i worked in blown insulation and my throat is swore and i am really itchy i dont know if it is serious. I didnt use any protection from inhelling the insulation.

OMG, why would you not wear protection especially knowing their is a disease which is caused by inhallation?

Incidentally, the wearing of a mask (and other protective clothing such as gloves) provided by your employer is compulsory under the Health and Safety at Work Act. by not wearing yours (the duration of the job is irrelevant) you have committed what's called 'contributory negligence'. this should have been pointed out to you during your induction into the job.

Most blown in now is cellulose and its safe to breath and touch with bare hands. if its fiberglass, then you will be itchy for a while. did you sneeze alot? when i use fiberglass i always end up sneezing tons. with the cellulose you won't sneeze.

Organisms need to alter body functions and behavior to accommodate seasonal changes in their environment. The measurement of day length is one obvious way of determining the time of year. To this end, the body uses its internal circadian clock, and against this background measures the extent and timing of light and dark.

The team noted that an increase in day length induces activity in the gene for thyroid stimulating hormone beta (TSHβ) in the pars tuberalis (PT) region of the pituitary gland. TSHβ plays a key role in the pathway that regulates photoperiodism in vertebrate animals. However, the detailed mechanism that links information about day length with induction of the production of TSHβ is unknown.

Masumoto, Ueda and colleagues found the genes that stimulate the activity of the TSHβ gene in mammals by observing the activity of genes in the PT of photoperiod-responsive mice under chronic ’short-day’ (eight hours of light) and ‘long-day’ (16 hours) conditions. they identified 57 genes stimulated by short days and 246, including TSHβ, by long days.

Then, the researchers placed chronic short-day mice into a long-day regime—they switched off the lights eight hours later—and observed that it took five days for TSHβ to become fully active. they could, however, stimulate full activity of TSHβ within a single 24-hour period if they subjected the mice to a short burst of light during a sensitive ‘photo-inducible’ period late at night. Thirty-four other long-day genes responded in the same way, including the transcription factor, Eya3, which seemed a likely candidate for regulating TSHβ activity. In laboratory studies, the researchers determined that Eya3 and its partner binding factor Six1 do indeed act together to activate TSHβ. And this activity is enhanced by two other genes, Tef and Hlf.

“we are next planning to identify the upstream gene of Eya3,” Ueda says. “And we are also hoping to elucidate why the photo-inducible phase is late at night.”

Posted on: Tuesday, 30 November 2010, 15:34 CST

SAN DIEGO, Nov. 30, 2010 /PRNewswire/ — Prometheus Laboratories Inc., a specialty pharmaceutical and diagnostic company, announced today that it has extended its distribution agreement with AstraZeneca LP for the exclusive marketing, sales and distribution of ENTOCORT® EC (budesonide) Capsules in the United States until December 31, 2011. ENTOCORT EC is the only FDA-approved drug for the induction and maintenance of clinical remission in mild to moderate Crohn’s disease involving the ileum and/or the ascending colon. ENTOCORT EC is indicated for the treatment of mild to moderate active Crohn’s disease involving the ileum and/or the ascending colon (up to 8 weeks with repeated 8-week courses as necessary for recurring episodes of active disease), and the maintenance of clinical remission of mild to moderate Crohn’s disease involving the ileum and/or the ascending colon for up to 3 months. Clinical remission is defined as a Crohn’s Disease Activity Index (CDAI) score of < 150.

“We are extremely pleased that we are able to continue to build upon our Gastroenterology franchise with our promotion and distribution of ENTOCORT EC through 2011,” said Joseph M. Limber, President and Chief Executive Officer of Prometheus. “Prometheus’ long-standing commitment to help patients suffering from Crohn’s disease manage their disease includes ENTOCORT EC, our IBD Serology 7 diagnostic test, as well as our recently launched proprietary Crohn’s Prognostic test, the first ever serogenetic prognostic test for Crohn’s disease.”

The original distribution agreement included a six-year exclusive term ending December 31, 2010. AstraZeneca will continue to supply the product to Prometheus and be responsible for all manufacturing, clinical and regulatory processes relating to the product. AstraZeneca launched ENTOCORT EC Capsules in November 2001.

ENTOCORT EC is the only FDA-approved drug for the induction and maintenance of clinical remission in mild to moderate Crohn’s disease involving the ileum and/or the ascending colon. ENTOCORT EC consists of an encapsulated formulation of budesonide granules, a glucocorticosteriod. the granules are coated to protect dissolution in gastric juice, but dissolve at pH >5.5, normally when the granules reach the duodenum. thereafter, a matrix controls the release of the drug into the intestinal lumen in a time-dependent manner. eighty to ninety percent of ENTOCORT EC does not enter the systemic circulation. ENTOCORT EC may reduce the incidence of some corticosteroid-associated side effects such as acne and moon face compared to prednisolone.(1)

Important Safety Information

Since ENTOCORT® EC (budesonide) Capsules is a glucocorticosteroid (GCS), general warnings about GCSs should be followed. GCSs can reduce the response of the hypothalamus-pituitaryadrenal axis to stress. Supplementation with a systemic GCS is recommended before surgery or other stress situations.

Adrenocortical function monitoring may be required in patients being transferred to ENTOCORT EC from a systemic GCS, and the dose of the systemic GCS should be reduced cautiously.

Patients on drugs that suppress the immune system are more susceptible to infections, which may be more severe, and should avoid exposure to infections such as chicken pox or measles.

Caution should be taken in patients with tuberculosis, hypertension, diabetes mellitus, osteoporosis, peptic ulcer, glaucoma or cataracts, or with a family history of diabetes or glaucoma, or with any other condition where GCSs may have unwanted effects.

Reduced liver function affects the elimination of GCSs, and increased systemic availability of oral budesonide has been observed in patients with liver cirrhosis. Patients with moderate to severe liver disease and patients who are concomitantly taking ketoconazole or any other CYP3A4 inhibitor should be closely monitored for increased signs and/or symptoms of hypercorticism. Reduction in the dose of ENTOCORT EC should be considered in these patients. Patients should be advised to avoid consuming grapefruits and grapefruit juice while being treated with ENTOCORT EC.

Safety and effectiveness in pediatric, geriatric, and pregnant patients have not been established. ENTOCORT EC should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Hypoadrenalism may occur in infants born of mothers receiving corticosteroids during pregnancy.

Budesonide is secreted in human milk. A decision should be made whether to discontinue nursing or to discontinue ENTOCORT EC, taking into account the clinical importance of ENTOCORT EC to the mother and the potential for serious adverse reactions in the nursing infant.

The adverse event profile of ENTOCORT EC in 6 mg once daily clinical trial treatment (52-week) was similar to that of 9 mg daily clinical trial treatment (8-week). the most frequently reported adverse events in clinical trials with ENTOCORT EC were headache, respiratory infection, nausea, and symptoms of hypercorticism.

Please see full Prescribing Information for ENTOCORT EC.

About Crohn’s Disease

Crohn’s disease is an inflammatory bowel disease. it is a chronic disorder that causes inflammation of the digestive or gastrointestinal tract. the inflammation caused by Crohn’s disease is usually found in a part of the small intestine called the ileum and in the large intestine (colon). Symptoms of the disease include diarrhea, abdominal pain, fever, rectal bleeding, appetite loss, and weight loss. Symptoms may range from mild to severe. there is no known cure for Crohn’s disease. Crohn’s patients may require long-term medical care, including multiple hospitalizations, surgeries and therapeutics. the condition can be difficult to manage clinically.

About Prometheus

Prometheus Laboratories Inc. is committed to improving lives through the development and commercialization of novel pharmaceutical and diagnostic products that enable physicians to provide greater individualized patient care. Prometheus is a leader in applying the principles of personalized medicine to the diagnosis and treatment of gastrointestinal diseases and is applying these principles to oncology. Its strategy includes the marketing and delivery of pharmaceutical products complemented by proprietary diagnostic testing services. By integrating therapeutics and diagnostics, Prometheus believes it can provide physicians with more targeted solutions to optimize care for their patients. Prometheus’ corporate offices are located in San Diego, California.

(1) ENTOCORT® EC (budesonide) Capsules Prescribing Information

SOURCE Prometheus Laboratories Inc.

More News in this Category

NDA filing planned in second half of 2011 following completion of extended use study

Conference call to begin at 4:30 p.m. Eastern time today

SAN DIEGO–(BUSINESS WIRE)–Santarus, Inc. (NASDAQ:SNTS), a specialty biopharmaceutical company, today announced positive top-line results from a second Phase III clinical study evaluating the safety and efficacy of budesonide MMX® for the induction of remission of mild or moderate active ulcerative colitis. The study results show that budesonide MMX 9 mg taken once daily met the primary endpoint of superiority to placebo (p=0.0047) in achieving clinical remission as measured by the ulcerative colitis disease activity index (UCDAI) score after eight weeks of treatment. this second budesonide MMX Phase III clinical study was conducted in Europe in collaboration with Cosmo Technologies Ltd., a subsidiary of Cosmo Pharmaceuticals.

“we plan to submit a new Drug Application to the U.S. Food and Drug Administration (FDA) in the second half of 2011, following completion of an extended use study.”

“Positive top-line results from the European Phase III study are consistent with those from the U.S. Phase III study that we announced in late September. both studies indicate that the higher, 9 mg dosage strength of budesonide MMX was statistically superior to placebo for the induction of remission of mild or moderate active ulcerative colitis,” said Gerald T. Proehl, president and chief executive officer of Santarus. “We plan to submit a new Drug Application to the U.S. Food and Drug Administration (FDA) in the second half of 2011, following completion of an extended use study.”

as specified in the statistical analysis plans that were submitted to the FDA for both Phase III studies, a p-value of 0.025 was required to achieve statistical significance for the comparison of each budesonide MMX dosage strength (9 mg and 6 mg) with placebo.

The intent-to-treat (ITT) population was pre-defined in the statistical analysis plan as all randomized patients who received at least one dose of a study drug, excluding patients with normal histology at baseline as determined by biopsy, Good Clinical Practice (GCP) violations or major entry criteria violations.

Based on the preliminary analysis, the remission rates for the four treatment groups in the ITT population are summarized in the table below (the p-values correspond to the statistical comparison of remission rates in the three active treatment groups with placebo):

Treatment Arm

Number of Patients

Patients in Remission (%)

p-value

Budesonide MMX 9 mg   109   19 (17.4%)   0.0047* Budesonide MMX 6 mg   109   9 ( 8.3%)   Entocort®EC (budesonide) reference arm(a)   103   13 (12.6%)   Placebo   89   4 ( 4.5%)      

*Statistically significant vs placebo at p=0.025

**Statistically significant vs placebo at p=0.05

(a)Not powered to show a statistical difference between budesonide MMX treatment arms and Entocort EC

please refer to Santarus’ Current Report on Form 8-K filed today with the Securities and Exchange Commission for additional information on the European budesonide MMX Phase III clinical study results.

Safety

The top-line study results indicate that budesonide MMX 9 mg and 6 mg were generally well tolerated and the frequency of treatment related adverse events was similar across all treatment groups.

Budesonide MMX Phase III Study Design

Budesonide MMX was evaluated for the treatment of mild or moderate active ulcerative colitis in two Phase III clinical studies, both of which are intended to support U.S. regulatory submission. The primary endpoint was the achievement of clinical remission, defined as a UCDAI score ? 1 after eight weeks of treatment with a score of 0 for rectal bleeding and stool frequency, and ? 1 point reduction from baseline in the endoscopy score without any sign of mucosal friability (an indicator of mucosal inflammation).

Each clinical study was a multicenter, randomized, double-blind, double-dummy, placebo-controlled four-arm study.

• Study CB-01-02/02 was conducted in Europe and compared budesonide MMX 9 mg or 6 mg dosed once daily to placebo. a reference arm using three Entocort EC 3 mg capsules for a total of 9 mg dosed once daily was also included.
• Study CB-01-02/01 was conducted in the U.S. and India and compared budesonide MMX 9 mg or 6 mg dosed once daily to placebo. a reference arm using two Asacol® (mesalamine) 400 mg delayed-release tablets dosed three times a day for a total of 2400 mg daily was also included.

The Phase III clinical studies were powered to show a statistical difference between the two budesonide MMX treatment arms and placebo. The reference arms using Entocort EC in the European study and Asacol in the U.S. study were not powered to show statistical differences versus budesonide MMX.

Extended use Study Ongoing Through Second Quarter 2011

as previously reported, the FDA requested that the results from an additional 12-month extended use study be included in the Phase III clinical program to support a U.S. regulatory submission. this study is designed to:

• Evaluate the long-term safety and tolerability of budesonide MMX 6 mg, and
• Collect data on the efficacy of budesonide MMX 6 mg in the maintenance of remission of ulcerative colitis compared to placebo.

a total of 123 patients from the Phase III clinical studies in the U.S., India and Europe were enrolled in this double-blind, placebo-controlled extended use study, which is scheduled to be completed in the second quarter of 2011.

Achievement of Clinical Milestone

Based on the results of the U.S. and European Phase III clinical studies, Cosmo is entitled to receive a $3.0 million milestone payment, payable in cash or through issuance of shares of Santarus’ common stock, at Cosmo’s option, subject to certain limitations.

Conference Call

Santarus has scheduled an investor conference call at 4:30 p.m. Eastern time (1:30 p.m. Pacific time) today, November 8, 2010 to discuss this announcement and the company’s third quarter 2010 financial results. Individuals interested in participating in the call may do so by dialing 888-803-8275 for domestic callers, or 706-643-7736 for international callers. a telephone replay will be available for 48 hours following conclusion of the call by dialing 800-642-1687 for domestic callers, or 706-645-9291 for international callers, and entering reservation code 17860587. The live conference call also will be available via the Internet by visiting the Investor Relations section of the company’s website at santarus.com and a recording of the call will be available on the company’s website for 14 days following the completion of the call.

About Budesonide MMX

Budesonide MMX is an investigational drug that is a locally acting corticosteroid in a novel, patented, oral tablet formulation, which utilizes Cosmo’s proprietary MMX® multi-matrix system technology and is designed to result in the controlled release and distribution of budesonide throughout the length of the colon. Budesonide has topical anti-inflammatory activity and due to an extended first pass effect, has less systemic absorption than other corticosteroids.

About Ulcerative Colitis

Ulcerative colitis is a form of inflammatory bowel disease (IBD) that produces inflammation and ulcers along the inside of the colon. The inflammation can interfere with the normal function of the colon, often causing cramping, bloating, diarrhea, bleeding, fatigue, weight loss and frequent bowel movements, which may also strongly affect quality of life. it is believed that as many as 1.2 million people in the U.S. have IBD.

Ulcerative colitis is a chronic relapsing-remitting illness for which there is no known cure, but with appropriate treatment patients can manage their symptoms. However, it is estimated that up to 30% of patients with mild or moderate ulcerative colitis require add-on therapy to aminosalicylate (5-ASA) drugs. Patients refractive to treatment with 5-ASA drugs typically receive a course of an oral, systemically absorbed corticosteroid, the success of which may be limited by significant side effects. for moderate to severe cases of ulcerative colitis, immunosuppressant drugs or biologic drugs may be prescribed. if the condition does not respond to pharmaceutical therapy and the symptoms are severe, the patient may be referred for surgery.

About Santarus

Santarus, Inc. is a specialty biopharmaceutical company focused on acquiring, developing and commercializing proprietary products that address the needs of patients treated by physician specialists. The company’s current commercial efforts are focused on GLUMETZA® (metformin hydrochloride extended release tablets) and CYCLOSET® (bromocriptine mesylate) tablets, which are indicated as adjuncts to diet and exercise to improve glycemic control in adults with type 2 diabetes. The company expects to commercially launch CYCLOSET in November 2010.

Santarus also has a diverse development pipeline with three late-stage product candidates in Phase III clinical programs: budesonide MMX® for induction of remission of active ulcerative colitis, rifamycin SV MMX® for treatment of travelers’ diarrhea and RHUCIN® (recombinant human C1 inhibitor) for treatment of acute attacks of hereditary angioedema. in addition, Santarus plans to initiate a Phase I clinical study in the first half of 2011 with SAN-300, its anti-VLA-1 antibody, which the company expects to investigate for the treatment of rheumatoid arthritis. More information about Santarus is available on the company’s website at santarus.com.

Santarus cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. these forward-looking statements include statements regarding the timing of the completion of the extended use study and the U.S. NDA submission for budesonide MMX. The inclusion of forward-looking statements should not be regarded as a representation by Santarus that any of its plans or objectives will be achieved. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in Santarus’ business, including, without limitation: Santarus’ ability to successfully develop its budesonide MMX and other product candidates in a timely manner or at all (including timely and successful completion of the budesonide MMX extended use study); whether Santarus is able to obtain regulatory approval for budesonide MMX and its other product candidates in a timely manner or at all, including whether the FDA agrees with the statistical analysis plan for the budesonide MMX Phase III studies, the clinical interpretation of the results and the conduct of the studies; risks associated with the collaboration with Cosmo relating to the MMX product candidates, including the potential for termination of the collaboration; competition from other products; unexpected adverse side effects or inadequate therapeutic efficacy of Santarus’ products and product candidates; the scope and validity of patent protection for Santarus’ products and product candidates; and other difficulties or delays relating to the development, testing, manufacturing and marketing of, and obtaining and maintaining regulatory approvals for, Santarus’ products and product candidates; and other risks detailed in Santarus’ prior press releases as well as in prior public periodic filings with the Securities and Exchange Commission.

You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Santarus undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.

Santarus® is a registered trademark of Santarus, Inc. MMX® is a registered trademark of Cosmo Technologies Limited. GLUMETZA® is a registered trademark of Biovail Laboratories International S.r.l. licensed exclusively in the United States to Depomed, Inc. CYCLOSET® is a registered trademark of VeroScience LLC. RHUCIN® is a registered trademark of Pharming Group NV. Any other trademarks in this press release are the property of their respective owners.