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Takeda recebe parecer positivo do CHMP recomendando o ALUNBRIG® (brigatinibe) para o tratamento de câncer de pulmão de não pequenas células ALK positivo em pacientes tratados anteriormente com crizotinibeOpen in a New Window

CAMBRIDGE, Massachusetts e OSAKA, Japão--(BUSINESS WIRE)--Takeda Pharmaceutical Company Limited (TSE: 4502) anunciou hoje que o Comitê de Medicamentos para Uso Humano (CHMP) da Agência Europeia de Medicamentos (EMA) adotou um parecer positivo, recomendando a aprovação total do ALUNBRIG® (brigatinibe) como parte de uma monoterapia para o tratamento de pacientes adultos com câncer de pulmão de não pequenas células (CPNPC) avançado, positivo para a quinase de linfoma anaplásico (ALK+) e tratados a

 

Riassunto: Takeda riceve l'opinione positiva del CHMP che raccomanda ALUNBRIG® (brigatinib) per il trattamento del carcinoma polmonare non a piccole cellule ALK-positivo in pazienti precedentemente trattati con crizotinibOpen in a New Window

CAMBRIDGE, Massachusetts e OSAKA, Giappone--(BUSINESS WIRE)--Takeda Pharmaceutical Company Limited (TSE: 4502) oggi ha annunciato che il Comitato per i medicinali per uso umano (CHMP) dell'Agenzia europea del farmaco (EMA) ha adottato un'opinione positiva, raccomandando l'approvazione senza riserve di ALUNBRIG® (brigatinib) utilizzato in monoterapia per il trattamento di pazienti adulti con carcinoma polmonare non a piccole cellule (NSCLC) avanzato positivo per chinasi del linfoma anaplastico (

 

Kala Pharmaceuticals Reports Inducement Grants Under NASDAQ Listing Rule 5635(c)(4)Open in a New Window

WALTHAM, Mass.--(BUSINESS WIRE)--Kala Pharmaceuticals, Inc. (NASDAQ:KALA), a biopharmaceutical company focused on the development and commercialization of therapeutics using its proprietary mucus-penetrating particle (MPP) technology, today announced that the Company granted non-statutory stock options to new employees as inducement awards outside the Company’s 2017 Equity Incentive Plan in accordance with NASDAQ Listing Rule 5635(c)(4). The Company granted stock options to purchase up to an ag

 

Arrowhead Pharmaceuticals Reports Inducement Grants under NASDAQ Marketplace Rule 5635(c)(4)Open in a New Window

PASADENA, Calif.--(BUSINESS WIRE)--$arwr--Arrowhead Pharmaceuticals Reports Inducement Grants under NASDAQ Marketplace Rule 5635(c)(4)

 

Pace International’s ecoFOG® Receives Sustainability RecognitionOpen in a New Window

WAPATO, Wash.--(BUSINESS WIRE)--Pace International’s ecoFOG® receives sustainability recognition and reveals expansion plans for its award winning technology

 

Ichor's Auctus Biologics Closes Quick $1.5MMOpen in a New Window

LAFAYETTE, N.Y.--(BUSINESS WIRE)--Auctus Biologics, Inc., a new portfolio company of Ichor Therapeutics, Inc., announced today the closure of $1.5MM in seed funding. The company will develop RPtag, a hyper-stable antibody mimetic scaffold published earlier this year in the peer-reviewed journal ACS Biochemistry, to take on conventional clinical antibody therapy as an orally bioavailable formulation. New high priority immunosenescence and gastrointestinal targets will also be pursued. "The RPtag

 

Synergy Biomedical Announces Launch of BIOSPHERE MIS PUTTYOpen in a New Window

COLLEGEVILLE, Pa.--(BUSINESS WIRE)--Synergy Biomedical announces the launch of the BIOSPHERE MIS PUTTY bone graft delivery system.

 

CoreLink Surgical Announces the launch of Articulating Expandable Posterior Lumbar System – FLXfit®15Open in a New Window

ST. LOUIS--(BUSINESS WIRE)--#NASS--CoreLink Surgical today announces the expanded commercial launch for the FLXfit®15 articulating-expandable intervertebral body fusion device. FLXfit15 is a posterior lumbar expandable interbody device that offers up to 15 degrees of controlled and continuous expansion and is one of the only expandable cages on the market that offers articulation, providing ease in precise anterior placement. FLXfit15’s open device architecture enables ample space for graft material a

 

Seattle Genetics Announces ADCETRIS® (Brentuximab Vedotin) Approval in Japan for Frontline Hodgkin LymphomaOpen in a New Window

BOTHELL, Wash.--(BUSINESS WIRE)--Seattle Genetics, Inc. (Nasdaq: SGEN) today announced that its collaborator, Takeda Pharmaceutical Company Limited (Takeda), has received approval from the Japanese Ministry of Health, Labour and Welfare for ADCETRIS (brentuximab vedotin) in combination with doxorubicin, vinblastine and dacarbazine (AVD) as a frontline treatment option for CD30-positive Hodgkin lymphoma patients in Japan. As a result, Seattle Genetics will receive a milestone payment from Takeda

 

Remedy Plan Therapeutics Named Winner of MTC’s Inaugural Start-Up Pitch Contest at Bio+Tech18Open in a New Window

GAITHERSBURG, Md.--(BUSINESS WIRE)--#BT18Conf--The Maryland Tech Council (MTC) concluded its Bio+Tech18 Conference yesterday in Baltimore with the announcement of Remedy Plan Therapeutics as the winner of its Inaugural Start-Up Pitch Contest. Remedy Plan Therapeutics is a biotechnology company developing drugs that target cancer stem cells to inhibit tumor growth and proliferation. “The judges were very impressed with the quality of all five companies who pitched and were excited to see the potential thes

 

Enigma Biomedical and Invicro Sign a Memorandum of Understanding to Co-Develop Synaptic Density Biomarker ImagingOpen in a New Window

TORONTO--(BUSINESS WIRE)--Enigma Biomedical Group (EBG) today announced a collaboration agreement with Invicro, a Konica Minolta Company and a leading provider of imaging services and software for research and drug development, to cooperate in the development of Synaptic Density Biomarker Imaging (“SDI”). SDI promises to provide an important new tool in understanding neurodegenerative diseases such as Alzheimer’s and other dementias. As part of the agreement, both parties will contribute their

 

Takeda Receives Positive CHMP Opinion Recommending ALUNBRIG® (brigatinib) for the Treatment of ALK+ Non-Small Cell Lung Cancer in Patients Previously Treated with CrizotinibOpen in a New Window

CAMBRIDGE, Mass. & OSAKA, Japan--(BUSINESS WIRE)--Takeda Pharmaceutical Company Limited (TSE: 4502) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending the full approval of ALUNBRIG® (brigatinib) as a monotherapy for the treatment of adult patients with anaplastic lymphoma kinase-positive (ALK+) advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib. ALUNBRIG is a ty

 

California Life Sciences Association Announces Winner of “Giants of Science” Life Sciences Grant CompetitionOpen in a New Window

SAN FRANCISCO--(BUSINESS WIRE)--California Life Sciences Association announces that Los Altos High School has been selected as the winner of the Giants of Science STEM competition.

 

Guided Therapeutics Announces New Agreement to Promote Sales and Marketing in Russia and Eastern EuropeOpen in a New Window

NORCROSS, Ga.--(BUSINESS WIRE)--#cervicalcancer--Guided Therapeutics Announces New Agreement to Promote Sales and Marketing in Russia and Eastern Europe

 

MicuRx Announces Receipt of FDA’s QIDP and Fast Track Designations for Contezolid and Contezolid AcefosamilOpen in a New Window

FOSTER CITY, Calif. & SHANGHAI--(BUSINESS WIRE)--MicuRx Pharmaceuticals, Inc. today announced the receipt of the qualified infectious disease product (QIDP) classification and grant of fast track status by the U.S. Food and Drug Administration (FDA) for contezolid (MRX-I) and its prodrug contezolid acefosamil (MRX-4) for the treatment of acute bacterial skin and skin structure infections (ABSSSI). QIDP designation is granted under the U.S. Generating Antibiotic Incentive Now (GAIN) Act, which i

 

Hesperos, Inc. Among GrowFL 2018 Florida Companies to WatchOpen in a New Window

ORLANDO, Fla.--(BUSINESS WIRE)--Hesperos has been named one of the 50 statewide companies expected to see significant growth over the next several years by GrowFL.

 

GTx Announces Top-Line Results from Placebo-Controlled ASTRID Trial of Enobosarm in Women with Stress Urinary IncontinenceOpen in a New Window

MEMPHIS, Tenn.--(BUSINESS WIRE)--GTx, Inc. (Nasdaq: GTXI) today announced that the ASTRID Trial, a Phase 2 double-blind, placebo-controlled clinical trial of orally-administered enobosarm (3 mg or 1 mg) in post-menopausal women with stress urinary incontinence (SUI), did not achieve statistical significance on the primary endpoint of the proportion of patients with a greater than 50% reduction in incontinence episodes per day compared to placebo. The percentage of patients with a greater than 5

 

Trelegy Ellipta Receives Positive CHMP Opinion Supporting Expanded COPD Indication in EuropeOpen in a New Window

LONDON--(BUSINESS WIRE)--Trelegy Ellipta receives positive CHMP opinion supporting expanded COPD indication in Europe

 

uBiome Announces Expansion into Microbiome-Based Therapeutics, Appoints Pharmaceutical Veteran Joseph Jimenez to Board of DirectorsOpen in a New Window

SAN FRANCISCO & CAMBRIDGE, Mass.--(BUSINESS WIRE)--uBiome, the leader in microbial genomics, today announced that the company will leverage its deep knowledge of the microbiome and expand upon its current portfolio of commercially available microbiome tests into drug discovery, development, and commercialization. In conjunction with its expansion into therapeutics, the company has appointed Joseph Jimenez, the former CEO of Swiss pharmaceutical company Novartis, to its board of directors, and o

 

uBiome Announces $83 Million Series C FinancingOpen in a New Window

SAN FRANCISCO--(BUSINESS WIRE)--uBiome, the leader in microbial genomics, today announced the Company has raised $83 million in Series C financing. OS Fund led the round, with participation from 8VC, Y Combinator, Dentsu Ventures, and additional new and existing investors. The microbiome plays a vital role in every aspect of health – it has been correlated with a wide range of conditions and can provide insights into predispositions to diseases ranging from inflammatory bowel disease to metabol

 

Catching the Future of Life Sciences and the Opportunities for CanadaOpen in a New Window

OTTAWA, Ontario--(BUSINESS WIRE)--#biotech--In celebration of Global Biotech Week, CDRD and BIOTECanada are presenting biotech futurist Juan Enriquez in Ottawa.

 

BioTime Warrants to Expire on October 1, 2018Open in a New Window

ALAMEDA, Calif.--(BUSINESS WIRE)--BioTime, Inc. (NYSE American: BTX), a clinical-stage biotechnology company focused on degenerative diseases, is advising the holders of its publicly traded warrants (NYSE American: BTX.WS) that the warrants will expire and not be exercisable after 5:00 p.m., New York City time, on October 1, 2018 (the “Expiration Date”). A warrant holder can obtain information on exercising the warrants by contacting their broker or American Stock Transfer & Trust Company,

 

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