Tag: FDA

Omnix Medical Receives U.S. FDA Approval of a Phase II Trial of its Next-Generation Anti-Infective OMN6

– Phase I data show safety and tolerability at clinically significant dose levels

– New class of anti-infectives to treat infections with Gram-negative bacteria

Omnix Medical, a biopharmaceutical company developing next-generation anti-infectives for the treatment of life-threatening infections, today announced that the U.S. Food and Drug Administration (FDA) has approved a planned Phase II trial of the Company´s novel anti-infective OMN6.

Read more…

Company News: Anergis Reaches Important Milestones with Second Product Candidate AllerR

– US Regulatory path for new vaccine against ragweed pollen allergies established –

Anergis, a company developing breakthrough allergy vaccines for fast and safe allergen-specific immunotherapy, reported today that it has reached several preclinical development milestones with AllerR, a novel allergy vaccine candidate for the treatment of patients with allergies to ragweed pollen. In addition, the company received positive feedback from the FDA on its AllerR development program.

In the development of AllerR, its second allergy vaccine candidate, Anergis reached essential preclinical milestones and held its first meeting with the US FDA in preparation for  the first clinical trial of AllerR in patients allergic to ragweed pollen.

In preclinical experiments carried out by Anergis, binding of the AllerR peptides to IgE antibodies of allergic patients remained consistently undetectable in all conditions tested. In mice pre-sensitized to ragweed pollen, AllerR, unlike natural ragweed allergens, did not elicit an anaphylaxis-like response. And, importantly, AllerR was found to elicit antibody responses in mice, in which the antibodies recognized the natural ragweed allergens. Following collection of these data, Anergis held a pre-IND meeting with the U.S. FDA during which the regulatory path was clearly established until and including the clinical Phase I trial protocol.

akampion Meets…. Victoria English, Co-Founder and Editor of MedNous

In 2006, long-time journalists Victoria English and William Ellington decided to quit their jobs and to establish their own publication, the biomedical trade journal MedNous (pronounced Med-Nows). A year later, in September 2007, the first issue appeared alongside with the website www.mednous.com.

akampion: Why did you establish MedNous?

Victoria English: Both of us thought Europe’s very innovative life science industry needed better communication. Back then, everyone was thinking in clusters and areas, and we felt by connecting the dots we could support the industry in its efforts to increase efficiency. Second, at that time the European Commission and the EMEA were very worried about the decreasing productivity of the biopharmaceutical industry, and Europe developed the Innovative Medicines Initiative, similar to the FDA’s Critical Path policy. This, too, called for better collaboration, and we wanted to capture this shift in official politics to encourage collaboration and translation of discoveries into products. Third, after working for many years in big corporations such as Reuters, DowJones, McGraw Hill and Informa, I thought it is time to start my own company.

akampion: What kind of preparations were necessary?

V. E.: After quitting our jobs we spent about 12 months to set up a website and a database, before we the first issue went out. During that time, we looked at every single bio-cluster in Europe and its member companies. Our database entries are updated ever since on a regular basis.

akampion: What exactly is MedNous focusing on?

V. E.: Originally, we focused on genetic therapy and stem cell therapy as we thought these were the most innovative areas and because no one else was writing about it. But it soon became obvious that these technologies were not that advanced as we thought, so we added other areas as well. Now we report about all companies developing products that will be regulated under the centralized procedure of the EMEA, plus projects validated by either venture capital funding or pharma collaborations. In fact, some companies emerge on our radar screen only after a huge financing.

akampion: How do you work?

V. E.: We do interviews on the phone, but for bigger stories we travel to the companies to get a first-hand impression. We also visit conferences. We are very interested in data, of course, but our key interest is answering questions like “what is the management like?”, “what is their strategy?”, “what have been their failures and successes?”

akampion: What does it take to fund a publication?

V. E.: You need to have capital, an interest in marketing and the business side. Luckily, we were able to finance the start ourselves, and now the company is generating revenues from subscriptions. And of course you need to adapt your technology all the time to spread the word. As an example, RSS feeds increasingly lost their importance – now it is all about Twitter and other social networks.

akampion: You still stick to a publication printed on paper. Why is that?

V. E.: Simply because we want to have an impact by providing a product that allows for a comprehensive view, which we think is valuable to the industry. For this reason we have also chosen not to break it down to single articles that can be purchased. We do, however, provide a PDF version of each issue.

akampion: You established an editorial board for MedNous. Why?

V. E.: We want to add some depth to our editorial coverage. So we take advice from the board on topics to write about, and we also ask members of the board to review our interviews before publication. Neither William nor I are scientists. We keep to the time-honored journalistic practice of maintaining independence from our sources, e. g, the people we interview do not vet articles about themselves. Yet we recognize that we need advice on some of the technical aspects. Members of the editorial board provide this advice. They are active and very valuable contributors.

akampion: How many people are working at MedNous?

V. E.: Currently we employ six people, including a contributing editor, web and production editors, proofreaders, etc.

akampion: What is your take on the European sector right now?

V. E.: In my view, Europe has a big competitive advantage over the US: the European healthcare systems may be diverse, but all are built on some kind of reimbursement and this guarantees a much closer look at the patient benefits of new medicines. So in this respect, feedback is much better and this will lead to products better serving the need of patients.

akampion: Do you still have time to do other things?

V.E.: Running a publication is a job that needs your attention most of your days, including the weekends. But I do enjoy visiting the British Library to read and I take modern dance and tap dance classes. In addition, I also help manage a number of community organizations including our local community center where I am a trustee.

Food for Thought: Trade Media Update

MedNous this week opens up with an article on FDA’s revoking the breast cancer indication for Avastin, saying that the decision did not come as a surprise after the FDA’s Oncologic Drugs Advisory Committee (ODAC) in June voted unanimously to have the indication removed. Avastin had been subject to FDA’s accelerated approval process in this indication.

In contrast, BioCentury Extra reports that FDA encouraged Genentech Inc to continue to study the drug in this indication to identify patients who may benefit and also details Genentech’s plans for Avastin in this indication. It also writes that in the previous months, the National Comprehensive Cancer Network (NCCN) continued to recommend Avastin as an option in breast cancer despite the negative ODAC vote.

The In Vivo Blog comments on the Avastin decision by saying that it introduced some predictability into the accelerated approval regulatory pathway. Companies should continue to use progression-free survival as a surrogate endpoint but not forget to that FDA has some expectations, e.g. for quality of life benefits, and that sponsors should design trials with supportive measures that can themselves turn into additional claims.

BioCentury this week in its cover story reports on the next-generation, interferon-free treatment regimes for HCV which have been in the focus of the recent Liver Meeting of the American Association for the Study of Liver Diseases (AASLD), stating that the new standard of care introduced only this year  following the approval of two HCV protease inhibitors, may be supplanted quickly by new regimes that are tailored to virus subtypes and patient populations.

SciBx is focusing on novel small molecule inhibitors of Monoacylglycerol lipase (MAGL), which regulates the levels of several compounds that signal through the endocannabinoid pathway. However, now that researchers have shown that it MAGL inhibitors reduce neuroinflammation, there is increased interest in the industry in these inhibitors. MAGL also is explored as a cancer target as reported by Derek Lowe in its “In the Pipeline” blog.

SCRIP this week deals with plans of the French health ministry to collect more than €290 million for the pharmaceutical industry in 2012 to reduce health care spending. In addition, it reports on plans to widening the tax on pharmaceutical industry promotion.In its editorial, SCRIP focuses on German media trying to scandalize the deaths attributed to Boehringer Ingelheim’s Pradaxa drug (see the akampioneer).

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