WHO, Wyeth Launch Trial In Africa To Test New River Blindness Drug
The WHO on Wednesday announced plans for a clinical trial to test a new drug that "could halve the treatment period for river blindness [or onchocerciasis], a disease that threatens 100 million people mostly in Africa," AFP/Dow Jones Newswires/CNN Money reports (7/1).Current Status Of The Development Programs Of New Indications And Formulations For Aricept(R) For Enhancing Patient Value
Eisai Co., Ltd. (Headquarters: Tokyo, President & CEO: Haruo Naito, "Eisai") and Eisai Corporation of North America (Headquarters: Woodcliff Lake, NJ, Chairman and CEO Hajime Shimizu) are currently focusing on three clinical development programs for the company's major product Aricept(R) (donepezil hydrochloride tablets) to further contribute to patients with Alzheimer's disease. As progress in those programs has been made, Eisai announces the status as follows: 1.Spanish Government Selects Novavax’s VLP Technology For Comprehensive Flu Vaccine Solution In Spain
Novavax, Inc. (Nasdaq: NVAX) announced its initial agreement to license its proprietary, recombinant virus-like-particle (VLP) vaccine technology to ROVI Pharmaceuticals (Madrid: ROVI) of Spain.FDA Approves Multaq(R) For Patients With Atrial Fibrillation Or Atrial Flutter
Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced that the U.S. Food and Drug Administration (FDA) has approved Multaq(R) (dronedarone) 400 mg Tablets. Patients with atrial fibrillation (AF) or atrial flutter (AFL) soon will have a new treatment option to help improve current management of their disease. Multaq(R) is the first drug approved in the United States that has shown a clinical benefit to reduce cardiovascular hospitalization in patients with AF/AFL.Acura And King Receive FDA Complete Response Letter Regarding Acurox(R)
Acura Pharmaceuticals, Inc. (Nasdaq: ACUR) and King Pharmaceuticals, Inc. (NYSE: KG) announced today that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter regarding the New Drug Application (NDA) for Acurox (oxycodone HC1, USP and niacin, USP) Tablets CII, an immediate release product intended for the relief of moderate-to-severe pain. The Complete Response Letter raises issues regarding the potential abuse deterrent benefits of Acurox(R).Lixte Biotechnology Holdings’ Lead Compound, LB-1.2, Enhances The Effectiveness Of Standard Cancer Chemotherapy In Animal Models
Lixte Biotechnology Holdings (OTC Bulletin Board: LIXT) announced that investigators of the National Institute of Neurological Disorders and Stroke (NINDS) and the National Cancer Institute (NCI), National Institutes of Health and Lixte reported that its novel compound, LB-1.2, enhances the effectiveness of two standard chemotherapy drugs in mouse models of human cancers. This research is being conducted under a Cooperative Research and Development Agreement between NINDS and Lixte.Drug Industry Increases Lobbying Efforts And Targets Democrats
The drug industry began ramping up its lobbying efforts in 2003, when Medicare Part D began, and now is targeting Democrats. CQ Politics reports: "The industry is increasingly employing Democratic lobbyists with ties to the Obama administration and congressional leaders such as Sen. Max Baucus, D-Mont., chairman of the Senate Finance Committee.Questions Linger Over Pharmaceutical Deal Agreement To Cut Costs
"As details emerge of the pharmaceutical industry's agreement to kick in $80 billion to help pay for health care reform, the deal is facing increasing skepticism from inside and outside the health care industry," Politico reports.Roche To Offer Developing Countries Discounted Tamiflu
The pharmaceutical company Roche on Wednesday announced a program to help ensure developing countries have access to its antiviral Tamiflu, for "the management of a novel influenza strain defined by the WHO as having significant and current pandemic potential," Reuters reports (Egenter, 7/1).Potential New Drugs: 970 Million And Still Counting - Journal Of The American Chemical Society
Like astronomers counting stars in the familiar universe of outer space, chemists in Switzerland are reporting the latest results of a survey of chemical space - the so-called chemical universe where tomorrow's miracle drugs may reside. The scientists conclude, based on this phase of the ongoing count, that there are 970 million chemicals suitable for study as new drugs.Peregrine Awarded European Patent For Innovative Labeling Technology Featured In New Study In The Journal Of Nuclear Medicine
Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM) today announced that it has been awarded a European patent for a novel device and methods for linking biological agents to labels for diagnostic and therapeutic applications. The technology, which is known as In-Line labeling, was developed for the production of radiolabeled anti-cancer antibodies, but is applicable to other agents as well.DeCODE-led Megastudy Finds New Genetic Clues To Causes Of Schizophrenia
The largest study of the genetics of schizophrenia ever undertaken has revealed several new common single-letter variants in the sequence of the human genome (SNPs) linked to risk of the disease. The study, by a multinational consortium of scientists led by a team from deCODE genetics (Nasdaq: DCGN), analyzed the genomes of more than 50,000 patients and control participants from fourteen countries. It is published today in the online edition of Nature.Calixa Therapeutics Announces Initiation Of Phase 2 Clinical Trial Of Its Antibiotic, CXA-101, In Patients With Complicated Urinary Tract Infections
Calixa Therapeutics Inc. today announced the initiation of a Phase 2 clinical trial of CXA-101 in patients with complicated urinary tract infections. CXA-101 is a new broad-spectrum, parenteral cephalosporin antibiotic with excellent in vitro and in vivo activity against Pseudomonas aeruginosa, including drug resistant isolates. Calixa is investigating CXA-101 as a potential treatment for serious bacterial infections in hospitalized patients.Cephalon Submits NUVIGIL Supplemental New Drug Application For The Treatment Of Excessive Sleepiness Associated With Jet Lag Disorder
Cephalon, Inc. (Nasdaq: CEPH) announced that it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) requesting approval of NUVIGIL(R) (armodafinil) Tablets [C-IV] for the indication of improved wakefulness in patients with excessive sleepiness associated with jet lag disorder resulting from eastbound travel.PROLOR Biotech Awarded Two U.S. Patents For Its Longer-Acting Human Growth Hormone And Longer-Acting Erythropoietin
PROLOR Biotech, Inc. (OTC Bulletin Board: PBTH), formerly Modigene Inc., announced that the U. S. Patent and Trademark Office (PTO) has issued two new patents for the company's long-acting CTP-enhanced human growth hormone (hGH-CTP) and human erythropoietin (EPO-CTP). The patents cover the composition of PROLOR's proprietary pharmaceutical compounds as well as certain associated methods.Amira Pharmaceuticals Announces Initial Positive Phase 1 Clinical Data For AM211, A Novel Product Candidate For The Treatment Of Respiratory Diseases
Amira Pharmaceuticals, Inc. announced initial positive data from a Phase 1 clinical study of AM211, the company's oral selective antagonist of the DP2 (also known as CRTH2) receptor. The interim results demonstrate that a sustained pharmacodynamic (PD) effect can be achieved with a single dose of AM211. The pharmacokinetic profile indicates safety multiples as compared to exposures observed in safety species.Teva Reveals “Man on the Street” Wants Lower Healthcare Costs. Surprised?
Teva Pharmaceuticals USA, a wholly-owned subsidiary of Teva Pharmaceutical Industries Ltd., is making a full-court press on getting the word out on the need for follow-on biologics. In its “Year of Affordable Healthcare” campaign, Teva is putting put together videos to argue for generics, just as the White House is making its position known on the need for biogenerics (read: need for lower costs).
The program commemorates the 25th anniversary of the Waxman-Hatch Act which created the modern generic drugs industry and features videos that ask the “man on the street” in Washington, D.C. what they think about healthcare in the U.S. It wouldn’t take the Amazing Kreskin to guess that people want lower healthcare costs. It’s a thorny issue with some biotech therapies costing as much as $500,000 annually.
See more here.
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Maximizing Pharmaceutical Patent Lifecycles
The American Conference Institute’s Maximizing Pharmaceutical Patent Lifecycles, the 10th Anniversary Edition will be held at the Helmsley Park Lane Hotel, New York, New York, on Wednesday, October 7, 2009 to Thursday, October 8, 2009.
Overview
This 10th American Conference Institute event on Maximizing Pharmaceutical Patent Life Cycles will bring you the thoughtful and targeted commentary and in-depth analysis that you have come to expect from this industry leading conference. This year’s conference will help you prepare for the sweeping changes currently underway by providing you with:
- Focused panels on the pending Follow-On Biologics and Patent Reform legislation that will allow you to assess how both legislative proposals will impact pharmaceutical patent life cycle management
- Access to key officials from the FTC’s Bureau of Competition’s Health Care Division and the EC’s DG Competition’s Pharmaceuticals Task Force who will provide you with direct insights into the logic of these agencies on some of the most pressing antitrust matters currently affecting the industry
- An in-depth review of new FDA determinations regarding exclusivity, forfeitures, patent listing and delistings and strategies for incorporating these guidelines into your initial life cycle management plan
- Analyses of key cases that have affected patent life cycle strategies and tips for using these rulings to your advantage
Also, this year they have added the following specialized class:
Hatch-Waxman Boot Camp – A Primer on IP Basics and Regulatory Fundamentals
This Boot Camp, together with in-depth Master Classes for brand names and generics on:
- New Strategies for Obtaining Pharmaceutical Patent Extensions in a Post-KSR World
- Updated Drafting Guidelines for Paragraph IV Certifications and Notice Letters
will offer hands-on practical advice on core Hatch-Waxman principles as well as some of the most critical day–to–day concerns for both sides of the pharmaceutical industry.
Nearly 2,000 pharmaceutical patent professionals – for both brand names and generics – have made this conference their source of information for the legal issues surrounding life cycle management for nearly the last ten years.
Register today to reserve your place at this timely event by calling 888-224-2480, faxing your registration form to 877-927-1563 or registering on-line.
Let me know if you are interested in attending, anyone who attends the conference as a referral from Patent Baristas is entitled to $200 off the registration price. Just drop me a line for the keycode.
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Is FDA Picking Up the Regulatory Pace?
It seems early in the oversight of the new FDA Commissioner and Deputy Commissioner to the agency turning a corner, or maybe not.
There have been two indications of possible increased enforcement that have emerged in the past few days that lead one to at least wonder if the FDA is getting more serious about enforcement.
First, as mentioned in the Weekly Roundup on Friday, Caraco Pharmaceuticals experienced a seizure by U.S. Marshalls of product. This occurred after a long period of regulatory interaction.
Second, in the same week, the FDA issued a Notice of Intent to Revokethe biologics manufacturing license to Immucor regarding a facility in Georgia, also following regulatory interactions.
Regulatory actions take time to organize and move in the bureacratic machinery and it could be that these efforts were in the works for a while and it is perhaps too early to determine if the FDA is picking up the regulatory pace. But if we start seeing Consent Decrees, then we may be in fact seeing a sea change in enforcement.
