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Cimzia approved in U.S. for rheumatoid arthritis

UCB announced today that the U.S. Food and Drug Administration (FDA) approved Cimzia, the only PEGylated anti-TNF (Tumor Necrosis Factor), for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA).

13 May 2009

Baylor Research Institute receives multi-million dollar grant to develop flu vaccine

Scientists at Baylor Institute for Immunology Research (BIIR) in Dallas, part of Baylor Research Institute (BRI) and the Baylor Health Care System, announced today that they received a renewal of a multi-million dollar grant from the National Institutes of Health (NIH) to design new vaccines to prevent influenza - including swine flu (H1N1).

13 May 2009

FDA accepts Pharmaxis’ Aridol NDA for review

Pharmaxis has announced it had received notification from the United States Food and Drug Administration (FDA) that the New Drug Application (NDA) for its mannitol bronchial challenge test Aridol has been accepted for standard review. The FDA will advise the result of the review on 27 December 2009.

13 May 2009

Independent pharmacists raise concerns over letters from CVS Caremark indicating members must pay higher copayments at non-CVS pharmacies

An unidentified trade group representing independent pharmacies on Wednesday plans to send to Federal Trade Commission Chair Jon Leibowitz a series of letters from pharmacy benefits manager CVS Caremark that indicate the PBM charges higher copayment rates for some of its members who opt to fill their prescriptions at pharmacies other than CVS, the Wall Street Journal reports.

13 May 2009

GlaxoSmithKline to acquire 16% shareholding in Aspen Pharmacare

GlaxoSmithKline plc (GSK) today announced that it has agreed to extend its strategic relationship with Aspen Pharmacare Holdings Limited (Aspen) and to acquire a 16% shareholding in the South African based pharmaceuticals company.

12 May 2009

Sinobiopharma announces Chinese approval of Perindopril

Sinobiopharma, Inc. has announced that it has received approval from the Chinese State Food and Drug Administration (SFDA) to manufacture and market its formulation of Perindopril, an anti-hypertension drug.

12 May 2009

Sanofi-aventis to acquire Oforta, oral chronic lymphocytic leukemia treatment

Sanofi-aventis U.S. announced today that it has acquired from biotechnology company Antisoma plc the U.S. commercial rights to Oforta (fludarabine phosphate film-coated tablets), an oral B-cell chronic lymphocytic leukemia (CLL) drug. Oforta is currently approved in the United States for use as a second-line therapy to treat adults with B-cell CLL.

12 May 2009

FDA approves Samsca tablets (tolvaptan) to treat hyponatremia

The U.S. Food and Drug Administration has approved Samsca tablets (tolvaptan) to treat hyponatremia, an abnormally low concentration of sodium in the blood.

8 May 2009

FDA approves Besivance for the treatment of bacterial conjunctivitis

The U.S. Food and Drug Administration has approved Besivance (besifloxacin ophthalmic suspension 0.6 percent) for the treatment of bacterial conjunctivitis (non-viral), a contagious condition marked by irritation of the eyes and a discharge from the mucous membranes.

8 May 2009

FDA approves Avastin (bevacizumab) for treatment of glioblastoma multiforme

The U.S. Food and Drug Administration recently approved Avastin (bevacizumab) to treat patients with glioblastoma multiforme (GBM) when this form of brain cancer continues to progress following standard therapy.

7 May 2009

Study reveals current multi-component vaccines may need reworking

Current strategies for designing vaccines against HIV and cancers, for instance, may enable some components in multi-component vaccines to cancel the effect of others on the immune system, eliminating their ability to provide protection, according to an article to be published shortly in the Proceedings of the National Academy of Sciences (PNAS).

7 May 2009

FDA approves Creon (pancrelipase) - designed to help those with cystic fibrosis

The U.S. Food and Drug Administration announced that it has approved Creon (pancrelipase), a pancreatic enzyme replacement product designed to help patients with cystic fibrosis and others with exocrine pancreatic insufficiency (EPI) digest and absorb nutrients from foods.

7 May 2009

Safety concerns over testosterone gel prompt FDA to require label changes

The U.S. Food and Drug Administration today announced that it is requiring manufacturers of two prescription topical testosterone gel products, AndroGel 1% and Testim 1%, to include a boxed warning on the products' labels.

7 May 2009

FDA licenses Sanofi Pasteur's new flu vaccine manufacturing facility

Sanofi Pasteur announced today that the U.S. Food and Drug Administration (FDA) has licensed its new influenza vaccine manufacturing facility.

7 May 2009

FDA approve Fanapt tablets (iloperidone) to treat adults with schizophrenia

The U.S. Food and Drug Administration has approved Fanapt tablets (iloperidone) to treat adults with schizophrenia, a chronic, severe and disabling brain disorder.

7 May 2009

Healthcare providers should explain vaccine refusal risks

Physicians and nurses need to explain the risks of vaccine refusal while respectfully listening to parents' concerns, a special article in the May 7 issue of the New England Journal of Medicine urges.

6 May 2009

FDA approves new flu vaccine production facility

The U.S. Food and Drug Administration (FDA) today announced that it has approved a new manufacturing facility used to produce influenza virus vaccines. The facility is approved for seasonal influenza vaccine production and could be used for the production of vaccine against the new 2009 H1N1 influenza strain.

6 May 2009

GSK to divest U.S. rights for Wellbutrin XL to Biovail

GlaxoSmithKline has announced that it has entered into an agreement to divest full commercial rights to Wellbutrin XL in the United States to Biovail International Laboratories SRL, a subsidiary of Biovail Corporation, for $510 million (euro 340 million). The agreement is subject to Hart-Scott-Rodino regulatory clearance in the United States.

6 May 2009

Panic buying of flu drug results in rationing

Even though Australia is yet to have had any confirmed cases of influenza A H1N1 (swine flu) there has been such a demand for the anti-viral drug Tamiflu that the drug must now be rationed - it is reported that in the last week 120,000 courses of Tamiflu were sold, compared with about 10,000 courses in a normal flu season and many chemists have run out.

6 May 2009

IBM and University of Texas Medical Branch launch effort to find flu drug treatments

IBM and the University of Texas Medical Branch (UTMB) launched an effort using IBM's World Community Grid "virtual supercomputer" to allow laboratory tests on drug candidates for drug-resistant influenza strains and new strains, such as H1N1, in less than a month.

6 May 2009