Pharmaceuticals News and Research

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Particle Sciences to expand sterile manufacturing for complex products and particulates

Particle Sciences, Inc (PSI), the leading CDMO for micro and nano-particulates is expanding its sterile and aseptic manufacturing capacity generally and specifically for nano-milled drug products.

9 Mar 2015

G-treeBNT to receive $7.28 million to expand international development of RGN-259/GBT-201

RegeneRx Biopharmaceuticals, Inc. has been notified that its joint venture partner and licensee, G-treeBNT Co. Ltd., will receive $7.28 million USD to expand international development of its product candidate, RGN-259 (designated GBT-201).

9 Mar 2015

EMD Serono executes amendment agreement with Opexa for development of Tcelna (imilecleucel-T)

EMD Serono, the biopharmaceutical division of Merck KGaA, Darmstadt, Germany, announced today the execution of an amendment to its agreement with Opexa Therapeutics, Inc. for the development and commercialization of its investigational compound Tcelna (imilecleucel-T).

9 Mar 2015

Phase 3 trial results show that new testosterone nasal gel is effective and practical

A new testosterone nasal gel raises men's low testosterone levels to normal, with few side effects, according to the results of a phase 3 clinical trial to be presented Saturday at the Endocrine Society's 97th annual meeting in San Diego.

9 Mar 2015

Researchers present new findings about 'key players' involved in brain inflammation

Inflammatory processes occur in the brain in conjunction with stroke and neurological diseases such as Alzheimer's and Parkinson's disease. Researchers from Lund University and Karolinska Institutet in Sweden, in close cooperation with a group led by Professor José L. Venero at the University of Seville, have presented new findings about some of the 'key players' in inflammation.

6 Mar 2015

Researchers study safety, effectiveness of experimental Ebola vaccine following high-risk exposure

A physician who received an experimental Ebola vaccine after experiencing a needle stick while working in an Ebola treatment unit in Sierra Leone did not develop Ebola virus infection, and there was strong Ebola-specific immune responses after the vaccination, although because of its limited use to date, the effectiveness and safety of the vaccine is not certain, according to a study appearing in JAMA.

6 Mar 2015

New computational approach to determine viability and suitability of complex molecular structures

New York University chemists have developed a computational approach for determining the viability and suitability of complex molecular structures—an advancement that could aid in the development of pharmaceuticals as well as a range of other materials.

6 Mar 2015

Mallinckrodt enters into definitive agreement to acquire Ikaria

Mallinckrodt plc, a leading global specialty biopharmaceutical company, and Ikaria, Inc. a privately-held critical care company, announced today that they have entered into a definitive agreement under which a subsidiary of Mallinckrodt will acquire Ikaria, Inc. from a Madison Dearborn-led investor group in a transaction valued at approximately $2.3 billion.

5 Mar 2015

ANI acquires approved ANDA for Flecainide Acetate tablets USP

ANI Pharmaceuticals, Inc. today announced that it has acquired the approved abbreviated new drug application ("ANDA") for Flecainide Acetate tablets USP 50mg, 100mg and 150mg, previously marketed by Teva Pharmaceuticals.

5 Mar 2015

Lucideon welcomes University College Dublin students on work placements

Lucideon is pleased to announce that it has offered three healthcare technology placements to students from University College Dublin (UCD).

From Lucideon 5 Mar 2015

Uroglide technology could improve comfort for catheter users

A new pharmaceutical product that could significantly improve quality of life for catheter users all over the world is to be developed by Queen's University Belfast after it won a national award.

5 Mar 2015

Study shows how mutations that cause Alzheimer's disease lead to neurodegeneration, dementia

A study from researchers at Massachusetts General Hospital and Brigham and Women's Hospital reveals for the first time exactly how mutations associated with the most common form of inherited Alzheimer's disease produce the disorder's devastating effects.

5 Mar 2015

New approach could dramatically increase survival rate of cancer patients

Michail Sitkovsky, an immunophysiology expert at Northeastern University, and his research colleagues have made a breakthrough discovery in cancer treatment. The new approach, some 30 years in the making, could dramatically increase the survival rate of patients with cancer, which kills some 8 million people each year.

5 Mar 2015

Bayer announces FDA acceptance of BAY 81-8973 BLA for treatment of hemophilia A

Bayer HealthCare today announced that the U.S. Food and Drug Administration has accepted the company's Biologics License Application for BAY 81-8973, a recombinant Factor VIII compound. Bayer is seeking FDA approval of the investigational compound, proposed trade name Kovaltry, for the treatment of hemophilia A in children and adults.

4 Mar 2015

Symbiomix Therapeutics announces positive results from SYM-1219 Phase 1 clinical program

Symbiomix Therapeutics, a late-stage, privately held biopharmaceutical company developing innovative medicines for serious women's health infections, today announced results from its Phase 1 clinical program demonstrating that its lead product candidate, SYM-1219, was safe and well tolerated and had predictable pharmacokinetics (PK), and that contraceptive efficacy for birth control pills would not be altered by SYM-1219 administration.

4 Mar 2015

Diplomat Pharmacy selected to distribute Novartis' COSENTYX (secukinumab)

Diplomat Pharmacy, Inc. has been selected to the Novartis limited-distribution panel to distribute COSENTYX (secukinumab), a drug approved in January by the U.S. Food and Drug Administration to treat adults with moderate-to-severe plaque psoriasis.

4 Mar 2015

Lexicon updates drug development progress, reports 2014 financial results

Lexicon Pharmaceuticals, Inc., a biopharmaceutical company focused on developing breakthrough treatments for human disease, today updated its drug development progress and reported financial results for the three months and year ended December 31, 2014.

4 Mar 2015

Enrollment completed in Pharma Two B's P2B001 Phase IIb study for Parkinson's disease treatment

Pharma Two B announced today that enrollment has been completed in the company's Phase IIb study of P2B001 for the treatment of early stage Parkinson's disease. One hundred and forty-nine patients enrolled in the study conducted at 29 clinical sites throughout the US and Israel.

4 Mar 2015

Grifols, Alkahest sign definitive agreements

Grifols, a global healthcare company and leading producer of plasma therapies, and Alkahest, a Redwood City, California based, privately held biopharmaceutical company founded upon the pioneering work of Dr. Tony Wyss-Coray and other leading scientists at Stanford University, today announced that they have signed definitive agreements whereby Grifols will make a major equity investment in Alkahest, and the companies will work together to develop novel plasma-based products for the treatment of cognitive decline in aging and disorders of the central nervous system (CNS), including Alzheimer's.

4 Mar 2015

SARAH study completes patient enrolment to evaluate treatment for primary liver cancer

SARAH, a large French study of patients with advanced, inoperable primary liver cancer (hepatocellular carcinoma, or HCC) has completed patient enrolment, exceeding its 400-patient target, according to its principal investigator, Professor Valérie Vilgrain MD, PhD, Department of Radiology, Beaujon Hospital, Assistance Publique - Hôpitaux de Paris (AP-HP) and Université Paris Diderot, Sorbonne Paris Cité, France.

4 Mar 2015

Pharmaceuticals News and Research

Particle Sciences to expand sterile manufacturing for complex products and particulates

G-treeBNT to receive $7.28 million to expand international development of RGN-259/GBT-201

EMD Serono executes amendment agreement with Opexa for development of Tcelna (imilecleucel-T)

Phase 3 trial results show that new testosterone nasal gel is effective and practical

Researchers present new findings about 'key players' involved in brain inflammation

Researchers study safety, effectiveness of experimental Ebola vaccine following high-risk exposure

New computational approach to determine viability and suitability of complex molecular structures

Mallinckrodt enters into definitive agreement to acquire Ikaria

ANI acquires approved ANDA for Flecainide Acetate tablets USP

Lucideon welcomes University College Dublin students on work placements

Uroglide technology could improve comfort for catheter users

Study shows how mutations that cause Alzheimer's disease lead to neurodegeneration, dementia

New approach could dramatically increase survival rate of cancer patients

Bayer announces FDA acceptance of BAY 81-8973 BLA for treatment of hemophilia A

Symbiomix Therapeutics announces positive results from SYM-1219 Phase 1 clinical program

Diplomat Pharmacy selected to distribute Novartis' COSENTYX (secukinumab)

Lexicon updates drug development progress, reports 2014 financial results

Enrollment completed in Pharma Two B's P2B001 Phase IIb study for Parkinson's disease treatment

Grifols, Alkahest sign definitive agreements

SARAH study completes patient enrolment to evaluate treatment for primary liver cancer

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