Novartis says flu vaccine US interim data shows lower doses of antigen may suffice to generate a protective immune response against A(H1N1)

Novartis announced new interim data from ongoing clinical trials demonstrating that a single 7.5µg dose of the company's influenza A(H1N1) 2009 unadjuvanted vaccine, half of the currently-approved US dose, fulfilled immune response criteria associated with protection in adults and the elderly (>=65 years of age).

The details can be read here.

AstraZeneca Submits US New Drug Application for Ticagrelor (Brilinta), an Investigational Antiplatelet Agent

AstraZeneca today announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ticagrelor, an investigational oral antiplatelet treatment for the reduction of major adverse cardiac events in patients with acute coronary syndrome (ACS).

The details can be read here.

Astellas and XenoPort Announce Submission of a New Drug Application in Japan Requesting PMDA Approval of ASP8825/XP13512 for Restless Legs Syndrome

Nov 19, 2009 - Astellas Pharma Inc. and XenoPort, Inc. today announced that a new drug application (NDA) has been filed with the Pharmaceuticals and Medical Device Agency (PMDA) in Japan for ASP8825 (gabapentin enacarbil), also known as XP13512, as a potential treatment for restless legs syndrome (RLS).

The details can be read here.

Otsuka Pharmaceutical Europe Ltd withdraws its application for an extension of indication for Abilify (aripiprazole)

Nov. 19, 2009- The European Medicines Agency has been formally notified by Otsuka Pharmaceutical Europe Ltd of its decision to withdraw its application for an extension of indication for the centrally authorised medicine Abilify (aripiprazole) tablets, orodispersible tablets and oral solution.

The details can be read here.

US Food and Drug Administration grants priority review for Actelion's miglustat in Niemann-Pick type C disease

19 November 2009 - Actelion Ltd announced today that a supplemental new drug application (sNDA) for an extension of indication for Zavesca® (miglustat) for the treatment of progressive neurological manifestations in adult and pediatric patients with Niemann-Pick type C disease (NP-C) has been accepted by the U.S. Food and Drug Administration (FDA).

The details can be read here.

Sucampo Receives Marketing Authorization for Amitiza in Switzerland for Treatment of Chronic Idiopathic Constipation

Nov 19, 2009 - Sucampo Pharma Europe Ltd., a subsidiary of Sucampo Pharmaceuticals, Inc., today announced that Swissmedic, the Swiss Agency for Therapeutic Products, has granted a marketing authorization for Amitiza® (lubiprostone) 24 microgram (mcg) gel capsules for the long-term treatment of patients with chronic idiopathic constipation (CIC).

The details can be read here.

Birth control ring NuvaRing launched in India

With the introduction of a product that will augment the contraception options currently available to Indian women, NuvaRing, the first vaginal birth control ring was formally launched in India. NuvaRing is a once-monthly vaginal ring that offers the same benefits as ‘the Pill’ but with the added convenience of not having to be used daily.

The details can be read here.

Wockhardt launches anti-hypertensive drug Nicardipine injections in USA

Pharmaceutical and biotechnology major Wockhardt has received final approval from the United States Food & Drug Administration (US FDA) for marketing the 25mg/10 ml injection of Nicardipine HCl, which is used for short-term management of hypertension or increased blood pressure.

the details can be read here.

Genentech and Biogen Idec Receive a Complete Response from the FDA for Rituxan for Chronic Lymphocytic Leukemia

Nov 18, 2009 - Genentech, Inc., a wholly-owned member of the Roche Group, and Biogen Idec announced today that the U.S. Food and Drug Administration (FDA) issued a complete response on the companies' applications for Rituxan® (rituximab) plus fludarabine and cyclophosphamide (FC) for the treatment of people with previously untreated and previously treated chronic lymphocytic leukemia (CLL).

The details can be read here.

NicOx announces FDA accepts naproxcinod NDA for filing

November 18, 2009-NicOx S.A. today announced that it has received a filing communication from the U.S. Food and Drug Administration (FDA) stating that the New Drug Application (NDA) for naproxcinod is accepted for filing.

The details can be read here.

Basilea's Toctino Receives Marketing Authorization in Canada

November 18, 2009 - Basilea Pharmaceutica Ltd. announces that Toctino® (alitretinoin), a new once-daily oral treatment for adults with severe chronic hand eczema (CHE) unresponsive to potent topical corticosteroids, has obtained regulatory approval from Health Canada.

The details can be read here.

Merz Pharmaceuticals Announces Approval of Post-stroke Upper Limb Spasticity Indication for Xeomin in the EU

Today, Merz Pharmaceuticals announced Xeomin®, the first botulinum toxin type A free from complexing proteins has been granted an extension of indication for post-stroke spasticity of the upper limb presenting with flexed wrist and clenched fist in adults in various European countries.

The details can be read here.

Now Available: Lusedra (fospropofol disodium) Injection CIV

November 16, 2009 – EisaiInc. today announced that LUSEDRA™ (fospropofol disodium) Injection is now available for use by persons trained in the administration of general anesthesia. LUSEDRA, an aqueous solution, is an intravenous sedative-hypnotic agent indicated for monitored anesthesia care (MAC) sedation in adult patients undergoing diagnostic or therapeutic procedures.

The details can be read here.

Sun Pharma announces USFDA approval for Nicardipine injection

November 18, 2009: Sun Pharmaceutical Industries Ltd. announced that the USFDA has granted its subsidiary an approval for its application for Nicardipine Hydrochloride Injections.

the details can be read here.

GAVI Alliance manages to lower cost of pentavalent vaccines to US$ 3 per dose

The Geneva-based public-private partnership, GAVI Alliance, has managed to bring down the price of the pentavalent vaccines by 50 cents and it now costs US$ 3 per dose effective from 2010.

The details can be read here.