Article Listing - Endo Pharma pulls out of axomadol deal with Grunenthal
Regulatory briefs: Sanofi's Fluzone; Roche' RoActemra; Takeda's Rienso
10 June 2013
French pharma major Sanofi (Euronext: SAN) today (June 10) announced that the US Food and Drug Administration has approved the supplemental Biologics License Application (sBLA) for Fluzone Quadrivalent vaccine or use in children six months of age and older, adolescents, and adults. Fluzone Quadrivalent vaccine includes two A strains and two B strains for protection against influenza disease. The Fluzone Quadrivalent vaccine will be available to health care providers in the USA for the 2013-2014 influenza season in prefilled syringes and single-dose vials for intramuscular administration.
New Zealand to fund AstraZeneca's Brilinta for acute coronary syndromes
10 June 2013
New Zealand's Pharmaceutical Management Agency, PHARMAC, says it has reached an agreement with the local subsidiary of Anglo-Swedish drug major AstraZeneca (LSE: AZN) to fund the company's antiplatelet agent ticagrelor (Brilinta).
AstraZeneca to pay up to $1.15 billion to acquire Pearl Therapeutics
10 June 2013
In a further "strategic" bolt-on acquisition for Anglo-Swedish drug major AstraZeneca (LSE: AZN) in less than a month, the company revealed this morning (June 10) that it has entered into a definitive agreement to buy Pearl Therapeutics, a privately held company based in Redwood City, California, focused on the development of inhaled small-molecule therapeutics for respiratory disease, for a total cost of up to $1.15 billion.
Royalty Pharma hikes offer for Elan to $13 a share, plus CVR of up to $2.50
10 June 2013
Ireland-based Elan Corp (NYSE: ELN) saw its shares to 5.3% to $13.35 by mid morning last Friday (June 7), when hostile bidder Royalty Pharma said that it was increasing its offer for the Irish company) to $13.00 per share in cash plus a contingent value right (CVR) worth up to $2.50 per share, up from the earlier May raised offer of $12.50, that Elan's board rejected as grossly inadequate, but considerably higher than the original $11 proposed in February (The Pharma Letters passim).
Gilead gains FDA priority review for hep C candidate sofosbuvir; new data on Boehringer's faldaprevir
10 June 2013
US biotech firm Gilead Sciences (Nasdaq: GILD) revealed on Friday (June 7) that the US Food and Drug Administration has granted priority review to the company's New Drug Application for sofosbuvir, a once-daily oral nucleotide analogue inhibitor for the treatment of chronic hepatitis C virus (HCV) infection.
EU Pharma leaders call for right balance between health care budget and economic growth objectives
10 June 2013
The Executive Committee of the European Federation of Pharmaceutical Industries and Associations (EFPIA), representing RD based drugmakers, met in Paris, France, last week, for discussions focused on how the industry can best respond to the financial crisis in a spirit of partnership with European governments, while striking the right balance between the objectives of securing rapid patient access to innovative medicines, controlling public health expenditure and preserving a stable, predictable and attractive environment for research and manufacturing investments.
UK's NICE plans to recommend Abilify for children with bipolar disorder
10 June 2013
UK drugs watch dog the National Institute for Health and Care Excellence (NICE) has issued new draft guidance proposing to recommend Abilify (aripiprazole), from Japanese drugmaker Otsuka Pharmaceutical (TYO: 4578) and Danish partner Lundbeck (LUND: DC), for treating moderate to severe manic episodes in adolescents aged 13 and older with bipolar I disorder.
Arena/Eisai's Belviq at last to launch in the USA
7 June 2013
USA-based Arena Pharmaceuticals (Nasdaq: ARNA) says that its long-awaited weight loss drug Belviq (lorcaserin) will finally become available to US patients on June 11, on prescription via pharmacies. The US subsidiary of Japanese drug major Eisai (TYO: 4523) is responsible for the marketing and distribution of Belviq.
Valneva to sell French CMO operations to India's Biological E
7 June 2013
Biotech firm Valneva (Euronext: VLA), the company recently created through the merger of France's Vivalis and Austria's Intercell (The Pharma Letter May 14) (Valneva), says it has signed a binding term sheet to sell its Clinical Manufacturing Operations (CMO) in Nantes, France, to Biological E, an Indian biopharmaceutical company.
Shire's Elvanse shows significantly faster response in ADHD symptoms than Strattera
7 June 2013
Ireland-headquartered Shire (LSE: SHP, NASDAQ: SHPG) presented positive scientific data comparing the efficacy and safety of the attention-deficit hyperactivity disorder (ADHD) treatments lisdexamfetamine dimesylate (LDX; Elan's Elvanse)) and atomoxetine (ATX; Eli Lilly's Strattera) at the 4th World Congress on ADHD, Milan, Italy.
- Aspen Pharma offers to buy GlaxoSmithKline's thrombosis brands and manufacturing site
- FDA probes two deaths possibly linked to Lilly's antipsychotic Zyprexa Relprevv
- Athera and Boehringer Ingelheim enter option agreement on a novel therapy for atherosclerosis
- US Supreme Court says patent settlement can "sometimes" be illegal
- Actavis and Kissei file law suits against Sandoz and Hetero over Rapaflo patent
