Pharmaceuticals News and Research

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Mercator, Pepscan enter multi-program cancer research collaboration

Mercator Therapeutics, the first biopharmaceutical company to systematically use in vivo phage display technology to develop novel cancer drugs and Pepscan Therapeutics, a world leader in protein mimicry technologies for improved therapeutic peptides and anti-GPCR antibodies, today announced a multi-program research collaboration. The companies will collaborate to optimize Mercator's 'Homing Peptides' using Pepscan's proprietary CLIPS technology.

4 Jan 2011

The Scientist examines how nonprofit, for-profit pharma groups are working together to make drugs more affordable for developing countries

"With philanthropists funneling billions of dollars into biomedical research and traditional drug discovery efforts producing fewer and fewer therapies, the line between for-profit and nonprofit life science companies is beginning to blur as both sides of the divide look for new options," The Scientist magazine writes in an article that examines the rise in collaborations between nonprofit pharmaceutical companies and for-profit groups.

4 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

Infinity named to NASDAQ Global Select Market

Infinity Pharmaceuticals, Inc. announces that, effective today, it has been named to the NASDAQ Global Select Market tier, the premier listing tier for NASDAQ companies. The NASDAQ Global Select Market tier was created in July 2006 for companies that meet the highest listing standards in the world, based on financial and liquidity requirements.

3 Jan 2011

Genocea announces close of $35 million Series B venture financing round

Genocea Biosciences Inc., a vaccine discovery and development company pioneering a new class of T cell-based vaccines, today announced that it has closed a $35 million Series B round of venture financing, with new investors Johnson & Johnson Development Corporation (JJDC), Skyline Ventures and MP Healthcare Venture Management, Inc. (MPH) joining existing investors Polaris Venture Partners, Lux Capital Management, SR One, Cycad Group, Auriga Partners and Morningside Ventures.

3 Jan 2011

Top-line results of TIGER-2 Phase 3 clinical trial for CF treatment

Inspire Pharmaceuticals, Inc. announced today the top-line results from its second Phase 3 clinical trial, TIGER-2, with denufosol tetrasodium for the treatment of cystic fibrosis.

3 Jan 2011

Aceto closes transaction for acquisition of Rising's assets

Aceto Corporation, a global leader in the sourcing, quality assurance, regulatory support, marketing and distribution of pharmaceuticals, nutraceuticals, specialty chemicals and crop protection products, today announced that it has closed the previously announced transaction for its wholly-owned subsidiary to acquire certain assets of Rising Pharmaceuticals, Inc ("Rising").

3 Jan 2011

Akorn-Strides joint venture enters purchase agreement with Pfizer for ANDAs

Akorn, Inc., a niche generic pharmaceutical company, today reported that its Akorn-Strides LLC joint venture has entered into a purchase agreement with Pfizer Inc. to sell 16 Abbreviated New Drug Approvals (ANDAs) and 6 filed ANDAs. For its portion, Akorn, Inc. will receive $35 million in cash. Akorn-Strides LLC will continue to manufacture and distribute the approved products until April 30, 2011.

30 Dec 2010

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

Intellipharmaceutics granted extension of deadline to regain compliance with Nasdaq Listing Rule

Intellipharmaceutics International Inc., a pharmaceutical company specializing in the research, development and manufacture of novel or generic controlled release and targeted release oral solid dosage drugs, today announced that the staff of the Nasdaq Stock Market has granted the Company an extension of the deadline to regain compliance with Nasdaq Listing Rule 5550(b).

30 Dec 2010

FDA approves Impax's ANDA for generic Doryx 75 and 100mg tablets

Impax Laboratories, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted final approval of the Company's Abbreviated New Drug Application for the generic version of Doryx® (doxycyline hyclate delayed-release) 75 and 100mg tablets. The Company is preparing for product launch through Global Pharmaceuticals, Impax's generic division.

29 Dec 2010

Positive results from OMS201 Phase 1/2 trial in patients undergoing urologic procedures

Omeros Corporation, a biopharmaceutical company committed to discovering, developing and commercializing products focused on inflammation and disorders of the central nervous system, today announced results from the Phase 1/2 clinical trial of OMS201, the Company's urological PharmacoSurgery™ product candidate.

29 Dec 2010

FDA approves Endo's FORTESTA Gel for low testosterone

Endo Pharmaceuticals today announced that the U.S. Food and Drug Administration (FDA) has approved FORTESTA Gel for the treatment of low testosterone, or 'Low T,' also known as hypogonadism. Symptoms associated with Low T include erectile dysfunction and decreased sexual desire, fatigue and loss of energy, mood depression, regression of secondary sexual characteristics and osteoporosis.

29 Dec 2010

CEL-SCI initiates Multikine Phase III trail for head and neck cancer

CEL-SCI Corporation announced today that it has commenced its Phase III clinical trial for Multikine®, the Company's flagship immunotherapy. CEL-SCI has now completed all of the manufacturing and regulatory requirements to begin enrollment of the study.

29 Dec 2010

FDA stops pain drug trial over safety concerns

Johnson & Johnson revealed Tuesday this week that a clinical trial of its experimental pain drug, fulranumab, has been stopped after the Food and Drug Administration expressed concerns that patients taking the drug could suffer increased joint damage.

29 Dec 2010

Florida Hospital, Sanford-Burnham and Takeda enter obesity research collaboration

Florida Hospital, Sanford-Burnham Medical Research Institute (Sanford-Burnham), and Takeda Pharmaceutical Company Limited (Takeda)(TSE: 4502), announced today that they have signed a research agreement to form a collaboration to discover and evaluate new therapeutic approaches to obesity, a growing worldwide health problem. The partnership aligns complementary strengths in biomedical research, clinical research and drug development to identify and validate obesity- related biomarkers and new peripheral molecular targets of mutual interest.

29 Dec 2010

Santarus, Pharming submit RHUCIN BLA to FDA for treatment of HAE attacks

Specialty biopharmaceutical company Santarus, Inc. and biotech company Pharming Group NV today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) to obtain marketing approval for RHUCIN® (recombinant human C1 inhibitor) for the treatment of acute angioedema attacks in patients with Hereditary Angioedema (HAE).

29 Dec 2010

Sinovac's inactivated EV71 vaccine clinical trial against HFMD receives Chinese SFDA approval

Sinovac Biotech Ltd., a leading provider of biopharmaceutical products in China, announced today that it received approval from the China State Food and Drug Administration (SFDA) to commence clinical trials for its proprietary inactivated EV71 vaccine against Hand, Foot and Mouth Disease (HFMD).

28 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