Abbott launches Xience Prime drug eluting stent in international markets

Abbott announced at the European Society of Cardiology Congress the widespread availability of its next-generation Xience Prime Everolimus Eluting Coronary Stent System for the treatment of coronary artery disease.

The details can be read here.

Novartis challenges IPAB's Glivec patent rejection in the Supreme Court

The Swiss pharma major Novartis AG has filed a special leave petition with the Supreme Court of India against the of Intellectual Property Appellate Board (IPAB) decision to reject the company's plea for patenting its imatinib mesylate - the blood cancer drug Glivec - in the country.

The details can be read here.

FDA Approves Valcyte (valganciclovir hydrochloride) to Prevent Cytomegalovirus (CMV) Disease in Pediatric Patients Who Receive Heart/Kidney Transplant

Roche announced today that the U.S. FDA has approved Valcyte (valganciclovir hydrochloride) for the prevention of cytomegalovirus (CMV) disease in pediatric kidney and heart transplant patients (4 months to 16 years of age) at high risk of developing CMV disease.

The details can be read here.

DCGI to revise timeline for approvals, efforts on for speedy disposal of pending cases

The Drug Controller General of India's (DCGI's) office is reworking the timeline for approvals fixed in last July for disposal of various approval applications with the authority. The authority has also initiated efforts to streamline its approval process on the pending cases, on applications filed prior to January 1, 2009, for speedy disposal.


The details can be read here.

Lumavita's pentamycin gets Swiss marketing nod to treat infectious vaginitis

Lumavita AG, the Swiss biopharmaceutical company specializing in novel anti-infectives for women's health, announced its first product approval. Following notice of preliminary approval issued in March 2009, the Swiss regulatory authority has granted final marketing authorisation to Lumavita's proprietary prescription medication, pentamycin, for the treatment of all types of infectious vaginitis.


The details can be read here.

Several drugs banned in US, Europe freely marketed in India

Several drugs, banned for their serious side effects in developed nations like US, Canada and European Union, are freely available in the country. Though the list of such drugs is long, the latest among them is a combination drug of flupenthixol and melitracen, sold under the brand name of Deanxit.

The details can be read here.

Supreme Court dismisses Roche's plea on Terceva patent, orders High Court to expedite trial proceedings

The Supreme Court of India has dismissed the petition filed by the Swiss pharma major Hoffman La Roche, against the Delhi High Court's order on patent litigation on its anti-cancer drug Tarceva with the Mumbai-based Cipla Ltd, it is learnt.

The details can be read here.

Unichem Lab gets US FDA nod for clonidine HCl tabs

Unichem Laboratories, a Mumbai based Rs 725 crore plus pharma major has received US FDA approval for clonidine hydrochloride tablets. These tablets are a low dose potent and popular molecule in the anti-hypertensive category.

The details can be read here.

Aurobindo gets US & Swiss nod for two products

Aurobindo Pharma has received US FDA's final approval for Clindamycin Hydrochloride capsules USP 150mg (base) and 300mg. Similarly, Swissmedic, Government of Switzerland has approved the license of Cefepime APL for Injection 1g and 2g.

The details can be read here.

Neuland Lab begins peptides production, starts new High Potent API facility

Neuland Laboratories, a reliable global provider of APIs and other essential drug discovery and development support services today announced successfully commencement of manufacturing of peptides blocks by successfully commercializing the production of Fmoc Pseudoproline Dipeptides and other building blocks in India and the US subsidiary.


The details can be read here.

Govt under pressure to reconsider revised Mashelkar Committee report

In the light of the recent reports that Dr Mashelkar has misinterpreted Carlos Correa's, a patent expert of international repute, views to support its conclusions in the revised report, the central government is under pressure from the NGOs working on patent issues to reconsider its decision to accept the revised report of Mashelkar Committee.


The details can be read here.

Sagent Pharmaceuticals Announces Launch of Fluconazole Injection in Premix Ready-to-Use IV Bags

Sagent Pharmaceuticals, Inc., a privately held specialty pharmaceutical company, today announced that it has launched fluconazole injection in premix bags. IMS Health estimates that 2008 U.S. sales of fluconazole injection approximated $18 million.

The details can be read here.

Mylan Begins Marketing First Generic Version of BenzaClin Acne Treatment

Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has begun to market 1% Clindamycin and 5% Benzoyl Peroxide Gel based on an agreement with licensing partner Dow Pharmaceutical Sciences, a subsidiary of Valeant Pharmaceuticals International.

The details can be read here.

Caraco Pharmaceutical Laboratories, Ltd. Announces Reversal of Summary Judgment in Ultracet(R) ANDA Patent Litigation

Caraco Pharmaceutical Laboratories, Ltd. announced today that a US Federal Circuit Court has reversed a portion of a previously decided summary judgment on ANDA Patent litigation between Ortho McNeil and Caraco regarding Ultracet .

The details can be read here.

The whole judgement can be read here.

Nanotherapeutics gets $30.9 mn NIAID contract to develop inhaled antiviral for prophylaxis & treatment of smallpox

Nanotherapeutics, Inc, has been awarded a $30.9 million, five-year contract from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), to develop an inhaled version of the injectable antiviral drug, cidofovir, for non-invasive, post-exposure prophylaxis and treatment of the Category A bioterrorism agent smallpox (Variola major).


The details can be read here.