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Mar 20 2017

Esperion Announces FDA Confirmation Regarding Regulatory Pathway to Approval for an LDL-C Lowering Indication for Bempedoic Acid

Mar 20 2017

ANN ARBOR, Mich., March 20, 2017 (GLOBE NEWSWIRE) — Esperion Therapeutics, Inc. (NASDAQ:ESPR), the lipid management company focused on developing and commercializing convenient, complementary, cost-effective, once-daily, oral therapies for the treatment of patients with elevated low density lipoprotein cholesterol (LDL-C), today announced the U.S. Food and Drug Administration (FDA) recently confirmed that Esperion’s LDL-C lowering program is adequate to support approval of an LDL-C lowering indication for bempedoic acid.

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Mar 8 2017

Intersect ENT Submits New Drug Application to FDA for Office-Based RESOLVE Steroid Releasing Implant for Recurrent Chronic Sinus Disease

Mar 8 2017

Menlo Park, Calif. – March 8, 2017 – Intersect ENT, Inc. (Nasdaq: XENT), a company dedicated to improving the quality of life for patients with ear, nose and throat conditions, today announced submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for review and approval of the company’s investigational RESOLVE steroid releasing implant. Placed during a routine physician office visit, the RESOLVE steroid releasing implant is designed to provide a less invasive treatment option for patients with recurrent ethmoid sinus obstruction, including polyps, who might otherwise warrant a repeat surgical procedure.

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Mar 7 2017

Biohaven Closes Second Tranche Of Private Placement And Appoints Two New Directors To Board

Mar 7 2017

NEW HAVEN, Conn., March 7, 2017 /PRNewswire/ — Biohaven Pharmaceutical Holding Company Ltd. (“Biohaven”), a privately-held, clinical stage biopharmaceutical company with a portfolio of innovative, late-stage product candidates targeting neurological diseases, including rare disorders, announced today that it has completed the second tranche of its previously disclosed $80 million private financing. Together with the proceeds raised under the first tranche, Biohaven has now raised over $100 million in private capital since its inception.  The financing was led by Venrock and joined by other leading biotech investors including Vivo Capital, RA Capital Management, Aisling Capital, Rock Springs Capital, John W. Childs, Greg Bailey, Knoll Capital Management, Osage University Partners, Aperture Venture Partners, Connecticut Innovations, and Litmore Capital. All investors who participated in the first tranche also participated in the second tranche.

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Mar 2 2017

Versartis Announces Data on Long-Acting Somavaratan for Growth Hormone Deficiency to be Featured in Late-Breaker Presentation at ENDO 2017

Mar 2 2017

MENLO PARK, Calif., March 02, 2017 (GLOBE NEWSWIRE) — Versartis, Inc. (NASDAQ:VSAR), an endocrine-focused biopharmaceutical company that is developing somavaratan (VRS-317), a novel, long-acting form of recombinant human growth hormone (rhGH) for growth hormone deficiency (GHD), announced that a comparison of data from its U.S. and Japanese Phase 2 studies was accepted as a late-breaking poster presentation at the Endocrine Society’s 99th Annual Meeting & Expo (ENDO 2017), to be held April 1-4, in Orlando, Florida. The abstract has been published online and is available on the ENDO 2017 website. This is the sixth Versartis abstract that has been accepted for presentation at the conference, including five that were announced previously.

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Feb 27 2017

ViewRay Receives FDA 510(k) Clearance for MRIdian Linac

Feb 27 2017

CLEVELAND, February 27, 2017 – ViewRay, Inc. (Nasdaq: VRAY) announced today that the company received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the MRIdian Linac system, the company’s next generation linear accelerator-based MRI-guided radiation therapy system.

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Feb 27 2017

Aclaris Therapeutics Submits New Drug Application for A-101 as a Novel Treatment for Seborrheic Keratosis – a Common Skin Condition

Feb 27 2017

MALVERN, Pa., Feb. 27, 2017 (GLOBE NEWSWIRE) — Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a dermatologist-led, biotechnology company focused on defining new standards of care in medical and aesthetic dermatology, today announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for A-101 40% topical solution (A-101) as a treatment for seborrheic keratosis (SK). A-101, an investigational drug, is being developed by Aclaris as a non-invasive, in-office topical treatment for SK.

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Feb 24 2017

Intersect ENT Announces FDA Approval of Newest Steroid Releasing Implant, PROPEL® Contour, for Use in Treating the Frontal and Maxillary Sinuses

Feb 24 2017

Menlo Park, Calif. – February 24, 2017 – Intersect ENT, Inc. (Nasdaq:XENT), a company dedicated to transforming care for patients with ear, nose and throat conditions, today announced that the company has received approval from the U.S. Food and Drug Administration (FDA) for its PROPEL® Contour steroid releasing sinus implant. PROPEL Contour features an innovative hourglass design that facilitates treatment of patients with chronic sinusitis in the frontal (behind the forehead) and maxillary (behind the cheeks) sinuses.With this approval, Intersect ENT’s PROPEL family of steroid releasing implants allows for treatment of patients undergoing ethmoid, frontal or maxillary surgeries, which represent the majority of procedures for the treatment of chronic sinusitis.

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Feb 13 2017

Allergan to Acquire ZELTIQ, Best-in-Class Company in Fast-Growing Body Contouring Segment, for $2.47 Billion

Feb 13 2017

DUBLIN and PLEASANTON, Calif., Feb. 13, 2017 /PRNewswire/ — Allergan plc (NYSE: AGN), a leading global biopharmaceutical company, and ZELTIQ® Aesthetics, Inc. (NASDAQ: ZLTQ) a medical technology company focused on developing and commercializing products utilizing its proprietary controlled-cooling technology platform, today announced that they have entered into a definitive agreement under which Allergan has agreed to acquire ZELTIQ for $56.50 per share, or $2.475 billion, subject to customary adjustments.

The acquisition of ZELTIQ is immediately accretive and enhances Allergan’s global medical aesthetics portfolio with the addition of ZELTIQ’s flagship CoolSculpting® System, the sales leader in the fast-growing cash pay body contouring segment of medical aesthetics. The CoolSculpting System is FDA-cleared to affect appearance through lipolysis or reduction of unwanted fat using a patented cooling technology. CoolSculpting works by gently cooling targeted fat cells in the body to induce a natural, controlled elimination of fat cells without affecting surrounding tissue. Body contouring is a $4 billion market opportunity worldwide and growing.

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Jan 25 2017

Esperion Completes Enrollment of Pivotal Phase 3 Long-Term Safety and Tolerability Study of Bempedoic Acid in Patients with Hypercholesterolemia

Jan 25 2017

ANN ARBOR, Mich., Jan. 25, 2017 (GLOBE NEWSWIRE) — Esperion Therapeutics, Inc. (NASDAQ:ESPR), the lipid management company focused on developing and commercializing convenient, complementary, cost-effective, once-daily, oral therapies for the treatment of patients with elevated low density lipoprotein cholesterol (LDL-C), today announced completion of patient enrollment in the global pivotal Phase 3 long-term safety and tolerability study of bempedoic acid. Enrollment of this study was completed ahead of schedule in approximately 2,000 patients treated with bempedoic acid or placebo at high cardiovascular disease (CVD) risk with hypercholesterolemia whose LDL-C is not adequately controlled with current lipid-modifying therapies. Top-line results from this study are expected by Q2 2018.

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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.

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