FLAGS AND HITS
DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO
FACEBOOK
...................................................................Join me on twitter
..................................................................Join me on google plus
GoogleplusMYSELF
TMC310911, Ascletis In-Licenses China Rights to HIV Drug from Janssen
TMC310911, credit pubchem
see structure http://aac.asm.org/content/55/12/5723/F1.expansion.html
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3232804/ structure available
TMC310911, Ascletis In-Licenses China Rights to HIV Drug from Janssen
Apr 30, 2013
Ascletis, a China-US drug developer, has in-licensed China rights to a next-generation HIV protease inhibitor from Janssen R&D Ireland, a subsidiary of Johnson & Johnson. Janssen believes the drug, known as TMC310911, is likely to prove more effective against drug-resistant strains of HIV than currently available PIs. The molecule is the third drug candidate in-licensed by Ascletis, which is also developing its own siRNA anti-cancer drug candidate.
Clinical trial starts in the UK to heal hearts with genetic virus
A group of UK heart failure patients have been enrolled on a new clinical trial to see if a genetically engineered virus can help heal their ailing hearts.
Researchers at Imperial College London will introduce a genetic virus into the heart muscles of the 200 participants, in a bid to reverse the heart muscle’s decline.
READ ALL AT
NDA-MAP Pharmaceuticals, Inc Levadex (dihydroergotamine) Oral Inhalation
Dihydroergotamine
Levadex (dihydroergotamine) Oral Inhalation
MAP Pharmaceuticals, Inc.
Treatment for: Migraine
Levadex (dihydroergotamine) is an investigational orally inhaled migraine therapy.
Dihydroergotamine (/daɪˌhaɪdroʊ.ɜrˈɡɒtəmiːn/ dy-HY-droh-ur-GOT-ə-meen; brand names D.H.E. 45 and Migranal) is an ergot alkaloid used to treat migraines. It is a derivative of ergotamine. It is administered as a nasal spray or injection and has an efficacy similar to that of sumatriptan. Nausea is a common side effect.
It has similar actions to the triptans, acting as an agonist to the serotonin 5-HT(1D) receptors and causing vasoconstriction of the intracranial blood vessels, but also interacts centrally with dopamine and adrenergic receptors. It can be used to treat acute intractable headache or withdrawal from analgesics.
Dihydroergotamine (DHE) is a semi-synthetic form of ergotamine approved in the US in 1946. Oral bioavailability is poor and it is not available in oral form in the US. DHE is available as Migranal nasal spray and in ampules for subcutaneous, intramuscular and intravenous injection. Efficacy is variable in the nasal spray form with bioavailability 32% of injectable administration. Subcutaneous and intramuscular injections are generally more effective than the nasal spray and can be self-administered by patients.Intravenous injection is considered very effective for severe migraine or status migrainosus. DHE is also used in the treatment of medication overuse headache.
Nausea is a common side effect of IV administration and less common in other modes. Antiemetics can be given prior to DHE to counteract the nausea. Risks and contraindications are similar to the triptans. DHE and triptans should not be taken within 24 hours of each other due to the potential for coronary artery vasospasm. DHE produces no dependence.
MAP Pharmaceuticals submitted an inhaled version of DHE (Levadex) for FDA approval in May 2011.
Penicillin Prevents Return of Leg Infection Called Cellulitis: Study
Penicillin core structure, where “R” is the variable group.
WEDNESDAY, May 1 (HealthDay News) — For people who have suffered from cellulitis of the leg, a long course of low-dose penicillin prevents the painful infection from returning, British researchers report.
Once the penicillin is stopped, however, its protective effect diminishes and the condition can flare up again, the researchers noted.
read more
http://www.philly.com/philly/health/topics/HealthDay676011_20130501
_Penicillin_Prevents_Return_of_Leg_Infection_Called_Cellulitis__Study.html
Daratumumab Receives Breakthrough Therapy Designation From US Food and Drug Administration
May 1, 2013
Genmab A/S announced today that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for daratumumab for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD) or who are double refractory to a PI and IMiD. Breakthrough Therapy Designation is a program intended to expedite the development and review of drugs to treat serious or life-threatening diseases in cases where preliminary clinical evidence shows that the drug may provide substantial improvements over available therapy. In August 2012, Genmab granted Janssen Biotech, Inc. an exclusive worldwide license to develop and commercialize daratumumab.
Daratumumab is an investigational anti-cancer drug. It binds to CD38.Daratumumab was originally developed by Genmab, but it is now being jointly developed by Genmab along with the Johnson & Johnson subsidiary Janssen Biotech, which acquired worldwide commercialization rights to the drug from Genmab
The U.S. Food and Drug Administration today announced that it has approved an amended application submitted by Teva Women’s Health, Inc. to market Plan B One-Step (active ingredient levonorgestrel) for use without a prescription by women 15 years of age and older
April 30, 2013 — The U.S. Food and Drug Administration today announced that it has approved an amended application submitted by Teva Women’s Health, Inc. to market Plan B One-Step (active ingredient levonorgestrel) for use without a prescription by women 15 years of age and older.
After the FDA did not approve Teva’s application to make Plan B One-Step available over-the-counter for all females of reproductive age in December 2011, the company submitted an amended application to make the product available for women 15 years of age and older without a prescription.
FDA Approves Procysbi for Nephropathic Cystinosis
Cysteamine bitartrate
April 30, 2013 — The U.S. Food and Drug Administration today approved Procysbi (cysteamine bitartrate) for the management of nephropathic cystinosis in children and adults. Procysbi was granted orphan product designation because it is intended to treat a rare disease or condition.
Cystinosis is a rare genetic condition that affects an estimated 500 patients in the United States and about 3,000 patients worldwide. Fatal if not treated in early childhood, cystinosis causes a protein building block called cystine to build up in every cell of the body. The buildup of cystine causes kidney problems, which can cause the body to lose too much sugar, proteins and salts through the urine. Cystinosis may lead to slow body growth and small stature, weak bones and developing and worsening kidney failure. There are three types of cystinosis, the most severe being nephropathic cystinosis, which severely damages the kidneys.
Currently the FDA approved drugs used to treat cystinosis include Cystagon (cysteamine bitartrate), an immediate-release tablet that was approved in 1994, and Cystaran (cysteamine ophthalmic solution) eye drops, approved last year to treat corneal cystine crystal accumulation.
Procysbi is a delayed-release capsule intended for patients ages 6 years and older. While Cystagon is taken every six hours around the clock to control cystine levels, Procysbi is a long-acting formulation that is taken every 12 hours.
“Procysbi is the only delayed-release product approved by FDA to treat nephropathic cystinosis, offering patients with this rare disease an important new treatment option,” said Andrew E. Mulberg, M.D., deputy director, Division of Gastroenterology and Inborn Errors Products, Center for Drug Evaluation and Research, FDA.
The major study supporting Procysbi’s safety and effectiveness involved 43 adult and pediatric patients with nephropathic cystinosis. Patients were randomly assigned to receive Cystagon or Procysbi for three weeks before being switched to the other product for an additional three weeks. Blood testing showed Procysbi was as effective as Cystagon in controlling cystine levels.
The most common side effects in patients treated with cysteamine products include nausea, bad breath, abdominal pain, constipation, indigestion or upset stomach, headache, drowsiness and dizziness. Other uncommon but serious side effects include ulcers or bleeding of the stomach or intestine, altered mental state, seizures, severe skin rashes and allergic reactions.
Procysbi is marketed by Novato, Calif.-based Raptor Pharmaceuticals. Cystagon is marketed by Canonsburg, Pa.-based Mylan Inc. Cystaran is marketed by Gaithersburg, Md.-based Sigma-Tau Pharmaceuticals, Inc.
FDA Approves Actemra for Children with Polyarticular Juvenile Idiopathic Arthritis
tocilizumab
April 30, 2013
Roche announced today that the U.S. Food and Drug Administration (FDA) has approved Actemra (tocilizumab) for the treatment of polyarticular juvenile idiopathic arthritis (PJIA). The medicine can be used in children two years of age and older with active disease. Actemra can be given alone or in combination with methotrexate (MTX) in people with PJIA.
PJIA is a form of juvenile idiopathic arthritis (JIA), also known as juvenile rheumatoid arthritis, a chronic disease of childhood.1 JIA affects approximately 100 in every 100,000 children2 of which PJIA accounts for around 30 percent.3 PJIA is characterised by inflammation in five or more joints within the first six months of the disease and most commonly affects the small joints in the body such as the hands and feet.3
“Polyarticular juvenile idiopathic arthritis is a rare debilitating condition in children that worsens over time,” said Hal Barron, M.D., chief medical officer and head, Global Product Development. “We are pleased to offer Actemra to doctors and parents of children aged two or older to help improve the signs and symptoms of this often painful disease.”
This FDA approval marks the second Actemra indication in children and is the first FDA approval for the treatment of PJIA in approximately five years. The EU Committee for Medicinal Products for Human Use (CHMP) also announced a positive opinion for this indication on Friday, April 26. The final approval from the European Medicines Agency (EMA) is expected this summer.
The expanded indication for Actemra was based on positive data from the Phase III CHERISH study in children with PJIA, which had an open label phase, followed by a randomised double-blind placebo-controlled withdrawal phase. The study demonstrated that patients treated with Actemra experienced clinically meaningful improvement in signs and symptoms of PJIA. A total of 91 percent of patients taking Actemra plus MTX and 83 percent of patients taking Actemra alone achieved an ACR 30 response at week 16 compared to baseline. In the randomised double-blind placebo-controlled withdrawal phase of the trial, Actemra-treated patients experienced significantly fewer disease flares compared to placebo-treated patients [26 percent (21/82) vs. 48 percent (39/81)].
The safety data collected to date for Actemra in PJIA patients is consistent with that observed in previous studies in Actemra-treated patients.4 In the CHERISH study, infections were the most common adverse events (AEs) and serious adverse events (SAEs) over 40-weeks. Laboratory abnormalities known to occur with Actemra were also observed in this study, including decreases in white blood cell counts and platelet counts, and elevation in ALT and AST liver enzyme levels.
About Actemra (tocilizumab)
Actemra is the first humanised interleukin-6 (IL-6) receptor antagonist approved for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more disease-modifying antirheumatic drugs (DMARDs). The extensive Actemra clinical development programme included five Phase III clinical studies and enrolled more than 4,000 people with RA in 41 countries, including the United States. In addition, Actemra is also approved for the treatment of active systemic juvenile idiopathic arthritis (SJIA) in patients two years of age and older and polyarticular juvenile idiopathic arthritis (PJIA) in patients two years of age and older who have responded inadequately to previous therapy with MTX.
Actemra is part of a co-development agreement with Chugai Pharmaceutical Co. and has been approved in Japan since June 2005. Actemra is approved in the European Union, where it is known as RoActemra, and several other countries, including China, India, Brazil, Switzerland and Australia.
Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, infectious diseases, inflammation, metabolism and neuroscience. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Roche’s personalised healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2012 Roche had over 82,000 employees worldwide and invested over 8 billion Swiss francs in R&D. The Group posted sales of 45.5 billion Swiss francs. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.
Tocilizumab (INN, or atlizumab, developed by Hoffmann–La Roche and Chugai and sold under the trade names Actemra and RoActemra) is an immunosuppressive drug, mainly for the treatment of rheumatoid arthritis (RA) and systemic juvenile idiopathic arthritis, a severe form of RA in children. It is a humanized monoclonal antibody against the interleukin-6 receptor (IL-6R). Interleukin 6 (IL-6) is a cytokine that plays an important role in immune response and is implicated in the pathogenesis of many diseases, such as autoimmune diseases, multiple myeloma and prostate cancer.
Merck & Co and Pfizer join forces on diabetes pill
ertugliflozin
PF04971729
(1S,2S,3S,4R,5S)-5-[4-Chloro-3-(4-ethoxybenzyl)phenyl]-1-(hydroxymethyl)-6,8-dioxabicyclo[3.2.1]octane-2,3,4-triol
Drug giants Merck & Co and Pfizer have formed a new alliance to jointly develop and commercialise the latter’s ertugliflozin for the treatment of type II diabetes.
The drug is an investigational oral sodium glucose cotransporter (SGLT2) inhibitor, which is on the verge of entering Phase III trials, scheduled for later this year.
read more
http://www.pharmatimes.com/Article/13-04-30/Merck_Co_and_Pfizer_join_forces_on_diabetes_pill.aspx
DR ANTHONY MELVIN CRASTO
ORGANIC SPECTROSCOPY
New Drug Approvals 