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Posting solid 2nd-qtr results, AstraZeneca announces another cost-cutting program.(Financial report)
August 6, 2007... Despite what were generally viewed as a solid set of second-quarter 2007 results, Anglo-Swedish pharmaceutical major AstraZeneca revealed a second restructuring initiative (on top of 3,300 job cuts announced earlier this year (Marketletter...
B-MS' 2nd-qtr income up 5.8% on Plavix resurgence; future cost cuts planned.(Financial report)
August 6, 2007... Second quarter sales of Bristol-Myers Squibb's blockbuster blood thinner Plavix (clopidogrel) increased 4% to $1.19 billion, as supplies of generic versions of the drug began to run out (Marketletters passim). The resurgence of the product,...
Millennium reports flat 2nd-qtr losses.(Financial report)
August 6, 2007... US biopharmaceutical firm Millennium Pharmaceuticals says that, for the second quarter of 2007, net losses were $17.7 million, a slight increase on the year-earlier comparable period. The deficit, which was equivalent to $0.06 per share,...
Mylan's 1st-qtr FY 2006 income up 5% on sales.(Financial report)
August 6, 2007... USA-based drugmaker Mylan Laboratories says that its income for the first quarter of the fiscal year 2008, ended Tune 30, 2007, was $79.7 million, up 5.4% on the opening three months of the previous financial year.
The...
US generics trade group tries to set record straight on its copy drugs.
August 6, 2007... Responding swiftly to the USA's NBC Today Show on the use of copy versions of branded medicines, the Generic Pharmaceutical Association (GPhA) has defended its products, saying the broadcaster included misinformation about such agents.
The...
Nanotech Task Force urges US FDA to develop guidelines on products using this technology.(Brief article)
August 6, 2007... The US Food and Drug Administration's Nanotechnology Task Force has released a report that recommends the agency should consider developing guidance and taking other steps to address the benefits and risks of drugs and medical devices using...
Another negative for GSK's Avandia and Takeda/Lilly's Actos.
August 6, 2007... Even as they await the deliberations of the US Food and Drug Administration's Metabolic Drugs and Drug Safety Advisory Committee on the safety of their diabetes type 2 treatments which have been linked to cardiovascular problems starting July...
Roche extend offer for Ventana.(Xinshun Shipyard )(Brief article)
August 6, 2007... Switzerland Roche says that it has extended its offer to acquire all of the outstanding common shares of Ventana Medical Systems to 5:00 pm, New York City time on August 23.
The Swiss drug major made a $3.0 billion unsolicited bid for the...
Sepracor and Eisai to sell eszopiclone in Japan.(Brief article)
August 6, 2007... US research-based pharmaceutical company Sepracor has signed an agreement with Japanese drugmaker Eisai that will focus on the commercialization of the former's insomnia treatment eszopiclone, which is marketed in the USA as Lunesta.
Under...
Shire's Vyvanse made available in USA.(Brief article)
August 6, 2007... UK drugmaker Shire says that its attention-deficit hyperactivity disorder drug Vyvanse (lisdexamfetamine dimesylate) is now available in pharmacies across the USA. The drug was approved by the Food and Drug Administration earlier this year...
TG halts tgAAC94 trial after death of patient.(Targeted Genetics)
August 6, 2007... Seattle, USA-based biotechnology firm Targeted Genetics has reported the death of a trial volunteer who suffered a serious adverse event during the recent Phase I/II study of the developmental arthritis treatment tgAAC94. The company's...
Javelin initiates 2nd Ph III Dyloject study.(Javelin Pharmaceuticals )(Brief article)
August 6, 2007... Javelin Pharmaceuticals of the USA says that three patients have begun treatment in the second of two planned Phase III clinical studies for its Dyloject (injectable diclofenac sodium). This US study will enroll patients with moderate-to-severe...
BioAlliance Pharma in 40M-euro fund raising.
August 6, 2007... Paris, France-based BioAlliance Pharma, which is focused on the development and commercialization of therapeutics targeting drug resistance in cancer, HIV, and opportunistic infections, says that it has raised funds by means of a private...
BioChem starts Ph III study for Arthromir and Alphamir.(BioChem Solutions )(Brief article)
August 6, 2007... Florida, USA-based BioChem Solutions says it has now committed to proceeding with the Phase III trials for Arthromir and Alphamir, drugs that have been developed and derived from trioxolane. This research is being conducted under Food and Drug...
Cell Thera to sell $20.25M of stock.(Cell Therapeutics )(Brief article)
August 6, 2007... Seattle, USA-based Cell Therapeutics has entered into agreements to sell around $20.25 million of its 3% convertible preferred stock and warrants in a registered offering to several institutional investors, including existing securities...
Cancer Research UK Oks Champix approval.
August 6, 2007... A mixed response has greeted the recommendation of global drug behemoth Pfizer's smoking-cessation drug, Champix (varenicline), by the National Institute of Health and Clinical Excellence, the UK advisory body which recommends medical...
UK pharmacists launch Rx drug exchange.(Brief article)
August 6, 2007... The UK's National Pharmacy Association has launched a stock exchange system with Rxchange Ltd following a three-month pilot study involving 770 prescription drug outlets. Rxchange is an on-line registry that allows pharmacists to record and...
Pharmaceutical pollution investigation in France.
August 6, 2007... France's pharmacy academy is finalizing a report into the effects on humans, flora and fauna of dumped pharmaceutical products in the water supply. Yves Levi, professor of public health at the Paris-Sud II University, says that existing...
UK animal extremist attacks fall again.(Brief article)
August 6, 2007... Figures released by the Association of the British Pharmaceutical Industry reveal a continuation of the recent trend of declining animal rights campaigner attacks in the UK. In the first half of 2007, there were no violent attacks on drug...
Indian insurer offers first HIV cover.(human immunodeficiency virus)(Brief article)
August 6, 2007... A Chennai, India-based insurance company is offering the country's first insurance policy for HIV positive people, UK broadcaster the BBC reports. Star Health and Allied Insurance Company offers up to $1,100 coverage for an annual premium of...
India and China join WHO CT register.(World Health Organization)(Brief article)
August 6, 2007... The World Health Organization has announced the expansion of its clinical trial registry platform to include trial registers from China and India. The move was declared by the agency as "a major step for policy makers and scientists, who can...
Pfizer's maraviroc fares well vs efavirenz.(Brief article)
August 6, 2007... World drug giant Pfizer says that rates of virologic suppression in patients receiving its novel CCR5 antagonist, maraviroc, were 70.6% versus 73.1% for those on efavirenz in terms of the under 400 copies/ml efficacy benchmark and 65.3% vs...
Truvada/Sustiva cuts viral load vs Combivir/Sustiva.(Brief article)
August 6, 2007... USA-based Gilead Sciences presented strong 144-week data from an ongoing clinical trial comparing a once-daily regimen of its product Truvada (emtricitabine and tenofovir disoproxil fumarate) plus US drug major Bristol-Myers Squibb's Sustiva...
Encouraging data for GSK's Lexiva.(GlaxoSmithKline )(Brief article)
August 6, 2007... UK drug major GlaxoSmithKline presented encouraging data from a head-to-head study evaluating its drug Lexiva (fosamprenavir calcium) versus US drug major Bristol-Myers Squibb's protease inhibitor Reyataz (atazanavir) in an open-label,...
Strong female-specific data for Aptivus.(Brief article)
August 6, 2007... At the International AIDS Society congress, held in Sydney, Australia, German drug major Boehringer Ingelheim presented an analysis of the RESIST trials, which it says shows that Aptivus (tipranavir) boosted with the protease inhibitor...
ARV tax break call from Nigerian industry group.(Brief article)
August 6, 2007... The Nigerian Manufacturers Association, which includes a pharmaceutical sector representative group, has called for the establishment of a tax credit for the production of antiretroviral drugs in the west African country, the Vanguard of...
Philippines drug price cuts contested.(Brief article)
August 6, 2007... A new attempt to introduce a price control board for drugs in the Philippines is opposed by the research-based pharmaceutical firms and by the Department of Health, according to local reports. The last attempt to enact legislation designed to...
WHO panel reviews MDR-TB diagnostics.(World Health Organization)(multidrug-resistant tuberculosis)(Brief article)
August 6, 2007... The World Health Organization has conducted a review of drug resistant tuberculosis because of difficulties in diagnosing multidrug-resistant TB versus extremely drug-resistant TB. The meeting in Geneva, Switzerland is the first of its kind...
Amgen sees slow revenue growth in 2nd-qtr 2007 as FDA warnings harm ESA drug sales.(Financial report)
August 6, 2007... World biotechnology giant Amgen's second-quarter 2007 net income totalled $1.02 billion, or $0.90 per share, versus $14.0 million, or $0.01 per share, in the like, year-ago period, as total revenue rose 3% to $3.73 billion.
Analysts polled...
Genzyme's 2nd-qtr net income jumps 4%.(Financial report)(Brief article)
August 6, 2007... US biotechnology major Genzyme's second-quarter 2007 profit totaled $139.9 million, or $0.51 per share, up 4% on the like, year-ago period, as revenues jumped 18% to $933.4 million, reflecting growth across all product areas. On the day the...
Celegene's 2nd-qtr 2007 income soars 187.2%.(Financial report)(Brief article)
August 6, 2007... US drugmaker Celegene's second-quarter 2007 net income totaled $54.9 million, or $0.13 per share, versus $9.6 million, or $0.03 per share, including an after-tax share-based employee compensation expense of $20.7 million.
During the...
Japan's MHLW takes another look at pharma industry's prospects.(Ministry of Health, Labor and Welfare)
August 6, 2007... Japan's Ministry of Health, Labor and Welfare has completed a draft of the New Vision of the Pharmaceutical Industry in Japan which is a revised version of the previous one in 2002. This takes into account the recent changes in the industry's...
IRB option for clinical trials granted in Japan.(institutional review board )(Brief article)
August 6, 2007... It has been agreed at a meeting of the Committee on the Role of Clinical Trials within Japan's Health, Labor and Welfare that an option will be granted for the selection of an institutional review board (IRB) to Japanese medical facilities by...
ReNeuron buys Amcyte assets for $4M.
August 6, 2007... Guildford, UK-based ReNeuron Group has entered into arrangements to acquire the business assets of AmCyte Inc, a US development-stage cell therapy company headquartered in Santa Monica, California.
ReNeuron is acquiring AmCyte's proprietary...
GPC Biotech named in US class action.(Brief article)
August 6, 2007... The US law firm Howard G Smith says that a securities class action law suit has been filed on behalf of shareholders who purchased the securities of Germany's GPC Biotech AG between December 5, 2005 and July 24, 2007, inclusive. The class...
Ranbaxy and GSK settle over Valtrex.(Ranbaxy Laboratories Ltd.)(GlaxoSmithKline)(Brief article)
August 6, 2007... Indian generic drugs major Ranbaxy Laboratories says that it has reached a deal with UK pharmaceutical giant GlaxoSmithKline resulting in the dismissal of their US litigation over the antiviral Valtrex (valacyclovir HCl). The dispute concerned...
ImClone and B-MS amend Erbitux deal.(ImClone Systems)(Bristol-Myers Squibb )(Brief article)
August 6, 2007... US drug developer ImClone Systems and major Bristol-Myers Squibb have amended their Erbitux (cetuximab) US co-development and co-promotion agreement. The revision will see the firms expand, by several hundred million US dollars, their ongoing...
Abbott begins Ph I trial of ABT-560.(Abbott Laboratories )(Brief article)
August 6, 2007... Danish biopharmaceutical firm NeuroSearch says that licensee US health care major Abbott Laboratories has enrolled and dosed the first patients in a Phase I clinical trial of the drug candidate ABT-560. The move triggers a milestone payment to...
Phytopharm completes Ph Ib Myogane trial.(Brief article)
August 6, 2007... UK plant-based drugmaker Phytopharm says it has completed a Phase Ib trial of Myogane, its novel, orally-active neurotrophic factor inducer, in healthy volunteers. The drug, which is being developed for the treatment of amyotrophic lateral...
Boeh Ing's 1st half 2007 sales up 2.1%.(Financial report)
August 6, 2007... German privately-owned drugmaker Boehringer Ingelheim says that net sales for the first six months of the year were 5.41 billion euros ($7.37 billion), up 2.1% on those achieved during the comparable period of 2006. The company said that key...
Solvay's income falls 15% in 1st-half 2007.(Financial report)(Brief article)
August 6, 2007... Net income for the first half of the year at Belgian drugmaker Solvay fell 15% to 413.0 million euros ($564.6 million). The decline was due to non-operating item charges of 34.0 million euros and a 50.5% increase, to 146.0 million euros, in tax...
Elan's 2nd-qtr 2007 loss deepens 56%.(Financial report)(Brief article)
August 6, 2007... Irish drugmaker Elan says that its net loss for the three months ended June 30, 2007, amounted to $141.1 million, up 55.9% on the deficit it recorded in the comparable period last year. The firm attributed the loss, which is equivalent to $0.30...
UCB's 1st-half profits fall 39% on Schwarz buy.
August 6, 2007... Belgian drugmaker UCB says that the 39% fall, to 171.0 million euros ($233.7 million), in profits for the first half of the year reflects the impact of one-time expenses and charges of 224.0 million euros, related to its integration of...
The European Union Penalties Regulation explained by Hogan and Hartson lawyers.
August 6, 2007... After much debate about its contents, purpose and legal basis, the European Commission Regulation on Penalties relating to new drug approvals was finally adopted on June 14 and entered into force on July 5. As a consequence of the Regulation,...
Boeh Ing's Viramune may cut CV risk.(Boehringer Ingelheim)
August 6, 2007... Encouraging new data from two studies of Boehringer Ingelheim's Viramune (nevirapine) were presented at the 4th International AIDS Society
meeting, held in Sydney, Australia. Results from an extended three-year follow-up analysis of the...
Xenomics gets European patent on transrenal DNA.(Brief article)
August 6, 2007... Xenomics, a USA-based molecular diagnostic company, has been awarded its first European patent. Entitled Methods for detection of nucleic acid sequences in urine, patent number EP 1634966 A2 covers use of its proprietary transrenal nucleic acid...
Myconostic raises L40 per share in series C.(Brief article)
August 6, 2007... London UK-based Amphion Innovations says that its partner company, Myconostica, a Manchester University spin-out that specializes in a new type of molecular diagnostic test for infectious diseases, has raised L570,000 ($779,458) at L40 per...
Sepracor files Lunivia MAA with EMEA.(Marketing Approval Application)(European Medicines Agency)(Brief article)
August 6, 2007... Massachusetts, USA-based Sepracor has submitted a Marketing Approval Application for Lunivia (eszopiclone) to the European Medicines Agency (EMEA) for review under the centralized procedure. This provides for a single, coordinated technical...
Phoqus files Chronocort IND in USA.(Brief article)
August 6, 2007... UK drug developer Phoqus says that it has filed an Investigational New Drug application with the US Food and Drug Administration for its lead product Chronocort in the indication of congenital adrenal hyperplasia. This is in preparation for the...
FDA clears OTC use of Akorn's ketotifen fumarate.(Food and Drug Administration)(over-the-counter )(Brief article)
August 6, 2007... US drugmaker Akorn says that the Food and Drug Administration has granted approval for over-the-counter use of Akorn's Abbreviated New Drug Application for ketotifen fumarate ophthalmic solution, 0.025%.
Akorn's product is the generic...
Wyeth's Lybrel now on sale in USA.(Brief article)
August 6, 2007... US drug major Wyeth Pharmaceuticals that Lybrel (90mcg levonorgestrel/20mcg ethinyl estradiol tablets) is now available by prescription in US pharmacies.
It is indicated for the prevention of pregnancy and is the first and only low-dose...
FDA advisory panel votes to keep GSK's Avandia on US market but with warnings.(GlaxoSmithKline)
August 6, 2007... UK pharmaceutical giant GlaxoSmithKline received a welcome reprieve for its recently-battered type 2 diabetes drug Avandia (rosiglitazone), when a joint meeting of the US Food and Drug Administration's Endocrinology and Metabolic Drugs and the...
Targacept shares leap 20% on an NNR drug collaboration with GSK worth up to $1.5B.
August 6, 2007... UK drug major GlaxoSmithKline and USA-based Targacept have formed a strategic alliance to discover, develop and market novel therapeutics that selectively target specified neuronal nicotinic receptors (NNRs).
The deal, which is potentially...
FDA permits restricted use of Novartis' Zelnorm.(Food and Drug Administration )(Brief article)
August 6, 2007... The US Food and Drug Administration has permitted restricted use of Swiss drug major Novartis' withdrawn drug Zelnorm (tegaserod maleate) under a treatment Investigational New Drug protocol for irritable bowel syndrome with constipation (IBS-C)...
French govt launches Rx tax for medicines R&D.
August 6, 2007... France's President Nicolas Sarkozy has announced the creation of a "medical franchise" of 0.50 euros ($0.68) per drug package to fund research into cancer, Alzheimer's disease and palliative care. The news came during a presidential visit to a...
Taxpayer group says privatize troubled CNAM.(Brief article)
August 6, 2007... A potential political conflict over both the French health insurance budget and a proposed regime of patient charges has erupted following a council meeting of the national sickness insurance funds (CNAM). The problems stem from the...
IBM and Czech RFID test for hospital chemo drugs.(Brief article)
August 6, 2007... The Masaryk Memorial Cancer Institute in Brno, Czech Republic, and US information technology giant IBM's local unit are making use of a radio-frequency identification (RFID) pilot scheme for tracking the movement of chemotherapy drugs within...
Russia's drug imports fall, lack of subsidies blamed.(Brief article)
August 6, 2007... Russia's pharmaceutical imports have declined 17% to $2.2 billion in the first five months of 2007, according to official figures. The downturn is reportedly the first of its kind in a decade.
The drop in Russian drug imports can be...
Crestor boosts Shionogi 1st-qtr fiscal sales 8.7%.(Financial report)(Brief article)
August 6, 2007... Japanese drugmaker Shionogi says that, for the three months ended June 30, 2007, the first quarter of the fiscal year, net sales rose 8.7% on the like, year-ago period, to 50.21 billion yen ($421.1 million), boosted by the steady expansion of...
Kyowa Hakko's fiscal 1st-qtr sales rise 10.8%.(Kyowa Hakko Kogyo Company Ltd.)(Financial report)(Brief article)
August 6, 2007... Tokyo, Japan-based Kyowa Hakko Kogyo's consolidated net sales for the three months ended June 30, 2007, totaled 94.9 billion yen ($796.6 million), an increase of 10.8% on the like, year-ago period, driven mainly by a strong performance from its...
MorpoSys' six-month income plunges 55.5%.(Financial report)(Brief article)
August 6, 2007... German synthetic antibody specialist MorphoSys AG says that, for the six months ended June 30, 2007, net income fell 55.5% to 2.0 million euros ($2.7 million), equivalent to 0.49 euros per diluted share. The news caused the company's share...
Schwarz' 1st-half net profit falls 30%.
August 6, 2007... German drugmaker Schwarz Pharma, which is now owned by Belgian drug and chemicals firm UCB, says that net earnings for the first six months of the year fell 30% to 26.1 million euros ($35.7 million), corresponding to earnings of 0.80 euros per...
NicOx cuts 1st half loss 55%, revenue up 203%.(NicOx S.A.)(Financial report)(Brief article)
August 6, 2007... First-half losses at French drug developer NicOx narrowed to 6.6 million euros ($9.0 million), a reduction of 55.1% on the deficit it recorded in the comparable period last year. The firm said that this was due to the strong increase in...
Richter's 1st-half 2007 profits plummet 41%.(Richter Gedeon)(Financial report)(Brief article)
August 6, 2007... Hungarian drugmaker Richter Gedeon said that the 41% slump in its half year profits, to 18.5 billion forint ($101.3 million), which was in line with forecasts, was a result of an 8.4% drop, to 27.1 billion forint, in domestic sales.
...
Pharming loss deepens 8.7% in 1st-half 2007.(Pharming Group N.V.)(Financial report)(Brief article)
August 6, 2007... Dutch biotechnology firm Pharming NV says that first-half net loss was 11.3 million euros ($15.5 million), an increase of 8.7% on the shortfall in the opening six months of 2006, which was towards the high end of analysts' expectations. The...
MMI provides R&D update.(Medical Marketing International)(research and development)(Brief article)
August 6, 2007... UK Pharmaceutical group Medical Marketing International says that, using its modified lentiviral vector-delivered ribozymes, it has been able to inhibit the expression of two cell surface receptors, CCR5 and CXCR4, required by the HIV virus for...
Shire beats expectations, with sales up 34% driven by Adderall XR and Elaprase.(Shire Pharmaceuticals Group PLC)(Financial report)(Brief article)
August 6, 2007... UK drugmaker Shire not only beat consensus forecasts with its second-quarter 2007 results, but also upped its guidance for full-year sales growth of not less than 25% versus 20% projected earlier.
The company reported a solid 34% rise in...
Japan stock market week to July 30, 2007.
August 6, 2007... Tokyo continued a downturn in the week ended July 30. The Nikkei 225 fell 3.8%, to close at the 17,200 level, while the Topix index lost 2.9%. The ruling Liberal Democratic Party suffered a heavy defeat in the national election for the House of...
Eye disease risk rising among Americans.(Survey)(Brief article)
August 6, 2007... A new national health survey of 1,200 US citizens conducted for the American Academy of Ophthalmology finds that most Americans are unaware of the risks associated with age-related eye diseases, despite a projected 65% spike in those...
ImmunoGen gets $5M milestone.(Genentech Inc.)(Brief article)
August 6, 2007... ImmunoGen, a US biopharmaceuticals company that develops targeted anticancer therapeutics using its Tumor-Activated Prodrug (TAP) technology, says that biotechnology major Genentech has started Phase II clinical testing of trastuzumab-DM1. This...
Qiagen completes Digene purchase.(Brief article)
August 6, 2007... Netherlands-based Qiagen says it has successfully completion of its acquisition of US firm Digene through a tender offer and subsequent merger of Digene into one of its wholly-owned subsidiaries. As a result, it will become wholly-owned by...
Cell Thera closes $20M offering.(Cell Therapeutics Inc.)(Brief article)
August 6, 2007... Seattle, USA-based Cell Therapeutics says that it has received around $20.25 million from the sale of its 3% convertible preferred stock and warrants in a previously-announced registered offering to several institutional investors, including...
Curudium generates $5.1M in financing round.(Curidium Medica)(Brief article)
August 6, 2007... London, UK-based Curidium Medica has placed 100 million 0.1 pence ordinary shares with strategic investors at a price of 2.5 pence per share resulting in gross proceeds of L2.5 million ($5.1 million).
The funds will be used to expand the...
Laureate enters cGMP deal with Enobia.(certified Good Manufacturing Principles)(Enobia Pharma)(Laureate Pharma)(Brief article)
August 6, 2007... USA-based Laureate Pharma has entered into a certified Good Manufacturing Principles contract manufacturing agreement with Enobia Pharma, a biotechnology company actively engaged in the development of enzyme replacement therapy for...
Sanofi-Aventis 2nd-qtr profit falls as generics take toll on Eloxati and Ambien.(revenue report)(Financial report)
August 6, 2007... Leading French pharmaceutical group Sanofi-Aventis disappointed investors, posting second-quarter 2007 results which were below consensus estimates. Moreover, its announcement of an up to 3.0 billion euros ($4.1 billion) share buyback program...
J&J cost restructuring will see 4,800 job cuts.
August 6, 2007... Diversified US health care giant Johnson & Johnson, despite posting strong second-quarter financial results (Marketletter July 23), has announced initiatives that it says are expected to generate pretax annual cost savings of $1.3-$1.6 billion...
US Sarbanes-Oxley reforms fail, says BIO.(Biotechnology Industry Organization)(Brief article)
August 6, 2007... An attempt by the US Securities and Exchange Commission to reform the 2002 Sarbanes-Oxley Act (SOX) has made a crucial error by not defining what a "small company" is for the purposes of auditing regulations, the Biotechnology Industry...
US govt requests "rapid" drug action from China.(United States. Department of Health and Human Services)(Brief article)
August 6, 2007... The US Secretary of Health and Human Services, Michael Leavitt, called on the Chinese government to ensure "rapid action to accomplish certain goals related to the safety of food and drugs." He added that the DHHS had "emphasized the need for...
Less severe CMS limits for reimbursement of ESAs after 2,600 consultation responses.(Centers for Medicare and Medicaid Services)(erythropoiesis stimulating agents)
August 6, 2007... The US Centers for Medicare and Medicaid Services (CMS) has announced a less severe than expected national coverage determination for the use of erythropoiesis stimulating agents in cancer and related neoplastic conditions. The agency had...
Study suggests low LDL-C and cancer link.(low-density lipoprotein cholesterol )
August 6, 2007... For decades, reducing low-density lipoprotein cholesterol levels has been seen as the key measure in heart disease prevention, giving rise to a massive market for drugs that have this effect. However, the results of a new study have hinted that...
DOR gets $940,000 FDA grant for RiVax.(DOR BioPharma )(Brief article)
August 6, 2007... US biopharmaceutical firm DOR BioPharma says it has received a $940,000 grant from the Food and Drug Administration's Office of Orphan Products Development for the further clinical evaluation of its vaccine for ricin toxin, RiVax. Specifically,...
FDA clears EvaMist for menopause symptoms.(Brief article)
August 6, 2007... Specialty drugmaker KV Pharmaceutical says that fellow US firm Vivus has received Food and Drug Administration marketing approval for EvaMist, the novel estrogen transdermal spray that KV acquired US rights to earlier this year (Marketletter...
Sanofi and Chugai to end marketing deal.(Brief article)
August 6, 2007... French drug major Sanofi-Aventis and Japanese pharmaceutical firm Chugai have agreed to terminate their current marketing collaboration on December 31 this year. The deal, which was established through the company's local subsidiary...
Tibotec files TMC125 MAA with EMEA.(Tibotec Pharmaceuticals)(European Medicines Agency)(Brief article)
August 6, 2007... Irish drugmaker Tibotec Pharmaceuticals has submitted a Marketing Authorization Application to the European Medicines Agency (EMEA), seeking approval for TMC125 (etravirine), a next-generation non-nucleoside reverse transcriptase inhibitor...