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138 records returned

First approval for IlarisEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Novartis has received its first market approval of Ilaris (canakinumab) in the US. Ilaris is a human monoclonal antibody directed against interleukin-1beta... more
Source: Pharmaprojects' Pharma R&D Pipeline News - June 19, 2009 Category: Pharmaceuticals Source Type: news

US approval for macular oedema implantEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The US FDA has approved Allergan's Ozurdex (dexamethasone) injectable biodegradable implant, for the treatment of macular oedema following branch retinal vein occlusion or central retinal vein occlusion... more
Source: Pharmaprojects' Pharma R&D Pipeline News - June 18, 2009 Category: Pharmaceuticals Source Type: news

Breathing new life into inhaled insulin?Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Mannkind Corporation has presented new data on its inhaled insulin propect, Afresa, indicating that it may be comparable to the injectable standard of care... more
Source: Pharmaprojects' Pharma R&D Pipeline News - June 11, 2009 Category: Pharmaceuticals Source Type: news

Merck discontinues rolofylline following Phase III trial resultsEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Rolofylline (MK-7418) has failed to meet its primary and secondary efficacy endpoints in two Phase III trials (PROTECT-1 and PROTECT-2) across a total of 2,034 patients for the treatment of acute heart failure... more
Source: Pharmaprojects' Pharma R&D Pipeline News - June 10, 2009 Category: Pharmaceuticals Source Type: news

Takeda delays EU registration filings for alogliptinEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Takeda has announced that it will delay two EU MAA filings for its dipeptidyl peptidase-4 inhibitor alogliptin, following a review of its development strategy... more
Source: Pharmaprojects' Pharma R&D Pipeline News - June 5, 2009 Category: Pharmaceuticals Source Type: news

US group speaks out against prasugrelEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
A US consumer advocacy group has written to the FDA urging them to cease their review of Daiichi Sankyo and Eli Lilly's antithrombotic prasugrel... more
Source: Pharmaprojects' Pharma R&D Pipeline News - June 5, 2009 Category: Pharmaceuticals Source Type: news

Positive Phase III results for Novartis' indacaterolEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Novartis has reported positive results from three pivotal Phase III trials for its investigational bronchodilator indacaterol... more
Source: Pharmaprojects' Pharma R&D Pipeline News - May 27, 2009 Category: Pharmaceuticals Source Type: news

Brilinta meets Phase III primary endpointEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
AstraZeneca's oral P2Y12 ADP purinoreceptor antagonist Brilinta (ticagrelor) has met its primary endpoint in the Phase III 'PLATO' trial... more
Source: Pharmaprojects' Pharma R&D Pipeline News - May 18, 2009 Category: Pharmaceuticals Source Type: news

Additional launch for Dong-A's ZydenaEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Dong-A Pharmaceutical has launched their phosphodiesterase V inhibitor, Zydena, in Russia... more
Source: Pharmaprojects' Pharma R&D Pipeline News - May 15, 2009 Category: Pharmaceuticals Source Type: news

GlaxoSmithKline and Pfizer join forces for HIV researchEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The HIV research field is preparing for some significant shifts in the landscape in upcoming years. Treatment options for HIV infection and AIDS have changed dramatically since the initial identification of AIDS... more
Source: Pharmaprojects' Pharma R&D Pipeline News - May 13, 2009 Category: Pharmaceuticals Source Type: news

EU negative opinion for LyricaEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Pfizer's Lyrica (pregabalin), a gabapentinoid anticonvulsant, has received a negative opinion from the EU CHMP for use in fibromyalgia... more
Source: Pharmaprojects' Pharma R&D Pipeline News - May 6, 2009 Category: Pharmaceuticals Source Type: news

Zebinix receives EU approvalEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The novel once-daily anti-epileptic Zebinix (eslicarbazepine acetate) has been granted marketing authorization... more
Source: Pharmaprojects' Pharma R&D Pipeline News - May 1, 2009 Category: Pharmaceuticals Source Type: news

Nexavar fails Phase III melanoma trialEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The multi-targeted kidney and liver cancer drug Nexavar (sorafenib tosylate) has failed the first Phase III trial conducted in melanoma patients... more
Source: Pharmaprojects' Pharma R&D Pipeline News - April 30, 2009 Category: Pharmaceuticals Source Type: news

GlaxoSmithKline to acquire Stiefel LaboratoriesEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Industry heavyweight GlaxoSmithKline is to acquire the family-run specialty dermatology company Stiefel Laboratories for US$3.6 billion... more
Source: Pharmaprojects' Pharma R&D Pipeline News - April 21, 2009 Category: Pharmaceuticals Source Type: news

UK launch for PrasugrelEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Lilly and Daiichi Sankyo's antiplatelet agent, prasugrel, has been launched in the UK for the treatment of atherothrombotic events in patients with acute coronary syndrome... more
Source: Pharmaprojects' Pharma R&D Pipeline News - April 14, 2009 Category: Pharmaceuticals Source Type: news

European approval for SynflorixEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Synflorix (formerly Streptorix) has been approved in the EU for the prophylaxis of invasive pneumococcal disease and acute otitis media caused by Streptococcus pneumoniae... more
Source: Pharmaprojects' Pharma R&D Pipeline News - April 14, 2009 Category: Pharmaceuticals Source Type: news

Positive outlook for long-acting ExenatideEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
A Phase III meta-analysis of primary cardiovascular events associated with exenatide (Byetta) has been successfully completed, showing no associated increase in risk of cardiovascular events... more
Source: Pharmaprojects' Pharma R&D Pipeline News - April 14, 2009 Category: Pharmaceuticals Source Type: news

Roche purchases GenentechEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
On Thursday 26 March 2009, the Swiss-based pharmaceutical company Roche completed its tender offer for Genentech shares, concluding the US$46 billion takeover bid of the US-based biotechnology firm... more
Source: Pharmaprojects' Pharma R&D Pipeline News - April 14, 2009 Category: Pharmaceuticals Source Type: news

Merck & Co plans to purchase Schering-PloughEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
In March 2009, Merck & Co and Schering-Plough announced unanimous approval of a definitive merger agreement... more
Source: Pharmaprojects' Pharma R&D Pipeline News - March 26, 2009 Category: Pharmaceuticals Source Type: news

Dual filing for GlaxoSmithKline's pazopanibEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
GlaxoSmithKline's angiogenesis inhibitor, Armala (pazopanib), has been filed for approval in the the EU and the US for the treatment of renal cell carcinoma... more
Source: Pharmaprojects' Pharma R&D Pipeline News - March 13, 2009 Category: Pharmaceuticals Source Type: news

Intradermal 'flu vaccine receives first approvalEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Sanofi Pasteur has received EU approval for its intradermal influenza vaccine, Intanza, for the prevention of 'flu in adults and elderly patients... more
Source: Pharmaprojects' Pharma R&D Pipeline News - March 9, 2009 Category: Pharmaceuticals Source Type: news

Intercytex discontinues lead cellular therapyEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Intercytex has discontinued development of its lead candidate, Cyzact....
Source: Pharmaprojects' Pharma R&D Pipeline News - March 6, 2009 Category: Pharmaceuticals Source Type: news

EU Approval for prasugrelEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Eli Lilly and Daiichi Sankyo have announced the EU approval of their blood-thinning drug Efient (prasugrel)... more
Source: Pharmaprojects' Pharma R&D Pipeline News - March 4, 2009 Category: Pharmaceuticals Source Type: news

Suspension of marketing of Raptiva in EuropeEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The European Medicines Agency (EMEA) has recommended that the European Commission suspend marketing authorization for Raptiva (efalizumab), a humanised anti-CD11a monoclonal antibody... more
Source: Pharmaprojects' Pharma R&D Pipeline News - February 27, 2009 Category: Pharmaceuticals Source Type: news

New biologic gives hope to UK psoriasis sufferersEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Johnson & Johnson's novel fully-human antibody Stelera (ustekinumab) is now available in the UK for use in patients with moderate-to-severe plaque psoriais... more
Source: Pharmaprojects' Pharma R&D Pipeline News - February 12, 2009 Category: Pharmaceuticals Source Type: news

Double filing for novel antibody therapyEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
In the space of a week, Genmab and their partner GlaxoSmithKline have submitted filings to both the US FDA and the EMEA for their first-in-class anti-CD20 monoclonal antibody... more
Source: Pharmaprojects' Pharma R&D Pipeline News - February 10, 2009 Category: Pharmaceuticals Source Type: news

Pfizer's axitinib fails Phase III trial in pancreatic cancerEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Pfizer has terminated a Phase III trial of Axitinib, a novel small-molecule vascular endothelial growth factor receptor (VEGFR) inhibitor... more
Source: Pharmaprojects' Pharma R&D Pipeline News - February 4, 2009 Category: Pharmaceuticals Source Type: news

Roche gets EU green light for tocilizumabEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Roche has received EU approval for RoActemra (tocilizumab), its first-in-class therapy... more
Source: Pharmaprojects' Pharma R&D Pipeline News - February 3, 2009 Category: Pharmaceuticals Source Type: news

First approval for Prism PharmaceuticalsEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Prism Pharmaceuticals has received US approval for Nexterone, its intravenous formulation of the antiarrhythmic amiodarone... more
Source: Pharmaprojects' Pharma R&D Pipeline News - January 16, 2009 Category: Pharmaceuticals Source Type: news

First approval for next-generation fibrateEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The US FDA has approved TriLipix (fenofibric acid), a next-generation micronized fenofibrate co-developed by Abbott and Solvay, for cholesterol management... more
Source: Pharmaprojects' Pharma R&D Pipeline News - December 18, 2008 Category: Pharmaceuticals Source Type: news

Erbitux filed for non-small cell lung cancer in the USEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
ImClone Systems and Bristol-Myers Squibb have submitted a US filing for approval of their anti-EGFR monoclonal antibody therapy, Erbitux... more
Source: Pharmaprojects' Pharma R&D Pipeline News - December 18, 2008 Category: Pharmaceuticals Source Type: news

Merck KGaA's Kuvan becomes first European therapy for hyperphenylalaninaemiaEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Merck KGaA and its Merck Serono division have received EU approval for their monoamine biosynthesis enhancer Kuvan... more
Source: Pharmaprojects' Pharma R&D Pipeline News - December 9, 2008 Category: Pharmaceuticals Source Type: news

Ark refiles gene therapy treatment in the EUEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
UK company Ark Therapeutics has refiled its novel gene therapy Cerepro in the EU. Cerepro was originally filed for approval in 2005... more
Source: Pharmaprojects' Pharma R&D Pipeline News - December 8, 2008 Category: Pharmaceuticals Source Type: news

EU approvals for Daiichi Sankyo’s SevikarEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Daiichi Sankyo has received European approvals for its combination product Sevikar, for the treatment of hypertensive patients inadequately controlled on monotherapy regimes... more
Source: Pharmaprojects' Pharma R&D Pipeline News - November 20, 2008 Category: Pharmaceuticals Source Type: news

EU approvals for Daiichi Sankyo's SevikarEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Daiichi Sankyo has received European approvals for its combination product Sevikar, for the treatment of hypertensive patients inadequately controlled on monotherapy regimes... more
Source: Pharmaprojects' Pharma R&D Pipeline News - November 20, 2008 Category: Pharmaceuticals Source Type: news

Another one bites the dustEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Solvay has joined the recent trend for the discontinuation of cannabinoid type 1 receptor (CB1R) antagonists, by dropping its Phase II antiobesity compound, ibipinabant... more
Source: Pharmaprojects' Pharma R&D Pipeline News - November 20, 2008 Category: Pharmaceuticals Source Type: news

Heplisav shows unfavourable risk benefit profile in healthy subjectsEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The US FDA has advised that further clinical evaluation of Heplisav, a hepatitis-B vaccine, is no longer warranted in healthy adults and children due to an unacceptable risk benefit balance... more
Source: Pharmaprojects' Pharma R&D Pipeline News - October 22, 2008 Category: Pharmaceuticals Source Type: news

Long-awaited approval for EpiCept's acute myeloid leukaemia therapyEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Tarrytown, New York headquartered company EpiCept has received European Commission approval for its acute myeloid leukaemia (AML) therapy histamine dihydrochloride (Ceplene)... more
Source: Pharmaprojects' Pharma R&D Pipeline News - October 9, 2008 Category: Pharmaceuticals Source Type: news

Blow for Merck & Co as it terminates development of late-stage obesity drugEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Merck & Co has discontinued development of taranabant, its most advanced antiobesity agent... more
Source: Pharmaprojects' Pharma R&D Pipeline News - October 6, 2008 Category: Pharmaceuticals Source Type: news

US Approval for ProStrakan's SancusoEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
ProStrakan has received US approval for its transdermal 5HT3 antagonist, Sancuso (granisetron), for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients receiving moderately/highly emetogenic chemotherapy for up to 5 consecutive days... more
Source: Pharmaprojects' Pharma R&D Pipeline News - September 22, 2008 Category: Pharmaceuticals Source Type: news

Gamunex become first ever US-approved therapy for CIDPEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Gamunex has become first therapy ever to be approved in the US for the treatment of chronic inflammatory demyelinating polyneuropathy... more
Source: Pharmaprojects' Pharma R&D Pipeline News - September 18, 2008 Category: Pharmaceuticals Source Type: news

Gamunex becomes first ever US-approved therapy for CIDPEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Gamunex has become first therapy ever to be approved in the US for the treatment of chronic inflammatory demyelinating polyneuropathy... more
Source: Pharmaprojects' Pharma R&D Pipeline News - September 18, 2008 Category: Pharmaceuticals Source Type: news

First approval for oral direct Factor Xa inhibitorEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Health Canada has approved Bayer's Xarelto (rivaroxaban) as a once-daily tablet for the prevention of venous thromboembolic events (VTE) in patients who have undergone elective total hip or total knee replacement surgery... more
Source: Pharmaprojects' Pharma R&D Pipeline News - September 16, 2008 Category: Pharmaceuticals Source Type: news

UCB brings new hope for epilepticsEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
With the approval in Europe of UCB's Vimpat (lacosamide) comes the first success of a new antiepileptic drug for partial onset seizures since 2004... more
Source: Pharmaprojects' Pharma R&D Pipeline News - September 16, 2008 Category: Pharmaceuticals Source Type: news

New hope for sufferers of chronic hand eczema- Toctino approved in the UKEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Basilea Pharmaceuticals' Toctino (alitretinoin) for the treatment of chronic hand eczema... more
Source: Pharmaprojects' Pharma R&D Pipeline News - September 10, 2008 Category: Pharmaceuticals Source Type: news

Withdrawal of global marketing application for Pfizer’s cSSSI compoundEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Pfizer is to globally withdraw all marketing applications for its glycopeptide antibiotic dalbavancin, following discussions with the regulatory agencies... more
Source: Pharmaprojects' Pharma R&D Pipeline News - September 9, 2008 Category: Pharmaceuticals Source Type: news

Withdrawal of global marketing application for Pfizer's cSSSI compoundEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Pfizer is to globally withdraw all marketing applications for its glycopeptide antibiotic dalbavancin, following discussions with the regulatory agencies... more
Source: Pharmaprojects' Pharma R&D Pipeline News - September 9, 2008 Category: Pharmaceuticals Source Type: news

Aurograb Dropped: Novartis to take financial hitEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Novartis will be subject to a US$235 million impairment charge in the third quarter of 2008, following its decision to halt development of Aurograb... more
Source: Pharmaprojects' Pharma R&D Pipeline News - September 1, 2008 Category: Pharmaceuticals Source Type: news

NICE - Lucentis gets the seal of approvalEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The UK healthcare watchdog NICE has recommended Lucentis (ranibizumab), the age-related macular degeneration (AMD) therapeutic, for use in the National Health Service... more
Source: Pharmaprojects' Pharma R&D Pipeline News - August 28, 2008 Category: Pharmaceuticals Source Type: news

First ever approval for Freidreich's Ataxia therapeuticEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Santhera Pharmaceuticals has received the first marketing authorisation in the world for a Freidreich's Ataxia therapy... more
Source: Pharmaprojects' Pharma R&D Pipeline News - August 19, 2008 Category: Pharmaceuticals Source Type: news

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