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Post by a1nb2p on Jul 26, 2014 21:37:28 GMT -5
Interesting article published last night on Newstimes.com (local Danbury, CT online newspaper) about the jobless rate in the state, with a little ditty on Mannkind: "MannKind Corp., a biopharmaceutical company that has been in Danbury for the last seven years, is seeking city approval for new land to increase the size and scope of its facility. "It's reclaiming a brownfield and waiting for approval on a drug from the FDA," Bull said. "The new drug will be used to treat different types of breathing problems. If that's approved, the company will be ramping up employment and hiring over 200 people." www.newstimes.com/business/article/State-s-lowest-jobless-rate-5648210.php
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Post by seanismorris on Jul 26, 2014 22:33:22 GMT -5
The mention of Mannkind in the article is a bit confusing. I think the FDA reference is to Belimo Air Control USA Inc., and not Mannkind. Mannkind may very we'll be looking for land to expand the Danbury facility, but we need confirmation before we get to excited. If true, this is very bullish news assuming the new building is for factory space and not a place for a marketing staff, etc.
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Post by seanismorris on Jul 26, 2014 22:42:59 GMT -5
Mannkinds job search for the last four days -lots of Quality Control personnel Sr. Supervisor - QC MannKind - Danbury, CT MannKind Corporation is currently seeking Supervisor/Sr. Supervisor, Finished Product to develops, implements and maintains the activities of Quality Control systems. Oversees... 4 days ago from MannKind Corporation Save - Share - Hide - Report - Description QC Associate - Raw Materials MannKind - Danbury, CT MannKind Corporation is currently seeking Raw Materials Associate, Quality Control to provides general support and maintain quality control systems within the company. Ensures... 4 days ago from MannKind Corporation Save - Share - Hide - Report - Description QC Associate - Product Testing MannKind - Danbury, CT MannKind Corporation is currently seeking Product Testing Associate, Quality Control to provides general support and maintain quality control systems within the company. Ensures... 4 days ago from MannKind Corporation Save - Share - Hide - Report - Description QC Associate - Microbiology MannKind - Danbury, CT MannKind Corporation is currently seeking Microbiology Associate, Quality Control to provides general support and maintain quality control systems within the company. Ensures that... 4 days ago from MannKind Corporation Save - Share - Hide - Report - Description QC Supervisor – Raw Materials MannKind - Danbury, CT MannKind Corporation is currently seeking Supervisor, Raw Materials to develops, implements and maintains the activities of Quality Control systems. Oversees development and... 4 days ago from MannKind Corporation Save - Share - Hide - Report - Description QC Associate – Stability MannKind - Danbury, CT MannKind Corporation is currently seeking Stability Associate, Quality Control to provides general support and maintain quality control systems within the company. Provides... 4 days ago from MannKind Corporation Save - Share - Hide - Report - Description Full list www.simplyhired.com/search?q=Mannkind&l=Danbury%2C+CT
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Post by babaoriley on Jul 26, 2014 23:45:11 GMT -5
The obesity drugs are just not that great, if you stand 5'10' and weigh 300 lbs, take a drug and shed 8%-10% of your weight, guess what, you're still very obese! And, there are some real side effects to those drugs, as I understand it. Now, if a 300 lb guy could get down to 200 lbs, or a 200 lb woman to 140, you'd have something that a whole lot of people would be willing to take a risk for.
Goes without saying that Afrezza is very different. Plus, there's only one Afrezza, and there are at least two weight drugs.
Doctors will wait and see - sure, some will, but many won't. And those that do, will find their patients telling them, "put me on this now."
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Post by seanismorris on Jul 29, 2014 19:03:13 GMT -5
I knew it.
Ignore the nurses at your peril!!!
JULY 28, 2014
Lack of marketing partner delays Afrezza launch No marketing; no money. It's been four weeks since the approval of MannKind's novel inhalable insulin, Afrezza, and the company has yet to find a marketing partner. The drug's failure to launch illustrates the difficulties in post-approval market access—even with an innovative product.
After 10 years jumping through regulatory hurdles (which included two outright rejections), Afrezza's approval was greeted by some as the inflection point MannKind needed for its fast-acting insulin. And while the rapid-acting segment has not been as successful as the long-acting insulins (Sanofi's Lantus is the best-selling diabetes drug), MannKind expected Afrezza's unique mechanism of action to grow the pie—especially with diabetes prevalence on the rise.
As the deadline for MannKind's second-quarter earnings call approaches, though, pressure is mounting on the firm to announce a launch partner. Afrezza faces entrenched competition in Novo Nordisk's NovoLog and Eli Lilly's Humalog. NovoLog and Humalog brought in $1.4 billion and $1.2 billion in US sales last year, respectively.
Some members of the analyst community have already doomed Afrezza's commercial chances. Their standard reference case is Pfizer's Exubera—the first inhalable insulin to be approved. While many remember a similar level of excitiment around it, Exubera was pulled from the market in 2008 after less than one year due to poor sales, and scattered cases of cancer in clinical trials.
To lay Pfizer's faults at the feet of MannKind, however, is reductive at best. Jami Rubin, at the time an analyst with Goldman Sachs, characterized the drug's launch simply as “poor marketing.”
"I think Pfizer felt that the drug would sell itself," Rubin stated. "Samples were sparse, the TV ads were late, and they were too benign and not exciting. They did not court the nurses, the certified diabetic educators, who play an even bigger role than physicians in deciding to put patients on insulin. They ignored them."
And not only was the earlier drug saddled by irrelevant messaging, the inhaler's shape and size was oft-described as unwieldy and “bong-like." Afrezza, by contrast, touts a much smaller device (pictured above).
Another commonly cited reservation for Afrezza is the drug's warning label. Its black-box warning, the most severe kind, cautions that difficulty breathing was observed in patients with a history of asthma and COPD. But it's unlikely MannKind would market the drug to people with either condition.
There is one warning, though, which may seem to be more of a pitfall to a potential co-marketer. Before receiving Afrezza, patients must receive a lung test—which in and of itself doesn't seem too difficult. But patients must also get a follow-up lung test, “after the first six months and annually thereafter,” even if they aren't experiencing symptoms.
While these factors may or may not be what's keeping commercial partners at arm's length, what is clear is that without a big pharma company to hitch its drug to, Afrezza may never get properly out of the gate.
Out of the three big names in diabetes—Eli Lilly, Novo Nordisk and Sanofi—the latter, Sanofi, could have the most to gain from a co-promotion deal. While Eli Lilly and Novo Nordisk both already sell blockbuster fast-acting insulins, sales of Sanofi fast-acting mealtime insulin Apidra lag behind its competitors in the category.
Paris-based Sanofi also has the best-selling diabetes drug in the world in Lantus and knowledgeable reps who have helped it attain that lofty perch.
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Post by Chris-C on Jul 29, 2014 19:09:59 GMT -5
I suspect the company is in the period before an announcement where they cannot respond, which allows the bashers to have a field day. Scumbags!
Chris
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Post by seanismorris on Jul 29, 2014 19:21:12 GMT -5
This article is about LASIK and the FDA, but the conclusion is interesting 'the industry (drug & device manufactures) owns the FDA'...we saw something similar with Afrezza. If there was no ADCOM would Afrezza ever have been approved? This is something to think about when investing in biotech. --------piece of article FDA told Waxler that his allegations that laser manufacturers had withheld and distorted safety data in their marketing applications and had pressured FDA to classify post-LASIK surgery glare, halos, dry eye and night driving difficulties as “symptoms” instead of the more serious term “adverse events” lacked sufficient support. On July 22, Waxler plunged onward, filing a petition for reconsideration in which he charged that FDA “grossly underestimates the risks of LASIK by conflating data used to legally support the [marketing approvals] with LASIK industry information used to promote sales.” In doing so, he wrote, FDA had sent two messages: that the LASIK industry could feel secure because “the agency has your back,” and that the public should beware because “FDA does not have your back.” Waxler told the agency that it had “made deals” with the LASIK industry that “degraded the scientific quality of the collection and analysis of adverse event data of LASIK devices.” He listed alleged deals with the following entities: Kremer Laser, American Society for Cataract and Refractive Surgery, CRS Inc., and more than 100 user facilities that he says received IDEs “to study LASIK in order to minimize their exposure to violating off-label rules.” Waxler is sanguine about his chance of changing minds at FDA: “The industry owns them,” he says. --------- Link to full article www.mmm-online.com/in-sunny-world-of-lasik-marketers-a-dark-underbelly/article/363200/
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Post by lynn on Jul 29, 2014 22:06:27 GMT -5
@ Seanismorris , Regarding your comment re : ignore Nurses at your peril ,) I hope that Nurses will play a big part helping patients get on Afrezza , these days the Docs & Nurses work more as a team , we're the ones who spend the most time with our patients & we advocate for them , in my unit when the Docs round they typically ask us if there's anything we need and they usually listen to our suggestions my specialty is not dealing with Adults but I'd hope that it works that way in other specialties as well , at least in the hospital environment . Not sure about clinics but maybe someone else has input . Lynn
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Post by coco on Jul 30, 2014 1:03:00 GMT -5
I totally agree. Doctors and nurses work in a collaborative effort for the patient. To disregard nurses input would be wrong.I have doctors ask me all the time what I think. Also sometimes we give suggestions that doctors take very seriously. Coco
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Post by seanismorris on Jul 30, 2014 1:17:25 GMT -5
Lynn & Coco
I have nothing but respect for nurses, they are glue that holds the system together. Nurses pay, in no way reflects their contribution to medicine.
I found it very interesting that when looking at why Exubera failed, failure to reach out to nurses were mentioned specifically. This observation, in my mind gives the author greater credibility.
I also think, Mannkind has already demonstrated greater awareness of the market for inhaled insulin (than Pfizer ever did) when they had several diabetes association present (and support) at the ADCOM. Whenever I hear the Short argument that Afrezza is going to fail because Exubera failed, all I have to do in recall the ADCOM (and the people/groups present).
I'll be watching closely when the partner is announced, to make sure it's one that's already successfully marketed diabetes treatments to the different groups - Doctors, Nurses, Pharmacists, etc. and not just a consumer (patient) focused mentality.
If the partner turns out to be Pfizer....SELL
Fortunately, Al is smarter than that ; )
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Post by brentie on Jul 30, 2014 18:25:56 GMT -5
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Post by lynn on Jul 30, 2014 20:10:52 GMT -5
For Lynn and Coco... Afrezza: Inhaled Insulin for Treating Diabetes: www.nursingjobs.org/blog/afrezza-inhaled-insulin-for-treating-diabetes.htmRead more: mnkd.proboards.com/thread/970?page=9#ixzz390DFz7CrSorry Liane & BD , I did this from my phone & know I did it wrong ./ Anyways , Brentie the thought briefly crossed my mind to change careers as I spent many years in sales prior to becoming a RN & as an RN I know I could sell the heck out of Afrezza ! But I absolutely Love my Job !! & could never leave the babies behind , I am blessed to work in a world where we witness miracles on a daily basis ( yes we also have bad days but the good out weigh the bad ) There's nothing like seeing an ex 1 pound 24 weeker go home w/ mom & dad healthy several months later , it's a long journey but those are PRICELESS moments & I can't imagine doing anything else But since Coco might be retiring soon if MNKD goes Boom !! She may be open to some easy PT work ,) as I can't imagine anything easier to sell than Afrezza !! As I've said before between Social Media & word of mouth , this will sell itself & nice to see the new YMB peeps over here , I've followed all of you over there only bc of the handful of quality posters , no offense but this is my favorite board GLTA Lynn
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Post by joeypotsandpans on Jul 30, 2014 20:24:02 GMT -5
Hey Brentie, that cat in your avatar sure looks like it could use some inhalable seizure medication
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Post by ralphm1999 on Jul 30, 2014 22:34:40 GMT -5
Not sure if this has already been posted. Another great article by Dr. Hung V. Tran: tinyurl.com/noydbke
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Post by thekindaguyiyam on Jul 30, 2014 23:33:33 GMT -5
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