Article Listing - Biotechnology
US FDA delays approval of Gilead's elvitegravir and cobicistat for HIV
30 April 2013
US antiviral drug specialists Gilead Sciences (Nasdaq: GILD) says it has received Complete Response Letters from the US Food and Drug Administration for its New Drug Applications for elvitegravir and cobicistat for use as part of HIV treatment regimens. Gilead's shares, which have almost doubled in the past 12 months, dipped less than 1% to $51.09 by close of New York trading yesterday (April 29) following the announcement.
GSK returns IPX066 rights to Impax; Merck & Co and Pfizer link up on diabetes drug
30 April 2013
US biotech firm Impax Laboratories (Nasdaq: IPXL) saw its shares fall 2% to $17.32 in premarket trading, after the company revealed the termination of its collaboration with UK pharma giant GlaxoSmithKline (LSE: GSK for the development and commercialization of IPX066 outside the USA and Taiwan has been terminated.
Theravance to split into two, halting speculation of a full takeover by GSK
29 April 2013
US drug developer Theravance (Nasdaq: THRX) has announced its intention to create two independent publicly traded companies with differing business objectives and opportunities, designed to unlock potential value, facilitate return of capital to shareholder. The split plan comes after weeks of speculation that the company could be bought by UH pharma giant GlaxoSmithKline (LSE: GSK), Theravance's largest shareholder with a stake of about 27% and partner on the development of some of its drug candidates.
Japan briefs: Takeda files for Azilva comb; Sandoz seeks filgrastim biosimilar approval
29 April 2013
Japan's largest drugmaker Takeda Pharmaceutical (TYO: 4502) says that it submitted a New Drug Application to the Ministry of Health, Labor and Welfare in Japan for a fixed-dose combination of Azilva (azilsartan) and amlodipine besylate tablets for treatment of hypertension.
GlaxoSmithKline files for umeclidinium monotherapy approval in Europe
29 April 2013
UK pharma giant GlaxoSmithKline (LSE: GSK) has submitted a regulatory application in the European Union for the investigational once-daily medicine, umeclidinium bromide (UMEC), for patients with chronic obstructive pulmonary disease (COPD).
Celgene 1st-qtr revenues leap 15% but profit falls 4%
28 April 2013
US biotech firm Celgene (Nasdaq: CELG) last week posted first-quarter 2013 financial results, showing that profit fell 4.1% year-on-year to $385 million, , or $0.89 per diluted share, as increased expenses offset higher revenues for its leading drugs. Overall sales jumped 15% to $1.4 billion, falling in line with analyst estimates, with Revlimid posting revenue of $1 billion, up 16%.
EU member states urged to boost biosimilars market access
26 April 2013
"Safe and effective biosimilar monoclonal antibodies will arrive soon," announced Gudbjorg Edda Eggertsdottir, president of the European Generic Medicines Association (EGA) in her opening address at the 11th EGA International Symposium on Biosimilars in London.
Biogen Idec GAAP diluted EPS leaps 43%, beating forecasts
25 April 2013
US biotech firm Biogen Idec (Nasdaq: BIIB) reported first quarter 2013 total revenues of $1.4 billion, an increase of 10% compared to the first quarter of 2012. Non-GAAP diluted EPS for the first quarter of 2013 were $1.97, an increase of 41% over the first quarter of 2012, and beating the $1.63 average of 28 analysts' estimates compiled by Bloomberg. Biogen shares were up more than 3% to $210.26 on the news.
Janssen files for European approval of hep C candidate simeprevir
25 April 2013
Janssen-Cilag International, a European subsidiary of US health care giant Johnson & Johnson (NYSE: JNJ), has submitted a Marketing Authorization Application to the European Medicines Agency seeking approval for simeprevir (TMC435) for the treatment of adult patients with chronic hepatitis C genotype 1 or genotype 4.
Sanofi's Aubagio delayed onset of clinically definite MS in TOPIC study
25 April 2013
French drug major Sanofi (Euronext: SAN) US biotech subsidiary Genzyme announced today positive top-line results from the TOPIC trial for Aubagio (teriflunomide). The trial was designed to assess whether early initiation of the drug in patients who experienced their first neurological symptoms consistent with Clinically Isolated Syndrome (CIS) can prevent or delay conversion to clinically definite multiple sclerosis (CDMS)
- Novo Nordisk's diabetes drug Victoza produced 8% weight loss in Ph III obesity trial
- Proposal to list Roche's Neulastim and Actemra in New Zealand
- Alchemia and Merck Serono collaborate on HA-Irinotecan with Erbitux
- Positive new data on Novartis' Galvus in elderly type 2 diabetes patients
- Johnson & Johnson expects 10 NDA filings by 2017, saying pharma sector poised for growth
