Pharmaceuticals

01 June 2009 -- AstraZeneca and Merck & Co., Inc. today announced a collaboration to research a novel combination anticancer regimen composed of two investigational compounds, MK-2206 from Merck and AZD6244 (ARRY-886*) from AstraZeneca.

Preclinical evidence indicates that combined administration of these compounds could enhance their anticancer properties. This is the first time that two large pharmaceutical companies have established a collaboration to evaluate the potential for combining candidate molecules at such an early stage of development. The collaboration will more quickly advance a potentially promising anticancer treatment. In general, such combinations would only be studied when one or both of the drugs has entered late-stage development or received marketing approval.    » read more »

WHITEHOUSE STATION, N.J., May 29, 2009 - Merck & Co., Inc. today provided the following statement regarding the decision by the U.S. Patent and Trademark Office (PTO) to reexamine the SINGULAIR patent.

Reexamination is an administrative procedure within the PTO that can be initiated by any person. Essentially, if a potential new issue of invalidity is raised, the PTO will examine this issue and determine whether it should take any further action regarding the current claims of the patent. In the event that the PTO decides further action is warranted, it may amend or revoke the claims in the patent.    » read more »

Orlando FL, 29 May 2009 -- GlaxoSmithKline [NYSE: GSK] and Genmab A/S [OMX: GEN] today announced that the United States Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 10 to three that the ARZERRA™ (ofatumumab) data are reasonably likely to predict clinical benefit for patients with chronic lymphocytic leukemia (CLL) whose disease is refractory to fludarabine and alemtuzumab. Ofatumumab is an investigational treatment.    » read more »

Only treatment shown to benefit patients with advanced kidney cancer whose disease progressed following targeted therapy; Phase III trials underway to explore potential in multiple additional cancers

Basel, May 29, 2009 - Novartis has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) supporting European Union (EU) approval of Afinitor® (everolimus) Tablets for the treatment of patients with advanced renal cell carcinoma (RCC)[1].    » read more »

Approximately 22 million women in US have osteopenia, or low bone mass, putting them at increased risk of fractures of hip, spine and wrist.

Basel, June 1, 2009 - Reclast® (zoledronic acid 5 mg) Injection[*] has been approved by the US Food and Drug Administration (FDA) as the first and only therapy to prevent postmenopausal osteoporosis for two years with a single dose[1]. Reclast, or Aclasta® as it is known outside the US, is already approved in more than 80 countries including the US and EU as a once-yearly infusion for the treatment of postmenopausal osteoporosis[1],[4].    » read more »

May 29, 2009 -- Genzyme Corp. (Nasdaq: GENZ) today announced that the European Medicines Agency’s Committee for Human Medicinal Products (CHMP) has adopted a positive opinion on the marketing authorization application for Mozobil ® (plerixafor injection).

The committee's opinion will be forwarded to the European Commission, which will make a final decision on the authorization. The Commission has 66 calendar days to act on the CHMP’s opinion.

In the EU, Mozobil would be indicated in combination with granulocyte-colony stimulating factor to enhance mobilization of hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with lymphoma and multiple myeloma whose cells mobilize poorly.    » read more »

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 »

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 »