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Category: Therapeutics

FAREVA Selects TraceLink to Comply with EU FMD Regulations

NORTH READING, Mass., Oct. 8, 2018 /PRNewswire/ — TraceLink Inc., the World’s Largest Track and Trace Network for connecting the life sciences supply chain and providing real-time information sharing for better patient outcomes, today announced that FAREVA has selected TraceLink’s serialization solutions to ensure compliance with the EU Falsified Medicines Directive (FMD). TraceLink and FAREVA will be at CPhI Worldwide, October 9 – 11 in Madrid, partnering together to provide education around EU FMD readiness and serialization.

A global pharmaceutical and API leading contract development and manufacturing organization (CDMO), FAREVA produces various dosage forms and API as well as offers packing options. With over 1,000 customers, FAREVA operates 35 sites across Europe, Russia, Turkey and The Americas.

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Orchard Therapeutics plans $172.5 million U.S. IPO

Orchard Therapeutics is seeking to raise up to $172.5 million from a planned stock offering in the U.S., according to a regulatory filing.

The U.K. biopharmaceutical company, which has yet to post a profit, filed documents for the offering under Orchard RX Ltd. but said it would change its name to Orchard Therapeutics PLC. It plans to apply for its American depositary shares to trade on the Nasdaq under the symbol ORTX.

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Buoy Health Receives Robert Wood Johnson Foundation Artificial Intelligence Award for Patient Health Education

BOSTON–(BUSINESS WIRE)–Buoy Health, an AI health assistant that helps people from the moment they get sick start their care on the right foot, today announced they were awarded the Robert Wood Johnson Foundation’s Artificial Intelligence (AI) Challenge Award for Patient Health Education at last month’s Health 2.0 Conference, held in Santa Clara, California. The award was the result of a year-long contest that asked companies to submit health-focused technologies incorporating AI. After being assessed against 250 competitors and advancing through multiple evaluation rounds, Buoy Health was chosen as one of three finalists. During a final live pitching session at the conference, the competition’s judges determined Buoy Health’s AI-powered chatbot technology to have the most impact, potential for adoption, creativity, scalability and design intuitiveness.

“We are honored to have received the AI Challenge Award from such a prestigious institution as the Robert Wood Johnson Foundation. Their recognition of Buoy Health’s AI health assistant as both a benefits tool for employers and a more helpful alternative for consumers that are prone to Googling their symptoms has emboldened us as we continue towards our goal of improving the patient journey,” said Dr. Andrew Le, CEO of Buoy Health. “Buoy was designed using real world data points based on trusted medical literature and guides patients to care by asking questions, just like a real doctor would. After a consumer answers questions for 2 to 3 minutes, we narrow the possible diagnoses and, through our employer, payer, and provider partners, show exactly what services exist for that particular ailment.”

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TraceLink Surpasses 1,000 Customer Milestone, Including Over 500 Pharmaceutical Manufacturing Companies

NORTH READING, Mass., Oct. 3, 2018 /PRNewswire/ — TraceLink Inc., the World’s Largest Track and Trace Network for connecting the life sciences supply chain and providing real-time information sharing for better patient outcomes, today announced that it now serves over 1,000 customers in 43 countries, delivering proven solutions for companies that are complying with U.S. Drug Supply Chain Security Act (DSCSA), EU Falsified Medicines Directive (FMD) and additional track and trace requirements in Russia, India, South Korea, China and Brazil.

In the third quarter of 2018, TraceLink reached 1,016 customers, representing a 46 percent year-over-year increase in total customers, including:

  • 63 percent representing pharmaceutical and contract manufacturers;
  • 5 percent representing wholesale distributors and parallel importers; and
  • 32 percent representing pharmacies, hospitals, clinics and health systems

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Centogene, Denali Therapeutics Partner to Recruit Parkinson’s Patients for Drug Program

NEW YORK (GenomeWeb) – German diagnostics firm Centogene said today that it has entered into an agreement with Denali Therapeutics to conduct a targeted global patient identification and recruitment campaign for the company’s Parkinson’s disease LRRK2 inhibitor program.

Centogene will use its CentoCard, a proprietary dried blood spot collection kit, to collect samples that can identify Parkinson’s patients who carry mutations in the LRRK2 gene. According to the company, these mutations are one of the most commonly known genetic causes of Parkinson’s disease, driving lysosomal dysfunction, which contributes to the formation of Lewy body protein aggregates and neurodegeneration.

The arrangement is not Centogene’s first in the area of Parkinson’s disease. The firm has also been collaborating with the Parkinson’s Institute to use a large gene panel to screen patients for genetic variants associated with the disease.

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FierceBiotech Names Compass Therapeutics a 2018 “Fierce 15” Biotech Company

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Compass Therapeutics, a biotechnology company committed to the ambitious goal of comprehensively drugging the human immune system, today announced that it has been named by FierceBiotech as one of 2018’s Fierce 15 biotechnology companies, designating it as one of the most promising private biotech companies in the industry.

Compass, which completed its $132 million Series A financing this year, is forging a new approach to identifying antibody drug candidates that engage all targets in the biologically complex human immune synapse. The company’s antibody discovery platform enables the rapid identification of therapeutic candidates that engage with a broad range of epitopes and its StitchMabs™ bispecific screening platform enables the empirical, high-throughput identification of novel synergistic combinations and bispecifics. To date, the company’s integrated R&D approach has generated therapeutic candidates for more than 30 targets in cancer, inflammation and autoimmune disease. More than 15 of them are now advancing through preclinical development.

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Modis Therapeutics Announces $30M Series A Financing

OAKLAND, Calif., Oct. 1, 2018 /PRNewswire/ — Modis Therapeutics, Inc., a company developing medicines for patients with rare genetic diseases, announced today a $30M Series A investment led by F-Prime Capital Partners and OrbiMed. Joshua Grass, former F-Prime Entrepreneur-in-Residence and head of Corporate Development at BioMarin Pharmaceutical, has joined as President and Chief Executive Officer. F-Prime’s Ben Auspitz and OrbiMed’s Rishi Guptahave joined the board, with Mr. Auspitz as Chairman.  F-Prime and OrbiMed have each invested in multiple successful rare disease companies, including Ultragenyx, Orchard Therapeutics, Enobia Pharma, True North Therapeutics, Dimension Therapeutics, and others. Founding investor Aceras Life Sciences, LLC and new investor Osage University Partners also participated in the financing.

Modis is advancing its lead experimental therapy, MT1621, as a treatment for thymidine kinase 2 deficiency (TK2d), a rare, genetically defined mitochondrial DNA (mtDNA) depletion disorder.  TK2d results from inherited mutations in the nuclear TK2 gene and leads to severe muscle weakness and premature death.  TK2d symptom onset varies in age from infants to adults and there are currently no approved treatments.  The development of MT1621 is based on research from the lab of Dr. Michio Hirano, the chief of the Division of Neuromuscular Medicine at Columbia University Irving Medical Center, the lab of Dr. Ramon Martí, the head of the Neuromuscular and Mitochondrial Pathology Research Group at Vall d’Hebron Research Institute in Barcelona, and other academic collaborators.  Modis has exclusively licensed worldwide rights to data and intellectual property related to a broad range of mtDNA depletion disorders from Columbia University Irving Medical Center and Vall d’Hebron Research Institute.

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Pharmeasy raises $50 million in Series C funding

Online healthcare and pharma aggregator Pharmeasy has raised $50 million in Series C funding from Eight Roads Ventures India, the proprietary investment arm of Fidelity International Ltd.

The other investors are F-Prime Capital, Nandan Nilakeni, Sanjeev Aggarwal-backed Fundamentum Partnership and San Francisco-based hedge fund Think Investments.

Existing investors BVP also participated in this round which was run by investment banking firm Avendus. With this round, the total fund raised by Pharmeasy stands at $75 million. Its earlier investors include BVP, Orios Venture Partners, Aarin Capital and MEMG.

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Innovent Receives an Approval from the US FDA to Initiate Clinical Trials for its Anti-CD47 Monoclonal Antibody IBI-188

SUZHOU, China, Sept. 29, 2018 /PRNewswire/ — Innovent Biologics, Inc. (Innovent), a world-class China-based biopharmaceutical company that develops high quality drugs, announced yesterday that its IND application for IBI-188, a fully human anti-CD47 monoclonal antibody (mAb) drug candidate, has been approved by the US Food & Drug Administration (FDA) to initiate clinical trials for patients with advanced malignancies and lymphomas.

IBI-188 is the second Innovent molecule to be approved for clinical trials by the FDA. In January, 2018 the FDA IND for IBI308 (Sintilimab, an anti-PD-1 antibody) was also approved. Innovent is the first Chinese biopharmaceutical company to receive clinical trial approval for a CD47 monoclonal antibody from the FDA.

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Akrevia Therapeutics Launches with $30M Series A Financing Led by F-Prime Capital Partners and Atlas Venture

CAMBRIDGE, Mass., Sept. 27, 2018 /PRNewswire/ — Akrevia Therapeutics, a privately-held biopharmaceutical company focused on developing highly-potent, tumor-targeted immuno-oncology therapeutics, today announced the closing of a $30 million Series A financing led by F-Prime Capital Partners and Atlas Venture. The investors have come together to recruit an experienced management team to accelerate Akrevia’s pipeline and proprietary Aklusion® platform, which allows therapeutic antibodies, cytokines and chemokines to be specifically activated in the tumor microenvironment and tailored with precisely optimized pharmacologic properties.

Akrevia will be led by Tim Clackson, Ph.D., as President and Head of R&D and Nessan Bermingham, Ph.D., as Executive Chairman. Dr. Clackson joins Akrevia after serving as President of R&D at ARIAD Pharmaceuticals, where he led the discovery and development of Iclusig® (ponatinib) and Alunbrig® (brigatinib), two FDA-approved cancer therapeutics. Dr. Bermingham was most recently CEO of Intellia Therapeutics, a leading gene editing company which he founded, built, and took public.

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