KEYTRUDA Is Now Approved for the Adjuvant Treatment of Patients With RCC at Intermediate-High or High Risk of Recurrence Following Nephrectomy, or Following Nephrectomy and Resection of Metastatic Lesions
KEYTRUDA Is the First Immunotherapy Approved for the Adjuvant Treatment of These Patients With RCC
https://finance.yahoo.com/news/fda-approves-merck-keytruda-pembrolizumab-114500052.html
Danish drugmaker Novo Nordisk has agreed a $3.3 billion cash deal to buy Dicerna Pharmaceuticals which specializes in therapeutics that counteract disease-causing genes, it said on Thursday.
With the deal, Novo is following rivals including Novartis by betting on RNA interference technology, or RNAi, where genes that contribute to disease are silenced or rendered ineffective. Genes play a primary role in thousands of diseases.
Novo started a research collaboration with Dicerna in 2019, pursuing several clinical candidates for disorders including chronic liver disease, non-alcoholic steatohepatitis (NASH), type 2 diabetes, obesity and rare diseases.
"This acquisition supports Novo Nordisk's strategy of developing and applying a broad range of technology platforms across all Novo Nordisk therapeutic areas," the company said in a statement.
The deal for $38.25 per share represents a premium of 79.7% to the closing price on Wednesday for Dicerna, which is based in Lexington, Massachusetts.
Novo, the world's biggest producer of diabetes drugs, said it expects to initiate clinical development of the first investigational therapeutic to emerge from this collaboration in 2022.
Novartis bought anti-cholesterol RNAi drug Leqvio, or inclisiran, in 2019 as part of its $9.7 billion takeover of The Medicines Co. The compound is approved for use in Europe but the U.S. clearance has been delayed.
Other companies that work on RNAi cardiovascular drugs include Amgen with partner Arrowhead Pharmaceuticals as well as Regeneron and partner Alnylam Pharmaceuticals.
Novo's U.S.-listed shares traded 1.2% higher in premarket. Its Copenhagen-listed shares were up 0.5%, largely unchanged.
The transaction, which will mainly be debt-financed, is expected to close in the fourth quarter of 2021.
The acquisition will not impact Novo's full-year guidance, but is estimated to have a negative impact on operating profit growth in 2022 of around 3%.
https://finance.yahoo.com/news/1-denmarks-novo-nordisk-buy-122033100.html
Shares of Arcus Biosciences (NYSE:RCUS) jumped by as much as 21% in premarket trading Thursday morning. The biotech's stock is heating up in early morning action today on the news that Gilead Sciences (NASDAQ:GILD) has decided to exercise its options for Arcus' two anti-TIGIT molecules, domvanalimab and AB308, as well as for the adenosine receptor antagonist etrumadenant and the small molecule CD73 inhibitor quemliclustat.
Arcus will pocket a healthy $725 million as a result of this option exercise on the part of Gilead. Additionally, the two companies announced that they will co-develop and share the global costs associated with these oncology programs.
This updated partnership agreement will give Gilead the flexibility to explore a variety of novel anti-cancer combination therapies in the clinic. In its press release, for example, the biotech noted that it plans on assessing potential combo therapies consisting of Arcus' various pipeline candidates and its potent antibody–drug conjugate sacituzumab govitecan-hziy (brand name: Trodelvy).
What's important to understand from an investing perspective is that this deal could prove to be a significant milestone in the biotech giant's quest to move beyond infectious diseases as its main value driver. Gilead has long wanted to pivot toward oncology due to the long-lived nature of these therapies in the marketplace.
Why didn't Gilead simply buy Acrus? With a market cap of $2.6 billion at Wednesday's close, Gilead easily could have bought Arcus lock, stock, and barrel. By going the licensing route, the biotech seems to be signaling to shareholders that it no longer has an appetite for risky business development deals. That's not surprising after its pricy Kite Pharma acquisition a few years back. Gilead, in effect, is clearly taking a far more cautious approach to pipeline development these days, which is a great sign for shareholders. That being said, Gilead could still pull the trigger on an Arcus buyout if one or more of these combo therapies bears fruit in the clinic.
https://www.fool.com/investing/2021/11/18/why-arcus-biosciences-stock-is-on-fire-today/
-Labcorp (NYSE: LH), a leading global life sciences company, today announced that it has entered into a definitive agreement to acquire Toxikon, a contract research organization delivering best-in-class nonclinical testing services. Once completed, the transaction will create a strategic footprint for Labcorp to partner with pharmaceutical and biotechnology clients in the Boston, Mass., area and bolster its strong nonclinical development portfolio.
Adding Toxikon underscores our commitment to nonclinical development and advances our capabilities for both drug development and medical device testing," said Dr. Paul Kirchgraber, CEO of Labcorp Drug Development. "This acquisition extends Labcorp’s portfolio of full-service drug development and medical device solutions from discovery to market approval."
Toxikon’s strategic location allows Labcorp to further engage with large pharmaceutical companies and biotech firms in the region on nonclinical work, as well as facilitating entry into medical device investigational device exemption (IDE) submissions. As such, Toxikon will also complement Labcorp’s existing nonclinical medical device efficacy and safety testing and the associated clinical work performed by Labcorp’s medical device and diagnostics unit.
Headquartered in Bedford, Mass., and with annual revenues of around $40 million, Toxikon maintains specialized, state-of-the-art facilities and a robust roster of pharmaceutical, biotech and medical device clients. Its highly trained staff provides an extensive portfolio of in vivo and in vitro testing and related consulting services to support life sciences companies. The facility in Bedford also has capacity for growth and provides Labcorp Drug Development with an opportunity to expand its traditional toxicology business.
https://finance.yahoo.com/news/labcorp-acquire-toxikon-expanding-nonclinical-120900788.html
Company expects to initiate Phase 2 trial in basal cell carcinoma in 1Q 2022
Non-melanoma skin cancers are the most common form of cancer in the U.S., with over 5 million diagnoses each year
Verrica Pharmaceuticals Inc. (“Verrica”) (Nasdaq: VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, today announced that the U.S. Food and Drug Administration (“FDA”) has accepted the Company’s Investigational New Drug Application (“IND”) for LTX-315, a potential first-in-class oncolytic peptide, for the treatment of basal cell carcinoma. The Company expects to initiate its Phase 2 trial of LTX-315 in basal cell carcinoma in the first quarter of 2022.
https://finance.yahoo.com/news/verrica-pharmaceuticals-announces-fda-acceptance-123000989.html
- Millions of people in the region could benefit from the COVID-19 vaccine candidate- faster, easier, without the cold chain: The Oravax Oral Vaccine
- The new partnership builds on the respective strengths of Oravax Medical and Genomma Lab to create compelling value for both companies and their stakeholders
- Press conference with Nadav Kidron, CEO of Oramed & Chairman of Oravax, and Rodrigo Herrera, Chairman of Genomma Lab, to take place today, Thursday, November 18 at 11:00 am EST
To view the press event: https://us02web.zoom.us/webinar/register/WN_QTGUI13dTdmWdUFKrg_Tbg
https://finance.yahoo.com/news/oramed-subsidiary-oravax-medical-genomma-124000187.html
AstraZeneca said on Thursday its COVID-19 antibody drug cocktail cut the risk of contracting symptomatic illness by 83% in a long-term follow-up, while the therapy also cut the risk of symptoms worsening when given within three days of first symptoms.
