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FDA issues complete response letter to Ipsen for Dysport BLA

Ipsen has announced that the US Food and Drug Administration (FDA) issued a Complete Response Letter for its Biologics License Application (BLA) for its Botulinum toxin Type A, Dysport.

30 Dec 2008

FDA approves injectable drug degarelix for advanced prostate cancer

The U.S. Food and Drug Administration recently approved the injectable drug degarelix, the first new drug in several years for prostate cancer.

29 Dec 2008

Seniors warned about mixing OTC and prescription drugs

According to researchers in the United States about 2.2 million seniors put themselves at high risk for drug interactions - they say many non-prescription medication, which are bought over-the-counter (OTC) can produce a harmful drug interactions.

29 Dec 2008

Warning about severe allergic reactions to recalled cold and flu tablets

The Therapeutic Goods Administration (TGA) have recalled two types of cold and flu tablets following reports of a number of allergic and anaphylactic reactions.

22 Dec 2008

Teva's acquisition of Barr cleared by FTC

Teva Pharmaceutical Industries Ltd. and Barr Pharmaceuticals, Inc. have announced that the U.S. Federal Trade Commission ("FTC") has accepted the proposed consent order in connection with the pending acquisition of Barr by Teva and granted early termination of the Hart Scott Rodino waiting period.

22 Dec 2008

Teva and Barr receive European approval for acquisition

Teva Pharmaceutical Industries Ltd. and Barr Pharmaceuticals, Inc. have announced that they received approval from the European Commission to proceed with Teva's acquisition of Barr.

22 Dec 2008

Johnson & Johnson extends cash tender offer for Omrix Biopharmaceuticals

Johnson & Johnson has announced it has extended its previously announced cash tender offer, through its wholly-owned subsidiary, Binder Merger Sub, Inc., for all outstanding shares of common stock of Omrix Biopharmaceuticals, Inc. until 12:00 midnight (Eastern time), on Dec. 26, 2008, unless further extended.

22 Dec 2008

GlaxoSmithKline ready to supply Biota's Relenza to meet CDC recommendations

GlaxoSmithKline (GSK) is prepared to respond to public health needs for Relenza (zanamivir) Inhalation Powder this flu season following a Health Alert Advisory issued by the Centers for Disease Control and Prevention (CDC).

21 Dec 2008

FDA issues complete response to biologics license application for ustekinumab

Centocor, Inc., has announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response letter for its Biologics License Application (BLA) for ustekinumab.

21 Dec 2008

AstraZeneca submits sNDA for NEXIUM (esomeprazole magnesium)

AstraZeneca has announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for NEXIUM(R) (esomeprazole magnesium) to seek approval for the short-term (up to 6 weeks) treatment of gastroesophageal reflux disease (GERD) in pediatric patients ages 0 to 1 year old.

21 Dec 2008

AstraZeneca and MAP Pharmaceuticals announce collaboration on Unit Dose Budesonide

AstraZeneca and MAP Pharmaceuticals, Inc. have announced an exclusive worldwide agreement to develop and commercialize Unit Dose Budesonide (UDB), MAP Pharmaceuticals' proprietary nebulized formulation of budesonide.

21 Dec 2008

FDA approves Gleevec (imatinib mesylate) to prevent gastrointestinal stromal tumor

The U.S. Food and Drug Administration has approved Gleevec (imatinib mesylate) for a new indication – keeping cancer from growing in patients following surgical removal of a gastrointestinal stromal tumor or GIST.

21 Dec 2008

Merck KGaA acquires manufacturing rights for Stimuvax from Oncothyreon

Oncothyreon Inc. announced today that Merck KGaA of Darmstadt, Germany has licensed the right to manufacture Stimuvax and, through its affiliate EMD Serono Canada Inc., purchased current inventory and certain assets utilized for the manufacture of Stimuvax from Oncothyreon for consideration which includes net payments to Oncothyreon totaling approximately U.S. $13 million.

18 Dec 2008

FDA approves Mozobil (plerixafor) for multiple myeloma or non-Hodgkin's lymphomas

The U.S. Food and Drug Administration has approved Mozobil (plerixafor), a drug that helps increase the number of blood stem cells for bone marrow transplantation in patients with certain forms of blood cancer.

18 Dec 2008

Watson Pharmaceuticals receives FDA approval for generic Razadyne ER capsules

Watson Laboratories, Inc., has received approval from the United States Food and Drug Administration on its Abbreviated New Drug Application (ANDA) for galantamine hydrobromide extended-release capsules, eq. to 8 mg, 16 mg and 24 mg (galantamine base).

17 Dec 2008

GlaxoSmithKline extends Genelabs acquisition offer

GlaxoSmithKline has announced that it has extended its previously announced tender offer to purchase all of the outstanding shares of common stock of Genelabs Technologies, Inc., for $1.30 in cash per share without interest and less any required withholding taxes, until 5:00 p.m. New York City time on Monday, December 29, 2008, unless the tender offer is further extended.

17 Dec 2008

Synerx Pharma announces FDA submission of Isosulfan Blue injection ANDA

Synerx Pharma, LLC has announced the submission to the FDA of Isosulfan Blue Injection (generic equivalent to Lymphazurin, Covidien (formerly US Surgical)).

16 Dec 2008

FDA requires stronger warnings on antiepileptic medicines

The U.S. Food and Drug Administration has announced it will require the manufacturers of antiepileptic drugs to add to these products' prescribing information, or labeling, a warning that their use increases risk of suicidal thoughts and behaviors (suicidality). The action includes all antiepileptic drugs including those used to treat psychiatric disorders, migraine headaches and other conditions, as well as epilepsy.

16 Dec 2008

Natural product from red seaweed brings new antiviral spray

Marinomed Biotechnologie GmbH has been awarded the top prize in the Mercur 2008 innovation awards. This award to Marinomed honours the discovery of antiviral properties in a natural product and the rapid development of the discovery into a nasal spray for treating the common cold.

16 Dec 2008

GlaxoSmithKline statement on FDA advisory committee vote on use of asthma medicines containing long-acting beta agonists

The following is GlaxoSmithKline's statement regarding recommendations of a combined Advisory Committee to the FDA on the use of asthma medicines containing long-acting beta agonists, including GSK's Serevent (salmeterol) and Advair (salmeterol/fluticasone proprionate).

14 Dec 2008