Article Listing - Biovitrum's 2nd-qtr 2007 income soars 33%
US FDA to allow generic copies of Endo's Opana
13 May 2013
Endo Health Solutions (Nasdaq: ENDP) announced Friday (May 10) that the US Food and Drug Administration has denied a Citizen Petition filed by its subsidiary, Endo Pharmaceuticals, regarding the potential approval of additional non-abuse deterrent formulations of generic oxymorphone, the active ingredient of its Opana. Endo's shares fell 5.3% to $34.97 on the news.
Lilly drops enzastaurin development; Remoxy future viewed by Pfizer and partners
10 May 2013
US drug major Eli Lilly (NYSE: LLY) revealed that Phase III clinical trial results from enzastaurin's PRELUDE study, which explored the molecule as a monotherapy in the prevention of relapse in patients with diffuse large B-cell lymphoma (DLBCL), failed to show a statistically significant increase compared to placebo in disease-free survival in patients at high risk of relapse following rituximab-based chemotherapy.
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.
US FDA Benefit-Risk Assessment Plan viewed by PhRMA
10 May 2013
US trade group Pharmaceutical Research and Manufacturers of America (PhRMA) says it shares the Food and Drug Administration's belief that a structured approach to benefit-risk assessment can improve and facilitate greater understanding of FDA's regulatory decisions by public stakeholders including patients, consumers, health care professionals and biopharmaceutical companies.
Shire prevails in US Lialda patent dispute with Watson
10 May 2013
Ireland-headquartered drugmaker Shire's (LSE: SHP) subsidiary Shire Development has prevailed in its US litigation against three companies (now trading as Actavis: NYSE: ACT) in connection with their Abbreviated New Drug Application for a generic version of Shire's Lialda (mesalamine) delayed release tablets for the induction of remission in adults with active, mild to moderate ulcerative colitis and for the maintenance of remission of ulcerative colitis.
Launch of Biotie/Lundbeck's Selincro will see a paradigm shift in alcohol addiction market
10 May 2013
US and European psychiatrists and US managed care organization (MCO) pharmacy directors surveyed by advisory firm Decision Resources agree that a therapy's ability to support abstinence is one of the attributes that most influences their decisions regarding prescribing and formulary status determinations, respectively, in the treatment of alcohol addiction.
India's NPPA says drugmakers cannot raise prices of imported products
10 May 2013
At a meeting earlier this month, India's drug price regulator the National Pharmaceutical Pricing Authority (NPPA) has denied a price rise for some imported products from French drug major Sanofi (Euronext: SAN), Lantus (insulin glargine), Switzerland's Novartis (NOVN: VX), Vitalux Plus TR (a multivitamin and minerals supplement for vision & the eye care), and USA-based Allergan (NYSE: AGN), Pred Forte (prednisolone), according to a Business Standard report posted on the NPPA's web site.
ScinoPharm Taiwan and Coland in strategic alliance for generic oncology injectables
10 May 2013
ScinoPharm Taiwan (TSE: 1789.TW) and Coland Holdings (TSE: 4144.TW) have formed a strategic alliance to develop a series of generic oncological drugs for Mainland China. Several active pharmaceutical ingredients (APIs) have been initially selected for development and future sales as injectable formulation products from the list of ScinoPharm-developed APIs. This will allow the companies to compete within the anti-cancer drug market in China and tap into this large and growing business potential.
Novartis' Ilaris gets new indication of childhood arthritis from US FDA
10 May 2013
Swiss pharmaceutical major Novartis (NIVN: VX) said this morning (May 10) that the US Food and Drug Administration has approved its Ilaris (canakinumab) for the treatment of active systemic juvenile idiopathic arthritis (SJIA) in patients aged two years and older.
- Bristol-Myers' data on Yervoy and nivolumab causes a stir
- Boehringer Ingelheim transitions to propellant-free Combivent Respimat; names new BMD member
- Encouraging results with Sangamo's SB-728-T in HIV treatment
- New study shows UCB's Neupro reduces NSBP in RLS patient
- Sanofi prepares for regulatory filing of MF candidate on positive JAKARTA study results
