Article Listing - Aronex' Atragen not approvable, says FDA

Sagent Pharma expands voluntary withdrawal of vecuronium inj vials

13 June 2013

US drugmaker Sagent Pharmaceuticals (Nasdaq: SGNT) said today (June 13) that it is expanding its voluntary nationwide recall of vecuronium bromide for injection 10mg (NDC number 25021-657-10) manufactured by Turkey-based Mustafa Nevzat Ilac Sanayii (MN Pharmaceuticals) and distributed by Sagent. This recall is being conducted with the knowledge of the US Food and Drug Administration.

Increased focus on generics and biosimilars only way to make European health care sustainable, says EGA

13 June 2013

Addressing delegates at the 19th European Generic medicines Association (EGA) Annual Conference in Athens, Greece, its president Gudbjorg Edda Eggertsdottir stressed that generic and biosimilar medicines companies ensuring high-quality manufacturing jobs and know-how should remain in Europe; benefiting society and patients and increasing the competitiveness and innovative capacity of this strategic industry.

Amgen's trebananib meets primary end-point in Ph III study of recurrent ovarian cancer

13 June 2013

USA-based Amgen (Nasdaq: AMGN), the world's largest independent biotech firm, has announced that the Phase III TRINOVA-1 trial evaluating trebananib (AMG 386) plus paclitaxel versus placebo plus paclitaxel in recurrent ovarian cancer met its primary endpoint of progression-free survival (PFS).

First approved new class of IBS-C therapy, Constella, now available in Europe

13 June 2013

Spain's largest drugmaker Almirall (ALM: MC) and US partner Ironwood Pharmaceuticals, (Nasdaq: IRWD) today (June 13) announced the launch of Constella (linaclotide 290mcg capsules once daily), the first approved prescription therapy in a new class of treatments for adults suffering from moderate to severe IBS-C, in Europe. Constella is now available in Germany, the UK and Nordic countries and is expected to be launched in several other European countries in 2013.

Rising drug resistance driving early-line use of powerful antibiotics, according to surveyed EU5 physicians

13 June 2013

More than half of physicians surveyed by health care advisory firm, Decision Resources from the EU5 (France, Germany, Italy, Spain and the UK) prescribe carbapenems, especially meropenem (Cubist/AstraZeneca's Merrem/Meronem; Dainippon Sumitomo's Meropen; generics) and imipenem/cilastatin (Merck's Primaxin/Tienam; generics), as first- or second-line therapy for Gram-negative infections (GNIs) due to ESBL-producing Enterobacteriaceae.

Generics triple-therapy just as effective as brand-name Enbrel, new study shows

13 June 2013

Global biotech leader Amgen's (Nasdaq: AMGN) branded drug Enbrel (etanercept) is no more effective in treating rheumatoid arthritis than cheaper generic drugs, according to new research published in the Journal of the Medical Association, funded by the US Department of Veteran Affairs.

Teva and Active Biotech to move forward with laquinimod on positive Ph IIa results in active lupus nephritis

13 June 2013

Israel's Teva Pharmaceutical Industries (NYSE: TEVA) and Swedish partner Active Biotech (OMX NORDIC: ACTI) have released positive results of a Phase IIa study of oral laquinimod designed to assess safety, tolerability and clinical efficacy in patients with active lupus nephritis, one of the most serious manifestations of systemic lupus erythematosus (SLE or lupus) that can lead to chronic kidney failure.

Over 200 novel drugs in development for heart disease and stroke, says PhRMA

13 June 2013

America's biopharmaceutical research companies are developing 215 medicines for two of the leading causes of death of Americans - heart disease and stroke, according to a new report and overview released yesterday (June 12) by the Pharmaceutical Research and Manufacturers of America (PhRMA).

NICE final draft guidance on Eli Lilly's Alimta negative

13 June 2013

UK drugs watch dog the National Institute for Health and Care Excellence (NICE) this morning (June 13) issued final draft guidance not recommending US drug major Eli Lilly's Alimta (pemetrexed) for the maintenance treatment of non-small-cell lung cancer (NSCLC) following induction therapy with pemetrexed and cisplatin.

Pfizer in $2.15 billion settlement from Teva and Sun for infringement of Protonix patent

12 June 2013

Global pharma behemoth Pfizer (NYSE: PFE) today (June 12) said it has reached a $2.15 billion settlement reached with Israel-based Teva Pharmaceuticals Industries (NYSE: TEVA) and India's Sun Pharmaceutical Industries (SUNP: IN) for patent-infringement damages resulting from their "at-risk" launches of generic Protonix (pantoprazole) in the USA.

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