Pharma Marketletter back issues from February 2005:
Tougher pharma patent laws bringing multinationals back to India.
Feb 07, 2005 ... The new, tougher patent protection that came into effect by decree in India at the end of December through the enactment of the Patents (Amendment) Ordinance (Marketletters passim) has encouraged multinational pharmaceutical companies to introduce new drug products in that country. ...
Eisai signs deal with Cardinal for US sales.(Brief Article)
Feb 07, 2005 ... The US subsidiary of Japanese drug major Eisai has signed a multi-year distribution service agreement with Cardinal Health, a provider of services supporting the health care industry. Under the terms of the deal, Cardinal will be paid service fees to distribute Eisai's full ...
FDA OKs FerriScan, non-invasive test for iron overload disease.(Brief Article)
Feb 07, 2005 ... Australia-based Resonance Health has announced that its subsidiary, Inner Vision Biometrics, has received US Food and Drug Administration marketing approval for FerriScan, its novel non-invasive diagnostic test for liver iron concentration. FDA approval allows IVB to market the ...
Voyager Pharma moves forward with During implant for AD.(alzheimers disease)(Voyager Pharmaceutical)(Brief Article)
Feb 07, 2005 ... Voyager Pharmaceutical, a specialty US pharmaceutical company focused on diseases of aging and development, says that its recently-approved study for its Durin (leuprolide implant) is fully enrolled. The US Food and Drug Administration accepted Voyager's Investigational New Drug ...
Aesica secures major Alzheimer's contract.(Aesica Pharmaceuticals, Myriad Pharmaceuticals)(Brief Article)
Feb 07, 2005 ... UK-based Aesica Pharmaceuticals has signed a multi-million-dollar agreement with US biopharmaceutical company Myriad Pharmaceuticals. The contract, which will last an initial 10 years, is for the supply of R-flurbiprofen, an active pharmaceutical ingredient for Myriad's investigational ...
Cornerstone and Lupin in Suprax deal.(Cornerstone BioPharma)(Lupin Pharmaceuticals)(Brief Article)
Feb 07, 2005 ... Cornerstone BioPharma, a US specialty pharmaceutical company focused in the pain, wound-healing and respiratory markets, has entered into a co-promotion agreement with Lupin Pharmaceuticals, the US division of the like-named Indian drugmaker. This agreement names Cornerstone as the US ...
Danger from same brand names for different drugs.(Brief Article)
Feb 07, 2005 ... Many US health care professionals and consumers fail to realize that the same brand name may be used for different drugs around the world, and this is an overlooked issue which has major safety implications, especially in light of the growing US interest in drug re-importation, the ...
US Medicare Rx benefit "threatens 6M+ poor".
Feb 07, 2005 ... Many of the 6.4 million US seniors and people with disabilities whose prescription drugs are covered by Medicaid will be without critical medicines when their Medicaid drug coverage is terminated in January 2006, unless the federal government adopts stop-gap measures to ensure continuity, ...
Conference.(Brief Article)
Feb 07, 2005 ... Combination drug development: leveraging the current scientific, regulatory and legal environment to gain regulatory approval will be discussed at a ...
Oklahoma's overseas drug-buying proposal.(Brief Article)
Feb 07, 2005 ... Brad Henry, Governor of the US state of Oklahoma, has unveiled his Prescription for Savings plan, which he will present to the state Legislature when it convenes this month. The plan would: set up a program to let Oklahoma pharmacies buy US-made prescription drugs from Canada ...
Neuro3d starts Ph I of novel antidepressant.(Brief Article)
Feb 07, 2005 ... French biopharmaceutical group Neuro3d says it has commenced a double-blind, placebo-controlled, dose-escalation Phase I clinical trial of ND7001, a new type of antidepressant drug with anxiolytic activity, to investigate its safety, tolerability and pharmacokinetics. On ...
Vasogen's VP025 cleared for clinical trials.(Brief Article)
Feb 07, 2005 ... Canadian drugmaker Vasogen says it has obtained regulatory approval from Health Canada to initiate a Phase I clinical study of VP025, its lead drug candidate under investigation for the treatment of neuro-inflammatory disease. The double-blind, placebo-controlled Phase I trial ...
American PP announces Abraxane launch date.(American Pharmaceutical Partners )(Brief Article)
Feb 07, 2005 ... American Pharmaceutical Partners says that it plans to launch its Abraxane for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) on February 8. The product, indicated for the treatment of breast ...
J&JPRD completes Zarnestra NDA.(Johnson & Johnson Pharmaceutical Research & Development )(Brief Article)
Feb 07, 2005 ... USA-based Johnson & Johnson Pharmaceutical Research & Development has completed the submission of a New Drug Application for its anticancer candidate Zarnestra (tipifarnib) to the US Food and Drug Administration under its Continuous Marketing Application Pilot-1 Program. ...
Pharmos gets $12.1M milestone for Zylet launch.(Brief Article)
Feb 07, 2005 ... New Jersey, USA-headquartered Pharmos says it has received a gross milestone payment of $12.1 million from Bausch & Lomb, its former marketing partner for ophthalmology products, triggered by latter's commercial launch of Zylet (loteprednol etabonate). Pharmos ...
EMEA accepts Nabi's StaphVAX for review.(European Medicines Agency)(Nabi Biopharmaceuticals)(Brief Article)
Feb 07, 2005 ... Nabi Biopharmaceuticals of the USA says that the European Medicines Agency has accepted for review its StaphVAX (Staphylococcus aureus polysaccharide conjugate vaccine) for the prevention of infection with S aureus bacteria in end-stage renal disease patients. The group's shares closed up ...
ViroLogic's eTAG to predict cancer treatment outcome?(Brief Article)
Feb 07, 2005 ... US biotechnology group ViroLogic says that assessment of data from a recent clinical trial, which evaluated the ability of its eTAG System to accurately predict treatment outcomes for patients with metastatic colorectal cancer, indicate that the ...
Novartis launches Zometa in Japan.(Brief Article)
Feb 07, 2005 ... Novartis has begun shipping its Zometa (zoledronic acid) Injection 4mg, a bisphosphonate indicated for the treatment of hypercalcemia of malignancy, to medical institutions across Japan. ...
Bayer wins FDA OK for two hepatitis tests.(Bayer Healthcare)(Brief Article)
Feb 07, 2005 ... Bayer Healthcare's diagnostics division says it has received approval from the US Food and Drug Administration for two new hepatitis assays - an automated assay for HAV IgM antibodies, as well as an automated assay for anti-HBc Total (IgG and ...
GB Thera acquires Ph III PD agent from Chiesi.(GB Therapeutics)(Chiesi Farmaceutici SpA )(Brief Article)
Feb 07, 2005 ... GB Therapeutics has entered into an agreement with Italian drugmaker Chiesi Farmaceutici SpA for an exclusive license to the latter's CHF1512 molecule, resulting in an equity investment by the latter firm in the Canadian company. The compound is a methyl-ester of levodopa and ...
Despite a tough year, AstraZeneca's full-year 2004 results fall in target range.
Feb 07, 2005 ... "2004 was quite a year," was the statement that kicked off AstraZeneca's chief executive Sir Tom McKillop's opening speech at the firm's annual financial results conference in London, UK, on January 27, and what a year it has been. Especially towards the latter part of 2004, the ...
Altana says earnings will be above forecast.(Altana AG )
Feb 07, 2005 ... German pharmaceutical and chemicals firm Altana AG has posted record 2004 results, with sales of almost 3.0 billion euros ($3.92 billion), a rise of 8.0% on the previous year, and says that pretax earnings, which will be released March 17, will exceed its forecast of 600.0 million euros, ...
Recordati buys unit of German's Merckle.(Brief Article)
Feb 07, 2005 ... Italian drugmaker Recordati, which last year lost out to US firm IVAX in a bid to acquire the Polish pharmaceutical company Polfa Kutno (Marketletters passim), has agreed to acquire Merckle GmbH of Germany's branded pharmaceutical business. The purchase price of 65.0 million ...
GSK's US tax bill excalates to $7.8B.(GlaxoSmithKline )(Brief Article)
Feb 07, 2005 ... UK-headquartered GlaxoSmithKline has received a further claim from the USA's Internal Revenue Services for additional taxes, bringing the current total allegedly owed by the firm to around $7.8 billion. The latest IRS bill is for $1.9 billion, which it is claimed that legacy firm Glaxo ...
US HHS plans new Medicare e-Rxing regs; says they will improve quality, accuracy.(United States. Department of Health and Human Services)
Feb 07, 2005 ... The USA's newly-appointed Department of Health and Human Services Secretary, Mike Leavitt, has announced proposed new regulations to support electronic prescribing for Medicare when the prescription drug benefit takes effect in January 2006. The proposed rule will be published in the ...
Only 20% of US adults are aware of pharma's Together Rx plan, poll finds.
Feb 07, 2005 ... While 65% of US adults have heard of prescription drug discount cards for seniors which cover medicines from many different manufacturers, there is relatively low awareness of prescription drug programs which assist lower-income adults with the costs of medication, according to the ...
Lehman Bros conference.(Brief Article)
Feb 07, 2005 ... Lehman Brothers' Washington Healthcare Conference will be held March 10 in the Rayburn House Office Building, Washington DC, USA. Speakers include Acting Food and Drug Administration ...
Mylan's pain patch gets FDA clearance.(Mylan Laboratories )(Brief Article)
Feb 07, 2005 ... Mylan Laboratories of the USA says its fentanyl pain patch, a generic version of US health care giant Johnson & Johnson unit Alza Corp's Duragesic, has been approved by the US Food and Drug Administration. Consequently, the company will begin shipping the product immediately in ...
Chiesi and Novartis sign licensing accord.(Chiesi Farmaceutici SpA )(Brief Article)
Feb 07, 2005 ... Italian drugmaker Chiesi Farmaceutici SpA and Swiss pharmaceutical major Novartis have signed an international licensing and supply agreement for the former's Formoterol Modulite, an HFA-based pressurized metered-dose inhaler product. Under the terms of the deal, Novartis gains ...
Flamel and B-MS settle terms of Basulin deal.(Bristol-Myers Squibb )(pharmaceutical industry)(Brief Article)
Feb 07, 2005 ... Flamel Technologies of France has reached an agreement with US health care giant Bristol-Myers Squibb which resolves all outstanding matters regarding their former licensing deal for Flamel's formulation of long-acting human insulin, Basulin (Marketletter September 27, 2004). ...
NTI's Viprinex gets fast-track status for stroke.(Neurobiological Technologies)(Brief Article)
Feb 07, 2005 ... USA-based Neurobiological Technologies' Viprinex (ancrod) has been granted fast-track status by the US Food and Drug Administration for its intended use in patients suffering from ischemic stroke. News of this development on January 28 propelled the group's shares up 16.1% to close at ...
GPC starts Ph I trial of MorphoSys MAb.(GPC Biotech AG )(Brief Article)
Feb 07, 2005 ... Biotechnology group GPC Biotech AG says it has commenced a Phase I clinical study of 1D09C3, an anti-major histocompatibility complex monoclonal antibody isolated from fellow Germany-based MorphoSys' library of human antibodies, which is under evaluation as a potential treatment for ...
Meiji Seika aims to boost Chinese sales.(Meiji Seika Kaisha )(Brief Article)
Feb 07, 2005 ... Japanese drugmaker Meiji Seika Kaisha aims to increase its drug sales in China more than 10 times current rates to hit 10.0 billion yen ($96.0 million) by 2009 by producing antibiotics materials at a new factory from April, according to the Nihon Keizai Shimbun. Meiji Lukang ...
Fen-phem charges gouge Wyeth results.(Wyeth Pharmaceuticals)
Feb 07, 2005 ... Despite reporting a healthy rise in sales of 7.0% to $4.60 billion and 10.0% to $17.40 billion for the fourth quarter and full-year 2004, Wyeth reported a net loss of $1.76 billion, or $1.32 per share, for the quarter, compared with a profit of $335.3 million in the like, year-earlier ...
Dr Reddy's revenues fall 8%, net plunges.(Dr Reddy's Laboratories )(Brief Article)
Feb 07, 2005 ... Hit by higher R&D costs and declining sales for the third fiscal quarter ended December 31, 2004, Indian drugmaker Dr Reddy's Laboratories posted an 8.0% decline in revenues to 4.70 billion rupees ($107.7 million). Sales outside India were 3.20 billion rupees for the quarter versus 3.50 ...
GSK licenses MetaBase from GeneCo.(GlaxoSmithKline)(Brief Article)
Feb 07, 2005 ... US firm GeneGo, a provider of software and databases for systems biology, says that UK drug major GlaxoSmithKline has licensed its MetaBase database of human biology and medicinal chemistry. MetaBase represents a comprehensive, manually-curated database which covers all levels ...
Genetix debuts novel technology for biopharma development.(Brief Article)
Feb 07, 2005 ... Genetix, a UK genomics and proteomics technology group, has announced the launch of its next-generation mammalian cell imaging and picking instrument, the ClonePixFL. The instrument is being debuted at LabAutomation, now taking place in San Jose, California, USA. ClonePixFL ...
Xoma to sell $60M convertible notes.(Brief Article)
Feb 07, 2005 ... California, USA-based Xoma says that it intends, subject to market and other conditions, to sell approximately $60.0 million principal amount of its convertible senior notes due 2012 to qualified institutional buyers. The company expects the terms of the offering to include an option for ...
ArQule completes $30M financing.(Brief Article)
Feb 07, 2005 ... US biotechnology firm ArQule says that it has closed its previously-announced registered direct offering. The company sold approximately 5.78 million shares of its common stock at $5.25 per share, for aggregate proceeds of approximately $30.0 million. The small group of investors included ...
Japan stock market week to January 31.
Feb 07, 2005 ... Tokyo saw a moderate rebound in the week to January 31 following seesaw movements in a relatively narrow price range. The Nikkei 225 closed at the 11,300 level, up 0.9%, while the Topix index gained 0.6%. Investors were generally sensitive to ongoing reports of third-quarter earnings and ...
Phased withdrawal of co-proxamol in UK.(Brief Article)
Feb 07, 2005 ... The UK Medicines and Healthcare products Regulatory Agency is to phase out the widely-prescribed painkiller co-proxamol, after a consultation on its safety and effectiveness found that benefits did not outweigh its risks. Co-proxamol contains a combination of acetaminophen and ...
Pfizer CEO warning to Germany over prices.(Henry McKinnell )(Brief Article)
Feb 07, 2005 ... Pfizer chief executive Henry McKinnell has stated that he is "very concerned that Germany is on the wrong track toward rationing and price control" of pharmaceuticals. Speaking at the World Economic Forum summit in Davos, Switzerland (Marketletter January 31), Mr McKinnell said ...
Irish 10-month foreign med/pharma trade.(pharmaceutical industry)(Brief Article)
Feb 07, 2005 ... Ireland exported pharmaceutical and medical products worth 12.5 billion euros ($16.29 billion) during January-October 2004, compared to a level of 11.4 billion euros for the like, year-earlier period, ...
Freedom of Info accord with PAGB.(Proprietary Association of Great Britain )(Brief Article)
Feb 07, 2005 ... The Proprietary Association of Great Britain has now signed up to the UK Medicines and Healthcare products ...
New Enforcement/Intelligence Group.(United Kingdom. Medicines and Healthcare Products Regulatory Agency)(Brief Article)
Feb 07, 2005 ... A freestanding Enforcement and Intelligence Group has been set up by the UK Medicines and Healthcare products Regulatory Agency, reporting directly to chief executive Kent Woods. It will work across the ...
Poland boosts locally-made insulin.(Brief Article)
Feb 07, 2005 ... In Poland, the Ministry of Health has lowered the price of domestically-produced insulin and reduced reimbursement levels for foreign-manufactured versions, which are used by 80% of patients in the country. The difference in the locally-manufactured insulin's price is being covered by the ...
Public Citizen renews call for Celebrex ban on new info related to CV risks.
Feb 07, 2005 ... US consumer group Public Citizen has repeated its earlier demand to the Food and Drug Administration to withdraw drug giant Pfizer's COX-2 inhibitors Bextra (valdecoxib) and Celebrex (celecoxib; Marketletter January 31), following "recently-uncovered" trial results which, the group says, ...
Migrainers snot getting most effective therapy: Datamonitor.(Brief Article)
Feb 07, 2005 ... More than 70 million people suffer from migraine worldwide, but the quality of currently-available treatments is far from ideal, says a recent report by business information group Datamonitor. Although the triptan class of drugs is considered to be the gold standard in migraine therapy, ...
Cambridge scientists develop new tech for cancer drug discovery.(Brief Article)
Feb 07, 2005 ... Scientists at the University of Cambridge, UK, have developed a new technology that could potentially lead to more targeted and effective treatments for some cancers. The technology separates cancer stem cells from cancer cell lines, thereby making it possible to identify and target the ...
Michigan Blues' generics plan "a model for safe, affordable drugs ".(Blue Cross Blue Shield of Michigan)(Brief Article)
Feb 07, 2005 ... Blue Cross Blue Shield of Michigan's generic drug savings program (Marketletters passim) has been recognized by Harvard Medical School as a national model that enhances health care affordability, US Blue Cross and Blue Shield Association president Scott Serota told the annual World Health ...
Cholesterol drugs "still poised for US OTC switch, despite Mevacor setback".
Feb 07, 2005 ... In its US application to switch its cholesterol-lowerer Mevacor (lovastatin) from prescription to over-the-counter status, Merck & Co maintains that the statin is safe to use without a physician's guidance. Last month, a US Food and Drug Administration advisory committee disagreed, ...
EU pharma ad ban "should be lifted".(Brief Article)
Feb 07, 2005 ... The European Union's ban on pharmaceutical advertising should be lifted, according to Frits Bolkestein, the former EU Commissioner for the Internal Market. Speaking in Brussels, Belgium, Mr Bolkestein said that he believed in freedom of information, adding that, as the ...
Irish pharmacists seek limited Rxing powers.(Brief Article)
Feb 07, 2005 ... The Irish Pharmaceutical Union has urged the government to grant pharmacists the power to prescribe medicines in certain limited circumstances. Union president Karl Hilton told a seminar organized by the IPU that the experience of pharmacists in the UK showed that extending limited ...
French HAS views pharma evaluation.(health authority)(Brief Article)
Feb 07, 2005 ... France's new health authority, the HAS, is studying the current list of conditions relating to long-term illnesses, or ALDs (see story this page), and may propose revisions. It is also looking afresh at basic issues of health spending and reimbursement, including whether ...
Long-term illness "will raise French health bill".(Brief Article)
Feb 07, 2005 ... French health spending costs are expected to increase again sharply during the period to 2010 because of the number of patients treated who suffer from illnesses of long duration, or ALDs, according to the new council responsible for the future of the health fund system. ALD ...
Hungary: Rx export boom.(Pharmaceutical industry)(Brief Article)
Feb 07, 2005 ... Hungary exported pharmaceutical and medical products worth $990 million during the first 11 months of 2004, a year-on-year ...
Israel agrees Rx data exclusivity amendments.(Brief Article)
Feb 07, 2005 ... Israel is to alter two recommendations of an inter-ministerial panel regarding pharmaceutical data exclusivity, including its suggestion that the marketing of a generic in any third country should not end the five-year exclusivity period. Israel also agrees to extend the data ...
Guatemalan drug test data protections return.
Feb 07, 2005 ... Guatemala has introduced legislation to reverse its recent repeal of laws protecting test data for drugs and President Oscar Berger has sent the country's Congress legislation to implement the US/Central American Free Trade Agreement. A spokesman for the Office of the US Trade ...
South Africa: govt court move over Rx price regs.(Pharmaceutical industry)(Brief Article)
Feb 07, 2005 ... On March 15, South Africa's Department of Health will ask the Constitutional Court to hear its appeal against the December 2004 Bloemfontein Court of Appeal ruling which overturned the new drug pricing regulations, stating that they were not viable for the industry ...
Indian pharma "fully equipped for patent reg".(Brief Article)
Feb 07, 2005 ... Indian drugmakers are poised and fully equipped to take advantage of the $50.0 billion worth of drugs going off patent in the next five years, under its new patent regime, Shri Kamal Nath, the Union Minister of Commerce and Industry, has told the Royal Institute of International Affairs in ...
Shire and River sign deal for ADHA drug.(Attention deficit hyperactivity disorder)(Pharmaceutical industry)(Brief Article)
Feb 07, 2005 ... The UK's Shire Pharmaceuticals and New River Pharmaceuticals of the USA have entered into an agreement for the global commercialization of NRP104, the latter's compound currently in Phase III clinical evaluation for the treatment of attention-deficit hyperactivity disorder. ...
ICOS and Solvay form AndroGel alliance.(Pharmaceutical industry)(Brief Article)
Feb 07, 2005 ... USA-based ICOS Corp and Belgian drugmaker Solvay Pharmaceuticals have signed a co-promotion deal for AndroGel (testosterone gel) 1% CIII, cleared in the USA as a replacement therapy in males for conditions associated with a deficiency or absence of testosterone. According to ...
BioMarin's rhASB gets FDA priority review.(United States. Food and Drug Administration)(Brief Article)
Feb 07, 2005 ... The US Food and Drug Administration has granted priority review status to BioMarin Pharmaceuticals' rhASB (galsulfase), a potential enzyme replacement therapy for the treatment of mucopolysaccharidosis VI. Also known as Maroteaux-Lamy Syndrome, the condition is an inherited, debilitating, ...
Northwest's DCVax Prostate OK for Ph III.(Pharmaceutical industry)(Brief Article)
Feb 07, 2005 ... Northwest Biotherapeutics of the USA has obtained clearance from the US Food and Drug Administration to commence a double-blinded, placebo-controlled Phase III clinical trial investigating its DCVax-Prostate in around 600 patients at 30-50 sites in the USA. Commenting on the ...
Norwood gets FDA OK for Ph II BMT study.(Food and drug administration)(Brief Article)
Feb 07, 2005 ... UK firm Norwood Immunology, which trades on the UK Alternative Investment Market, says that the US Food and Drug Administration has accepted the firm's Investigational New Drug application for the initiation of a Phase II clinical trial evaluating autologous bone marrow transplant in the ...