News

Oct 17 2018

ADMA Biologics Receives PDUFA Date for RI-002

Oct 17 2018

RAMSEY, N.J. and BOCA RATON, Fla., Oct. 17, 2018 (GLOBE NEWSWIRE) — ADMA Biologics, Inc. (NASDAQ: ADMA) (“ADMA” or the “Company”), a vertically integrated commercial biopharmaceutical company that develops, manufactures and markets specialty plasma-based biologics for the treatment of Primary Immune Deficiency Disease (“PIDD”) and the prevention and treatment of certain infectious diseases, announces that the U.S. Food and Drug Administration (“FDA”) has acknowledged the receipt of ADMA’s September 28, 2018 BLA resubmission for RI-002.  The FDA stated that it considers the RI-002 BLA resubmission ‘a complete, Class 2 response’ and has established an action due date of April 2, 2019, under the Prescription Drug User Fee Act (“PDUFA”).

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Oct 15 2018

Aclaris Therapeutics to Acquire Worldwide Rights to RHOFADE® from Allergan

Oct 15 2018

WAYNE, Pa., Oct. 15, 2018 (GLOBE NEWSWIRE) — Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a dermatologist-led biopharmaceutical company focused on identifying, developing, and commercializing innovative therapies to address significant unmet patient needs in aesthetic and medical dermatology and immunology, today announced it has entered into a definitive asset purchase agreement with Allergan Sales, LLC to acquire worldwide rights to RHOFADE® (oxymetazoline hydrochloride) cream, 1% and additional intellectual property. The acquisition includes an exclusive license to certain intellectual property for RHOFADE, which is approved for the topical treatment of persistent facial erythema (redness) associated with rosacea in adults. This transaction, which is subject to customary closing conditions, including certain governmental regulatory clearances, is expected to close in the fourth quarter of 2018. Allergan has agreed to provide support to Aclaris to allow for a smooth transition of RHOFADE.

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Oct 6 2018

Loxo Oncology Announces LOXO-292 Durability Update in Patients with RET-Mutant Medullary Thyroid Cancer and RET Fusion-Positive Thyroid Cancer from LIBRETTO-001 at the 88th Annual Meeting of the American Thyroid Association

Oct 6 2018

STAMFORD, Conn., Oct. 06, 2018 (GLOBE NEWSWIRE) — Loxo Oncology, Inc. (Nasdaq: LOXO), a biopharmaceutical company developing highly selective medicines for patients with genomically defined cancers, today announced updated interim clinical data for LOXO-292 from the global Phase 1/2 LIBRETTO-001 trial in patients with RET-mutant medullary thyroid cancer (MTC) and RET fusion-positive thyroid cancer who were initially included in the LOXO-292 presentation at the 2018 ASCO Annual Meeting. In these 38 patients, approximately 3.5 months of additional patient follow-up were available, as were first follow-up scans for the nine patients most recently enrolled. Sixteen of 17 (94%) responding RET-mutant MTC patients remained on therapy, with median follow-up of 8.4 months. Seven of seven (100%) responding RET fusion-positive thyroid cancer patients remained on therapy, with median follow-up of 8.5 months. Inclusion of new restaging data for the most recently enrolled patients resulted in a 59% overall response rate (56% confirmed overall response rate) in the presented subset of RET-mutant MTC patients, and a 78% confirmed overall response rate in the presented subset of RET fusion-positive thyroid cancer patients. These data are being presented today at the 88th Annual Meeting of the American Thyroid Association.

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Oct 3 2018

ObsEva SA reports additional positive Phase 3 results of IMPLANT 2 trial showing significant increase of Live Birth Rate (LBR) following IVF with Single Embryo Transfer (SET)

Oct 3 2018

Geneva, Switzerland and Boston, MA – October 3, 2018 – ObsEva SA (NASDAQ: OBSV / SIX: OBSN), a Swiss clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapeutics for serious conditions that compromise a woman’s reproductive health and pregnancy, today announced additional positive Phase 3 data from the IMPLANT 2 trial of its oral, oxytocin receptor antagonist, Nolasiban in patients undergoing IVF procedures, as well as future development plans following receipt of EU regulatory feedback. Data from the IMPLANT 2 trial showed that Nolasiban significantly increased live birth rate following IVF treatment.

Live birth rate (LBR), also called “Take Home Baby” rate is a key secondary endpoint in IMPLANT 2 trial of Nolasiban in IVF, and these new results show a clinically and statistically significant benefit in favor of Nolasiban. In the primary population, combined Day 3 and Day 5 embryo transfer (ET), treatment with Nolasiban as a single 900mg oral dose 4h prior ET resulted in a live birth rate of 34.8% vs. 27.7% for patients receiving placebo, a 25% relative increase (p=0.025). The live birth rate in women undergoing Day 5 ET was 44.8% for those receiving Nolasiban, vs 33.2% for those receiving placebo, a 35% relative increase (p value=0.025). LBR is an important endpoint as live birth is the ultimate goal of couples who undergo IVF treatment. These data are very consistent with the 10-week pregnancy rate of 35.6% for Nolasiban vs. 28.5% for placebo (p=0.031) that were reported in February 2018.

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Oct 3 2018

ADMA BioCenters Receives FDA Approval for Third Plasma Collection Center

Oct 3 2018

RAMSEY, N.J. and MARIETTA, Ga., Oct. 03, 2018 (GLOBE NEWSWIRE) — ADMA Biologics, Inc. (NASDAQ: ADMA) (“ADMA” or the “Company”), a vertically integrated commercial biopharmaceutical company that develops, manufactures and markets specialty plasma-based biologics for the treatment of Primary Immune Deficiency Disease (“PIDD”) and the prevention and treatment of certain infectious diseases, announces that the Company’s wholly-owned subsidiary, ADMA BioCenters, has received U.S. Food and Drug Administration (“FDA”) approval for its third plasma collection center, located at 166 Ernest W Barrett Parkway, NW, Marietta, Georgia. The facility commenced operations and initiated source plasma collection in December 2017, and is now FDA licensed to collect and enter into interstate commerce to sell and use the human source plasma for further manufacturing in the U.S.

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Oct 1 2018

AVROBIO Announces Updated Clinical Data for AVR-RD-01 Gene Therapy in Fabry Disease

Oct 1 2018

CAMBRIDGE, Mass., Oct. 01, 2018 (GLOBE NEWSWIRE) — AVROBIO, Inc. (Nasdaq: AVRO) (the “Company”), a Phase 2 clinical-stage gene therapy company developing gene therapies to potentially cure rare diseases with a single dose, today announced clinical data and patient updates from the investigator-sponsored Phase 1 study and the AVROBIO-sponsored Phase 2 clinical trial of AVR-RD-01. AVR‑RD‑01 is an ex vivo lentiviral gene therapy being investigated in Fabry disease. Designed to be a one-time therapy, it works by inserting the GLA gene that encodes functional α‑galactosidase A (AGA, the enzyme that is deficient in Fabry disease) to enable continuous AGA production and distribution to tissues and organs.

“We are encouraged by the AGA enzyme activity we are seeing after treatment with AVR-RD-01 in the first two patients with Fabry disease in the Phase 1 study. Both of these patients have AGA activity that remains above the diagnostic range for males with classic Fabry disease, and all patients will continue to be followed for assessment of long-term durable response. We are especially pleased that patient 1 was taken off ERT in mid-July and remains off,” said Geoff MacKay, President and CEO of AVROBIO.

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Sep 28 2018

Final results of ObsEva SA Phase 2b EDELWEISS trial of Linzagolix show sustained efficacy and Bone Mineral Density safety, for the treatment of endometriosis-associated pain

Sep 28 2018

Geneva, Switzerland and Boston, MA – September 28, 2018- ObsEva SA (NASDAQ: OBSV / SIX: OBSN), a Swiss clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapeutics for serious conditions that compromise a woman’s reproductive health and pregnancy, today announced additional positive results from the EDELWEISS clinical trial of its oral GnRH receptor antagonist, linzagolix, for the treatment of endometriosis-associated pain.

In the EDELWEISS trial, hallmark pain symptoms of endometriosis, dysmenorrhea (DYS) and non-menstrual pelvic pain (NMPP), showed sustained reduction or further improvement after 24 weeks of treatment, as compared to the positive 12-week results that were announced in June 2018. Sustained efficacy was also seen in additional endpoints such as dyspareunia and dyschezia, as well as in the assessments of patient well-being, most notably the Patient Global Impression of Change (PGIC) and Endometriosis Health Profile-30 (EHP-30) questionnaire.

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Sep 23 2018

TransEnterix Acquires Assets, Intellectual Property and Retains R&D Team from MST Medical Surgery Technologies

Sep 23 2018

RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–Sep. 23, 2018– TransEnterix, Inc. (NYSE American: TRXC), a medical device company that is digitizing the interface between surgeons and patients to improve minimally invasive surgery, today announced that it has acquired substantially all of the assets of MST Medical Surgery Technologies Ltd. (“MST”), an Israelmedical technology company, in a cash and stock transaction with a total consideration, further described below. MST is a leader in the field of surgical technology, having developed a software-based image analytics platform powered by advanced visualization, scene recognition, artificial intelligence, machine learning and data analytics.

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Sep 19 2018

Zosano Pharma Completes Manufacture of M207 Registration Batches

Sep 19 2018

FREMONT, Calif., Sept. 19, 2018 (GLOBE NEWSWIRE) — Zosano Pharma Corporation (NASDAQ:ZSAN) (“Zosano” or the “Company”), a clinical-stage biopharmaceutical company focused on providing rapid systemic administration of therapeutics to patients using its proprietary Adhesive Dermally-Applied Microneedle (“ADAM™”) technology, today announced the release of three registration batches of M207, the Company’s lead development candidate.

The registration batches will be used to support Zosano’s New Drug Application (NDA) filing with the U.S. Food and Drug Administration (FDA). Twelve months of room temperature stability for a product candidate are typically required in order for the FDA to assess manufacturability and stability of a drug product. Zosano’s batches have been placed on stability per regulatory requirements and will complete the 12-month timepoint in September of 2019.

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Sep 17 2018

Eidos Therapeutics Presents Data From Its Phase 1 Clinical Trial Of AG10 At The 22nd Annual Scientific Meeting Of The Heart Failure Society Of America

Sep 17 2018

SAN FRANCISCO, Sept. 17, 2018 (GLOBE NEWSWIRE) — Eidos Therapeutics, Inc. (Eidos) (Nasdaq:EIDX) announced the presentation of results from its Phase 1 clinical trial of AG10 during a poster session at the 22nd Annual Scientific Meeting of the Heart Failure Society of America (HFSA). The poster, entitled “AG10, A Novel, Potent, and Selective Transthyretin Stabilizer, Is Well-Tolerated at Doses Resulting in Target Therapeutic Blood Levels, and Demonstrates Clinical Proof-of-Concept in Healthy Volunteers,” was presented on Saturday, September 15, and is accessible through the science section of the company’s website.

In this initial Phase 1 study in healthy adult volunteers, AG10 was well-tolerated with no safety signals of potential clinical concern identified. At the highest tested dose, AG10 achieved 100% transthyretin (TTR) stabilization at peak concentration and over 95% TTR stabilization on average at steady state. Serum TTR concentrations, an in vivo indicator of TTR stability, were increased to a greater degree in AG10-treated patients than placebo-treated patients from baseline to Day 12.

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