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Manufacturers in the European active pharmaceutical ingredients market are struggling to overcome a variety of challenges

Manufacturers in the crowded and highly fragmented European active pharmaceutical ingredients (API) market are struggling to overcome a variety of challenges. One of the most pressing of these is the problem of overcapacity.

29 Nov 2004

FDA approves Combunox tablets for the short-term treatment of acute, moderate to severe pain

Forest Laboratories have announced that Combunox (Oxycodone HCl and Ibuprofen) Tablets (CII), the first and only fixed-dose combination of the opioid oxycodone HCl (5 mg) and the nonsteroidal anti-inflammatory drug (NSAID) ibuprofen (400 mg), was approved by the U.S. Food and Drug Administration (FDA) for the short-term management of acute, moderate to severe pain.

29 Nov 2004

FDA approves Remodulin for the treatment of pulmonary arterial hypertension

United Therapeutics Corporation announced today that the U.S. Food and Drug Administration (FDA) has issued an approval letter for the intravenous use of Remodulin based on data establishing its bioequivalence with the previously approved subcutaneous administration of Remodulin.

24 Nov 2004

Scientists join forces to improve the effectiveness of a drug used to treat chronic myeloid leukaemia

Scientists from Glasgow and Liverpool are joining forces to improve the effectiveness of a drug used to treat a form of leukaemia, chronic myeloid leukaemia (CML), which affects 750 people in the UK each year.

24 Nov 2004

MedImmune and Medarex have announced a collaboration to develop antibodies

MedImmune and Medarex have announced a collaboration to develop antibodies targeting interferon-alpha and the type I interferon receptor 1.

24 Nov 2004

FDA approval of Tysabri, for the treatment of multiple sclerosis

Biogen and Elan Corporation have announced that the U.S. Food and Drug Administration (FDA) has approved Tysabri (natalizumab), as treatment for relapsing forms of multiple sclerosis (MS) to reduce the frequency of clinical relapses.

24 Nov 2004

Topical cream alternative to Vioxx

A clinical study recently published in The Journal of Rheumatology concludes that a topical cream consisting of a blend of natural oils called cetylated fatty acids significantly increased range of motion and physical performance in patients with osteoarthritis of the knee with no reported side effects.

24 Nov 2004

FDA incapable of protecting America against another Vioxx

The Food and Drug Administration (FDA) tried to discredit one of its own experts after he told a US Senate hearing that the FDA had failed to protect the public over rofecoxib (Vioxx), according to two articles published online by the British Medical Journal.

24 Nov 2004

FDA approves Vesicare (solifenacin succinate) for the treatment of overactive bladder

Vesicare (solifenacin succinate) has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of overactive bladder (OAB) with symptoms of urgency, frequency, and urge incontinence.

23 Nov 2004

Information about serious adverse effects of cerivastatin were known within months after drug launched

A review of the published literature and of internal company documents from the manufacturer of cerivastatin, a cholesterol lowering drug removed from the market in 2001, suggests that information about serious adverse effects of this medication was known to the company within months after this drug was launched

23 Nov 2004

Hetero Drugs withdraws antiretrovirals

Following an inspection by the World Health Organization (WHO), generic manufacturer Hetero Drugs Limited, in Hyderbad, India, is withdrawing six antiretrovirals from the WHO prequalification list in order to review data on their bioequivalence.

20 Nov 2004

AstraZeneca reconfirms the safety of Crestor

In the case of Crestor (rosuvastatin calcium), the application for approval was the most extensive ever for a statin involving more than 12,000 patients, and was unanimously recommended for approval by the FDA's advisory board in July of 2003.

20 Nov 2004

FDA approves Tarceva (erlotinib)

OSI Pharmaceuticals and Genentech have announced that the U.S. Food and Drug Administration (FDA) has approved, after priority review, Tarceva (erlotinib) for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen.

20 Nov 2004

Vaccinex and Biocon to co-develop at least four therapeutic antibody products

The collaboration combines Vaccinex's unique capabilities to discover fully human monoclonal antibodies using its proprietary antibody discovery technology and Biocon's proven expertise in clinical research and biologics manufacturing.

19 Nov 2004

FDA Vioxx fiasco raises questions about AIDS drug approvals for developing world

AIDS Healthcare Foundation (AHF), today noted that the current "FDA fiasco" involving the agency's initial approval and subsequent recall of Merck's troubled arthritis drug, Vioxx, raises serious questions about the FDA's ongoing parallel role in the approval of generic AIDS drugs for widespread use in Africa and the developing world.

19 Nov 2004

FDA clarifies it's position on Vioxx

For the past several weeks, various allegations and characterizations have circulated and been reported on regarding FDA's approval and post market review of the drug Vioxx, a "Cox-2 inhibitor," that its sponsor, Merck, voluntarily withdrew from the market September 30th, 2004.

17 Nov 2004