Pharmaceuticals News and Research

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Omni Bio to expand Type 1 diabetes Phase I/II trial from 15 to 50 patients

Omni Bio Pharmaceutical, Inc., an emerging biopharmaceutical company formed to acquire, license, and develop existing therapies for indications with substantial commercialization potential, has committed to expand its Phase I/II human clinical trial in recently diagnosed Type 1 diabetes patients from 15 patients to 50.

28 Feb 2011

EPO grants three core patents to caprotec's CCMS technology

caprotec bioanalytics GmbH announced today that the European Patent Office has granted the last of three core patents protecting its proprietary and revolutionary Capture Compound Mass Spectrometry technology.

28 Feb 2011

Daiichi Sankyo enters merger agreement to acquire Plexxikon

Plexxikon Inc. today announced it has entered into a merger agreement with Daiichi Sankyo Company, Limited, a Japan-based global pharmaceutical company.

28 Feb 2011

UCSF collaborates with Zcube to develop new ways to deliver drugs

A pill filled with microscopic, drug-laden adhesive squares is at the center of an agreement between UCSF and Zcube srl, the research corporate venture arm of Italian pharmaceutical leader Zambon Co., SpA, to license UCSF-developed microtechnology and support early research into new ways to deliver oral medications directly to a targeted site in the body.

28 Feb 2011

ACT Biotech files SPA with FDA for telatinib combination Phase 3 trial for stomach cancer

ACT Biotech, Inc., a biopharmaceutical company focused on the development of highly targeted, oral therapeutics for the treatment of cancer, announced today that it has filed a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA) related to a randomized Phase 3 trial of telatinib in combination with chemotherapy for the first-line treatment of patients with advanced stomach cancer.

28 Feb 2011

Synageva supports Fourth International Rare Disease Day

Synageva BioPharma Corp., a privately held biopharmaceutical company that is developing therapeutic products for rare disorders, announced today that the company is supporting the Fourth International Rare Disease Day observance on February 28, 2011.

28 Feb 2011

Endo fourth quarter total revenues increase 31% to $511 million

Endo Pharmaceuticals today reported financial results for the fourth quarter 2010.

28 Feb 2011

Regeneron's ARCALYST meets primary, secondary endpoints in second Phase 3 gout flare study

Regeneron Pharmaceuticals, Inc. announced that in a second Phase 3 study (PRE-SURGE 2) in gout patients initiating allopurinol therapy, ARCALYST (rilonacept) met the primary and all secondary study endpoints. The primary endpoint was the number of gout flares per patient over the 16-week treatment period.

28 Feb 2011

Celgene's ISTODAX sNDA granted FDA Priority Review classification for progressive/relapsed PTCL

Celgene Corporation today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review classification to its Supplemental New Drug Application (sNDA) regarding ISTODAX (romidepsin) for injection for the treatment of peripheral T-cell lymphoma (PTCL) in patients who have received at least one prior therapy.

28 Feb 2011

Rexahn's novel anti-cancer quinoxalinyl-piperazine compounds granted European patent

Rexahn Pharmaceuticals, Inc., a clinical stage pharmaceutical company commercializing potential best in class oncology and CNS therapeutics, today announced that the European Patent Office has granted European patent No. 1819698 to Rexahn for its novel anti-cancer quinoxalinyl-piperazine compounds.

28 Feb 2011

FDA grants 510(k) clearance for Derma Sciences MEDIHONEY Gel Wound and Burn Dressing

Derma Sciences, Inc., a medical device and pharmaceutical company focused on advanced wound care, today announced receipt of 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Company's patent-pending MEDIHONEY® Gel Wound and Burn Dressing.

28 Feb 2011

FDA approves Matrix Labs generic Neurontin ANDA

Mylan Inc. today announced that its subsidiary Matrix Laboratories Limited has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Gabapentin Capsules USP, 100 mg, 300 mg and 400 mg, the generic version of Pfizer's Neurontin® Capsules used to treat a painful complication of shingles.

28 Feb 2011

Alexion joins EURORDIS, NORD and medical communities to observe Rare Disease Day 2011

Alexion Pharmaceuticals, Inc. joins the European Organization for Rare Diseases, the National Organization for Rare Disorders and families, governments, companies and medical communities around the world in observing the fourth annual Rare Disease Day today.

28 Feb 2011

Medunik to introduce novel orphan drugs to Canadians with rare diseases

Éric Gervais, Executive Vice-President of Medunik Canada, is proud to announce the Management Team of this recently created company. Medunik Canada is a Quebec pharmaceutical company with 60 employees and one unique mission - bring novel orphan drugs to Canadians with rare diseases.

28 Feb 2011

Almac's new North American Headquarters launches schedule I-V controlled capabilities

Packaging, storage and distribution of schedule I-V controlled substances is now a fully functional capability of Almac's new North American Headquarters in Souderton, PA. As the phased transition nears its end, the portfolio of services and capacity offered to customers continues to grow as a result of the $120 million investment.

28 Feb 2011

Pharming, Santarus receive FDA refusal to file letter for RHUCIN BLA

Specialty biopharmaceutical company Santarus, Inc.and biotech company Pharming Group NV today announced the receipt of a "refusal to file" letter from the U.S. Food and Drug Administration for the RHUCIN Biologics License Application submitted by Pharming.

28 Feb 2011

FUJIFILM enters definitive agreement to acquire Merck

FUJIFILM Corporation and Merck, known as MSD outside the United States and Canada, today announced they have entered into a definitive agreement by which Fujifilm will acquire the Merck BioManufacturing Network, a leading provider of contract manufacturing and development services for the biopharmaceutical industry and wholly owned by Merck.

28 Feb 2011

Samsung enters strategic partnership with Quintiles to support biopharmaceuticals market

Samsung Electronics Co., Ltd., the world's largest electronics company, and its affiliated companies have entered into a strategic partnership with Quintiles, the world's leading pharmaceutical services company, to support Samsung's entry into the biopharmaceuticals market, Quintiles announced today.

27 Feb 2011

Encouraging preliminary results from Synta's ganetespib Phase 2 trial against non-small cell lung cancer

Synta Pharmaceuticals Corp., a biopharmaceutical company focused on discovering, developing, and commercializing small molecule drugs to treat severe medical conditions, today announced that encouraging preliminary results of a Phase 2 trial of ganetespib as a single agent in non-small cell lung cancer were presented at the International Association for the Study of Lung Cancer 11th Annual Targeted Therapies for the Treatment of Lung Cancer Meeting.

27 Feb 2011

Takeda receives FDA approval for EDARBI to treat hypertension in adults

Takeda Pharmaceutical Company Limited and its wholly-owned subsidiary, Takeda Pharmaceuticals North America, Inc., today announced that the U.S. Food and Drug Administration approved EDARBI for the treatment of hypertension, or high blood pressure, in adults.

27 Feb 2011

Pharmaceuticals News and Research

Omni Bio to expand Type 1 diabetes Phase I/II trial from 15 to 50 patients

EPO grants three core patents to caprotec's CCMS technology

Daiichi Sankyo enters merger agreement to acquire Plexxikon

UCSF collaborates with Zcube to develop new ways to deliver drugs

ACT Biotech files SPA with FDA for telatinib combination Phase 3 trial for stomach cancer

Synageva supports Fourth International Rare Disease Day

Endo fourth quarter total revenues increase 31% to $511 million

Regeneron's ARCALYST meets primary, secondary endpoints in second Phase 3 gout flare study

Celgene's ISTODAX sNDA granted FDA Priority Review classification for progressive/relapsed PTCL

Rexahn's novel anti-cancer quinoxalinyl-piperazine compounds granted European patent

FDA grants 510(k) clearance for Derma Sciences MEDIHONEY Gel Wound and Burn Dressing

FDA approves Matrix Labs generic Neurontin ANDA

Alexion joins EURORDIS, NORD and medical communities to observe Rare Disease Day 2011

Medunik to introduce novel orphan drugs to Canadians with rare diseases

Almac's new North American Headquarters launches schedule I-V controlled capabilities

Pharming, Santarus receive FDA refusal to file letter for RHUCIN BLA

FUJIFILM enters definitive agreement to acquire Merck

Samsung enters strategic partnership with Quintiles to support biopharmaceuticals market

Encouraging preliminary results from Synta's ganetespib Phase 2 trial against non-small cell lung cancer

Takeda receives FDA approval for EDARBI to treat hypertension in adults

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