Adderall

FDA approves Lilly's ADHD drug Strattera

Thu, 08 May 2008 06:59:56 -0400

Eli Lilly has won FDA approval of Strattera, a therapy designed to treat ADHD. Lilly says this is the first regulatory win for a non-stimulant ADHD drug in a market dominated by two stimulants--Adderall (Shire) and Ritalin (Novartis). And researchers say that the data indicates the drug works past the 3 o'clock bell and into the evening.

There is a slight increase of suicidal thoughts for children and teens in the data; .4 percent in the Strattera group compared to none in the control group. In adults there was no discernible increase in suicidal thoughts.

"The approval provides physicians and their patients with the first treatment option that is indicated for maintenance of ADHD" said Thomas J. Spencer, M.D., Associate Professor of Psychiatry, Harvard Medical School. "This is critical as ADHD may be a life-long disease and effective long-term control of symptoms may mean improved outcomes in children and adolescents."

- check out the press release
- read the AP report

FDA rejects Impax Labs' Parkinson's drug

Wed, 30 Jan 2008 06:59:56 -0500

Impax Laboratories says the FDA has formally turned thumb's down on Vadova, its experimental Parkinson's drug. In a release, the company said that the nonapprovable letter stated that the agency was rejecting the drug "based on unresolved issues relating to product nomenclature and its belief of a likelihood of medication errors resulting from confusion of Vadova with other marketed forms of carbidopa/levodopa."

"We are very disappointed with the receipt of this letter, and we continue to believe that Vadova represents a significant improvement in the choices available to patients in the treatment of the symptoms of Parkinson's disease," said Larry Hsu, Ph.D., president and chief executive officer of IMPAX Laboratories. "We will continue to pursue discussions with the FDA concerning this decision and we are evaluating all options for the product."

- read the release for more

Related Articles:
FDA nixes Impax Labs' Parkinson's therapy. Report
Shire, Impax settle Adderall XR dispute. Report

ALSO NOTED: FDA delays Adderall decision;Actavis raises Pliva bid; and much more...

Thu, 20 Apr 2006 20:00:50 -0400

> Shire says that the FDA has told the company that it hasn't been able to make a decision on its concerns that copycat versions of Adderall XR are too easy to produce. Shire wants the agency to require more rigorous bioequivalence testing. Report

> Iceland's Actavis has raised its bid for Pliva by 11 percent. Report

> Omrix Biopharmaceuticals has priced its IPO at $10 a share. Report

> NovaDel has raised $12 million from a stock sale to fund new clinical development work. Release

> Akorn and India's Natco have inked a deal to commercial two injectable therapies. Release

> An updated safety review by Nymox of NX-1207 for benign prostatic hyperplasia has revealed no serious side effects. Report

> GTx is launching a Phase IIIb trial of Acapodene in men undergoing androgen deprivation therapy for prostate cancer. Report

> The FDA has yet to complete a review of Advancis' marketing approval request for additional Keflex products. Keflex is a popular antibiotic. Release

And Finally… Researchers have found a genetic link for the hard-to-diagnose chronic fatigue syndrome. Article

ALSO NOTED: Revlimid gets priority review; Endrate linked to deaths;and much more...

Thu, 02 Mar 2006 19:00:50 -0500

> The FDA has agreed to give priority review for Revlimid as a treatment for cancer of the plasma cells found in bone marrow. Report

> The lead-poisoning drug Endrate has been linked to the death of two children. Report

> A hedge fund that holds nine percent of Chiron's stock says it will vote against a planned buyout by Novartis. Report

> The FDA has broadened the indication for Medicis Vanos, a Class I corticosteroid launched in April 2005 and originally indicated for the treatment of plaque-type psoriasis. Report

> A study involving mice shows that an experimental compound stopped both forms of brain lesions found in patients suffering from Alzheimer's. Report

> Roche has received its first product patent in India. Report

> Shire has sued Teva for alleged patent infringement involving Adderall XR. Report

> Research indicates that a new vaccine may cut the rate of inner ear infections. Report

> Takeda Pharmaceutical announced it received the exclusive right to use LG474, a substance discovered through its collaboration with Lexicon Genetics in the US. Release

> India's Amabalal Sarabhai Enterprises has closed its manufacturing operations. Report

And Finally… Amgen CEO Kevin Sharer says that biosimilars will first appear in Europe and later gain approval in the U.S. But he says the market for biosimilars will develop in a dramatically different fashion than generic alternatives for pharma's compounds. Article

FDA panel wants 'black box' on ADHD drugs

Thu, 09 Feb 2006 19:01:39 -0500

A federal advisory panel is suggesting that the FDA should require its toughest warning label for ADHD drugs like Ritalin. The recommendation came as a surprise to the FDA, which typically follows the advice of its advisory panels but isn't required to. One possible follow-up would be for the FDA to ask for advice from a separate panel. At issue are reports of heart disease that may be linked to the drugs. The agency has track the deaths of 25 people and 54 cases of serious cardiovascular problems among the many people taking the drugs. A "black box" warning could be removed at a later stage if follow-up studies failed to confirm the link.

- read this AP report for more information

ALSO: The U.K.'s Shire, which makes Adderall XR, immediately followed up with a call for further studies into ADHD therapeutics. Article

SPOTLIGHT: FDA committee to review ADHD risks

Wed, 01 Feb 2006 19:01:33 -0500

An FDA committee is scheduled to meet in a week to review how the agency should best study the cardiovascular risks posed by ADHD drugs. Concerns were heightened by Canada's decision to pull Adderall XR from the market last year. Report

Shire, Impax settle Adderall XR dispute

Thu, 19 Jan 2006 19:01:38 -0500

Shire has settled a patent dispute with generic drug maker Impax for the attention-deficit disorder drug Adderall XR. Under the terms of the settlement, Impax's generic version of the drug will be allowed to enter the market as of 2010. Shire will receive royalties on all sales. The company is still in litigation with Barr Laboratories over Adderall XR. "We are very pleased to have resolved the lawsuits against Impax. The settlement terms are consistent with our beliefs that Shire's patents are valid and enforceable," stated Matthew Emmens, Shire's CEO. Shire's stock surged on the news.

- read this AP report

ALSO NOTED: Vasogen to complete Phase III trials this year; Viventia to go private; and much more...

Sun, 13 Nov 2005 19:00:50 -0500

> Canada's Vasogen said that the biggest of its ongoing Phase III trials for Celacade for heart failure will be completed by the end of the year. Report

> Viventia Biotech of Toronto has struck a deal to go private. Report

> Merck has received FDA approval to expand the use of Invanz for diabetic foot infections. Article

> The European Medicines Agency granted Pharmaxis orphan status for Bronchitol for the treatment of cystic fibrosis. Release

> Australia's Pharmaxis has raised $87 million in new capital. Release

> Hana Biosciences of South San Francisco has posted positive interim results for a Phase I study of Talotrexin (PT-523) in relapsed or refractory advanced non-small cell lung cancer. Release

And Finally... Impax Laboratories has filed a fresh complaint against Shire in their dispute over Adderall XR. Report

Shire gambit aimed at delaying generic Adderall XR

Wed, 12 Oct 2005 20:01:37 -0400

Seeking to protect its market for the hyperactivity drug Adderall XR, Shire Pharmaceuticals filed a Citizens Petition asking regulators to require any generic competitor to demonstrate its equal effectiveness from the patient's perspective. That kind of testing requirement would likely delay any approval of a copycat competitor. A group of generic drug makers, including Teva, have filed abbreviated new drug applications for generic Adderall XR. Adderall XR represents half of Shire's annual sales revenue.

- read this report from AFX for more

Health Canada allows Adderall back on the market

Tue, 23 Aug 2005 20:01:36 -0400

The UK's Shire Pharmaceuticals says that it has received the approval of Health Canada to reintroduce Adderall for the treatment of hyperactivity disorder. Evidence that some patients taking Adderall suffered sudden death and strokes prompted Canadian officials to suspend the drug earlier this year. The FDA limited its response to changing the label for Adderall to warn against its use by adults or children with heart defects.

"Adderall XR is a safe and effective treatment for people diagnosed with Attention Deficit Hyperactivity Disorder, and Shire is very pleased that this medicine will once again be available for patients in Canada," said Shire CEO Matt Emmens.

- read this report from AFX for more

ALSO NOTED: NBTY buys Solgar; Ind-Swift expanding; Shire gets new Adderall letter; and much more...

Mon, 06 Jun 2005 20:00:50 -0400

> NBTY is buying Wyeth's Solgar Vitamin and Herb for $115 million. Story

> India's Ind-Swift is expanding its manufacturing operations. Article

> The UK's Shire Pharmaceuticals has received a second letter from Teva covering an amendment to its ANDA on a generic version of Adderall XR. Story

> Toronto-based Lorus says its cancer drug Virulizin has been granted orphan drug status in the European Union. Release

> Evotec has received its first milestone from its partnership with Boehringer Ingelheim. Release

> San Diego-based TorreyPines Therapeutics has filed an IND for NGX267, the first of several compounds in the company's product pipeline that are designed to treat Alzheimer's disease. Release

And Finally... The New York Times examines the widespread incidence of shingles and breakthrough research on a vaccine that could cure it for a majority of patients. Story