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ddn conducts interview with lead plaintiff related to embryonic stem cell research case

Drug Discovery News, a news organization covering issues, trends and product news in the pharmaceutical drug development and discovery industry, recently conducted exclusive interviews with the lead plaintiffs in the controversial Sherley v. Sebelius lawsuit challenging President Barack Obama's order granting funding for embryonic stem cell research.

4 Jan 2011

BNA announces publication of Second Edition of Pharmaceutical Patent Law

BNA Books, a division of BNA, announces the publication of the Second Edition of Pharmaceutical Patent Law, the most relied upon reference available with a detailed, practitioner-oriented treatment of pharmaceutical patent law from the perspective of both patent law and the food and drug laws.

4 Jan 2011

Embryome Sciences announces $4M equity financing, changes name to ReCyte Therapeutics

BioTime, Inc. today announced a $4 million equity financing by its subsidiary, Embryome Sciences, Inc. Concurrent with the financing, Embryome Sciences will be renamed ReCyte Therapeutics, Inc. and will develop therapeutic products for cardiovascular and blood diseases. The new equity financing is being led by a $2.5 million investment by private investors and a $1.5 million investment from BioTime that valued ReCyte Therapeutics at a post money valuation of $60 million on a fully diluted basis.

4 Jan 2011

FDA authorizes Juventas' JVS-100 Phase II clinical trial for critical limb ischemia

Juventas Therapeutics, a clinical-stage regenerative medicine company developing novel therapies for cardiovascular disease, announces that the U.S. Food and Drug Administration (FDA) authorized commencement of a Phase II clinical trial evaluating the efficacy and safety of its lead product, JVS-100, for the treatment of critical limb ischemia (CLI).

3 Jan 2011

FDA grants orphan drug status for Senesco's SNS01-T in treatment of multiple myeloma

Senesco Technologies, Inc., announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for the company's lead drug candidate SNS01-T for treatment of multiple myeloma.

3 Jan 2011

FDA clears ACT's IND to treat AMD using hESC derived RPE cells

Advanced Cell Technology, Inc., a leader in the field of regenerative medicine, announced today that the US Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) application to treat Dry Age-Related Macular Degeneration (AMD) using retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs).

3 Jan 2011

Enrollment commences in belinostat-Tarceva combination trial for NSCLC

Spectrum Pharmaceuticals, a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology, and Topotarget A/S announced today that the first patient has been dosed in an Investigator Initiated Trial of belinostat in combination with Tarceva® for patients with Non-Small Cell Lung Cancer (NSCLC).

30 Dec 2010

Clinical Data closes sale of genetic, pharmacogenomic testing and biomarker development business

Clinical Data, Inc. today announced that the Company has closed the sale of its genetic and pharmacogenomic testing and biomarker development business to Transgenomic, Inc. for $15.5 million. The sale completes Clinical Data's transformation into a pharmaceutical company with a deep product pipeline, including two promising late-stage compounds, the most advanced of which is vilazodone, a new treatment in development for Major Depressive Disorder.

30 Dec 2010

Merck confirms plans for developing vernakalant drug for atrial fibrillation

Cardiome Pharma Corp. today announced that it has been advised by its partner, Merck, that the current review of vernakalant is complete, and that Merck has informed Cardiome of its next steps in clinical development for vernakalant beginning in 2011.

29 Dec 2010

ISCO to conduct discussion on ethical and medical advantages of human parthenogenetic stem cells

International Stem Cell Corporation, will lead a free public discussion highlighting the ethical considerations and medical advantages surrounding the derivation of human stem cells from unfertilized human eggs using ISCO's patented technology known as parthenogenesis.

29 Dec 2010

Warburg Pincus affiliates to acquire ReSearch Pharmaceutical Services for $6.10 per share

ReSearch Pharmaceutical Services, Inc. (RPS) announced today it has entered into an agreement to sell the company to affiliates of Warburg Pincus, LLC, the global private equity firm, in an all cash transaction valued at $6.10 per share. The Board of Directors of RPS unanimously approved the acquisition agreement and recommended that RPS shareholders approve the transaction. It is presently anticipated that closing of the transaction will occur in February 2011.

28 Dec 2010

ACT, Roslin Cells collaborate to establish hESC line bank using single-ceblastomere technique

Advanced Cell Technology, a leader in the field of regenerative medicine, announced today that it has entered into a Memorandum of Understanding with Roslin Cells LTD of Scotland, in which the two companies contemplate a definitive collaboration agreement in the near future.

28 Dec 2010

Cephalon receives second FDA Complete Response Letter for NUVIGIL sNDA

Cephalon, Inc. today announced that the company received a second Complete Response Letter from the U.S. Food and Drug Administration (FDA) for the supplemental new drug application (sNDA) for NUVIGIL(R) (armodafinil) Tablets [C-IV] for the treatment of patients with excessive sleepiness associated with jet lag disorder resulting from eastbound travel. In its letter to the company, the FDA reiterated its previously stated concerns regarding the NUVIGIL sNDA.

28 Dec 2010

Discovery Labs to implement reverse stock split

Discovery Laboratories, Inc. today announced that it has filed a Certificate of Amendment to its Amended and Restated Certificate of Incorporation (the "Amendment") to effect a 1-for-15 share consolidation, or reverse stock split ("reverse split"), effective at 12:01 a.m. on December 28, 2010 (the "Effective Time").

28 Dec 2010

Stem cell therapy helps patient with diabetes gangrene recover from foot ulcer: ICMS conference

During ICMS Annual International Congress on Regenerative and Cell Based Medicine Conference held on November 12, 2010 in Las Vegas, Nevada, it was announced that a patient with complications of diabetes gangrene recovered from foot ulcer through stem cell therapy.

27 Dec 2010

$1.1 billion Martek sale measures success of UMD-Mtech 'grads'

The latest success of Martek Biosciences, a rising-star among Maryland biotechs, began more than a decade ago in a plain, brick building on the University of Maryland campus. With a good idea and early-stage nurturing from the university's Maryland Technology Enterprise Institute (Mtech), the company has been able to grow into a major international business.

24 Dec 2010

RegeneRx common stock to be quoted on OTC Bulletin Board following NYSE Amex suspension

RegeneRx Biopharmaceuticals, Inc. announced today that beginning with the opening of trading on December 23, 2010, the Company's common stock is expected to be quoted on the OTC Bulletin Board under the symbol RGRX following its suspension from the NYSE Amex as of that date.

24 Dec 2010

Teva receives FDA complete response letter for glatiramer acetate 0.5mL injection sNDA

Teva Pharmaceutical Industries Ltd. announced today that it has received a complete response letter from the U.S. Food and Drug Administration (FDA) for its supplemental New Drug Application (sNDA) for a lower-volume (0.5mL) injection of glatiramer acetate. Copaxone® containing 20mg of glatiramer acetate in 1ml is the global market leader in the treatment of relapsing-remitting multiple sclerosis (RRMS).

24 Dec 2010

Alimera receives FDA CRL for ILUVIEN NDA

pSivida Corp., a leader in developing sustained release, drug delivery products for treatment of back-of-the-eye diseases, including the investigational drug ILUVIEN® for the treatment of Diabetic Macular Edema (DME), today announced that Alimera Sciences, Inc, pSivida's collaborative partner, received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for ILUVIEN. The FDA issued the CRL to communicate its decision that the NDA cannot be approved in its present form.

24 Dec 2010

Target enrollment reached in belinostat Phase 2 study in Carcinoma of Unknown Primary

Spectrum Pharmaceuticals, a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology, announced today that the target enrollment has been reached for the Phase 2 study of belinostat in Carcinoma of Unknown Primary (CUP).

23 Dec 2010

Biotechnology News and Research

ddn conducts interview with lead plaintiff related to embryonic stem cell research case

BNA announces publication of Second Edition of Pharmaceutical Patent Law

Embryome Sciences announces $4M equity financing, changes name to ReCyte Therapeutics

FDA authorizes Juventas' JVS-100 Phase II clinical trial for critical limb ischemia

FDA grants orphan drug status for Senesco's SNS01-T in treatment of multiple myeloma

FDA clears ACT's IND to treat AMD using hESC derived RPE cells

Enrollment commences in belinostat-Tarceva combination trial for NSCLC

Clinical Data closes sale of genetic, pharmacogenomic testing and biomarker development business

Merck confirms plans for developing vernakalant drug for atrial fibrillation

ISCO to conduct discussion on ethical and medical advantages of human parthenogenetic stem cells

Warburg Pincus affiliates to acquire ReSearch Pharmaceutical Services for $6.10 per share

ACT, Roslin Cells collaborate to establish hESC line bank using single-ceblastomere technique

Cephalon receives second FDA Complete Response Letter for NUVIGIL sNDA

Discovery Labs to implement reverse stock split

Stem cell therapy helps patient with diabetes gangrene recover from foot ulcer: ICMS conference

$1.1 billion Martek sale measures success of UMD-Mtech 'grads'

RegeneRx common stock to be quoted on OTC Bulletin Board following NYSE Amex suspension

Teva receives FDA complete response letter for glatiramer acetate 0.5mL injection sNDA

Alimera receives FDA CRL for ILUVIEN NDA

Target enrollment reached in belinostat Phase 2 study in Carcinoma of Unknown Primary

Industry Focus eBook - Biotechnology (4th edition) eBook

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Evaluating new approaches for rare disease genomics

Expanding access to NMR with the Fourier 80 Duo

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