Pfizer Inc. announce that the coronavirus vaccine that is has developed with German partner, BioNTech , has a 95% efficacy rate, in its complete results from a late-stage trial.The result is an improvement from the interim results of efficacy rate of 90% last month, which was based a cohort of around 94 patients.
The latest result is consistent across all age and race demographics and based on a total case cohort of 170, according to Pfizer.
A few days ago, Moderna published a efficacy rated of 94.5% of its vaccine, based on early look of its late-stage trial.
Pfzer and BioNTech said they the will apply for Emergency Use Authorization from the U.S. Food & Drug Administration in the coming days.
On Monday, Pfizer and BioNTech announced that their coronavirus vaccine was more than 90% effective in preventing Covid-19 among those without evidence of prior infection
“I think we can see light at the end of the tunnel,” Pfizer Chairman and CEO Dr. Albert Bourla told CNBC’s Meg Tirell on “Squawk Box.” “I believe this is likely the most significant medical advance in the last 100 years, if you count the impact this will have in public health, global economy.”
The coronavirus pandemic has claimed over 1.2 million lives worldwide.
Pfizer’s findings were based on the first interim efficacy analysis conducted by an external Data Monitoring Committee from the phase three clinical study.By evaluating 94 confirmed Covid-19 infections among the trial’s 43,538 participants, the analysis was split between vaccinated individuals and those who received a placebo.
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The company mentioned that around two-thirds of the 42,000 patients enrolled in late-stage clinical trials have been dosed with its developing coronavirus vaccine.It plans to apply Emergency Use Authorization (EUA) approval from the U.S. Food & Drug Administration in late November.
The acquisition is expected to bolster Gilead’s cancer portfolio.
Gilead’s tender offer includes buying all the outstanding shares of Immunomedics for $88 per share, which implies a premium of about 108% over their closing price on Friday.
Through the deal, Gilead will have access to Immunomedics’ breast cancer treatment drug Trodelvy, which was granted an accelerated FDA approval in April.The tumor types are aggressive and tough to treat.
“This acquisition represents significant progress in Gilead’s work to build a strong and diverse oncology portfolio,” Gilead Chief Executive Officer Daniel O’Day said in a statement.
The pharmaceutical company also raised its full-year earnings outlook.
The company's non-GAAP earnings for the three months ending June came in at $1.63 per share, ahead of the Street consensus estimate of $1.48 per share .
Revenues surged +61% to $10.13 billion, beating analysts' forecasts of $9.97 billion.
Looking ahead, Bristol-Myers said it projects its full-year non-GAAP earnings in the range of $6.10 to $6.25 per share, compared to a prior forecast of $6.00 to $6.20.
Many of the top pharmaceutical companies are working on a vaccination for COVID-19.The global pandemic has certainly changed the fortunes for a number of companies and the attention is obviously warranted.
We don’t have a vaccine yet and there is definitely a race on between big pharma companies to produce a viable vaccine.
Biotech company Biogen received a double upgrade to an overweight rating from analysts at Morgan Stanley.P/S Ratio (3.31) is also within normal values, averaging (1243.63).
The Tickeron PE Growth Rating for this company is 68 (best 1 - 100 worst), pointing to slightly better than average earnings growth.
Pharmaceutical company Pfizer Inc. agreed to provide 600 million doses of its developing coronavirus vaccine to the U.S. government.
In an agreement with the U.S. Department of Health and Human Services and the Department of Defense, Pfizer, and its German partner, BioNTech BNTX, will receive $1.95 billion for the first 100 million doses of its BNT162 mRNA-based vaccine.The vaccine is subject to regulatory approval.
Last week, Pfizer’s BNT162 vaccine candidates received 'fast track' designation by the U.S. Food and Drug Administration, based on preliminary data from Phase 1 and Phase 2 studies.
According to Tickeron, PFE's price moved above its 50-day Moving Average on July 15, 2020
This price move indicates a change in the trend, and may be a buy signal for investors.
Britain's biopharmaceutical AstraZeneca plc and Oxford University published data from an early stage trial of a coronavirus vaccine study .
The two groups described humoral and cellular immune responses in human trials, with an acceptable safety profile.According to the study, there were 'potent' cellular and humoral immunogenicity in all 1,077 participants in the Phase 1/Phase II study.
“The immune responses observed following vaccination are in line with what we expect will be associated with protection against the SARS-CoV-2 virus, although we must continue with our rigorous clinical trial programme to confirm this.
The COVID-19 virus has wreaked havoc on countries around the globe in 2020, both in medical terms and economic ones.The virus has taken a great toll on almost every economy around the world.
Many pharmaceutical and biotechnology firms are working on vaccines for the COVID-19 virus.
AstraZeneca received more than $1 billion funding from the U.S. government for expanding the manufacturing of an experimental coronavirus vaccine from the University of Oxford.
The U.K.-based company said it received the amount from the U.S. Biomedical Advanced Research and Development Authority for the development, production, and delivery of the vaccine.The vaccine is being developed by Oxford and the U.K. government.
The development includes a phase 3 clinical trial consisting of 30,000 participants and a pediatric trial.
AstraZeneca has secured a total manufacturing capacity for 1 billion doses.
The pharmaceutical company also confirmed its 2020 profit guidance.
The pharmaceutical company’s non-GAAP earnings for the three months ending in March increased +56% year-over-year to $1.72 per share in the quarter, ahead of the Street consensus estimate of $1.49 per share.However, the company revised its revenue forecast downwards by around $500,000- to a range of $40 billion to $42 billion –from its prior estimate.
Gilead Sciences shares got downgraded by BMO Capital and Wells Fargo analysts.
BMO Capital's Matthew Luchini slashed his rating on the bitotech company’s stock to market perform from outperform. Luchini re-iterated his price target at $79.
While Luchini thinks that Gilead’s anti-COVID-19 drug remdesivir is encouraging, he also mentions "continued uncertainty around the remdesivir commercial opportunity," .
Gilead Sciences announced a successful clinical trial of its antiviral drug to treat the coronavirus .
“The majority of patients in this international cohort demonstrated clinical improvement and no new safety signals were identified with remdesivir treatment,” Gilead said in a statement.
"We cannot draw definitive conclusions from these data, but the observations from this group of hospitalized patients who received remdesivir are hopeful," Jonathan Grein, director of hospital epidemiology at Cedars-Sinai Medical Center, Los Angeles, and lead author of the NEJM article, mentioned in the company’s statement.
The drug hasn’t been yet approved for general use by the Food and Drug Administration.
Gilead Sciences’ experiment with coronavirus treatment is already being used in the US.
The Centers for Disease Control director Robert Redfield told lawmakers on a House appropriations panel Tuesday that remdesivir, the coronavirus treatment that Gilead is developing, was being used on compassionate grounds in Washington state.
Federal Food & Drug Administration regulations allow the use of unapproved drugs in critical situations when there are very limited alternatives for treating a disease.
Gilead’s treatment for Cornavirus was first designed to fight the Ebola virus.
Gilead is expecting results from trials as early as next month.It has said that it would increase supplies as early as possible in the near term.
Eli Lilly & Co. reaffirmed its guidance for 2019 earnings, and expects revenues to continue to grow in the coming year.
The pharmaceutical company has projected 2020 non-GAAP earnings in the range of $6.70 to $6.80 per share, which exceeds the Refinitv forecast of $6.63 per share.The group also re-iterated its 2019 full-year earnings guidance (which it had boosted in October) at a range of $5.75 to $5.85 per share.
Eli Lilly is expecting revenues in the range of $23.6 billion to $24.1 billion, with a compound annual growth rate of 7%.
CEO David Ricks mentioned an expanding portfolio of new medicines focused on diabetes, oncology, immunology, and neuroscience as key drivers of growth for the company.
Ricks also cited “attractive commercial portfolio and limited patent exposure through the latter half of the upcoming decade” as factors that should enable the company to deliver sustainable volume-based revenue growth and drive further operating marg
The analyst cited the following factors behind his optimism for JNJ’s attractiveness in 2020: “(1) multiple regulatory actions aimed at controlling pharmaceutical pricing are more reflected, (2) pharma growth like accelerates in 2020, which historically has lifted the multiple and (3) the portfolio is now more balanced with consumer stabilizing and medical devices and diagnostics coming off six consecutive quarters of momentum improvement."
Major growth drivers include the cooling off of pharma headwinds, strong performances by franchises such as Stelara and Darzalex, and pipeline drivers such as Tremfya and Spravato – according to Lewis.
France’s pharmaceutical company Sanofi will buy biotech company Synthorx.
Sanofi will pay $68 cash a share, or $2.5 billion for the acquisition.Synthorx is focused on treating cancer and autoimmune disorders.
The deal, expected to close in the first quarter next year, is expected to boost Sanofi’s immuno-oncology portfolio, as indicated by the company.
In a separate announcement, Sanofi revealed that its Sanofi Pasteur global vaccines unit entered a $226 million collaboration with the U.S. Department of Health and Human Services, to increase the company’s domestic pandemic influenza vaccine production capabilities at its Swiftwater, Pa., plant.
Merck & Co. will acquire oncology specialist ArQule in a $2.7 billion deal.
Merck said it will pay $20 for each ArQule share, which would be a premium of more than 100% to the stock's closing price of $9.66 Friday on the Nasdaq.
ArQule specializes in research and development of targeted therapeutics for treatment of cancers and rare diseases. The merger would allow Merck access to ArQule’s experimental treatment ARQ 531, a precision medicine that customizes treatment to a patient’s genetic profile.
Biogen Inc. topped analysts’ estimates in both earnings and revenue, while also indicating renewed hope for a Alzheimer’s therapy.
The biotech company's third-quarter 2019 earnings per share of $9.17 beat the Zacks Consensus Estimate of $8.28.Earnings rose +24% year over year.
The company’s sales for the quarter increased +5% year-over-year to $3.6 billion, surpassing Zacks Consensus Estimate of $3.53 billion.
Biogen’s product revenue increased +4% year-over-year for the quarter, while its royalty from sales of Roche’s MS drug, Ocrevus surged +37% year-over-year.