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Cardium to purchase Transdel's business assets

Cardium Therapeutics today announced that it had entered into an agreement with Transdel Pharmaceuticals to acquire substantially all of Transdel's business assets including a Phase 3 product candidate Ketotransdel (TDLP-110), which is a topically-administered analgesic for the treatment of musculoskeletal pain.

27 Jun 2011

Positive top line data from Mimetogen MIM-D3 Phase II clinical trial for dry eye disease

Mimetogen Pharmaceuticals Inc. today announced positive top line data from the Phase II clinical trial of MIM-D3 for dry eye disease. The trial demonstrated statistically significant improvements in signs and symptoms with its low (1%) and high (5%) doses of MIM-D3, together with excellent safety and tolerability profiles.

27 Jun 2011

EMA acceptance of brentuximab vedotin MAA triggers $5M milestone payment to Seattle Genetics

Seattle Genetics, Inc., today announced that it will receive a $5 million milestone payment under its brentuximab vedotin (ADCETRIS) collaboration with Millennium: The Takeda Oncology Company, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited.

27 Jun 2011

NovaSom completes $35M equity financing led by Safeguard Scientifics

NovaSom, Inc., the market leader in technology-driven, payer-aligned cost-saving solutions for Obstructive Sleep Apnea (OSA) management, today announced it has closed $35 million in equity financing.

27 Jun 2011

Teva concludes Site Initiation Visit for Israeli clinical center in CEL-SCI's Multikine Phase III clinical trial

CEL-SCI Corporation announced today that its partner Teva Pharmaceuticals, a leading global pharmaceutical company, has concluded the Site Initiation Visit for the first Israeli clinical center in CEL-SCI's Phase III clinical trial for Multikine, the Company's flagship cancer immunotherapy.

27 Jun 2011

EnVivo initiates EVP-0962 GSM Phase 1 clinical trial for Alzheimer’s disease

EnVivo Pharmaceuticals, a company dedicated to developing a broad range of novel central nervous system (CNS) therapies, announced today that it recently initiated a Phase 1 clinical trial of EVP-0962, its potent and selective gamma secretase modulator (GSM), in healthy volunteers.

27 Jun 2011

Flamel, Digna Biotech enter joint development agreement for multiple products

Flamel Technologies SA and Digna Biotech SL today announced that the two companies have entered into a joint development agreement for the pre-clinical and clinical development of multiple products.

27 Jun 2011

Endo recalls two lots of Endocet Tablets

Endo Pharmaceuticals today issued a voluntary nationwide consumer level recall of Endocet (oxycodone/acetaminophen, USP) Tablets, 10 mg/325 mg 100 count bottles, NDC 60951-712-70, Lot # 402415NV and #402426NV.

27 Jun 2011

Health Canada approves Tasigna for newly diagnosed Philadelphia chromosome-positive CML

Over a decade ago, Canadian patients diagnosed with chronic myeloid leukemia (CML), celebrated when PrGleevec (imatinib mesylate) was approved in Canada.

27 Jun 2011

Yissum, BioLineRx sign license deal to develop and commercialize BL-7040 for IBD

BioLineRx, a biopharmaceutical drug development company, and Yissum Research Development Company Ltd., the Technology Transfer Company of the Hebrew University of Jerusalem, announced today that they have signed a worldwide, exclusive license agreement for BioLineRx to develop and commercialize BL-7040, an orally available Phase II ready molecule for treating Inflammatory Bowel Disease (IBD) and other inflammatory diseases.

27 Jun 2011

Derma Sciences announces $29 million financing

Derma Sciences, Inc., a medical device and pharmaceutical company focused on advanced wound care, today announced it has closed its previously announced private placement.

27 Jun 2011

FDA accepts for filing Columbia's PROCHIEVE progesterone gel NDA

Columbia Laboratories, Inc. and Watson Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing Columbia's New Drug Application (NDA) for PROCHIEVE (progesterone gel) for the reduction of risk of preterm birth in women with short uterine cervical length in the mid-trimester of pregnancy.

27 Jun 2011

Positive results from Stealth's Bendavia Phase I renal impairment study

Stealth Peptides Inc. (Stealth), a privately held biopharmaceutical company developing innovative mitochondrial therapies, announced today the results of a Phase I renal impairment study with Bendavia.

27 Jun 2011

EMA accepts Millennium's MAA for ADCETRIS to treat lymphoma

Millennium: The Takeda Oncology Company with its parent company Takeda Pharmaceutical Company Limited today announced that the European Medicines Agency (EMA) has accepted the filing of the Marketing Authorization Application (MAA) for ADCETRIS for the treatment of relapsed or refractory Hodgkin lymphoma (HL) and relapsed or refractory systemic anaplastic large cell lymphoma.

27 Jun 2011

New bardoxolone methyl Phase 2 trial data on kidney disease, diabetes presented at ERA-EDTA 2011

New Phase 2 clinical trial data published online today in The New England Journal of Medicine show that patients with moderate to severe chronic kidney disease and type 2 diabetes receiving bardoxolone methyl for 52 weeks experienced a sustained improvement in kidney function throughout the treatment period, as measured by estimated glomerular filtration rate.

27 Jun 2011

Lilly, Harbour Antibodies complete non-exclusive research and licence deal

Harbour Antibodies BV, an Erasmus MC spin-off company, announced today the completion of a non-exclusive research and licence agreement with Eli Lilly and Company, a global pharmaceutical company, to generate and develop human therapeutic antibodies comprising immunoglobulin heavy and light chains(H2L2) using one of Harbour's transgenic mouse antibody discovery platforms.

27 Jun 2011

New data from Zafgen's ZGN-433 Phase 1b study on obesity presented at ADA 2011

Zafgen, Inc., a pharmaceutical company pioneering novel obesity therapeutics to help the body regain and sustain a lean, healthy state by targeting imbalances in fat metabolism, today announced new data from a Phase 1b study of ZGN-433, a selective methionine aminopeptidase 2 inhibitor (MetAP2), which showed a significant improvement in cardiovascular risk markers in severely obese subjects.

27 Jun 2011

New drug improves kidney function for patients with type 2 diabetes and chronic kidney disease

A new anti-inflammatory drug used by patients with type 2 diabetes improved their kidney function during a year-long study involving researchers from UT Southwestern Medical Center.

24 Jun 2011

FDA approves Laureate's Electronic Submission Gateway application

Laureate Biopharmaceutical Services, Inc. announced today that the U.S. Food and Drug Administration ("FDA") approved its application for an Electronic Submissions Gateway (ESG) to the Agency.

24 Jun 2011

EMA approves Shire's new REPLAGAL manufacturing facility in Lexington

Shire plc, the global specialty biopharmaceutical company, today announced that the European Medicines Agency has approved the purification of REPLAGAL® (agalsidase alfa) drug substance at its new manufacturing facility in Lexington, MA, US. REPLAGAL, Shire's enzyme replacement therapy for the treatment of Fabry disease is the first product that will be made available to patients from the new facility.

24 Jun 2011