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Incyte's (INCY) application for pipeline candidate, retifanlimab, for adult patients with locally advanced or metastatic squamous cell carcinoma of the anal canal (SCAC) gets Priority Review.

Merck (MRK)/Bayer's (BAYRY) vericiguat gets FDA approval for symptomatic chronic heart failure and reduced ejection fraction

The Zacks Analyst Blog Highlights: Novartis, QUALCOMM, Accenture, MetLife and Electronic Arts

Top Stock Reports for Novartis, QUALCOMM & Accenture

By John Vandermosten, CFA NASDAQ:TENX Tenax Acquires PH Precision Med Tenax Therapeutics, Inc. (NASDAQ:TENX) announced yesterday the acquisition of privately held, clinical stage PH Precision Med (PHPM) in an equity deal valued at approximately $21.6 million 1 . PHPM was founded by Dr. Stuart Rich with the intent to develop imatinib, a tyrosine kinase inhibitor (TKI), in pulmonary arterial

Novartis (NVS) gets Breakthrough Therapy designation by the FDA for ligelizumab for the treatment of chronic spontaneous urticaria.

Lilly's (LLY) candidate, donanemab shows slowing of cognitive decline in Alzheimer's disease patients. Novartis (NVS) and Sanofi (SNY) announce M&A deals.

Beigene stock broke out and surged to a record high Thursday after China's regulators approved its lung cancer treatment. Earlier this week, Novartis signed on to commercialize the drug.

Stocks of start-ups wielding tools like Crispr-Cas9 that allow companies to edit DNA and attack genetic diseases and cancer are suddenly hot. But the science is moving with incredible speed and the competition is rising.

Beigene stock jumped Tuesday on a cancer drug development deal with Novartis worth up to $2.2 billion, as Vir Biotechnology also announced a hepatitis B tie-up with Gilead Sciences.

Novartis (NVS) in-licenses BeiGene's anti-PD-1 monoclonal antibody, tislelizumab, in major markets outside of China.

Here's a roundup of top developments in the biotech space over the last 24 hours:Scaling The Peaks (Biotech Stocks Hitting 52-week Highs Jan. 11) * 10X Genomics Inc (NASDAQ: TXG) * AbbVie Inc (NYSE: (ABBV) * Aldeyra Therapeutics Inc (NASDAQ: ALDX) * Atea Pharmaceuticals, Inc. (NASDAQ: AVIR) * AtriCure Inc. (NASDAQ: ATRC) (reacted to the company's preliminary fourth-quarter results) * Bioanalytical Systems, Inc. (NASDAQ: BASI) * Biodesix Inc (NASDAQ: BDSX) * C4 Therapeutics Inc (NASDAQ: CCCC) * CareDx Inc (NASDAQ: CDNA) (announced preliminary fourth-quarter results) * Celsius Holdings, Inc. (NASDAQ: CELH) * Chimerix Inc (NASDAQ: CMRX) * Curis, Inc. (NASDAQ: CRIS) * Dyne Therapeutics Inc (NASDAQ: DYN) (announced positive preclinical data from its myotonic dystrophy type 1 program) * Edap Tms SA (NASDAQ: EDAP) * Eli Lilly And Co (NYSE: LLY) (announced positive data from midphase study of its investigational asset in treating early symptomatic Alzheimer's) * ESSA Pharma Inc (NASDAQ: EPIX) * EXACT Sciences Corporation (NASDAQ: EXAS) (reacted to preliminary fourth-quarter results) * Eyenovia Inc (NASDAQ: EYEN) * Guardant Health Inc (NASDAQ: GH) * Johnson & Johnson (NYSE: JNJ) * Kaleido Biosciences Inc (NASDAQ: KLDO) * Oxford Immunotec Global PLC (NASDAQ: OXFD) * Pacira Biosciences Inc (NASDAQ: PCRX) * Supernus Pharmaceuticals Inc (NASDAQ: SUPN) * Syneos Health Inc (NASDAQ: SYNH) * Theratechnologies Inc (NASDAQ: THTX) * Twist Bioscience Corp (NASDAQ: TWST) * United Therapeutics Corporation (NASDAQ: UTHR) * Vascular Biogenics Ltd (NASDAQ: VBLT) * Xencor Inc (NASDAQ: XNCR)Down In The Dumps (Biotech Stocks Hitting 52-week Lows Jan. 11) * AbCellera Biologics Inc (NASDAQ: ABCL)Stocks In Focus T2 Biosystems' Molecular Diagnostic Test Capable Of Detecting Multiple Coronavirus Variants T2 Biosystems Inc (NASDAQ: TTOO) announced that its T2SARS-CoV-2 Panel, a molecular diagnostic test that detects SARS-CoV-2, is capable of detecting multiple variants of the SARS-CoV-2 virus most recently identified in the U.K., South Africa and the U.S."I'm proud that we can confidently say, after extensive analysis, that our T2SARS-CoV-2 Panel, which has demonstrated clinical sensitivity of 95 percent and specificity of 100 percent, can continue to help impact lives by detecting multiple variants of the SARS-CoV-2 virus," T2 Biosystems President and CEO John Sperzel said in a statement. The stock was up 39.38% premarket Tuesday to $2.23.GSK, Vir To Begin COVID-19 Antibody Study In Patients With Mild-To-Moderate Infection GlaxoSmithKline plc (NYSE: GSK) and Vir Biotechnology Inc (NASDAQ: VIR) announced an agreement with the U.K.-based AGILE initiative to evaluate VIR-7832 in patients with mild-to-moderate COVID-19 in a Phase 1b/2a clinical trial.VIR-7832 is a neutralizing COVID-19 antibody that showed promising results in preclinical studies. It enhanced the ability to clear infected cells and possessed potential to enhance virus-specific T-cell function, which could help treat and/or prevent COVID-19 infection.The trial is expected to begin in the first quarter at multiple sites across the U.K.GlaxoSmithKline shares were down 0.53% premarket at $37.73. Roche To Present Positive Results For Late-Stage Kidney Cancer Combo Therapy Roche Holdings AG Basel ADR Common Stock (OTC: RHHBY) announced updated overall survival data from the Phase 3 IMbrave150 study evaluating Tecentriq in combination with Avastin, compared with Bayer AG's (OTC: BAYRY) Nexavar, in people with unresectable hepatocellular carcinoma.The data showed that after a median follow-up of 15.6 months, Roche's combo reduced the risk of death by 34%, with a median overall survival of 19.2 months compared with 13.4 months for Nexavar."These results show that Tecentriq in combination with Avastin provides the longest survival that we've ever seen in a front-line Phase III study in unresectable HCC," said Levi Garraway, Roche's chief medical officer.Roche will present the data at the ASCO Gastrointestinal Cancers Symposium from 3:30-4:15 p.m. Sunday.Novartis In-Licenses BeiGene's Cancer Drug For $650M Novartis AG (NYSE: NVS) and Beigene Ltd (NASDAQ: BGNE) signed a strategic collaboration agreement to in-license BeiGene's tislelizumab in major markets outside of China. Tislelizumab is an anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages.The agreement provides for Novartis obtaining the development and commercialization rights to tislelizumab in the U.S., Canada, Mexico, the EU, U.K., Norway, Switzerland, Iceland, Liechtenstein, Russia and Japan in exchange for an upfront payment of $650 million plus royalties and milestone payments. BeiGene will retain the rights to tislelizumab in China and other countries. The transaction has been approved by the boards of both companies.BeiGene shares were up 2.12% premarket at $284.84. Amneal To Buy Specialty Pharms Company Kashiv Amneal Pharmaceuticals Inc (NYSE: AMRX) announced an agreement to acquire a 98% interest in Kashiv Specialty Pharmaceuticals for a cash payment of $70 million at closing and a payment of $30 million at the one-year anniversary point of the deal. The company is engaged in the development of complex generics, innovative drug delivery platforms and novel 505(b)(2) drugs.Kashiv is also eligible to receive up to an additional $8 million in contingent payments upon the achievement of certain regulatory milestones. In addition to the foregoing contingent payments, Amneal has agreed to pay Kashiv certain royalty payments equal to an escalating percentage of aggregate annual net sales for certain pharmaceutical products.Related Link: The Week Ahead In Biotech (Jan 10-16): Expect Stocks To Move As J.P. Morgan Healthcare Conference Kicks Off IGM In-Licenses Cancer Drug From Sweden's Medivir For Up To $352.5M IGM Biosciences Inc (NASDAQ: IGMS) announced that it has entered into an exclusive license agreement with Medivir AB through which IGM will receive global, exclusive development and commercialization rights for the cancer drug birinapant.The combination of IGM-8444, an IgM antibody targeting death receptor 5 being developed by IGM, and birinapant has been shown to enhance anti-tumor activity preclinically.IGM will pay $1 million upon signing the agreement, followed by an additional $1.5 million when birinapant is included by IGM in clinical Phase I studies. The terms of the agreement also entitle Medivir to receive development and regulatory milestone payments up to a total of approximately $350 million, plus tiered royalties from the mid-single digits up to mid-teens on net sales.Adaptive Biotechnologies, AstraZeneca To Collaborate On Mapping Immune Response To Cancer Antigens Adaptive Biotechnologies Corp (NASDAQ: ADPT) announced a translational collaboration with AstraZeneca plc (NASDAQ: AZN) to investigate the use of immunoSEQ T-MAP -- a product that combines the sequencing and mapping capabilities of Adaptive's proprietary immune medicine platform to map T-cell receptors to antigens -- across AstraZeneca's oncology portfolio.Adaptive stands to receive quarterly payments plus sequencing and data mapping fees. In addition, AstraZeneca has an option to enter into a separate agreement with Adaptive for the development and commercialization of a companion diagnostic or therapeutic application based on T-MAP data.La Jolla Licenses European Rights To 2 Drugs For Up To $122M La Jolla Pharmaceutical Company (NASDAQ: LJPC) announced an exclusive licensing agreement with PAION AG for Giapreza and Xerava in the European Economic Area, the U.K. and Switzerland for an upfront cash payment of $22.5 million and potential commercial milestone payments of up to $109.5 million. La Jolla will also receive double-digit tiered royalty payments based on net sales.La Jolla shares were up 61.42% to $6.36 in premarket trading Tuesday.Merck's Pneumococcal Conjugate Vaccine Accepted For Priority ReviewMerck & Co., Inc. (NYSE: MRK) said the FDA accepted for priority review a BLA for V114, its investigational 15-valent pneumococcal conjugate vaccine, for the prevention of invasive pneumococcal disease in adults 18 and older. The FDA set a PDUFA goal date of July 18.In premarket trading Tuesday, Merck shares were adding 0.12% to $85.10.Pre-Announcements GenMark Diagnostics, Inc (NASDAQ: GNMK) preannounced full-year 2020 revenues of about $171 million, up 95% year-over-year, with ePlex revenues climbing 155% to $152 million.Fourth-quarter revenues are expected at $50 million, an 84% increase from a year-ago. Analysts, on average, estimate full-year revenues of $167.48 million and fourth-quarter revenues of $45.87 million.The stock was up 5.3% premarket at $16.30. Orthopediatrics Corp (NASDAQ: KIDS) announced preliminary fourth-quarter revenues of $21.7 million, up 14% year-over-year, and full-year revenues $73.8 million, representing annual growth of 2%. The consensus estimates call for revenues of $20.31 million for the quarter and $72.46 million for the full year.Offerings RedHill Biopharma Ltd (NASDAQ: RDHL) said it has entered into an underwriting agreement with H.C. Wainwright & Co. for the purchase on a firm commitment basis of 1.28 million ADSs at a price of $7.84 per ADS. The closing of the offering is expected to occur on or about Jan. 14, subject to satisfaction of customary closing conditions.The stock was down 7.58% premarket at $8.05. Theratechnologies entered into an agreement with Mackie Research Capital as the lead underwriter and sole bookrunner, on behalf of a syndicate of underwriters, pursuant to which the underwriters have agreed to purchase, on a bought-deal basis, 14.55 million units of the company for aggregate gross proceeds of $40 million at a price of $2.75 per unit.The stock was declining 5.66% premarket to $3. MediciNova, Inc. (NASDAQ: MNOV) said it has entered into a securities purchase agreement pursuant to which MediciNova has agreed to issue $20 million in shares of its common stock to 3D Opportunity Master Fund, a fund managed by 3D Investment Partners, in a private placement transaction.MediciNova intends to use the proceeds received from the private placement primarily for its clinical programs.Polarityte Inc (NASDAQ: PTE) said it has entered into a securities purchase agreement with a single, health care-dedicated institutional investor providing for the purchase and sale of 9.09 million shares of its common stock, or pre-funded warrants to purchase common stock in lieu thereof, and accompanying warrants to purchase up to 9.09 million shares of common stock.The stock eased 5.62% to $1.18 in premarket trading Tuesday.Related Link: Attention Biotech Investors: Mark Your Calendar For January PDUFA Dates See more from Benzinga * Click here for options trades from Benzinga * The Week Ahead In Biotech (Jan 10-16): Expect Stocks To Move As J.P. Morgan Healthcare Conference Kicks Off * The Daily Biotech Pulse: Sarepta Gene Therapy Study Readout, Novavax Vaccine Supply Deal, 2 IPOs(C) 2021 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

* Agreement expands Novartis Oncology portfolio, adding late-stage PD-1 for monotherapy and potential proprietary PD-1 combinations, driving mid- and long-term growth * Novartis secures development and commercialization rights in North America, Europe, and Japan * Accelerates Novartis immuno-oncology combination strategy with multiple potential tislelizumab plus Novartis therapy combinations * Tislelizumab already approved for patients with classical Hodgkin’s lymphoma and metastatic urothelial carcinoma in China; 15 registration-enabling clinical trials under way in non-small cell lung cancer (NSCLC) and other solid tumorsBasel, January 11, 2021 — Novartis has signed a strategic collaboration agreement to in-license tislelizumab from BeiGene, Ltd. in major markets outside of China, accelerating the potential for Novartis to enter the large and growing checkpoint inhibitor field. Tislelizumab is an anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages. In pre-clinical studies, binding to FcγR on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells. Under the terms of the agreement, Novartis will obtain the development and commercialization rights to tislelizumab in the United States, Canada, Mexico, the European Union, United Kingdom, Norway, Switzerland, Iceland, Liechtenstein, Russia, and Japan in exchange for an upfront payment of USD 650 million plus royalties and milestone payments. BeiGene will retain the rights to tislelizumab in China and other countries. The transaction has been approved by the Boards of Directors of both companies.More than 7,700 patients have been enrolled in 15 potentially registration-enabling clinical trials with tislelizumab in a dozen indications, including non-small cell lung cancer (NSCLC), hepatocellular carcinoma (HCC), esophageal squamous cell carcinoma, gastric cancer and nasopharyngeal carcinoma. The first ex-China regulatory filing is expected in 2021. In addition, Novartis and BeiGene have identified multiple tislelizumab plus Novartis therapy combination clinical trial opportunities in solid tumors. “Novartis has a bold ambition to reimagine medicine and find new cures for cancer and blood disorders. This agreement expands on our strategy as the only company pursuing four different approaches to treating cancer: targeted therapy, radioligand therapy, cell and gene therapy, and immunotherapy. No other company has this range of therapeutic approaches, and the opportunity to combine them to offer the best outcomes for each patient,” said Susanne Schaffert, PhD, President, Novartis Oncology. “We are excited about collaborating with BeiGene, a leading global biotechnology company with roots in China, to bring tislelizumab to patients around the world, and pair it with our extensive portfolio and pipeline to develop transformative combination therapies for patients.”Tislelizumab is approved by the China National Medical Products Administration (NMPA) as a treatment for certain patients with classical Hodgkin’s lymphoma and metastatic urothelial carcinoma. In addition, BeiGene has filed three supplemental new drug applications for tislelizumab in China for first-line treatment of patients with advanced squamous NSCLC in combination with chemotherapy, first-line treatment of patients with advanced non-squamous NSCLC in combination with chemotherapy, and previously treated unresectable HCC. Closing of the transaction is subject to expiration or early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act.Disclaimer This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “potential,” “can,” “will,” “plan,” “may,” “could,” “would,” “expect,” “anticipate,” “seek,” “look forward,” “believe,” “committed,” “investigational,” “pipeline,” “launch,” “to develop,” “development,” “ambition,” or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for tislelizumab, or regarding potential future revenues from tislelizumab; or regarding the agreement to in-license tislelizumab from BeiGene in major markets outside of China. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the transaction described in this press release will be completed in the expected time frame, or at all. Neither is there any guarantee that the expected benefits and synergies from such transaction will be achieved in the expected timeframe, or at all. Nor can there be any guarantee that tislelizumab will be submitted or approved for sale in any market, or at any particular time. Neither can there be any guarantee that tislelizumab will be commercially successful in the future. In particular, our expectations regarding the transaction described in this press release and tislelizumab could be affected by, among other things, the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act; the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases such as COVID-19; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.About Novartis Novartis is reimagining medicine to improve and extend people’s lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world’s top companies investing in research and development. Novartis products reach nearly 800 million people globally and we are finding innovative ways to expand access to our latest treatments. About 110,000 people of more than 140 nationalities work at Novartis around the world. Find out more at https://www.novartis.com.Novartis is on Twitter. Sign up to follow @Novartis at https://twitter.com/novartisnews For Novartis multimedia content, please visit https://www.novartis.com/news/media-library For questions about the site or required registration, please contact media.relations@novartis.com Novartis Media Relations E-mail: media.relations@novartis.comAnja von TreskowJulie Masow Novartis External CommunicationsNovartis Oncology Communications +41 79 392 86 97 (mobile)+1 862 579 8456 (mobile) anja.von_treskow@novartis.com julie.masow@novartis.com    Eric Althoff  Novartis US External Communications  +1 646 438 4335  eric.althoff@novartis.com  Novartis Investor Relations Central investor relations line: +41 61 324 7944 E-mail: investor.relations@novartis.comCentral North America  Samir Shah+41 61 324 7944Sloan Simpson+1 862 778 5052 Thomas Hungerbuehler        +41 61 324 8425   Isabella Zinck+41 61 324 7188

Incyte (INCY) enters into a collaboration with Cellenkos to evaluate the combination of Jakafi and CK0804 in patients with myelofibrosis.

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3 Large Drugmakers Set to Rule the Sector in 2021

Novartis (NVS) gets CRL from the FDA for its cholesterol drug, inclisiran, due to unresolved facility inspection-related conditions.

The FDA's inability to inspect an overseas manufacturing facility is holding up an application for inclisiran.