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Daily Archives: January 12, 2021

Rapid Micro Biosystems Hires Chief Operating Officer

LOWELL, Mass., Jan. 12, 2021 (GLOBE NEWSWIRE) — Rapid Micro Biosystems, the leading provider of automated, non-destructive, rapid microbial detection, is pleased to announce the appointment of John Wilson as Chief Operating Officer reporting directly to the company’s CEO, Robert Spignesi.

In this newly created role, John will be responsible for quality, supply chain and manufacturing operations. He brings over 20 years of progressive operations experience to RMB from Medtronic and Becton Dickinson. He joins us from Becton Dickinson where he was the Vice President Operations, Biosciences Division.  John has held multiple leadership positions in quality, operational excellence, global operations, product development and direct day-to-day plant management activities.  “I am excited to welcome John to our executive leadership team,” said Mr. Spignesi. “He brings extensive experience in operations strategy, driving manufacturing and supply chain efficiencies and developing new methodologies to connect quality and product development with a focus on the customer. John will be essential in helping us expand our operational capabilities globally and deliver our Growth Direct™ systems and consumables to leading BioPharma companies around the world.”

“I am extremely pleased to be joining Rapid Micro Biosystems at such a critical time in the Company’s growth trajectory. I am very impressed with our offering and the opportunity we have in front of us, to make a tremendous impact in this very important space. I look forward to helping to grow the Company’s execution capabilities to allow us to continue to deliver on this promise,” said Mr. Wilson. “I am excited to work with the leadership team and the employees to build scalable processes to support our rapid global growth and to actively and broadly engage our employees in bringing these important capabilities to our customers.”

John has served his country in the United States Army.  He holds an BSBM from University of Phoenix and an MBA from University of San Francisco.

About Rapid Micro Biosystems

Rapid Micro Biosystems (RMB) creates, sells, validates and services innovative products for fast, accurate, and efficient detection of microbial contamination in the manufacture of pharmaceuticals, biologics, biotechnology products, medical devices, and personal care products. The company’s Growth Direct™—the first and only growth-based system to automate rapid compendial QC Micro testing—ensures data integrity, compliance, and operational efficiencies driven by rapid methods and automation. RMB is dedicated to providing groundbreaking technology and products to support companies in their journey to achieve greater reliability, efficiency, and better predictability, ultimately providing higher quality products for improved patient outcomes. For more information, visit www.rapidmicrobio.com. Follow RMB at @rapidmicrobio or LinkedIn.

Contact(s)

Courtney Makolandra
Rapid Micro Biosystems
CMakolandra@rapidmicrobio.com
978.349.3200

Berkeley Lights Launches Opto Plasma B Discovery 4.0 to Accelerate Therapeutic Antibody Discovery Against Difficult Targets

EMERYVILLE, Calif., Jan. 12, 2021 (GLOBE NEWSWIRE) — Berkeley Lights, Inc. (Nasdaq: BLI), a leader in Digital Cell Biology, today announced the Opto™ Plasma B Discovery 4.0 workflow. Opto Plasma B Discovery 4.0 is the industry’s premier antibody discovery workflow by advancing from B cells to lead molecules in just 1 week.

This workflow enables our customers to:

  • Sample 4x more of the relevant biodiversity, screening up to 100,000 cells
  • Functionally test with highly sensitive cell-based assays
  • Recover not only sequences, but also re-expressed molecules without requiring costly gene synthesis and bacterial cloning
  • Increase the probability of success against hard-to-hit targets such as GPCRs and Ion Channels

By leveraging our proprietary OptoSeq™ Barcoded BCR, we enable rapid, accurate sequencing of paired heavy/light chain antibody genes by DNA fragmentation, NGS sequencing, and bioinformatics analysis. Additionally, Opto BCR Rapid Re-expression can be leveraged to rapidly re-express over one thousand antibodies in just one week to confirm their function in plate-based assays, reducing the cost and labor associated with gene synthesis and bacterial cloning.

“Our customers are facing great challenges today, trying to find therapeutics against very difficult targets such as GPCRs for cancer and neurological disorders, while working under extreme timeline pressure. Opto Plasma B Discovery 4.0 workflow is a game changer,” said Eric Hobbs, Ph.D., CEO of Berkeley Lights. “In 1 week from a sera positive mouse, our customers can now discover and advance lead molecules for hard-to-hit targets in one integrated workflow on the Berkeley Lights Beacon system. In addition to re-expressed molecules, we also provide sequences to our customers for further acceleration of these candidates to market by immediately initiating antibody engineering and cell line development efforts.”

About Berkeley Lights
Berkeley Lights is a leading Digital Cell Biology company focused on enabling and accelerating the rapid development and commercialization of biotherapeutics and other cell-based products for our customers. The Berkeley Lights Platform captures deep phenotypic, functional and genotypic information for thousands of single cells in parallel and can also deliver the live biology customers desire in the form of the best cells. Our platform is a fully integrated, end-to-end solution, comprising proprietary consumables, including our OptoSelect™ chips and reagent kits, advanced automation systems, and application software. We developed the Berkeley Lights Platform to provide the most advanced environment for rapid functional characterization of single cells at scale, the goal of which is to establish an industry standard for our customers throughout their cell-based product value chain.

Berkeley Lights’ Beacon® and Lightning™ systems and Culture Station™ instrument are FOR RESEARCH USE ONLY. Not for use in diagnostic procedures.

Forward-Looking Statements
To the extent that statements contained in this press release are not descriptions of historical facts regarding Berkeley Lights or its products, they are forward-looking statements reflecting the current beliefs and expectations of management. Such forward-looking statements involve substantial known and unknown risks and uncertainties that relate to future events, and actual results and product performance could differ significantly from those expressed or implied by the forward-looking statements. Berkeley Lights undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties relating to the Company’s products, including the performance of Company workflows such as the Opto Plasma B Discovery 4.0 workflow, see the statements in the “Risk Factors” sections, and elsewhere, in our filings with the U.S. Securities and Exchange Commission.

Press Contact
berkeleylights@bulleitgroup.com

Investor Contact
ir@berkeleylights.com

SweeGen Announces Successful Scale-up of Bestevia® Reb N

Further expands the sweet taste solution toolbox for tackling sugar reduction.

Rancho Santa Margarita, Calif., Jan. 12, 2021 (GLOBE NEWSWIRE) — SweeGen is making possible a healthier, more guilt-free, and sweeter world with the commercialization of Bestevia® Rebaudioside N (Reb N), a special zero-calorie, highly sought-after natural stevia sweetener.

Reb N is a naturally occurring sweetener found in stevia leaves. The unique sensory profile of Bestevia Reb N makes it especially attractive for beverage applications, which is an application space that has already been exclusively licensed out. With its unique functionality, Reb N also works very well in a variety of foods.

Following SweeGen’s commercial announcements of Bestevia Rebs B and I this year, and with the addition of Reb N, the company’s portfolio of sugar reduction solutions is the broadest available in the industry for tackling sugar reduction challenges.

“Bestevia Reb N has a unique sweet profile that helps us create solutions that have a taste profile closer to both full-calorie and high intensity sweeteners,” said Shari Mahon, SVP of global application technology. “Our solutions are one of the most unique and tailored in the industry because of our access to the widest range of Rebs for sugar reduction.”

SweeGen’s entire proprietary portfolio of natural stevia sweeteners are classified as next generation non-GMO, high-purity, and clean tasting. The Bestevia portfolio includes Rebs B, D, E, I, M, and now Reb N. These Rebs translate to highly-relevant, clean-label, sustainable, natural sweeteners that consumers are seeking in finished products.

Much like Bestevia Rebs M, E and I, Reb N is found in trace quantities in the stevia leaf, which historically made it difficult and expensive to isolate. SweeGen’s Bestevia Reb N is now accessible because it is produced by a patented bioconversion technology, which starts with sustainably-sourced stevia leaf, and results in great tasting, pure molecules that are found in nature. This process was developed by Conagen, a biotech innovator of sustainable ingredients.

“The introduction of Reb N is another great example of how Conagen’s deep expertise in bioconversion technology enables the creation of unique stevia sweeteners,” said Conagen’s VP of Innovation, Dr. Casey Lippmeier. “With such a wide range of next generation stevia offerings now available, we will see a new level of innovation in better-for-you products that was previously considered impossible.”

About SweeGen

Sweegen provides sweet taste solutions for food and beverage manufacturers around the world.

We are on a mission to reduce the sugar and artificial sweeteners in our global diet.  Partnering with customers, we create delicious zero-sugar products that consumers love.  With the best next generation stevia sweeteners in our portfolio such as Bestevia® Rebs B, D, E, I, M, and N, along with our deep knowledge of flavor modulators and texturants, SweeGen delivers market-leading solutions that customers want and consumers prefer.

For more information please contact info@sweegen.com and visit SweeGen’s website, www.sweegen.com.

About Conagen

Conagen is making the impossible possible. Our scientists and engineers are bettering humankind and the world by employing advanced synthetic biology tools for the bioproduction of high-value ingredients for food, nutrition, flavor and fragrance, pharmaceutical, and renewable materials industries. www.conagen.com

Cautionary Statement Concerning Forward-Looking Statements

This press release contains forward-looking statements, including, among other statements, statements regarding the future prospects for Reb M stevia leaf sweetener. These statements are based on current expectations, but are subject to certain risks and uncertainties, many of which are difficult to predict and are beyond the control of SweeGen, Inc.

Relevant risks and uncertainties include those referenced in the historic filings of SweeGen, Inc. with the Securities and Exchange Commission. These risks and uncertainties could cause actual results to differ materially from those expressed in or implied by the forward-looking statements, and therefore should be carefully considered. SweeGen, Inc. assumes no obligation to update any forward-looking statements as a result of new information or future events or developments.

Attachments

Ana Arakelian
SweeGen, Inc.
+1-949-635-1991 and +1-949-750-6812
ana.arakelian@sweegen.com

Helsinn Announces First Patient Dosed in Phase 1/2 Study of TAS0953/HM06 in Patients with Advanced Solid Tumors with RET Gene Abnormalities

Helsinn Announces First Patient Dosed in Phase 1/2 Study of TAS0953/HM06 in Patients with Advanced Solid Tumors with RET Gene Abnormalities

Lugano, Switzerland, January 12, 2021 – Helsinn, a Swiss pharmaceutical group focused on building quality cancer care and rare disease products, today announces the first patient has been dosed in a Phase 1/2 Study of TAS0953/HM06 in Patients with Advanced Solid Tumors with RET Gene Abnormalities.

TAS0953/HM06 is an investigational oral treatment which inhibits several RET abnormalities identified as oncogenic driver alterations in NSCLC, papillary and medullary thyroid cancers, and several other tumor types. This innovative drug candidate offers several differentiating features as compared to other RET inhibitors.

The study will be initially conducted at sites in US and Japan.

Helsinn is developing TAS0953/HM06 together with its partner Taiho Pharmaceutical Co., Ltd.  In 2017, Helsinn and Taiho signed a global co-development and commercialization agreement for TAS0953/HM06.

Riccardo Braglia, Helsinn Group Vice Chairman and CEO commented: “We are very pleased to have dosed the first patient in this Phase 1/2 study with TAS0953/HM06.  Based on pre-clinical data generated thus far, TAS0953/HM06 has been shown to have several differentiating features in comparison to other targeted therapies, and we believe it has therefore the potential to offer significant benefits for patients with NSCLC and other tumors which harbor RET abnormalities. 

We have had a very collaborative relationship with Taiho to date and are looking forward to continuing to work closely with them to advance this potential innovative treatment through the clinic.”

Further information on the study can be found at: https://www.clinicaltrials.gov/ct2/show/NCT04683250?term=hm06&draw=2&rank=1.

TAS0953/HM06 is an investigational agent and is not approved for commercial use in any country.

About TAS0953/HM06

TAS0953/HM06 is an oral RET inhibitor in development for advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) and other tumors which express RET gene abnormalities. Preclinical data showed several differentiating features in comparison to other targeted therapies acting on RET abnormalities.

Taiho and Helsinn signed a co-development and commercialization agreement for TAS0953/HM06 in 2017 and will continue to pursue together all preclinical, clinical and CMC developments. This alliance also includes efforts to reach as many patients as possible around the world through their own commercial infrastructures or through valued partners.

About RET abnormalities in NSCLC and other cancers1

RET kinase abnormalities have been identified as targetable oncogenic drivers in NSCLC, papillary and medullary thyroid cancers, and several other tumor types. In NSCLC, RET fusions are more common in younger patients with no prior history of smoking and in those with adenocarcinomas, however the underlying mechanisms remain unknown.

About the Helsinn Group

Helsinn is a privately-owned Swiss Pharma Company which, since 1976, has been improving the lives of patients, guided by core family values of respect, integrity and quality. The Group has an extensive portfolio of marketed innovative cancer and rare disease therapies, a robust drug development pipeline and ambitions to further accelerate its growth through in-licensing and acquisition to address unmet medical needs. Helsinn operates a unique integrated licensing business model, achieving success with over 80 long-standing partners in 190 countries, who share our values. The Group’s pharmaceutical business, (Helsinn Healthcare) is headquartered in Lugano, Switzerland with operating subsidiaries in the U.S. (Helsinn Therapeutics US) and China (Helsinn Pharmaceuticals China) which market the Group’s products directly in these countries. The Group has additional operating subsidiaries in Switzerland (Helsinn Advanced Synthesis, an active pharmaceutical ingredient manufacturer) and Ireland (Helsinn Birex Pharmaceuticals, a drug product manufacturer). Helsinn Investment Fund was created to enhance the future of healthcare by providing funding and strategic support to innovative companies.

Helsinn Group plays an active and central role in promoting social transformation in favor of people and the environment. Corporate social responsibility is at the heart of everything we do which is reinforced in the company’s strategic plan by a commitment to sustainable growth.

To learn more about Helsinn Group please visit www.helsinn.com

About Taiho Pharmaceutical

Taiho Pharmaceutical, a subsidiary of Otsuka Holdings Co., Ltd., is an R&D-driven specialty pharma focusing on the three fields of oncology, allergy and immunology, and urology. Its corporate philosophy takes the form of a pledge: “We strive to improve human health and contribute to a society enriched by smiles.” In the field of oncology in particular, Taiho Pharmaceutical is known as a leading company in Japan for developing innovative medicines for the treatment of cancer, a reputation that is rapidly expanding through their extensive global R&D efforts. In areas other than oncology, as well, the company creates and markets quality products that effectively treat medical conditions and can help improve people’s quality of life. Always putting customers first, Taiho Pharmaceutical also aims to offer consumer healthcare products that support people’s efforts to lead fulfilling and rewarding lives. For more information about Taiho Pharmaceutical, please visit: https://www.taiho.co.jp/en/

Helsinn Group Media Contact:

Paola Bonvicini

Group Head of Communication

Lugano, Switzerland

Tel.: +41 91-985-21-21

Info-HHC@helsinn.com

For more information, please visit www.helsinn.com and follow us on TwitterLinkedIn and Vimeo

HELS–0006


1 Helsinn and Taiho research and analysis of ASCO 2018; ASCO 2019; Cancer Biol Ther 2015; Cell Rep 2017; JCO 2018; Johns Hopkins 2019; Nat Med 2012; Nat Rev Clin Oncol 2018; OMIM; Onco Targets Ther 2019

Kedah to PBAPP: Don’t interfere in affairs of Kedah

The Kedah government has today reminded the Penang Water Supply Corporation (PBAPP) not to interfere with issues of sovereignty, especially on water catchment areas in the state.

Menteri Besar Muhammad Sanusi Md Nor advised companies, especially PBAPP, not to issue any more statements touching on matters related to forests, rivers and regions in Kedah, as only the Penang state government was qualified to deal with its Kedah counterpart.

“The Kedah government will only deal with the Penang government, not with any companies (in the issue of raw water charges) because, after the signing of the agreement to join Malaysia in 1963, Kedah is a sovereign government covering a legitimate government, laws are complied with, state borders are respected and the people are protected, this is the sovereignty of the state of Kedah.

“We will defend this sovereignty, no company like PBAPP can interfere in the affairs of the state government, rivers and forests in Kedah,” he told reporters after chairing the state executive council meeting here today.

He said the state government had also received a report on Penang’s Dependence on Kedah Water Resources from the Kedah State Water Resources Board (LSANK), which detailed the legislation and history related to the borders and rivers in the state.

“I will scrutinise the report, related to the issue of Penang’s dependence on Kedah, we will study what process can be taken (against the Penang government),” said Muhammad Sanusi.

The Kedah government had repeatedly submitted demands in writing to the Penang government since 2010 to claim raw water charges of RM50 million a year for its use of water from Sungai Ulu Muda source located in Kedah.

Subsequently, several parties, including PBAPP, were said to have issued statements numerous times relating to the water catchment area in Ulu Muda and which were seen as interfering in the affairs of the (Kedah) government.

Source: BERNAMA News Agency

Parit Yaani rep Aminolhuda tests positive for COVID-19

— Parit Yaani state assemblyman Aminolhuda Hassan, who is also Johor Pakatan Harapan (PH) chairman, has tested positive for COVID-19.

He said he had been having fever for the past four days and decided to go for a swab test at a private clinic here today. The result was positive.

“The doctor contacted the hospital and was told there were no empty beds to receive patients. So, for now I have to quarantine at home, “he told Bernama when contacted.

Aminolhuda, who is also Johor Parti Amanah Negara chairman, said he did not know how he contracted the virus.

He had shared his predicament on his official Facebook and urged anyone who had met him in the last few days to go for a COVID-19 test.

“I apologise to all. Please also pray that God will make it easier and speed up my recovery,” he said.

Source: BERNAMA News Agency

COVID-19: Highest daily tally of 3,309 recorded today – Health D-G

Malaysia recorded the highest number of daily COVID-19 cases when 3,309 cases were reported today, taking the total number of active cases with infectivity potential to 30,390, said Health director-general Tan Sri Dr Noor Hisham Abdullah.

Of the new cases, six were imported while the remaining 3,303 were local transmissions.

“Four fatalities were also reported today while the total infection tally now stands at 141,533,” he said on his official Twitter posting today.

The previous highest number of daily cases was 3,027, which was recorded on Jan 7.

As for the local transmissions, he said 2,461 of the cases involved Malaysians and 842 foreigners.

Meanwhile, more than half of the new cases were reported in the three states set to be placed under the Movement Control Order (MCO) from tomorrow, with Selangor recording 1,007 cases (30.4 per cent); Johor 442 cases (13.4 per cent); and Sabah 409 cases (12.4 per cent).

Dr Noor Hisham said that in Selangor, a total of 825 cases were detected from clusters and active on-field contact tracing.

“A total of 439 cases (13.3 per cent) which were reported are linked to clusters in lock-ups, Immigration detention depots and prisons involving the Jalan Harapan Prison Cluster (192 cases), Tembok Choh Cluster (162 cases), Tembok Mempaga Cluster (70 cases), Tembok Gajah Cluster (seven cases), Pagar Siput Cluster (three cases), Telok Mas Cluster (three cases) and Seberang Perai Prison Cluster (two cases),” he said.

Dr Noor Hisham said three of the four fatalities reported today were in Selangor and one in Perak, with all the victims aged between 52 and 69, taking the death toll to 559.

— MORE

COVID-NOOR HISHAM (CASE) 3 (LAST) KUALA LUMPUR

Thus far, 190 cases are currently being treated in the intensive care unit, with 83 of them intubated, he said.

Malaysia also recorded 1,469 recoveries, taking the cumulative total number of recovered cases to 110,584 (78.1 per cent of the total number of cases).

Meanwhile, Dr Noor Hisham said the Ministry of Health (MOH) also detected 11 new clusters, taking the total number of active clusters currently to 261, with 77 clusters reporting an increase in cases today.

The 11 new clusters are the Jalan Manan Cluster in Selangor (83 cases); Persiaran Kuala Cluster (Selangor, 44 cases); Udarama Cluster (Kuala Lumpur, 21 cases); Iris Cluster (Kuala Lumpur, 11 cases); Jalan Kiara Cluster (Kuala Lumpur, 22 cases); Batu Dialysis Cluster (Kuala Lumpur, six cases); Bukit Sekubong Cluster (Sarawak, 21 cases); Kampung Badak Cluster (Kelantan, 39 cases); Taman Kesedar (Kelantan, 14 cases); Putra Dialysis Cluster (Putrajaya, 10 cases); and Permint Harmoni Cluster (Terengganu, eight cases).

“The clusters which reported the highest number of cases are the Jalan Harapan Prison Cluster (192 cases), Teratai Cluster (176 cases) and Tembok Choh Cluster (162 cases),” he said.

In the meantime, a total of 344 clusters were also declared over today, including the Atabara Cluster, Senu Setia Cluster, Bonggaya Cluster, Jernai Cluster, Pengkalan Barat Cluster, Puteh Lama Construction Site Cluster, Jalan Bukit Construction Site Cluster and Sabaru Cluster.

Source: BERNAMA News Agency