Category: Pharmaceutical

Moderna, Inc. (MRNA) 9/22/21 9:54 AM

Moderna, Inc. is a biotechnology company that is focused on creating a transformative medicines based on messenger RNA (mRNA). The Company’s mRNA medicines are designed to direct the body’s cells to produce intracellular, membrane, or secreted proteins that have a therapeutic or preventive benefit with the potential to address a range of spectrum of diseases. The Company develops technologies that enable the development of mRNA medicines for diverse applications. The Company has created modalities, including Prophylactic vaccines, Systemic secreted and cell surface therapeutics, Cancer vaccines, Intratumoral immuno-oncology, Localized regenerative therapeutics, and Systemic intracellular therapeutics. Its diverse development pipeline which consists of 27 development candidates across its 24 programs.

BioNTech SE (BNTX) 9/22/21 9:30 AM

BioNTech SE, a biotechnology company, develops and commercializes immunotherapies for cancer and other infectious diseases.

BioNTech SE is a Germany-based clinical-stage biotechnology company. The Company focuses on patient-specific immunotherapies for the treatment of cancer and other serious diseases. It develops a broad product pipeline using different scientific approaches and technology platforms, including individualized mRNA-based product candidates, chimeric antigen receptor T-cells, checkpoint immunomodulators, targeted cancer antibodies and small molecules. In addition, the Company offers diagnostic products and drug discovery services for other therapeutic areas, including infectious diseases, allergies and autoimmune disorders.

BioNTech SE

EU will speed up approval of eventual COVID-19 vaccine, in contrast to what has happened in U.S.

BioNTech SE

BioNTech SE is a Germany-based clinical-stage biotechnology company. The Company focuses on patient-specific immunotherapies for the treatment of cancer and other serious diseases. It develops a broad product pipeline using different scientific approaches and technology platforms, including individualized mRNA-based product candidates, chimeric antigen receptor T-cells, checkpoint immunomodulators, targeted cancer antibodies and small molecules. In addition, the Company offers diagnostic products and drug discovery services for other therapeutic areas, including infectious diseases, allergies and autoimmune disorders.

Astrazeneca PLC (AZN)

Report of CoronaVirus-Vaccine Progress

AstraZeneca PLC is a bio pharmaceutical company. It focuses on discovery and development of products, which are then manufactured, marketed and sold. It focuses on three main therapy areas: Oncology, Cardiovascular, Renal & Metabolic (CVRM) and Respiratory, while selectively pursuing therapies in Autoimmunity, Infection and Neuroscience. In CVRM, it is expanding its portfolio into the cardiovascular-renal area with roxadustat, as well as investing to explore the benefits of its SGLT2 and GLP-1 franchises in chronic kidney disease (CKD) and heart failure (HF).

It has approximately 38 projects in Phase I, including 26 new molecular entities (NMEs), and 12 oncology combination projects. It has approximately 43 projects in Phase II, including 25 NMEs; six additional indications for projects that have reached phase II, and 12 oncology combination projects. It has approximately 22 projects in late-stage development, either in Phase III/pivotal Phase II studies or under regulatory review.

National Emergency Coronavirus

Exploiting the Virus

Google (GOOG +5.9%) is helping to develop a website where people can find drive-through testing sites if they have symptoms, according to Dr. Deborah Birx, White House Coronavirus Response Coordinator. The website will be online starting Sunday evening, Trump said.

Walmart (WMT +6.7%), CVS (CVS +8.6%), Walgreens (WBA +9.2%), Target (TGT +9.7%), Roche Diagnostics (OTCQX:RHHBY), LabCorp (LH +8.6%), Quest Diagnostics (DGX) and Becton Dickinson (BDX +6.2%) are among companies working with the government.

Roche Coronavirus Test

FDA grants Emergency Use

The FDA has issued an Emergency Use Authorization for Roche’s (OTCQX:RHHBY) fully automated cobas SARS-CoV-2 Test for the qualitative (yes or no answer) detection of the coronavirus causing the current outbreak COVID-19. The test, also available in markets accepting the CE Mark, is performed on nasopharyngeal and oropharyngeal swab samples. The company says it has the capacity to perform “millions” of tests per month on its cobas 6800 and 8800 analyzers.

CGC – Canopy Growth Corporation

First & Free – a hemp-derived CBD product line

Canopy Growth (NYSE:CGC) has launched First & Free – a hemp-derived CBD product line offered in a variety of formats, including softgels, oil drops and creams. The products will be available for purchase through e-commerce site: www.firstandfree.com.

Recreational marijuana legal in Illinois

Illinois is ringing in the new decade by becoming the 11th state in the country and the District of Columbia to allow the legal sale and purchase of marijuana.

Under the new state law, adults over the age of 21 may own 30 grams of cannabis flower, 500 milligrams of THC in pot products and 5 grams of cannabis concentrate.

Cannabis stocks are enjoying end-of-the-year buying today, giving battered longs hope for a better 2020. Selected tickers: Cronos Group (CRON +11.7%), Aurora Cannabis (ACB +11.3%), Tilray (TLRY +8.5%), Canopy Growth (CGC +9.2%), Alternative Harvest ETF (MJ +4.3%), The Cannabis ETF (THCX +4%), Aphria (APHA +7%)

CANNABIDIOL (CBD)

Cannabidiol is a chemical in the Cannabis sativa plant, also known as marijuana or hemp. Over 80 chemicals, known as cannabinoids, have been identified in the Cannabis sativa plant. While delta-9-tetrahydrocannabinol (THC) is the major active ingredient in marijuana, cannabidiol is also obtained from hemp, which contains only very small amounts of THC.

Cannabidiol has effects on the brain. The exact cause for these effects is not clear. However, cannabidiol seems to prevent the breakdown of a chemical in the brain that affects pain, mood, and mental function. Preventing the breakdown of this chemical and increasing its levels in the blood seems to reduce psychotic symptoms associated with conditions such as schizophrenia. Cannabidiol might also block some of the psychoactive effects of delta-9-tetrahydrocannabinol (THC). Also, cannabidiol seems to reduce pain and anxiety.

Merck & Co. ~ ArQule $2.7 Billion

ArQule shares surge after the cancer drug specialists agreed to a $2.7 billion takeover bid from Merck & Co.

Merck & Co. said Monday that it will acquire oncology specialist ArQule in a $2.7 billion deal that marks the latest in a string of takeovers in the cancer drug sector. Merck said it will pay $20 a share for Woburn, Massachusetts-based ArQule, a premium of more than $10 to the stock’s closing price of $9.66 Friday on the Nasdaq. The group, which focuses on research and development of targeted therapeutics to treat cancers and rare diseases, will be merged into the broader Merck & Co., the companies said.

“We are proud that Merck has recognized the contributions that ArQule, together with its scientific collaborators, has made to the field of precision medicine in oncology with ARQ 531 for the treatment of B-cell malignancies and with the rest of our clinical-stage pipeline,” said ArQuel CEO Paolo Pucci. “With this agreement, ArQule’s pipeline will benefit from Merck’s vast capabilities and determined engagement to benefit the patients who we have always strived to serve.”  

ArQule shares were indicated some 103% higher in early trading following news of the Merck takeover to change hands at $19.64 each. Merck shares, meanwhile, were marked 0.57% lower at $88.34 each.

Merck’s move to buy ArQule follows a $2.5 billion takeover of San Diego, California-based Synthorx by France’s Sanofi SA earlier Monday. Sanofi said it will pay $68 a share for Synthorx, which focuses on cancer and autoimmune disorder treatments, in a deal that will bolster its immuno-oncology pipeline. 

FDA accepts Pfizer’s application for Braftovi doublet for colorectal cancer

Under Priority Review status, the FDA accepts Pfizer’s (PFE -0.5%) supplemental application seeking approval for Braftovi (encorafenib), combined with Eli Lilly’s (LLY +3.2%) Erbitux (cetuximab), for the treatment of BRAFV600E mutation-positive metastatic colorectal cancer in patients who have previously received one or two prior lines of therapy. The agency’s action date is in April 2020. The FDA approved the kinase inhibitor in June 2018 for BRAFV600E- or BRAFV600K-positive melanoma.

As published in The New England Journal of Medicine (NEJM), results from the BEACON CRC trial showed improvements in overall survival (OS) and objective response rates (ORR) for both the BRAFTOVI Doublet and BRAFTOVI Triplet (BRAFTOVI, MEKTOVI and ERBITUX) combination, compared to ERBITUX plus irinotecan-containing regimens (Control).1 In descriptive analyses comparing the Doublet and Triplet arms, the results showed comparable efficacy between the Doublet and Triplet in the overall population. The BRAFTOVI Triplet and Doublet showed no unexpected toxicities.

AstraZeneca PLC ADR

FDA advisory committee backs AstraZeneca’s Lynparza for pancreatic cancer

AstraZeneca PLC (AstraZeneca) is a biopharmaceutical company. The Company focuses on discovery and development of products, which are then manufactured, marketed and sold. The Company focuses on three main therapy areas: Oncology, Cardiovascular & Metabolic Disease (CVMD) and Respiratory, while selectively pursuing therapies in Autoimmunity, Infection and Neuroscience.

In CVMD, it is expanding its portfolio into the cardiovascular-renal area with late-stage assets, such as ZS-9 and roxadustat, as well as investing to explore the benefits of its SGLT2 and GLP-1 franchises in chronic kidney disease (CKD) and heart failure (HF). The Company has approximately 40 projects in Phase I, including 29 new molecular entities (NMEs), and 11 oncology combination projects. It has approximately 40 projects in Phase II, including 25 NMEs; four significant additional indications for projects that have reached phase II, and seven oncology combination projects.

“English-Swedish multinationalpharmaceutical and biopharmaceutical company. In 2013, it moved its headquarters to Cambridge, UK, and concentrated its R&D in three sites: Cambridge; Gaithersburg, Maryland, USA (location of MedImmune) for work on biopharmaceuticals; and Mölndal (near Gothenburg) in Sweden, for research on traditional chemical drugs.[5] AstraZeneca has a portfolio of products for major disease areas including cancercardiovasculargastrointestinal, infection, neurosciencerespiratory and inflammation.” ~ Wikipedia