FDA accepts sNDA for Astellas cancer drug

Pharma |  Regulatory | By BioSpectrum Bureau  | 0 Comment | 17 Jan, 2013

Singapore: The US FDA has accepted Astellas Pharma's US subsidiary filing of a supplemental New Drug Application (sNDA) for Tarceva (erlotinib) for first-line use in people with locally adv...Read more

AstraZeneca, BMS gets FDA nod for diabetes drug

Pharma |  Regulatory | By BioSpectrum Bureau  | 0 Comment | 09 Jan, 2014

Singapore: AstraZeneca and Bristol-Myers Squibb have recieved U.S. Food and Drug Administration (FDA) approval for diabetes drug Farxiga (dapagliflozin). AstraZeneca and Bristol-Myers Squi...Read more

EMA to review marketing plea for antipsychotic medication

Pharma |  News | By BioSpectrum Bureau  | 0 Comment | 29 Oct, 2012

Singapore: The European Medicines Agency (EMA) has accepted the marketing authorization application for review of an atypical antipsychotic medication lurasidone hydrochloride. The product ...Read more

Leo launches psoriasis education program

Pharma |  News | By BioSpectrum Bureau  | 0 Comment | 30 Jan, 2013

Singapore: Leo Pharma launched Psoriasis Coach All-Round Education (PsorCARE) program in Singapore on January 26, 2013. Developed by LEO Pharma Asia and PsorAsia, PsorCARE's goal is to enh...Read more

Chipscreen gets SFDA nod after accelerated review

Pharma |  Regulatory | By BioSpectrum Bureau  | 0 Comment | 17 Apr, 2013

‎Singapore: China-based Chipscreen Biosciences announced the achievement of the primary endpoint in the pivotal, registrational phase II Chipel trial of Chidamide (Epidaza), an orally...Read more

Bird flu cases erupt in Cambodia

Pharma |  News | By BioSpectrum Bureau  | 0 Comment | 04 Feb, 2013

Singapore: Cambodia's Ministry of Health (MoH) has reported five new human cases of avian influenza (bird flu), which were confirmed positive for the H5N1 virus in January 2013. The five ...Read more

Indian pharma clocks 8.9% growth in June 2013: IMS

Pharma |  News | By BioSpectrum Bureau  | 0 Comment | 24 Jul, 2013

New Delhi: The IMS Health Total Sales Audit (TSA) has released a report stating that the Indian pharmaceutical market has clocked a growth of 8.9 percent during the month of June 2013. The...Read more

Sanofi withdraws diabetes drug NDA in the US

Pharma |  News | By BioSpectrum Bureau  | 0 Comment | 13 Sep, 2013

Singapore: Global pharmaceutical company, Sanofi has temporarily withdrawn new drug application (NDA) for lixisenatide in the US and plans to resubmit in 2015.Lixisenatide is approved in Eu...Read more

Antithrombotic drug market to be $24 bn by 2015

Pharma |  Analysis | By BioSpectrum Bureau  | 0 Comment | 18 Feb, 2013

Singapore: Visiongain, a business information provider, estimates in its report 'Antithrombotic Drugs: World Market 2013-2023' that the global antithrombotic drug market to reach revenue of...Read more

Ranbaxy advisory: All our products are safe and efficacious

Pharma |  News | By BioSpectrum Bureau  | 0 Comment | 03 Jun, 2013

New Delhi: Ranbaxy issued an advisory claiming that all their products in the Indian and global markets are safe and efficacious. The firm revealed that the advisory was issued in public i...Read more

Amgen to acquire Onyx for $10 bn cash

Pharma |  News | By BioSpectrum Bureau  | 0 Comment | 26 Aug, 2013

Singapore: Global biopharmaceutical company Amgen plans to acquire all the outstanding shares of Onyx Pharmaceuticals for $125-per-share, totalling to $10.40 billion, in cash. The deal woul...Read more

Rabies claims 100 lives annually in Vietnam: UN

Pharma |  Analysis | By BioSpectrum Bureau  | 0 Comment | 30 Sep, 2013

Singapore: Vietnam has seen a substantial increase in the number of rabies fatalities from 34 deaths in 2003 to 131 deaths in 2007, according to United Nations (UN). World Rabies Day, whic...Read more

GSK Parkinson's drug can make you homosexual

Pharma |  News | By BioSpectrum Bureau  | 0 Comment | 03 Dec, 2012

Singapore: A landmark appeal court ruling in Britain has ordered British drug giant GlaxoSmithKline (GSK) to provide compensation worth $256,384 (£160,000) to 52-year-old Mr Didier Jambart...Read more

QIAGEN reports 9% growth in Q2 2012

Pharma |  Company results | By BioSpectrum Bureau  | 0 Comment | 25 Jul, 2012

Singapore: QIAGEN reported results of operations for the second quarter and first half of 2012, delivering a solid performance and making significant progress on strategic initiatives to dr...Read more

AstraZeneca makes initial payment of $3.2 billion to Amylin

Pharma |  News | By BioSpectrum Bureau  | 0 Comment | 10 Aug, 2012

Singapore: Following the successful completion of the acquisition of Amylin Pharmaceuticals by Bristol-Myers Squibb, AstraZeneca has made an initial payment of approximately $3.2 billion to...Read more

Effient trial by Daiichi, Lilly fails to meet primary endpoint

Pharma |  News | By BioSpectrum Bureau  | 0 Comment | 27 Aug, 2012

Singapore: The TRILOGY ACS study, a phase III trial comparing prasugrel plus aspirin to clopidogrel plus aspirin in patients with unstable angina (UA) or non-ST elevation myocardial infarct...Read more

Top 20: Singapore - High growth

Pharma |  Analysis | By BioSpectrum Bureau  | 0 Comment | 09 Jul, 2014

Singapore: Singapore has been witnessing strong performance. Here are a few developments in the country that are proof to increasing its bioscience presence. Alcon, global eye-care firm,...Read more

Now Ranbaxy's Mohali unit under FDA scanner

Pharma |  News | By BioSpectrum Bureau  | 0 Comment | 24 Jun, 2013

Singapore: Merely a month after Indian drug major, Ranbaxy, pleaded guilty of having misled the USFDA investigations, selling adulterated drugs in the US and paying a penalty of $500 millio...Read more