Regeneron Pharma receives marketing authorization from EU for rilonacept to treat CAPS

Regeneron Pharmaceuticals, Inc has received marketing authorization in the European Union for rilonacept, an interleukin-1 blocker, for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS) with severe symptoms, including Familial Cold Auto-inflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS), in adults and children aged 12 years and older.

The details can be read here.

Transcept Pharmaceuticals Receives Complete Response Letter from FDA on Intermezzo New Drug Application

Transcept Pharmaceuticals announced today that the U.S. FDA issued a Complete Response Letter regarding the New Drug Application (NDA) for Intermezzo® (zolpidem tartrate sublingual tablet). The NDA, submitted by Transcept in September 2008, seeks approval to market Intermezzo® for use as-needed for the treatment of insomnia when a middle of the night awakening is followed by difficulty returning to sleep.

The details can be read here.

DTAB to review Sun Pharma's drug, letrozole, for sub-fertility on Nov 9

The Drugs Technical Advisory Board (DTAB), the highest body under the Union Health Ministry on technical matters concerning the pharma industry in the country, will re-examine the controversial drug letrozole which is indicated for sub-fertility in young menstruating women in the country. The DTAB is meeting on November 9.


The details can be read here.

European Commission Grants Promedior's PRM-151 Orphan Drug Designation for the Prevention of Scarring Post Glaucoma Filtration Surgery

Oct 29, 2009 - Promedior, Inc., a leader in the development of novel therapeutics for the treatment of fibrotic diseases and tissue remodeling, announced today that the European Commission has granted Orphan Medicinal Product Designation to its lead drug candidate PRM-151 for use in the prevention of scarring post glaucoma filtration surgery.

The details can be read here.

Shire Secures European Wide Label Extension for Fosrenol in Chronic Kidney Disease

October 28-- Shire plc, the global specialty biopharmaceutical company, today announced it has received approval through the European Mutual Recognition Procedure for an extension to the current indication for FOSRENOL(R) (lanthanum carbonate), paving the way to make the non-calcium, non-resin phosphate binder available throughout the EU to control hyperphosphataemia in chronic kidney disease (CKD) patients who are not on dialysis with a serum phosphorus level greater than or equal to 1.78mmol/L (5.5mg/dL).

The details can be read here.

Novartis on track to deliver Influenza A (H1N1) vaccine for the US

October 29, 2009 - Novartis confirmed today that it has shipped over 7.5 million doses of Influenza A(H1N1)[1] vaccine ready to use and expects 25 to 30 million doses of unadjuvanted vaccine to become available in pre-filled syringes and multi-dose vials by the end of November. Smaller changes in delivery timelines and volumes can result out of the variability of the underlying biological production process.

The details can be read here.

Watson and Barr Settle Lawsuit Over Oxytrol

Watson Pharmaceuticals, Inc., a leading specialty pharmaceutical company, announced today that its subsidiary Watson Laboratories, Inc. has reached a settlement with Barr Laboratories, Inc. on outstanding patent litigation related to Watson's Oxytrol® (Oxybutynin Transdermal System, 3.9mg/24hr.) product.

The details can be read here.

AstraZeneca Withdraws Regulatory Submissions For Zactima (Vandetanib) In Combination With Chemotherapy For Advanced NSCLC

28 October 2009 - AstraZeneca announced today that it has withdrawn the regulatory submissions for the use of ZACTIMA (vandetanib) 100mg in combination with chemotherapy in patients with advanced non-small cell lung cancer (NSCLC) from the US FDA and the European Medicines Agency (EMEA). The applications were submitted to regulatory agencies in June 2009.

The details can be read here.

Novartis Biological Drug Ilaris Approved In EU To Treat Children And Adults With CAPS, A Rare Debilitating Auto-Inflammatory Disease

October 28, 2009 - The new biological medicine Ilaris® (canakinumab) has been approved in the European Union (EU) to treat adults and children as young as four years old with cryopyrin-associated periodic syndrome (CAPS), a rare life-long auto-inflammatory disease with debilitating symptoms and few treatment options

The details can be read here.

Sandoz filed for declaratory Judgement of Invalidity and non-infringement of patents listed for Caduet

As reported on Patentdocs Sandoz has filed for the Declaratory judgment of invalidity and non-infringement of U.S. Patent Nos. 6,126,971 ("Stable Oral CI-981 Formulation and Process for Preparing Same," issued October 3, 2000), 5,969,156 ("Crystalline [r- (R*,R*)]-2-(4-DFluorophenyl)-b,δ-Dihydroxy-5-(1-Methylethyl)-3-Phenyl-4-[(Phenylamino)Corbonyl]-1HPyrrole-1Heptanoic Acid Hemi Calcium Salt (Atorvastatin)," issued October 19, 1999), and 5,686,104 ("Stable Oral CI-981 Formulation and Process of Preparing Same," issued November 11, 1997) based on Sandoz's filing of an ANDA to manufacture a generic version of Pfizer's Caduet®.

The details can be read here.

The complaint can be read here.

New data shows patients more satisfied with liraglutide than exenatide

New data on patient treatment satisfaction from the LEAD 6 trial presented at the 20th World Diabetes Congress (International Diabetes Federation) shows that patients have higher overall treatment satisfaction with liraglutide than they do with exenatide.

The details can be read here.

Sinovac Biotech gets approval to distribute swine flu vaccine Panflu in Mexico

Sinovac Biotech Ltd, a leading developer and provider of vaccines in China, has received a Certificate of Approval from the Secretaria de Salud to distribute Panflu.1, its H1N1 pandemic influenza (swine flu) vaccine, in Mexico.

The details can be read here.

Allergan Announces Victory in Brimonidine Patent Infringement Case

Oct 24, 2009 - Allergan, Inc. announced today that the United States District Court for the District of Delaware ruled in favor of Allergan, Inc. in its patent infringement suit against Exela PharmSci, Inc., Exela PharmSci Pvt., Ltd., Apotex, Inc. and Apotex Corp. for seeking to market purported generic versions of Allergan's drugs ALPHAGAN® P (brimonidine tartrate ophthalmic solution) 0.1% and 0.15%. Specifically, after a trial in March of 2009, the Court ruled today that all five patents (U.S. Patent Nos. 6,627,210; 6,641,834; 6,673,337; 6,562,873; and 5,424,078) asserted by Allergan are valid and enforceable, that Apotex's proposed generic versions of ALPHAGAN® P 0.1% and 0.15% infringe each of the five patents, and that Exela's proposed generic version of ALPHAGAN® P 0.15% infringes U.S. Patent No. 6,641,834, which was the only patent asserted against it. Pursuant to the Hatch-Waxman Act, the United States Food and Drug Administration is required to delay approval of Defendants' proposed generic products until the last to expire of the infringed patents, which is 2022.

The details can be read here.

Movetis obtains EU authorisation for the commercialisation of Resolor (prucalopride)

October 23, 2009 - Movetis, the GI specialty pharmaceutical company based in Belgium, announces that it has obtained approval from the European Commission for the commercialisation of its lead product Resolor (prucalopride – a 1mg and 2mg once a day oral tablet) for the symptomatic treatment of chronic constipation (CC) in women in whom laxatives fail to provide adequate relief.

The details can be read here.

Sun Pharma loses patent battle against Forest Labs on Alzheimer’s drug

The Mumbai-based Sun Pharmaceuticals has agreed to stop manufacturing and marketing of its generic version of Namenda (memantine hydrochloride), the lucrative Alzheimer’s drug patented by Forest Laboratories with the resolving of the dispute between the two firms at the US District Court for the District of Delaware.

The details can be read here.

Acorda Therapeutics Announces Extension of Fampridine-SR PDUFA Goal Date to January 22, 2010

Oct 22, 2009 - Acorda Therapeutics, Inc. today announced that the U.S. Food and Drug Administration (FDA) has extended the PDUFA goal date for its review of the New Drug Application (NDA) for Fampridine-SR to January 22, 2010.

The details can be read here.

FDA Approves New Use for Micardis in Cardiovascular Risk Reduction and Twynsta as New Combination Treatment for High Blood Pressure

Boehringer Ingelheim Pharmaceuticals, Inc. announced today that the U.S. FDA approved the supplemental New Drug Application (sNDA) for its angiotensin II receptor blocker (ARB) Micardis® (telmisartan) Tablets 80 mg for reduction of the risk of myocardial infarction, stroke, or death from cardiovascular causes in patients 55 years of age or older at high risk of developing major cardiovascular events who are unable to take angiotensin-converting enzyme (ACE) inhibitors.

The details can be read here.

DCGI to notify guidelines attached to Spurious Drugs Act to curb harassment of drug units

In a bid to curb the possible misuse of powers by drug inspectors under the newly amended Drugs & Cosmetics Act, the Drug Controller General of India has started initiatives to notify the guidelines attached to the Bill to avoid unnecessary harassment to genuine drug manufacturers by the drug inspectors.

The details can be read here.

FDA Issues Complete Response Letter for CorVue

Oct 21, 2009 - King Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) issued a complete response letter regarding the New Drug Application (NDA) for CorVue™ (binodenoson) for injection.

the details can be read here.

APP Pharmaceuticals Receives Approval for the First Generic Chlorothiazide Sodium for Injection, USP

APP Pharmaceuticals, Inc., announced today that it has received approval from the U.S. Food and Drug Administration (FDA) to market Chlorothiazide Sodium for Injection, USP. APP expects to launch Chlorothiazide Sodium for Injection, USP in the fourth quarter of 2009.

The details can be read here.

International public interest groups slam EU on double standards on drug laws

International public interest organizations have charged the European Union with adopting double standards vis-à-vis poor and developed countries, and blocking the access to essential medicines across the world, especially in the underdeveloped countries.

The details can be read here.

US FDA panel backs Acorda Therapeutics' MS drug Fampridine-SR

Acorda Therapeutics, Inc announced the US FDA Peripheral and Central Nervous System Drugs (PCNSD) Advisory Committee voted 12 to 1 that clinical data on Fampridine-SR 10 mg twice daily demonstrated substantial evidence of effectiveness as a treatment to improve walking in people with multiple sclerosis (MS) and voted 10 to 2 (1 abstention) that it is clinically meaningful and can be safe for use.

The details can be read here.

Apollo pharmacy chain gets DCGI nod for selling oseltamivir

Apollo Pharmacy, India's leading pharmacy network with over 1000 outlets across the country, has received license from the Drug Controller General of India for the retail sale of oseltamivir, a drug for the treatment of H1N1 Influenza.

The details can be read here.

Dexferrum (iron dextran injection): Risk of anaphylactic-type reactions, including fatalities, following parenteral administration of iron dextran

Oct. 16, 2009--American Regent and FDA notified healthcare professionals that anaphylactic-type reactions, including fatalities, have followed the parenteral administration of iron dextran injection. The Boxed Warning has been modified to recommend administering a test dose prior to the first therapeutic dose and observing for signs or symptoms of anaphylactic-type reactions during administration of Dexferrum.

The details can be read here.

Winston Laboratories, Inc. Receives Notice of Non-Compliance in Canada for its New Drug Submission of CIVANEX to Treat Osteoarthritis

Oct 19, 2009 - Winston Laboratories, Inc., a wholly-owned subsidiary of Winston Pharmaceuticals, Inc. today announced that it has received a Notice of Non-compliance from the Therapeutics Drug Directorate, Health Canada for its New Drug Submission (NDS) for CIVANEX (zucapsaicin cream 0.075%) for the treatment of the signs and symptoms of osteoarthritis.

The details can be read here.

Exclusive European Sublicensing Agreement Signed for Teijin-developed TMX-67 Gout Treatment

October 20, 2009 -- Teijin Pharma announced today the signing of an exclusive sublicense agreement for TMX-67 (febuxostat) between Ipsen of France, the European TMX-67 licensee, and the Menarini Group of Italy. Discovered and developed by Teijin Pharma, TMX-67 is a novel drug for the treatment of hyperuricemia in patients with gout, and is a strategic product for the expansion of the company's overseas businesses.

The details can be read here.

Ipsen Grants Menarini Exclusive European Licence Rights to Adenuric (Febuxostat), Its Novel Treatment for Chronic Hyperuricaemia in Gout

Ipsen, an innovation-driven global specialty pharmaceutical group, today announced an agreement whereby Ipsen grants the Menarini Group the exclusive licence rights to Adenuric® (febuxostat) in 41 countries. Ipsen retains co-promotion rights for Adenuric® in France.

the details can be read here.

India to lodge complaint with WTO against seizure of drug exports at EU ports

The Indian government will soon file a complaint at the World Trade Organisation (WTO) against the European Union (EU) on the issue of seizure of Indian drug shipments at EU ports, as efforts at different international forums to find an amicable solution to the nagging issue did not bear fruits so far.

The details can be read here.

AstraZeneca Submits Marketing Authorisation Application to European Union for Vimovo

Oct. 16, 2009-AstraZeneca and POZEN Inc. today announced that they have submitted a Marketing Authorisation Application (MAA) in the European Union via the Decentralised Procedure (DCP) for VIMOVO™ (enteric-coated naproxen/immediate release esomeprazole magnesium, formerly known as PN 400) tablets, a product under investigation for the treatment of the signs and symptoms of osteoarthritis (OA), rheumatoid arthritis (RA) and ankylosing spondylitis (AS) in patients who are at risk of developing NSAID-associated ulcers.

The details can be read here.

Talecris Biotherapeutics Receives FDA Approval for Prolastin-C

Talecris Biotherapeutics today received approval from the U.S. Food and Drug Administration for PROLASTIN®-C (Alpha1-Proteinase Inhibitor [Human]), a more concentrated version of PROLASTIN® produced using advances in manufacturing technology.

The details can be read here.

FDA Approves Elitek (rasburicase) for Management of Plasma Uric Acid Levels in Adults with Leukemia, Lymphoma, and Solid Tumors Receiving Anti-Cancer

Sanofi-aventis U.S. announced that the U.S. FDA has granted marketing approval for Elitek® (rasburicase) to be used for the initial management of plasma uric acid (PUA) levels in adult patients with leukemia, lymphoma, and solid tumor malignancies who are receiving anti-cancer therapy expected to result in tumor lysis syndrome (TLS) and subsequent elevations of plasma uric acid.

The details can be read here.

FDA approves Cervarix, GlaxoSmithKline’s cervical cancer vaccine

Oct. 16, 2009--GlaxoSmithKline (GSK) announced today that the U.S. FDA has approved CERVARIX® [Human papillomavirus bivalent (types 16 and 18) vaccine, recombinant] for the prevention of cervical pre-cancers and cervical cancer associated with oncogenic human papillomavirus (HPV) types 16 and 18 for use in girls and young women (aged 10-25).

The details can be read here.

Symbicort Turbuhaler Approved for the Treatment of Adult Asthma in Japan

Oct. 16, 2009--AstraZeneca today announced that Symbicort Turbuhaler (budesonide/formoterol) has been approved by Japan’s Ministry of Health, Labor and Welfare (MHLW) for the maintenance treatment of bronchial asthma in patients aged 16 and over when a combination therapy of an inhaled steroid and a long-acting beta-2 agonist is necessary.

The details can be read here.

U.S. Food and Drug Administration Approves Crestor for Use in Pediatric Patients With Heterozygous Familial Hypercholesterolemia

AstraZeneca today announced the U.S. FDA approved CRESTOR® (rosuvastatin calcium) for use in pediatric patients ages 10-17 with heterozygous familial hypercholesterolemia (HeFH) when diet therapy fails to reduce elevated cholesterol. HeFH, a genetic disease, is characterized by high LDL cholesterol (the "bad" cholesterol) and increased risk of early cardiovascular disease.

The details can be read here.

Court Imposes Record Fine and Forfeiture of $1.3 Billion for Pharmacia & Upjohn Company's Fraudulent Marketing of Bextra

PHARMACIA & UPJOHN COMPANY, INC., a subsidiary of Pfizer Inc. today was sentenced today in federal court for a felony violation of the Food, Drug & Cosmetic Act, for misbranding the drug, Bextra, with the intent to defraud or mislead.

The details can be read here.

Federal Circuit Court Hands Academic Inventors a Big Win – IP Advocate Founder Says Decision Affirms That Faculty Inventors, Own Their inventions

A recent Federal Circuit Court decision confirms that universities do not automatically have the right to claim ownership of a faculty researcher's federally funded invention. That's a critical distinction that could protect faculty inventors and students nationwide from being forced by universities to sign away the rights to their life's work, according to Dr. Renee Kaswan, inventor of the billion-dollar drug Restasis® and founder of the non-profit organization IPAdvocate.org.

The details can be read here.

Teva Comments on Mylan Paragraph IV Filing for Copaxone; Files Lawsuit against Generic Filer for Patent Infringement

Oct 16, 2009 - Teva Pharmaceutical Industries Ltd. commented today on the abbreviated new drug application (ANDA) containing a Paragraph IV certification for COPAXONE® (glatiramer acetate injection), filed by Mylan Pharmaceuticals Inc. Teva also announced that it has filed a lawsuit against Mylan Pharmaceuticals, Inc., Mylan Inc. and Natco Pharma Ltd. for patent infringement in the U.S. District Court for the Southern District of New York.

the details can be read here.

Boehringer Ingelheim Receives Approval from the European Commission for Mirapexin/Sifrol Prolonged-release, Once Daily Tablet

14 October 2009 – Boehringer Ingelheim today announced that the Mirapexin®/Sifrol® (pramipexole) new prolonged-release, once daily tablet has been granted marketing authorisation by the European Commission in all EU/EEA*) countries for the treatment of early and advanced idiopathic Parkinson’s disease (PD). The approval was based on the submission of clinical trial results showing that the new formulation can offer an efficacy and safety profile comparable to the immediate release tablet taken three times daily.1-6

The details can be read here.

US Court rules Ranbaxy's generic valganciclovir does not infringe Roche's Valcyte patent

In a verdict on the patent litigation between Roche Palo Alto and the Daiichi-Ranbaxy on the former's patent rights with crystalline valganciclovir, the active ingredient in anti-viral drug Valcyte, the District Court of New Jersey has ruled that Ranbaxy's generic version does not infringe the patent even as Roche's patent on the product is valid.

The details can be read here.

Mylan Receives FDA Approval for Generic Version of Anticonvulsant Topamax Sprinkle Capsules

Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Topiramate Capsules (Sprinkle), 15 mg and 25 mg.

The details can be read here.

Pfizer Announces Settlement And License Agreement With Mylan Related To Vfend

Oct 14, 2009 - Pfizer Inc today announced that it has entered into an agreement with two subsidiaries of Mylan Inc. relating to a generic version of Vfend (voriconazole), an antifungal agent. The agreement is limited to the tablet form of Vfend and does not cover Pfizer's Vfend products for intravenous use or oral suspension.


The details can be read here.

GlaxoSmithKline Withdraws its Marketing Authorisation Application for Zunrisa (casopitant mesilate)

Oct. 13, 2009--The European Medicines Agency has been formally notified by GlaxoSmithKline Research and Development Limited of its decision to withdraw its application for a centralised marketing authorisation for the medicine Zunrisa (casopitant mesilate), 50 mg and 150 mg film coated tablets.

The details can be read here.

Ipsen and Debiopharm Group Announce That Decapeptyl (triptorelin embonate) 6-Month Successfully Completes the European Decentralised Procedure

Oct 13, 2009 - Debiopharm Group, a Swiss-based global biopharmaceutical group of companies with a focus on the development of prescription drugs that target unmet medical needs, and Ipsen, an innovation-driven global specialty pharmaceutical Group, announced that the 6-month sustained-release formulation of Decapeptyl®1 (triptorelin embonate2 22.5 mg) successfully completed its European decentralised registration procedure involving nine countries: Germany (reference member state), France, Austria, Finland, Norway, Belgium, Denmark, Spain and The Netherlands.

the details can be read here.

Sinovac Receives Certificate of Approval to Distribute Panflu (H5N1) Vaccine in Hong Kong

Sinovac Biotech Ltd., a leading developer and provider of vaccines in China, announced today that its wholly-owned subsidiary, Sinovac Biotech (Hong Kong) Ltd, has received the Certificate of Approval to distribute Panflu(TM) (H5N1), its H5N1 (bird flu) pandemic influenza vaccine, in Hong Kong.

The details can be read here.

Novartis Pharma Acquires Exclusive Rights From Vanda Pharmaceuticals for Commercialization of Fanapt in the United States and Canada

Oct 13, 2009 - Titan Pharmaceuticals, Inc today announced that Vanda Pharmaceuticals, Inc. reported its entry into an exclusive agreement with Novartis Pharma AG to commercialize and develop Fanapt™ (iloperidone) in the U.S. and Canada. Fanapt™, an atypical anti-psychotic, was approved by the U.S. Food and Drug Administration earlier this summer for the acute treatment of schizophrenia in adults. The U.S. anti-psychotic market is approximately $14 billion a year.

The details can be read here.

Emisphere Technologies Introduces First Commercially Available Product, Oral Eligen B12

October 8, 2009 – Emisphere Technologies, Inc. today announced that the Company is introducing and launching its first commercially available product, oral Eligen® B12 (100 mcg). Oral Eligen® B12 (100 mcg) has been specifically developed to help improve Vitamin B12 absorption and bioavailability with a patented formulation.

The details can be read here.

Shire and Sandoz Settle all Pending Litigation Concerning Adderall XR

October 13/PRNewswire-FirstCall/ -- Shire plc, the global specialty biopharmaceutical company, announces that it has settled all pending litigation with Sandoz, Inc. in connection with Sandoz's Abbreviated New Drug Application ("ANDA") and its attempt to market generic versions of Shire's ADDERALL XR(R) (mixed amphetamine salts) for the treatment of Attention Deficit Hyperactivity Disorder.


The details can be read here.

Welchol (colesevelam HCl) Receives FDA Approval to Lower LDL Cholesterol in Pediatric Patients with Heterozygous Familial Hypercholesterolemia

Daiichi Sankyo, Inc. (DSI) announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for Welchol® (colesevelam HCl) to be used as an adjunct to diet and exercise for the reduction of elevated low-density lipoprotein cholesterol (LDL-C) in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia (heFH) alone or in combination with a statin after failing an adequate trial of diet therapy.

The details can be read here.

Baxter Receives European Commission Approval for CELVAPAN H1N1 Pandemic Influenza Vaccine

Oct 7, 2009 - Baxter International Inc. today confirmed that the European Commission (EC) has granted marketing authorization for CELVAPAN H1N1 pandemic vaccine using Baxter's Vero cell technology. CELVAPAN H1N1 is the first cell culture-based and non-adjuvanted pandemic influenza vaccine to receive marketing authorization in the European Union.

The details can be read here.

Impax Laboratories Settles Pending Litigation for Flomax

Oct 7, 2009 - Impax Laboratories, Inc. today announced that it has reached agreement with Astellas Pharma Inc. and Boehringer Ingelheim Pharmaceuticals, Inc. to settle pending U.S. litigation with regard to US Patent No. 4,703,063 for FLOMAX® (generic name: tamsulosin hydrochloride) capsules through the entry of a consent judgment confirming the validity and infringement of the patent. FLOMAX® is a treatment for the functional symptoms of benign prostatic hyperplasia.

The details can be read here.

APP Pharmaceuticals Receives Approval for Sumatriptan Succinate Injection, USP

Oct 8, 2009 - APP Pharmaceuticals, Inc., a wholly owned subsidiary of Fresenius Kabi Pharmaceuticals Holding, Inc., announced today that it has received approval from the U.S. Food and Drug Administration (FDA) to market Sumatriptan Succinate Injection, USP, in two dosage strengths.

The details can be read here.

Genzyme Receives FDA Complete Response Letter for Clolar

Oct 6, 2009 - Genzyme Corporation announced today that the FDA provided a complete response letter regarding the company's supplemental New Drug Application for Clolar® (clofarabine) in previously untreated older adult patients with acute myeloid leukemia (AML) and at least one unfavorable baseline prognostic factor.

the details can be read here.

Orexo confirms FDA acceptance of Abstral filing

6th October, 2009 - Orexo AB today confirms that its partner, ProStrakan Group plc, has announced that the New Drug Application (NDA) filing for Abstral has been accepted for review by the US Food and Drug Administration (FDA).

The details can be read here.

Simponi (golimumab) Receives European Approval as Once-Monthly Subcutaneous Anti-TNF

Centocor Ortho Biotech Inc. and Schering-Plough Corporation (NYSE: SGP) announced today that the European Commission has approved SIMPONI(TM) (golimumab) as a once-monthly, subcutaneous therapy for the treatment of moderate-to-severe, active rheumatoid arthritis (RA), active and progressive psoriatic arthritis (PsA) and severe, active ankylosing spondylitis (AS).

The details can be read here.

GlaxoSmithKline Update: Government Orders for Pandemic (H1N1) 2009 Vaccine

06 October 2009, GSK is committed to supporting governments and health authorities around the world respond to the pandemic (H1N1) 2009 influenza strain.

The company today provided an update on orders received for its pandemic (H1N1) adjuvanted vaccine.

The details can be read here.

PCT reforms at WIPO will benefit Indian innovators, exporters: OPPI

The Organisation of Pharmaceutical Producers of India (OPPI), which represents multinational pharma companies in the country, has joined issue with the forces who are opposing the efforts of the developed nations at WIPO for the patent harmonization which is feared to undermine the flexibilities available under TRIPS.


The details can be read here.

NicOx seeks US FDA approval for osteoarthritis drug naproxcinod

NicOx SA announced that a New Drug Application (NDA) for naproxcinod has been submitted to the United States Food and Drug Administration (FDA), seeking approval for an indication for the relief of the signs and symptoms of osteoarthritis (OA).

The details can be read here.

Astellas US sues Wockhardt for alleged patent infringement of Adenoscan

Astellas US LLC, the US subsidiary of the Japanese drug major Astellas Pharma, has sued the Mumbai-based Wockhardt Ltd and its US subsidiary for alleged infringement of its patent on pharmacological stress agent Adenoscan - adenosine injection - as the latter has filed an abbreviated new drug application (ANDA) for generic version of the product.


The details can be read here.

GlaxoSmithKline Receives Unanimous FDA Panel Approval Recommendation for Votrient

GlaxoSmithKline today announced that the United States Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) voted unanimously in support of the approval of VOTRIENT(TM) (pazopanib). Specifically, the panel voted that the benefit-to-risk profile is acceptable for patients with advanced renal cell carcinoma (RCC).

The details can be read here.

Meda: Onsolis Filed in Canada

Oct 2, 2009 - Regulatory News:The registration file for Onsolis (fentanyl buccal soluble film) has been submitted to the Canadian regulatory authority; Health Canada. If approved, it may become the first available fentanyl product approved for breakthrough pain in opioid tolerant patients with cancer in Canada.

The details can be read here.

UCB (BE) - Cimzia, the only PEGylated anti-TNF, approved in Europe and available in a syringe designed in partnership with OXO Good Grips

UCB announced today that the European Commission (EC) approved Cimzia®, in combination with MTX, for the treatment of moderate to severe active RA in adult patients inadequately responsive to disease-modifying antirheumatic drugs (DMARDs) including MTX.

The details can be read here.

Allos Therapeutics Announces U.S. Availability of FOLOTYN (pralatrexate injection)

Oct 5, 2009 - Allos Therapeutics, Inc. today announced that FOLOTYN™ (pralatrexate injection) is now available for commercial sale in the United States. The U.S. Food and Drug Administration (FDA) granted accelerated approval for FOLOTYN for use as a single agent for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) on September 24, 2009.

The details can be read here.

License to Market Kremezin (drug for chronic renal failure) in Japan

Oct. 5, 2009--KUREHA CORPORATION and Mitsubishi Tanabe Pharma Corporation have entered into an agreement, effective on November 1, 2009, under which KUREHA shall grant Mitsubishi Tanabe a license to market Kremezin® in Japan, a drug for chronic renal failure developed by KUREHA.

The details can be read here.

Vivaldi Biosciences Inc. Announces Issuance of US Patent for Influenza Vaccines

Oct 5, 2009 - Vivaldi Biosciences Inc. (Vivaldi), a biotechnology company focused on development of vaccines for influenza, today announced that the United States Patent and Trademark Office has issued US Patent 7,588,768 covering live attenuated influenza vaccines (LAIVs) with modifications to the viral NS1 gene, and methods for producing the vaccines in cell culture systems.

The details can be read here.

Impax Laboratories Receives Tentative FDA Approval for Generic FLOMAX 0.4mg Capsules

Oct 5, 2009 - Impax Laboratories, Inc. today confirmed that the U.S. FDA has granted tentative approval of the Company's Abbreviated New Drug Application (ANDA) for generic version of FLOMAX® (tamsulosin hydrochloride) 0.4mg capsules.

The details can be read here.

Addrenex Pharmaceuticals Files sNDA Submission for Clonicel to Treat ADHD

Oct 1, 2009 - Addrenex Pharmaceuticals and Sciele Pharma, Inc., a Shionogi company today announced that Addrenex has submitted a supplemental New Drug Application (sNDA) to the United States Food and Drug Administration (FDA) for Clonicel (modified-release clonidine) to treat attention deficit hyperactivity disorder (ADHD).

The details can be read here.

Avodart (dutasteride) Regulatory Update

Oct. 1, 2009--GlaxoSmithKline (GSK) announced today that it has filed a supplemental New Drug Application (sNDA) for Avodart® (dutasteride) with the US Food and Drug Administration (FDA) for prostate cancer risk reduction among men at increased risk of developing the disease. EU filings also are underway via the European Mutual Recognition Variation Procedure, with Sweden acting as the Reference Member State.

Astellas and Theravance Announce Approval of Vibativ (telavancin) in Canada

October 1, 2009 - Astellas Pharma Canada, Inc. and Theravance, Inc. announced today that Health Canada has approved VIBATIV™ (telavancin) for the treatment of adult patients with complicated skin and skin structure infections (cSSSI) caused by susceptible Gram-positive bacteria, including Staphylococcus aureus, both methicillin-resistant (MRSA) and methicillin-susceptible (MSSA) strains.

The details can be read here.

FDA Approves New Indication For Mirena to Treat Heavy Menstrual Bleeding in IUD Users

Bayer HealthCare Pharmaceuticals, Inc., announced today that the U.S. Food and Drug Administration (FDA) approved a new indication for Mirena® (levonorgestrel-releasing intrauterine system) for the treatment of heavy menstrual bleeding in women who choose to use intrauterine contraception as their method of contraception.

The details can be read here.

Nutra Pharma Announces Manufacturing Release of Cobroxin, a Treatment for Chronic Pain

Oct 2, 2009 - Nutra Pharma Corp., a biotechnology company that is developing treatments for Adrenomyeloneuropathy (AMN), HIV and Multiple Sclerosis (MS), has announced today that it has completed manufacturing the first commercial batch of Cobroxin and has successfully released it for final distribution.

The details can be read here.

Impax Laboratories Commences Shipment of Generic Adderall XR Capsules

Oct 1, 2009 - Impax Laboratories, Inc. today announced that it is commencing shipment of its authorized generic version of Adderall XR® (Amphetamine and dextroamphetamine mixed salts) Capsules, 5mg, 10mg, 15mg, 20mg, 25mg and 30mg, through Global Pharmaceuticals, Impax's generic division.

The details can be read here.

Actavis (IS) - Actavis' clients launch first generic Atorvastatin in Spain

1 October 2009 -- Actavis Group, the international generic pharmaceuticals company, today announced that its third-party sales division, Medis, has delivered 30 million tablets of Atorvastatin to its clients in Spain. This is the first generic version of the blockbuster molecule to reach the Spanish market.


The details can be read here.

Mylan Receives FDA Approval for Generic Version of Parkinson's Treatment Sinemet

Mylan Inc.today announced that its subsidiary Mylan Pharmaceuticals Inc. has received approval from the U.S. FDA for its Abbreviated New Drug Application (ANDA) for Carbidopa and Levodopa Tablets USP, 10mg/100mg, 25mg/100mg and 25mg/250 mg.

The details can be read here.

Hospira Acquires Worldwide Rights to Biogeneric Version of Filgrastim

Hospira, Inc., a global specialty pharmaceutical and medication delivery company, today announced the acquisition of worldwide rights to a biogeneric version of filgrastim and an affiliated European manufacturing facility from PLIVA Hrvatska d.o.o. (Zagreb, Croatia) , a move that will help extend Hospira's reach and vertical integration in biogenerics. Financial terms of the agreement were not disclosed.

The details can be read here.

Labopharm receives notice of ANDA submission with paragraph IV certification for generic of Ryzolt

Labopharm Inc. today announced it has received notice from Sun Pharma Global FZE advising that Sun has submitted an Abbreviated New Drug Application (ANDA) to the U.S. FDA for approval to market 100, 200 and 300 mg generic versions of Ryzolt(TM) (tramadol hydrochloride extended-release 100, 200 and 300 mg tablets) in the United States.

The details can be read here.