Article Listing - First Approval For Ethyol, But FDA Panel Says No
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).
Actavis and Warner Chilcott leap on merger talks; possible bid for Adcock Ingram
13 May 2013
US generics major Actavis NYSE: ACT) confirmed on Friday (May 10) that it has entered into early stage discussions with Ireland-based Warner Chilcott (Nasdaq: WCRX) regarding a potential combination of the two companies. Actavis further stated that no agreement has been reached and it does not intend to issue further comment regarding its business development initiatives. A similar statement was issued by Warner Chilcott.
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.
- AstraZeneca's naloxegol meets endpoints; EMA validates Gilead's sofosbuvir MAA
- Is failure to adopt business process management putting the pharma industry at risk?
- Boehringer Ingelheim gets FDA warning letter on cGMP failures
- Sanofi and Regeneron's dupilumab shows 87% reduction in risk of asthma exacerbations
- Ignyta acquires Actagene Oncology and entry into cancer personalized medicine
