Article Listing - ZymoGenetics out-licenses non-core drugs
IQWiG re-assessments come up with same view for saxagliptin and different for crizotinib
14 May 2013
Under the rules of the German Act on the Reform of the Market for Medicinal Products (AMNOG), the Institute for Quality and Efficiency in Health Care (IQWiG) has now assessed additional information to studies for two drugs, US pharma behemoth Pfizer's (NYSE: PFE) Xalkori (crizotinib) and Drug major Bristol-Myers Squibb (NYSE: BMY) and AstraZeneca's (LSE: AZN) Onglyza/Komboglyze (saxagliptin).
US DoJ says Ranbaxy pleads guilty and agrees to pay $500 million in settlements
14 May 2013
In the largest drug safety settlement to date with a generic drug manufacturer, Ranbaxy USA, a subsidiary of Indian generic pharmaceutical manufacturer Ranbaxy Laboratories 9BSE; 500359) has pleaded guilty to felony charges relating to the manufacture and distribution of certain adulterated drugs made at two of Ranbaxy's manufacturing facilities in India, the US Justice Department announced yesterday (May 13).
Shire's ADHA drug Elvanse accepted for NHS use in Scotland; UK guidance on fidaxomicin
14 May 2013
Ireland-headquartered Shire plc (LSE: SHP) said yesterday (May 13) that its single-daily dose long-acting prodrug stimulant, Elvanse (lisdexamfetamine dimesylate), is accepted for use within the National Health Service (NHS) in Scotland as part of a comprehensive treatment program for attention-deficit hyperactivity disorder (ADHD) in children aged six years of age and over when response to previous methylphenidate treatment is considered clinically inadequate.
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.
Brazilian pharma exports to GCC up 73% to reach over $7.4 million in 2012
13 May 2013
Brazil exported $7.48 million worth of pharmaceutical products to the Gulf Cooperation Council (GCC) region in 2012, increasing by over 73% compared to $4.31 million in 2011, according to figures released by the Arab Brazilian Chamber of Commerce (ABCC). The Kingdom of Saudi Arabia and the United Arab Emirates (UAE) accounted for the biggest share of the Brazilian pharmaceutical exports at 57.02% and 41.61%, respectively.
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).
Vectura sets up JV, Kinnovata, for new respiratory business in China
13 May 2013
UK-based developer of inhaled therapies Vectura (LSE: VEC) saw its shares rise 4.8% to 96.93 pence in morning trading (May 13), after it revealed that it has established Tianjin Kinnovata Pharmaceutical Company in China with two partners; Tianjin KingYork Group Company, a leading Chinese pharmaceutical company and specialist manufacturer of corticosteroid based products, and Zendex Bio Strategy, a private equity investor based in Hong Kong.
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).
Africa's pharmaceutical industry faces numerous challenges, VoA reports
13 May 2013
Providing Africans with affordable health care could be realized if pharmaceutical products were produced on the African continent, writes Marthe van der Wolf for Voice of America. The continent faces many challenges before it will be able produce its own medicines.
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