R&D

Saneca Pharma appoints new CEO

February 19, 2018

Contract development and manufacturing organisation (CDMO) Saneca Pharma has announced the appointment of its new CEO, Richard Král. Richard, who has been the sales and marketing director at Saneca for almost three years, has previously worked for GlaxoSmithKline and Zentiva Group across the Central and Eastern Europe (CEE) and the Commonweath of Independent States (CIS) […]

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February 19, 2018

Arrowhead Pharmaceuticals Receives Orphan Drug Designation for ARO-AAT

February 16, 2018

PASADENA, Calif.–(BUSINESS WIRE)–Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) today announced the United States Food and Drug Administration (FDA) has granted orphan drug designation to ARO-AAT, Arrowhead’s second-generation investigational medicine for the treatment of a rare genetic liver disease associated with alpha-1 antitrypsin deficiency. Arrowhead filed a Clinical Trial Application in December 2017 requesting regulatory permission to […]

Kura Oncology Provides Update on Phase 2 Trial of Tipifarnib in HRAS Mutant Head and Neck Cancer

February 16, 2018

SAN DIEGO, Feb. 15, 2018 (GLOBE NEWSWIRE) — Kura Oncology, Inc. (Nasdaq:KURA), a clinical-stage biopharmaceutical company focused on the development of precision medicines for oncology, today announced the presentation of updated preliminary results from its Phase 2 clinical trial of its lead product candidate, tipifarnib, in patients with head and neck squamous cell carcinomas (HNSCC) […]

FDA Accepts New Drug Application and Grants Priority Review for Ivosidenib in Relapsed or Refractory AML with an IDH1 Mutation

February 16, 2018

CAMBRIDGE, Mass., Feb. 15, 2018 (GLOBE NEWSWIRE) — Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a leader in the field of cellular metabolism to treat cancer and rare genetic diseases, today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) for ivosidenib (AG-120) for the treatment of patients with relapsed […]

Pacira Pharmaceuticals Statement on FDA Advisory Committee for EXPAREL® for Use as a Nerve Block to Produce Regional Analgesia

February 16, 2018

PARSIPPANY, N.J., Feb. 15, 2018 (GLOBE NEWSWIRE) — Pacira Pharmaceuticals, Inc. (NASDAQ:PCRX), announced today that the U.S. Food and Drug Administration’s (FDA) Anesthetic and Analgesic Drug Products Advisory Committee did not reach a unanimous decision on the efficacy and safety of the use of EXPAREL® (bupivacaine liposome injectable suspension) as a nerve block to produce […]

Akcea Announces FDA Advisory Committee Meeting to Review Volanesorsen as a Treatment for Familial Chylomicronemia Syndrome

February 16, 2018

CAMBRIDGE, Mass., Feb. 15, 2018 (GLOBE NEWSWIRE) — Akcea Therapeutics, Inc. (NASDAQ:AKCA), an affiliate of Ionis Pharmaceuticals, Inc., focused on developing and commercializing drugs to treat patients with serious cardiometabolic diseases caused by lipid disorders, today announced that the Division of Metabolism and Endocrinology Products of the U.S. Food and Drug Administration (FDA) will hold […]

Avillion Advances Co-development Programme with Merck: IND Now Open for Phase 2 Study of M1095, an Anti-IL-17 A/F Nanobody® in Psoriasis

February 16, 2018

LONDON, February 16, 2018 /PRNewswire/ —   Avillion LLP, a drug development company focused on the co-development and financing of pharmaceutical candidates from proof-of-concept through to regulatory approval, announces that it has opened an Investigational New Drug (IND) application for a Phase 2 study in plaque psoriasis under its co-development agreement with Merck (Darmstadt, Germany), […]

Apricus Biosciences Receives Complete Response Letter from FDA for Vitaros™

February 16, 2018

SAN DIEGO, Feb. 16, 2018 (GLOBE NEWSWIRE) — Apricus Biosciences, Inc. (Nasdaq:APRI), a biopharmaceutical company advancing innovative medicines in urology and rheumatology, today announced that the U.S. Food and Drug Administration (“FDA”) has issued a complete response letter (“CRL”) for the New Drug Application (“NDA”) of Vitaros™ (alprostadil, DDAIP.HCl), a topical cream for the treatment […]

Proteomics International announces Strategic Alliance and Investment in CPR Pharma Services

February 15, 2018

PERTH, W. AUS.,  Feb 16, 2018 – MedTech pioneer Proteomics International (PILL; ASX: PIQ) has entered into a strategic alliance with CPR Pharma Services (CPR), targeting the high growth area of clinical trials and related research, with an offer to acquire 10% of CPR’s share capital through the issue of 4 million PIQ shares. This alliance […]

Crispr Therapeutics: Is There Something Else Behind The Potential Gilead Acquisition?

February 15, 2018

Back on Feb. 8, 2018, we featured Crispr Therapeutics (NASDAQ:CRSP), a leading gene-editing innovator to service cancers and rare genetic diseases, in the Integrated BioSci Merger and Acquisition (M&A) report. We noted that a stellar growth company, Gilead Sciences (NASDAQ:GILD), is facing the declining sales for its flagship Hepatitis C products (Sovaldi and Harvoni). Consequently, […]

Amgen Announces FDA Advisory Committee Meeting To Review Potential New Use Of BLINCYTO® (blinatumomab)

February 15, 2018

THOUSAND OAKS, Calif., Feb. 14, 2018 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced that the Oncologic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) will review data supporting the BLINCYTO® (blinatumomab) supplemental Biologics License Application (sBLA) for the treatment of patients with minimal residual disease (MRD)-positive B-cell precursor acute lymphoblastic leukemia (ALL) at […]

Neurocrine Biosciences Will File New Drug Application for Opicapone for Parkinson’s Disease Based on Existing Pivotal Clinical Trial Data

February 15, 2018

SAN DIEGO, Feb. 14, 2018 /PRNewswire/ — Neurocrine Biosciences, Inc. (NASDAQ: NBIX), a biotechnology company focused on neurological and endocrine related disorders, today announced that the U.S. Food and Drug Administration (FDA) has provided guidance on the regulatory path forward to support the New Drug Application (NDA) for opicapone, an investigational drug for Parkinson’s disease, […]

Evofem Biosciences Completes Enrollment of Phase 3 Contraceptive Trial of Amphora Ahead of Schedule

February 15, 2018

SAN DIEGO, Feb. 15, 2018 /PRNewswire/ — Evofem Biosciences, Inc., (NASDAQ: EVFM) (“Evofem” or the “Company”), a biotechnology company developing innovative products to fill women’s unmet healthcare needs, announced early completion of enrollment in its Phase 3 clinical trial evaluating Amphora® (L-lactic acid, citric acid, and potassium bitartrate) vaginal gel for the prevention of pregnancy. […]

Shire Announces FDA Acceptance of sBLA for CINRYZE® for Pediatric Hereditary Angioedema Use

February 15, 2018

CAMBRIDGE, MA – February 15, 2018 – Shire plc (LSE: SHP, NASDAQ: SHPG), the global biotechnology leader in rare diseases, announced today that the U.S. Food and Drug Administration (FDA) accepted the CINRYZE® (C1 esterase inhibitor [human]) supplemental Biologics License Application (sBLA) to expand the currently approved indication to include children aged 6 years and […]

Protalix BioTherapeutics Announces Final Dosing of Last Patient in Phase II Clinical Trial of OPRX-106 in Patients with Ulcerative Colitis

February 15, 2018

CARMIEL, Israel, Feb. 15, 2018 (GLOBE NEWSWIRE) — Protalix BioTherapeutics, Inc. (NYSE American:PLX) (TASE:PLX), announced today the final dosing of the last patient in the Company’s phase II clinical trial evaluating OPRX-106, the Company’s oral antiTNF product candidate, in patients with ulcerative colitis (UC). OPRX-106 is the Company’s proprietary plant cell-expressed recombinant human tumor necrosis […]

Selumetinib Granted Orphan Drug Designation by the U.S. FDA for Neurofibromatosis Type 1

February 15, 2018

KENILWORTH, N.J.–(BUSINESS WIRE)–AstraZeneca and Merck (NYSE:MRK), known as MSD outside the U.S. and Canada, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for selumetinib, a MEK 1/2 inhibitor, for the treatment of neurofibromatosis type 1 (NF1).   NF1 is an incurable genetic condition that affects one in […]

The New England Journal of Medicine Publishes SPINRAZA® (nusinersen) Phase 3 Study Results in Individuals with Later-Onset Spinal Muscular Atrophy

February 15, 2018

CAMBRIDGE, Mass. & CARLSBAD, Calif.–(BUSINESS WIRE)–Biogen (Nasdaq: BIIB) and Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) announced end of study results from CHERISH, the Phase 3 study evaluating SPINRAZA® (nusinersen) for the treatment of individuals with later-onset spinal muscular atrophy (SMA), were published today in The New England Journal of Medicine. The full manuscript titled, “Nusinersen Versus […]

Corbus Pharmaceuticals Announces Publication Demonstrating Lenabasum as First Drug to Stimulate Resolution of Innate Immune Responses in a Clinical Model

February 15, 2018

NORWOOD, MA–(Marketwired – February 15, 2018) – Study identifies lenabasum as important upstream trigger of resolution of innate immune responses Data provides mechanistic validation of positive clinical data reported from Company’s Phase 2 clinical studies in systemic sclerosis, cystic fibrosis and dermatomyositis Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or the “Company”), a clinical stage […]

Knight Therapeutics and SIFI S.p.A. Announce Filing of New Drug Submission for NETILDEX™ in Canada™

February 15, 2018

MONTREAL, QUEBEC–(Marketwired – Feb. 15, 2018) – Knight Therapeutics Inc. (TSX:GUD) (“Knight”), a leading Canadian specialty pharmaceutical company, and S.I.F.I- Società Industria Farmaceutica Italiana S.p.A. (“SIFI”), a prominent Italian Eye Care company, today announced that Knight’s New Drug Submission (NDS) for NETILDEX™ has been accepted for review by Health Canada. NETILDEX™ is a fixed combination […]

Moleculin Announces Breakthrough Discovery of a New Molecule for Cancer Treatment

February 15, 2018

HOUSTON, TX–(Marketwired – February 15, 2018) – Moleculin Biotech, Inc., (NASDAQ: MBRX) (“Moleculin” or the “Company”), a clinical stage pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on license agreements with The University of Texas System on behalf of the MD Anderson Cancer Center (“MD Anderson”), today announced […]

Neurocrine Biosciences Will File New Drug Application for Opicapone for Parkinson’s Disease Based on Existing Pivotal Clinical Trial Data

February 15, 2018

SAN DIEGO, Feb. 14, 2018 /PRNewswire/ — Neurocrine Biosciences, Inc. (NASDAQ: NBIX), a biotechnology company focused on neurological and endocrine related disorders, today announced that the U.S. Food and Drug Administration (FDA) has provided guidance on the regulatory path forward to support the New Drug Application (NDA) for opicapone, an investigational drug for Parkinson’s disease, […]

Education system failing to properly prepare STEM students for the working world

February 15, 2018

Survey of chemistry professionals finds 61% believe that curricula are not suitable for industry needs   The inability of chemistry to recruit new STEM students is a crisis for the industry according to more than a third (36%) of 180+ chemistry professionals from academia and industry, in a survey carried out by Elsevier’s Reaxys team. […]

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