FDA Approval Treasure Hunters

[Stowe]

On December 10, 2015 Regen Biopharma, Inc. (“Regen”) was informed by the United States Food and Drug Administration that Regen has satisfactorily addressed all clinical hold issues related to Regen’s Investigational New Drug Application for HemaXellerate and may initiate a Phase I clinical trial assessing HemaXellerate in patients with drug-refractory aplastic anemia.

[locksflooring]

FDA’s position on adult stem cells is contained in multiple places and can be tough to decipher.

Basically, to treat disease, your adult stem cells need to be grown a bit ( incubated) in culture. If you don't do this, the stem cells are unlikely to help the patient. However, FDA's current regulatory framework makes this type of cell culture the manufacture of a new drug, essentially removing cell therapy from your doctor's black bag (until the FDA approves your stem cells as drugs for each and every medical condition). So while your doctor could do all of this safely in a physician run lab and begin treating a host of diseases, you have to wait 5-20 years for access to your own stem cells (as a drug).

So what's the public health rationale for why you would want to regulate the patient's own stem cells as a drug? If we look at mass production of anything such as food, drugs or someone's cells placed in a vial, the public health implications can be tremendous. A bad batch of food or drugs can make a lot of people very sick very quickly. However, an autologous procedure is very different, in that it involves taking one person's tissue and placing it back into the same person. For example, disease transmission risks from one person to another don't apply; the idea of one "bad batch" of anything making many people sick doesn't apply. The worst that can happen is that one person gets sick from something that happened to their own tissue. This is therefore not something for mass production rules, but rather things like professional treatment guidelines and implantation registries.
As we have been discussing, the FDA’s position on your adult stem cells is that they are biological drugs. How did this happen? FDA’s definition of stem cells (a type of ‘”human cell, tissue, or cellular or tissue-based products” (HCT/Ps)) is found at 21 CFR § 1271.3(d).

As revealed HERE, that definition has undergone a very significant change over the past five years. Originally, HCT/P was defined as follows: “any human tissue derived from a human body and intended for transplantation into another human…” Now, however, HCT/P is defined as “articles containing or consisting of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient.” Thus, the regulation currently in effect purports to give FDA the authority to regulate even those tissue products being used for autologous purposes (i.e. tissue products being used in a bypass surgery), and therefore gives the FDA more authority than Congress has ever authorized. Congress does not hide elephants in mouse holes, and it has never granted FDA the authority to regulate the practice of medicine.
Why is this important? The FDA made these changes to the law without public comment. Federal law provides that the FDA cannot make new regulations without noticing the public and offering the public the opportunity to comment. In this case, had the FDA noticed the public of a proposed change to 21 CFR § 1271.3(d), the proposed change would have infuriated doctors and others involved in medical procedures because the new regulation purports to give the FDA authority to regulate the practice of medicine.
Why make this change? What was in it for FDA? By changing one simple phrase, the agency has given itself new sweeping powers to regulate stem cells as biological drugs. In fact, the very existence of CBER (the cell based therapy group at FDA) depends on this little change of phrase. Without it, the FDA has no authority to regulate the patient’s own stem cells as a drug. But with it, FDA gives itself unheard of authority and a whole new section of the federal government has a reason to exist.



Please take a minute right now to send the following to the FDA/Ombudsman (feel free to edit/add your own comments):
Dear sirs,
I oppose the change made in 21 CFR § 1271.3(d) from “any human tissue derived from a human body and intended for transplantation into another human…” (2004 and prior) to “articles containing or consisting of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient.” (recent regulation). This change allows FDA to regulate the practice of medicine, even though Congress never gave the FDA such power. Please put this regulation change to public comment as is required by law.



Please join the ICMS and protect these therapies

[MinnieM]

I'm recycling one of your posts biomanbaba. ;)

Get yourself some VVUS..........FDA advisory committee meeting coming on 7/15/10 re their Qnexa.......my #2 play behind MMRF right now
www.vivus.com/pipeline/qnexa-obesity

Recently, VIVUS, Inc. (VVUS - Snapshot Report) announced that the New Drug Application (NDA) for its obesity candidate, Qnexa, will be reviewed by the Endocrinologic and Metabolic Drugs advisory committee of the U.S. Food and Drug Administration (FDA) tentatively on July 15, 2010.

The US regulatory authority accepted the NDA filed by VIVUS for Qnexa on March 1, 2010. The NDA was filed in December 2009. A response from the FDA should be out in the fourth quarter of 2010 (action date: Oct 28, 2010). Even though the US agency is not bound to follow the advice of its advisory committees, the recommendation of the panel is usually considered by the agency while deciding on the fate of a drug candidate.

Qnexa is VIVUS’ lead pipeline candidate. It is a proprietary oral drug candidate that combines two previously approved products, topiramate and phentermine, to employ a dual mechanism to treat obesity. The drug is designed to address the excess appetite and high threshold for satiety that impact eating behavior. The full dose of Qnexa is a combination of 15mg phentermine and 92mg of a proprietary controlled release (CR) topiramate. Qnexa is being developed to treat other indications also.

[sea_devil]

No kidding. Been in that one a long time

[biomanbaba]

that one has a real nice chart
http://finance.yahoo.com/q/ta?s=GNVC&t=3m

http://stockcharts.com/c-sc/sc?s=gnvc&p=D&yr=0&mn=6&dy=0&i=p25650043489&r=1510

[MinnieM]

VRML was the best one I've seen. It was in the .03 to .06 range the morning the FDA came out with approval of its ovarian cancer test in Sept. 2009. It closed Friday at $33. We need to find others like that. lol

I remember seeing the volume surge and price jump to .50 the morning the news came out. But, I made a huge mistake in not looking to see what news propelled it and dissed it since it had a Q on the end of the ticker at the time. Big mistake. Was in abolute shock when I looked at it later. lol

Chart

[locksflooring]

Information Portal http://www.fda.com/

[locksflooring]

Recalls http://www.fda.gov/Safety/Recalls/default.htm

[locksflooring]

No link between bone drug, fractures
FDA: Women taking Fosamax not at increased risk



Study: Bone-strengthening drugs could backfire
March 10: Two small studies suggest that a small percentage of patients who use certain drugs to prevent bone loss for more than five years could be at greater risk for a rare type of hip fracture. NBC's Robert Bazell reports.
Nightly News


updated 12:56 p.m. ET, Thurs., March. 11, 2010
BOSTON - U.S. regulators said they have found no link between oral bisphosphonate osteoporosis medications such as Merck & Co Inc.'s Fosamax and certain thigh bone fractures.

The U.S. Food and Drug Administration issued its statement Wednesday following the publication of case reports of atypical subtrochanteric femur fractures — or fractures in the bone just below the hip joint — in women with osteoporosis using oral bisphosphonates.

Bisphosphonates are a class of drug aimed at preventing bone fractures and offseting bone loss associated with menopause.

Story continues below ?
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They include Fosamax, Roche Holding AG's Boniva, Novartis' Reclast and Warner Chilcott's Actonel.

In June 2008, the FDA requested information from all bisphosphonate drug makers related to these type of fractures. The agency said a review of the data did not show an increased risk for women using the medications.

The FDA said that, although its review of the data did not show a clear connection between bisphosphonates and atypical subtrochanteric femur fractures, the agency is working closely with outside experts to gain more insight into the issue.

Bisphosphonates, which have been on the market for roughly a decade, have raised safety concerns in the past, including heart risks.

But in 2008, the FDA said the drugs showed no overall risk of heart problems. The agency's review followed reports in the New England Journal of Medicine of serious atrial fibrillation, a type of abnormal heartbeat.

In January, a Manhattan federal judge refused to dismiss a lawsuit alleging that Fosamax caused jaw damage to a woman during the nearly eight years she took the pill.

Merck faces a slew of lawsuits involving almost 900 cases by patients who say Fosamax caused osteonecrosis of the jaw, or death of jaw bone tissue.

"In clinical studies, Fosamax has not been associated with increased fracture risk at any skeletal site," Merck spokesman Ron Rogers said in a statement.

"Low energy femoral shaft and subtrochanteric fractures have been reported in the medical literature as occurring in non-bisphosphonate users," Rogers noted, adding that Merck is currently conducting studies "to further investigate the issue of low energy femoral shaft and subtrochanteric fractures."

The FDA recommended patients keep taking their medication unless told not to by their doctor. It also recommended that healthcare professionals be aware of a "possible risk" of atypical subtrochanteric femur fractures in patients taking oral bisphosphonates.

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[locksflooring]

http://www.fda.gov/

[Kobe Ginobili]

ELTP FDA approval PR:


Elite Pharmaceutics and ThePharmaNetwork Announce FDA Approval for Generic Methadone Tablets
Wednesday 12/02/2009 10:50 AM ET - Globenewswire

Related Companies
Symbol Last %Chg
ELTP 0.135 39.90%
As of 3:59 PM ET 12/2/09

Elite Pharmaceuticals, Inc. ("Elite" or the "Company") (OTCBB:ELTP) and ThePharmaNetwork, LLC ("TPN") announced today the approval of an Abbreviated New Drug Application (ANDA) for methadone hydrochloride 10 mg tablets by the U.S. Food and Drug Administration (FDA). Elite and TPN co-developed the product and the product was filed under ThePharmaNetwork name. The methadone hydrochloride tablets are the generic equivalent of the Dolophine(R) hydrochloride 10 mg tablets. The product and its equivalents had annual sales of approximately $48 million in 2008. Under the Product Collaboration Agreement, Elite will manufacture the product and Elite and TPN will share in the profits from the sale of the product.

About TPN

ThePharmaNetwork, LLC is engaged in the development, manufacturing, licensing, and marketing of strategically selected generic pharmaceuticals as well as providing comprehensive business development solutions that utilize its well established network of international business relationships. ThePharmaNetwork, LLC sells generic pharmaceuticals under its Ascend Laboratories label to all major classes of trade.

About Elite Pharmaceuticals

Elite Pharmaceuticals, Inc. develops oral sustained and controlled release products. Elite's strategy includes assisting partner companies in the life cycle management of products to improve off-patent drug products and developing generic versions of controlled release drug products with high barriers to entry. Two of Elite's products, Lodrane 24(R) and Lodrane 24D(R), are marketed by a partner, ECR Pharmaceuticals, for allergy treatment. Elite's lead pipeline products are novel sustained release oral formulations of oxycodone for the treatment of chronic pain, which address two of the limitations of existing oral opioids: the provision of consistent relief of baseline pain levels and deterrence of potential abuse. Both products, ELI-216, a once-daily abuse resistant oxycodone, and ELI-154, a once-daily oxycodone, are in late-stage development. Elite, with partners, also has an ANDA filed with the FDA for a generic equivalent of a pain product and has a generic gastrointestinal drug product in clinical development. Elite operates a GMP and DEA registered facility for research, development, and manufacturing located in Northvale, NJ.

[Kobe Ginobili]

BIEL 10Q arrived yesterday

[buffalobillsgone]

BIEL is making real nice progress right now with that Tylenol Study going to be released on Monday evening. An FDA approval and an uplisting could see this in the dollar range and higher.. which IMO could make this the best penny play out there right now.

[Kobe Ginobili]

LLBO

Lifeline Biotechnologies Reports on FDA Filing Status
2:35p ET October 26, 2009 (Business Wire)

Lifeline Biotechnologies, Inc. (Pink Sheets: LLBO) today reported on the status of the pending FDA submission of its First Warning System(TM), filed in late July 2009.

Jim Holmes, Lifeline's CEO, said, "This past July we filed with the FDA to determine if our technology and testing of over 600 patients would meet the requirements for a 510(k). We have checked with our FDA consulting firm, the firm that assisted us with the preparation and submission of our July 2009 filing, who advised us that the FDA is running anywhere from 30 to 60 days past the normal time expected to provide a response. We have been advised to exercise patience and we ask that our shareholders do the same. It's been a long road and we feel we're getting close. If the FDA is satisfied with our testing process and the supporting information is sufficient, we could proceed and file a 510(k) application immediately. However, the possibility must be considered that the FDA could request additional testing or other technical validations.

"If we can proceed with an 510(k) filing, our best estimate at this time is that it could take four to six months, possibly longer, for the FDA to clear our 510(k) application. Once cleared by the FDA the First Warning System(TM) could immediately commence commercialization.

"We have had many questions from shareholders and interested parties concerning the status of our FDA filing; we ask that they continue to be patient along with us. As soon as the FDA's response is received, we will make a press release and post the response on Lifeline's website.

"We've also received many questions concerning the prospect of a reverse split of the common stock. Even though the outstanding common stock is approximately 2.9 billion shares, we have no plans for a reverse split."

[buffalobillsgone]

When the FDA waves that magical "approval" sign, how high do you think BIEL can go? I have been looking at this for a long while now, since early in the summer, the stock has moved up quite nicely for a penny stock

[dalemj]

BIEL should go up soon as they have a very useful product I know lots of people that are unable to take NSAID due to high blood presure and liver damage and so on Drs.telling them no more .They are getting with it financially and FDA great things going on JMO

[Kobe Ginobili]

Been following BIEL a number of months- remember when analyst project .30-.50 share price estimate- keep this in my sights

[Kobe Ginobili]

Will keep everyone informed- doing some due diligence in order to locate more!!

[buffalobillsgone]

Any other FDA gems out there?

[buffalobillsgone]

Thanks for the alert on REPR =D I will keep this on radar

[Rawnoc]

REPR -- profitable, cash-rich, rapidly growing, recession-proof, tiny float OS & market cap with a juicy FDA approval pending any week...

Management is so confident of continued much higher profits than last quarter going forward that they have set aside a "deferred tax asset" in the balance sheet "based the valuation allowance calculations on the prospect of future profitability"
http://pinksheets.com/edgar/GetFilingHtml?FilingID=6632631

Products are recession-proof with no direct competition with sales rapidly expanding due to a new treatment (Vivaglobin) where their infusion pump is the best, cheapest, safest, and most convenient form of delivery:
http://investorshub.advfn.com/boards/read_msg.asp?message_id=28775119
http://investorshub.advfn.com/boards/read_msg.asp?message_id=28777209
http://investorshub.advfn.com/boards/read_msg.asp?message_id=28838178

Medicare reimbursement for the Freedom60 (their biggest & most exciting revenue-generating product) was increased 20 fold in June of 2007 and is the ONLY infusion pump accepted by Medicare for reimbursement for Subcutaneous Immune Globulin treatment (Vivaglobin):
http://investorshub.advfn.com/boards/read_msg.asp?message_id=28776642
http://investorshub.advfn.com/boards/read_msg.asp?message_id=28776847

They are hiring like crazy:
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=39063328
http://www.rmsmedicalproducts.com/Careers.htm

FDA Approval pending and could be announced any day which should help accelerate sales & earnings:
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=38239770

Based on seasonal & cylical patterns as well as their recent hiring and doubling of shifts and landing business with a huge hospital & the pending FDA approval, I suspect REPR is 1 or 2 quarters away from +.02 EPS per quarter or more or an annualized +.08 EPS pace IMO. 10 PE = .80/share, 15 PE = $1.20/share. 20 PE = $1.80/share

REPR Board:
http://investorshub.advfn.com/boards/board.aspx?board_id=201

[Cool_Trader]

im also waiting on BIEL, there is talk that it may go all the way up to .50 and then stay at .30.

[classic cars]

Add IOPM to your list.

[dalemj]

BIEL waiting on fda

[sea_devil]

Nice new board. I'm waiting on GNVC.

[PIERRAT]

GETA Will be huge winnner

[Kobe Ginobili]

Welcome to FDA Approval Treasure Hunters!!!

Last approval located Friday and the source where located from is IHUB Hunt for next 5-10 bagger:


EPIX: Here is FDA Approval from Friday:


EPIX Pharmaceuticals Announces FDA Approval of a Physician-Sponsored IND for Fourth 6-month Open Label Extension of PRX-03140 for Alzheimer's Disease Patient
Friday 10/16/2009 3:24 PM ET - Pr Newswire Europe

Related Companies
Symbol Last %Chg
EPIX 0.115 1,050.00%
As of 4:00 PM ET 10/16/09

The FDA has approved a Physician-Sponsored IND and continuation of the fourth 6-month open label extension of PRX-03140, a novel 5HT4 partial agonist for the potential treatment of Alzheimer's Disease. The patient was enrolled initially in a two week Phase 2a study in August 2007 where she received 100 mg per day of PRX-03140 in combination with her normal daily dose of Aricept(R) (10 mg). Based on the marked progress during the original two week study, the patient's daughter sought continued compassionate use of PRX-03140 for her mother and a protocol was submitted to the FDA and approved. The progress seen in the first 2-week study has continued during the past two years (19 months of dosing) and four FDA approved 6-month open label extensions. The latest open label extension will be administered under a new Physician-Sponsored IND under the supervision of Dr. Lucy Hornstein(1). "When I was approached by the patient's daughter to continue the compassionate use therapy of PRX-03140 for her mother, I was compelled by the progress her mother had experienced and the overall apparent safety of the drug," notes Dr. Hornstein.

On July 20, 2009, EPIX Pharmaceuticals, Inc. (the "Company") entered into an Assignment for the Benefit of Creditors (the "Assignment") in accordance with Massachusetts law. The purpose of the Assignment is to conclude the Company's operations and provide for an orderly liquidation of its assets. The Assignment is a common law business liquidation mechanism under Massachusetts law that is an alternative to a formal bankruptcy proceeding. Under the terms of the Assignment, the Company transferred all of its assets to an assignee for orderly liquidation and distribution of the proceeds to the Company's creditors. The designated assignee for the Company is Joseph F. Finn, Jr. at Finn, Warnke & Gayton, 167 Worcester Street, Suite 201, Wellesley Hills, MA 02481.

The PRX-03140 program will be sold at auction on Wednesday, October 21 at 3 pm EDT. Please contact Joseph F. Finn, Jr. at [phone] if you are interested in participating in the auction.

(1) Lucy Hornstein, M.D. is a private practice physician in Valley Forge, PA. She is the author of a recently released book, "Declarations of a Dinosaur: 10 Laws I've Learned as a Family Doctor" by Kaplan Publishing.