News

Mar 18 2019

Biohaven Secures Priority Review Voucher (PRV) To Expedite Regulatory Review Of Rimegepant Zydis ODT New Drug Application

Mar 18 2019

NEW HAVEN, Conn., March 18, 2019 /PRNewswire/ — Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN), a clinical-stage biopharmaceutical company with a portfolio of innovative, late-stage product candidates targeting neurological and neuropsychiatric diseases, including rare disorders, today announced that the company has purchased a U.S. Food and Drug Administration (FDA) priority review voucher (PRV) to use with the NDA submission of rimegepant Zydis®ODT in the second quarter of 2019. The PRV entitles the holder to designate an NDA for priority review and provides for an expedited 6-month review.

READ MORE

Mar 18 2019

U.S. FDA Accepts BLA Filing of Aimmune Therapeutics’ AR101 for Peanut Allergy

Mar 18 2019

BRISBANE, Calif.–(BUSINESS WIRE)–Mar. 18, 2019– Aimmune Therapeutics, Inc. (Nasdaq: AIMT), a biopharmaceutical company developing treatments for life-threatening food allergies, today announced that the Biologics License Application (BLA) for AR101 has been accepted for review by the U.S. Food and Drug Administration (FDA).

READ MORE

Mar 18 2019

Alcon Announces Acquisition of PowerVision, Inc.

Mar 18 2019

Fort Worth, Texas, March 18, 2019 – Alcon, the global leader in eye care and a division of Novartis, announced today that it has acquired PowerVision, Inc., a privately-held, US-based medical device development company focused on creating fluid-based intraocular lens implants. The acquisition furthers Alcon’s commitment to bring this innovative, accommodating lens to cataract patients throughout the world.

READ MORE

Mar 4 2019

Verona Pharma Reports Positive Interim Data with Ensifentrine Dry Powder Inhaler Formulation in First of Two-Part Phase 2 Clinical Trial in COPD

Mar 4 2019

LONDON, March 04, 2019 (GLOBE NEWSWIRE) — Verona Pharma plc (AIM:VRP) (Nasdaq: VRNA) (“Verona Pharma”), a clinical stage biopharmaceutical company focused on developing and commercializing innovative therapies for respiratory diseases, announces positive interim efficacy and safety data from part one of a two-part Phase 2 clinical trial of a dry powder inhaler (“DPI”) formulation of ensifentrine in patients with moderate-to-severe chronic obstructive pulmonary disease (“COPD”). The positive data support initiation of the second part of the Phase 2 trial to evaluate the ensifentrine DPI formulation in patients with moderate-to-severe COPD over one week of twice-daily treatment.

READ MORE

Feb 27 2019

Eidos Therapeutics Initiates ATTRibute-CM, A Phase 3 Study Of AG10 In ATTR-CM With Registrational 12-Month Endpoint

Feb 27 2019

SAN FRANCISCO, Feb. 27, 2019 (GLOBE NEWSWIRE) — Eidos Therapeutics, Inc. (Eidos) (Nasdaq:EIDX), today announced the initiation and design of its pivotal global Phase 3 trial (ATTRibute-CM) of AG10 in patients with transthyretin (TTR) amyloid cardiomyopathy (ATTR-CM). The design of the ATTRibute-CM study, which incorporates feedback from FDA, includes two potentially registrational endpoints. In Part A, benefit in change from baseline in 6-minute walk distance (6MWD) will be evaluated at 12 months, potentially accelerating the time to registration. In Part B, reduction in all-cause mortality and frequency of cardiovascular-related hospitalizations will be evaluated at 30 months.

READ MORE

Feb 21 2019

Zosano Announces Completion of the Final Milestone in the Long-Term Safety Study of Qtrypta™ for the Acute Treatment of Migraine Disease

Feb 21 2019

FREMONT, Calif., Feb. 21, 2019 (GLOBE NEWSWIRE) — Zosano Pharma Corporation (NASDAQ:ZSAN), a clinical-stage biopharmaceutical company, today announced the completion of the second and final goal of the long-term safety study for Qtrypta, in which patients treated migraine attacks over a one year period.  The long-term data generated in this trial reinforced the well-tolerated safety profile and strong efficacy results previously reported in the six-month dosing portion of this safety study and in the randomized Phase 2/3 ZOTRIP pivotal study. Throughout the clinical program, over 5,800 migraine attacks have been treated with Qtrypta to date.

READ MORE

Feb 19 2019

Nabriva Therapeutics Announces Acceptance of New Drug Applications by the FDA for Intravenous and Oral Lefamulin to Treat Community-Acquired Bacterial Pneumonia in Adults

Feb 19 2019

DUBLIN, Ireland, Feb. 19, 2019 (GLOBE NEWSWIRE) — Nabriva Therapeutics plc (NASDAQ: NBRV), a clinical-stage biopharmaceutical company engaged in the research and development of innovative anti-infective agents to treat serious infections, announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Applications (NDAs) and granted a priority review for both the intravenous (IV) and oral formulations of lefamulin, a potentially first-in-class, semi-synthetic pleuromutilin antibiotic, for the treatment of community-acquired bacterial pneumonia (CABP). The acceptance of lefamulin’s two NDAs indicates that the FDA has deemed both applications sufficiently complete to allow a substantive review. Both applications have been granted priority review and the Prescription Drug User Fee Act (PDUFA) goal date for the completion of the FDA’s review is August 19, 2019. In addition to priority review, lefamulin has been granted Qualified Infectious Disease Product (QIDP) and Fast Track designations by the FDA.

READ MORE

Feb 12 2019

ADMA Biologics Enters Into $72.5 Million Loan Facility With Perceptive Advisors

Feb 12 2019

RAMSEY, N.J. and BOCA RATON, Fla., Feb. 12, 2019 (GLOBE NEWSWIRE) — ADMA Biologics, Inc. (NASDAQ: ADMA) (“ADMA” or the “Company”), a vertically integrated commercial biopharmaceutical and specialty immunoglobulin company that manufactures, markets and develops specialty plasma-derived biologics for the treatment of immune deficiencies and the prevention of certain infectious diseases, announces that it has entered into a senior secured term loan facility with Perceptive Advisors (“Perceptive”) for up to $72.5 million under two funding tranches. The first loan facility tranche from Perceptive of $45 million was used to prepay ADMA’s former senior secured credit facility of $30 million in full plus associated costs and fees. The second loan facility tranche from Perceptive of $27.5 million is predicated on United States Food and Drug Administration (“FDA”) approval of either the BIVIGAM® Prior Approval Supplement or the RI-002 Biologics License Application and is available at ADMA’s election through June 30, 2020, with a minimum draw down of $10 million. The Perceptive loan facility provides for an interest only period through the entire duration of the loan facility maturing in March 2022, as well as a more favorable interest rate as compared to ADMA’s former senior secured credit facility. Additionally, the new Perceptive loan facility does not include any back-end fees.

READ MORE

Feb 12 2019

Harmony Biosciences Announces File Acceptance Of Its New Drug Application For Pitolisant

Feb 12 2019

PLYMOUTH MEETING, Pa.Feb. 12, 2019 /PRNewswire/ — Harmony Biosciences, LLC (Harmony) announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for its investigational product, pitolisant, and has granted Priority Review for this NDA. Pitolisant is a first-in-class molecule with a novel mechanism of action; it is a potent and highly selective histamine 3 (H3) receptor antagonist/inverse agonist for the potential treatment of excessive daytime sleepiness (EDS) and/or cataplexy in adult patients with narcolepsy. A Priority Review designation by the FDA indicates that, if approved, pitolisant would provide a significant improvement in the safety or effectiveness of the treatment of EDS and/or cataplexy in adult patients with narcolepsy when compared to existing treatments. Harmony’s goal is to obtain FDA approval to market pitolisant in the U.S. in 2019.

READ MORE

Feb 12 2019

Harmony Biosciences Announces File Acceptance Of Its New Drug Application For Pitolisant

Feb 12 2019

PLYMOUTH MEETING, PA, February 12, 2019 — Harmony Biosciences, LLC (Harmony), announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for its investigational product, pitolisant, and has granted Priority Review for this NDA. Pitolisant is a first-in-class molecule with a novel mechanism of action; it is a potent and highly selective histamine 3 (H₃) receptor antagonist/inverse agonist for the potential treatment of excessive daytime sleepiness (EDS) and/or cataplexy in adult patients with narcolepsy. A Priority Review designation by the FDA indicates that, if approved, pitolisant would provide a significant improvement in the safety or effectiveness of the treatment of EDS and/or cataplexy in adult patients with narcolepsy when compared to existing treatments. Harmony’s goal is to obtain FDA approval to market pitolisant in the U.S. in 2019.

READ MORE