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Delcath completes NDA submission for chemosaturation system

Delcath Systems, Inc. today announced that the Company has submitted the remaining modules of its 505(b)(2) New Drug Application (NDA) for its proprietary chemosaturation system to the U.S. Food & Drug Administration (FDA). The Company had previously submitted Module 4, consisting of literature based non-clinical data, to the FDA in late April 2010. The Company is seeking an indication for the percutaneous intra-arterial administration of melphalan hydrochloride for use in the treatment of patients with metastatic melanoma in the liver.

22 Dec 2010

FDA issues CRL to Cumberland's Acetadote sNDA for non-acetaminophen acute liver failure

Cumberland Pharmaceuticals Inc. announced today that it has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) regarding its supplemental new drug application (sNDA) for Acetadote® (acetylcysteine) Injection to treat patients with non-acetaminophen induced acute liver failure.

22 Dec 2010

Intellipharmaceutics announces delay of patent approvement to market Protonix drug

Intellipharmaceutics International, today announced that it has notified the U.S. Food and Drug Administration that it has not received notification, as provided for under the Hatch-Waxman Act, of any patent infringement proceedings by the brand owner, Wyeth Pharmaceuticals, a wholly-owned subsidiary of Pfizer, for its application to market a generic of Wyeth's Protonix® tablets.

22 Dec 2010

LFB receives positive review feedback for closing of Willfact 1000 IU Mutual Recognition Procedure

LFB received from the German regulatory authority (Paul-Ehrlich-Institute) a positive review feedback for the closing of the Mutual Recognition Procedure (MRP) of Willfact® 1000 IU with Germany as the reference member state.

22 Dec 2010

Maternal prenatal supplements boost child's intellectual and motor function

In an area where iron deficiency is prevalent, children of mothers in rural Nepal who received prenatal iron, folic acid and vitamin A supplementation performed better on measures of intellectual and motor functioning compared to offspring of mothers who received vitamin A alone, according to a study in the December 22/29 issue of JAMA.

22 Dec 2010

Biogen Idec, Elan propose updated product labeling for TYSABRI to FDA and EMA

Biogen Idec and Elan Corporation, plc announced that the companies have submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) and a Type II Variation to the European Medicines Agency (EMA) to request review and approval to update the respective TYSABRI Prescribing Information and Summary of Product Characteristics.

22 Dec 2010

Poison centers raise concern over dangerous substance marketed as bath salts

Doctors and clinicians at U.S. poison centers are increasingly concerned about products marketed as bath salts that are causing increased blood pressure, increased heart rate, agitation, hallucinations, extreme paranoia and delusions.

22 Dec 2010

Takeda completes settlements in patent litigation over generic ACTOS, ACTOplus met, and duetact ANDAs

Takeda Pharmaceutical Company Limited ("Takeda") today announced that Takeda and its wholly-owned subsidiary, Takeda Pharmaceuticals North America, Inc. ("TPNA"), have completed settlements with all defendants in patent litigation brought against the companies in response to their Abbreviated New Drug Applications ("ANDAs") for generic ACTOS® (pioglitazone HCl), ACTOplus met® (pioglitazone HCl and metformin HCl), and duetact® (pioglitazone HCl and glimepiride).

22 Dec 2010

Spinal Botox injection reduces pain

Botulinum neurotoxin type A (BoNT/A)—better known as Botox—reduces responses to an inflammation-related pain stimulus when injected into the spinal canal in mice, reports a study in the January issue of Anesthesia & Analgesia, official journal of the International Anesthesia Research Society (IARS).

22 Dec 2010

Prenatal iron-folic acid supplementation increases intellectual, motor function in children

In developing countries where iron deficiency is prevalent, prenatal iron-folic acid supplementation increased offspring intellectual and motor functioning during school age, according to researchers from the Johns Hopkins Bloomberg School of Public Health.

22 Dec 2010

CHMP recommends to grant marketing authorization for Espriet drug against PF to CPF

The Coalition for Pulmonary Fibrosis announced to more than 128,000 patients news that the first drug for the treatment of the deadly lung disease Pulmonary Fibrosis has passed a major hurdle in the European regulatory process and is likely to be approved in all 27 member countries of the European Union.

22 Dec 2010

Genmed obtains marketing authorization license for paracetamol in Europe

Genmed Holding Corp. is announcing its entry into the European generic drug market with the receipt of its first marketing and distribution license for paracetamol. Also known as acetaminophen, paracetamol is an over-the-counter drug used to treat mild to moderate pain from headaches, backaches, osteoarthritis, and to reduce fever.

22 Dec 2010

3M sues Andover for patent infringement over two layer compression bandage systems

3M and 3M Innovative Properties Co. filed a lawsuit in the U.S. District Court for the District of Minnesota today against Andover Healthcare Inc. seeking a preliminary injunction as well as a permanent injunction and damages regarding Andover's two layer compression bandage systems.

22 Dec 2010

Exercise and Vitamin D supplementation most effective in reducing fall among seniors

A systematic review of over 50 clinical trials finds that exercise and Vitamin D supplements are the best ways to reduce the risk of falling in people aged 65 and over. The review is published in the December 21 issue of Annals of Internal Medicine and was commissioned by the US Preventive Services Task Force.

22 Dec 2010

Today's Opinions: The collective benefits of the new health law; Patient safety; Legalizing marijuana

If President Obama's reform package remains intact, [cancer patient Michelle] Mindlin will be able to shop for potentially more affordable coverage in an insurance "exchange" where companies will be prevented from turning people away because of their medical history. But that doesn't go into effect until 2014. And it might not happen at all if the courts overturn a requirement that nearly everyone buy health insurance (David Lazarus, 12/21).

21 Dec 2010

AIDS Healthcare Foundation sues AIDS drug maker for overcharging

AIDS Healthcare Foundation (AHF) will host a press teleconference on Wednesday, December 22nd at 9:30 AM Pacific/12:30 PM Eastern to announce that it has filed a lawsuit against Johnson & Johnson’s Tibotec Therapeutics for overcharging AHF for AIDS drugs purchased under the 340B program.

21 Dec 2010

UCB's Cimzia and Centocor's Simponi penetrate first line biologic position in RA

In its recently released annual 2010 update, ChartTrends®: Biologics in Rheumatoid Arthritis, BioTrends Research Group, Inc. finds that newer biologic agents such as UCB's Cimzia and Centocor OrthoBiotech's Simponi, although lagging in overall market share, have begun to penetrate the first line biologic position primarily at the expense of Pfizer/Amgen's Enbrel and Abbott's Humira.

21 Dec 2010

Genzyme provides information on peak sale of alemtuzumab for multiple sclerosis

Genzyme Corporation today provided an extensive briefing on the market potential of alemtuzumab for multiple sclerosis at an event for investors and analysts in New York.

21 Dec 2010

BioInvent, Japanese pharmaceutical extends partnership for therapeutic candidate development

BioInvent International AB today announced that it has signed an agreement to extend its existing collaboration with an undisclosed Japanese pharmaceutical group.

21 Dec 2010

Gilenya offers more benefits for MS therapy than previously realized

In September, patients suffering from multiple sclerosis (MS) received the welcome news that the U.S. Food and Drug Administration (FDA) had approved a promising new drug for their condition called Gilenya. Now, a team from The Scripps Research Institute has discovered that this drug's success may involve an unexpected biological mechanism acting within the central nervous system (CNS). This difference may mean that Gilenya offers even more benefits than previously realized and would represent the first MS therapy with direct CNS activities.

21 Dec 2010

Pharmaceutical News

Delcath completes NDA submission for chemosaturation system

FDA issues CRL to Cumberland's Acetadote sNDA for non-acetaminophen acute liver failure

Intellipharmaceutics announces delay of patent approvement to market Protonix drug

LFB receives positive review feedback for closing of Willfact 1000 IU Mutual Recognition Procedure

Maternal prenatal supplements boost child's intellectual and motor function

Biogen Idec, Elan propose updated product labeling for TYSABRI to FDA and EMA

Poison centers raise concern over dangerous substance marketed as bath salts

Takeda completes settlements in patent litigation over generic ACTOS, ACTOplus met, and duetact ANDAs

Spinal Botox injection reduces pain

Prenatal iron-folic acid supplementation increases intellectual, motor function in children

CHMP recommends to grant marketing authorization for Espriet drug against PF to CPF

Genmed obtains marketing authorization license for paracetamol in Europe

3M sues Andover for patent infringement over two layer compression bandage systems

Exercise and Vitamin D supplementation most effective in reducing fall among seniors

Today's Opinions: The collective benefits of the new health law; Patient safety; Legalizing marijuana

AIDS Healthcare Foundation sues AIDS drug maker for overcharging

UCB's Cimzia and Centocor's Simponi penetrate first line biologic position in RA

Genzyme provides information on peak sale of alemtuzumab for multiple sclerosis

BioInvent, Japanese pharmaceutical extends partnership for therapeutic candidate development

Gilenya offers more benefits for MS therapy than previously realized

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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