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TraceLink, Selected by Pioneering German Biotechnlogy Company, to Comply with EU FMD Serialization Regulations

NORTH READING — 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 biosyn Arzneimittel GmbH has selected TraceLink’s serialization solutions to ensure compliance with the EU Falsified Medicines Directive (FMD) requirements.
As one of the first biotechnology companies in Germany, biosyn was founded in 1984 and specializes in keyhole limpet hemocyanin products and high-dose selenium injectable pharmaceuticals. Since its founding, the company has developed into a pharmaceutical enterprise with subsidiaries in Liechtenstein, Austria and the U.S., and has customers in over 25 countries.

With a large customer base in Europe, biosyn needed a serialization solution that would ensure on-time compliance with the EU FMD regulations through a simple and direct path to the European hub. As biosyn works with multiple contract manufacturers, the chosen solution would need to simplify connectivity and enable the seamless exchange of data. The solution also needed to meet requirements in South Korea, Brazil and other future markets.

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Cipla ties up with Roche to sell 2 cancer drugs in India

New Delhi : Drug firm Cipla today said it has entered into an agreement with Roche Pharma to promote and distribute the latter’s cancer drugs in India.

The pharma major will distribute Tocilizumab and Syndyma — the second brand of Roche’s cancer therapy bevacizumab — in India.

This partnership is in line with Cipla and Roche’s efforts to improve healthcare and increase access to innovative, life-changing medicines in India, particularly to patients who currently do not have access to them, Cipla said in a filing to BSE.

Commenting on the development, Cipla MD & Global CEO Umang Vohra said: “The prevalence of cancer and rheumatoid arthritis is widely spread across India, and Cipla can contribute to provide broader access to innovative medicines like tocilizumab and bevacizumab.”

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AllSpire Health GPO Adopts Lumere’s Solutions to Support Value-Based Initiatives

CHICAGO — AllSpire Health GPO, LLC—a health system alliance created to escalate the improvement of clinical outcomes, enable greater access to affordable healthcare, ensure economic sustainability, and enhance patient, physician, and clinician satisfaction—announced a partnership with Lumere today. AllSpire will implement the company’s Category Optimization and Product Introduction Management solutions as part of its ongoing initiatives to optimize the value its members provide to patients.

“Lumere’s clinical approach to managing medical device selection and utilization aligns with AllSpire’s mission to drive comprehensive clinical excellence to the communities our member hospitals serve,” said AllSpire Executive Director Michael Dankwerth. “Collaboration with physicians is fundamental to driving change, and Lumere’s recommendations take a clinical evidence-based and patient-first approach to uncovering saving opportunities. As a result, we can ensure that clinical and administrative leaders are making informed decisions about what’s best for our patients based on information presented in a language they all understand.”

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Cargill, Precision BioSciences team up to develop next generation of low saturate, high oleic canola oil

MINNEAPOLIS — In continuing its innovation efforts in plant-based oils, Cargill’s latest endeavor is a collaboration with Precision BioSciences. Together, the partners are using Precision’s ARCUS® genome-editing technology to further reduce saturated fat in canola oil, putting Cargill at the forefront of a next-generation innovation.
The new oil is intended for the quick-service restaurants and food ingredients industries, and products made with it – particularly fried foods – may be able to use front-of-package nutrient content claims on saturated fat levels, such as “Low in Saturated Fat” or “No Saturated Fat,” depending on their overall nutritional profile. This continued innovation demonstrates Cargill’s ongoing efforts to remain focused on consumer health benefits, especially as the USDA and Health and Human Services 2015-2020 Dietary Guidelines encourage Americans to limit saturated fat intake to 10 percent of their daily calories.

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Surface Oncology Expands Board of Directors

CAMBRIDGE, Mass.–Surface Oncology, an immuno-oncology company developing next-generation antibody therapies that target the tumor microenvironment, today announced the expansion of the company’s board of directors with the addition of three new members. Elliott Sigal, M.D., Ph.D., Geoff McDonough, M.D., and Laurie Stelzer will work with the other members of the Surface board of directors to guide the company as it advances its broad portfolio of immuno-oncology therapies.

“The Surface team is delighted to welcome Elliott, Geoff and Laurie to our board of directors,” said Jeff Goater, chief executive officer of Surface Oncology. “They are accomplished biopharma leaders and their considerable experience will be invaluable as we continue our evolution into a clinical stage company.”

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Toast Partners with TripAdvisor to Boost Restaurant Ads Business

Needham-based TripAdvisor Inc. is partnering with one of Boston’s fastest-growing startups, Toast Inc., to boost its recently launched restaurant ads business. The companies announced on Wednesday that they are both integrating their technologies and offering joint marketing incentives to restaurant owners.

The tech integration will allow restaurants that use Toast’s point-of-sale system to also buy ads on TripAdvisor (Nasdaq: TRIP) through the same software interface. On the marketing side, restaurant owners who are registered on TripAdvisor but don’t already use Toast will be offered a $500 ad-buying credit or a free six month subscription to TripAdvisor Premium when they buy Toast’s software.

The deal comes a few months after TripAdvisor launched its ads service for restaurants, which allows owners to pay in order to have listings for their restaurants appear near the top of relevant searches. The service is meant to open up a new line of revenue for travel-review site TripAdvisor, which has faced challenges in its core hotel business and seen its stock price suffer over the past two years.

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Surface Oncology Promotes Jeff Goater to Chief Executive Officer

CAMBRIDGE, Mass.–Surface Oncology, an immuno-oncology company developing next-generation antibody therapies that target the tumor microenvironment, announced today that Jeff Goater, currently the company’s chief business officer, has been promoted to chief executive officer. Mr. Goater succeeds interim chief executive officer Dan Lynch, who will remain executive chairman of Surface’s board of directors. Mr. Goater, a seasoned biotech executive with nearly 20 years of experience, will lead Surface as the company enters its next stage of growth, advancing the first program from its broad pipeline of novel immuno-therapeutics into clinical development.

“We are thrilled to have Jeff step into the CEO role at Surface during such a pivotal time in the company’s evolution,” said Mr. Lynch. “Jeff has made an incredibly positive impact on Surface over the past year as a member of our executive team. During our extensive search process, it became apparent that we already had the right person for the job internally. Jeff has the strategic vision, leadership qualities and capabilities to lead Surface as we look to rapidly advance our portfolio.”

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Denali Therapeutics and Lonza Pharma & Biotech Announce Exclusive Partnership to Develop and Produce Biologic Medicines

BASEL, Switzerland and SOUTH SAN FRANCISCO, Calif. — Lonza Pharma & Biotech and Denali Therapeutics (NASDAQ:DNLI) announced today an exclusive strategic partnership on Denali’s biologic pipeline products for neurodegenerative diseases. The agreement covers all stages of the development and manufacturing.

A major hurdle for treating neurodegenerative diseases is the inability of most biologics to cross the tightly controlled blood-brain barrier (BBB). Denali is engineering its biologic product candidates to overcome this fundamental obstacle. Manufacturing these sophisticated therapies requires a tailor-made approach, together with expertise and agility in cell line, process and formulation development.

Through this partnership Denali will have access to Lonza’s extensive expertise and technologies: from cell-line development using the GS Xceed® Gene Expression System to process development and manufacturing at facilities in Slough (UK) and Hayward, CA (USA). In addition, Lonza’s in-house Drug Product Services in Basel (CH) will focus on ensuring that Denali’s finished product candidates are designed with optimal formulation, stability and delivery system in mind.

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Zenflow Raises $31.4M in Series A Funding

Zenflow, Inc., a San Francisco, CA-based medical device company, closed a $31.4m Series A equity financing round.

The round was led by Invus Opportunities, F-Prime Capital Partners, and Medical Technology Venture Partners.

The company, which has also received grant funding from the National Institutes of Health (NIH) and National Science Foundation (NSF).

Founded by Nick Damiano and Shreya Mehta out of the Stanford Biodesign Innovation Fellowship in 2014, Zenflow develops minimally invasive devices to treat obstructive urinary symptoms related to benign prostatic hyperplasia (BPH or enlarged prostate). Its first product is the Spring System, a technology device that delivers a low-profile superelastic implant into the prostatic urethra. This system is intended to permanently relieve BPH symptoms in a single procedure with fast recovery and minimal side effects.

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Adaptimmune Begins In-house T-Cell Therapy Manufacture at PA Plant

Adaptimmune Therapeutics has manufactured the first SPEAR-T cells for a patient at its Navy Yard facility, which will be the primary site for its future manufacturing requirements.

The company’s unique SPEAR (Specific Peptide Enhanced Affinity Receptor) T-cell platform enables the engineering of T-cells to target and destroy cancer, including solid tumors. Adaptimmune is currently conducting clinical trials with SPEAR T-cells targeting MAGE-A4, MAGE-A10, and AFP across several solid tumor indications.

Adaptimmune CEO James Noble told Biopharma-Reporter that he was confident that the Philadelphia-based Navy Yard facility would be able to cope with the company’s future manufacturing needs through clinical trials and potentially commercialization.

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