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AstraZeneca submits sNDA for Seroquel XR for generalized anxiety disorder
Mon, 12 May 2008 15:53:07 GMT
AstraZeneca's sustained release formulation of quetiapine fumarate (Seroquel XR) is now awaiting approval in the US for the treatment of generalised anxiety disorder (GAD)... more -
World Asthma Day
Mon, 6 May 2008 10:05:44 GMT
"You Can Control Your Asthma" was the theme of this year's World Asthma Day... more -
Cimzia approved in the US for moderate-to-severe Crohn's disease
Mon, 28 Apr 2008 11:48:42 GMT
UCB has announced that the US FDA has approved Cimzia (certolizumab pegol), the first and only PEGylated anti-TNFalpha antibody for use in Crohn's disease... more -
Perampanel development for Parkinson's disease terminated at Phase III
Thu, 17 Apr 2008 15:33:32 GMT
Perampanel (E-2007), Eisai's non-competitive AMPA-type glutamate receptor antagonist, has been discontinued for the treatment of Parkinson's disease... more -
Paricalcitrol capsules lauched in the UK
Tue, 15 Apr 2008 15:45:23 GMT
Abbott has launched paricalcitrol capsules (as Zemplar) in the UK, a first launch in this format in Europe following its US release in 2005...more -
Lilly enters its first Phase III trial for Alzheimer's disease
Fri, 04 Apr 2008 14:32:30 GMT
Eli Lilly has announced that it has progressed its gamma secretase inhibitor, semagacestat (LY-450139), into a Phase III trial. This trial will be Lilly's first... more -
Acomplia set for launch in the UK market
Mon, 31 Mar 2008 09:48:49 GMT
Sanofi-Aventis has received a boost with a National Institute for Health and Clinical Excellence (NICE) recommendation for Acomplia (rimonabant) to be available on the UK's National Health Service for obesity and weight management... more -
EU approval for Boehringer Ingelheim's Pradaxa
Mon, 31 Mar 2008 08:32:26 GMT
Boehringer Ingelheim's oral direct thrombin inhibitor, dabigatran etexilate (Pradaxa), has been granted EU approval... more -
European and US filings for eprodisate withdrawn
Tue, 25 Mar 2008 15:23:06 GMT
The Canadian biopharmaceutical company Neurochem has withdrawn marketing applications in the EU, Switzerland and the US for eprodisate (Kiacta).... more -
World Glaucoma Day
Mon, 10 Mar 2008 09:23:27 GMT
The World Glaucoma Association and the World Glaucoma Patient Association initiated the first ever World Glaucoma Day on March 6th... more -
Glaxo terminates Phase III antimalarial
Wed, 05 Mar 2008 16:43:50 GMT
GlaxoSmithKline (GSK) has discontinued development of its antimalarial fixed-dose combination product Dacart... more -
Phase III trial of sorafenib in lung cancer halted early
Fri, 22 Feb 2008 16:35:08 GMT
Bayer and its partner Onyx Pharmaceuticals have stopped a Phase III trial of sorafenib (Nexavar) earlier than planned... more -
EU filing for Sanofi Pasteur's intradermal 'flu vaccine
Fri, 22 Feb 2008 14:29:56 GMT
Sanofi Pasteur's intradermal seasonal influenza vaccine is now awaiting approval in the EU... more -
US approval for a novel cholesterol management combination
Wed, 20 Feb 2008 14:05:49 GMT
Simcor (Niaspan + simvastin), a novel fixed-dose combination of two well-established drugs developed by Abbott, has been approved in the US... more -
Neose Technologies discontinues NE-180
Wed, 06 Feb 2008 11:55:54 GMT
Pennsylvania-based Neose Technologies announced that it has discontinued development of NE-180... more -
Champix receives Japanese marketing authorization
Thu, 31 Jan 2008 16:31:07 GMT
Champix (varenicline tartrate) has been approved for marketing in Japan, following the results of a Japanese clinical trial... more -
Merck launches first-in-class HIV treatment in the UK
Tue, 29 Jan 2008 14:27:04 GMT
Merck & Co's first-in-class antiretroviral treatment Isentress (raltegravir) is now available in the UK... more -
Second inhaled insulin product disappoints
Tue, 22 Jan 2008 15:34:36 GMT
Following the recent withdrawal by Pfizer from its deal to co-market Exubera, Novo Nordisk has halted development of its own inhaled insulin, AERx iDMS... more -
Elan and Biogen Idec secure US approval for Crohn's disease therapeutic
Fri, 18 Jan 2008 15:26:27 GMT
Elan Corporation and Biogen Idec have been granted US approval for their supplemental Biologics License Application regarding Tysabri... more -
Long-awaited submission of US NDA for prasugrel
Tue, 15 Jan 2008 15:30:15 GMT
Daiichi Sankyo and Eli Lilly have submitted an NDA to the US FDA for their antiplatelet therapy, prasugrel...more -
Oncomed Pharmaceuticals adds anticancer antibody to GlaxoSmithKline's pipeline
Mon, 17 Dec 2007 10:37:19 GMT
Oncomed Pharmaceuticals has strengthened GlaxoSmithKline's cancer pipeline through a US$1.4bn strategic alliance for anticancer antibodies...more -
First filing for J&J's novel anti-psoriasis antibody
Mon, 10 Dec 2007 10:44:10 GMT
Sufferers of psoriasis in the EU and the US welcomed the news from Johnson & Johnson that it has filed for approval of ustekinumab... more -
Adolor and Pfizer join forces on novel pain compounds
Fri, 07 Dec 2007 12:01:28 GMT
Pfizer has signed a deal with Adolor securing exclusive worldwide rights to two novel compounds for pain... more -
World AIDS Day offers chance to reflect on recent therapeutic advances
Fri, 30 Nov 2007 17:42:12 GMT
December 1st marks the 20th anniversary of World Aids Day. Twenty years ago, the WHO established World AIDS Day in order to raise awareness and focus attention on the global AIDS epidemic... more -
Quark initiates Phase I trial of novel siRNA product for acute renal failure
Fri, 30 Nov 2007 11:26:11 GMT
Quark Pharmaceuticals has announced that it has progressed AKIi-5, a small interfering RNA therapeutic for the treatment of acute renal failure, into a Phase I clinical trial... more -
Bad news for Vertex Pharmaceuticals' aurora kinase inhibitors
Thu, 29 Nov 2007 16:47:22 GMT
Vertex Pharmaceuticals' pipeline suffered a setback after its two anticancer aurora kinase inhibitors, VX-680 and its follow-on compound VX-667, were suspended and discontinued... more -
Marketing suspensions hit Novartis' lumiracoxib
Thu, 29 Nov 2007 16:16:07 GMT
Marketing of Novartis' selective COX-2 inhibitor lumiracoxib (Prexige) has been suspended in Germany and the UK... more -
Acambis and Sanofi Pasteur join forces on a West Nile virus vaccine
Wed, 28 Nov 2007 11:50:36 GMT
Sanofi Pasteur and the British vaccine development company Acambis have announced they have signed an agreement to collaborate on the development of Acambis' West Nile virus vaccine... more -
First hyperphenylalaninaemia drug filed in Europe
Fri, 23 Nov 2007 16:25:26 GMT
Merck Serono has filed a marketing approval application with the EMEA for its hyperphenylalaninaemia (HPA) drug sapropterin. As there are currently...more -
ProEthic Pharmaceuticals Announces Availability of Lipofen in the US
Mon, 08 Oct 2007 09:45:57 GMT
Cipher Pharmaceuticals' Lipofen, a new prescription cholesterol-lowering drug, has been launched in the US by ProEthic Pharmaceuticals, after it acquired exclusive 10 year rights to the product's...more -
Influenza drug misses crucial primary endpoint in Phase II trial
Wed, 26 Sep 2007 09:54:58 GMT
BioCryst Pharmaceuticals has announced preliminary Phase II findings for its influenza drug peramivir, which has failed to meet the primary endpoint of significant alleviation of...more -
Preos on route to first-in-class treatment for hypoparathyroidism
Mon, 24 Sep 2007 14:40:07 GMT
NPS Pharmaceuticals' recombinant human parathyroid hormone Preos has been granted US orphan drug status for the treatment of hypoparathyroidism. Already launched for the treatment of...more -
Acambis receives US FDA approval for ACAM-2000, a biodefence smallpox vaccine
Wed, 05 Sep 2007 14:02:20 GMT
ACAM-2000 has become the first biodefence vaccine to be approved under the Bioterrorism Act (2002) by the US FDA. It is a live, single-dose smallpox vaccine developed by Acambis in collaboration with...more -
First new kind of anti-HIV medicine for over four years gains approval
Thu, 09 Aug 2007 08:37:19 GMT
Pfizer has received approval in the US for Selzentry (maraviroc), a first-in-class drug for use in HIV/AIDS. The product, a CCR5 antagonist, is the first new kind of anti-HIV medication...more -
Tuberculosis vaccine trials are initiated
Tue, 07 Aug 2007 15:24:23 GMT
For the first time in over 80 years, mid-stage clinical trials in tuberculosis (TB) patients are underway with a completely new kind of novel TB vaccine developed by researchers at Oxford University...more -
Universal influenza vaccine enters Phase I trials
Mon, 23 Jul 2007 14:45:39 GMT
Acambis has announced the initiation of Phase I trials for the first 'universal' influenza vaccine, ACAM-FLU-A, designed to target all A strains of the influenza virus...more -
First Therapeutic Brain Cancer Vaccine Approved
Thu, 12 Jul 2007 14:23:00 GMT
Northwest Biotherapeutics has received authorisation for use of its DCVax-Brain vaccine from the Swiss Institute of Public Health, making it the first....more -
Novartis gains approval for first ever Alzheimer's disease skin patch
Wed, 11 Jul 2007 14:44:15 GMT
Novartis has been granted FDA approval to market its transdermal patch formulation of Exelon (rivastigmine tartrate), making this the first skin patch treatment for Alzheimer's disease...more -
Bayer discontinues late-stage candidates after Major R&D streamline
Tue, 26 Jun 2007 15:44:33 GMT
Bayer has ceased development of 20 products during a major streamlining of its R&D pipeline, including its antiangiogenic oral VEGF KDR receptor tyrosine kinase inhibitor PTK/ZK (vatalanib)....more -
Disappointment as Allos discontinues late-stage cancer compound
Fri, 22 Jun 2007 13:23:35 GMT
Allos Therapeutics has discontinued development of one of its lead compounds, Efaproxyl (efaproxiral sodium), after it failed a pivotal Phase III trial for...more -
Cephalon wins US approval for new sleep disorder treatment
Tue, 19 Jun 2007 14:48:53 GMT
Cephalon has been granted US FDA approval to market Nuvigil (armodafinil) for the treatment of excessive sleepiness associated with obstructive sleep apnoea/hypopnoea syndrome, narcolepsy, and...more -
Johnson & Johnson offers up a money-back deal for Velcade
Wed, 13 Jun 2007 15:07:05 GMT
Johnson and Johnson's (J&J) multiple myeloma drug Velcade (bortezomib) finally looks set to become available in England, after the UK's National Institute for Clinical Excellence (NICE)...more -
China sentences former drugs chief to death
Mon, 04 Jun 2007 08:59:06 GMT
A Chinese court has sentenced to death the former director of the State Food and Drug Administration (SFDA) on charges of corruption...more
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Safety concerns over GSK's Avandia
Fri, 25 May 2007 15:43:22 GMT
GlaxoSmithKline (GSK) is fighting for the reputation of its second best-selling drug, Type 2 diabetes therapy Avandia (rosiglitazone maleate), after the emergence of...more -
GSK's Cervarix approved in first major market
Thu, 24 May 2007 11:16:37 GMT
GlaxoSmithKline's cervical cancer vaccine Cervarix has been approved in Australia, its first major market...more -
EU approval for Novartis' pandemic influenza vaccine
Thu, 10 May 2007 13:12:12 GMT
Novartis has furthered its contribution to Europe's preparedness for the expected coming influenza pandemic with the EU approval of...more -
Invega gains US approval for the long-term maintenance of schizophrenia
Wed, 02 May 2007 14:30:38 GMT
Johnson & Johnson (J&J) has gained further US approval for Invega (paliperidone ER), so that it is now indicated for both the short- and long-term treatment of schizophrenia. Initially approved as...more -
US approval for Veramyst - sniff competition from GSK
Wed, 02 May 2007 14:05:54 GMT
US approval for GlaxoSmithKline's (GSK's) seasonal and perennial allergic rhinitis treatment, Veramyst (fluticasone furoate) could not have come at a better time...more -
AstraZeneca to acquire MedImmune
Wed, 25 Apr 2007 13:16:27 GMT
AstraZeneca has agreed to purchase the US biopharmaceutical company MedImmune in an all-cash transaction of US $58 per share, for a total price of US $15.6 billion. The deal is the biggest announced by AstraZeneca since...more -
FDA approves first H5N1 vaccine from Sanofi Pasteur
Thu, 19 Apr 2007 12:50:18 GMT
Sanofi Pasteur's (Sanofi-Aventis) H5N1 inactivated vaccine against avian flu has been granted approval by the US FDA as a "stop-gap" medical measure that could provide some protection against a potential pandemic...more
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Abbott agrees to expand HIV drug access and affordability
Fri, 13 Apr 2007 11:30:06 GMT
Abbott has agreed to expand access to its blockbuster HIV therapy Kaletra/Aluvia (lopinavir + ritonavir) to over 40 low income countries and NGOs at the reduced price of US $1,000/patient/year. In a deal initiated by the WHO Director-General, Margaret Chan.. more -
Mesenchymal stem cells show their mettle
Thu, 05 Apr 2007 09:58:56 GMT
Osiris Therapeutics has announced positive Phase I results with Provacel, an adult mesenchymal stem cell (MSC) therapy with potential as a cardiovascular therapy. These postnatal multipotent progenitor cells are similar to embryonic stem cells.. more -
Sanofi-Aventis takes first step into the cancer vaccine arena
Tue, 03 Apr 2007 11:46:23 GMT
Sanofi-Aventis has entered into an exclusive global agreement to develop and commercialize TroVax, Oxford BioMedica's Phase III gene therapy-based anticancer vaccine, in a deal worth up to US $690 million.. more -
Biodefence contracts cause problems for Acambis and Vaxgen
Tue, 27 Mar 2007 14:08:08 GMT
Acambis has abandoned its modified vaccinia ankara smallpox vaccine, MVA-3000, after missing out on a US$1 billion US government contract. The vaccine had reached Phase II clinical trials and had been awarded fast track status.. more -
GSK's US approval for Tykerb: more positive news for breast cancer
Fri, 16 Mar 2007 17:01:17 GMT
GlaxoSmithKline (GSK) looks set to make a major mark in the breast cancer arena, after its EGFR and HER2 inhibitor, Tykerb (lapatinib ditosylate), received its first approval for this indication this week.. more -
Patent infringement leads to growth stunt for Insmed
Thu, 15 Mar 2007 14:45:56 GMT
Following the decision of a US jury in late 2006 that Insmed had infringed Genentech's patent rights relating to its growth retardation therapies, the two companies have reportedly struck a settlement agreement.. more -
Update on Oncalis's novel anticancer among more news from BIO-Europe Spring
Thu, 08 Mar 2007 15:29:11 GMT
Swiss pharmaceutical company Oncalis's update on its oncology-focused pipeline, and in particular its lead candidate ONC-101, was among the highlights from the final day of the BIO-Europe Spring meeting, held in Milan, Italy.. more -
Relieving the pressure - novel antihypertensive receives first approval
Thu, 08 Mar 2007 14:52:40 GMT
The first new type of drug for the treatment of high blood pressure in over a decade has received its first approval in the US. Unlike all other currently marketed products, Tekturna (aliskiren) acts by direct inhibition of renin, an enzyme which cleaves angiotensinogen to produce angiotensin, which itself eventually constricts blood vessels.. more -
BIO-Europe Spring offers a web of opportunities for investors
Wed, 07 Mar 2007 11:09:25 GMT
Italian start-up company Spider Biotech has announced a licensing opportunity for its first, novel antimicrobial multiple antigen peptide (MAP), SB-006, at BIO-Europe Spring in Milan.. more -
FDA puts a dampener on Pharmacyclics' Xcytement
Thu, 01 Mar 2007 10:15:54 GMT
Following submission of an NDA in January of this year, Pharmacyclics has received a refuse to file letter from the US FDA for its application for its new chemo/radio-sensitizer, Xcytrin injection (motexafin gadolinium).. more -
Richard Branson takes a virgin flight into stem cell therapy
Mon, 26 Feb 2007 15:15:33 GMT
British tycoon Sir Richard Branson is set to expand his global enterprise with the launch of a stem-cell and biotech business.. more -
Cord stem-cell therapy reaches the end of its tether
Fri, 23 Feb 2007 16:02:46 GMT
The cell therapeutics-based biotech company ViaCell has announced the discontinuation of its lead product, an umbilical cord blood stem cell transplant therapy coded CB-001. The cells had been expanded using ViaCell's proprietary selective amplification technology and incorporated 2 Amgen growth factors.. more -
PPAR-gamma : A new avenue for cancer therapeutics?
Mon, 19 Feb 2007 10:20:14 GMT
Researchers from the University of Rochester Medical Center in New York have inadvertently stumbled across a potential new treatment for colorectal cancer.. more -
Once-daily mesalamine receives first approval in the US for ulcerative colitis
Tue, 06 Feb 2007 14:58:36 GMT
Shire has received its first US approval in 2007 for Lialda - a once-daily preparation of mesalamine prepared with the gastro-resistant MMX technology -for the induction of remission of patients with active.. more -
Scientists suggest how TeGenero's cytokine storm brewed
Mon, 05 Feb 2007 15:43:22 GMT
Scientists from Imperial College in London have revealed a possible explanation for the devastating outcome of TeGenero's TGN-1412 clinical trial last March.. more -
European launch of Novartis' Lucentis - relieving the burden of AMD
Thu, 01 Feb 2007 16:06:30 GMT
Swiss-based pharmaceutical company Novartis has reported good news for European sufferers of wet age related macular degeneration (AMD), with the EU approval of Lucentis (ranibizumab).. more -
Disappointment as HIV microbicide trials halted
Thu, 01 Feb 2007 15:28:13 GMT
The world of HIV infection prevention is coming to terms with the fact that one of its most advanced microbicide products appears to have failed in Phase III trials.. more -
Michael J. Fox Foundation's Therapeutic Development Initiative
Wed, 31 Jan 2007 11:26:10 GMT
Ten industry research teams have benefited to the collective tune of US$4.6 million from the Michael J. Fox Foundation's Therapeutic Development Initiative. The aim of the initiative according to Deborah Brooks, president and CEO of the Foundation, is to make Parkinson's 'a more attractive bet' to pharmaceutical companies.. more -
Pfizer reports first filing of CCR5 inhibitor
Mon, 22 Jan 2007 17:24:54 GMT
Pfizer has reported that its anti-HIV CCR5 antagonist, maraviroc, is now awaiting registration in the EU. A US filing will follow.. more -
Domantis sale completion: GSK proves a dAb hand at acquisition
Fri, 19 Jan 2007 13:47:16 GMT
GlaxoSmithKline (GSK) has bolstered its biopharmaceuticals portfolio with the purchase of UK-based speciality antibody company, Domantis.. more -
Cambridge Antibody Technology licenses anti-eotaxin-1 monoclonal antibody to iCo Therapeutics
Mon, 15 Jan 2007 12:28:50 GMT
Following an internal review of its development priorities, Cambridge Antibody Technology (CAT), which became a subsidiary of AstraZeneca in May 2006, has granted.. more -
Eli Lilly enters into agreement for exclusive rights to OSI's GKA programme
Thu, 11 Jan 2007 15:49:32 GMT
Indianapolis-headquartered pharmaceutical company Eli Lilly has entered into a licensing agreement with wholly-owned subsidiary of OSI, Prosidion.. more -
Evolutec abandons lead candidate
Mon, 08 Jan 2007 14:44:37 GMT
Following the failure of two Phase II trials in two months of its lead compound rEV-131, the future of UK biopharmaceutical company Evolutec is reported to be in doubt.. more -
Adverse events result in the termination of Pfizer's CETP inhibitor torcetrapib
Thu, 07 Dec 2006 17:25:16 GMT
Only 2 days after Pfizer held its analyst meeting in New York, the US, it announced on December 2nd 2006 that it has terminated the development of the late-stage candidate torcetrapib.. more -
Sanochemia's tablet formulation of tolpensone (mydocalm)
Mon, 20 Nov 2006 16:55:37 GMT
At Cowens 7th Annual Global Health Care Conference, held in London's Landmark hotel, it was reported that Sanochemia's tablet formulation of tolpensone (mydocalm) has been approved in the EU.. more -
Corautus Genetics discontinue development of its angiogenic vascular endothelial growth factor-2
Mon, 20 Nov 2006 16:57:59 GMT
Atlanta-based Corautus Genetics announced at the beginning of November that it had discontinued development of its angiogenic vascular endothelial growth factor-2 (VEGF-2) gene therapy.. more
