positive bacteria, including methicillin resistant Staphylococcus aureus (MRSA). DISCOVER 2 results ...

New Phase III trial results of Xolair (Genentech/Roche/Novartis) for patients with Urticaria

Results from a Phase III trial, ASTERIA II, demonstrate that Xolair (omalizumab), from Genentech/Roche and Novartis, met its primary endpoint in patients with moderate to severe chronic Idiopathic Urticaria (CIU), who remained symptomatic despite treatment with approved H1 antihistamine doses. The primary endpoint was measured using a 21-point scale known as a weekly Itch Severity Score (ISS). Three dose groups ...

Phase III study shows TR 701 (Trius Therapeutics) equivalent to best alternative treatment for ABSSSI

New results from a Phase III study of TR 701 (tedizolid phosphate), from Trius Therapeutics, shows it is as effective as current best treatment for acute bacterial skin and skin structure infections(ABSSSI). The ESTABLISH 1 trial examined the efficacy and safety of 200 mg tedizolid given once a day for six days versus 600 mg linezolid given twice a day ...

GSK files at EMA trametinib (monotherapy) and in combination with dabrafenib for Metastatic Melanoma

GSK announced submission of a Marketing Authorisation Application to the European Medicines Agency (EMA) for trametinib (MEK) as monotherapy and in combination with dabrafenib (BRAF) for the treatment of adult patients with unresectable or Metastatic Melanoma with a BRAF V600 mutation. The EMA’s Committee for Medicinal Products for Human Use (CHMP) has granted GSK’s request for accelerated assessment of ...

GSK initiates Phase III study of combination dabrafenib and trametinib for Melanoma

GlaxoSmithKline plc. announced the start of COMBI-AD, a Phase III study evaluating the combination of dabrafenib, its BRAF inhibitor and trametinib, its MEK inhibitor as adjuvant therapy for Melanoma. This global study will investigate whether combining the two investigational agents can delay or prevent the recurrence of melanoma (Relapse Free Survival) in patients with Stage IIIa, IIIb, or IIIc ...

Tavaborole (Anacor Pharma) success in Phase III for Onychomycosis

Anacor Pharmaceuticals has announced positive preliminary results from the first of two Phase III trials of tavaborole, its topical anti-fungal for Onychomycosis, a fungal infection of the nail and nail bed that affects approximately 35 million people in the United States. Tavaborole achieved a high degree of statistical significance on all primary and secondary endpoints.

In this first Phase ...

Dalbavancin (Durata Therapeutics) reports on DISCOVER 1 trial for Skin Infections

Durata Therapeutics has announced additional preliminary, top-line results for its DISCOVER 1 ("Dalbavancin for Infections of the Skin COmpared to Vancomycin at an Early Response") Phase III study of dalbavancin, which is under investigation for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible gram-positive bacteria, including MRSA (methicillin resistant Staphylococcus aureus).

As ...

Apremilast(Celgene) success in ESTEEM 1 & 2 trials for Psoriasis

Celgene International Sàrl, has announced that statistical significance for the primary endpoint of PASI 75 at week 16 was achieved for patients receiving apremilast 30 mg BID monotherapy in both the ESTEEM 1 & 2 phase III studies. ESTEEM 1 & 2 are the two pivotal phase III, randomized, placebo-controlled studies evaluating apremilast, the company’s oral small-molecule inhibitor of phosphodiesterase ...

FDA approves Celluma (BioPhotas) for treatment of Acne

The FDA has cleared Celluma, a biophotonic medical device, from BioPhotas, for six separate Indications-For-Use, including the treatment of Acne, Muscle and Joint Pain, muscle and joint stiffness, muscle spasm, Arthritis and compromised local blood circulation. Celluma provides light therapy to the body. It uses three distinct wavelengths of light, modulated with proprietary electronic algorithms to effectively treat a variety ...

Successful Phase II trial for ponesimod (Actelion) in Plaque Psoriasis

Actelion has announced that its selective S1P1 modulator, ponesimod, successfully met the primary endpoint - the proportion of patients with at least 75% improvement in Psoriasis Area and Severity Index (PASI) from baseline (PASI75) at week 16 - in a double blind, placebo-controlled study conducted in 326 patients with moderate to severe chronic Plaque Psoriasis. Results of the primary ...

Antares Pharma files Otrexup at FDA for Rheumatoid Arthritis

Antares Pharma has submitted a New Drug Application (NDA) to the FDA for Otrexup, a combination product for the delivery of methotrexate (MTX) using Medi-Jet technology. Otrexup was developed for easy subcutaneous administration of MTX to enhance the treatment of rheumatoid arthritis (RA), poly-articular-course juvenile RA and moderate to severe psoriasis....

NICE recommends Yervoy (BMS) and Zelboraf (Roche) for Melanoma

NICE, The National Institute of Health and Clinical Excellence, has provided final and binding guidance that recommends both Yervoy (ipilimumab) from BMS and Zelboraf (vemurafenib) from Roche, for melanoma patients. Both recommendations were conditioned on a discount offered under a patient access scheme. Yervoy is recommended for the treatment of advanced Malignant Melanoma in people who have received prior ...

Two Phase III studies of efinaconazole (Valeant Pharma) show positive results in patients with Onychomycosis

Positive results have been published from two pivotal, Phase III multicenter, randomized, double-blind, vehicle-controlled studies of efinaconazole, from Valeant Pharma, that were conducted in 1,655 subjects with Onychomycosis. The study's primary endpoint was the complete cure rate at Week 52, meaning the target nail showed no clinical involvement and no evidence of fungus present by both KOH testing and a ...

Updated results in Phase III trial of Abraxane (Celgene Oncology) for patients with Metastatic Melanoma

New results from the CA 033 Phase III trial of Abraxane (nab-paclitaxel), from Celgene Oncology, show a statistically significant improvement in progression-free survival in chemotherapy-naïve patients with Metastatic Melanoma compared to patients receiving dacarbazine chemotherapy (4.8 vs. 2.5 months, respectively (HR:0.792; 95.1% CI: 0.631, 0.992; P=0.044). An interim analysis of overall survival, the secondary endpoint, shows a trend in favour ...

Abraxane (Celgene Oncology) success in Phase II study for Metastatic Melanoma

A Phase III, randomized, international study (CA033) reported for Abraxane (paclitaxel protein-bound particles for injectable suspension) (albumin-bound), from Celgene Oncology, in chemotherapy-naïve patients with Metastatic Melanoma. In the study, the primary endpoint was met with patients receiving Abraxane demonstrating a statistically significant improvement in progression-free survival compared to patients receiving dacarbazine (DTIC) chemotherapy. The safety profile of Abraxane observed in ...

FDA approves new sNDA for Sorilux (Stiefel/GSK) to treat Plaque Psoriasis of the scalp

The FDA has approved a supplemental New Drug Application for Sorilux (calcipotriene) Foam, from Stiefel/GSK. The sNDA expands the indication for Sorilux Foam to include the topical treatment of Plaque Psoriasis of the scalp in patients aged 18 years and older. It is not known if the product is safe and effective in people under 18 years old. The treatment ...

Novartis reports on Phase II study of AIN 457 in Plaque Psoriasis

Novartis announced Phase II data showing AIN 457 (secukinumab) may significantly improve moderate-to-severe Plaque Psoriasis on the hands, feet and nails when used every week for the first month of treatment, compared to placebo. Additional analysis on patients with moderate-to-severe Plaque Psoriasis also showed that AIN 457 may successfully improve quality of life by Week 12 in the study. The ...

CHMP recommends Picato (Leo Pharma) for treatment of Actinic Keratosis

On 20 September 2012, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Picato, 150 micrograms/g, 500 micrograms/g gel intended for the cutaneous treatment of non-hyperkeratotic, non-hypertrophic Actinic Keratosis in adults. The applicant for this medicinal product is LEO Pharma A/S....

CHMP recommends NexoBrid for treatment of Burns

The European Medicines Agency has recommended approval of NexoBrid (concentrate of proteolytic enzymes enriched in bromelain) from Teva, an orphan-designated medicine, for removal of eschar in adult patients with deep partial- and/or full-thickness thermal burn. Eschar is the dried-out, thick, leathery, black necrotic tissue that covers severe burn wounds. Its removal is essential to initiate the wound healing process and ...

Dalbavancin (Durata Therapeutics) QT study results

Results from a QT study of dalbavancin from Durata Therapeutics were presented at the 52nd Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) and showed that in this study dalbavancin had no clinically significant impact on cardiac conduction. The drug is currently under investigation in two ongoing, global, Phase III clinical trials for the treatment of acute bacterial skin and ...

EU approves Zinforo (AstraZeneca) for cSSTI and CAP infections

AstraZeneca announced that the European Commission has granted Marketing Authorisation to Zinforo(ceftaroline fosamil), a new intravenous cephalosporin antibiotic, for the treatment of adult patients with complicated Skin and Soft Tissue Infections (cSSTI) or Community Acquired Pneumonia (CAP). This makes Zinforo the only approved cephalosporin monotherapy in Europe with demonstrated clinical efficacy against methicillin-resistant Staphylococcus aureus (MRSA), a common cause ...

EU approves Zyclara (Meda AB) for Actinic Keratoses

Meda AB has announced that the European Commission (EC) has granted marketing authorization for Zyclara (imiquimod 3.75% cream) in the European Union. Zyclara is a patented product for the treatment of Actinic Keratosis. The approval is valid in all EU countries....

Glaxo Smith Kline files NDA and MAA for dabrafenib in Metastatic Melanoma patients

Glaxo Smith Kline has filed a New Drug Application to the FDA for dabrafenib for the treatment of patients with unresectable or Metastatic Melanoma with BRAF V600 mutation as detected by an FDA-approved test. The company has also filed a Marketing Authorisation Application to the EMA for dabrafenib for treating adult patients with the same mutation. This follows positive results ...

GSK files trametinib at the FDA for Metastatic Melanoma

GSK has filed trametinib, a drug developed by Japan Tobacco , at the FDA to treat unresectable Metastatic Melanoma and is planning a EU filing. The molecule targets patients with BRAF V600 mutation positive forms of Metastatic Melanoma. The V600 mutation applies to some 60% of Melanoma patients. A companion diagnostic has already been filed by BioMerieux. The application is ...

EMA award orphan status to A 4250 (Albireo) for the treatment of Primary Biliary Cirrhosis

The European Medicines Agency Committee for Orphan Medicinal Products (COMP) has issued a positive opinion on an application for orphan medicinal product status for A 4250, from Albireo, for the treatment of Primary Biliary Cirrhosis (PBC), Progressive Familial Intrahepatic Cholestasis (PFIC) and Alagille Syndrome. A 4250 belongs to a class of inhibitors of the ileal bile acid transporter (IBAT, syn. ...

CHMP recommends EU approval of Zyclara (Meda) for Actinic Keratoses

The CHMP has adopted a positive opinion regarding marketing authorization of Zyclara (imiquimod), from Meda, for the treatment of Actinic Keratoses (AK) on large skin areas. Zyclara shares the same active ingredient as Aldara and while both are approved by the FDA for the treatment of AK, there are key differences: Zyclara is indicated for daily use on an accelerated ...

Study shows positive results with dabrafenib (Glaxo Smith Kline) in Melanoma patients

A new study compared dabrafenib, from Glaxo Smith Kline, with the most commonly used existing treatment, dacarbazine (DTIC), in 250 patients suffering from spreading or inoperable BRAF-positive Melanoma. Half of the patients demonstrated a partial (47%) or complete response (3%) to the treatment in an independent review. By comparison, just 6% of patients treated with DTIC showed an improvement. Progression-free ...

Two papers and an editorial in the New England Journal of Medicine hail Erivedge (Roche) as great advance in BCC

An editorial accompanying 2 papers in the New England Journal of Medicine hails Erivedge (vismodegib), from Roche, as "the greatest advance in therapy yet seen" for patients with advanced Basal Cell Carcinoma. Following its first tests in 2007, the FDA approved the drug earlier this year. FDA approval in five years is a remarkable achievement because clinical trials typically progress ...

NICE does not recommend Zelboraf(Roche) for Metastatic Melanoma

NICE, the health technology appraisal institute for England and Wales, has not recommended Zelboraf (vemurafenib) from Roche, for the treatment of unresectable locally advanced or metastatic BRAF V600 mutation-positive melanoma in its daft guidance. NICE was uncertain about both the long-term effect of drug on survival and its cost, even though Roche had put forward a patient access scheme....

Stiefel takes world rights to Toctino from Basilea for Chronic Hand Eczema

Stiefel,a unit of GSK, is gaining exclusive worldwide rights to Toctino (alitretinoin.) from Basilea Pharma. Toctino is commercially available in 14 countries (and approved in an additional 15) for severe Chronic Hand Eczema that is refractory to treatment with potent topical corticosteroids. In the USA, oral alitretinoin is in a Phase III trial. Stiefel will assume responsibility for the development ...

Phase III PHOENIX 1 study of Stelara (J&J Janssen Cilag) shows consistent results for plaque Psoriasis

New efficacy and safety data from the Phase III PHOENIX 1 study, one of two pivotal registration trials, showed that maintenance treatment with Stelara (ustekinumab), from J&J Janssen Cilag, for up to five years of follow up resulted in consistent, significant clinical response in adults with moderate to severe plaque Psoriasis. In the PHOENIX 1 trial, patients receiving ustekinumab 45 ...

Ceptaris Therapeutics receives Complete Response Letter from FDA for mechlorethamine hydrochloride treatment for Mycosis Fungoides

Ceptaris Therapeutics (formerly Yaupon Therapeutics) has received a Complete Response Letter (CRL) from the FDA for mechlorethamine hydrochloride gel as a treatment for early-stage Mycosis Fungoides, the most common type of cutaneous T-Cell lymphoma a rare form of non-Hodgkin's lymphoma. Mechlorethamine hydrochloride is a water-soluble, greaseless topical gel, which could lead to better compliance for patients with Mycosis Fungoides....

Trametinib and dabrafenib(GSK) success in BREAK 3 and METRIC studies for Melanoma

GSK announced at the Annual Meeting of the American Society of Clinical Oncology in Chicago positive results for investigational BRAF and MEK inhibitors dabrafenib and trametinib.The BREAK 3 study of dabrafenib (BRAF inhibitor) and the METRIC study of trametinib (MEK inhibitor) demonstrated a statistically significant benefit in the length of time patients with BRAF V600 mutation positive advanced or Metastatic ...

FDA approves Absorica (Ranbaxy) for severe Acne

FDA has approved Absorica on 25 May 2012, a patented formulation of isotretinoin, as a treatment for severe recalcitrant nodular acne. Ranbaxy is expected to launch Absorica in the USA in the fourth-quarter 2012....

Dabrafenib (GSK) impressive in Metastatic Melanoma

A total of 184 patients with incurable solid tumours were enrolled (156 with Metastatic Melanoma) in a Phase 1 trial and given escalating doses of dabrafenib from Glaxo Smith Kline. The investigators established a recommended phase II dose (RP2D) of 150 mg twice daily.In the second stage, efficacy at the RP2D was studied in three groups of patients with BRAF-mutant ...

FDA approves Fabior (Allergan) for Acne vulgaris in 12 year olds and upwards

The FDA has approved the New Drug Application for Fabior (tazarotene) Foam, 0.1%, from Allergan, for the treatment of Acne vulgaris in patients 12 years of age and older. It is the only retinoid in a topical foam formulation approved for this indication in the US. The approval of tazarotene foam was based on two multi-centre, randomized, double-blind, vehicle-controlled pivotal ...

NICE rejects Benlysta (GSK) for SLE in final guidance

The health technology appraisal body in England and Wales, NICE, has in its final guidance rejected Benlysta ((belimumab ) from GSK/Human Genoma Sciences for Systemic Lupus Erythematosus (SLE) treatment. The decision was criticised by GSK, which said the UK's failure to adopt innovative medicines is a continuing systemic problem....

Study shows Zostavax (Merck Inc.) safe for Shingles

A retrospective study of 193,083 adults shows that Zostavax, the vaccine for Herpes Zoster, from Merck Inc., is safe for preventing Shingles. The study was conducted in patients over the age of 50, between 2007 and 2008. The results reveal a small rise in local reactions to the injection which occurred from 1 to 7 days after vaccination. However once ...

Toctino(Basilea Pharma) success in Phase III HANDEL study for Chronic Hand Eczema

Topline results were reported from the U.S. Phase III 596 patient HANDEL study of Toctino(alitretinoin) from Basilea Pharma in severe Chronic Hand Eczema refractory to potent topical corticosteroids. Patients with severe Chronic Hand Eczema unresponsive to potent topical corticosteroids were randomized either to a once-daily dose of 30 mg alitretinoin or placebo for a treatment duration of up to six ...

Omadacycline (Paratek Pharma)special protocol with FDA is agreed for Phase III study for ABSSSI and CABP

Paratek Pharmaceuticals has reached agreement with the FDA on its second Special Protocol Assessment (SPA) related to the Phase III program design for the Company's lead antibiotic candidate, omadacycline (formerly PTK 0796). Omadacycline is a broad-spectrum, first-in-class aminomethylcycline antibiotic with oral and IV formulations that Paratek is developing to address the leading organisms that cause bacterial infections such as serious ...

Brodalumab (Amgen) success in Psoriasis Phase II study

Amgen announces the results of a Phase II trial evaluating the safety and efficacy of Brodalumab (formerly AMG 827) in 198 patients with moderate to severe plaque Psoriasis which were published in the New England Journal of Medicine. The 12-week, dose-ranging study achieved its primary endpoint with the mean percentage improvement in psoriasis area and severity index (PASI) score higher ...

Phase II success for ixekizumab(EliLilly) in Psoriasis

New Phase II data, published in the New England Journal of Medicine, showed that Eli Lilly and Company's ixekizumab , (previously known as LY2439821), an anti-IL-17 monoclonal antibody, met its primary endpoint in patients with moderate-to-severe plaque psoriasis, with significantly more patients achieving at least a 75 percent improvement in Psoriasis Area and Severity Index (PASI) scores from baseline (PASI ...

FDA approves Binosto (EffRx) for Osteoporosis

The FDA has approved Binosto (alendronate sodium) Effervescent Tablets, previously known as EX101, for the treatment of Osteoporosis in postmenopausal women, and as a treatment to increase bone mass in men with Osteoporosis. EffRx anticipates that Binosto will be commercially available in the United States in the third quarter of 2012. Binosto was developed by EffRx based on an agreement ...

Glaucoma drug BOL-303259-X (Bausch & Lomb) meets endpoints in Phase IIb Study

The Phase IIb study conducted with BOL-303259-X, a novel nitric oxide-donating prostaglandin F2-alpha analog from Bausch & Lomb, in patients with open-angle Glaucoma or Ocular Hypertension, met its primary efficacy endpoint and showed positive results on a number of secondary endpoints. The primary efficacy endpoint was the reduction in mean diurnal intraocular pressure (IOP) on day 28. Two of the ...

Wheat bran Brana Vita(Fugeia NV) positive in Gut trial

Brana Vita, a wheat bran, from Fugeia NV, is associated with an increase in gut levels of bifidobacteria according to a placebo controlled trial published in the British Journal of Nutrition.Results showed that 10 grams produced significant changes to levels of bifidobacteria in the faeces and an increase in short chain fatty acids.see British Journal of Nutrition published online ahead ...

Oral powder formulation of Fosrenal (Shire) approved in EU

The Swedish Medical Products Agency acting as reference member state through the European Decentralised Procedure has approved a new oral powder formulation of Fosrenal (lanthanum carbonate), from Shire. Submissions for national marketing authorisations of Fosrenol in oral powder form have been made to Sweden and the other 27 European markets. The oral powder formulation was developed to give patients more ...

Avastin (Roche) possible new treatment for Haemorrhagic Telangiectasia

A new study suggests that Avastin (bevacizumab), from Roche, may help to improve cardiac function and reduce the number of potentially life-threatening nose bleeds caused by a rare genetic vascular disorder known as Haemorrhagic Telangiectasia. In a Phase II study of 24 patients treated in France, the duration of nosebleeds dropped from a mean of 221 minutes per month to ...

Positive interim analysis of blisibimod (Anthera Pharma) clinical trial for SLE

The Phase IIb PEARL-SC clinical study of blisibimod, from Anthera Pharma, for Systemic Lupus Erythematosus (SLE) is recommended for continuation following an interim analysis of all safety and efficacy data. Following the review by the Company's Data Safety Monitoring Board, the study will proceed as planned without modification. PEARL-SC is examining the therapeutic benefit of weekly and monthly subcutaneous injections ...

Erivedge (Genentech/Roche)is FDA approved for Basal Cell Carcinoma

The FDA has approved Erivedge (vismodegib) from Genentech/Roche to treat adult patients with Basal Cell Carcinoma, the most common type of skin cancer. The drug is intended for use in patients with locally advanced Basal Cell Cancer who are not candidates for surgery or radiation and for patients whose cancer has spread to other parts of the body (metastatic). Erivedge, ...

Picato (Leo Pharma) is FDA approved for Actinic Keratosis

The FDA has approved Picato (ingenol mebutate) gel in the 0.015%/0.05% strength from Leo Pharma for the topical treatment of Actinic Keratosis which is a precancerous condition resulting from cumulative sun exposure that has the potential to lead to squamous cell carcinoma. The drug is the first and only topical therapy available in the USA for Actinic Keratosis that can ...

Novel antibacterial ozenoxacin (Ferrer) enters Phase III for treatment for Impetigo

Ferrer has received approval to initiate Phase III clinical trials of ozenoxacin as a topical treatment for infectious dermatological conditions such as Impetigo. Ozenoxacin is a novel second generation non-fluorinated quinolone antibacterial agent. The first patients are expected to enter the trials in February 2012 and the studies are scheduled to complete in the first quarter, 2013. The multicentre clinical ...

NVC-422 (NovaBay) shows potential against adenoviral Conjuctivitis

A new study has demonstrated the virucidal activity of NVC-422 (aganocide) against adenovirus type 5 that causes Conjunctivitis. In vitro assays show that NVC-422 has a good therapeutic index and the virucidal activity of NVC-422 is rapid with complete inactivation of Ad5 within 15 min. The virucidal activity of NVC-422 is due to its reacting with key viral proteins. If ...

AzaSite and DexaSite (InSite Vision) enter Phase II for Blepharitis

InSite Vision Inc. commences a 900 patient Phase III trial (DOUBle study)for Azasite Plus ( dexamethasone plus azithromycin)-ISV 502 and DexaSite (dexamethasone)-ISV-305 both using its DuraSite drug delivery platform in the treatment of chronic Blepharitis (or lid margin disease). This condition is an inflammation of the eyelid for which there is no FDA approved treatment....

FDA to review vismodegib(Genentech) for Basal Cell Carcinoma

The FDA will review vismodegib from Genentech/Roche, being the first-in-class oral treatment that inhibits signalling in the Hedgehog pathway which is implicated in more than 90% of Basal Cell Carcinoma cases.The FDA review is planned to take place on 8 March 2012. The filing is supported by the ERIVANCE BCC study....

TRANSIT study of Stelara in Psoriasis

The TRANSIT Phase IV study of Stelara (ustekinumab)from Janssen Cilag compared two methods of transiting patients from methotrexate therapy to Stelara in moderate to severe psoriasis patients. The study showed serious adverse events were infrequent regardless of transition strategy: 2.9% in the methotrexate immediate cessation arm versus 2.0% in the gradual withdrawal arm and a health related quality of life ...

AIN 457 a new approach to Psoriasis

Novartis has announced positive results from three Phase II trials showing that AIN 457 (secukinumab) produced a quick and significant improvement of symptoms in patients with moderate-to-severe plaque psoriasis. The results were presented at the annual European Academy of Dermatology and Venereology (EADV) Congress, in Lisbon, Portugal. In one study, 81% of patients receiving AIN457 150mg subcutaneously once a month ...

Ameluz has CHMP recommendation for Actinic Keratosis

The Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Ameluz (5-aminolevulinic acid) from Biofrontera AG for the treatment of actinic keratosis....

BioAlliance files Sitavir in the EU for Orofacial Herpes

BioAlliance has filed its orofacial herpes drug Sitavir (aciclovir Lauriad) through the decentralised procedure in Austria, Denmark, Finland, France, Germany, Italy, Norway, Poland, Spain, Sweden and the UK, with Sweden acting as the reference member state. Sitavir is a mucoadhesive buccal tablet delivering high concentrations of the active ingredient to the mucosa and lips, the sites of the herpes infection, ...

MedImmune and Pfizer collaborate on anti cancer tremelimumab

Pfizer and MedImmune ( a subsidiary of AstraZeneca) will collaborate to develop tremelimumab. The drug was unsuccessful in a Phase III trial for Melanoma but discovery of a biomarker has spurred development and DebioPharm are running a Phase III trial for treatment of Melanoma.The agreement will give MedImmune global rights for cancer indications and Pfizer will retain rights to certain ...

NICE refuses to recommend Benlysta for SLE

In a draft guidance, NICE, the health technology appraisal institute for England and Wales, has provisionally rejected Benlysta (belimumab) from GlaxoSmithKline (GSK) and Human Genome Sciences (HGS), for the treatment of adult patients with active autoantibody-positive systemic lupus erythematosus, where patients have a high degree of disease activity despite the individual receiving standard therapy. GSK plans to contest the decision....

Genentech files vismodegib at FDA for Basal Cell Carcinoma

Genentech/Roche has submitted a new drug application to the FDA for vismodegib as a treatment for patients with advanced, inoperable basal cell carcinoma . The new oral drug is designed to selectively inhibit signaling in the Hedgehog pathway, which is implicated in more than 90% of basal cell carcinoma cases, the most common type of skin cancer, which is generally ...

Novabay introduces a new class of agonacides with NVC422

NovaBay Pharmaceuticals, Inc., based in Emeryville, CA, is innovating a new class of drugs, known as Aganocide compounds, that mimic the body's natural defense against infection. The Aganocides could potentially equal or exceed the utility of antibiotics and address the problem of antibiotic resistance via their novel mechanism. A poster relating to a study of NVC422, was presented at the ...