Pharma Marketletter back issues from November 2005:
211 US med school profs tell FDA: "ban DTC".(direct-to-consumer)(Food and Drug Administration)
Nov 07, 2005 ... 211 professors from US medical schools have endorsed a statement urging the Food and Drug Administration to prohibit direct-to-consumer marketing of prescription drugs. The statement, which was to be presented at the FDA's November 1-2 public hearing on DTC, was written and ...
US Medicare: catastrophic cover for 98% of seniors?
Nov 07, 2005 ... The number of Medicare beneficiaries with coverage for catastrophic drug costs in 2006 will rise dramatically under the new US Medicare prescription drug program, and that of seniors paying over $4,000 annual out-of-pocket drug costs, with no catastrophic-cost coverage, will drop from over ...
US GOP Senators defend Medicare Rx benefit.(Government of Parliament)(Brief Article)
Nov 07, 2005 ... More insurers than anticipated are now participating in the US Medicare prescription drug benefit, and competition between them means enrollees will save more than expected, says the US Senate Republican Policy Committee. Defending the benefit against its critics, the Senators ...
UK NHS special status for orphan drugs?(National Health Service)
Nov 07, 2005 ... The growing number and costs of rare-disease treatments, or orphan drugs, are straining health care budgets, say two articles in the October 29 issue of the British Medical Journal, asking whether the National Health Service should continue to pay for them and how this will affect other ...
Euro scientists develop H7N1 bird flu vaccine.
Nov 07, 2005 ... European influenza experts have developed RD-3, the first human candidate vaccine for the H7N1 virus, and it is expected to go into clinical trials next spring 2006. So far, most vaccine development has centered on H5N1, the highly-pathogenic form of avian flu. However, ...
EU Commission plans biotech strategy update, says competitiveness still needs to improve.
Nov 07, 2005 ... The European Commission's in-house Joint Research Centre has launched a study on the social, economic and environment consequences, and the challenges, of modern biotechnology. It is estimated that over 80% of biotechnology-related activity in the European Union is health ...
UCB says Ph III Keppra trial data positive.(Brief Article)
Nov 07, 2005 ... Belgian drugs and chemicals firm UCB has announced positive results from a clinical study of Keppra (levetiracetam) used in the treatment of pediatric patients suffering from idiopathic generalized epilepsy and regular tonic-clonic seizures. The Phase III trial, which was a ...
Flamel completes Ph III drug delivery trials.(Flamel Technologies S.A.)(Brief Article)
Nov 07, 2005 ... French biopharmaceutical company Flamel Technologies, which is principally involved in the development of polymer-based delivery systems for medical applications, says the results of Phase III trials, which it has been running with developmental partner GlaxoSmithKline, have been deemed a ...
Taro to test Ovide as Rx head lice treatment.(Taro Pharmaceuticals USA Inc.)(Brief Article)
Nov 07, 2005 ... Hawthorne, New York, USA-headquartered drugmaker Taro Pharmaceutical says that it plans to initiate a multi-center Phase III study to evaluate a novel formulation of Ovide (malathion), a prescription product for the control of head lice (Pediculus humanus capitis) in pediatric and adult ...
Hemisperx extends drug synergy research prog.(Hemisperx Biopharma)(Brief Article)
Nov 07, 2005 ... Hemisperx Biopharma, a USA-based company involved in the manufacture and clinical development of new drug entities for the treatment of viral and immune-based chronic disorders, says it has extended a preclinical research program investigating potential therapeutic synergies with more than ...
ZymoGenetics starts Ph III trial of rhThrombin in surgery.(Brief Article)
Nov 07, 2005 ... ZymoGenetics, a biopharmaceutical company based in Seattle, USA, says it has begun a Phase III study of recombinant human thrombin in patients undergoing surgery. The trial is designed to assess the efficacy of the drug against bovine-derived thrombin in support of the proposed broad ...
Biothera begins trial of Imprime PGG in cancer therapy.(Brief Article)
Nov 07, 2005 ... USA-based Biothera, a healthcare company specializing in immunology, says it has filed an Investigational New Drug application with the Food and Drug Administration for Imprime PGG, a monoclonal antibody, for the treatment of cancer in combination with approved monoclonal antibodies, ...
Biosite's Triage stroke panel launched in Europe.(Biosite Diagnostics Inc.)(Brief Article)
Nov 07, 2005 ... Biosite, a San Diego, USA-headquartered biomedical company, says it has released its Triage Stroke Panel, a battery of blood tests in a compact, portable format, onto the European market. The firm says that the kit can be used at either the point of care or in the laboratory, it ...
Quigley sees potential in its MS drug QR-442.(Quigley Pharma Inc.)(multiple sclerosis)(Brief Article)
Nov 07, 2005 ... USA-based Quigley Pharma, a natural health medical science company and subsidiary of the Quigley Corp, says it has completed an animal model study of its compound QR-442 as a potential therapeutic for the treatment of multiple sclerosis. During the study, the drug was ...
Amgen's Kepivance cleared by EC.(European Union)(Brief Article)
Nov 07, 2005 ... USA-based biotechnology giant Amgen's Kepivance (palifermin) has received regulatory approval in the European Union as a treatment for mucositis (mouth sores) in patients with hematologic cancers undergoing myeloablative therapy associated with a high incidence of severe oral mucositis, ...
S-P discontinues vicriviroc trial on efficacy issues.(Schering-Plough Corp.)(Brief Article)
Nov 07, 2005 ... US drugmaker Schering-Plough has discontinued a Phase II study of its investigational CCR5 receptor antagonist, vicriviroc, used in combination with GlaxoSmithKline's Combivir (lamivudine/zidovudine) in treatment-naive HIV patients, due to a return of detectable virus in some patients late ...
Eisai to resubmit Aricept sNDA.(supplemental New Drug Application)(Brief Article)
Nov 07, 2005 ... Japanese drugmaker Eisai's supplemental New Drug Application for Aripcept (donepezil) for the treatment of severe Alzheimer's disease, has been rejected by the US Food and Drug Administration because of deficiencies in the format of the application. The agent, which is ...
Troubles for B-MS and Merck & Co's Pargluva.(Bristol-Myers Squibb Co. and )(Brief Article)
Nov 07, 2005 ... US drug major Bristol-Myers Squibb says that its key pipeline product, the type 2 diabetes drug candidate Pargluva (muraglitazar), may need another five years of clinical testing to answer questions raised by the US Food and Drug Administration. The firm is also in discussions ...
Schwarz posts 3rd-qtr loss on rotigotin buy.(Schwarz Pharma)(Brief Article)
Nov 07, 2005 ... German drugmaker Schwarz Pharma has posted a net third-quarter 2005 loss of 50.5 million euros ($60.5 million) after a 1.6 million euros profit in the like, year-earlier quarter. Analysts had forecast higher losses of about 58.0 million euros for the reporting quarter. Sales went up 5.5% ...
Zeltia sees profits rise on falling sales.(Brief Article)
Nov 07, 2005 ... Spanish group Zeltia has posted a decline of 8% to 58.3 million euros ($69.9 million) in turnover for the first nine months of 2005, although operating profit leapt 60% to 6.6 million euros, but losses increased to 22.8 million euros versus 16.5 million in the like period of 2004. R&D ...
Sharp fall in 3rd-qtr losses for Elan.(Elan Corporation PLC)(Brief Article)
Nov 07, 2005 ... Troubled Irish drug company Elan Corp, which - with partner Biogen Idec - last year withdrew its key multiple sclerosis drug Tysabri (natalizumab; Marketletters passim) from the market, has significantly reduced its loss for the third quarter of 2005, reducing this 38% to $67.1 million, ...
Novo Nordisk beats consensus forecasts.(Brief Article)
Nov 07, 2005 ... Danish drugmaker Novo Nordisk exceeded consensus analysts' expectations, reporting net earnings for the first nine months of 2005 of $791.0 million, a rise of 31% on the like, year-earlier period, and operating profit up 20% at $1.4 billion. Reported sales for the period ...
Biolex and Kringle collaborate on novel protein targeting cancer.(Biolex Therapeutics and Kringle Pharma)(Brief Article)
Nov 07, 2005 ... USA-based Biolex Therapeutics, a protein therapeutics company, and Kringle Pharma, an Osaka, Japan-based biopharmaceutical firm developing cancer therapeutics, have formed a collaboration under which the former will use its LEX System for protein expression to create a commercial line for ...
Third Wave selects Genzyme Genetics as marketing partner.(Third Wave Technologies Inc.)(Genzyme Genetics Corp.)(Brief Article)
Nov 07, 2005 ... Third Wave Technologies has announced the formation of a preferred marketing relationship with fellow US firm Genzyme Genetics to provide testing with the Invader UGT1A1 Molecular Assay for colorectal cancer patients in the North American market who are being considered for, or currently ...
UK gives go-ahead for Biopure's Ph II Hemopure study.(Brief Article)
Nov 07, 2005 ... USA-based Biopure Corp says that it has received regulatory authorization in the UK to initiate a Phase II clinical trial of its investigational oxygen therapeutic Hemopure (hemoglobin glutamer - 250 [bovine]) as a potential cardioprotective agent in patients undergoing coronary artery ...
Global cancer diagnostics market to reach $7.4B by 2009.(Brief Article)
Nov 07, 2005 ... The worldwide market for in vitro cancer diagnosis will reach the $7.4 billion mark by 2009, according to a new study released by Kalorama Information. As the demand for more sophisticated diagnostics continues to grow and synergies between tests and new therapeutics emerge, IVD tests for ...
Bayer selects name for sorafenib.(Bayer HealthCare L.L.C. Bayer Biological Products Div.)(Onyx Pharmaceuticals Inc.)(Brief Article)
Nov 07, 2005 ... Bayer HealthCare and Onyx Pharmaceuticals have announced the selection of Nexavan as the global trade name for sorafenib tosylate, their oral ...
Australia rejects flu drug compulsory license call.
Nov 07, 2005 ... Australian Health Minister Tony Abbott has rejected calls from Australian National University experts for compulsory licensing of antiviral drugs used in the treatment of avian flu. Writing in the Medical Journal of Australia (October 27 issue), public health specialist Buddhi ...
Apotex Tamiflu move as Roche halts sales.(Brief Article)
Nov 07, 2005 ... Canadian generic drugmaker Apotex says that it has started work on developing a copy version of Roche's antiviral drug Tamiflu (oseltamivir). The firm announced late October that it would know within six to eight weeks whether the project was viable and that, after then, it ...
Jamaica to pay up 80% of diabetics' Rx costs.(Jamaica's National Health Fund )(Brief Article)
Nov 07, 2005 ... On November 1, Jamaica's National Health Fund increased the subsidy on diabetes drug treatments to 80% of their reference prices, and began subsidizing other products used by diabetics, in a move which is expected to cost ...
Vietnamese firms to produce generic Tamiflu.(Brief Article)
Nov 07, 2005 ... Three Vietnamese firms will start making Roche's antiviral drug Tamiflu (oseltamivir) by December, the Swiss firm has agreed with Cao Minh Quang, director of ...
New Zealand Rx trade.(pharmaceutical industry)(Brief Article)
Nov 07, 2005 ... New Zealand exported pharmaceutical products valued at NZ$206.0 million ($146.0 million) in the 12 months to end-September 2005, ...
Chiron to supply US flu vaccine stockpile.(Brief Article)
Nov 07, 2005 ... US biotechnology firm Chiron has won a $62.5 million contract to supply the US government with pre-pandemic influenza vaccine for a stockpile to protect against the H5N1 avian influenza virus strain. Under the agreement with the Department of Health and Human Services, the ...
Biogen Idec's 3rd qtr EPS down 26%.(Brief Article)
Nov 07, 2005 ... The world's third-largest biotechnology firm, Biogen Idec, has posted earnings of $27.2 million, or $0.08 per share, for the third quarter of 2005, down 26% on the like period of the previous year, disappointing analysts' expectations. Thomson First Call predicted EPS of $0.42 ...
ImClone Systems' 3rd-qtr income falls 22.1%.(Brief Article)
Nov 07, 2005 ... US cancer specialist ImClone Systems said that its third-quarter 2005 net income dropped 22.1% on the year-ago period, to $31.0 million, due to lower manufacturing revenue and higher operating costs. Diluted earnings per share totaled $0.35 versus $0.44, following a decline in ...
Celera's 1st-fiscal qtr net loss narrows 21.7%.(Brief Article)
Nov 07, 2005 ... US small-molecule drugmaker Celera Genomics reported a net loss of $16.7 million, or $0.23 per share, for the first quarter of fiscal 2006 ended September 30, 2005, an improvement of 21.7% on the year-ago period following a $4.5 million pretax gain from the sale of an investment. ...
ULURU set up for wound management.(Brief Article)
Nov 07, 2005 ... ULURU Inc is an emerging pharmaceutical company focused on the development of a portfolio of innovative topical delivery technologies to provide patients and consumers with an improved clinical outcome through controlled delivery, which has been formed to acquire the topical assets of ...
Merck KGaA reorganizes in Japan.(Brief Article)
Nov 07, 2005 ... German drugmaker Merck & Co is to reorganize its pharmaceuticals business in Japan. It says that, effective April 2006, the ethicals division and the Japanese generic drugs subsidiary Merck Hoei Ltd will be combined to form the new company Merck Pharma Ltd, which will be headquartered in ...
Chiron succumbs to increased offer from Novartis, previously rejected as too low.
Nov 07, 2005 ... US biotechnology group Chiron, having previously rejected overtures from Swiss drug major Novartis to acquire the remaining 57.8% stake in the company it does not already own (Marketletter September 5), has now accepted a higher offer. This news, on the morning of October 31, sent the ...
B-MS posts 3rd-qtr 30% non-GAPP earnings slump on flat sales.(Bristol-Myers Squibb Co.)
Nov 07, 2005 ... US health care conglomerate Bristol-Myers Squibb disappointed investors after it posted flat sales from continuing operations of $4.80 billion for the third quarter of 2005. The company has recently sold its US and Canadian non-prescription medicines business to Swiss drug major Novartis ...
Amylin slumps on increased 3rd-qtr loss.(Brief Article)
Nov 07, 2005 ... US biopharmaceutical group Amylin saw its share price plunge 10.5% in after-hours trading on October 26, following the firm's release of third-quarter 2005 results which showed that its net loss had more than doubled to $69.5 million, or $0.65 per share. Analysts polled by Thomson ...
Strong 1st-qtr sales for Myriad Genetics.(Brief Article)
Nov 07, 2005 ... USA-based Myriad Genetics has reported total turnover of $25.1 million for its first quarter of its 2006 fiscal year, an increase of 50.0%, with predictive medicines sales up 49.3% at $21.5 million. Research revenues grew 57% to $3.6 million. R&D costs for the quarter were up ...
Medicis files suit against Upsher-Smith and Prasco.
Nov 07, 2005 ... Arizona, USA-based Medicis says that it filed suit on October 27 against Upsher-Smith Laboratories of Plymouth, Minnesota, and Prasco Laboratories of Cincinnati, Ohio, for infringement of patent no 6,905,675, entitled Sulfur Containing Dermatological Compositions and Methods for Reducing ...
FDA accepts PharmaFrontiers' MS drug protocol.(Food and Drug Administration)(multiple sclerosis)(Brief Article)
Nov 07, 2005 ... Texas, USA-based PharmaFrontiers, a company involved in the development and commercialization of cell therapies, says that the protocol for its Phase IIb clinical trial of Tovaxin, a novel T cell therapeutic vaccine for multiple sclerosis, has been accepted by the US Food and Drug ...
Merck & Co/B-MS to contribute AIDS drugs to IPM.(International Partnership for Microbicides)(Merck and Company Inc.)(Bristol-Myers Squibb Co.)(Brief Article)
Nov 07, 2005 ... In a preliminary announcement, US drug majors Merck & Co and Bristol-Myers Squibb have said that they will each contribute promising new anti-HIV entry inhibitor compounds to the International Partnership for Microbicides for development as microbicides. They note that a study ...
Accentia Biopharma prices offering.(Brief Article)
Nov 07, 2005 ... Florida, USA-based Accentia Biopharmaceuticals says that it has priced its initial public offering of 2.4 million of its common stock at a price to the public of $8.00 per share. All of the shares are being offered by the company. In addition, Accentia has granted the underwriters a 30-day ...
Natural alternative to arthritis drugs?
Nov 07, 2005 ... Arthritis sufferers could have a natural alternative for the treatment of this painful condition, according to new university-based research. The work, conducted by the Australian Centre for Complementary Medicine Education and Research, shows that Biolane Green-Lipped Mussel Extract has a ...
Nutratech's Advantra Z safe in weight loss.(Brief Article)
Nov 07, 2005 ... Two recent scientific studies, conducted at McGill Nutrition and Food Science Center and University of California at San Francisco, USA, have shown Advantra Z, US nutraceutical ingredient maker Nutratech's proprietary Citrus aurantium (bitter orange) extract for weight-loss and sports ...
Pomegranate juice may cut CHD progress.(coronary heart disease )
Nov 07, 2005 ... Men and women with coronary heart disease who drink one glass of pomegranate juice daily may improve blood flow to their heart, according to a new study. This research is the first randomized, double-blind, placebo-controlled trial showing that pomegranate juice may affect the ...
Chromium picolinate aids glycemic control.
Nov 07, 2005 ... A sub-set of analysis from a Diachrome XLHealth clinical trial has demonstrated that adding daily supplementation with Diachrome (a chromium picolinate and biotin supplement from Nutrition 21) to prescription treatment regimens can significantly improve glycemic control in type 2 diabetes ...
Arakis' AD 337 completes Ph I.(Brief Article)
Nov 07, 2005 ... Japanese drugmaker Sosei says that its wholly-owned subsidiary Arakis has successfully completed Phase I single and multidose studies of AD 337, a novel enantiomer of an approved centrally-acting non-opioid analgesic, which is under investigation for the treatment of fibromyalgia syndrome ....
Actelion's Tracleer: strong results in Eisenmenger's syndrome.(Brief Article)
Nov 07, 2005 ... Swiss drugmaker Actelion says that its cardiac drug Tracleer (bosentan) is the first ever to demonstrate clinical benefit in patients with Eisenmenger's syndrome, as part a multicenter, randomized, double-blind, placebo-controlled trial. The BREATHE-5 study, presented at CHEST ...
Roche and PDL expand daclizumab accord.(Protein Design Labs Inc.)(Brief Article)
Nov 07, 2005 ... Swiss drug major Roche and USA-based humanized antibody specialist Protein Design Labs have expanded their partnership to co-develop and commercialize daclizumab for organ transplant patients on long-term, maintenance therapy. The two firms partnered for the development of the ...
US FDA extends review period for Pfizer/ Sanofi-Aventis' Exubera three months.
Nov 07, 2005 ... US Food and Drug Administration approval of Exubera (insulin [rDNA origin] powder), an inhaled insulin product with peak annual US sales forecast at $1.5 billion, has been delayed by three months. Approval of the potential blockbuster, co-developed by world drug giant Pfizer, ...
FDA approves GSK's cancer drug Arranon.(GlaxoSmithKline PLC)(Brief Article)
Nov 07, 2005 ... UK drug major GlaxoSmithKline says that the US Food and Drug Administration has approved its injectable chemotherapeutic Arranon (nelarabine), for the treatment of patients with T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma patients whose disease has not responded ...
Group Health's five principles for US health plans when deciding which drugs to cover.
Nov 07, 2005 ... With prescription drug costs rising faster than any other part of health care, more US insurers and health systems have begun adopting restrictive policies for coverage of newer drugs. How consumers and health care organizations can be sure these policies do not lean too far in either ...
US FDA mulls case-by-case approvals of follow-on biologics.(Food and Drug Administration)
Nov 07, 2005 ... The US Food and Drug Administration is considering making case-by-case decisions on biogeneric product approvals, according to Steven Kozlowski, acting director of the agency's Biologics Products Office. For some biogenerics there may be a simple burden, while for others it may be greater, ...
Calif Rx Props neck-and-neck ahead of Nov 8.(Brief Article)
Nov 07, 2005 ... A late-October Internet poll showed Californians to be virtually equal in terms of support and opposition to the dueling pharmaceutical access initiatives included in Governor Arnold Schwarzenegger's November 8 Special Election. The Stanford University/Hoover ...
Abbott's Kaletra: price rise slammed.(Abbott Laboratories Inc.)(Brief Article)
Nov 07, 2005 ... The AIDS Healthcare Foundation has attacked the 7.9% price rise granted to Abbott Laboratories' reformulated HIV/AIDS drug Kaletra (lopinavir/ritonavir), approved by the US Food and Drug Administration on October 31, saying this increase far exceeds the inflation rate and that it will also ...
Core products boost Chugai's results.(Brief Article)
Nov 07, 2005 ... Chugai, the Japanese subsidiary of Swiss drug major Roche, has reported strong results for the January-September 2005 period, due to growth of core products such as anti-influenza agent Tamiflu (oseltamivir) and cost controls. Despite better-than-projected earnings, the company retains the ...
Ranbaxy to invest $59M in new SEZ.(pharmaceutical special economic zone facility )(Brief Article)
Nov 07, 2005 ... India's largest pharmaceutical firm, Ranbaxy, says that it plans to establish a "product-specific" pharmaceutical special economic zone facility on 80 acres of land in Mohali, Punjab, involving an investment of 2.65 billion rupees ($58.8 million). Ranbaxy already has a production unit in ...
Dr Reddy's profit up 72%, despite US pressures.(Brief Article)
Nov 07, 2005 ... Indian drugmaker Dr Reddy's Laboratories has posted a 7% rise to 5.80 billion rupees ($128.9 million) in revenues for the second quarter ended September 2005 and, despite pricing pressure in the US generics market, a 72% leap to 890.0 million rupees in net profit. Turnover of ...
GlaxoSmithKline pleases with 3rd-qtr results and raised full-year guidance.
Nov 07, 2005 ... The world's second-largest pharmaceutical group, GlaxoSmithKline, has reported a 16% increase (at constant exchange rates) in pretax profit for the third quarter of 2005, which reached L1.75 billion ($3.10 billion), or 21.3 pence per share, on a 9% (11% in sterling terms) rise in revenues ...
AstraZeneca posts whopping 52% 3rd-qtr EPS rise but disappoints investors.(Brief Article)
Nov 07, 2005 ... Anglo-Swedish pharmaceuticals major AstraZeneca failed to please analysts and investors, despite reporting extremely strong third-quarter 2005 results, showing that turnover had increased 10% to 5.79 billion, with operating profit up 45% to $1.70 billion and pretax earnings leaping 23% to ...
Japan stock market week to Oct 31.
Nov 07, 2005 ... Tokyo saw a comeback in the week ended October 31 on active buying of domestic economy-oriented issues with favorable earnings prospects. The recovery of New York markets and positive economic data were also factors pushing up the Tokyo market. The Nikkei 225 advanced 3.8%, recovering the ...