 Dr.Shruti Bhat, Star formulator and Ace leader within pharmaceutical R&D,a specialist with hiTech formulations and quality-by-design. Shruti brings to you some highlights from current pharma and clinical research news, views and data. Bloomberg News reports that a study in the medical journal Gut found that "people who take even a very low dose of aspirin every day for five years can cut the risk of developing colon cancer by almost a third." According to researchers, "as little as 75 milligrams of aspirin a day...lowered the risk of colon cancer by 22 percent after just a year." While it was already know that aspirin can protect the colon, the "study showed for the first time that a low dose of aspirin is sufficient to ward off cancer, and that the drug needs to be taken for at least five years to get the full benefit." According to MedPage Today "Aspirin has not as yet been recommended for primary chemoprevention of colorectal cancer...because of unanswered questions on dose, duration, and effects on survival." WebMD the UK's Press Association and the UK's Daily Mail also covered this study. References:
http://www.bloomberg.com/news/2010-09-15/low-dose-of-aspirin-taken-daily-cuts-colon-cancer-risk-researchers-find.htmlhttp://www.medpagetoday.com/HematologyOncology/ColonCancer/22207http://www.webmd.com/cancer/news/20100915/low-dose-aspirin-lowers-risk-of-colorectal-cancer?src=RSS_PUBLIChttp://www.google.com/hostednews/ukpress/article/ALeqM5hFNKz7ksAdXZuXyQDViwYLSYFdBwhttp://www.dailymail.co.uk/health/article-1312475/Aspirin-cuts-bowel-cancer-risk-22.html
Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
Http://www.drshrutibhat.com
Expert at leading Pharmaceutical R&D.
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 Dr.Shruti Bhat, Star formulator and Ace leader within pharmaceutical R&D,a specialist with hiTech formulations and quality-by-design. Shruti brings to you some highlights from current pharma and clinical research news, views and data. On its website, ABC News reported, "A former Food and Drug Administration official who helped get the vision correction surgery LASIK approved back in the 1990s but later spoke out against the procedure is taking his concerns directly to current regulators at the FDA." Yesterday, "Morris Waxler, who is now an independent regulatory consultant, filed a citizen's petition...urging the agency to take steps to stop what he calls 'the epidemic of permanent vision problems' caused by LASIK." According to "Waxler's analysis of FDA data, half of LASIK patients experience side effects, and more than a third continue to need glasses or contacts," ABC World News (9/22, story 6, 1:55, Sawyer) reported. After being asked if he "would you ever recommend LASIK to somebody" he cares about, "knowing what" he "knows now," Dr. Waxler replied, "No, absolutely not." While the "industry counters that most LASIK side effects are minor or temporary, and that complications are much lower with today's modern LASIK," the agency nevertheless is "now reviewing the procedure." http://abcnews.go.com/Health/EyeHealth/lasik-advocate-files-petition-criticizing-procedure/story?id=11689793 Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.Http://www.drshrutibhat.com
Expert at leading Pharmaceutical R&D.
Translates innovative concepts to PROFITS.
YouTube Channel : Http://www.youtube.com/user/ShrutiBhat10
 Dr.Shruti Bhat, Star formulator and Ace leader within pharmaceutical R&D, a specialist with hiTech formulations and quality-by-design. Shruti brings to you some highlights from current pharma and clinical research news, views and data. Frederick Frank, a leading biotechnology banker and vice chairman ofinvestment advisory firm Peter J. Solomon, said Genzyme Corp (GENZ.O) has no chance of remaining an independent company.French drugmaker Sanofi-Aventis SA (SASY.PA) has made a hostile tender offer of $18.5 billion, or $69 a share, for the Cambridge, Massachusetts-based maker of drugs for rare diseases. Genzyme has rejected the bid but Sanofi is expected ultimately to prevail."Genzyme is history," Frank said at the Reuters Health Summit on Monday. "It's only a question of when and at what price."
Genzyme's shares closed on Monday at $71.06, and Frank said that if a deal were to fall through the stock price would likely fall into the mid-$50 range."I would estimate that 40 to 50 percent of the shares are held in the arbitrage community," he said, referring to short-term investors who specialize in takeover targets. "That's a big load to be sold."Frank, former vice chairman of Lehman Brothers and, until 2009, of Barclays Capital, has advised on countless transactions in the pharmaceuticals and biotech sector.He said he expects mergers and acquisitions in the space to continue, since big pharmaceuticals companies are eager to acquire products to replace those that are losing patent protection.But once Genzyme is gone, there will only be a handful of large biotech companies left, including Amgen Inc (AMGN.O), Gilead Sciences Inc (GILD.O) and Biogen Idec Inc (BIIB.O). If and when they too disappear, it is unlikely the industry will see new companies of their ilk emerge, he said."Today, venture capitalists are willing to finance a company through mid-stage trials but with the goal of selling it at that point," he said. "You're not going to see a lot of new Amgens or Genentechs."Genentech, the oldest and second-biggest biotech after Amgen, was fully acquired by Swiss drugmaker Roche Holding AG (ROG.VX) in early 2009.Still, Frank said acquisitions will depend on valuations. Biogen Idec Inc (BIIB.O), which makes the multiple sclerosis drugs Avonex and Tysabri, has long been considered an acquisition target. But in 2007 the company tried and failed to sell itself.Frank said he was approached by a big pharmaceuticals company to represent them in a possible purchase of Biogen but he recommended against it."On the surface the numbers look very attractive," he said, "but their wonderful drug Tysabri, for a very small group of people, has the potential to kill you."Tysabri has been linked with PML, a potentially deadly brain infection, and is competing in an ever-more crowded space. Recently U.S. regulators approved the first oral MS drug, Gilenya, made by Novartis AG (NOVN.VX) that is widely expected to become a leading player in the space.Biogen is working on a test that could potentially screen patients at higher risk for developing PML, but uncertainty remains.Despite Sanofi's hostile bid for Genzyme, Frank does not expect hostile offers to increase."I don't think you'll see a lot of them," he said. "These companies are very management intensive; you do a hostile tender offer, you tend to lose the management."For big pharmaceuticals companies, a new era is at hand, in which insurance companies are increasingly in the driver's seat, he said."In the past, the payer community was not very active; the pharma companies set their prices and their prices were largely paid. Now the focus of power has changed."No longer can drug companies develop products with only marginal improvements over rival drugs. Payers won't pay, he said."We're entering a new world," he said. "Pharma companies are going to spend a lot of time developing first-in-class drugs."Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances. Http://www.drshrutibhat.comExpert at leading Pharmaceutical R&D.Translates innovative concepts to PROFITS.YouTube Channel : Http://www.youtube.com/user/ShrutiBhat10
 Dr.Shruti Bhat, Star formulator and Ace leader within pharmaceutical R&D. Shruti is a specialist with hiTech formulations, pharmaceutical patents and quality-by-design. Shruti brings to you some highlights from current patent news, views and data. This was an application brought by AstraZeneca under the provisions of the Patented Medicines (Notice of Compliance) Regulations for an order prohibiting the Minister of Health from issuing a notice of compliance to Apotex for 20 and 40 mg esomeprazole magnesium tablets until after the expiry of Canadian Patent No. 2,139,653 (the '653 patent). If successful on the application, this would have prevented Apotex from marketing a generic version of NEXIUM in Canada for treating conditions wherein a reduction of gastric acid secretion is required until May 27, 2014. Apotex, on the other hand, sought early market entry by arguing that the '653 patent was invalid for lack of sound prediction, anticipation (or lack of novelty), and obviousness. The '653 patent relates to an improved process for preparing highly optically pure esomeprazole, one of the enantiomers of the racemate omeprazole, that is stable against racemisation (i.e. recombination). Claim 8 was the claim at issue and could be read as claiming a salt (e.g. magnesium) of esomeprazole having an optical purity of 99.8% or greater. There was no provision as to utility (or use of the invention) in claim 8. This was an important fact, as the Court noted that where the invention relates to a new compound, utility does not need to be included in the claim, so long as it is described in the description portion of the patent. On the other hand, when the patent relates to a new use for an old, known compound, that new use must be set out in the claims. In this case, claim 8 was not directed to a new compound; it was directed to a previously known compound having a particular purity. Moreover, utility of the compound was simply described in the description of the patent as follows: It is desirable to obtain compounds with improved pharmacokinetic and metabolic properties which will give an improved therapeutic profile such as a lower degree of interindividual variation. The present invention provides such compounds, which are novel salts of single enantiomers of omeprazole. However, nowhere in the patent, whether in the Examples or otherwise, was any information given to the person skilled in the art as to whether, in fact, the highly pure esomeprazole salt does give an improved therapeutic profile such as a lower degree of interindividual variation. Moreover, there was no evidence from any witness to say that there was anything in the disclosure of the '653 patent that would inform a person skilled in the art that the purified esomeprazole salt would fulfill this promise. As a result, there was a clear question as to whether the invention had a basis for a "sound prediction" as to utility. The requirements for sound prediction are well established: 1) there must be a factual basis for the prediction; 2) the inventors must have as of the date of the patent application an articulable and sound line of reasoning from which the desired result can be inferred from the factual basis; and 3) there must be proper disclosure. The facts of the present case did not show that as of the priority date, May 1993, or even the Canadian filing date, May 1994, that the inventors had either a factual basis for a prediction that an esomeprazole salt of a particular purity would have the utility indicated in the patent, nor did they have an articulable and sound line of reasoning for inferring such a result. In addition, clearly there was no proper disclosure in the patent in that respect. As a result, the patent was invalid for a lack of sound prediction. As to anticipation, the question was, given that prior art German patent application DE 40 35 455 A1 (DE '455) described a process for separating the enantiomers of omeprazole (and salts) into "optically pure" fractions, did the description, particularly Examples 5 and 6 (incorporating Examples 1 and 2) "enable" what was claimed in claim 8 of the '653 patent, a purity of 99.8% (ee) or greater? In this respect, the Court found that to practice DE '455 "would at best only occasionally result in a product with the purity level stipulated in claim 8." On this basis, there was no enablement such as would support an allegation of anticipation. As to obviousness, the Court was satisfied on the evidence that, as of the claim date, May 1993, it was known that omeprazole could be separated into its enantiomers (+) and (-), that they would be useful, just as omeprazole was, in treating gastric problems, and that they could be processed in salt form with a salt such as magnesium. A purity of 95.6% (ee) for esomeprazole had been reported as having been achieved in the prior art, and such technique could have been used to increase that purity to 99.8% (ee) if desired. In the result, the '653 patent was also found to be invalid for obviousness. More at http://www.pharmaceuticalpatentsandintellectualproperty.com/2010/09/apotex-vs-astra-zeneca-court-finds.html Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances. Http://www.drshrutibhat.comExpert at leading Pharmaceutical R&D.Translates innovative concepts to PROFITS.YouTube Channel : Http://www.youtube.com/user/ShrutiBhat10Do you have questions for the author?
 Dr.Shruti Bhat, Star formulator and Ace leader within pharmaceutical R&D,a specialist with hiTech formulations and quality-by-design. Shruti brings to you some highlights from current pharma and clinical research news, views and data.
A lineup of blockbuster monoclonal antibodies produced by a group of the world's top biopharma companies are now squarely in the crosshairs of the world's top biosimilar developers.Last Friday the European Medicines Agency laid out exactly what developers will need to do to gain approvals for follow-on antibody therapies. And Roche, with its lineup of aging cancer therapies like Rituxan, Herceptin and Avastin, was quickly singled out as the most vulnerable to a new lineup of competitive treatments that could hit the European market as early as 2012. The Financial Times also notes that Merck KGaA, Johnson & Johnson ($JNJ) and Abbott ($ABT) also face near-term competition from the biosimilar crowd. GlaxoSmithKline ($GSK) and AstraZeneca ($AZN) are likely to face new competition at a later stage.Several big outfits like Novartis ($NVS), Teva and Hospira ($HSP) are likely to lead the charge in creating biosimilar versions of the blockbuster antibodies. But it won't be cheap. The research group Collins Stewart has estimated that developers will need to budget $100 million for the kinds of clinical trials that will be required to gain an approval. And once they hit the market, the follow-ons are expected to offer discounts of 10 to 15 percent. Roche wants regulators to be cautious and slow. "We believe that patient safety must be of highest concern when evaluating the development, approval and marketing of biosimilar products." In the U.S., the FDA is just beginning the process of laying out the rules for developing biosimilars.EU adopts new biosimilar guideline :European regulators have adopted a guideline on biosimilar antibody drugs; industry can expect its publication in a couple of weeks. However, many experts already anticipate a cautious approach, requiring separate clinical trials for different diseases addressed by the same antibody, as Reuters notes.In a release, the EMA briefly touched on the guidelines, titled 'Similar Biological Medicinal Products Containing Monoclonal Antibodies,' which will be released for a five-month public consultation period. "This guideline lays down the nonclinical and clinical requirements for monoclonal antibody-containing medicines claiming to be similar to another one already marketed," it explains.Earlier this week, Lincoln Tsang, a partner at London law firm Arnold & Porter, told Reuters he expects the EMA to play it safe by requiring extensive testing. "My hunch is that they will be cautious in saying that if you can establish clinical efficacy and safety of a given product for a given indication you can't readily seek approval for another indication," he said. "Given it is such a big therapeutic area, I think they will not like to be seen to be too generous." As Reuters notes, such testing could drive up the costs of producing biosimilars, thus making it hard for smaller companies to enter the arena. If costs are too high, only well-established players like Teva, Novartis and Hospira might have the ability to bring such products to market.http://www.pharm-education.com/2010/11/blockbuster-antibodies-now-face-quick.html Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances. Http://www.drshrutibhat.com Expert at leading Pharmaceutical R&D.Translates innovative concepts to PROFITS.YouTube Channel : Http://www.youtube.com/user/ShrutiBhat10
 Dr.Shruti Bhat, Star formulator and Ace leader within pharmaceutical R&D. Shruti is a specialist with hiTech formulations, pharmaceutical patents and quality-by-design. Shruti brings to you some highlights from current pharmaceutical and clinical research news, views and data.
Recently, there has been an increase in so-called "scams" involving apparent IP-related companies sending misleading letters to applicants and owners of IP rights in an attempt to extract money from those persons. A number of official intellectual property organisations, including the World Intellectual Property Organisation (WIPO), have recognised this issue and distributed warnings against these scams.Often these scam letters take the appearance of invoices requesting the applicant/owner to pay for services that are essentially worthless. Examples include offers or invoices for registering patents or trade marks in international registers and offers for patent and trade mark monitoring services.These companies obtain their targets' details from official registers where details of their patent, trade mark or application are published, often together with the applicant/owners personal details. The companies use e-mails, fake websites, faxes and telephone numbers to give the appearance of a legitimate IP-related organisation.In a recent example, late last year, a Florida-based company had been found to have violated the state's Deceptive and Unfair Trade Practices Act by sending misleading invoices requesting payment for essentially worthless IP-related services. This company, trading as "Federated Institute for Patent and Trademark Registry", was found to have distributed misleading invoices to patent and trade mark applicants, including applicants of international Patent Cooperation Treaty patent applications.This victory is a small step towards combating this deceptive practice. However, recently, WIPO has witnessed a rise in the number of IP related scams. IP Australia has also advised that they occasionally receive notification of similar instances.To combat this issue, if you are an owner or applicant of a patent or trade mark, you should question correspondence from unfamiliar organisations offering services such as those mentioned above. Typically, the only organisations sending IP-related correspondence to applicants/owners of IP rights should be their legal representatives such as patent or trade mark attorneys, the official intellectual property offices such as WIPO and IP Australia, and Computer Patent Annuities (CPA), which is an organisation involved in managing renewal fees for patents and patent applications.If you are unsure of the origin or intention of a certain piece of correspondence, particularly if that correspondence requests money, you should contact us to ascertain the legitimacy of the party concerned. IP Australia and WIPO have issued lists of companies reported to have distributed unsolicited communications. The WIPO list also includes examples of the misleading correspondence sent by each listed organisation. These lists can be found at the following addresses.http://www.ipaustralia.gov.au/factsheets/unsolicited_ip.shtml http://www.wipo.int/pct/en/warning/pct_warning.htm Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances. http://www.pharmaceuticalpatentsandintellectualproperty.com/2010/11/australia-not-all-patent-protection-is.html Http://www.drshrutibhat.com Expert at leading Pharmaceutical R&D.Translates innovative concepts to PROFITS.YouTube Channel : Http://www.youtube.com/user/ShrutiBhat10Do you have questions for the author?
 Dr.Shruti Bhat, Star formulator and Ace leader within pharmaceutical R&D. Shruti is a specialist with hiTech formulations, pharmaceutical patents and quality-by-design. Shruti brings to you some highlights from current pharmaceutical and clinical research news, views and data.
The Italian Medicines Agency (AIFA) has issued new guidelines on its future policy on the disclosure of generics (Gxs) applications.AIFA stated that "further to consultations with Italian and European institutions, as well as the industry and the Italian courts" (presumably the Italian administrative courts where cases were recently brought by leading pharmaceutical companies), AIFA has decided to change the procedure whereby AIFA will process patent holders' requests for information on Marketing Authorisation (MA) applications filed by generics manufacturers.Further, AIFA will publish a list of all the active substances for which MA applications have been filed in accordance with Article 10(1) and 10(3) of Directive 2001/83/EC. According to AIFA, publishing that list will meet the requirements of the Italian Freedom of Information Act (Law 241/1990), according to which affected third parties are entitled to be informed of any administrative procedure being commenced.AIFA has decided that it will not authorise the disclosure of Gxs files to patent holders before the completion of the regulatory procedure, unless exceptional circumstances require otherwise. In particular, for medicinals that are not reimbursed by the National Health Service, such disclosures will be authorised only once the opinion of the Scientific Commission has been submitted. In terms of medicinals that are reimbursed, disclosures will be authorised once price negotiations have been completed. In essence, this will mean that disclosure of Gxs files will be authorised at the very end of the regulatory process, i.e. just before Gxs MAs are published in the Official Gazette.AIFA has gone on to confirm that it will be adhering to recent case law by the Supreme Administrative Court whereby it judged that the existence of patent rights is irrelevant in terms of including approved Gxs in the reimbursement list.The List of Active Substances :AIFA did not clarify whether the list of active substances for which article 10 (1) or 10 (3) MA applications are filed will include just the active substances or the names of the actual generics manufacturers filing the MA applications as well. The first list for new MA applications filed for September 2010 was published online on 7 October: http://www.agenziafarmaco.it/it/content/lista-sostanze-attive . The list indicates the relevant active substances, the type of procedure (national, mutual recognition or centralised/decentralised) and the number of MA applications filed for each active substance. The identity of the Gxs manufacturers is not revealed.What will this mean?In the past, AIFA's reaction to requests made by right holders (under the Freedom of Information Act) for the disclosure of Gxs applications was to send the relevant generics manufacturer a letter asking if it objected to such request. A copy of such letter was also sent to the patent holder and the right holder was thus officially informed of the identity of the Gxs manufacturer filing the MA application.Under the new procedure – assuming that AIFA will not include the names of the Gxs manufacturers in the next lists – it may become increasingly harder for right holders to be officially informed of who is filing Gxs applications. As a result, the new AIFA procedure may well be seen to be breaching the Freedom of Information Act.On a more positive note, since 7 October 2010, patent holders are able to monitor MA submissions by active substances in Italy using an online tool.Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances. http://www.pharmaceuticalpatentsandintellectualproperty.com/2010/11/italy-disclosing-generics-applications.html
New cancer drugs are a top priority for most pharmaceutical companies these days, but the sector's sales trajectory has flattened as key medicines lose patent protection and new breakthrough products prove scarce.
U.S. sales of oncology drugs increased just 3.5 percent in the first nine months of this year, according to pharmaceutical market information company IMS Health.
The sector saw sales growth of 23 percent in 2006, after Roche Holding AG's Avastin was launched. It grew by 14 percent in 2007 and 9 percent in both 2008 and 2009.
"This is an unprecedented slowdown," IMS representatives said at the Reuters Health Summit. "Growth is largely being driven by pricing increases," as well as the entrance of lower-cost generic drugs. Read more...
http://www.pharm-education.com/2010/11/cancer-drug-sales-fast-sliding-35-in.html
 Drug recalls reached a record high 1,742 in 2009 — more than four times the amount in 2008. Bowman Cox, managing editor of the Gold Sheet told CNN Money that in light of the 296 recalls issued in the first six months of 2010, there could be 600 or more recalls this year. Why So Many Recalls? Analysts and legislators are examining the recall statistics to find sources and solutions to the pharmaceutical safety issue. 1. Drug repackaging :Advantage Dose, a now-defunct Shreveport, LA based drug re-packager, was responsible for more than 1,000 of the 2009 recalls. Companies like Advantage Dose repackage and re-label drugs into smaller units for resale or distribution to health care facilities. After excluding Advantage Dose from the count, there still remains a 50% jump in recalls from 2008 to 2009. 2. The generic rush : Gold Sheet’s Cox suggests that generic manufacturers cut drug design costs in their rush to be first to market after a branded-drug’s patent protection expires, decreasing quality. “The first generic applicant typically gets the lion’s share of the business for the new drug…the 180 day exclusivity… So they get the application. They make and market the drug, but they could still have problems down the road if they haven’t really understood the optimum way to make that drug(product).” One example of a design failure is Caraco Pharmaceutical Laboratories’ “tablet thickness” recalls in March 2009. 3. Manufacturing lapses: Some experts say the biggest culprits include the quality of raw materials and contamination. Some months ago, HealthReformWatch.com reported in Pharmaceutical Outsourcing: Trading Quality for Lower Costs? that India’s largest pharmaceutical manufacturer had been cited several times in recent years for manufacturing violations. Additional recalls include vaccines produced by Shantha Biotechnics for Sanofi-Aventis and injectible drugs made by Claris Lifesciences for Pfizer. The FDA stated its intent on May 5, 2010 to “propose stronger regulation for pharmaceutical companies that outsource manufacturing, putting more responsibility on the companies to ensure the purity and safety of the products…” 4. Increased FDA scrutiny of manufacturing facilities: Which came first, the chicken or the egg? Increased FDA oversight may or may not have led to the increased number of recalls; however, the recalls will probably lead to increased FDA regulatory power.As Jennifer Jascoll reported, Senator Michael F. Bennet (D-CO) proposed the Drug Safety and Accountability Act of 2010 on August 3, 2010. According to Bennet’s press release, “[t]he bill would strengthen manufacturer quality standards, enhance the USFDA’s ability to protect Americans through improved tracking of foreign manufacturing sites, and give the FDA much-needed authority to recall potentially dangerous drugs.”Currently, the FDA is empowered to issue warnings and recommend that a manufacturer issue a recall. According to CNN Money, the FDA has not identified any alarming pattern. FDA spokeswoman Elaine Gansz Bobo stated, “[s]ince every recall situation is unique, it would be difficult to assess whether there are any trends or increases in recalls this year… At this time, however, we have not identified any trends.” Despite the FDA’s lack of concern, other federal agencies are interested in the practices of pharmaceutical companies. Further Federal InvestigationsAccording to the N.Y.Times, federal prosecutors and securities regulators are investigating pharmaceutical companies for potential violations of the Foreign Corrupt Practices Act (FCPA). The FCPA is an anti-bribery law which bars companies from offering foreign government officials items of value for profit. For instance, Pfizer disclosed in April “that it paid $35m over six months to 4,500 doctors in private practice for education and the development and marketing of new drugs.” Although this practice is legal in the U.S., such payments are illegal in many foreign countries where physicians are employed by the government. On November 17, 2009, Assistant Attorney General Lanny A. Breuer stated that the Department of Justice intended to focus its attention on the pharmaceutical industry: In some foreign countries and under certain circumstances, nearly every aspect of the approval, manufacture, import, export, pricing, sale and marketing of a drug product may involve a “foreign official” within the meaning of the FCPA. The depth of government involvement in foreign health systems, combined with fierce industry competition and the closed nature of many public formularies, creates, in our view, a significant risk that corrupt payments will infect the process. Our remarkable FCPA unit and our terrific health care fraud unit will be working together to investigate FCPA violations in the pharmaceutical industry in an effort to maximize our ability to effectively enforce the law in this high-risk area. “Corrupt practices” under the FCPA are not limited to cash in envelopes. Inappropriate payments for lavish hospitality, consulting, licensing agreements, and even charitable donations may raise red flags for government investigators. Could bribery be contributing to decreased quality and the sudden rise in recalls? According to the Financial Times, the DoJ is focusing its efforts elsewhere: [T]he DoJ is particularly interested in corrupt payments that may have influenced the reliability or integrity of data in clinical trials performed outside the US. A recent report by the Department of Health and Human Services found 80 percent of marketing applications for drugs approved by the Food and Drug Administration in the US had relied on at least one foreign trial. It appears that the DoJ’s scrutiny of clinical trials is not without merit. The N.YTimes reports that “[l]ast month, a federal drug official reported that he found repeated instances in a landmark clinical trial of Avandia, a controversial diabetes medicine, in which patients taking Avandia appeared to suffer serious heart problems that were not counted in the study’s crucial tally of adverse events.” The clinical trials for Avandia included many foreign trial sites, which were submitted in support of the drugs’ application to enter and remain on the U.S. market. GlaxoSmithKline, the trial’s sponsor, has not been accused of fraud. According to recent regulatory filings, the following companies are under investigation for possible violations of the FCPA: - Merck is cooperating with a federal investigation of company activities in multiple foreign nations.
- Medtronic is cooperating with investigations of company activities in Greece, Poland, Germany, Turkey, Italy, and Malaysia.
- Eli Lilly is cooperating with the investigations of subsidiaries in several countries, including Poland.
- Federal investigators are looking into improper payments related to the sale of Zimmer products abroad.
- Johnson & Johnson voluntary disclosed the possibility that company subsidiaries abroad had made improper payments to government officials in two countries relating to the sale of medical devices.
- Pfizer and Bristol-Myers Squibb have also disclosed that they are subject to federal investigations. AstraZeneca, GlaxoSmithKline, and Baxter SciClone have also received inquiries from federal enforcement agencies.
Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.Http://www.drshrutibhat.comExpert at leading Pharmaceutical R&D.
Translates innovative concepts to PROFITS.
YouTube Channel : Http://www.youtube.com/user/ShrutiBhat10Introducing ! A new blog- Http://www.PharmaceuticalCareerDevelopment.blogspot.com which contains articles on motivation, career counselling and coaching, job search strategies, personal branding etc. especially for pharma professionals.More at http://www.pharm-education.com/2010/09/drug-recalls-in-usa-reached-record-high.html
 Dr.Shruti Bhat, Star formulator and Ace leader within pharmaceutical R&D, a specialist with hiTech formulations and quality-by-design. Shruti brings to you some highlights from current pharma and clinical research news, views and data.
Misoprostol May Be As Effective As Oxytocin In Speeding Labor For Women With Inadequate Contractions.
"Titrated oral doses of misoprostol (Cytotec) may be as effective as intravenous oxytocin in speeding labor in women who have inadequate contractions, according to" a study published in J. Obstetrics & Gynecology. Taiwanese researchers found that in "a randomized trial of more than 200 Chinese women, the median times from treatment to vaginal delivery were virtually identical at 5.2 hours whether oral misoprostol or intravenous oxytocin was used." They also noted that there "were also no differences in adverse effects and birth outcomes, allaying concerns that oral misoprostol might not be as safe as intravenous oxytocin."
Trastuzumab May Help Extend Stomach Cancer Patients' Survival By Nearly Three Months.
Patients with HER2-positive advanced gastric cancer might benefit from a drug produced by Roche Holding AG. “Use of the drug trastuzumab in addition to chemotherapy can extend stomach cancer patients' survival by nearly three months," researchers in Seoul found after evaluating "584 patients at 122 centers in 24" nations. The "addition of trastuzumab to standard cisplatin/fluoropyrimidine chemotherapy resulted in a median survival of 13.8 months, compared with 11.1 months for patients who received chemotherapy alone -- a 26 percent difference." But, an editorial accompanying The Lancet paper questions the cost-effectiveness of that treatment. "In the 24 countries that contributed to the study, yearly health expenditure per citizen varies from $40 (£25) to $5,500, which reiterates the important moral question -- what is the justification for introducing a treatment that might enable one individual to live a few months longer, but will consume, for each person treated, the total yearly health expenditure for scores of their fellow citizens?" Breast Cancer Drug Fulvestrant Appears More Effective In The Presence Of CK8 And CK18.
Women’s responsiveness to the second-line breast cancer drug fulvestrant may depend on whether the cancer cells are expressing two key proteins, Indiana University Bloomington scientists report in this month’s Cancer Biology & Therapy.Fulvestrant appeared to exert maximum anti-cancer effects in vitro when cells produced normal or elevated quantities of the cytokeratins CK8 and CK18, structural proteins that help give the nucleus its shape. For fulvestrant to work well, the cells must also be responsive to estrogen, and producing the estrogen receptor ER-alpha. ER-alpha’s importance to fulvestrant’s anti-estrogenic action had been established in previous reports. The present study confirms fulvestrant’s binding relationship to ER-alpha, while also showing two other proteins, cytokeratins 8 and 18, can strongly enhance fulvestrant’s anti-estrogenic activity. Testing for the presence of these three proteins, and perhaps many others, could help doctors decide whether fulvestrant should be prescribed to their patients.Eprotirome May Lower Cholesterol Levels Without Feared Side Effects Of Thyroid-Based Drugs.
"A thyroid-derived cholesterol-lowering drug," called eprotirome, "that could be an alternative to the widely used statin medications has done well in a small, early trial, Swedish and American researchers report." For the 12-week trial, various doses of eprotirome "were added to statin treatment for 168 people whose high levels of LDL cholesterol had not been lowered by previous use of statins," and the combination was found to "lower cholesterol levels" and "did not cause the feared side effects...that have plagued similar thyroid-based treatments." Eprotirome, which is still several years away from the market, is unlikely to replace statins. Third Study Shows Bisphosphonates May Cut Risk Of Breast Cancer.
According to a study appearing in the British Journal of Cancer, researchers "found a reduction in the risk for breast cancer among postmenopausal women taking bisphosphonates for the treatment of osteoporosis." The study showed that "the use of bisphosphonates was associated with a 30% reduction in the risk for breast cancer." The findings back results "reported in two other studies." Still, researchers remain unclear "how bisphosphonates could prevent breast cancer." Intravitreous Dexamethasone Effective Treatment For DME.
According to a study published in the Archives of Ophthalmology, "intravitreous treatment with dexamethasone is well tolerated and significantly improves visual acuity in patients with persistent diabetic macular edema (DME)." In a trial in which 315 DME patients were randomized to intravitreous "dexamethasone 700 µg (n=105) or 350 µg (n=105) to one eye, or observation (n=105)," researchers found that "at day 90, a BCVA improvement of 10 letters or more was seen in 33.3%, 21.1%, and 12.3% of the dexamethasone 700 µg, 350 µg, and observation groups, respectively." Anti-TNF Therapy For Psoriatic Arthritis May Improve Physical Disability, Quality Of Life. According to a study published in the March issue of Arthritis Care & Research, "treatment with anti-tumor necrosis factor (TNF) agents can significantly improve physical disability and quality of life for patients with psoriatic arthritis." In a study of 596 patients, researchers found that "at six months, patients undergoing anti-TNF therapy had improved on the physical component scale of the Short Form (SF)-36 health survey instrument from a mean score of 19.1 to a mean of 29.3." In addition, scores "on the mental component scale...had risen from a mean of 41.7 to 48.8." Anti-TNF therapy drugs included in the study were etanercept, infliximab, and adalimumab. Combination Therapy For Some Alzheimer's Patients May Help Ease Caregiver Distress.
According to research presented at a geriatric psychiatry meeting, "caregiver distress is significantly attenuated when patients with moderate to severe Alzheimer's disease (AD) are treated with a combination of extended-release memantine plus a cholinesterase inhibitor (ChEI) vs. ChEI monotherapy." Researchers came to this conclusion after randomizing "335 patients with a diagnosis of probable AD who had been undergoing stable ChEI therapy for at least three months...to extended-release memantine, 28 mg daily, and another 342 patients" to placebo, then following them for 24 weeks. Quetiapine Associated With More Rapid Onset Of Metabolic Disturbances In Elderly Patients. According to a study presented at a geriatric psychiatry meeting, "the antipsychotic quetiapine (Seroquel, AstraZeneca) is associated with a more rapid onset of metabolic disturbances than other antipsychotics in elderly patients with no baseline metabolic abnormalities before treatment initiation." In a study of 231 outpatients aged 70 and older treated for "psychosis, depression, bipolar disorders, or dementia," researchers found that "time to onset of hyperglycemia was significantly shorter among patients treated with quetiapine at 17.5 months, compared with patients who were treated with olanzapine at 32.6 months or risperidone at 36.3 months." References:http://www.medscape.com/viewarticle/718261http://www.medpagetoday.com/OBGYN/Pregnancy/21833http://online.wsj.com/article/BT-CO-20100819-715016.htmlhttp://consumer.healthday.com/Article.asp?AID=642267http://www.guardian.co.uk/society/2010/aug/20/price-cancer-drug-herceptinhttp://newsinfo.iu.edu/news/page/normal/13738.htmlDisclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.Http://www.drshrutibhat.comExpert at leading Pharmaceutical R&D.Translates innovative concepts to PROFITS.YouTube Channel : Http://www.youtube.com/user/ShrutiBhat10 Introducing ! A new blog- Http://www.PharmaceuticalCareerDevelopment.blogspot.com which contains articles on motivation, career counselling and coaching, job search strategies, personal branding etc. especially for pharma professionals.
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