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FDA approves Mallinckrodt's EXALGO (32 mg) sNDA to manage opioid-related pain

Zalicus Inc., a biopharmaceutical company that discovers and develops novel treatments for patients suffering from pain and immuno-inflammatory diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) filed by Mallinckrodt Inc., a subsidiary of Covidien plc, for the 32 mg dose strength of EXALGO (hydromorphone HCl) Extended-Release Tablets (CII), for the management of moderate to severe pain in opioid-tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time.

27 Aug 2012

Debiopharm initiates enrollment in triptorelin phase III study for central precocious puberty

Debiopharm Group (Debiopharm), a Swiss-based global biopharmaceutical group of companies with a focus on the development of prescription drugs that target unmet medical needs and companion diagnostics, today announced that the first patient has been enrolled in an open-label phase III study to investigate the efficacy, safety, and pharmacokinetics of the sustained release triptorelin pamoate 22.5 mg 6-month-formulation in children with central precocious puberty (CPP), a rare disease.

27 Aug 2012

Mylan, Pfizer partner to develop and market generic drugs in Japan

Pfizer Inc. and Mylan Inc. today announced that they have signed a definitive agreement to establish an exclusive long-term strategic collaboration to develop, manufacture, distribute and market generic drugs in Japan. The collaboration is designed to build upon each company's highly complementary strengths and quality assets.

23 Aug 2012

EMD Millipore enters definitive agreement to acquire Biochrom

EMD Millipore, the Life Science division of Merck KGaA of Darmstadt, Germany, today announced that it has entered into definitive agreements to acquire Biochrom AG located in Berlin, Germany.

From Biochrom Ltd. 23 Aug 2012

Bile duct cancer chosen as next indication for PCI Biotech

PCI Biotech (PCIB) the Norwegian biopharmaceutical company, reported today that it has chosen bileduct cancer as the next indication for the use of its PCI (photochemical internalisation) localised cancer therapy. In this indication PCI Biotech’s proprietary photosensitiser Amphinex® will be used in combination with the generic cytotoxic agent gemcitabine. The aim is to start the clinical Proof of Concept study within end of 1H 2013.

21 Aug 2012

Ipsen, Inspiration partner to commercialize IB1001 and OBI-1 for hemophilia

Inspiration Biopharmaceuticals Inc. today announced new license, development and commercialization agreements with its strategic partner, Ipsen.

21 Aug 2012

Preliminary results from Lexicon’s Phase 1 studies of LX2931 and LX7101 for RA

Lexicon Pharmaceuticals, Inc., a biopharmaceutical company focused on discovering breakthrough treatments for human disease, today reported preliminary results from Phase 1 studies of LX2931 and LX7101.

17 Aug 2012

Medicago, IDRI receive FDA approval to commence Phase 1 H5N1 vaccine trial

The Infectious Disease Research Institute (IDRI), a Seattle-based non-profit research organization that is a leading developer of adjuvants used in vaccines combating infectious disease, and Medicago Inc., a biopharmaceutical company focused on developing highly effective and competitive vaccines based on proprietary manufacturing technologies and Virus-Like Particles (VLPs), announce that they have been cleared by the U.S. Food and Drug Administration (FDA) to initiate a Phase 1 clinical trial for an H5N1 Avian Influenza VLP vaccine candidate.

16 Aug 2012

3SBio files APX001 IND application with SFDA in China

Apexigen, Inc., an emerging biopharmaceutical company focused on the discovery and development of monoclonal antibody therapeutics, announced today that its partner, 3SBio [SSRX] of Shenyang, China, filed an Investigational New Drug (IND) application for APX001, also known as SSS07, with the State Food and Drug Administration (SFDA) in China.

16 Aug 2012

AstraZeneca enters agreement with Pfizer for OTC NEXIUM

Pfizer Inc. today announced that it has entered into an agreement with AstraZeneca for the over-the-counter (OTC) rights for NEXIUM (esomeprazole magnesium), a leading prescription drug currently approved to treat the symptoms of gastroesophageal reflux disease (GERD).

14 Aug 2012

Quintiles acquires premier provider of genomics testing and analysis

To help biopharmaceutical companies dramatically improve drug development productivity and deliver greater value, Quintiles today announced the acquisition of Expression Analysis, Inc. (EA), a premier provider of genomics testing and analysis to biopharma, academic, government and non-profit customers.

13 Aug 2012

Verastem second quarter net loss increases to $6.8 million

Verastem, Inc., a biopharmaceutical company focused on discovering and developing drugs to treat breast and other cancers by targeting cancer stem cells, today reported financial results for the quarter ended June 30, 2012, and also commented on certain corporate accomplishments and plans.

13 Aug 2012

Lightlake announces final data from naloxone nasal spray Phase II study on Binge Eating Disorder

Lightlake Therapeutics Inc., an early stage biopharmaceutical company developing modern addiction treatments based on its expertise using opioid antagonists, announced today compelling final data from a Phase II study of the Company's proprietary opioid antagonist naloxone nasal spray treatment for patients with Binge Eating Disorder (BED).

9 Aug 2012

Creating new non-influenza vaccines: an interview with Julie Phillips, CEO of BioDiem

BioDiem recently signed a collaborative agreement with The Royal Melbourne Institute of Technology (RMIT) for the development of non-influenza vaccines using BioDiem’s proprietary live attenuated influenza virus (LAIV) technology.

7 Aug 2012

Orexigen Therapeutics reports net loss of $16.7 million for second quarter 2012

Orexigen Therapeutics, Inc., a biopharmaceutical company focused on the treatment of obesity, today announced financial results for the second quarter of 2012.

7 Aug 2012

Potential new drug to treat common inherited kidney disease

Scientists at UC Santa Barbara have demonstrated in the laboratory that a new drug is effective in treating a very common kidney disease -- although it will be a few years before it becomes available for clinical testing. The findings resulted from a collaboration between UCSB and a biotech firm based in Indiana. The study is published in this week's Journal of the American Society of Nephrology.

3 Aug 2012

Progress with GSK in advancing VaxiRNA technology earns Alnylam $3.2M milestone payment

Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, announced today that it has earned a development milestone payment from GlaxoSmithKline, totaling $3.2 million. The milestone payment is related to progress in the companies' collaboration on the use of VaxiRNA technology for the production of GSK influenza vaccine.

30 Jul 2012

Positive results from XIAFLEX phase IIIb multicord trial for Dupuytren's contracture

Auxilium Pharmaceuticals, Inc., a specialty biopharmaceutical company, today announced positive top-line data from its open-label phase IIIb trial evaluating XIAFLEX for the treatment of adult Dupuytren's contracture patients with multiple palpable cords. The Company enrolled 60 patients at eight sites throughout the U.S. and Australia.

30 Jul 2012

Paper highlights clinical and immunological activity of immatics’ IMA901 in renal cell carcinoma

immatics biotechnologies GmbH, a clinical-stage biopharmaceutical company developing advanced therapeutic vaccines that are active against cancer, today announced that key data covering the scientific and clinical development of its lead cancer vaccine, IMA901, have been published in Nature Medicine.

30 Jul 2012

FDA DODAC recommends approval of ThromboGenics’ ocriplasmin for VMA

ThromboGenics NV, a biopharmaceutical company focused on developing innovative ophthalmic medicines, today announces that the US Food and Drug Administration (FDA) Dermatologic and Ophthalmic Drugs Advisory Committee has recommended that the FDA grant ocriplasmin approval for the treatment of symptomatic Vitreomacular Adhesion.

27 Jul 2012