30th June, 2009 - Orexo announces that ProStrakan Group plc (LSE: PSK) Orexo's partner for Abstral in Europe and North America, today confirms that it has completed the reimbursement pricing process with the French authorities for its pan-European breakthrough cancer pain product, Abstral, earlier than expected and, as a result, plans to launch this product in the important French market next month.
The details can be read here.
Tuesday, June 30, 2009
Centocor Ortho Biotech Inc. Awarded $1.67 Billion Patent Jury Verdict from Abbott Laboratories
Centocor Ortho Biotech Inc. announced today that a federal jury has returned a verdict of $1.67 billion against Abbott Laboratories in a patent infringement suit.“We are pleased that the jury has ruled in our favor in the patent litigation case against Abbott,” said Kim Taylor, President, Centocor Ortho Biotech Inc.
The details can be read here.
The details can be read here.
Mylan Announces Strategic Collaboration with Biocon to Enter the Global Generic Biologics Market
Mylan Inc. today announced that it has executed a definitive agreement with Biocon Limited, a publicly traded company on the Indian stock exchanges, for an exclusive collaboration on the development, manufacturing, supply and commercialization of multiple, high value generic biologic compounds for the global marketplace.
The details can be read here.
The details can be read here.
Sunday, June 28, 2009
Matrix Labs turns corner, net profit at Rs 30 cr in FY'09
Matrix Laboratories, a subsidiary of Mylan Inc, has successfully turned the corner during the year ended March 2009 and earned a consolidated net profit of Rs 30 crore as against a huge net loss of Rs 457 crore in the previous year on account extra ordinary provision for impairment of goodwill of Rs 487 crore.
The details can be read here.
The details can be read here.
Glenmark net dips by 68% to Rs 193 cr in FY'09
Glenmark Pharmaceuticals, a Rs 2,000 crore plus pharmaceutical giant, has suffered heavy setback during the year ended March 2009 on account of slower growth in top line, higher interest burden as well as employees cost and the absence of outlicensing revenue due to overall global recession.
The details can be read here.
The details can be read here.
Simponi (golimumab) Receives Positive Opinion From CHMP for Once-Monthly Subcutaneous Treatment
Centocor Ortho Biotech Inc. and Schering-Plough Corporation announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) adopted a positive opinion recommending the approval of 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.
The details can be read here.
Ipsen: Azzalure Approved in Germany for Aesthetic Use in the Treatment of Glabellar Lines
Galderma, the leading pharmaceutical company in dermatology, and Ipsen (Paris:IPN), an international innovation-driven specialty pharmaceutical group, today announced that Azzalure® (botulinum toxin Type A manufactured by Ipsen), a muscle relaxant specifically developed for aesthetic use, has received a marketing authorization in Germany from the regulatory authorities for the temporary improvement in the appearance of moderate to severe glabellar lines seen at the frown (vertical lines between the eyebrows), in adult men and women aged 65 years and under, when the severity of these lines has an important psychological impact on the patient.
The details can be read here.
The details can be read here.
Once-Yearly Aclasta Approved in EU to Treat Osteoporosis Caused By Steroid Treatment in Men and Postmenopausal Women
Sandoz Receives Approval for First-ever Japanese Biosimilar
June 25, 2009 -Sandoz has received marketing authorization for the first-ever Japanese biosimilar, recombinant human growth hormone somatropin. The precedent-setting decision further reinforces Sandoz's global leadership position in the rapidly-emerging market for biosimilars, or follow-on versions of existing state-of-the-art biopharmaceuticals.
The details can be read here.
The details can be read here.
Novo Nordisk Insulin Analogs Have Proven Safety Profiles
On Friday June 26, Diabetologia, the journal of the European Association for the Study of Diabetes (EASD) published online data from four studies relating to a possible link between a long-acting insulin analog, insulin glargine, and cancer(1). As a basis for such a possible link, an accompanying editorial explains that certain insulin analogs have a structure making them more likely to bind to the IGF-1 receptor which is known to be involved in promoting tumor growth(2).
The details can be read here.
The details can be read here.
Wednesday, June 24, 2009
Glenmark's novel molecule for type 2 diabetes Melogliptin to enter phase-III trials
Glenmark Pharmaceutical has completed successfully phase-IIb trials in 494 patients for its novel molecule Melogliptin for type-2 diabetes and the Global phase-III trial is likely to start by end of 2009. Melogliptin improves glucose control and normal pancreatic function. Melogliptin is likely to be launched in 2013.
The details can be read here.
The details can be read here.
Astellas forays into Indian pharma market with immunosuppressant drug, Prograf
Astellas Pharma Inc, Japan's second largest ethical pharmaceutical company, has announced plans to enter the Indian market by launching its flagship product, Prograf, an immunosuppressant used after organ transplantation.
The details can be read here.
The details can be read here.
Cell Therapeutics Completes Pixantrone NDA Submission and Requests Priority Review
Cell Therapeutics, Inc. announced today that it has completed the submission of the New Drug Application (NDA) to the U.S. FDA for pixantrone to treat relapsed or refractory, aggressive non-Hodgkin's lymphoma (NHL).
The details can be read here.
The details can be read here.
Menarini International Operations Luxembourg Withdraws Its Marketing Authorisation Application For Factive (Gemifloxacin)
June 23, 2009-The European Medicines Agency Has Been Formally Notified By Menarini International Operations Luxembourg S.A. Of Its Decision To Withdraw Its Application For A Centralised Marketing Authorisation For The Medicine Factive (Gemifloxacin), 320 Mg Film-Coated Tablets.
The details can be read here.
The details can be read here.
Santarus Announces December 2009 Action Date for Schering-Plough's OTC Zegerid New Drug Application
Jun 23, 2009 - Santarus, Inc., a specialty biopharmaceutical company, today announced that Schering-Plough HealthCare Products, Inc. has received notification from the U.S. Food and Drug Administration (FDA) of a December 2009 action date for an over-the-counter (OTC) ZEGERID® branded omeprazole/sodium bicarbonate product with the dosage strength of 20 mg of omeprazole.
The details can be read here.
The details can be read here.
FDA Approves Cambia for Migraine
Jun 22, 2009 - Kowa Pharmaceuticals America, Inc., a privately-held specialty pharmaceutical company headquartered in Montgomery, AL, announced today that the U.S. FDA) has approved Cambia™, a diclofenac-based non-steroidal anti-inflammatory drug combined with potassium bicarbonate, for the treatment of acute migraine with or without aura in adults.
The details can be read here.
The details can be read here.
Court Grants Teva Summary Judgment of Non-Infringement on Eloxatin
Jun 18, 2009 - Teva Pharmaceutical Industries Ltd. announced today that the U.S. District Court for the District of New Jersey has granted summary judgment in Teva's favor on the issue of non-infringement with regard to Debiopharm's U.S. Patent No. 5,338,874. The patent is listed in the Orange Book for Sanofi-Aventis chemotherapy medication Eloxatin, which had annual sales of approximately $1.3 billion in the United States for the twelve months that ended December 31, 2008, based on IMS sales data.
The details can be read here.
The details can be read here.
Sun Pharma announces USFDA approval for generic Accupril tablets
June 19, 2009: Sun Pharmaceutical Industries Ltd. announced that USFDA has granted an approval for its Abbreviated New Drug Application for generic Accupril, quinapril hydrochloride tablets.
The details can be read here.
The details can be read here.
Perrigo Confirms That its Partner Synthon Has Filed for Generic Version of Xyzal Solution
Perrigo Company today announced that its partner Synthon Pharmaceuticals, Inc. has filed an Abbreviated New Drug Application (ANDA) for Levocetirizine solution 2.5mg/5ml, a generic version of Xyzal(R) solution 2.5mg/5ml. Under terms of an exclusive agreement between the companies, Perrigo has sales and marketing rights in Synthon's Levocetirizine products. The Company believes that Synthon is the first to file an ANDA with a Paragraph IV certification against Xyzal(R) solution that can entitle it to 180 days of generic exclusivity upon approval.
The details can be read here.
The details can be read here.
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