Covidien morphine sulfate oral solution gets FDA nod
01 August 2011
Covidien has received the US Food and Drug Administration (FDA) approval for its Mallinckrodt business for. morphine sulfate oral solution
The solution, which will be launched as a generic in 100 milligrams per 5ml (20 milligrams per 1 ml), is intended to relieve moderate to severe acute and chronic pain in opioid-tolerant patients.
Covidien Pharmaceuticals interim president and chief financial officer Matthew Harbaugh said FDA approval of this drug represents a key component in palliative care treatment.
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Sun Pharma generic Plavix gets FDA tentative approval
01 August 2011
Sun Pharmaceutical Industries has received the US Food and Drug Administration (FDA) tentative approval for the abbreviated new drug application (ANDA) of clopidogrel tablets USP.
Clopidogrel tablets USP are indicated for the treatment for acute coronary syndrome, recent myocardial infarction (MI), recent stroke, or established peripheral arterial disease.
Sun Pharma's clopidogrel tablets USP, 75 mg are generic equivalent to Plavix tablets of Sanofi-aventis. Plavix is used to prevent blood clots after a recent heart attack or stroke, and in people with certain disorders of the heart or blood vessels.
Pfizer’s Prevnar 13 delayed
01 August 2011
The US Food and Drug Administration (FDA) has delayed the approval of Pfizer's supplemental biologics license application (sBLA) of pneumococcal 13-valent conjugate vaccine [diphtheria CRM197 protein] (Prevnar 13).
Prevnar 13 is indicated for active immunization for the prevention of pneumococcal disease in adult patients aged 50 and older.
The FDA has extended the review period till January 2012.
The agency will review additional data from two studies which are submitted by Pfizer to support the sBLA, in the extended time period.
Pfizer Vaccine Research chief scientific officer Emilio Emini said they are working closely with the FDA on its review.
BMS Orencia SC gets FDA nod for RA treatment
01 August 2011
Bristol-Myers Squibb (BMS) has received the US Food and Drug Administration (FDA) approval for the subcutaneous (SC) formulation of Orencia (abatacept) as a treatment for rheumatoid arthritis (RA) in adult patients.
The SC formulation of Orencia is a fixed 125mg dose which can be given weekly through an injection under the skin following a single IV loading dose of approximately 10mg/kg.
In a trial, Orencia SC showed similar safety and efficacy to Orencia IV.
FDA approves new trade name for AstraZeneca vandetanib
02 August 2011
The US Food and Drug Administration (FDA) has approved new trade name
- Caprelsa - for
AstraZeneca's orphan drug vandetanib.
Caprelsa is indicated as a treatment of symptomatic or
progressive medullary thyroid cancer in patients suffering from unresectable (non-operable) locally advanced or metastatic disease.
The FDA approval for Caprelsa was given on the basis of results of ZETA Phase III trial which demonstrated improvement in progression-free survival (PFS) when compared to those randomized to placebo.
AstraZeneca Oncology executive director Eric Vogel said they choose to launch the drug as vandetanib without waiting for a trade name approval because there were no other FDA-approved medicines available for people with this rare type of thyroid cancer.
Merck seeks ridaforolimus marketing approval from EMA
02 August 2011
Merck has filed ridaforolimus marketing authorization application (MAA) with the
European Medicines Agency (EMA).
Ridaforolimus is an investigational mTOR inhibitor being developed by Merck that has completed a Phase 3 clinical trial in patients with soft-tissue and bone sarcomas and is being studied in multiple cancer indications.
Earlier in July 2007,
Merck and
ARIAD Pharmaceuticals entered into a collaboration to jointly develop ridaforolimus for multiple potential cancer indications.
In May 2010, the companies have made changes in the agreement, under which ARIAD granted Merck an exclusive license to develop, manfacture and commercialize ridaforolimus in oncology.
Subsequently, Merck has assumed responsibility for ridaforolimus activities, including clinical trials and regulatory filings.
The acceptance of MAA by EMA will allow ARIAD to receive $25m milestone payment from Merck.
Additionally, if ridaforolimus is approved in the US Merck will pay a sum of $25m to ARIAD and approval to sell ridaforolimus, including pricing approval, in the European Union will secure a $10m milestone payment.
ARIAD chairman and CEO Harvey Berger said they look forward to the submission of additional filings on ridaforolimus and to the review of ridaforolimus as a potential new treatment option for patients with metastatic soft-tissue and bone sarcomas.
Sunesis Pharma leukemia drug gets US patent
03 August 2011
Sunesis Pharmaceuticals has received a new US patent no. 7,989,468 from the US Patent and Trademark Office (USPTO) for vosaroxin as a treatment for leukemia.
The new patent covers the methods of using vosaroxin at clinically relevant dose ranges and schedules for leukemia treatment.
Sunesis is now recruiting patients for Valor Phase 3 double-blind, randomized, placebo-controlled trial to evaluate vosaroxin in combination with cytarabine in first relapsed or refractory acute myeloid leukemia.
Sunesis Pharma CEO Dan Swisher said the '468 patent adds another important facet to their global intellectual property estate for vosaroxin, providing significant coverage for uses of vosaroxin in the treatment of leukemia including the dose and schedule under evaluation in the pivotal, Phase 3 Valor trial.
"To supplement our granted patents, we have filed patent applications in territories around the world with claims covering additional vosaroxin formulations, combination uses, dosing, manufacturing processes and composition of matter claims, which may provide patent terms to 2030 when granted," Swisher said.
Incyte gets FDA acceptance to file ruxolitinib NDA
03 August 2011
Incyte has received the US Food and Drug Administration (FDA) acceptance to submit the new drug application (NDA) for ruxolitinib (INCB18424/INC424) to treat myelofibrosis (MF) patients.
Incyte has also received priority review status for ruxolitinib NDA, which the FDA aims to complete within six months.
The NDA submission is supported by the results from two Phase III Comfort-I and Comfort-II trials.
Ruxolitinib, Incyte's lead JAK1 and JAK2 inhibitor, entered clinical testing in May 2007 and has shown clinical activity in a number of hematologic conditions.
Boston Therapeutics files ANDA for type 2 diabetes drug
04 August 2011
Boston Therapeutics has filed abbreviated new drug application (ANDA) with the US Food and Drug Administration (FDA) for chewable metformin as a treatment of type 2 diabetes.
The drug, which can be used in combination with insulin or other medications, helps in controlling blood sugar levels.
Boston CEO David Platt said this new option in treatments fits into their pipeline of other diabetes therapeutics, including Ipoxyn for limb ischemia and PAZ-320 for blood glucose management.
HP introduces Global Authentication Service against counterfeit drugs
04 August 2011
HP has introduced Global Authentication Service to protect consumers against dangerous or ineffective drugs .
The application works in conjunction with HP's global printing partners who are able to print labels in high volumes even when required in some of the world's most remote locations.
The HP Global Authentication Service enables pharma firms to monitor the movement of products through their global supply chains with accuracy.
The cloud-based track-and-trace solution can be deployed in other industry sectors, offered in any geographical region and incorporated into an existing drug production system.
HP Labs Research senior vice president and director Prith Banerjee said the success to date with mPedigree and subsequent commercialization of their Global Authentication Service highlights how valuable social innovation initiatives can be in helping bring service offerings to the market.
Pfizer gives back rapamycin analogue program rights to Biotica
04 August 2011
Pfizer has given back full rights of rapamycin analogue program, including transfer of data and materials, to the UK based Biotica Technology.
Earlier in October 2006, Biotica has licensed all rights of rapamycin analogue program to Wyeth Pharmaceuticals, which was acquired by Pfizer in October 2009.
Biotica CEO Edward Hodgkin said their compounds are supported by a data package generated by Pfizer, and show evidence of meaningful differentiation in diseases with significant unmet need.
Boehringer Ingelheim Pradaxa gets EC approval
05 August 2011
Boehringer Ingelheim has received approval from the European Commission (EC) for Pradaxa (dabigatran etexilate) as a preventive measure for stroke in patients suffering from atrial fibrillation (AF).
Dabigatran etexilate is indicated as a preventive measure for stroke and systemic embolism in adult patients with non-valvular AF with one or more risk factors.
The EC approval is supported by the results of RE-LY study, a prospective, randomized, open-label with blinded endpoint evaluation (PROBE) trial, which compared fixed doses of the oral direct thrombin inhibitor dabigatran etexilate (110mg and 150mg bid) each administered in a blinded manner, with open label warfarin.
Dabigatran etexilate 150mg bid showed reduction in the risk of stroke and systemic embolism by 35% while also lowering the risk of life-threatening and intracranial bleeding compared to well-controlled warfarin.
RE-LY co-principal investigator Stuart Connolly said the study results also showed that dabigatran etexilate is consistently effective in preventing strokes across a wide range of patients with AF, irrespective of age, gender, stroke risk, type of atrial fibrillation, prior stroke, and comorbidities such as hypertension and diabetes.
Ranbaxy posts Rs.243-crore net
06 August 2011
Drug maker Ranbaxy Laboratories on Friday reported a consolidated profit after tax of Rs.243.20 crore for the second quarter ended June 30, 2011, against Rs.325.70 crore in the same period in the previous fiscal.
In a statement issued here, it said consolidated net sales of the company stood at Rs.2,059.30 crore against Rs.2,095.30 crore.
The company said its exclusivity on Donepezil used for treating amnesia, which was launched in the U.S. market in the last quarter of 2010, came to an end during the second quarter this year. In the corresponding quarter last fiscal, the company had benefited from marketing exclusivity of anti-viral Valacyclovir.
The U.S. Food and Drug Administration (USFDA) grants FTF status to a company for a product if it is the first to successfully apply and get approval to launch a generic copy of a patented drug and it gets to sell the product exclusively for 180 days.
WHO audits Nigerian pharmaceutical firms
06 August 2011
World Health Organisation (WHO) has begun an audit and inspection of three Nigerian pharmaceutical companies with a view to enhancing their potentials and standards towards attaining the WHO prequalification of medicines produced in the country.
Director-General of the National Agency for Food and Drug Administration and Control (NAFDAC), Dr. Paul Orhii, affirmed to the WHO team that the Federal Government is indeed committed towards the realisation of the WHO prequalification (WHO -PQ) requirements.
He noted the importance of WHO prequalification but lamented that “it is a shame that in spite of the population of Nigeria, not even one pharmaceutical company in Nigeria has attained WHO prequalification standard.”
According to him, “If our manufacturers should embrace WHO-PQ and build appropriate capacity to produce drugs locally that meet international standards of quality, safety and efficacy, we will attain self- sufficiency in our drug needs and may not need to import again, blocking the avenue of importing counterfeit medicines into Nigeria.”
Drug prices expected to tumble as patents expire
06 August 2011
Patents on some of the world's best selling prescription drugs will soon expire, meaning a significant cost saving to consumers, local pharmacists say.
This change in the next few years will affect everyone from employees of the drugmakers to the smallest consumers of these prescription medications.
This is because the standard 20-year patents on an unprecedented number of widely prescribed brand-name drugs, such as Lipitor, Plavix and Singulair, are set to expire in a very short time. That will open the doors for generic versions of those formulas to reach the marketplace.
The Associated Press reports that patents on seven of the world's 20 best-selling drugs will expire in the next 14 months and a flood of new generics will continue for the next decade as about 120 brand-name prescription drugs lose market exclusivity. In all, drugs with about $255 billion in global annual sales are going off patent by 2016.
This will mean a tightening of the belt for the pharmaceutical industry as it scrambles to get new and better brand name drugs into the marketplace in the face of falling revenues. Consumers, though, will likely view it as good news.
Tom Fite, director of pharmacy operations at Sandleben's and Stratman's pharmacies in Evansville said "prescription prices will drop precipitously" for everyone, from insurance companies and customers, to those receiving low-income subsidies and Medicare and Medicaid benefits.
"But the uninsured will probably see the most dramatic savings of all," said Jacob Mayer, pharmacist with Paul's Pharmacy in Evansville.
Mayer noted that the price of a generic drug traditionally settles in at about half the price of the brand name version; the antibiotic, Levaquin, for instance, which already has expired, has dropped from $120 for a 10-day supply to $60 for the generic version.
However, this cascade of pricing will not happen overnight. A provision in the patent law allows a pharmaceutical company to license its formula to a single company — often one of their own subsidiaries — for a period of six months after the patent expires.
"After that everybody can make it, and that is when you will see the prices really begin to drop," Fite said.
Rexahn Pharma receives European patent
08 August 2011
Rexahn Pharmaceuticals has received European patent no.
EP1212055 from the European Patent Office (EPO).
The new patent named,
'Neurotherapeutic compositions comprising a beta-lactam compound,' includes compounds including clavulanic acid and moxalactam as a treatment for neurological disorders like, Alzheimer's disease, anxiety, dementia, Parkinson's disease and depression.
The patent also covers the use and pharmaceutical formulation of those compounds.
Rexahn president Rick Soni said obtaining this European patent coverage for clavulanic acid and moxalactam broadens and strengthens their CNS-related portfolio, which includes Serdaxin, currently in Phase II clinical trials.
Alexza Pharma refiles schizophrenia drug NDA with FDA
08 August 2011
US based drug developer
Alexza Pharmaceuticals has refiled the new drug application (NDA) of
AZ-004 with the US Food and Drug Administration (FDA) in response to a complete response letter (CRL) obtained in October 2010.
AZ-004 is indicated as a treatment of agitation in patients with schizophrenia or bipolar disorder.
In the original CRL, the Center for Drug Evaluation and Research of FDA rejected the NDA and asked the company to provide additional data in support of the application.
The refiling of the NDA consists of original data plus new data from a human factors study, stability data from new production batches manufactured late last year, updated manufacturing and controls sections addressing findings from the company's Pre-Approval Inspection, and updated draft labeling and a comprehensive
REMS proposal.
FDA approves Hospira oncology drug
08 August 2011
The US Food and Drug Administration (FDA) has approved
Hospira's oncology drug,
gemcitabine injection.
The drug, which is a solution formulation, has been approved in 200mg, 1gm and 2gm with a concentration of 38 mg/ml strength.
The company expects to roll out the drug in September.
The current FDA approval follows the introduction of
Hospira's lyophilized or freeze-dried formulation, gemcitabine HCL for injection in November 2010.
Hospira president Thomas Moore said the company is excited to offer US pharmacists a solution form of gemcitabine that reduces preparation time.
"Hospira's generic gemcitabine solution gives the medical community access to a lower-cost, more convenient offering of this key oncology drug," Moore said.
apceth receives manufacturer licence for somatic cell therapeutics
09 August 2011
apceth, a Germany-based developer of stem cell and gene therapies, has received
manufacturer's licence for the production of somatic cell therapeutics.
The research work is focused to develop stem cell and gene therapies to treat benign and malignant diseases.
apceth CEO Christine Gunther said the manufacturer's licence has been issued by the Government of Upper Bavaria and the Paul-Ehrlich-Institute.
"we joined forces with the authorities to develop stringent guidelines to ensure that stem cell therapeutics will also fulfil the highest quality demands in the future", Gunther said.
FDA approves Innopharma generic Keppra injection ANDA
09 August 2011
The US Food and Drug Administration (FDA) has approved
Innopharma's levetiracetam injection's abbreviated new drug application (ANDA).
Levetiracetam Injection is indicated as adjunctive therapy in the treatment of partial onset seizures in adults with epilepsy.
Innopharma's levetiracetam injection is the generic version of UCB's Keppra injection.
Furthermore, the company has signed a licensing deal with X-GEN Pharmaceuticals to market and distribute levetiracetam injection in the US.
Innopharma is engaged in developing niche generic
and specialty pharmaceutical products.
FDA allows Teva to file allergic rhinitis drug NDA
09 August 2011
Israeli generic drug developer
Teva Pharmaceutical has received the US Food and Drug Administration (FDA) acceptance to submit new drug application (NDA) for
beclomethasone dipropionate hydrofluoroalkane (BDP Nasal HFA) to treat perennial allergic rhinitis (PAR) and seasonal allergic rhinitis (SAR).
The NDA is supported by the results of two Phase III clinical trials evaluating the efficacy and safety of BDP Nasal HFA which showed improvement in nasal symptoms such as runny nose, nasal itching sneezing and nasal congestion versus placebo.
The trials' results suggested that the drug was generally well tolerated and showed safety profile.
Teva Group Global Branded Products vice president Yitzhak Peterburg said BDP Nasal HFA has demonstrated promising results in the treatment of both
SAR and PAR.
Agennix gets new European patent for cancer drug
10 August 2011
Agennix, a Germany-based developer of novel therapies, has received a new patent number 1507554 from the
European Patent Office (EPO).
The newly issued patent, namely,
'Lactoferrin in the treatment of malignant neoplasms and other hyperproliferative diseases,' includes the usage of oral lactoferrins, including talactoferrin, to treat cancer.
The patent, which will be expired in 2023, also covers the usage of talactoferrin in conjunction with other therapies, including chemotherapy, immunotherapy, radiation therapy and other treatments.
Agennix chief financial officer Torsten Hombeck said this European patent provides protection for talactoferrin in this key market, as it covers the use of human lactoferrin for oral administration, used alone or in combination with other therapies, for the treatment of all cancer types.
"We also have cancer use patents that were recently issued in the US and Japan, two of the other major markets for talactoferrin, that provide protection until 2025 and 2023, respectively, and include coverage for our lead indication, non-small cell lung cancer," Hombeck said.
FDA issues CRL for Adventrx Exelbine NDA
10 August 2011
The US Food and Drug Administration (FDA) has issued complete response letter (CRL) to US based Adventrx Pharmaceuticals' new drug application (NDA) for Exelbine (vinorelbine injectable emulsion) as a treatment for non-small cell lung cancer.
In its CRL, the FDA has rejected to approve the drug in its present form and has requested information related to the product quality or CMC matters.
Additionally, the FDA has questioned on the authenticity of the drug used in the pivotal bioequivalence trial (Study 530-01), following inspections conducted by the agency at clinical sites.
The letter stated that the bioequivalence trial will need to be repeated to address this deficiency.
Adventrx CEO Brian Culley said they believe the authenticity of the drug products used in the pivotal study is verifiable and plan to discuss FDA's concerns in this regard.
"In the meantime, our resources and focus are on ANX-188 and ANX-514, which we believe are the long-term value drivers for our company," Culley said.
GSK files Horizant sNDA with FDA
10 August 2011
GlaxoSmithKline (GSK) has filed a supplemental new drug application (sNDA) seeking approval for Horizant (gabapentin enacarbil) extended release tablet with the US Food and Drug Administration (FDA).
Horizant is XenoPort's first approved product.
Horizant extended-release tablets are indicated for the management of postherpetic neuralgia (PHN) in adults patients.
GSK holds commercialization rights and certain development rights for gabapentin enacarbil in the US.
In April this year, GSK and XenoPort have received the FDA approval for Horizant extended-release tablets for the treatment of moderate-to-severe primary restless legs syndrome in adults.
The efficacy of Horizant in the treatment of patients with moderate-to-severe primary restless legs syndrome was showed in two 12-week clinical trials in adults.
Gilead Sciences gets FDA approval for HIV drug
11 August 2011
Gilead Sciences has received the US Food and Drug Administration (FDA) approval for
Complera (emtricitabine/rilpivirine/tenofovir disoproxil fumarate) as a treatment for
HIV-1 infection in treatment-naive adults.
Complera, which mixes three antiretroviral medications in one daily tablet, contains
Gilead's Truvada and Tibotec Pharmaceuticals' non-nucleoside reverse transcriptase inhibitor, rilpivirine.
The FDA approval is supported by the results from two Phase 3 studies (Echo and Thrive) that investigated the efficacy and safety of rilpivirine compared to efavirenz among treatment-naïve HIV-1 infected adults.
Gilead first entered into a license and collaboration agreement with Tibotec for the development and commercialization of Complera in July 2009.
FDA gives tentative approval for Watson generic cholesterol drug
11 August 2011
The US Food and Drug Administration (FDA)
has given tentative approval for
Watson Laboratories' rosuvastatin zinc 5, 10, 20 and 40mg tablets.
Watson's rosuvastatin zinc 5, 10, 20 and 40mg tablets are the
generic version of Astrazeneca's
Crestor (rosuvastatin calcium) tablets.
Crestor is indicated, as an adjunct to diet, to lower LDL cholesterol, raise HDL cholesterol, and slow the progression of atherosclerosis.
Earlier on 26 October 2010, Astrazenaca sued Watson in the US Court for the District of Delaware to prevent Watson from commercializing the drug before the expiration of US patent no. RE 37,314.
Watson expects to get the final approval for rosuvastatin zinc tablets, which are a new salt form of Crestor tablets following the final settlement of the case.
AvanirPharma files lawsuits against Par, Actavis
12 August 2011
Avanir Pharmaceuticals has filed lawsuits against
Par Pharmaceutical, Par Pharmaceutical companies, Actavis South Atlantic and Actavis in the US District Court for the District of Delaware.
Avanir alleged that Par's and Actavis' proposed generic products infringe certain patents held by the company.
The law suit was filed based on the response to abbreviated new drug applications (ANDAs) filed by Par and Actavis.
The application was made against Par and Actavis that they tend to market and sell generic versions of the currently approved dose of
Nuedexta prior to the expiration of US patents 7,659,282 and RE38,115.
Nuedexta, a combination of two components - dextromethorphan hydrobromide and quinidine sulfate, acts on sigma-1 and NMDA receptors in the brain and treats pseudobulbar affect (PBA).
USPTO grants patent to MAP Pharma migraine drug
12 August 2011
The
US Patent and Trademark Office (USPTO) has granted a US Patent No. 7,994,197 to
MAP Pharmaceuticals' Levadex, a proprietary formulation of dihydroergotamine (DHE).
Levadex is an orally inhaled investigational drug which is used for acute treatment of migraine in adults that targets the pharmacokinetic profiles as described in the patent.
MAP Pharmaceuticals president and CEO Timothy Nelson said they have designed Levadex to overcome the limitations of currently available migraine therapies by combining their formulation capabilities with their proprietary Tempo inhaler, and to target an optimal pharmacokinetic profile for rapid relief of migraine while minimizing side effects.
MAP Pharmaceuticals has partnered with Allergan to co-promote Levadex to neurologists and pain specialists in the US and Canada
Dr Reddy's calls back simvastatin fresh lots from US
15 August 2011
Dr Reddy's is recalling 60,000 bottles of 10mg and 40mg of simvastatin from the US due to complaints from consumers who found the
tablets smelled musty or moldy.
Simvastatin is used together with diet and exercise to reduce the amount of 'bad cholesterol' (low-density lipoprotein cholesterol or LDL-C) in the blood.
The US Food and Drug Administration stated that the Indian drug maker's investigation pointed to the presence of the same contaminants that were found last year due to which the company had to recall 25,896 bottles of the drug, the Business Standard reported.
Ranbaxy introduces OTC oral pain reliever Volini Duo in India
15 August 2011
Indian drug maker
Ranbaxy Laboratories has introduced over the counter (OTC) two-in-one
oral pain killer
Volini Duo in India through its OTC business division Ranbaxy Global Consumer Healthcare (RGCH).
Volini Duo, which is developed using advanced Matrix technology, is a bi-layered Acetaminophen tablet, specially formulated to give dual pain relief.
Matrix technology allows the regulated release of the medicine in the gastrointestinal tract.
Ranbaxy claims, the tablet is specifically effective for back & joint pains, which are primarily chronic in nature.
Court rules in favor of Pfizer over Viagra patent
16 August 2011
The US District Court for the Eastern District of Virginia has ruled in favor of Pfizer in a patent infringement case related to Viagra against Teva Pharmaceuticals.
Viagra, an oral therapy for erectile dysfunction, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5).
According to the court's decision,
Teva will not be able to receive approval for generic Viagra till October 2019.
Pfizer executive vice president and general counsel Amy Schulman said protecting the intellectual property rights of their core is critical, and the court decision acknowledges Teva's clear violation of their patent rights.
Aegis peptide analogs receive US patent
16 August 2011
Aegis Therapeutics,
a provider of drug delivery and drug formulation technologies, has received US patent for its GLP-1 peptide analogs.
GLP-1 peptide analogs are suitable for all routes of administration including the non-invasive oral or metered nasal spray delivery routes or injection.
Aegis' patented drug delivery and drug formulation technologies include Intravail drug delivery technology which enables the non-invasive delivery of a protein, peptide and non-peptide drugs.
The ProTek technology is used for aqueous or lyophilized dosage forms to maintain product integrity and reduce unwanted immunogenicity of protein and peptide therapeutics.
Abbott two new strengths of CPP drug gets FDA nod
17 August 2011
Abbott has received the US Food and Drug Administration (FDA) approval for two new strengths of
Lupron Depot-PED (leuprolide acetate for depot suspension) to treat children with
central precocious puberty (CPP).
The application was submitted to FDA on the basis of results from a 24-week study assessing 84 patients with central precocious puberty.
In the trial, the enrolled patients were given a total of two injections, 12 weeks apart, and were followed for nearly six months to investigate hormone suppression and safety.
The trial results suggested that hormone suppression with the new three-month depot formulation in both strengths was sustained in patients throughout the treatment period.
FDA to review Protalix taliglucerase alfa resubmitted NDA
18 August 2011
The US Food and Drug Administration (FDA) has accepted to review Protalix BioTherapeutics' resubmitted new drug application (NDA) of taliglucerase alfa.
The resubmission was done following the issuing of complete response letter (CRL) by the FDA in February 2011.
Taliglucerase alfa is Pfizer's proprietary plant cell expressed recombinant form of human Glucocerebrosidase (GCD) which is being developed as a treatment for gaucher disease.
The company's resubmission answers all the questions raised by the FDA in the CRL as well as the request for clinical data from the company's switchover trial and long-term extension trial, and additional information relating to chemistry, manufacturing and controls (CMC).
Earlier, on 30 November 2009, Pfizer and Protalix signed a deal for the development and commercialization of taliglucerase alfa.
Protalix president and CEO David Aviezer said they look forward to working with the FDA in moving taliglucerase alfa through the regulatory review process over the next few months.
EMA accepts to review Pfizer cancer drugs
18 August 2011
The European Medicines Agency (EMA) has accepted to review Pfizer's experimental compounds, crizotinib and bosutinib's applications.
Crizotinib is indicated as a treatment for patients with previously treated ALK-positive advanced non-small cell lung cancer (NSCLC).
Bosutinib is indicated as a treatment for patients with newly diagnosed Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in the chronic phase.
Pfizer Oncology Europe president Andreas Penk said with the EMA submissions, they are one step closer to bringing two agents to patient populations in areas of significant unmet medical need.
Endo Pharma sues Mylan on migraine drug
18 August 2011
Endo Pharmaceuticals has filed a lawsuit against
Mylan Pharmaceuticals in the US District Court for the District of Delaware.
The case was filed in connection with the submission of abbreviated new drug application (ANDA) for
Frovatriptan Succinate EQ, 2.5mg base tablets
with the US Food and Drug Administration (FDA).
Mylan's Frovatriptan Succinate EQ, 2.5mg base tablets are generic equivalent to Endo Pharma's
Frova which is used as a treatment of symptoms related to acute migraine headaches with or without aura, in adults.
U.S. FDA approves Roche's skin cancer drug
18 August 2011
The Food and Drug Administration has approved a first-of-its-kind drug to treat the deadliest form of skin cancer by targeting a particular genetic mutation found in about half of patients.
The pill called Zelboraf, made by Roche, is the first treatment for melanoma that targets a specific gene found in skin-cancer tumours. The FDA also approved a test to screen patients for the mutation.
The drug was studied in 675 patients who received either Zelboraf or a chemotherapy drug.
The study is ongoing, but 77 per cent of people on Zelboraf are alive, compared with 64 per cent of those taking the older drug, according to the FDA. More than 68,000 cases of melanoma were diagnosed in the U.S. last year.
Despite the higher survival rate, melanoma adapts quickly, and on average patients saw their tumours resume growth after seven months.
A new type of polio vaccine on the cards
18 August 2011
Oral vaccines have played huge part in the global battle to wipe out polio. When the WHO endorsed the goal of eradicating polio in 1988, some 350,000 children in 125 countries were being paralysed by the virus that caused the disease. That number has dropped precipitously and there were only about 1,000 cases of polio across the world last year.
If all goes well, this could be the year when the chain of transmission of wild polio is at last broken in India, one of just four countries in the world where the disease is still endemic.
The oral polio vaccines, which use live but weakened strains of the virus, are easy to administer as drops. But the live viruses they contain can occasionally turn virulent again. Such revertant viruses have the disease-causing potential of the wild forms and can readily spread.
Circulating vaccine-derived polio viruses have been implicated in over 15 outbreaks since 2000. One such outbreak began in Nigeria in 2005 and has still not been stamped out there. The virus turned up in two neighbouring countries as well and has been responsible for over 300 cases of paralysis.
In India, four lineages of vaccine-derived viruses that emerged independently have affected 16 patients in U.P. between July 2009 and March this year. So far this year there have been five such incidents and only one caused by a wild virus.
Using the oral vaccine could be considered an example of fighting fire with fire, remarked Neal Nathanson of the University of Pennsylvania's School of Medicine in an editorial commentary in the Journal of Infectious Diseases earlier this year.
“In countries or continents where wild polio viruses have been eliminated, there should be a transition from OPV to inactivated polio virus vaccine.” Many industrialised countries had already made this shift, he pointed out.
The inactivated vaccine (or IPV) is currently made from virulent strains of the virus that are grown in cell culture and then killed before being administered as an injection.
FDA grants fast track status to Dara cancer drug
19 August 2011
The US Food and Drug Administration (FDA) has granted
fast track designation to
Dara BioSciences' KRN5500 to treat cancer patients with
chemotherapy-induced neuropathic pain.
The company has previously released positive results from a Phase II (DTCL100) trial evaluating KRN5500, which demonstrated reduction of pain and safety and was superior to placebo.
Based largely on these positive findings, the National Cancer Institute (NCI) is partnering with Dara to initiate a second Phase II study, which it anticipates will commence later this year.
Dara chairman and CEO Richard Franco said the FDA fast track designation for KRN5500 is a significant positive step for the thousands of cancer patients who suffer this unremitting pain from a number of causes including from their chemotherapy.
CHMP accepts to review Merck, ARIAD ridaforolimus NDA
19 August 2011
The Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) has accepted
Merck and ARIAD Pharmaceuticals' new drug application (NDA) of
ridaforolimus for review.
Ridaforolimus is an experimental oral mTOR inhibitor developed as a treatment for patients with
metastatic soft-tissue or bone sarcomas who had a favorable response to chemotherapy.
Earlier, ARIAD and Merck entered into a licensing deal, under which Merck is responsible to develop and commercialize ridaforolimus in oncology.
ARIAD plans to co-promote ridaforolimus in the US.
Merck Global Human Health Oncology Franchise senior vice president and general manager Marty Duvall said this acceptance of the EMA filing for review is an important milestone as they seek to bring forward a potential treatment option for patients with metastatic bone and soft tissue sarcomas.
FDA Approves Seattle Genetics’ Adcetris
19 August 2011
The U.S. Food and Drug Administration today approved
Adcetris (brentuximab vedotin) to treat
Hodgkin lymphoma (HL) and a rare lymphoma known as systemic anaplastic large cell lymphoma (ALCL). Adcetris is marketed by
Seattle Genetics of Bothell, Wash.
Lymphomas are cancers of the lymphatic system. Adcetris is an antibody-drug conjugate that combines an antibody and drug, allowing the antibody to direct the drug to a target on lymphoma cells known as CD30.
Adcetris is to be used in patients with HL whose disease has progressed after autologous stem cell transplant or after two prior chemotherapy treatments for those who cannot receive a transplant. Autologous stem cell transplant is a procedure using a patient’s own bone marrow that is designed to repair damaged bone marrow after the use of high chemotherapy doses. Adcetris may also be used in patients with ALCL whose disease has progressed after one prior chemotherapy treatment.
“Early clinical data suggest that patients who received Adcetris for Hodgkin lymphoma and systemic anaplastic lymphoma experienced a significant response to the therapy,” said Richard Pazdur, M.D., director of the Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research.
According to the National Cancer Institute (NCI), common symptoms of HL include the enlargement of lymph nodes, spleen, fever, weight loss, fatigue, or night sweats. NCI estimates that 8,830 new cases of HL will be diagnosed in the United States in 2011 and about 1,300 people will die from the disease.
Valeant Pharma acquires AB Sanitas
22 August 2011
Valeant Pharmaceuticals, a developer, manufacturer and marketer of a range of pharmaceutical products primarily in the areas of neurology, dermatology and branded generics, has acquired
AB Sanitas.
Previously,
Valeant signed a deal to take over Lithuania-based specialty pharmaceuticals company AB Sanitas for around EUR314m.
Sanitas has a range of branded generics product portfolio consisting of 390 products in nine countries throughout Central and Eastern Europe, primarily Poland, Russia and Lithuania.
The company has in-house development capabilities in dermatology, ophthalmology and hospital injectables and also a pipeline of internally developed and acquired dossiers.
US court rules in favour of Affymetrix
22 August 2011
The US Court of Appeals for the Federal Circuit has ruled in favour of Affymetrix by dismissing the patent infringement lawsuits brought by Illumina regarding US Patent Nos. 7,510,841 and 7,612,020.
Affymetrix executive vice president, general counsel and secretary Rick Runkel said they are pleased that the Federal Circuit has affirmed the District Court's prior rulings that Affymetrix does not infringe the asserted patents and dismissing Illumina's lawsuits.
"we are committed to conducting our business with the utmost integrity and believe the ruling of both the District Court and the Court of Appeals underscore this commitment," Runkel said.
Sandoz sues Novo Nordisk on generic diabetes drug
22 August 2011
Sandoz has sued Danish Novo Nordisk in the US District Court, Eastern District of Michigan (Detroit) over a generic version of diabetes drug.
Sandoz has filed the case with a hope that the court will find that its generic version of Novo Nordisk's diabetes drug Prandin (repaglinide) is non-infringing, Bloomberg reported.
Sandoz intends to market a generic version of Prandin in low cost.
Prandin (repaglinide) is an oral blood glucose-lowering drug of the meglitinide class used in the management of type 2 diabetes mellitus (also known as non-insulin dependent diabetes mellitus).
FDA gives fast track status to Algeta radium-223 chloride
23 August 2011
The US Food and Drug Administration (FDA) has granted fast track status for Algeta's radium-223 chloride to treat castration-resistant (hormone refractory) prostate cancer in patients suffering from bone metastases.
Earlier in September 2009, Bayer has entered into a pact with Algeta to develop and commercialize radium-223 chloride.
A Phase III trial conducted by Algeta and Bayer Pharma investigating radium-233 chloride for treating symptomatic bone metastases in CRPC patients met primary endpoint by improving overall survival.
Algeta president and CEO Andrew Kay said the positive results at the pre-planned interim analysis of the pivotal phase III study was an achievement for Algeta and for Bayer, reinforcing the common belief of radium-223 chloride's potential to become an important treatment for bone metastases initially with prostate cancer.
Girard Gibbs sues Takeda, Eli Lilly on Actos
23 August 2011
US based litigation firm
Girard Gibbs has sued
Takeda Pharmaceuticals and
Eli Lilly on type 2 diabetes drug
Actos.
The lawsuit alleges that the companies failed to warn the consumers of Actos regarding the increased risk of bladder cancer associated with pioglitazone, sold under the brand name Actos.
Earlier in June 2011, the US Food and Drug Administration (FDA) has issued safety alert in connection with the risk of bladder cancer with prolonged usage of Actos.
One of the lead attorneys litigating the case AJ De Bartolomeo said prescription drug manufacturers are required to issue warnings about the possible risks of negative side effects from their products.
"When a manufacturer decides not to provide full disclosure of the potential risks from a medication, doctors and patients cannot make informed decisions about what drug is right for them, and as a result, people suffer injuries unnecessarily," Bartolomeo said.
Vertex Pharma chronic hepatitis C drug gets Health Canada nod
23 August 2011
US based
Vertex Pharmaceuticals has received the Health Canada approval for
Incivek (telaprevir) tablets for the treatment of patients with
chronic hepatitis C with liver disease.
The drug has been approved for use in conjunction with two different hepatitis C drugs, pegylated-interferon and ribavirin.
The combined dosage is indicated for the patients who are new to treatment, and for people who were treated previously but who did not achieve a sustained viral response (SVR, or viral cure).
The Health Canada approval was backed by the results of Phase 3 studies which demonstrated that people who received Incivek combination treatment achieved higher rates of viral cure (sustained viral response, or SVR) compared to those who received pegylated-interferon and ribavirin alone.
FDA grants fast track status to Pharmasset HCV
24 August 2011
The US Food and Drug Administration (FDA) has granted fast track designation for
Pharmasset's chronic hepatitis C virus (HCV) infection treatment,
PSI-938.
PSI-938 is an oral guanosine nucleotide analog polymerase inhibitor of HCV.
Earlier in Nuclear study , PSI-938 showed potent antiviral activity and was generally safe and well tolerated, both as monotherapy and in conjunction with the company's lead nucleotide analog, PSI-7977.
Currently, Pharmasset intends to start Quantum combination trial with PSI-938 and PSI-7977 in the third quarter of 2011.
Simcere anti-rheumatic drug wins SFDA approval
25 August 2011
Simcere Pharmaceutical Group, a developer of proprietary pharmaceuticals in China, has received the State Food and Drug Administration (SFDA) approval for its
Iguratimod drug - Iremod.
The drug is designed to treat active rheumatoid arthritis and comes under a category of disease modifying anti-rheumatic drugs (DMARDS).
The clinical studies demonstrate that Iremod can relieve symptoms caused by active
rheumatoid arthritis.
Simcere Pharmaceutical Group chairman and CEO Ren Jinsheng said they will continue to put their efforts and resources into developing and producing medicines for patients.
QRxPharma files MoxDuo IR NDA with FDA
26 August 2011
QRxPharma has filed a new drug application (NDA) clinical data package of
MoxDuo IR with the US Food and Drug Administration (FDA) as a treatment for
moderate to severe pain.
MoxDuo IR is an immediate-release Dual Opioid pain therapy comprised of a patented 3:2 fixed ratio combination of morphine and oxycodone.
The company's NDA Chemistry, Manufacturing and Controls (CMC) module is currently on FDA review.
QRxPharma has requested a priority (accelerated) FDA review for MoxDuo IR based on positive clinical data from several head-to-head comparisons with morphine, oxycodone, Percocet and placebo.
In the company's Study 022, the drug has showed reduction in respiratory depression which will support the company to submit European marketing authorisation application (MAA) in 2012.
EC approves Boehringer, Eli Lilly type 2 diabetes drug
26 August 2011
The European Commission (EC) has granted marketing authorization approval to
Boehringer Ingelheim and
Eli Lilly for
linagliptin 5mg film-coated tablets as a
type 2 diabetes treatment.
The EC approval has been granted for linagliptin in combination with metformin and metformin plus sulfonylurea.
The product will be marketed under Trajenta trade name in Europe.
The approval was backed by the results clinical trial program which included around 6,000 adults with type 2 diabetes.
In two monotherapy studies, linagliptin showed a mean difference in A1C from placebo of -0.6 to -0.7%.
Boehringer Ingelheim Medicine corporate senior vice president Klaus Dugi said the Phase III clinical trial program has demonstrated efficacy with linagliptin in the treatment of adults with type 2 diabetes.
"We are delighted that linagliptin will soon be available to patients across Europe," Dugi said.
U.S. Food And Drug Administration Approves Pfizer's XALKORI® (crizotinib)
29 August 2011
Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has approved XALKORI® (crizotinib) capsules, the first-ever therapy targeting anaplastic lymphoma kinase (ALK), for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that is ALK-positive as detected by an FDA-approved test. The effectiveness of XALKORI is based on objective response rates (ORR) and, as XALKORI received accelerated approval from the FDA, Pfizer is conducting post-marketing clinical trials to further evaluate its clinical benefit.
"Overall, lung cancer is responsible for more deaths each year worldwide than any other type of cancer. XALKORI is an advance in the treatment of this devastating illness, providing a new therapeutic option for a subset of patients with the disease,2 said Ian Read, president and chief executive officer of Pfizer. "The acceleration, collaboration and critical focus of the XALKORI clinical development program reflect Pfizer’s Precision Medicine approach to advancing our pipeline and strengthening our innovative core to deliver medicines that matter most."
FDA requests Novartis gouty arthritis drug additional clinical data
29 August 2011
The US Food and Drug Administration (FDA) has issued a complete response letter to
Novartis requesting more data to support
ACZ885 (canakinumab) approval in
gouty arthritis patients.
The FDA recommended that additional retreatment data would be needed to assess the overall safety profile of ACZ885.
Novartis submitted ACZ885 for regulatory review in the EU in 2010 and in the US, Canada and Switzerland in the first quarter of 2011.
The submissions were based on clinical trials that showed gouty arthritis patients treated with ACZ885 at the time of an attack experienced superior pain relief at 72 hours and reduction in the risk of new attacks over six months, compared to patients treated with the injectable steroid, triamcinolone acetonide (TA)
FDA approves Perrigo Ketoconazole Foam, 2%
30 August 2011
The US Food and Drug Administration (FDA)
has approved
Perrigo's abbreviated new drug application for
Ketoconazole Foam, 2%.
Perrigo's Ketoconazole Foam, 2% is generic equivalent to
Extina Ketoconazole Foam, 2%.
Ketoconazole Foam, 2% is indicated for topical treatment of
seborrheic dermatitis in immunocompetent patients 12 years of age and older.
Perrigo chairman and CEO Joseph Papa said this launch reflects their continuing investment in new products.
"It is an example of the excellent partnership we have with Cobrek for developing foam products which is a key product category for our Rx business," Papa said.
ESC recommends AstraZeneca Brilique as treatment for ACS
30 August 2011
The
European Society of Cardiology (ESC) has granted Class I recommendation for AstraZeneca's oral antiplatelet medicine
Brilique (ticagrelor) in the revised 'Guidelines for Management of Acute Coronary Syndromes (ACS) in patients presenting without persistent ST-segment elevation.'
According to the revised guidelines, ticagrelor is recommended for all
non-ST elevation ACS patients at moderate-to-high risk of ischemic events, regardless of initial treatment strategy and including those pre-treated with clopidogrel (which should be discontinued when ticagrelor is commenced) (Class 1, level of evidence B).
In addition, the guidelines recommend ticagrelor be considered for initiation or resumption following coronary artery bypass graft (CABG) surgery as soon as it is considered safe (Class IIa, level of evidence B).
The ESC guidelines was given on the basis of review of ticagrelor clinical programme, including results from a study of platelet inhibition and patient outcomes (PLATO) study.
The study results suggested that treating 54 ACS patients with ticagrelor instead of clopidogrel for one year prevented one atherothrombotic event and treating 91 patients prevented one cardiovascular (CV) death, with no increase in overall major/fatal bleeding over the course of one year of treatment.
FDA grants fast track status to AiCuris Letermovir
30 August 2011
The US Food and Drug Administration (FDA) has granted fast track status for
AiCuris' AIC246 (INN: Letermovir).
Recently, the company has confirmed positive results from a Phase IIb trial evaluating Letermovir, an inhibitor of the human cytomegalovirus (HCMV).
AiCuris CEO Helga Rubsamen-Schaeff said having obtained orphan drug status in the EU, receipt of fast track designation for Letermovir in the US is another significant milestone for the company.
"It will hopefully facilitate the regulatory process for this drug and supports our view that Letermovir has the potential to become the treatment of choice for patients at risk to develop
severe and life-threatening HCMV disease, such as transplant recipients, newborns, patients in intensive care, certain cancer patients and HIV patients," Rubsamen-Schaeff said.
Toyama, Eisai file MAA for anti-rheumatic drug
31 August 2011
Toyama Chemical and Eisai have filed
T-614's (iguratimod) marketing authorization application (MAA) as a treatment for
rheumatoid arthritis.
T-614 is a novel disease modifying anti-rheumatic drug (DMARD) originally discovered by Toyama Chemical.
Toyama Chemical and Eisai are jointly developing T-614 under a co-development and licensing deal signed in 1998.
If approved, the drug will be co-promoted by Taisho Toyama Pharmaceutical and Eisai under a two-brand, two-channel scheme.
