On January 27, 2021 Bristol Myers Squibb (BMS) reported its Revlimid (lenalidomide) has received a recommendation from the UK’s National Institute of Health and Care Excellence (NICE) for newly diagnosed multiple myeloma patients (Press release, Bristol-Myers Squibb, JAN 27, 2021, View Source [SID1234574410]).

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In its Final Appraisal Document (FAD), NICE recommended Revlimid as a maintenance treatment after autologous stem cell transplant (ASCT) for newly diagnosed multiple myeloma in adults.

In September 2020, NICE initially turned down NHS funding of Revlimid in this indication, after concluding that the cost-effectiveness estimates for the drug in this setting were uncertain.

According to BMS, around 1,150 eligible patients in England will have immediate access to Revlimid from today, with interim funding provided via the Cancer Drugs Fund (CDF).

The recommendation is supported by data from two Phase III studies, in which Revlimid maintenance treatment significantly improved progression-free survival (PFS) in newly diagnosed multiple myeloma patients after ASCT compared with placebo.

This includes the CALGB 100104 study, where median PFS for patients receiving Revlimid was 57.3 months compared to 28.9 months in the placebo group.

In the IFM 2005-02 study, median PFS was 41 months for patients receiving Revlimid compared to 23 months in the placebo group.

"We are delighted with this outcome. Patients who receive Revlimid maintenance after high-dose therapy and stem cell transplant have a significant increase in overall survival, so the decision to make this available through the NHS is fantastic news," said Laura Kerby, chief executive of Myeloma UK.

In the UK, around 1,500 newly diagnosed multiple myeloma patients undergo ASCT each year, although most will eventually relapse.

This first remission period is critical for people living with multiple myeloma, as it can be an indicator of the overall survival of the disease.

It has been shown that effective maintenance therapy at this stage of the disease could be ‘essential’ for long-term survival.

On January 27, 2021 Redx Pharma (AIM:REDX), the drug discovery and development Company focused on
oncology and fibrosis, reported its audited financial results for the year ended 30 September 2020 as well as an
operational update (Press release, Redx Pharma, JAN 27, 2021, View Source [SID1234574335]).

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Iain Ross, Non-Executive Chairman of Redx Pharma, commented:
"2020 was a transformational year for the Company. Redx has overcome the common industry challenge of funding and
has ended the period with a strong balance sheet and the backing of new specialist life science investors. Despite clinical
development challenges that have affected us, as well as many other companies in our sector, as a result of the global
COVID-19 pandemic, Redx has managed to progress its pipeline, further developing its lead programmes in oncology and
fibrosis, and is on track to deliver on key milestones in 2021. We have a strong and talented management and scientific
team and it is with this expertise that Redx has continued to grow and move forward with its strategy."

Lisa Anson, Chief Executive Officer of Redx Pharma, added:
"We are excited to report on the growing strength and capabilities of Redx. Over the past 12 months, with highly
experienced scientific and management teams in place, we have made significant progress with our pipeline as we continue to apply our distinctive approach to drug discovery. In further recognition of our capabilities we also completed two significant partnering deals with AstraZeneca and Jazz Pharmaceuticals.

Having now gained the backing of key specialist life science investors, we start 2021 in a strong and confident position. Key milestones lie ahead of us in the coming months. I look forward to reporting on these as we continue on our journey to becoming a leading biotech company focused on the development of novel targeted medicines that have the potential to transform the treatment of cancer and fibrosis."

Operational Highlights
· Progressed the Phase 1 trial of its lead oncology asset, RXC004, a potentially best-in-class, orally bioavailable, Porcupine inhibitor
o Dosing of the first four patient cohorts has successfully been completed
o The final cohort is ongoing and results are expected by mid 2021
· Nominated a second fibrosis development candidate, RXC007, a ROCK2 (Rho Associated Coiled-Coil Containing Protein
Kinase 2) selective inhibitor with potential for development in multiple fibrotic conditions
o RXC007 is expected to enter a Phase 1 study in H1 2021
· Announced the appointment of Dr Jane Robertson as Chief Medical Officer, effective 1 March 2021
· Licensed preclinical stage Porcupine inhibitor programme, RXC006, to AstraZeneca in return for $17 million in early
payments and up to a further $360 million in deferred milestone payments and tiered royalties
· Signed a two target research collaboration with Jazz Pharmaceuticals, with $10 million cash received on signing and a
further $10 million due in year two, together with further milestone payments and tiered royalties

Financial Highlights
During the year, the Company significantly improved its financial position, gaining the support of established specialist
healthcare and life sciences investors. Taken together with the income from commercial partnerships, the Company has
working capital until the end of 2022.
· $30 million financing package secured with Redmile Group LLC and Sofinnova Partners in July 2020, approved at the
general meeting on 20 July 2020
· Post period, in December 2020 a placing and Open Offer of £25.7 million, which received strong support from existing
investors and added healthcare specialist investors including Polar Capital, was approved at the General Meeting on 21
December 2020
· Cash balance at 30 September 2020 of £27.5 million (30 September 2019: £3.7 million), post placing cash balance of
£48.2 million on 24 December 2020, working capital secured until Q4 2022
· Total revenue for the year: £5.7 million (2019: £3.1 million)
· Loss for the year: £9.2 million (2019: £4.3 million)
· Total operating expenditure: £14.2 million (2019: £10.2 million)

On January 27, 2021 Abbott (NYSE: ABT) reported financial results for the fourth quarter and full year ended Dec. 31, 2020, and issued its financial outlook for 2021 (Press release, Abbott, JAN 27, 2021, View Source [SID1234574332]).

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Fourth-quarter sales of $10.7 billion increased 28.7 percent on a reported basis and 28.4 percent on an organic basis, which excludes the impact of foreign exchange.
Fourth-quarter GAAP diluted EPS was $1.20 and adjusted diluted EPS, which excludes specified items, was $1.45, reflecting 52.6 percent growth versus the prior year.1
Full-year 2020 GAAP diluted EPS from continuing operations was $2.49 and adjusted diluted EPS from continuing operations was $3.65, at the upper-end of guidance range issued in January 2020.2
Abbott issues full-year 2021 guidance for diluted EPS from continuing operations on a GAAP basis of at least $3.74 and full-year adjusted diluted EPS from continuing operations of at least $5.00, reflecting growth of more than 35 percent versus the prior year.3
In the fourth quarter, global COVID-19 testing-related sales were $2.4 billion, led by combined sales of $1.9 billion from Abbott’s BinaxNOW, Panbio and ID NOW rapid testing platforms.
R&D pipeline continued to be highly productive in 2020: U.S. approval of FreeStyle Libre 2 and CE Mark of FreeStyle Libre 3 and Libre Sense Glucose Sport Biosensor; CE Mark of MitraClip G4, TriClip and Tendyne heart valve devices; U.S. approval of Gallant cardiac rhythm devices; CE Mark of EnSite X 3D cardiac mapping system; portfolio expansions in Nutrition and Established Pharmaceuticals.
"Despite challenging conditions, we achieved double-digit EPS growth, delivered ground-breaking innovation and advanced our new product pipeline in 2020," said Robert B. Ford, president and chief executive officer, Abbott. "We exited the year with a lot of momentum and are forecasting EPS growth of more than 35 percent in 2021."

FOURTH-QUARTER BUSINESS OVERVIEW
Note: Management believes that measuring sales growth rates on an organic basis is an appropriate way for investors to best understand the underlying performance of the business. Organic sales growth excludes the impact of foreign exchange.

* Total Q4 2020 Abbott sales from continuing operations include Other Sales of approximately $16 million.

Note: In order to compute results excluding the impact of exchange rates, current year U.S. dollar sales are multiplied or divided, as appropriate, by the current year average foreign exchange rates and then those amounts are multiplied or divided, as appropriate, by the prior year average foreign exchange rates.

Fourth-quarter 2020 worldwide sales of $10.7 billion increased 28.7 percent on a reported basis and 28.4 percent on an organic basis.

Worldwide Nutrition sales increased 3.6 percent on a reported basis and 4.4 percent on an organic basis in the fourth quarter. Strong performance of Ensure, Abbott’s market-leading complete and balanced nutrition brand, and Glucerna, Abbott’s market-leading diabetes nutrition brand, led to global Adult Nutrition sales growth of 11.5 percent on a reported basis and 12.7 percent on an organic basis. In Pediatric Nutrition, U.S. sales growth of 5.2 percent was led by share growth of Similac, Abbott’s infant formula brand, which was offset by challenging conditions in Greater China.

Worldwide Diagnostics sales increased 111.1 percent on a reported basis in the fourth quarter and increased 108.9 percent on an organic basis. Strong growth in the quarter was driven by demand for Abbott’s portfolio of COVID-19 diagnostics tests across its rapid and lab-based platforms. Global COVID-19 testing-related sales were $2.4 billion in the fourth quarter, led by combined sales of $1.9 billion from Abbott’s BinaxNOW, Panbio and ID NOW rapid testing platforms.

During 2020, Abbott mobilized its teams across multiple fronts to develop and launch multiple diagnostic tests for COVID-19:

U.S. Emergency Use Authorization (EUA) of BinaxNOW COVID-19 Ag Card test, a portable, lateral flow rapid antigen test to detect COVID-19.
CE Mark and World Health Organization emergency use listing of Panbio rapid antigen test to detect COVID-19.
U.S. EUA of molecular test to detect COVID-19 on its ID NOW rapid point-of-care platform.
U.S. EUA and CE Mark of molecular test on its m2000 RealTime lab-based platform to detect COVID-19.
U.S. EUA and CE Mark of molecular test on its Alinity m system to detect COVID-19.
U.S. EUA and CE Mark of IgG (Immunoglobulin G) lab-based serology blood test on its ARCHITECT i1000SR and i2000SR laboratory instruments for the detection of an antibody to determine if someone was previously infected with the virus.
U.S. EUA and CE Mark of SARS-CoV-2 IgG lab-based serology blood test on its Alinity i system.
Lateral flow COVID-19 rapid antibody test on its Panbio system in select countries for the detection of an antibody to determine if someone was previously infected with the virus.
U.S. EUA and CE Mark of AdviseDx SARS-CoV-2 IgM (Immunoglobulin M) lab-based serology test for use on its ARCHITECT and Alinity platforms.
CE Mark of IgG (Immunoglobulin G) quantitative lab-based serology test for use on its ARCHITECT and Alinity platforms.
CE Mark of multiplex molecular tests on its Alinity m system to detect COVID-19, Flu A/B and RSV.
Established Pharmaceuticals sales decreased 2.3 percent on a reported basis in the fourth quarter and increased 3.4 percent on an organic basis.

Key Emerging Markets include India, Brazil, Russia and China along with several additional emerging countries that represent the most attractive long-term growth opportunities for Abbott’s branded generics product portfolio. Sales in these geographies decreased 7.1 percent on a reported basis in the quarter and increased 1.1 percent on an organic basis. Organic sales growth in India, Russia and Brazil was partially offset by market softness across several countries as a result of COVID-19.

Other sales increased 13.0 percent on a reported basis in the quarter and increased 10.8 percent on an organic basis, led by strong sales of Influvac.

Includes drug-eluting stents, balloon catheters, guidewires, vascular imaging/diagnostics products, vessel closure, carotid and other coronary and peripheral products.

Includes drug-eluting stents, balloon catheters, guidewires, vascular imaging/diagnostics products, vessel closure, carotid and other coronary and peripheral products.

Worldwide Medical Devices sales increased 1.7 percent on a reported basis in the fourth quarter and decreased 0.4 percent on an organic basis. Strong growth in Diabetes Care, led by FreeStyle Libre, was offset by reduced cardiovascular and neuromodulation procedure volumes due to the COVID-19 pandemic and lower Vascular sales in China, as a result of a new national tender program in that country. Excluding Vascular sales in China, global Vascular sales decreased 10.4 percent on an organic basis, and Medical Devices sales increased 1.4 percent on an organic basis in the fourth quarter.

In Diabetes Care, strong growth in the quarter was led by FreeStyle Libre, which grew 41.3 percent on a reported basis and 37.1 percent on an organic basis. For the full year, FreeStyle Libre grew 43.1 percent on a reported basis and 42.6 percent on an organic basis.

Abbott continues to strengthen its Medical Devices portfolio, with several key product approvals in 2020, including:

U.S. FDA clearance of FreeStyle Libre 2 as an integrated continuous glucose monitoring (iCGM) system for adults and children ages 4 and older with diabetes, achieving the highest level of accuracy and performance standards.4
CE Mark of FreeStyle Libre 3, which automatically delivers up-to-the-minute glucose readings, unsurpassed 14-day accuracy5 and real-time glucose alarms in the world’s smallest and thinnest6 wearable glucose sensor.
CE Mark of Libre Sense Glucose Sport Biosensor, a small wearable sensor that helps athletes better understand the efficacy of their nutritional choices on training and athletic performance.
CE Mark of MitraClip G4, Abbott’s next-generation MitraClip heart system, the leading minimally invasive mitral heart valve repair device in the world.
CE Mark of TriClip, the world’s first minimally invasive, clip-based device for repair of a leaky tricuspid heart valve.
CE Mark of Tendyne, a first-of-its-kind technology to replace a faulty mitral heart valve.
U.S. approval of Gallant implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) devices, which include Bluetooth technology and a new patient smartphone app for improved remote monitoring and enhanced patient-physician engagement to help manage heart rhythm disorders.
CE Mark of EnSite X EP System, a next-generation 3D cardiac mapping platform used for ablation therapy to treat abnormal heart rhythms.
U.S. FDA clearance and CE Mark of the IonicRF Generator, a non-surgical, minimally invasive device that uses heat to target specific nerves for the management of chronic pain.
ABBOTT ISSUES GUIDANCE FOR 2021
Abbott projects full-year 2021 diluted earnings per share from continuing operations under GAAP of at least $3.74. Abbott forecasts specified items for the full-year 2021 of $1.26 primarily related to intangible amortization, expenses associated with acquisitions, restructuring and cost reduction initiatives and other net expenses. Excluding specified items, projected adjusted diluted earnings per share from continuing operations would be at least $5.00 for full-year 2021.

ABBOTT DECLARES 388TH CONSECUTIVE QUARTERLY DIVIDEND
On Dec. 11, 2020, the board of directors of Abbott increased the company’s quarterly dividend to $0.45 per share from $0.36 per share, an increase of 25 percent. Abbott’s cash dividend is payable Feb. 16, 2021, to shareholders of record at the close of business on Jan. 15, 2021.

Abbott has increased its dividend payout for 49 consecutive years and is a member of the S&P 500 Dividend Aristocrats Index, which tracks companies that have annually increased their dividend for at least 25 consecutive years.

On January 27, 2021 Scopus BioPharma Inc. (Nasdaq: "SCPS") reported the pricing of a $9 million follow-on public offering (Press release, Scopus BioPharma, JAN 27, 2021, View Source,price%20of%20%249.00%20per%20share. [SID1234574299]). The offering consists of 1,000,000 shares of common stock at a public offering price of $9.00 per share. The company has granted the underwriters a 45-day option to purchase up to an additional 150,000 shares of common stock at the public offering price. The offering is expected to close on or about January 29, 2021, subject to customary closing conditions.

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Scopus is a biopharmaceutical company developing transformational therapeutics based on groundbreaking scientific and medical discoveries. The company’s lead drug candidate is a novel, targeted immuno-oncology gene therapy for the treatment of multiple cancers. This drug candidate is highly distinctive, encompassing both gene therapy and immunotherapy by synthetically linking siRNA to an oligonucleotide TLR9 agonist, creating the potential for targeted gene silencing with simultaneous TLR stimulation and immune activation in the tumor microenvironment.

Scopus intends to use the proceeds of the offering principally for further development of the company’s lead drug candidate, including in combination with checkpoint inhibitors.

The Benchmark Company, LLC acted as Sole Bookrunning Manager and Joseph Gunnar & Co., LLC acted as Co-Manager for the offering.

Greenberg Traurig, LLP is acting as counsel to the company. Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. is acting as counsel to the underwriters.

An offering statement relating to the shares of common stock was filed with the U.S. Securities and Exchange Commission and became qualified on January 26, 2021. The offering is being made only by means of an offering circular, copies of which may be obtained, when available, by contacting: The Benchmark Company, LLC, Attention: Prospectus Department, 150 E. 58th Street, 17th Floor, New York, NY 10155, by calling (212) 312-6700 or by e-mail at [email protected]; or Joseph Gunnar & Co., LLC, Attention: Prospectus Department, 30 Broad Street, 11th Floor, New York, NY 10004, by calling (212) 440-9600 or by email at [email protected]. The offering circular is also available on the U.S. Securities and Exchange Commission website at www.sec.gov.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification of these securities under the securities laws of any such state or jurisdiction.

n January 26, 2021 Shaperon reported that it had signed a memorandum of understanding (MOU) with Selvion for cooperation in the joint development of new drugs for diagnosis and treatment of cancer (Press release, Shaperon, JAN 26, 2021, View Source;idx=38&pNo=3&code=press_en [SID1234629323]).

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Based on precision medicine technology, Cellvion is a bio company that is conducting clinical trials and development of new drugs such as medicines for diagnosis and treatment of intravascular inflammation, specific cancer, and complex contrast media for imaging surgery with leading university hospitals in Korea. We have production facilities that have obtained GMP (Good Manufacturing Practice) approval from the Ministry of Safety and Security.

In addition, in August, it obtained QP certification from the European EMA, and produced and supplied GMP clinical trial drugs to be used in the European phase 2 clinical trial of Chaperone’s COVID-19 treatment.

Through this agreement, Chaperon plans to accelerate the development of new drugs for diagnosing and treating cancer diseases, such as nanobody-based positron emission tomography (PET) diagnostic radiopharmaceuticals.

Chaperon’s own nanobody antibody technology has high antigen binding ability and stability as well as low immunogenicity, so it is attracting attention as a next-generation antibody treatment for the development of complex antibodies.

Based on this, Chaperone plans to develop a radiopharmaceutical diagnostic agent for PET diagnosis by applying nanobody technology targeting cancer cells or specific T-cell markers to determine the drug for immuno-anticancer drug treatment and determine whether to continue treatment with Cellvion.

In addition, the two companies plan to jointly conduct research and development of oral mucositis treatment mixed with ‘HY209’, which is currently being developed as a new drug candidate for atopic dermatitis.

Lee Myung-se, CEO of Chaperon, said, "We expect to accelerate the research and development of our nanobody antibody-based technology and inflammatory complex inhibitor new drug candidates through cooperation with Cellvion, which has excellent precision medicine technology."

Cellvion CEO Kwon Kim said, "We are sincerely pleased to have signed an MOU with Chaperone, which is leading the development of fundamental treatments for inflammatory and immune diseases, and expect that this agreement will fully exert synergy for the development of new drugs for diagnosis and treatment of cancer diseases. "he said.

Meanwhile, Chaperon is leading the research and development of inflammatory and immune disease treatments based on the theory of DAMPs (Damage-Associated Molecular Patterns) presented by CEO Seung-yong Sung for the first time in the world in ‘Nature Review Immunology,’ a world-renowned academic journal in the field of immunology. It is a bio-venture company.

In September 2020, Chaperone successfully attracted a series C investment of KRW 26 billion, and will lead the next-generation bio field as well as a new mechanism of inflammatory complex inhibitor for the treatment of major inflammatory diseases such as atopic dermatitis, Alzheimer’s disease, and ulcerative colitis. It is expanding its pipeline in various fields, including nanobody antibody-based immuno-oncology drugs.