News

Jan 23 2017

ADMA Biologics to Acquire Certain Assets from Biotest Pharmaceuticals Corporation and Become a Vertically Integrated Commercial Plasma Products Company

Jan 23 2017

RAMSEY, N.J., Jan. 23, 2017 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (NASDAQ:ADMA), a late-stage biopharmaceutical company that develops, manufactures, and intends to commercialize specialty plasma-based biologics for the proposed treatment of immune deficiencies and prevention of certain infectious diseases, today announced it signed a definitive agreement to acquire certain manufacturing and therapy-related assets from Biotest Pharmaceuticals Corporation (BPC), a wholly-owned subsidiary of Biotest AG. The transaction, subject to customary closing conditions, including shareholder approval, is expected to close during the first half of 2017.

Jan 19 2017

Zavante Therapeutics Reports Completion Of Patient Treatment In The ZEUS Study Of ZTI-01 (fosfomycin for injection) For The Treatment Of Complicated Urinary Tract Infections

Jan 19 2017

SAN DIEGO, Jan. 19, 2017 /PRNewswire/ -- Zavante Therapeutics, Inc., a privately-held, late clinical-stage biopharmaceutical company, today announced the completion of patient recruitment and treatment in the ZEUS multinational pivotal clinical trial of TI-01 (fosfomycin for injection). ZTI-01 is an investigational antibiotic intended for the treatment of hospitalized patients with complicated urinary tract infections (cUTI), including acute pyelonephritis (AP). ZTI-01, the Company's lead product candidate, is a first-in-class, broad spectrum intravenous antibiotic under development in the U.S. to treat serious infections, including those caused by MDR Gram-negative pathogens.

Jan 18 2017

Paratek Announces Completion of Enrollment in Omadacycline Phase 3 Community-Acquired Bacterial Pneumonia Study

Jan 18 2017

BOSTON, Jan. 18, 2017 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (Nasdaq:PRTK), a biopharmaceutical company focused on the development and commercialization of innovative therapies based upon tetracycline chemistry, announced today that it has completed enrollment in the pivotal Phase 3 clinical study evaluating omadacycline for the treatment of Community Acquired Bacterial Pneumonia (CABP). This study, which is designed to assess the efficacy and safety of intravenous (IV) to once-daily oral omadacycline compared with moxifloxacin in subjects with CABP, enrolled its first patient in November 2015. The company expects to report top-line data from this study in the second quarter of 2017.

Dec 22 2016

Biohaven Enrolls First Patient in Pivotal Trial of BHV-4157 in Patients With Hereditary Spinocerebellar Ataxia

Dec 22 2016

NEW HAVEN, Conn., Dec. 22, 2016 /PRNewswire/ -- Biohaven Pharmaceutical Holding Company Ltd. ("Biohaven" or the "Company") announced today that it has enrolled the first patient in its potentially pivotal Phase 2b/3 clinical trial assessing the efficacy and safety of its drug candidate BHV-4157 in patients with hereditary spinocerebellar ataxia (SCA). SCA is a rare and debilitating neurodegenerative disorder with no currently approved therapies. In May 2016, the U.S. Food and Drug Administration (FDA) granted the company's request for orphan drug designation for BHV-4157, a new chemical entity (NCE) that modulates brain glutamate, for the treatment of SCA. SCA is estimated to affect approximately 10,000 to 20,000 people in the United States. The standard of care treatment is supportive treatment, and no medications are currently approved for this debilitating condition.

Dec 19 2016

Loxo Oncology Outlines Plans for Accelerated Path to U.S. FDA Approval for Larotrectinib (LOXO-101) and Provides Comprehensive Pipeline Update

Dec 19 2016

STAMFORD, Conn., Dec. 19, 2016 (GLOBE NEWSWIRE) -- Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers, today announced a comprehensive program update for larotrectinib (LOXO-101), a selective inhibitor of tropomyosin receptor kinase (TRK), and its pipeline drug candidates, LOXO-292 and LOXO-195.

Dec 19 2016

Loxo Oncology TRK Inhibitor Larotrectinib (LOXO-101) Shows Durable Anti-Tumor Activity Across TRK Fusion Cancers in ESMO Asia Phase 1 Update

Dec 19 2016

STAMFORD, Conn., Dec. 18, 2016 (GLOBE NEWSWIRE) -- Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers, today announced updated results from its adult Phase 1 open-label, dose-escalation trial of larotrectinib (LOXO-101), a selective inhibitor of tropomyosin receptor kinase (TRK). The data were presented today at the 2016 European Society for Medical Oncology (ESMO) Asia Congress in Singapore. Data from this ongoing Phase 1 trial were last reported at the American Association for Cancer Research (AACR) Annual Meeting in April 2016.

Dec 6 2016

Prolacta Bioscience® Raises $35 Million in Mezzanine Financing

Dec 6 2016

CITY OF INDUSTRY, CA--(Marketwired - Dec 6, 2016) - Prolacta Bioscience^®, the nation's leading provider of human milk-based neonatal nutritional products, today announced the closing of a $35 million mezzanine round of financing. The transaction was led by Essex Woodlands and included participation from Aisling Capital, with existing shareholder Health Evolution Partners.

Dec 4 2016

Global Blood Therapeutics Announces New Long-Term Clinical Data from Ongoing Phase 1/2 Trial of GBT440 in Sickle Cell Disease at ASH

Dec 4 2016

SOUTH SAN FRANCISCO, Calif., Dec. 04, 2016 (GLOBE NEWSWIRE) -- Global Blood Therapeutics, Inc. (GBT) (NASDAQ:GBT) today announced the presentation of results from its ongoing Phase 1/2 GBT440-001 study that further support the safety and efficacy profile of GBT440 as a potentially disease-modifying therapy for sickle cell disease (SCD). These data were presented at the 58^th American Society of Hematology (ASH) Annual Meeting & Exposition in San Diego. Results showing how GBT440 is metabolized in healthy subjects were also presented today.

Nov 15 2016

Aclaris Therapeutics Announces Positive Top-Line Phase 3 Results for A-101 In Treating Seborrheic Keratosis, a Common Undertreated Skin Condition

Nov 15 2016

MALVERN, Pa., Nov. 15, 2016 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a dermatologist-led clinical-stage pharmaceutical company focused on defining new standards of care in medical and aesthetic dermatology, today announced that two pivotal Phase 3 trials of its lead product candidate A-101 40% Topical Solution (A-101), a novel treatment for seborrheic keratosis (SK) met all primary and secondary endpoints of each trial, achieving clinically and statistically significant clearance of SK lesions.

Nov 4 2016

Aimmune Therapeutics Announces $145 Million Equity Investment by Nestlé Health Science, Demonstrating Shared Commitment to Advancing Food Allergy Therapeutics

Nov 4 2016

BRISBANE, Calif.--(BUSINESS WIRE)--Aimmune Therapeutics, Inc. (Nasdaq:AIMT), a biopharmaceutical company developing CODIT™ (Characterized Oral Desensitization ImmunoTherapy), an approach to treating life-threatening food allergies, today announced that Nestlé Health Science will make a $145.0 million equity investment in Aimmune. Aimmune and Nestlé Health Science also entered into a strategic collaboration agreement designed to enable the successful development and commercialization of innovative food allergy therapies. Aimmune will retain all current and future pipeline assets developed with the CODIT approach, including AR101, the company’s investigational oral biologic desensitization therapy for peanut allergy, which is currently in Phase 3 clinical development.