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New study offers first clinical recommendations for headache diagnosis in pregnant women

If a pregnant woman with high blood pressure and no history of headache suddenly develops a headache that quickly gets worse, she could be at risk for pregnancy complications, including preeclampsia, which put both the mother and fetus at risk.

20 Aug 2015

Telesta closes US$28.6 million in private placement financing

Telesta Therapeutics Inc. announced today that it has closed a private placement financing of US$28.6 million. This transaction was led by several prominent U.S. healthcare investors, including Consonance Capital Investors, Boxer Capital of Tavistock Life Sciences and Omega Funds. In addition, certain members of the senior management team and board of directors of Telesta participated in the transaction.

19 Aug 2015

AbbVie’s subsidiary to acquire United Therapeutics’ Rare Pediatric Disease Priority Review Voucher

United Therapeutics Corporation announced today that it has entered into an agreement to sell its Rare Pediatric Disease Priority Review Voucher (PPRV) to a subsidiary of AbbVie Inc.

19 Aug 2015

EnGeneIC begins Phase 1 Tailored-EDV trial for advanced solid tumor

EnGeneIC Ltd., an emerging biopharmaceutical company focused on developing its proprietary EDV™ nanocell platform for the targeted delivery of cancer therapeutics, today announced that the first patient has been dosed in its Phase 1 Tailored-EDV trial. The trial is being conducted at the Northern Cancer Institute in Sydney, Australia.

19 Aug 2015

Common diabetes drug metformin works in gut, not the bloodstream

Although metformin was introduced as a treatment for type 2 diabetes nearly 60 years ago and is now the recommended first-line treatment for newly diagnosed patients, researchers still debate precisely how the drug works.

19 Aug 2015

Synthorx employs synthetic DNA technology to produce proteins containing novel amino acids

Synthorx Inc. announced today that the company has employed its proprietary protein expression system to successfully produce proteins containing novel amino acids. Using a semi-synthetic DNA template (containing the synthetic base pair X and Y), Synthorx scientists were able to produce RNA containing X and Y, which was used with an otherwise fully natural biological system, to efficiently direct the incorporation of multiple novel amino acids at different sites in proteins.

19 Aug 2015

Palatin applauds FDA's approval of flibanserin for women living with hypoactive sexual desire disorder

Palatin Technologies, Inc. is a biopharmaceutical company developing targeted, receptor-specific peptide therapeutics for the treatment of diseases with significant unmet medical needs and commercial potential. Palatin's lead product under development is bremelanotide for the treatment of female sexual dysfunction (FSD).

19 Aug 2015

NIH grants Clinical and Translational Science Award to UC San Diego

The Clinical and Translational Research Institute (CTRI) at University of California, San Diego has received a five-year Clinical and Translational Science Award (CTSA) for approximately $52 million from the National Center for Advancing Translational Science, part of the National Institutes of Health.

19 Aug 2015

Intarcia Therapeutics announces positive top-line results from ITCA 650 Phase 3 FREEDOM-2 clinical trial

Intarcia Therapeutics, Inc. today announced positive top-line results from its 52-week Phase 3 FREEDOM-2 clinical trial to determine the comparative efficacy of the company's late-stage investigational candidate ITCA 650 to Merck's Januvia in reducing HbA1c in patients with type 2 diabetes following a year of treatment.

18 Aug 2015

Benitec prices initial public offering of 1,500,000 American Depositary Shares

Benitec Biopharma Limited, a clinical-stage biotechnology company, is pleased to announce the pricing of its U.S. initial public offering of 1,500,000 American Depositary Shares (ADSs), representing 30,000,000 fully paid ordinary shares of Benitec and warrants to purchase 500,000 ADSs, representing 10,000,000 fully paid ordinary shares, at a price of US$9.21 per ADS and US$0.01 per warrant.

18 Aug 2015

Omeros reports additional positive data from OMS721 Phase 2 trial for treatment of thrombotic microangiopathies

Omeros Corporation today announced additional positive data in the company's Phase 2 clinical trial of OMS721 for the treatment of thrombotic microangiopathies (TMAs). TMAs are a family of rare, debilitating and life-threatening disorders characterized by excessive thrombi (clots) – aggregations of platelets – in the microcirculation of the body's organs, most commonly the kidney and brain.

18 Aug 2015

New OTEMTO phase three results show potential improvement to quality of life for COPD patients

Boehringer Ingelheim announced the publication of new data from the Phase IIIb OTEMTO® 1&2 trials (NCT01964352/NCT02006732), which show Spiolto® Respimat® (tiotropium/olodaterol) provides consistent, clinically meaningful improvements in quality of life versus placebo in patients with COPD

17 Aug 2015

Omeros plans to file patent infringement lawsuit against Par

Omeros Corporation today, in response to investor questions, announced that it plans to file a patent infringement lawsuit against Par Pharmaceutical, Inc. and its subsidiary, Par Sterile Products, LLC in response to the Abbreviated New Drug Application (ANDA) filed by Par seeking FDA approval to market a generic version of Omeros' commercial drug Omidria (phenylephrine and ketorolac injection) 1%/0.3%.

17 Aug 2015

Unituxin (dinutuximab) granted EC Marketing Authorisation for treatment of childhood neuroblastoma

United Therapeutics Corporation announced today that the European Commission (EC) has granted Marketing Authorisation for Unituxin (dinutuximab) for the treatment of high-risk neuroblastoma in patients aged 12 months to 17 years, who have previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and autologous stem cell transplantation (ASCT).

17 Aug 2015

PTC Therapeutics closes $150 million of convertible senior notes

PTC Therapeutics, Inc. announced today the closing of its previously announced private offering of $150 million in aggregate principal amount of its convertible senior notes due 2022 (the "Notes"), including the full exercise by the initial purchasers of an option to purchase an additional $25 million in aggregate principal amount of the Notes.

14 Aug 2015

CASI reports financial results for second quarter 2015

CASI Pharmaceuticals, Inc., a biopharmaceutical company dedicated to the acquisition, development and commercialization of innovative therapeutics addressing cancer and other unmet medical needs for the global market with a commercial focus on China, today reported financial results for the three and six months ended June 30, 2015.

14 Aug 2015

Rhythm Metabolic completes $40 million Series A financing

Rhythm announced today the completion of a $40 million Series A financing for its subsidiary, Rhythm Metabolic, Inc., which is developing setmelanotide (RM-493), a novel peptide MC4 agonist for the treatment of obesity caused by genetic deficiencies in the MC4 pathway.

13 Aug 2015

ImmunoCellular signs agreement with FDA for phase 3 registrational trial of cancer immunotherapy ICT-107

ImmunoCellular Therapeutics, Ltd. announced today that it has reached agreement with the US Food and Drug Administration on a Special Protocol Assessment (SPA) for the phase 3 registrational trial of its cancer immunotherapy ICT-107 to treat patients with newly diagnosed glioblastoma.

13 Aug 2015

Inhibikase Therapeutics launches observational clinical study in patients who survived PML

Inhibikase Therapeutics, Inc. announces the launch of an observational clinical study in patients who contracted Progressive Multifocal Leukoencephalopathy (PML), the rare and often fatal brain infection that arises as an unintended side effect of some medications used for treatment of Multiple Sclerosis, Crohn's disease, Ulcerative Colitis and certain cancers of the blood and lymph.

13 Aug 2015

BDSI announces FDA approval of sNDA for new formulation of ONSOLIS (fentanyl buccal soluble film) CII

BioDelivery Sciences International, Inc. announced the approval by the U.S. Food and Drug Administration of a Supplemental New Drug Application (sNDA) for a new formulation of ONSOLIS (fentanyl buccal soluble film) CII for the management of breakthrough pain in patients with cancer who are opioid tolerant.

13 Aug 2015

Therapeutics News and Research

New study offers first clinical recommendations for headache diagnosis in pregnant women

Telesta closes US$28.6 million in private placement financing

AbbVie’s subsidiary to acquire United Therapeutics’ Rare Pediatric Disease Priority Review Voucher

EnGeneIC begins Phase 1 Tailored-EDV trial for advanced solid tumor

Common diabetes drug metformin works in gut, not the bloodstream

Synthorx employs synthetic DNA technology to produce proteins containing novel amino acids

Palatin applauds FDA's approval of flibanserin for women living with hypoactive sexual desire disorder

NIH grants Clinical and Translational Science Award to UC San Diego

Intarcia Therapeutics announces positive top-line results from ITCA 650 Phase 3 FREEDOM-2 clinical trial

Benitec prices initial public offering of 1,500,000 American Depositary Shares

Omeros reports additional positive data from OMS721 Phase 2 trial for treatment of thrombotic microangiopathies

New OTEMTO phase three results show potential improvement to quality of life for COPD patients

Omeros plans to file patent infringement lawsuit against Par

Unituxin (dinutuximab) granted EC Marketing Authorisation for treatment of childhood neuroblastoma

PTC Therapeutics closes $150 million of convertible senior notes

CASI reports financial results for second quarter 2015

Rhythm Metabolic completes $40 million Series A financing

ImmunoCellular signs agreement with FDA for phase 3 registrational trial of cancer immunotherapy ICT-107

Inhibikase Therapeutics launches observational clinical study in patients who survived PML

BDSI announces FDA approval of sNDA for new formulation of ONSOLIS (fentanyl buccal soluble film) CII

Advancing therapeutic biopolymer development eBook

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

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