Showing posts with label Pharma News. Show all posts
Showing posts with label Pharma News. Show all posts

Bayer Healthcare to acquire Pathway Medical Technologies


Bayer HealthCare announced today that its affiliate, MEDRAD, Inc. has acquired Pathway Medical Technologies, Inc., of Kirkland, Wash. Financial terms of the agreement were not disclosed. With this acquisition, Bayer HealthCare is strengthening its MEDRAD Interventional business by expanding its presence in the field of vascular intervention technologies.
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Pharma News

U.S. Food And Drug Administration Approves Pfizer's XALKORI® (crizotinib)
Posted: 28 Aug 2011 03:00 PM PDT
PfizerPfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has approved XALKORI® (crizotinib) capsules, the first-ever therapy targeting anaplastic lymphoma kinase (ALK), for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that is ALK-positive as detected by an FDA-approved test.

Boehringer Ingelheim licenses ProBioGen's novel GlymaxX® technology

Boehringer Ingelheim and ProBioGen AG have signed a non-exclusive Licensing Agreement regarding ProBioGen's GlymaxX® technology. Boehringer Ingelheim's Contract Manufacturing Business will apply the technology to enhance ADCC (Antibody-Dependent Cell-Mediated Cytotoxicity) activity of antibodies.
The GlymaxX® technology for production of afucosylated proteins is universally applicable, simple and potent. As a unique feature, differentiating it from other approaches, the GlymaxX® technology can also be applied to already existing antibody producer cell lines without altering their productivity. The technology can easily be integrated into Boehringer Ingelheim's high expression CHO-based BI-HEX® system.

Both parties agreed to jointly market the technology and to offer it to customers royalty free.

FDA approves Zelboraf and companion diagnostic for BRAF mutation-positive metastatic melanoma

Roche announced that the U.S. Food and Drug Administration (FDA) approved Zelboraf (vemurafenib) for the treatment of BRAF V600E mutation-positive, inoperable or metastatic melanoma, as determined by an FDA-approved test. The FDA today also approved the cobas 4800 BRAF V600 Mutation Test, a diagnostic test developed by Roche to identify patients eligible for treatment. Zelboraf is the first and only FDA-approved personalized medicine shown to improve survival in people with BRAF V600E mutation-positive metastatic melanoma, demonstrating the benefits of Roche’s personalized healthcare approach. It is designed to target and inhibit some mutated forms of the BRAF protein found in about half of all cases of melanoma, the deadliest and most aggressive form of skin cancer.

Merck and Serum Institute Announce Collaboration

Merck and Serum Institute of India Limited, an Indian company, announced an agreement to work together to develop and commercialize a pneumococcal conjugate vaccine (PCV) for use in the emerging and developing world countries. It is estimated that one out of every two children immunized in the world is vaccinated by a vaccine manufactured by Serum Institute. In addition, Merck has developed more than one-third of the world's vaccines for children, adolescents and adults.

Pharma News

New Senior Executives appointed at Sanofi

24 Jul 2011

Sanofi announced the appointment of Greg Irace, currently President and CEO of Sanofi's US operations, to the newly created role of Senior Vice President, Global Services.

Bristol-Myers Squibb to Acquire Amira Pharmaceuticals

22 Jul 2011
Bristol-Myers Squibb Company and Amira Pharmaceuticals, Inc., announced today that the companies have signed a definitive agreement under which Bristol-Myers Squibb will acquire privately held Amira Pharmaceuticals, a small-molecule pharmaceutical company focused on the discovery and early development of new drugs to treat inflammatory and fibrotic diseases.

FDA approves new medicine BRILINTA (ticagrelor) for use in the US

21 Jul 2011
AstraZeneca announced that the US Food and Drug Administration (FDA) has approved BRILINTA (ticagrelor) tablets to reduce the rate of heart attack (myocardial infarction [MI]) and cardiovascular (CV) death in adult patients with acute coronary syndrome (ACS), compared to clopidogrel.

Pfizer To Acquire Icagen

20 Jul 2011
Pfizer Inc. and Icagen, Inc. have entered into a definitive merger agreement. Pfizer, which currently owns approximately 11% of Icagen's fully diluted shares, will acquire the remaining 8.3 million shares at a price of $6.00 per share.

Novartis delivers strong financial results and four major approvals

Novartis' net sales rose 27% (+19% cc) to USD 14.9 billion. Currency benefited sales by 8% as the US dollar weakened against most currencies. Recently launched products grew 46% over the previous-year quarter, contributing USD 3.8 billion to total net sales for the Group.

Lilly CEO Says Biopharmaceuticals Should Be Included in Transatlantic Trade and Economic Discussions


John C. Lechleiter, Ph.D., chairman, president and chief executive officer of Eli Lilly and Company , urged that biopharmaceuticals be included in transatlantic trade and economic discussions.




Eli Lilly and Company

Pharma NEWS : Sanofi

Sanofi Reports Positive Top-Line Results from First Phase 3 Study of Alemtuzumab in Multiple Sclerosis.

11 Jul 2011,

Sanofi and its subsidiary Genzyme announced positive top-line results from CARE-MS I, the first of two randomized, Phase 3 clinical trials comparing the investigational drug alemtuzumab to the approved multiple sclerosis therapy Rebif® (high dose subcutaneous interferon beta-1a) in patients with relapsing-remitting pmultiple sclerosis (RRMS).

Pharma News


Phase III trial of Novartis drug Afinitor® met primary endpoint.

Novartis announced today Phase III trial results that showed more than one-third of patients taking Afinitor® (everolimus) tablets experienced a 50% or greater reduction in the size of their subependymal giant cell astrocytomas (SEGAs), non-cancerous brain tumors associated with tuberous sclerosis complex 

Zydus Pharma to acquire US based Nesher Pharmaceuticals

Zydus Pharmaceuticals USA Inc., through its subsidiary Zynesher Pharmaceuticals USA LLC, has entered into an agreement to acquire the assets of the US based pharmaceutical company Nesher Pharmaceuticals Inc. Nesher operates as the generic subsidiary of KV Pharmaceutical, based at St. Louis, Missouri, USA. The financial details of the agreement have not disclosed.

Nesher has considerable expertise in niche therapies which have development or production barriers, such as controlled release medications or DEA-controlled substances. The broad-based assets purchase agreement includes assets and assumption of certain liabilities, Nesher's existing and pipeline ANDAs, certain manufacturing facilities and a full fledged research and development lab. With this, Zydus will now be able to manufacture and distribute generic controlled substances in the US market, which otherwise cannot be imported. The market for controlled substances medications in the US is estimated at $7 billion.

Pankaj R Patel, chairman and managing director, Zydus Pharma, said, “We have always looked at value-accruing opportunities and we believe that this new development gives us access to a difficult-to-develop product pipeline, expertise and infrastructure that will add value to our operations in the US. It also presents the right fit as it helps us strengthen our generic operations in the US with technology-distinguished specialty generics.”

The acquired ANDA pipeline comprising eight existing filings and 5 products under development present a tremendous market potential as they belong to high growth, niche segments which have a combined estimated market size of over $2.1 billion.

GlaxoSmithKline and Valeant announce US FDA approval of Potiga™ (ezogabine)

GlaxoSmithKline (NYSE: GSK) and Valeant Pharmaceuticals International, Inc. (NYSE/TSX: VRX) announced today that the U.S. Food and Drug Administration (FDA) has approved Potiga™ (ezogabine) Tablets, a potassium channel opener, as adjunctive treatment of partial-onset seizures in patients aged 18 years and older.

Pfizer Announces Phase 3 Results of Investigational Compound Bosutinib

Pfizer Inc.announced that a significantly higher proportion of patients with newly diagnosed chronic myeloid leukemia who were treated with bosutinib (39 percent) experienced a major molecular response (MMR), a secondary endpoint, compared with patients treated with imatinib (26 percent) in the intent-to-treat (ITT) population (p=0.002). However, the study did not meet its primary endpoint of superior complete cytogenetic response (CCyR) rate at one year versus imatinib (70 percent vs. 68 percent, respectively, [p=0.601]), in the ITT population. These results are from a Phase 3 study of the investigational compound bosutinib as a first-line treatment in patients with Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML), called the Bosutinib Efficacy and safety in chronic myeloid LeukemiA [BELA] study. These data were presented at an oral presentation at the 52nd Annual Meeting of the American Society of Hematology

New technology to be used to check spurious drugs

The use of the latest technology to curb growing menace of spurious drugs has been suggested by Dr. BR Jagatshetty, Drugs Controller of Karnataka.
The Karnataka government has called for utilization of computerized techniques, enhance co-operation and co-ordination between states and empowering the drugs control department with more powers.
The drugs control department works in close tandem with the intelligence department of the state which provides it with the tip off of ongoing spurious trade.

Aurobindo Pharma gets USFDA's approval forDuloxetine

 The US Food and Drug Administration(USFDA) has given its nod to Aurobindo Pharma Ltd to produce and market Duloxetine Hydrochloride delayed-release capsules 20mg (base), 30mg (base) and 60mg (base).

USFDA approved JB Chemicals' diclofenace sodium tablets


NEW DELHI: The US Food and drug administration(USFDA) has approved JB Chemicals & Pharmaceuticals' (JBCPL) abbreviated new drug application (ANDA) for 25 mg and 50 mg delayed release tablets of Diclofenac Sodium (non-steroidal anti-inflammatory drug).

Merck is to buy SmartCells for $500 million


NEW DELHI: Merck & Co. (MRK), pharmaceutical major, is all set to acquire SmartCells, a privately held diabetes treatment developer, for $500 million.