Pharmaceutical industry

CORAL GABLES, FL, May 29, 2009 Catalyst Pharmaceutical Partners, Inc. (Nasdaq: CPRX) today announced top-line results from its U.S. Phase II clinical trial to treat cocaine addiction. The data from the trial showed that CPP-109 did not demonstrate statistical significance in the primary endpoint -- that a significantly larger proportion of CPP-109-treated subjects than placebo-treated subjects were cocaine-free during the last two weeks of the treatment period (Weeks 11 and 12). The clinical trial did not reveal any unexpected "serious" adverse events.    » read more »

May 28, 2009 -- WASHINGTON – Aventis Pharmaceutical Inc., a wholly owned subsidiary of sanofi-aventis U.S. LLC, has agreed to pay the United States $95.5 million to settle allegations that it violated the False Claims Act by misreporting drug prices in order to reduce its Medicaid Drug Rebate obligations, the Justice Department announced today.

The settlement resolves allegations that between 1995 and 2000, Aventis and its corporate predecessors knowingly misreported best prices for the steroid-based anti-inflammatory nasal sprays Azmacort, Nasacort and Nasacort AQ. Under the Medicaid Drug Rebate Statute, Aventis was required to report to Medicaid the lowest, or "best" price that it charged commercial customers, and pay quarterly rebates to the states based on those reported prices.    » read more »

Raritan, NJ (May 28, 2009) - Ortho-McNeil announced today that the U.S. Food and Drug Administration (FDA) issued a complete response letter regarding the new drug application (NDA) for rivaroxaban, an oral, once-daily anticoagulant. The NDA, filed in July 2008 by Johnson & Johnson Pharmaceutical Research and Development, L.L.C. (J&JPRD) on behalf of Ortho-McNeil, seeks approval to market rivaroxaban for the prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients undergoing hip or knee replacement surgery.    » read more »

FOSTER CITY, Calif. -- May. 28, 2009 -- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the company’s Marketing Authorisation Application (MAA) for regadenoson, an investigational pharmacologic stress agent for radionuclide myocardial perfusion imaging (MPI), was validated by the European Medicines Agency (EMEA).

Following validation of the MAA, the dossier is distributed to members of the Committee for Medicinal Products for Human Use (CHMP) for formal review to determine whether regadenoson is a safe and efficacious pharmacologic stress agent in humans.    » read more »

Company to take first steps toward large-scale production

Lyon, France and Swiftwater, Pa - May 27, 2009 - Sanofi Pasteur, the vaccines division of the sanofi-aventis Group (EURONEXT: SAN and NYSE: SNY), announced today it has received the new influenza A(H1N1) seed virus, enabling the world’s leading manufacturer of influenza vaccines to begin the production process for an A(H1N1) vaccine.

The emergence of a new A(H1N1) virus strain recently led the World Health Organization (WHO) to declare a Level 5 pandemic alert, following human-to-human spread of the virus into at least two countries in one WHO region.    » read more »

This release is neither an offer to purchase nor a solicitation of an offer to sell shares of Novartis India Ltd.

May 28, 2009 -- Basel, Switzerland, May 28, 2009 - Novartis announced today an increase in the offer price for Novartis India Ltd. to Rs 450 per share, from Rs 351 initially proposed.

The revised offer represents a premium of 63% to the closing share price of Rs 275.6 of Novartis India Ltd. on March 24, which was the last trading day before announcement of the offer.

This proposal represents Novartis' only and final price revision to this offer, as May 28 is the last day on which the price can be revised.

Source: Novartis

Arbitration Demand to Resolve Dispute over Agreements for REMICADE® and SIMPONI™

New Brunswick, N.J. (May 27, 2009) – In an arbitration demand filed today with the American Arbitration Association, Johnson & Johnson (NYSE:JNJ) has requested a ruling that the agreement and plan of merger between Merck & Co., Inc., and Schering-Plough Corporation constitutes a change of control that would permit the termination of the agreements between Schering-Plough and Johnson & Johnson’s subsidiary Centocor Ortho Biotech Inc., regarding the product REMICADE® (infliximab), a well-established biologic product for inflammatory/immunological diseases, and SIMPONI™ (golimumab), a next-generation treatment.    » read more »

WHO Pre-qualification Will Help to Facilitate Expanded Global Access and Implementation of HPV Vaccination Programs

WHITEHOUSE STATION, N.J., May 26, 2009 - GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant], Merck's cervical cancer vaccine, has been awarded World Health Organization (WHO) pre-qualification. GARDASIL is the first cervical cancer vaccine to receive WHO pre-qualification.

WHO pre-qualification means that GARDASIL is now eligible for procurement by the United Nations Children's Fund (UNICEF) and other United Nations (UN) agencies including the Pan American Health Organization (PAHO), for use in national immunization programs.    » read more »

Takeda will become the exclusive partner for Vaxem-Hib in Japan and pay Novartis 100 million Yen and milestone and royalty payments.

Basel, May 26, 2009 - Novartis announced today that it has entered an agreement with the Takeda Pharmaceutical Company in Japan for the distribution of the Novartis Vaxem-Hib® vaccine for the prevention of infection caused by Haemophilus influenzae type B (Hib).

Through this agreement, Novartis will manufacture the vaccine and supply it to Takeda, which will obtain exclusive rights to license, market and distribute the vaccine in Japan.    » read more »

Initial U.S. order for bulk vaccine valued at $190 million

Swiftwater, Pa. and Lyon, France – May 25, 2009 - Sanofi Pasteur, the vaccines division of the sanofi-aventis Group (EURONEXT: SAN and NYSE: SNY), announced today it has received the first of what is expected to be a series of orders from the U.S. Department of Health and Human Services (HHS) to commence production of a vaccine to help protect against the new influenza A(H1N1) virus.    » read more »

22 May 2009 -- GSK announced today that the US Department of Health and Human Services (HHS) has placed initial orders for A (H1N1) influenza vaccine antigen and the company’s proprietary adjuvant system, AS03, to support its pandemic influenza preparation efforts.

GSK manufactures both a traditional vaccine antigen, which will be made from the recently isolated A (H1N1) influenza strain, as well as an adjuvant system. An adjuvant system can be added to the antigen at time of administration.

GSK expects to fill the US adjuvant order within the next few months. The first doses of the vaccine antigen are expected to be available four to six months after the company receives the H1N1 seed strain, subject to regulatory approval. The new vaccine will be tested in clinical trials.    » read more »

Definitive agreement to acquire EBEWE Pharma's specialty injectables business for EUR 925 million (USD 1.2 billion) in an all-cash transaction

May 20, 2009 -- Basel, May 20, 2009 - Novartis has signed a definitive agreement to acquire the specialty generic injectables business of EBEWE Pharma, providing Sandoz - the Group's generic pharmaceuticals division - an opportunity to create a strong global platform for future growth while improving access for patients worldwide to many generic oncology medicines.

Under terms of the agreement, Novartis will acquire this business for EUR 925 million (USD 1.2 billion) in cash. Excluded from this transaction is EBEWE Pharma's separate injectable neurological products business.    » read more »

Applications Based on Data from Nearly 1,500 Patients in Two of the Largest Studies Ever Conducted in Chronic Lymphocytic Leukemia

SOUTH SAN FRANCISCO, Calif. and CAMBRIDGE, Mass. – May 19, 2009 – Genentech, Inc. and Biogen Idec (Nasdaq: BIIB) today announced that the companies submitted two supplemental Biologics License Applications (sBLAs) to the U.S. Food and Drug Administration (FDA) for Rituxan® (rituximab) plus standard chemotherapy for people with previously untreated or treated chronic lymphocytic leukemia (CLL).

The companies will request a priority review, and if granted, anticipate the FDA will make a decision within six months.    » read more »

May 21, 2009 -- Genzyme Corporation (Nasdaq: GENZ) announced today that it has submitted the final documentation to address all items in the FDA’s complete response letter for Lumizyme™ (alglucosidase alfa), produced at the 2,000 L bioreactor scale.

The submission included clinical data requested by the FDA from Genzyme’s Pompe Registry. The FDA has agreed that these data can fulfill the requirements for a verification study to demonstrate the clinical benefit of Lumizyme. Also included in the submission were the Risk Evaluation and Mitigation Strategy (REMS) and the final label for the product.    » read more »

May 20, 2009 -- NEW YORK -- Pfizer Inc announced today that it has entered into licensing agreements with two pharmaceutical companies based in India, strengthening its position in emerging markets and significantly expanding its portfolio of medicines in its Established Products Business Unit.

Off-patent medicines, including branded generics, represent one of the fastest growth segments in the global pharmaceutical market. This is especially true in emerging markets where costs and access are primary drivers of off-patent medicine growth.    » read more »