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FDA approves Taro's ANDA for Cetirizine Hydrochloride Oral Solution

Taro Pharmaceutical Industries Ltd. reported today that it has received approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Cetirizine Hydrochloride Oral Solution, 1 mg/mL.

24 May 2011

PolyPid announces new drug delivery system and an innovative biodegradable bone void filler

PolyPid, a developer of innovative drug carriers, announced today the company’s flagship platform – PolyPid. PolyPid is a new, innovative family of drug carriers, based on a fusion between two known drug delivery systems: polymers and lipid-based systems. The new drug carriers enable long-lasting and controlled release of therapeutic drugs. The revolutionary, patented carrier can be tailored to almost any drug – small molecules, peptides, protein and nucleic acids-based drugs. The formulations can be pre-planned in order to achieve the desired release rate of the drug/s and the optimal duration, which can last up to several months.

23 May 2011

Practical solutions for translational science from Randox Laboratories

The sole purpose of translational science is to transfer scientific discoveries made in ‘basic research’ to clinical reality, to improve the health of individuals and reduce suffering.

From Randox Laboratories Ltd. 23 May 2011

Elixir DESyne Drug Eluting Coronary Stent System granted CE Mark approval

Elixir Medical Corporation, a developer of product platforms combining state-of-the-art medical devices with advanced pharmaceuticals, announced that it has received CE Mark for its DESyne Drug Eluting Coronary Stent System for the treatment of coronary artery disease.

23 May 2011

FDA approves Amneal's generic Furadantin

Amneal Pharmaceuticals, LLC is pleased to announce that it has received U.S. FDA approval to manufacture Nitrofurantoin Oral Suspension in the 25 mg/5 ml strength effective May 13, 2011. Amneal's generic, the first on the market, is an AA-rated, therapeutically equivalent alternative to Furadantin.

23 May 2011

Archimedes launches new web interface, ARCHeS Innovator

Archimedes Inc., a healthcare modeling company, today announced the launch of a new web interface, ARCHeS Innovator, which will give health experts direct access to many of the features of the Archimedes Model.

23 May 2011

AMAC Telephony Based Communication Services receives large scale award

American Medical Alert Corp. a provider of healthcare communication services and advanced telehealth monitoring technologies, today announced that its Telephony Based Communication Services was awarded a three year, pharmaceutical brand support and clinical contact communications contract for an internationally recognized, top ten pharmaceutical manufacturer.

23 May 2011

Vertex receives FDA approval for INCIVEK to treat hepatitis C

Vertex Pharmaceuticals Incorporated announced that the U.S. Food and Drug Administration (FDA) has approved INCIVEK™ (telaprevir) tablets for a broad group of people with genotype 1 chronic hepatitis C with compensated liver disease (some level of damage to the liver but the liver still functions), including cirrhosis (scarring of the liver).

23 May 2011

Mylan introduces Divalproex Sodium Capsules for treatment of seizures

Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has launched Divalproex Sodium Capsules USP, 125 mg, the generic version of Abbott's Depakote® Sprinkle Capsules, a treatment for certain types of seizures.

23 May 2011

Micromet's blinatumomab data to be presented at two upcoming medical meetings

Micromet, Inc., a biopharmaceutical company focused on the development and commercialization of next-generation antibodies for the treatment of cancer, today announced that data on its lead product candidate blinatumomab will be reported at two upcoming medical meetings.

23 May 2011

Boston Healthcare announces acquisition of Alpha Care

Boston Healthcare announced today that it has acquired Alpha Care GmbH, a consulting firm based in Germany that provides health economics and policy solutions for pharmaceutical, medical device, payer and provider organizations.

23 May 2011

New RHUCIN study data in acute HAE attacks presented at 7th C1 Inhibitor Deficiency Workshop

Santarus, Inc., a specialty biopharmaceutical company, today announced that new data from open-label studies evaluating the efficacy and safety of the investigational drug RHUCIN for the treatment of acute attacks of angioedema in patients with Hereditary Angioedema were presented at the 7th C1 Inhibitor Deficiency Workshop on May 20 - 22, 2011 in Budapest, Hungary.

23 May 2011

Sosei to introduce NorLevo oral emergency contraceptive in Japan

Sosei Group Corporation, the biopharmaceutical company, today announced that Sosei Co., Ltd., its wholly owned Japanese subsidiary, will launch its emergency contraceptive pill, NorLevo(R) TABLETS 0.75mg, tomorrow 24 May, through the distribution network of its commercialization partner, ASKA Pharmaceutical Co., Ltd.

23 May 2011

Synthon opens state-of-the-art laboratory for biotechnology

Synthon opened its state-of-the-art laboratory for biotechnology today, an important step in the company’s development into a ‘specialty pharmaceutical’ firm. Ms. Renée Bergkamp, Director-General of Enterprise and Innovation of the Ministry of Economic Affairs, Agriculture and Innovation, and Mr. Thom de Graaf, Mayor of Nijmegen, attended the official opening.

22 May 2011

U.S. District Court grants Cephalon Temporary Restraining Order for generic AMRIX

Today, the United States District Court for the District of Delaware granted a motion filed by plaintiffs Cephalon, Inc., and Eurand, Inc., for a Temporary Restraining Order (TRO) enjoining Mylan Pharmaceuticals Inc., and Mylan Inc., from manufacturing, using, offering to sell or selling its cyclobenzaprine hydrochloride extended-release capsules, a generic version of Cephalon's branded product AMRIX.

21 May 2011

UM Board of Regents approves $13.7M renovation project for new health care policy institute

A new health care policy institute – one that is expected to become one of the largest of its kind in the nation – will be established at the University of Michigan's North Campus Research Complex.

21 May 2011

Phase 3 open-label study of RELISTOR presented at American Pain Society meeting

Salix Pharmaceuticals, Ltd. today announced findings from two analyses of a Phase 3 open-label study of RELISTOR (methylnaltrexone bromide) presented at the 30th Annual Scientific Meeting of the American Pain Society. The meeting is being held in Austin, TX, on May 19-21, 2011.

21 May 2011

Local production of pharmaceuticals could improve access in developing countries, U.N. report says

A U.N. Conference on Trade and Development report issued last week suggested "[l]ocal production of pharmaceuticals in some poor African and Asian countries, such as Ethiopia, Uganda, and Bangladesh, has the potential to improve access to essential drugs for many of the one billion people who live in the world's least developed countries," BMJ News writes.

21 May 2011

Bristol-Myers Squibb to present abstracts on oncology compounds at ASCO 2011 Annual Meeting

Bristol-Myers Squibb Company, a leading global BioPharma company in oncology, today announced that more than 95 scientific abstracts on its approved and investigational oncology compounds will be featured at the 47th Annual Meeting of the American Society of Clinical Oncology in Chicago from June 3-7.

21 May 2011

USPTO awards Serina patent for polymer drug delivery technology

Serina Therapeutics, Inc., a pharmaceutical research and development company, announced that the company was awarded a patent from the United States Patent and Trademark Office covering its polymer technology.

21 May 2011