Novartis Earnings Top Views

 Novartis stock rose slightly on Wednesday after the pharmaceutical company reported adjusted earnings of $1.66 per share on $12.96 billion in sales for its second quarter.

On average, analysts polled by FactSet expected Novartis (NVS) to earn $1.56 per share on $12.56 billion in sales. In the year-earlier period, Novartis earned $1.36 a share and reported $11.35 billion in sales.

For the year, the pharmaceutical company still sees mid-single-digit operating profit growth, with sales up in the low- to mid-single digits. Analysts called for adjusted Novartis earnings of $6.31 per share and $5.84 billion in sales.

In premarket trading on the stock market today, Novartis stock rose 1%, signaling a move back above its 50-day line. 

https://www.investors.com/news/technology/novartis-stock-novartis-earnings-q2-2021/

FDA grants AbbVie, Genentech breakthrough therapy tag for venetoclax

 The FDA granted breakthrough therapy designation to venetoclax in combination with azacitidine for treatment of certain patients with myelodysplastic syndrome.

The designation applies to adults with previously untreated intermediate-, high- and very high-risk myelodysplastic syndrome (MDS) based on the revised International Prognostic Scoring System.

Venetoclax (Venclexta; AbbVie, Genentech), a BCL-2 inhibitor, is approved in the United States for treatment of certain patients with acute myeloid leukemia, chronic lymphocytic leukemia or small lymphocytic lymphoma.

The FDA based the breakthrough therapy designation on interim results of the phase 1B M15-531 study, designed to evaluate venetoclax plus azacitidine for people with untreated higher-risk MDS.

Approximately 10,000 people in the United States are diagnosed with MDS each year. Median survival for patients with higher-risk disease is about 18 months.

“Higher-risk MDS is associated with poor prognosis, reduced quality of life and limited treatment options,” Levi Garraway, MD, PhD, chief medical officer and head of global product development for Genentech, said in a company-issued press release. “We are pleased that the FDA has granted Venclexta its sixth breakthrough therapy designation in recognition of its potential to improve outcomes for people with MDS in combination with azacitidine.”

https://www.healio.com/news/hematology-oncology/20210721/fda-grants-breakthrough-therapy-designation-to-venetoclax-for-myelodysplastic-syndrome

Oramed: Oravax Oral Covid Vaccine Gets IRB Approval for Clinical Trial

 Oravax's virus-like particle (VLP) vaccine being tested against COVID-19 variants including Delta

- Oravax signs licensing deal for VLP injectable vaccine technology with Premas Biotech for commercialization in India

Oramed Pharmaceuticals Inc. (NASDAQ: ORMP) (TASE: ORMP) (www.oramed.com), a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, today announced several updates for its majority-owned company Oravax Medical Inc.

Oravax is gearing up to commence clinical trials for its oral COVID-19 vaccine, first in Israel, then in additional clinical sites internationally. The study protocol has been approved by the Institutional Review Board (IRB) at Ichilov Hospital in Tel Aviv, Israel and is now pending approval from the Israeli Ministry of Health. GMP manufacturing for the oral vaccine is under way.

The oral VLP COVID-19 vaccine is being developed for use both as a standalone vaccine as well as a booster for people who have been previously vaccinated for COVID-19. Experts including at the World Health Organization expect booster shots will be needed for both general and at-risk populations. If successful, an oral vaccine would offer enormous logistical, financial, and environmental benefits for the billions of people slated to receive them, particularly in parts of the world where access to healthcare is limited.

Oravax, the exclusive owner of the VLP technology, has out-licensed certain rights in the territory of India to Premas Biotech, the original developer of the novel vaccine. As Oravax maintains its focus on oral vaccines, it has licensed to Premas the right to develop an injectable version of its VLP technology with an aim to address the urgent need for a vaccine which is effective against the Delta variant. Oravax is entitled to royalties upon commercialization of this vaccine in India.

https://www.yahoo.com/now/oramed-provides-oravax-oral-vaccine-122500625.html

Anthem raises its earnings forecast—again—as it posts $1.8B in profit for Q2

 Anthem is boosting its earnings forecast on the back of $1.8 billion in profit for the second quarter.

That bottom-line figure represents a drop of about 21% from the second quarterly of 2020, at the height of the COVID-19 pandemic. Insurers across the board raked in massive earnings in the prior-year quarter; plummeting care volumes pushed profits so high that Congress got involved.

Anthem posted $33.9 billion in revenue for the quarter, up nearly 16% from the $29.3 billion reported in Q2 2020.

The insurer's results for the second quarter surpassed Wall Street's expectations for both profit and revenue, according to predictions from Zacks Investment Research.

“We continued to deliver on our commitments to our stakeholders while making considerable progress against our long-term strategy during the second quarter, all while navigating an uncertain environment due to the pandemic,” said Gail Boudreaux, Anthem CEO, in a statement.

Through the first half of 2021, Anthem brought in $66.2 billion in revenue, up 12.5% from the first half of 2020, where the company reported $58.9 billion in revenue. Profits were down 9% through the first six months of 2021, sitting at $3.5 billion.

Anthem reported $3.8 billion in profit for the first half of 2020.

The insurer boasted 44.3 million members as of June 30, an increase of 1.9 million compared to the prior year quarter. This includes growth of 2.1 million lives in its government business.

Thanks to the strong Q2 results, Anthem is jacking up its guidance to greater than $24.89 per share, which accounts for about 61 cents per share in net unfavorable items. The company expects revenues for the year of about $137.1 billion.

https://www.fiercehealthcare.com/payer/anthem-raises-guidance-again-as-it-posts-1-8b-profit-for-q2

Merck-Bayer VERQUVO® (vericiguat) Approved in EU

 Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the European Commission (EC) has granted marketing authorization in the European Union (EU) for soluble guanylate cyclase (sGC) stimulator VERQUVO® (vericiguat). In the EU, VERQUVO (2.5 mg, 5 mg, and 10 mg) is indicated for the treatment of symptomatic chronic heart failure in adult patients with reduced ejection fraction who are stabilized after a recent decompensation event requiring intravenous (IV) therapy. VERQUVO is being jointly developed by Merck and Bayer AG. Merck has the commercial rights to VERQUVO in the United States and Bayer has the exclusive commercial rights in the rest of world. Bayer also issued a news release earlier today announcing the EC approval.

In January of this year, the U.S. Food and Drug Administration (FDA) approved VERQUVO in the U.S. to reduce the risk of cardiovascular death and heart failure hospitalization following a hospitalization for heart failure or need for outpatient IV diuretics in adults with symptomatic chronic heart failure and ejection fraction less than 45%. In the U.S., the product label for VERQUVO contains a boxed warning that indicates that VERQUVO should not be administered to pregnant females because it may cause fetal harm. For more information, see “Selected Safety Information” below. In June, the medicine was approved by the Ministry of Health, Labour, and Welfare (MHLW) in Japan. Bayer has also submitted applications for marketing authorization of the medicine in China as well as multiple other countries worldwide.

https://www.businesswire.com/news/home/20210721005499/en/VERQUVO%C2%AE-vericiguat-Approved-in-the-European-Union

bluebird bio Receives EC Approval for SKYSONA Gene Therapy

 One-time treatment with SKYSONA has been shown to have a durable effect in improving survival outcomes and preserving neurologic function across pivotal and long-term studies, with the longest follow-up of nearly seven years (82.7 months)

SKYSONA uses the patient’s own blood stem cells and there have been no reports of graft-versus-host disease (GVHD), graft failure or rejection, or transplant-related mortality (TRM) (n=51) across clinical studies to-date

bluebird bio, Inc. (Nasdaq: BLUE) today announced that the European Commission (EC) has granted marketing authorization of SKYSONA™ (elivaldogene autotemcel, Lenti-D™), a one-time gene therapy for the treatment of early cerebral adrenoleukodystrophy (CALD) in patients less than 18 years of age with an ABCD1 genetic mutation, and for whom a human leukocyte antigen (HLA)-matched sibling hematopoietic (blood) stem cell (HSC) donor is not available. SKYSONA is the first one-time gene therapy approved in the European Union (EU) to treat CALD, a rare neurodegenerative disease that occurs in childhood and can rapidly lead to progressive, irreversible loss of neurologic function, and death.

https://investor.bluebirdbio.com/news-releases/news-release-details/bluebird-bio-receives-ec-approval-skysonatm-elivaldogene

Viracta Therapeutics Gets FDA Clearance of IND Application for Phase 1b/2 Trial

  Viracta Therapeutics, Inc. (Nasdaq: VIRX), a precision oncology company targeting virus-associated malignancies, today announced that the U.S. Food and Drug Administration (FDA) has cleared Viracta's Investigational New Drug (IND) application to proceed into a Phase 1b/2 trial in patients with EBV+ recurrent or metastatic nasopharyngeal carcinoma (RM-NPC) and other EBV+ solid tumors. The global Phase 1b/2 trial is designed to evaluate the safety and preliminary efficacy of Viracta's all-oral combination regimen in advanced EBV+ solid tumors (including EBV+ RM-NPC), and in combination with the PD-1 inhibitor pembrolizumab in EBV+ RM-NPC. Initiation of the trial is expected in the second half of 2021.

https://www.prnewswire.com/news-releases/viracta-therapeutics-announces-fda-clearance-of-ind-application-for-phase-1b2-trial-in-epstein-barr-virus-positive-ebv-solid-tumors-301338482.html