Article Listing - US FDA warns on safety of Celgene's Revlimid; new Ph III trial results

Greek research-based drugmaker group AIFD challenges generics assumptions in Draft Patent Law

20 May 2013

One of the most important preconditions for Turkey to reach a reformist, sustainable economic growth with high-added-value and to attract more direct foreign investment is to create an effective patent system at international standards, protecting intellectual property rights, comments the research-based Turkish pharma industry group, the AIFD.

HIV vaccines: small biotech and government-funded organizations will step in where Big Pharma has fallen short, says analyst

20 May 2013

While the risks involved in HIV vaccine development have turned Big Pharma away from pursuing a preventative vaccine, government-funded organizations and smaller biotech firms may provide the answer, a GlobalData analyst has said in a research note as World AIDS Vaccine Day approaches.

Elan makes "transformational" acquisitions and a divestment

20 May 2013

Ireland-headquartered Elan Corp (NYSE: ELN) (Elan) this morning announced a series of transactions designed to decisively transform and advance the company. Upon shareholder approval, the totality of these strategically driven decisions, in addition to the $1 billion Theravance royalty participation agreement and dividend pass through announced last week (The Pharma Letter May 13) and the previously completed $3.23 billion Tysabri (natalizumab) transaction with Biogen Idec, will form a dynamic and unique business foundation for Elan in the years ahead. Elan is at the same time fighting off a hostile takeover approach from Royalty Pharma (TPLs passim).

Drug prices to plunge as Indian government announces plans to regulate rates of 652 medicines

20 May 2013

India's National Pharmaceutical Pricing Authority (NPPA) last week announced plans that will bring down the prices of essential medicines, increase the number of drugs under price control, and alter the way the government regulates prices in the 720 billion-rupee ($13.17 billion) domestic market.

SciClone gains China rights to Zensun's Neucardin

20 May 2013

USA-based SciClone Pharmaceuticals (Nasdaq: SCLN) today announced that the Company has entered into an agreement with Zensun (Shanghai) Science & Technology granting SciClone a license and the exclusive rights in China, Hong Kong and Macau to promote, market, distribute and sell Neucardin, a genetically engineered recombinant peptide fragment of neuregulin-1 and a novel, first-in-class therapeutic drug for the treatment of patients with intermediate to advanced chronic heart failure (CHF).

Impax launches authorized generic of Zomig, as Mylan debuts copy of Tricor in USA

20 May 2013

US drugmaker Impax Laboratories (Nasdaq: IPXL) says that its generics division, Global Pharmaceuticals, commenced shipment of an authorized generic version of Zomig (zolmitriptan) tablets and orally disintegrating tablets, 2.5mg and 5mg, in the USA, as part of a distribution, license, development and supply agreement with Anglo-Swedish drug major AstraZeneca (LSE: AZN).

Number of new PBS medicines in Australia hits 20-year low

20 May 2013

The number of new medicines listed on the Australian Pharmaceutical Benefits Scheme (PBS) in 2011-12 was the lowest for 20 years, according to a new report released today (May 20) by the Centre for Strategic Economic Studies and commissioned by the pharma trade group Medicines Australia.

Benefits of Diane 35 and generics outweigh risks in specific patient group, says EMA unit; other actions

17 May 2013

The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) has concluded that the benefits of Diane 35 (cyproterone acetate 2mg, ethinylestradiol 35mcg) and its generics outweigh the risks, provided that several measures are taken to minimize the risk of thromboembolism (formation of blood clots in the veins and arteries).

New study shows UCB's Neupro reduces NSBP in RLS patient

17 May 2013

Leading Belgian drugmaker UCB (Euronext Brussels: UCB) today (May 17) announced data from a double-blind, placebo-controlled study that found that Neupro (rotigotine transdermal system) reduced total nocturnal systolic blood pressure (NSBP) elevations associated with periodic limb movements during sleep (PLMS) and total PLMS in patients with idiopathic moderate-to-severe Restless Legs Syndrome (RLS)/Willis-Ekbom disease. The data were presented at the Annual Scientific Meeting of the American Society of Hypertension, May 15-18, 2013.

Boehringer Ingelheim transitions to propellant-free Combivent Respimat; names new BMD member

17 May 2013

German family-owned drug major Boehringer Ingelheim said today (May 17) that it is updating health care professionals (HCPs) and patients that the transition to Combivent Respimat (ipratropium bromide and albuterol) Inhalation Spray for the maintenance treatment of chronic obstructive pulmonary disease (COPD) is nearly complete.

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