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Jun 27 2017

Esperion Announces FDA Confirmation of Regulatory Pathway to Approval for the Combination of Bempedoic Acid and Ezetimibe

Jun 27 2017

ANN ARBOR, Mich., June 26, 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 the regulatory pathway to approval for the once-daily, oral combination pill of bempedoic acid 180 mg and ezetimibe 10 mg. Based on feedback received from the FDA, Esperion plans to initiate a single global pivotal Phase 3 bridging study (1002FDC-053) for the bempedoic acid / ezetimibe combination pill that will be conducted concurrently with the ongoing global pivotal Phase 3 program for bempedoic acid. The Phase 3 bridging study will support approval for an LDL-C lowering indication in both the U.S. and Europe. The randomized, double-blind, placebo-controlled study is expected to enroll up to 350 patients with hypercholesterolemia and with atherosclerotic cardiovascular disease (ASCVD) and/or heterozygous familial hypercholesterolemia (HeFH), including high cardiovascular risk primary prevention patients, whose LDL-C is not adequately controlled. The goal of this study is to evaluate the efficacy and safety of the bempedoic acid / ezetimibe combination, a convenient, cost-effective, once-daily, oral pill. Additional design details for this study will be provided upon initiation by the fourth quarter of 2017, with top-line results expected by the end of 2018.

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Jun 12 2017

Sientra to Acquire Miramar Labs

Jun 12 2017

SANTA BARBARA, Calif. and SANTA CLARA, Calif., June 12, 2017 (GLOBE NEWSWIRE) — Sientra, Inc. (NASDAQ:SIEN) (“Sientra” or the “Company”), a medical aesthetics company, and Miramar Labs, Inc. (OTCQB:MRLB) (“Miramar”), a global medical device company dedicated to bringing innovative and clinically proven applications to treat unmet needs in the aesthetic marketplace, announced today that they have entered into a definitive agreement under which Sientra has agreed to acquire Miramar for an aggregate transaction value of $20 million in upfront cash plus contractual rights for potential contingent payments of up to $14 million in cash upon the achievement of certain milestones, which would be paid to holders of Miramar equity, debt and other obligations.

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Jun 6 2017

ADMA Biologics Completes Acquisition of Biotest’s Therapy Business Unit Assets

Jun 6 2017

RAMSEY, N.J., June 06, 2017 (GLOBE NEWSWIRE) — ADMA Biologics, Inc. (NASDAQ:ADMA), a late-stage biopharmaceutical company that develops, manufactures and commercializes specialty plasma-based biologics for the proposed treatment of immune deficiencies and prevention of certain infectious diseases, announced today that its acquisition of the assets of Biotest Pharmaceuticals Corporation’s Therapy Business Unit (BTBU) has been completed.  ADMA has assumed operational control of the assets and has formally commenced integration activities. As a result of this transaction, ADMA has acquired two U.S. Food and Drug Administration (FDA) licensed products, Nabi-HB™ (Hepatitis B Immune Globulin, Human) and BIVIGAM™ (Immune Globulin Intravenous, Human), manufacturing and testing operations consisting of two facilities totaling approximately 126,000 square feet on approximately 15 acres of land located in Boca Raton, Florida and has received $27.5 million in cash ($15.0 million of which is in the form of a subordinated loan from Biotest Pharmaceuticals Corporation), with an additional $12.5 million commitment from Biotest Pharmaceuticals Corporation to invest in future ADMA equity financings.

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Jun 5 2017

Loxo Oncology Breakthrough Therapy Larotrectinib Demonstrates 76 Percent Confirmed Objective Response Rate in TRK Fusion Adult and Pediatric Cancers as Presented at the American Society of Clinical Oncology

Jun 5 2017

STAMFORD, Conn., June 03, 2017 (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 interim clinical data from all three ongoing larotrectinib (LOXO-101) clinical trials in patients whose tumors harbor tropomyosin receptor kinase (TRK) fusions. These data, demonstrating a 76 percent confirmed objective response rate (ORR) across tumor types, are being presented today at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago (abstract LBA2501). The larotrectinib pediatric data, included in this presentation, are also being presented in a separate oral presentation on Monday, June 5th (abstract 10510).

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May 30 2017

Protagonist Therapeutics Enters into Worldwide Agreement with Janssen to Co-Develop and Commercialize PTG-200 for Inflammatory Bowel Disease

May 30 2017

NEWARK, Calif., May 30, 2017 /PRNewswire/ — Protagonist Therapeutics, Inc. (Nasdaq: PTGX) today announced that the company has entered into a worldwide license and collaboration agreement with Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, for the co-development and commercialization of PTG-200, Protagonist’s first-in-class, oral peptide IL-23 receptor antagonist for all indications including inflammatory bowel disease (IBD). PTG-200 is expected to enter Phase 1 clinical testing in normal healthy volunteers in the second half of 2017. The agreement builds upon a Johnson & Johnson Innovation – JJDC, Inc. Series B venture financing from 2013 in support of the discovery and development of Protagonist’s pipeline of oral peptide therapeutics.

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May 30 2017

Biohaven Completes Enrollment In Spinocerebellar Ataxia Clinical Trial With Trigriluzole

May 30 2017

NEW HAVEN, Conn., May 30, 2017 /PRNewswire/ — (NYSE: BHVN) — Biohaven Pharmaceutical Holding Company Ltd. (Biohaven) announced today that the company has completed enrollment in its clinical study of trigriluzole (BHV-4157) in patients with spinocerebellar ataxia (SCA). Trigriluzole, a novel drug candidate being developed by Biohaven, has received both Orphan Drug Designation and Fast Track Designation from the U.S. Food and Drug Administration (FDA) as a potential treatment for SCA.  SCA is a rare, debilitating neurodegenerative disorder that is estimated to affect approximately 22,000 people in the United States. No medications are currently approved for this often severe condition.

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May 15 2017

Biohaven's Trigriluzole Receives Fast Track Designation From U.S. FDA

May 15 2017

NEW HAVEN, Conn., May 15, 2017 /PRNewswire/ — (NYSE: BHVN) — Biohaven Pharmaceutical Holding Company Ltd. (Biohaven) announced today that the U.S. Food and Drug Administration (FDA) has granted the company Fast Track Designation for Biohaven’s product candidate trigriluzole (BHV-4157) for the potential treatment of Spinocerebellar Ataxia (SCA).  Trigriluzole previously received Orphan Drug Designation from the FDA for the treatment of SCA in 2016. Biohaven is currently conducting a Phase 2/3 clinical trial in patients with SCA, with topline results expected in 2018.

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May 15 2017

Syros Announces First Patient Dosed in Phase 1 Clinical Trial of SY-1365, its First-in-Class Selective CDK7 Inhibitor, in Patients with Advanced Solid Tumors

May 15 2017

CAMBRIDGE, Mass.–(BUSINESS WIRE)–May 15, 2017– Syros Pharmaceuticals (NASDAQ: SYRS), a biopharmaceutical company pioneering the discovery and development of medicines to control the expression of disease-driving genes, announced today that the first patient has been dosed in the Phase 1 clinical trial of SY-1365, its first-in-class selective cyclin-dependent kinase 7 (CDK7) inhibitor, in patients with advanced solid tumors, including transcriptionally dependent cancers such as triple negative breast, small cell lung and ovarian cancers.

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May 10 2017

Loxo Oncology Announces Enrollment of First Patient in Phase 1 Clinical Trial for Highly Selective RET Inhibitor, LOXO-292

May 10 2017

STAMFORD, Conn., May 10, 2017 (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 that the first patient has been enrolled in the Phase 1 clinical trial of LOXO-292, an investigational, highly potent and selective RET inhibitor. RET gene alterations are thought to play a key role in the development of certain cases of lung, thyroid, colon and other cancers.

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May 9 2017

FDA Accepts Aclaris Therapeutics’ New Drug Application for Topical Treatment of Seborrheic Keratosis, a Common Skin Condition

May 9 2017

MALVERN, Pa., May 09, 2017 (GLOBE NEWSWIRE) — Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a dermatologist-led biotechnology company, today announced that the U.S. Food and Drug Administration has accepted its New Drug Application (NDA) A-101 40% topical solution (A-101 40%), an investigational drug, for the potential treatment of seborrheic keratosis (SK), a common skin condition. The NDA acceptance by the FDA in its 74-day letter indicates that the application is sufficiently complete to permit a substantive review. The PDUFA target action date for the completion of the FDA’s review of the NDA is December 24, 2017. If approved, A-101 40% would be the first FDA-approved topical medication for the treatment of SK.

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