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Generic biologics face 'tough, long road to realization'

The development of new generic versions of expensive biologic drugs "faces a long, tough road to realization" because the complex generics "will likely face tough regulatory scrutiny, as well as high development and marketing costs," the Wall Street Journal reports.

4 Mar 2009

FDA warning letter to Genzyme related to Allston manufacturing facility

BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) announced today that the FDA warning letter issued to Genzyme addressing deficiencies related to Genzyme's Allston Landing manufacturing facility during an inspection performed in September and October 2008 has no foreseeable impact on the supply of Aldurazyme.

3 Mar 2009

FDA provides positive review of InNexus' lead preclinical drug candidate

InNexus Biotechnology Inc. has announced the United States Food & Drug Administration (FDA) has completed its comprehensive review of the development plans for InNexus' lead preclinical candidate, DXL625 (CD20) for the prospective treatment of Non-Hodgkin's Lymphoma (NHL) and/or Chronic Lymphocytic Leukemia (CLL).

3 Mar 2009

FDA clears Cellectar's IND application for lead drug candidate

Cellectar, Inc. has announced that the U.S. Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) application for its (131)I-CLR1404 drug candidate for testing in patients with advanced solid malignancies.

3 Mar 2009

Endo Pharmaceuticals licenses investigational drug axomadol from Grunenthal

Endo Pharmaceuticals announced that it has licensed from Grunenthal the exclusive rights to develop and market the investigational drug axomadol in the United States and Canada.

2 Mar 2009

FDA takes action against KV Pharmaceutical Company

The FDA announced a Consent Decree of permanent injunction filed March 2, 2009, enjoining KV Pharmaceutical Company, its subsidiaries ETHEX Corporation and Ther-Rx Corporation, and its principal officers from making and distributing adulterated and unapproved drugs.

2 Mar 2009

Wyeth's Prevenar vaccine for pneumococcal disease registered in Russia

Wyeth announced today that its 7-valent pneumococcal conjugate vaccine, Prevenar (Pneumococcal saccharide conjugated vaccine, Adsorbed), has been registered by the Russian Ministry of Health and Social Development (Roszdravnadzor) and is expected to be commercially available later this year.

2 Mar 2009

FDA requires boxed warning and risk mitigation strategy for metoclopramide-containing drugs

The U.S. Food and Drug Administration announced today that manufacturers of metoclopramide, a drug used to treat gastrointestinal disorders, must add a boxed warning to their drug labels about the risk of its long-term or high-dose use.

1 Mar 2009

United States files complaint against Forest Labs for allegedly violating the false claims act with Celexa and Lexapro

A Complaint was unsealed today in U.S. District Court in Massachusetts against a New York pharmaceutical company for alleged False Claims Act violations arising from the company's marketing the drugs Celexa and Lexapro for unapproved pediatric use and for paying kickbacks to induce physicians to prescribe the drugs.

25 Feb 2009

Mylan's Matrix receives WHO approval for generic Lopinavir/Ritonavir tablets

Mylan Inc. has announced that Matrix Laboratories Limited, its India-based subsidiary in which it holds a 71.5% controlling interest, received the first and only World Health Organization (WHO) approval for Lopinavir/Ritonavir Tablets, 200 mg/50 mg. Matrix's version of this product is heat-stable and affordable, making it practical for distribution and use in warm climates.

25 Feb 2009

Supermarkets should offer free flu shots rather than free antibiotics

As influenza season shifts into high gear, with 24 states now reporting widespread activity, the nation's infectious diseases experts are urging supermarket pharmacies with free-antibiotics promotions to educate their customers on when antibiotics are the right prescription-and when they can do more harm than good.

25 Feb 2009

Aton Pharma acquires Timoptic product line from Merck & Co

Aton Pharma, Inc., a diversified specialty pharmaceutical company, today announced it has acquired the U.S. marketing rights to the Timoptic product line from Merck & Co., Inc. Timoptic (timolol maleate) is a non-selective beta-adrenergic receptor blocking agent indicated for the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.

25 Feb 2009

Implicit licenses clinical stage antibody program from Lilly

Implicit Bioscience Ltd has announced the acquisition of the clinical-stage monoclonal antibody IC14 from Eli Lilly and Company. Implicit has paid an undisclosed consideration combining cash and stock to Lilly. Lilly will also receive a royalty on future IC14 sales.

25 Feb 2009

Valdoxan granted marketing authorisation for the treatment of major depressive episodes in Europe

The European Commission has granted marketing authorisation for Servier's Valdoxan/Thymanax (agomelatine), the first melatonergic antidepressant for the treatment of adult patients with major depressive episodes.

24 Feb 2009

Ambrx and Merck Serono expand collaboration through multiple sclerosis drug

Ambrx Inc, and Merck Serono have announced a global strategic collaboration to develop and commercialize Ambrx's ARX424 preclinical product candidate for the treatment of multiple sclerosis.

24 Feb 2009

34 percent of all Medicare Part D enrollees select Medicare Advantage plans for 2009

More than nine million people, or 34 percent of all Medicare Part D enrollees, currently receive their prescription drug benefit through Medicare Advantage plans with prescription drug coverage (MA-PD plans), says new analysis by Avalere Health.

24 Feb 2009

Xencor and CSL Limited establish antibody optimization collaboration

Xencor, Inc., an antibody discovery and development company, announced today that it has entered into an antibody optimization collaboration with CSL, Ltd. The collaboration will provide CSL with access to Xencor's XmAb technology platform to enhance the ADCC effector function of its therapeutic antibodies.

23 Feb 2009

Genentech special committee rejects Roche’s $86.50 offer as inadequate

Genentech, Inc. has announced that a Special Committee of its Board of Directors unanimously recommended that shareholders reject the unilateral tender offer from Roche to acquire all of the outstanding shares of Genentech not owned by Roche for $86.50 cash per share.

23 Feb 2009

Shire to enter European ADHD market with acquisition of EQUASYM IR and XL

Shire plc has announced that it has signed an agreement with UCB to acquire the worldwide rights to EQUASYM IR and XL (methylphenidate hydrochloride) (excluding the USA, Canada and Barbados) used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

22 Feb 2009

Schering-Plough submits response to FDA for SAPHRIS (asenapine) in the acute treatment of schizophrenia and bipolar I disorder

Schering-Plough Corporation has announced that it has responded to the U.S. Food and Drug Administration (FDA) complete response letter for SAPHRIS (asenapine) sublingual tablets, which was received in January 2009.

22 Feb 2009