Article Listing - Biotechnology
US FDA grants priority review for Janssen's simeprevir, accepts Biogen Idec's Eloctate and Actavis' progestin-only patch filing
13 May 2013
The US Food and Drug Administration has granted Priority Review to the New Drug Application for simeprevir (TMC435), an investigational NS3/4A protease inhibitor administered as a 150mg capsule once daily with pegylated interferon and ribavirin for the treatment of genotype 1 chronic hepatitis C in adult patients with compensated liver disease under development at Johnson & Johnson (NYSE: JNJ) subsidiary Janssen Research & Development.
NovaBay Pharmaceuticals: tuning in for a crescendo of data, say analysts
13 May 2013
US biotech firm NovaBay Pharmaceutical's (Nasdaq: NBY) first-quarter 2013 results set the scene for a potentially transformational second half of 2013, with results expected from three Phase II studies of its topical anti-infective, auriclosene (NVC-422), comment analysts at Edison Investment Research.
Elan pays $1 billion for a 21% share of Theravance royalties on four respiratory programs
13 May 2013
US biotech firm Theravance (Nasdaq: THRX) has entered into a royalty participation agreement wherein Ireland-based Elan (NYSE: ELN) will purchase a participation interest in potential future royalty payments related to four respiratory programs partnered with UK pharma giant GlaxoSmithKline (LSE: GSK).
Third milestone for Neovacs in the Tracker program for rheumatoid arthritis
13 May 2013
French biotech firm Neovacs (Alternext Paris: ALNEV), a leader in active immunotherapies for the treatment of autoimmune diseases, has received 414,839 euros ($538,129) from the French Innovation agency Oseo following achievement of a third milestone in early April, under the schedule agreed between the parties as part of the Tracker Project in rheumatoid arthritis (RA).
FDA approves Theravance and GSK's Breo Ellipta to treat COPD
13 May 2013
The US Food and Drug Administration on Friday (May 10) approved Breo Ellipta (fluticasone furoate, an inhaled corticosteroid, and vilanterol inhalation powder, a long-acting beta2-adrenergic agonist), from UK pharma giant GlaxoSmithKline (LSE: GSK) and US biotech firm Theravance (Nasdaq: THRX).
CytRx to focus on aldoxorubicin after tamibarotene demise; Loss narrows
10 May 2013
US biotech firm CytRx Corp (Nasdaq: CYTR) says that it will now focus on the clinical development of aldoxorubicin and expansion of its oncology pipeline based on its proprietary linker platform technology, following the recommendation of an independent Data Safety Monitoring Committee (DSMC) to discontinue the Phase IIb clinical trial with tamibarotene as a first-line treatment for patients with advanced non-small-cell lung cancer.
Cancer treatments "unaffordable" and will drive rapid transition to generics and market decline, says GlobalData
10 May 2013
The rising prices of new cancer drugs are resulting in an increasing cost burden for patients and health care systems that does not necessarily correlate with the survival benefit the drug provides, and which is driving the rapid transition to generics and limiting the use of new market entrants, say analysts at research and consulting firm GlobalData.
Unigene and Nordic Bioscience amend JDV accord; Amgen Vectibix China deal
10 May 2013
USA-based Unigene Laboratories (PINK: UGNE) has entered into an equity transfer and exclusive license agreement with Nordic Bioscience, involving three proprietary metabolic peptide analogs for type 2 diabetes, osteoarthritis and osteoporosis developed as part of a joint development vehicle (JDV) established by both companies in October 2011.
European Medicines Agency simplifies processing of fee reductions for orphan medicines
9 May 2013
The European Medicines Agency has cancelled the procedure by which sponsors of medicines with an orphan designation need to inform the Agency of their intention to submit an application in order to be eligible for a fee reduction. This forms part of the EMA's effort to reduce administrative burden for applicants and streamline the procedures for fee reductions.
Myriad Genetics' gene patenting battle: BRACAnalysis won't suffer the consequences, says GlobalData analyst
9 May 2013
USA-based Myriad Genetics (Nasdaq: MYGN) is currently disputing its right to claim ownership to a human gene, drawing worldwide support and condemnation in equal measures. However, one GlobalData analyst asks, with the changing pace of gene testing, will the final decision make that much of a difference to the fate of Myriad's flagship BRCA gene test, BRACAnalysis?
- Drug prices to plunge as Indian government announces plans to regulate rates of 652 medicines
- Elan makes "transformational" acquisitions and a divestment
- HIV vaccines: small biotech and government-funded organizations will step in where Big Pharma has fallen short, says analyst
- Is failure to adopt business process management putting the pharma industry at risk?
- Greek research-based drugmaker group AIFD challenges generics assumptions in Draft Patent Law
