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Two 2008 drug approval reports highlight Ceplene benefits

EpiCept Corporation today announced that Ceplene (histamine dihydrochloride) has been highlighted in two separate reports issued recently reviewing 2008 drug approvals in the European Union.

3 Sep 2009

ODAC calls for randomized study of Vion's Onrigin injection for treatment of the elderly AML patients

VION PHARMACEUTICALS, INC. (OTC Bulletin Board: VION) today announced the results of the Oncologic Drugs Advisory Committee (ODAC) Meeting at which data for its lead oncology therapeutic Onrigin(TM)(laromustine) Injection were presented for the indication of remission induction treatment for patients sixty years of age or older with de novo poor-risk acute myeloid leukemia (AML).

3 Sep 2009

New Marketing Authorization Application for Rhucin submitted to the EMEA by Pharming

Biotech company Pharming Group NV ("Pharming" or "the Company") (NYSE Euronext: PHARM) today announced that it has submitted the Marketing Authorization Application (MAA) for Rhucin for the treatment of acute attacks of Hereditary Angioedema (HAE) to the European Medicines Agency (EMEA).

3 Sep 2009

FDA extends review period for Endo Pharmaceuticals' testosterone undecanoate

Endo Pharmaceuticals announced today that it has been informed by the U.S. Food and Drug Administration (FDA) that the agency has extended its review period for its long-acting testosterone undecanoate injection for men diagnosed with hypogonadism, from Sept. 2, 2009 to Dec. 2, 2009.

3 Sep 2009

Merck's SAFLUTAN launched in the UK and Spain

Merck & Co., Inc. has launched SAFLUTAN® (tafluprost) in the United Kingdom and Spain, and additional launches in other countries are expected over the next several months, pending regulatory approvals, the Company said today. SAFLUTAN is a preservative free, synthetic analogue of the prostaglandin F2α for the reduction of elevated intraocular pressure (IOP) in appropriate patients with primary open-angle glaucoma and ocular hypertension.

3 Sep 2009

MIPI to sub-license the Onalta brand 90-Y edotreotide radiotherapeutic

Molecular Insight Pharmaceuticals, Inc. today announced that it has completed an agreement to sub-license its Onalta™ brand 90-Y edotreotide radiotherapeutic in certain countries in Europe, the Middle East, North Africa, Russia and Turkey to BioMedica Life Sciences, S.A., Athens, Greece.

3 Sep 2009

Gloucester’s romidepsin recommended for approval by the FDA Oncologic Drug Advisory Committee

Gloucester Pharmaceuticals announced today that the Oncologic Drug Advisory Committee (ODAC) appointed by the U.S. Food and Drug Administration (FDA) voted 10 in favor with one abstention to recommend approval of romidepsin to treat patients with cutaneous T-cell lymphoma (CTCL). CTCL is a type of non-Hodgkin's lymphoma, which is a cancer of the immune system.

3 Sep 2009

Sinovac Biotech signs marketing agreement with Boryung Pharmaceutical Company

Sinovac Biotech Ltd., a leading provider of biopharmaceutical products in China, announced today that it has signed an agreement with Boryung Pharmaceutical Company Limited, a Korean manufacturer of pharmaceuticals, to collaborate on marketing efforts and possible vaccine supply efforts to the government of South Korea for Sinovac's H1N1 vaccine.

3 Sep 2009

Clinical trial results of sumatriptan published in a journal

NovaDel Pharma Inc. announced that an article titled “Rapid Oral Transmucosal Absorption of Sumatriptan, and Pharmacodynamics in Acute Migraine” was published online on June 22, 2009 in the peer-reviewed journal Headache: The Journal of Head and Face Pain.

3 Sep 2009

Millennium's sNDA to be reviewed by the FDA

The Takeda Oncology Company today announced the U.S. Food and Drug Administration (FDA) has accepted for review the Company’s supplemental new drug application (sNDA) based on long- term overall survival (OS) data from the landmark VISTA1 trial examining the use of VELCADE based therapy in patients with previously untreated multiple myeloma (MM).

3 Sep 2009

Pfizer to pay $301 million as setlement for illegal off-label promotion of Geodon

Blank Rome LLP represented three whistleblowers in two of nine lawsuits being settled today with Pfizer for $2.3 billion. The Blank Rome suits allege that Pfizer Inc. illegally off-label promoted the drugs Lyrica® and Geodon®. The cases are two among a group of nine similar suits, all alleging illegal drug promotion activities, that the United States Department of Justice is announcing today are being settled.

3 Sep 2009

FDA's Oncologic Drugs Advisory Committee votes in favor of FOLOTYN NDA

Allos Therapeutics, Inc. (Nasdaq: ALTH) today announced that the U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 10-4 that the response rate and duration of response observed with FOLOTYNTM (pralatrexate) are reasonably likely to predict clinical benefit in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).

3 Sep 2009

Bextra qui tam lawsuit leads to Pfizer's whopping $2.3 billion settlement

The decision by a Pfizer sales representative in Florida to file a whistleblower ("qui tam") lawsuit in 2003 kicked off the federal and state investigations that led to Pfizer's record-breaking $2.3 billion settlement today.

3 Sep 2009

Intendis GmbH forges agreement with SkinMedica to acquire two prescription dermatology products

Asset Purchase Agreement Signed for Marketed Prescription Products Desonate(R) and NeoBenz(R) Micro

3 Sep 2009

Hong Kong's healthcare workers to refuse H1N1 vaccine, says study

According to a study released August 26, 2009 by the British Medical Journal, more than half of Hong Kong's healthcare workers surveyed said they would refuse the H1N1 shot, which is not yet available, because they are afraid of side effects and doubt how safe and effective it will be. More importantly, the study suggested the trend would be repeated worldwide.

3 Sep 2009

BioMS Medical update on dirucotide development

BioMS Medical Corp. (TSX: MS), today provided an update on developments in respect of dirucotide, its drug candidate for multiple sclerosis (MS).

2 Sep 2009

FDA approves Meda's ASTEPRO Nasal Spray

Meda Pharmaceuticals Inc. today announced that the US Food and Drug Administration (FDA) has approved ASTEPRO(R) (azelastine HCl) Nasal Spray 0.15%, for the treatment of the symptoms of seasonal and perennial allergic rhinitis (SAR and PAR). New ASTEPRO Nasal Spray 0.15% is the first nasal antihistamine to offer convenient once-daily dosing for patients who suffer from seasonal allergies.

2 Sep 2009

NCI to announce the results of follow-up study of PharmaGap's lead drug GAP-107B8

PharmaGap Inc. (TSX-V: GAP; OTC.BB: PHRGF) ("PharmaGap" or "the Company") today announced that results are expected during September from the United States National Cancer Institute (NCI) follow-up study of the company's lead drug GAP-107B8.

2 Sep 2009

Cavit Sciences and McCoy form an agreement to finalize their merger

Cavit management has been negotiating with Randall McCoy and Joe Connell principle owners of McCoy Enterprises LLC to merge our companies. Maggie Smyth, CEO of Cavit states, “We all feel very good about this fit so we have added a breakup clause to show our commitment to each other”.

2 Sep 2009