Pharmaceutical – IMI Site http://www.imisite.org/ Wed, 22 Sep 2021 18:54:10 +0000 en-US hourly 1 https://wordpress.org/?v=5.8 https://www.imisite.org/wp-content/uploads/2021/05/imi-site-icon-150x150.png Pharmaceutical – IMI Site http://www.imisite.org/ 32 32 Activist investor Bluebell takes stake in GSK https://www.imisite.org/activist-investor-bluebell-takes-stake-in-gsk/ https://www.imisite.org/activist-investor-bluebell-takes-stake-in-gsk/#respond Wed, 22 Sep 2021 17:03:00 +0000 https://www.imisite.org/activist-investor-bluebell-takes-stake-in-gsk/ A GlaxoSmithKline factory is seen in Montrose, Scotland, Britain October 22, 2018. Andy Buchanan / Pool via REUTERS / File Photo

Sept. 22 (Reuters) – Activist investor Bluebell Capital Partners has taken an estimated € 10million stake in UK pharmaceutical group GlaxoSmithKline (GSK.L) in a bid to shake up management, a report from the Financial Times.

Bluebell said in a letter to GSK chairman Jonathan Symonds that chief executive Emma Walmsley would have to reapply for her post because she would have “renewed her credibility both internally and externally,” according to the FT report.

Earlier this year, activist Elliott also took a stake in GSK, calling for a change in leadership at the company. Bluebell largely supported Elliott’s demands, the FT said. Read more

GSK confirmed that Bluebell made requests in a letter.

“We continue to engage extensively with our shareholders with more than 500 meetings so far this year,” GSK said in a statement.

“They expressed widespread and strong support for our plans to bring about a radical change in terms of growth and performance, and made it clear that they need to focus on execution,” the company added.

The British pharmaceutical major, with a market value of more than 71 billion pounds ($ 96.95 billion), in July rejected Elliott’s demands to change its board of directors and sell its consumer health arm. Read more

GSK has plans to turn its consumer healthcare arm into a separately listed company, a move that will generate an £ 8 billion windfall and other financial benefits to spur drug development in its sub-pharmaceutical business. efficient. Read more

Bluebell was part of a successful investor campaign to oust Danone (DANO.PA) Chairman and CEO Emmanuel Faber in March. Read more

($ 1 = 0.7323 pounds)

Report by Aditi Sebastian in Bengaluru and Ludwig Burger in Frankfurt. Editing by Jane Merriman

Our Standards: Thomson Reuters Trust Principles.

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FDA Approves Incyte Eczema Cream with Boxed Warnings https://www.imisite.org/fda-approves-incyte-eczema-cream-with-boxed-warnings/ https://www.imisite.org/fda-approves-incyte-eczema-cream-with-boxed-warnings/#respond Wed, 22 Sep 2021 01:47:00 +0000 https://www.imisite.org/fda-approves-incyte-eczema-cream-with-boxed-warnings/ Signage can be seen outside the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, USA on August 29, 2020. REUTERS / Andrew Kelly

Sept. 21 (Reuters) – The U.S. Food and Drug Administration on Tuesday approved Opzelura Cream from Incyte Corp (INCY.O) for the treatment of inflammatory atopic dermatitis, commonly known as eczema, in adolescents and adults with boxed warnings.

Opzelura’s label carries the health regulator’s JAK class warning, signaling the risks of serious infections, increased risk of heart attack, stroke, or cardiac death.

Shares of the company, which plans to make the cream available at U.S. drug stores in the coming weeks, fell about 5% to $ 72.26 after the bell.

RBC analyst Brian Abraham said in a note to a client that boxed warnings may have limited impact on long-term opportunities and short-term stock reaction.

The brokerage’s physician survey had indicated that a boxed warning on Opzelura’s label could reduce adoption by about 30%, especially in lighter patients, Abraham said in a note. customer.

Ruxolitinib cream is the first topical inhibitor of JAK, a class of treatments that work by blocking inflammatory enzymes Janus kinases, to be approved in the United States.

Recent safety concerns regarding oral JAK inhibitors such as the arthritis drug from Pfizer Inc (PFE.N) Xeljanz and the treatment Rinvoq from AbbVie Inc (ABBV.N) and Eli Lilly (LLY.N) Olumiant , have resulted in regulatory delays. Read more

Atopic dermatitis is a chronic skin condition that causes inflammation and irritation of the skin. It affects about 30% of the American population, mostly children and adolescents, according to the National Institute of Allergy and Infectious Diseases.

Ruxolitinib is approved as an oral tablet under the brand name Jakafi in the United States for the treatment of a type of blood cancer called polycythemia essential, rare myelofibrosis in bone marrow cancer, and acute graft-versus-bone disease. host.

Brian of RBC estimates US sales at over $ 550 million for the year for the atopic dermatitis indication.

Reporting by Bhanvi Satija and Manojna Maddipatla; Editing by Aditya Soni and Vinay Dwivedi

Our Standards: Thomson Reuters Trust Principles.

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Verrica Pharmaceuticals shares drop 17% after full response letter from FDA https://www.imisite.org/verrica-pharmaceuticals-shares-drop-17-after-full-response-letter-from-fda/ https://www.imisite.org/verrica-pharmaceuticals-shares-drop-17-after-full-response-letter-from-fda/#respond Tue, 21 Sep 2021 14:55:00 +0000 https://www.imisite.org/verrica-pharmaceuticals-shares-drop-17-after-full-response-letter-from-fda/

By Chris Wack

Shares of Verrica Pharmaceuticals Inc. fell 17% to $ 9.99 after the company said the United States Food and Drug Administration issued a comprehensive response letter regarding its new drug application for VP- 102 for the treatment of molluscum contagiosum.

The company previously revealed that the FDA extended the Prescription Drug User Fee Act deadline for the NDA by three months, to give the FDA more time to review the information in response to comments regarding the study of the factors. humans of society.

According to CRL, the FDA has identified deficiencies in a facility of a contract manufacturing organization that are not specifically related to the manufacturing of VP-102, but rather raise general quality issues at the facility.

Verrica said that at no time before the LCR had the FDA been notified of any deficiencies to the CMO related specifically to the manufacture of VP-102 or that its general investigation of the facility would impact the NDA of the. company. In addition, the FDA has not identified any clinical, safety or chemical, manufacturing, and product-specific control deficiencies related to VP-102.

The company said that the CMO has implemented corrective actions to address the concerns of the FDA, and the CMO has informed Verrica that it expects a satisfactory resolution of the identified deficiencies of the facility by the FDA in the Next 30 working days.

Write to Chris Wack at chris.wack@wsj.com

]]> https://www.imisite.org/verrica-pharmaceuticals-shares-drop-17-after-full-response-letter-from-fda/feed/ 0 GENERAL: AFT: AFT further extends the Maxigesic® footprint; strengthens the EU Opens in a new window https://www.imisite.org/general-aft-aft-further-extends-the-maxigesic-footprint-strengthens-the-eu-opens-in-a-new-window/ https://www.imisite.org/general-aft-aft-further-extends-the-maxigesic-footprint-strengthens-the-eu-opens-in-a-new-window/#respond Mon, 20 Sep 2021 21:02:15 +0000 https://www.imisite.org/general-aft-aft-further-extends-the-maxigesic-footprint-strengthens-the-eu-opens-in-a-new-window/

September 21, 2021

AFT further extends the Maxigesic® footprint; strengthens the presence of the EU

New registrations for Maxigesic in South Korea, Panama, Chile and Peru; EU Business Development Team Grows As AFT Seeks To Increase Its Share Of The Global Pain Medication Market By US $ 47 Billion * And Overcome Bottlenecks At The New Zealand Border

AFT Pharmaceuticals (NZX.AFT, ASX.AFP) today announces that it has further expanded the global footprint of its patented pain relief drug Maxigesic by disclosing regulatory approvals for the intravenous form in South Korea and in Panama, and the tablet form of the drug in Chile and Peru.

It also announces a strengthening of its European activities with the addition of another business development manager to its European office, bringing the total number of employees in this market to three. Two of the staff on this team were transferred from the AFT office in New Zealand.

The records show the number of countries in which AFT has obtained regulatory approval for Maxigesic IV to 26 countries compared to 21 countries at the end of March 2021 and the number of countries in which AFT has obtained regulatory approval for the tablet. from 49 to 51 during the same period.

They also represent a further step towards AFT’s goal of selling the drug (in various forms) in more than 50 countries by the end of the current fiscal year, up from 43 at the end of fiscal 2021. .

South Korean registration of Maxigesic IV was approved in late August 2021 and licensee Kyongbo Pharmaceutical Co. is preparing to begin sales in early 2022.

The Panama Maxigesic IV licensee, the German company Pharma Bavaria, which has a licensing agreement for the drug in 17 countries in the Caribbean, Central America and Latin America, obtained regulatory approval in April 2021 and anticipates a launch of Maxigesic IV later this calendar year representing the first launch in this region.

Finally, with recordings made in Chile in September 2021 in addition to Peru earlier this year, the distributor of Maxigesic tablets in those countries, Barcelona-based Galenicum Vitae, is targeting launches in calendar year 2022.

The Maxigesic family of drugs is based on a novel combination of paracetamol and ibuprofen and offers clinicians around the world an alternative to dual-acting non-opioid pain management to traditional pain relievers.

AFT Pharmaceuticals Limited, Level 1, 129 Hurstmere Road, Takapuna, Auckland0622, New Zealand

Incorporated in New Zealand ARBN: ARBN 609 017 969

AFT Managing Director Hartley Atkinson said: “Faced with the significant challenges in bringing our employees overseas, I am pleased with the progress we are making in advancing the global commercialization of Maxigesic with the launches of the form IV dosing now looming in South America and Asia to add to previous launches in Australasia, Europe and the Middle East.

“The global market for the Maxigesic family of drugs is large with US $ 47 billion in 2020 and is expected to reach US $ 59.5 billion by 2026 *.

Dr Atkinson, however, noted that bottlenecks in international travel to the New Zealand border continued to pose a challenge for AFT in conducting international business.

“With our markets in North America and Europe living with COVID-19 and their markets reopening quickly, we must bring our employees overseas to continue to develop the markets for our products and maintain the momentum of our global operations.

“Our decision to transfer another of our New Zealand-based Business Development Managers to Europe to expand our team there as well as the continued use of remote work tools are examples of the short-term actions we are taking. have taken to respond to these pressures.

“The bottom line, however, is that nothing can replace the face-to-face engagement between our New Zealand-based team and our business partners and research collaborators around the world, so this remains an urgent and increasingly urgent issue. . ”

For and on behalf of AFT Pharmaceuticals Limited, Malcolm Tubby, Chief Financial Officer

For more information:

Dr Hartley Atkinson

Richard Inder

General manager

The project

AFT Pharmaceutical

Phone. : +64 21 645 643

Phone. : +64 9488 0232

About AFT Pharmaceuticals

AFT is a growing multinational pharmaceutical company that develops, markets and distributes a broad portfolio of pharmaceuticals across a wide range of therapeutic categories that are distributed across all major pharmaceutical distribution channels: over-the-counter (OTC), prescription and in a hospital environment. Our product portfolio includes both proprietary and licensed products, as well as patented, branded and generic drugs. Our business model is to develop and license products for sale by our own dedicated sales teams in our home markets of Australia and New Zealand and select markets in South East Asia, and to sublicense our products to local licensees and distributors for the rest of the world. For more information: aftpharm.com

*Source : https://www.expertmarketresearch.com/reports/analgesics-market

AFT Pharmaceuticals Limited, Level 1, 129 Hurstmere Road, Takapuna, Auckland0622, New Zealand

Incorporated in New Zealand ARBN: ARBN 609 017 969

Disclaimer

AFT Pharmaceuticals Limited published this content on September 21, 2021 and is solely responsible for the information it contains. Distributed by Public, unedited and unmodified, on September 20, 2021 09:01:06 PM UTC.

]]> https://www.imisite.org/general-aft-aft-further-extends-the-maxigesic-footprint-strengthens-the-eu-opens-in-a-new-window/feed/ 0 Leading Microbiologists to Meet at SMi’s 10th Annual Pharmaceutical Microbiology Conference https://www.imisite.org/leading-microbiologists-to-meet-at-smis-10th-annual-pharmaceutical-microbiology-conference/ https://www.imisite.org/leading-microbiologists-to-meet-at-smis-10th-annual-pharmaceutical-microbiology-conference/#respond Mon, 20 Sep 2021 02:00:00 +0000 https://www.imisite.org/leading-microbiologists-to-meet-at-smis-10th-annual-pharmaceutical-microbiology-conference/

SMi Reports: Leading Pharmaceutical Microbiologists and Industry Experts to Meet at SMi Pharmaceutical Microbiology UK 10th Anniversary Conference

LONDON, GREATER LONDON, UK, September 20, 2021 /EINPresswire.com/ – SMi Group announces the 10th Annual UK Pharmaceutical Microbiology Conference to be held January 17-18, 2022 in London. The theme of the 10th anniversary conference is “Exploring a Risk-Based Microbiological Control Strategy”.

The two-day conference will be chaired by Di Morris, Clinical Auditor, AstraZeneca.
Industry case studies will unveil their experiences and strategies in pharmaceutical microbiology by expert speakers such as Novo Nordisk, Roche, AstraZeneca, GSK, Amgen, Boehringer Ingelheim, Sanofi and many more.

Highlights of the conference:
• Discover case studies on establishing holistic strategies for contamination control and viable real-time air particle counting with leaders in the pharmaceutical industry
• Get an overview of the current state of endotoxin testing, including alternative test methods and strategic approaches for method validation
• Explore best practices in data integrity and automation of environmental monitoring in the microbiology quality control laboratory.
• Participate in the important roundtable on diversity and inclusion in the workplace with a roster of experienced life sciences speakers
• Discuss the latest developments in the detailed and rapid detection of microbes in pharmaceutical water

For interested parties there is a pre-registration offer with an offer of £ 400 for all registrations made before September 30, 2021, visit http://www.pharma-microbiology.com/PR1EIN

There will also be two interactive days of post-conference workshops led by leading speakers on January 19, 2022.

Workshop A on “The keys to a successful contamination control strategy” moderated by: STERIS and Sanofi

Workshop B on “Implementation of a CCS and associated aseptic containment strategy (ACS) with a case study on filling an ATMP viral vector” led by: F Ziel GmbH and PHSS

The full agenda and list of speakers can be downloaded online at http://www.pharma-microbiology.com/PR1EIN

The conference is proudly sponsored by: CTL Mat, ECOLAB, Microgenetics
For sponsorship requests contact Alia Malick, Director on +44 (0) 20 7827 6164 or amalick@smi-online.co.uk

For media inquiries and press pass requests contact Simi Sapal, Marketing Manager on +44 (0) 20 7827 6162 or ssapal@smi-online.co.uk

10th Annual SMi Pharmaceutical Microbiology Conference UK
Conference: January 17 – 18, 2022
Workshops: January 19, 2022
London, United Kingdom
http://www.pharma-microbiology.com/PR1EIN
#SMiPharmaMicroUK

— ENDS –

About the SMi group:
Established since 1993, the SMi Group is a global event production company specializing in business-to-business conferences, workshops, masterclasses and online communities. We create and organize events in the defense, security, energy, utilities, finance and pharmacy sectors. We pride ourselves on having access to the world’s most forward-thinking thought leaders and visionaries, which allows us to bring our communities together to learn, engage, share and network. You can find more information at http://www.smi-online.co.uk

Simi Sapal
SMi Group
02078276000
write us here

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Is CASI Pharmaceuticals (NASDAQ: CASI) Using Too Much Debt? https://www.imisite.org/is-casi-pharmaceuticals-nasdaq-casi-using-too-much-debt/ https://www.imisite.org/is-casi-pharmaceuticals-nasdaq-casi-using-too-much-debt/#respond Sun, 19 Sep 2021 13:07:30 +0000 https://www.imisite.org/is-casi-pharmaceuticals-nasdaq-casi-using-too-much-debt/

Howard Marks put it well when he said that, rather than worrying about stock price volatility, “The possibility of permanent loss is the risk I worry about … and every investor practice that I know is worried. ” It is only natural to consider a company’s balance sheet when looking at its level of risk, as debt is often involved when a business collapses. Like many other companies CASI Pharmaceuticals, Inc. (NASDAQ: CASI) uses debt. But the real question is whether this debt makes the business risky.

When Is Debt a Problem?

Generally speaking, debt only becomes a real problem when a company cannot repay it easily, either by raising capital or with its own cash flow. If things really go wrong, lenders can take over the business. However, a more common (but still costly) event is when a company has to issue stock at bargain prices, constantly diluting shareholders, just to strengthen its balance sheet. By replacing dilution, however, debt can be a very good tool for companies that need capital to invest in growth at high rates of return. The first thing to do when considering how much debt a business uses is to look at its cash flow and debt together.

What is the debt of CASI Pharmaceuticals?

You can click on the chart below for historical numbers, but it shows that as of June 2021, CASI Pharmaceuticals had a debt of US $ 2.01 million, an increase from none, year over year. However, his balance sheet shows that he holds $ 72.9 million in cash, so he actually has $ 70.9 million in net cash.

NasdaqCM: CASI Debt to Equity History September 19, 2021

A look at the responsibilities of CASI Pharmaceuticals

According to the latest published balance sheet, CASI Pharmaceuticals had liabilities of US $ 10.0 million due within 12 months and liabilities of US $ 17.0 million due beyond 12 months. In return, he had $ 72.9 million in cash and $ 5.77 million in receivables due within 12 months. He can therefore avail himself of $ 51.7 million in liquid assets more than total Liabilities.

It is good to see that CASI Pharmaceuticals has a lot of liquidity on its balance sheet, which suggests prudent management of liabilities. Due to its strong net asset position, it should not encounter any problems with its lenders. In short, CASI Pharmaceuticals has a net cash flow, so it’s fair to say that it doesn’t have a lot of debt! There is no doubt that we learn the most about debt from the balance sheet. But it is future profits, more than anything, that will determine CASI Pharmaceuticals’ ability to maintain a healthy balance sheet in the future. So if you are focused on the future you can check out this free report showing analysts’ earnings forecasts.

Year over 12 months, CASI Pharmaceuticals reported revenue of US $ 22 million, a gain of 115%, although it reported no earnings before interest and taxes. So there is no doubt that shareholders are encouraging growth

So how risky is CASI Pharmaceuticals?

By their very nature, businesses that lose money are riskier than those with a long history of profitability. And the point is that over the past twelve months, CASI Pharmaceuticals has lost money in earnings before interest and taxes (EBIT). Indeed, during that time it burned $ 54 million in cash and recorded a loss of $ 52 million. However, he has a net cash position of US $ 70.9 million, so he has some time before he needs more capital. It is important to note that the revenue growth of CASI Pharmaceuticals is coming. High growth nonprofits can be risky, but they can also offer great rewards. When analyzing debt levels, the balance sheet is the obvious starting point. But at the end of the day, every business can contain risks that exist off the balance sheet. For example, we have identified 1 warning sign for CASI Pharmaceuticals that you need to be aware of.

If, after all of this, you’re more interested in a fast-growing company with a strong balance sheet, take a quick look at our list of cash-flow net-growth stocks.

This Simply Wall St article is general in nature. We provide commentary based on historical data and analyst forecasts using only unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell shares and does not take into account your goals or your financial situation. Our aim is to bring you long-term, targeted analysis based on fundamental data. Note that our analysis may not take into account the latest announcements from price sensitive companies or qualitative documents. Simply Wall St has no position in the mentioned stocks.

Do you have any feedback on this item? Are you worried about the content? Get in touch with us directly. You can also send an email to the editorial team (at) simplywallst.com.

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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Egyptian Medicines Authority and South Korea plan to improve pharmaceutical cooperation https://www.imisite.org/egyptian-medicines-authority-and-south-korea-plan-to-improve-pharmaceutical-cooperation/ https://www.imisite.org/egyptian-medicines-authority-and-south-korea-plan-to-improve-pharmaceutical-cooperation/#respond Sat, 18 Sep 2021 22:23:02 +0000 https://www.imisite.org/egyptian-medicines-authority-and-south-korea-plan-to-improve-pharmaceutical-cooperation/

Tamer Essam, chairman of the Egyptian Medicines Authority (EDA), met South Korean Ambassador to Cairo Hong Jin Wook to discuss strengthening medical and pharmaceutical cooperation between the two countries.

At Saturday’s meeting, Ambassador Hong praised EDA’s role in meeting Egypt’s needs for medical supplies, despite the challenges resulting from the global pandemic.

He stressed that the health sector is one of the important facets of the cooperation of the two countries, which can be further strengthened, in particular with the designation of Egypt as a priority country for official development assistance (ODA). over the next five years.

He expressed the interest of Korean medical companies to enter the Egyptian market, given Egypt’s plan to be a regional hub for medical and pharmaceutical supply.

Ambassador Hong stressed the importance of cooperation with EDA to facilitate Korean companies’ access to the Egyptian market, which will help transfer Korea’s know-how and advanced technologies in the medical field.

For his part, Essam thanked Ambassador Hong for his efforts to strengthen bilateral medical cooperation, affirming the role of EDA in facilitating the access and presence of Korean companies in the Egyptian market through joint ventures and the location of strategic industries.

He expressed his desire to cooperate closely with the Korean Embassy to further strengthen medical and health cooperation between the two countries.

Ambassador Hong also referred to the briefing scheduled for September 27 to present the potentials of the Egyptian medical and pharmaceutical market to Korean investors with the possible presence of Egyptian Minister of Health Hala Zayed and some 50 Korean companies. .

Ambassador Hong invited the President of EDA to participate in the event, which will help promote a better understanding for Korean companies of the Egyptian medical sector.



]]> https://www.imisite.org/egyptian-medicines-authority-and-south-korea-plan-to-improve-pharmaceutical-cooperation/feed/ 0 Spectrum Pharmaceuticals Presents Late-Breaking Oral Presentation of Poziotinib Data in First-Line NSCLC Patients with Exon 20 HER2 Insertion Mutations at ESMO 2021 https://www.imisite.org/spectrum-pharmaceuticals-presents-late-breaking-oral-presentation-of-poziotinib-data-in-first-line-nsclc-patients-with-exon-20-her2-insertion-mutations-at-esmo-2021/ https://www.imisite.org/spectrum-pharmaceuticals-presents-late-breaking-oral-presentation-of-poziotinib-data-in-first-line-nsclc-patients-with-exon-20-her2-insertion-mutations-at-esmo-2021/#respond Sat, 18 Sep 2021 12:45:00 +0000 https://www.imisite.org/spectrum-pharmaceuticals-presents-late-breaking-oral-presentation-of-poziotinib-data-in-first-line-nsclc-patients-with-exon-20-her2-insertion-mutations-at-esmo-2021/

Initial data from cohort 4 of the ongoing ZENITH20 clinical trial show 44% ORR in 48 first-line patients treated with 16 mg poziotinib once daily

HENDERSON, Nevada, September 18, 2021– (BUSINESS WIRE) – Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biopharmaceutical company specializing in innovative and targeted oncology therapies, today announced the presentation of the safety and efficacy results of the cohort 4 of the ZENITH20 clinical trial. These data are from 48 first-line non-small cell lung cancer (NSCLC) patients with HER2 exon insertion mutations who received 16 mg of poziotinib orally once daily. These results showed a confirmed objective response rate (ORR) of 44%, as assessed centrally by an independent image review committee using the RECIST 1.1 criteria. The data was presented late at the 2021 congress of the European Society of Medical Oncology (ESMO) to be held in Paris from September 16 to 20, 2021.

“The data presented in Paris for Cohort 4 are very encouraging,” said François Lebel, MD, medical director of Spectrum Pharmaceuticals. “There is currently no specific approved treatment for patients with NSCLC with exon 20 HER2 insertion mutations. These data represent an important step in our development of poziotinib for patients with significant medical need. “

A copy of the ESMO presentation titled “Efficacy and Safety of Poziotinib in Naïve Treatment of NSCLC harboring HER2 exon 20 mutations: A multinational Phase 2 study (ZENITH20-4)” presented by Dr Robin Cornelissen, Erasmus MC Cancer Institute in Rotterdam, is available on the Spectrum corporate website at https://investor.sppirx.com/events-and-presentations.

ZENITH20 Trial Design and Early Safety and Efficacy Data for Cohort 4

Cohort 4 of the ZENITH20 clinical trial is recruiting treatment-naïve NSCLC patients with exon 20 HER2 insertion mutations. This cohort is studying the efficacy of poziotinib with a QD and BID dosing strategy (in progress). Poziotinib 16 mg was administered orally once daily to the first 48 patients resulting in dose reductions / interruptions due to toxicity. The primary endpoint was ORR centrally assessed by an independent image review board using RECIST 1.1 criteria. Secondary endpoints included disease control rate (DCR), duration of response (DoR), progression-free survival (PFS), and safety.

The primary endpoint of ORR was 44% (95% CI: 29.5-58.8%) in the 48 patients treated, including complete response. 88% of patients (42/48) experienced tumor reduction with a DCR of 75%. The median DoR was 5.4 months (range 2.8-19.1+). The median PFS was 5.6 months (range 0 to 20.2+). 88% of patients had dose interruptions and 77% had reductions from the initial dose of 16 mg once daily, while 13% had interruptions related to adverse events (AEs). The most common treatment-related Grade ≥ 3 adverse reactions were rash (35%), stomatitis (20%), diarrhea (14%) and paronychia (8%). In addition, only 1 patient had Grade ≥ 3 pneumonitis. Poziotinib demonstrated clinically significant anti-tumor activity in patients with newly diagnosed NSCLC with exon 20 HER2 mutations at a dose of 16 mg a times a day. The safety profile was manageable and similar to that previously observed in previous studies and other second generation tyrosine kinase inhibitors. The 8 mg BID portion of Cohort 4 continues to actively recruit.

About the ZENITH20 clinical trial

The ZENITH20 study includes seven cohorts of patients with NSCLC. Cohorts 1 (EGFR) and 2 (HER2) in NSCLS patients previously treated with exon 20 mutations and Cohort 3 (EGFR) in first-line patients have completed recruitment. Cohort 4 (HER2) in patients with first-line NSCLC with exon 20 mutations is still recruiting patients. Cohorts 1 to 4 are each fed independently for a predefined statistical hypothesis and the primary endpoint is the objective response rate (ORR). Cohort 5 comprises previously treated or treatment naïve NSCLC patients with EGFR or HER2 exon insertion mutations. Cohort 6 includes NSCLC patients with classic EGFR mutations who progressed during treatment with first-line osimertinib and developed an additional EGFR mutation. Cohort 7 includes patients with NSCLC with a variety of less common mutations in EGFR or HER2 exons 18-21 or extracellular or transmembrane domains.

On Spectrum Pharmaceuticals, Inc.

Spectrum Pharmaceuticals is a biopharmaceutical company focused on the acquisition, development and commercialization of new and targeted oncology therapies. Spectrum has a strong track record of successfully executing the biopharmaceutical business model, from licensing and acquisition of differentiated drugs, to clinical development of new assets, to successful regulatory approvals and commercialization. in a competitive healthcare market. Spectrum has an advanced pipeline with new assets that meet unmet needs. This pipeline has the potential to transform the business in the near future. For more information on Spectrum Pharmaceuticals, please visit www.sppirx.com.

Forward-looking statement – This press release may contain forward-looking statements concerning future events and the future performance of Spectrum Pharmaceuticals that involve risks and uncertainties that could cause actual results to differ materially. These statements are based on the beliefs and current expectations of management. These statements include, but are not limited to, statements relating to Spectrum’s business and its future, including certain important business milestones, the timing and results of FDA decisions, and any statements relating to the Spectrum’s intention, belief, plans or expectations or its management, or which are not a statement of historical fact. Risks that could cause actual results to differ include, but are not limited to, the possibility that the different methodologies, assumptions and applications used by the Company to assess particular parameters of safety or efficacy may produce statistical results. different, and although the company believes the data collected from clinical trials of its product candidates, including poziotinib, is positive, that data may not be sufficient to warrant FDA approval; the possibility that the success of the first clinical trials, especially if they are based on a small sample of patients, will not lead to the success of the subsequent clinical trials, and other unforeseen events during the clinical trials which could lead to delays or other undesirable consequences; other uncertainties inherent in the development of new products; the possibility that Spectrum’s new and existing drug candidates, including poziotinib, may not ultimately prove to be safe or effective; the possibility that our existing and new drug candidates, if approved, may not be more effective, safer or more cost effective than competing drugs; the possibility that our efforts to acquire or license and develop other drug candidates will fail; our reliance on third parties for clinical trials, manufacturing, distribution and quality control; and other risks which are more fully described in the Company’s reports filed with the Securities and Exchange Commission (SEC). The company does not intend to update these forward-looking statements and expressly disclaims any obligation to update the information contained in this press release, except as required by law. For more information about the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as the risks associated with Spectrum’s business in general, see the risk information in the annual report on Spectrum’s Form 10-K for the fiscal year ended December 31, 2020, and in subsequent reports on Forms 10-Q and 8-K and other documents filed with the SEC by Spectrum.

SPECTRUM PHARMACEUTICALS, INC.® is a registered trademark of Spectrum Pharmaceuticals, Inc and its subsidiary. REDEFINING CANCER CARE ™ and the Spectrum Pharmaceuticals logos are trademarks owned by Spectrum Pharmaceuticals, Inc. All other trademarks are the property of their respective owners.

© 2021 Spectrum Pharmaceuticals, Inc. All rights reserved

See the source version on businesswire.com: https://www.businesswire.com/news/home/20210918005006/en/

Contacts

Robert uhl
Managing Director, Westwicke ICR
858.356.5932
robert.uhl@westwicke.com

Kurt gustafson
Financial director
949.788.6700
Investor Relations@sppirx.com

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Vertex Pharmaceuticals (VRTX) wins as the market goes down: what you need to know https://www.imisite.org/vertex-pharmaceuticals-vrtx-wins-as-the-market-goes-down-what-you-need-to-know/ https://www.imisite.org/vertex-pharmaceuticals-vrtx-wins-as-the-market-goes-down-what-you-need-to-know/#respond Fri, 17 Sep 2021 21:45:21 +0000 https://www.imisite.org/vertex-pharmaceuticals-vrtx-wins-as-the-market-goes-down-what-you-need-to-know/

Vertex Pharmaceuticals (VRTX) closed at $ 188.30 on the last trading session, marking a rise of 0.64% from the previous day. This move exceeded the 0.91% daily loss of the S&P 500.

Prior to today’s trading, the drugmaker’s shares had lost 4.07% in the past month. This delayed the 0.52% loss of the medical sector and the 0.01% gain of the S&P 500 during this period.

Wall Street will research VRTX for positivity as the date of its next earnings report approaches. The company is expected to post EPS of $ 3.08, up 16.67% from the previous year quarter. Meanwhile, Zacks’ consensus estimate for revenue projects net sales of $ 1.84 billion, up 19.31% from the previous year.

For the full year, our Zacks consensus estimates project earnings of $ 12.37 per share and revenue of $ 7.25 billion, which would represent changes of + 19.86% and + 16.81%, respectively, over the previous year.

Investors should also note any recent changes in analyst estimates for VRTX. These revisions help show the ever-changing nature of short-term business trends. As a result, we can interpret positive estimate revisions as a good sign for the company’s business outlook.

Based on our research, we believe that these estimate revisions are directly related to stock movements close to the team. Investors can take advantage of this by using the Zacks Ranking. This model takes into account these changes in estimate and provides a simple and workable scoring system.

The Zacks Rank system, which ranges from # 1 (strong buy) to # 5 (strong sell), has an impressive externally audited outperformance history, with # 1 stocks generating an average annual return of + 25% since 1988. Zacks Consensus EPS estimate has remained stagnant over the past month. VRTX is currently a Zacks Rank # 2 (Buy).

Looking at its valuation, VRTX holds a forward P / E ratio of 15.13. This valuation marks a discount compared to the average Forward P / E for its sector of 26.75.

Investors should also note that VRTX currently has a PEG ratio of 1.54. This metric is used similarly to the famous P / E ratio, but the PEG ratio also takes into account the expected growth rate of the stock’s earnings. Medical – Biomedical and genetic stocks have, on average, a PEG ratio of 1.54 based on yesterday’s closing prices.

The Medical – Biomedical and Genetic industry is part of the Medical sector. This group has a Zacks Industry Rank of 195, which places it in the lowest 24% of all 250+ industries.

The Zacks Industry Rank includes is ranked from best to worst in terms of the average Zacks Rank of individual companies in each of these industries. Our research shows that the top 50% of industries top the bottom half by a factor of 2 to 1.

You can find more information on all of these metrics, and more, at Zacks.com.

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Each was selected by a Zacks expert as the # 1 favorite stock to earn + 100% or more in 2021. Previous recommendations climbed + 143.0%, + 175.9%, + 498.3% and + 673.0%.

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To read this article on Zacks.com, click here.

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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DeSantis wants to buy monoclonal antibodies directly from pharmaceutical companies https://www.imisite.org/desantis-wants-to-buy-monoclonal-antibodies-directly-from-pharmaceutical-companies/ https://www.imisite.org/desantis-wants-to-buy-monoclonal-antibodies-directly-from-pharmaceutical-companies/#respond Thu, 16 Sep 2021 22:38:13 +0000 https://www.imisite.org/desantis-wants-to-buy-monoclonal-antibodies-directly-from-pharmaceutical-companies/

Tallahassee, Florida – The governor of Florida is not happy that the Biden administration is taking over the distribution of monoclonal antibodies.

Gov. Ron DeSantis said Thursday he was concerned the state didn’t have enough.

“There will be a lot of confusion and the patient will suffer,” he said. said De Santis. “We will work like hell to overcome the hurdles the HHS and Biden administrations place on us.”

DeSantis is making monoclonal antibodies an important factor in the fight against the latest outbreaks of COVID-19. If given early enough, the chances of a sick person going to the hospital are reduced by 75%.

However, due to limited supply, health and wellness services Said earlier this week Made changes that prevent hospitals and treatment facilities from directly ordering early treatment for COVID-19.

Instead, HHS returned to its pre-vaccination position. The officials analyze the need there and send the cargo to the state for division.

“The HHS determines how much product each state and territory receives each week,” said Kirsten Allen, HHS national press secretary for COVID Response. In the statement. “State and regional health services then identify the sites that receive the products and their quantities. This system makes it possible to maintain a geographically and temporally equitable distribution across the country, and the states and territories. We will provide the state with a constant and fair supply over the next few weeks.

DeSantis called the deal change crude and pledged to work directly with drug company GlaxoSmithKline to evade federal authorities by purchasing the monoclonal drug Sotrovimab.

“The federal government bought all of the Regenerons,” DeSantis said. “With that in mind, you can’t buy directly from Regeneron. I think you can order Sotrobimab. If you can, do it.

The Governor has opened 25 monoclonal sites in Sunshine. According to his office, Florida needs about 72,000 doses per week to meet demand. this week’s allowance Less than half, about 31,000.

Florida is one of the seven states that make up the majority of recent monoclonal orders.

The White House champions change. Florida is one of seven states that account for 70% of recent monoclonal orders, so officials said it would ensure fairness in all states.

Press Officer Jen Psaki manipulate Monoclonal concerns during his regular briefing.

“Our offer is not unlimited and we believe it should be fair,” she said. “Our role as the government overseeing the whole country is to be fair about how we distribute. We’re not going to give Florida a bigger proportion than Oklahoma. “

Beyond that, critics have also said DeSantis needs to stop treating monoclonal drugs as frontline protection.

Some lawmakers and state doctors continue to urge the governor to focus more on virus mitigation and vaccines. They also prevent hospitalization and are plentiful across the country.

DeSantis wants to buy monoclonal antibodies directly from pharmaceutical companies

Source link DeSantis wants to buy monoclonal antibodies directly from pharmaceutical companies

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