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Denali Therapeutics Collaborates With Parkinson’s Institute and Clinical Center to Explore New Endpoints for Clinical Studies

SUNNYVALE, Calif.–The Parkinson’s Institute and Clinical Center and Denali Therapeutics today announced a partnership to explore new clinical endpoints for studies in patients with Parkinson’s Disease (PD).

The Institute and Denali aim to support the development of new PD therapeutics by better understanding the potential of new endpoints for clinical studies. Known clinical endpoints for PD can be affected by current standard treatments which, in turn, may confound the measurement of new therapeutics’ impact.

The agreement brings together the unique expertise of the Institute and its broad patient experience with Denali as it continues the development of its LRRK2 inhibitor clinical program for Parkinson’s Disease.

“This collaboration will allow us to explore new clinical endpoints that may help determine whether therapeutics like Denali’s LRRK2 inhibitors have a measurable effect on Parkinson’s patients,” said Chief Executive Officer, Parkinson’s Institute and Clinical Center, Carrolee Barlow, M.D., Ph.D.

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Acacia Pharma Group raises €40m at IPO for US growth

Acacia Pharma Group in Cambridge UK has raised €40 million (£35.69m) via an IPO on Euronext Brussels at €3.60 per share. The stock is due to start trading on Monday with unconditional dealings underway next Tuesday (March 6). The business, which also has US operations in Indianapolis, is using the cash for a targeted push at a specialised market in North America.

Founder and CEO Dr Julian Gilbert (pictured above) said: “The successful completion of our Initial Global Offering is a significant milestone for Acacia Pharma. The new funds provide us with a strong basis from which to build a successful US hospital-focused pharmaceutical business initially focused on commercialising our lead product: BAREMSIS® for the rescue treatment of patients with post-operative nausea & vomiting (PONV).

“The new funds will be used to build the sales and marketing infrastructure and undertake marketing, supply chain and other preparatory activities to launch BAREMSIS to the US hospital market in 2019, assuming US regulatory approval late 2018.

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Cancer immunotherapy biotech Unum Therapeutics files for an $86 million IPO

Unum Therapeutics, which is developing antibody-coupled T cell immunotherapies for cancers, filed on Friday with the SEC to raise up to $86 million in an initial public offering.

The Cambridge, MA-based company was founded in 2014 and plans to list on the Nasdaq under the symbol UNUM. Unum Therapeutics filed confidentially on November 3, 2017. Morgan Stanley and Cowen & Company are the joint bookrunners on the deal. No pricing terms were disclosed.
The article Cancer immunotherapy biotech Unum Therapeutics files for an $86 million IPO originally appeared on IPO investment manager Renaissance Capital’s web site renaissancecapital.com.

Investment Disclosure: The information and opinions expressed herein were prepared by Renaissance Capital’s research analysts and do not constitute an offer to buy or sell any security. Renaissance Capital, the Renaissance IPO ETF (symbol: IPO) or the Global IPO Fund (symbol: IPOSX) , may have investments in securities of companies mentioned.

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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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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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