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4:12 a.m. July 29, 2021 - By Jaimy Lee
Viatris gets FDA approval of first biosimilar version of Sanofi's insulin LantusShares of Viatris Inc. gained 3.3% in premarket trading on Thursday, the day after the Food and Drug Administration approved the first biosimilar verson of insulin glargine from Viatris and Biocon Biologics Ltd. Biocon is a privately held biopharma company based in India. The newly approved treatment, Semglee, is a biosimilar and interchangeable version of Lantus, Sanofi's once-blockbuster long-actin insulin. Semglee will be sold exclusively by the companies for 12 months before the FDA can approve another biosimilar version of Lantus. Biosimilar drugs are copies of complex biologic drugs; this is somewhat similar to how generic drugs compare to brand-name prescription medications, in that that biosimilars and generic drugs are less expensive than the brand-name alternatives. Viatris shares are down 24.0% so far this year, while the broader S&P 500 is up 17.1%.
4:01 a.m. July 28, 2021 - By Jaimy Lee
Pfizer shares limited data about its COVID-19 booster candidate, says it ups protection against the delta variantPfizer Inc. said Wednesday that a third dose of its COVID-19 vaccine likely provides further protection against the delta variant, which is more infectious and thought to be driving the recent surge in cases, hospitalizations, and deaths in the U.S. The drug maker announced the news as part of its , saying that an additional dose of its two-dose COVID-19 vaccine series produced neutralizing antibody titers against delta that are 5 times higher than getting two doses in younger people and 11 times higher than getting two doses in older people. Pfizer did not provide any additional information at this time. Pfizer's stock is up 14.3% so far this year, while the broader S&P 500 has gained 17.2%.
3:53 a.m. July 27, 2021 - By Jaimy Lee
Regeneron, AstraZeneca to develop obesity treatmentShares of Regeneron Pharmaceuticals Inc. were down 0.1% in premarket trading on Tuesday after the company announced a deal with AstraZeneca to develop and commercialize obesity treatments that target a specific gene, GPR75. The companies will split development costs and profits if the drug is successful. Regeneron's stock is up 19.6% so far this year, while the S&P 500 has gained 17.7%.
4:06 a.m. July 22, 2021 - By Jaimy Lee
Pfizer to pay at least $1 billion to develop, commercialize Arvinas' investigational breast-cancer therapyShares of Arvinas Inc. were up 6.0% in premarket trading on Thursday after the company announced a billion-dollar deal with Pfizer Inc. to develop and commercialize its experimental breast-cancer treatment. Pfizer will make a $650 million upfront payment to Arvinas, in addition to a $350 million equity investment. Separately, there are up to $1.4 billion in potential milestone payments. The therapy, ARV-471, is expected to move into Phase 3 clinical trials sometime next year. Arvinas' stock is down 8.7% for the year, while the S&P 500 is up 15.1%.
4:57 a.m. July 19, 2021 - By Jaimy Lee
Pfizer says FDA's decision to approve its COVID-19 vaccine is expected by JanuaryPfizer Inc. said Friday that the Food and Drug Administration accepted its application for of the COVID-19 vaccine it developed with BioNTech SE . As part of the application process, the FDA sets a decision date based on the rules of the Prescription Drug User Fee Act for applications that receive what is called Priority Review. The decision date is set for an undisclosed day in January, Pfizer said. This means that Pfizer's COVID-19 shot may not be fully approved in the U.S. until then, though the decision could occur sooner. Pfizer's shot was first authorized as part of emergency rules back in December 2020. Since then, of this vaccine have been administered to people in the U.S. Pfizer's stock is up 9.6% so far this year, while the broader S&P 500 is up 15.2%.
4:50 a.m. July 19, 2021 - By Jaimy Lee
BioNTech to buy T-cell receptor facility and platform from Gilead Sciences Shares of BioNTech SE were down 2.4% in premarket trading on Monday after the company said it plans to buy one of Gilead Sciences Inc.'s clinical manufacturing facilities and its platform for T-cell receptor therapies. The companies did not disclose financial terms of the deal, saying only that BioNTech will make a one-time payment for the platform and the facility in Gaithersburg, MD. The site will be used to support clinical trials in the U.S.; all employees at the facility will be offered jobs at BioNTech, which is a German biotechnology company. The new site is expected to be part of BioNTech's work developing new cancer therapies. BioNTech has become a well-known name outside of biotech circles since developing a COVID-19 vaccine with Pfizer Inc. . Shares of BioNTech have gained 183.9% so far this year, while the S&P 500 is up 15.2%.
8:45 a.m. July 12, 2021 - By Jaimy Lee
Prothena sells ATTR amyloidosis portfolio to Novo Nordisk for up to $1.2 billionShares of Prothena Corp. Plc were up 1.3% in premarket trading on Monday after the company announced a deal to sell its ATTR amyloidosis portfolio to Novo Nordisk in a $100 million deal that is worth up to $1.2 billion, based on milestones. ATTR amyloidosis is a rare disease that can cause a buildup of amyloid deposits in the body. One of the therapies in the portfolio is an experimental monoclonal antibody drug that has completed a Phase 1, open-label clinical trial. Prothena's stock has soared 393.2% so far this year, while the S&P 500 is up 16.3%.
3:44 a.m. July 12, 2021 - By Jaimy Lee
Celldex's stock jumps on positive data from early-stage, open-label clinical trial for hives treatmentsShares of Celldex Therapeutics Inc. soared 43.1% in premarket trading on Monday after the company shared positive data from an ongoing, open-label Phase 1b clinical trial for an experimental treatment for hives. Celldex said that 95% of participants diagnosed with two forms of chronic inducible urticaria reported a complete response to treatment and 5% had a partial response. The data was presented Friday during the European Academy of Allergy and Clinical Immunology Annual Congress. The study has 20 participants. The therapy is currently being tested intravenously but Celldex said it plans to begin testing a subcutaneous version of the drug in the third quarter. Celldex's stock has soared 84.9% this year, while the broader S&P 500 is up 16.3%.
3:48 a.m. July 7, 2021 - By Jaimy Lee
WHO recommends Roche, Sanofi/Regeneron drugs as COVID-19 treatments, calls for lower pricesThe World Health Organization began recommending the use of medicines called interleukin-6 receptor blockers as COVID-19 treatments for the severely ill, based on the findings of a large published Tuesday in JAMA. Roche Holding AG's Actemra and Sanofi and Regeneron Pharmaceuticals Inc.'s Kevzara are both approved in the U.S. as treatments for rheumatoid arthritis. The WHO said in a statement that "these are the first drugs found to be effective against COVID-19 since corticosteroids." Actemra received last month. Research indicates the drugs can reduce the risk of death by 13% and reduce the risk of needing ventilation by 28%. However, even after recommending the drugs, the health organization called on the manufacturers to reduce prices and provide the medicines to people in low- and middle-income countries.
5:20 a.m. July 6, 2021 - By Jaimy Lee
Agenus says its Bristol Myers Squibb licensing deal has up to $1.3 billion in milestone paymentsShares of Agenus Inc. were up 2.0% in premarket trading on Tuesday after the company said a licensing deal with Bristol Myers Squibb Co. had closed. As part of the agreement, Bristol plans to study an experimental Agenus immuno-oncology drug as a treatment for non-small cell lung cancer. Bristol will pay Agenus $200 million upfront, with up to $1.3 billion in possible milestones payments. Agenus' stock has gained 73.6% so far this year, while the broader S&P 500 is up 15.8.%
4:55 a.m. July 6, 2021 - By Jaimy Lee
Israel says Pfizer's COVID-19 shot is 64% effective against the infections from the delta variantIsrael's health ministry said Monday the effectiveness of the COVID-19 shot developed by BioNTech SE and Pfizer Inc. is now thought to be 64% at preventing symptomatic infections in that country. The vaccine had an efficacy rate of about 95% in clinical trials back in 2020; however, the emergence of the more transmissible delta variant in Israel has weakened the overall effectiveness of the shot, according to a statement posted on Twitter. The ministry said the vaccine remains much more effective at preventing hospitalizations and death, with an estimated effectiveness rate of 93%. Health researchers are paying close attention to vaccine performance in Israel. The country has vaccinated 57% of its residents, , and it has primarily used the BioNTech/Pfizer vaccine.
8:27 a.m. July 2, 2021 - By Jaimy Lee
Mizuho: Merck withdrawing Keytruda as a gastric cancer treatment won't impact the stockShares of Merck & Co. Inc. were up 0.7% in trading on Friday, the day after the company said it will voluntarily withdraw an accelerated approval for Keytruda as a third-line treatment for some patients with gastric cancer in the next six months. Keytruda is Merck's top-selling drug; it brought in $14.4 billion in sales in 2020. The decision to withdraw the drug for this indication is part of to assess whether certain cancer medicines that received a type of approval dependent on confirmatory post-market clinical studies should stay on the market. The withdrawal is not expected to have a material impact on company shares, according to Mizuho Americas analysts. Merck's stock is up 0.7% so far this year, while the broader S&P 500 is up 14.4%.
8:11 a.m. July 2, 2021 - By Jaimy Lee
Jazz's leukemia drug gets approved by the FDAShares of Jazz Pharmaceuticals plc gained 3.5% in premarket trading on Thursday, the day after the Food and Drug Administration said it had approved the company's acute lymphocytic leukemia treatment Rylaze. The therapy is an orphan drug, meaning it affects less than 200,000 people in the U.S. The drug is expected to be available later this month; a spokesperson for the company said that's when the price will be made public. Jazz's stock is up 7.6% so far this year, while the broader S&P 500 is up 14.4%.
5:04 a.m. July 1, 2021 - By Jaimy Lee
Novavax's experimental COVID-19 shot has 86.4% efficacy against the Alpha variantShares of Novavax Inc. were up 2.5% in premarket trading on Thursday, the day after The New England Journal of Medicine published a looking at how Novavax's COVID-19 vaccine candidate performed in a Phase 3 clinical trial conducted in 15,000 participants in the U.K. An earlier analysis of the data was previously published as a preprint. According to the new study, Novavax's experimental vaccine has an overall efficacy rate of 96.4% against the original strain of the virus and an 86.3% efficacy rate against the Alpha variant, which was first identified in the U.K. and has been the most dominant form of the virus in many countries since the start of the year. Novavax did not mention the Delta variant, which is now the most dominant form of the virus in the U.K., in this study. The company is conducting separate studies of its experimental shot in the U.S. Novavax's stock is up 90.4% for the year, while the broader S&P 500 has gained 14.4%.
1:47 p.m. June 29, 2021 - By Jaimy Lee
JAMA study: Ivermectin doesn't speed up recovery for patients with mild COVID-19New research indicates that ivermectin, a type of treatment for parasitic worms, does not help patients with mild COVID-19 recover any faster. The peer-reviewed , published Thursday in JAMA, examined the findings of a double-blind, randomized trial conducted in Cali, Colombia, in roughly 475 people with mild symptoms of COVID-19. Researchers concluded "the findings do not support the use of ivermectin for treatment of mild COVID-19, although larger trials may be needed to understand the effects of ivermectin on other clinically relevant outcomes." The drug first caught the attention of clinicians in the early days of the pandemic after an said the drug can inhibit replication of SARS-CoV-2, the virus that causes COVID-19. However, the Food and Drug Administration and others that trials needed to be conducted before the drug should be prescribed to COVID-19 patients.
4:40 a.m. June 22, 2021 - By Jaimy Lee
New research says Pfizer and Moderna's mRNA vaccines don't affect sperm parametersNew published in JAMA found there was no difference in sperm parameters in 45 men who received mRNA vaccines against COVID-19. The two authorized mRNA vaccines, which were developed by Pfizer Inc. and Moderna Inc. , are the most commonly utilized COVID-19 vaccines in the U.S. Researchers at the University of Miami Miller School of Medicine say they initiated the study after hearing concerns from some people that the vaccines could impact fertility. They noted the study has some limitations, given that the number of men enrolled in the study is a small sample size, and semen analysis is "an imperfect predictor of fertility potential." Back in April, concerns about fertility were cited as a top reason to avoid COVID-19 vaccination, , with 42% of adults between the ages of 18 and 29 saying they have heard the shots can cause infertility and 5% saying they believe this is true.
8:52 a.m. June 21, 2021 - By Jaimy Lee
Tarsus to submit application for new eye treatment to FDA in 2022Tarsus Pharmaceuticals Inc. said Monday that a Phase 2b/3 clinical trial evaluating an experimental treatment for a type of ocular disease met the study's primary and secondary endpoints. However, the stock was down 15.3% in trading on Monday afternoon. Tarsus is testing the investigational ophthalmic solution in patients with Demodex blepharitis. The company said in a news release that millions of people have been diagnosed with this eye disease, and there are currently no approved treatments in the U.S. Tarsus plans to submit data from this study in a new drug application to the Food and Drug Administration sometime next year. Tarsus shares are down 28.5% this year, while the broader S&P 500 is up 10.9%.
5:29 a.m. June 21, 2021 - By Jaimy Lee
Day One Biopharma's experimental glioma drug gets an orphan designation in EuropeShares of Day One Biopharmaceuticals Inc. gained 9.4% in premarket trading on Monday after the company said its experimental glioma treatment received an orphan designation in Europe. The drug candidate has already received a Breakthrough Therapy designation from U.S. regulators for one indication and an orphan designation as a treatment for malignant glioma. In the U.S., an orphan-drug designation supports developing treatments for diseases that affect fewer than 200,000 people. Gliomas are a type of nervous system tumor. Day One last month.
4:19 a.m. June 21, 2021 - By Jaimy Lee
Gilead says real-world data show COVID-19 drug Veklury can reduce the risk of deathShares of Gilead Sciences Inc. gained 0.3% in premarket trading on Monday after the drug manufacturer said retrospective research shows that Veklury, its COVID-19 treatment, reduces mortality among people who have been hospitalized with COVID-19. Veklury, which received full approval from the Food and Drug Administration last year, can be prescribed to people who have COVID-19, are hospitalized and are at least 12 years old. The new research examined real-world data from three databases that included roughly 98,000 patients who had been hospitalized with COVID-19, finding that the drug could reduce the risk of death. The Phase 3 clinical trial that was used to inform the FDA approval of Veklury found that the drug could help reduce the amount of time patients spent in the hospital but the data did not demonstrate that the therapy could reduce death at that time. Gilead's stock is up 14.3% so far this year, while the S&P 500 has gained 12.4%.
3:29 a.m. June 21, 2021 - By Jaimy Lee
Vir, GSK say new data confirms their COVID-19 treatment can reduce hospitalization and deathShares of Vir Biotechnology Inc. gained 1.4% in premarket trading on Monday after the company said the COVID-19 antibody treatment it developed with GlaxoSmithKline cut the risk of hospitalization and death among adults at high risk. The confirmatory data came from a Phase 3 clinical trial that was used to inform the emergency-use authorization granted last month to sotrovimab, the companies' COVID-19 monoclonal antibody treatment. Vir also said the National Institutes of Health updated its guidelines to recommend using the monoclonal antibody in people with mild or moderate forms of the disease who are at high risk for disease progression. The companies say there are 450,000 doses of the treatment "on hand" in the U.S. at this time. Vir's stock is up 6.6% so far this year, while the broader S&P 500 has gained 12.4%.
3:55 a.m. June 16, 2021 - By Jaimy Lee
Regeneron says its COVID-19 antibody treatment cuts the risk of death among hospitalized patientsShares of Regeneron Pharmaceuticals Inc. gained 0.1% in premarket trading on Wednesday after the company said its COVID-19 antibody therapy cut the risk of death in patients who have been hospitalized by 20%. This is the first time clinical research has demonstrated that Regeneron's antibody treatment has improved survival for hospitalized patients. The study, which is being conducted in the U.K. in patients who have not yet developed antibodies, follows other research that showed the company's antibody treatment can improve recovery times among people with mild or moderate forms of the disease. Regeneron said it is planning to ask the Food and Drug Administration to expand the emergency-use authorization in the U.S. to include these types of patients. Regeneron's stock is up 9.2% so far this year, while the broader S&P 500 has gained 13.0%.
5:36 a.m. June 15, 2021 - By Jaimy Lee
Novavax says efficacy of COVID-19 vaccine isn't affected when co-administered with the flu shotShares of Novavax Inc. were down 0.9% in trading on Tuesday, the day after the company said a study evaluating co-vaccination against COVID-19 and the flu demonstrated similar efficacy to administering Novavax's experimental COVID-19 shot alone. "Separate health care visits to cover both COVID-19 and influenza vaccinations will be burdensome," a Novavax executive said in a news release. As part of the Phase 3 clinical trial for its coronavirus vaccine in the U.K., the company also enrolled 431 participants in a sub-study that gave participants both the COVID-19 vaccine and the flu shot. In the , published Sunday, the researchers found that the immunogenicity of the flu shot was the same, while there was a "modest decrease" in the immunogenicity of the COVID-19 shot. Novavax also announced this week that its coronavirus vaccine when it comes to preventing symptomatic infection in roughly 30,000 participants enrolled in the Phase 3 clinical trial in the U.S. Novavax's stock has soared 86.2% so far this year, while the S&P 500 is up 13.3%.
4:42 a.m. June 14, 2021 - By Jaimy Lee
iTeos stock jumps 60% after company announces deal with GSKShares of iTeos Therapeutics Inc. soared 58.5% in premarket trading on Monday after the company announced a deal with GlaxoSmithKline to develop and commercialize an experimental cancer therapy. GSK will make a $625 million upfront payment to iTeos, with an additional $1.4 billion in possible milestone payments available in the future. The immuno-oncology drug candidate is currently being tested in an open-label, Phase 1 clinical trial in patients with advanced solid tumors; as part of this deal, the companies plan to pair the iTeos drug with GSK's Jemperli in studies next year. (Jemperli was initially approved by the Food and Drug Administration as a treatment for endometrial cancer in April.) Shares of iTeos are down 40.8% so far this year, while the S&P 500 has gained 13.1%.
4:28 a.m. June 14, 2021 - By Jaimy Lee
Moderna hires J&J executive as chief medical officerShares of Moderna Inc. were down 2.1% in premarket trading on Monday after the company said it hired Dr. Paul Burton as its new chief medical officer. Burton, a former Johnson & Johnson executive, will report to CEO Stéphane Bancel. He replaces Dr. Zal Taks, who announced plans to leave Moderna earlier this year. Burton most recently was the chief of global medical affairs for J&J's pharmaceuticals business. Both Moderna and J&J have received authorizations for their COVID-19 vaccines in the U.S. Moderna's stock is up 109.5% so far this year, while the broader S&P 500 has gained 13.1%.
4:46 a.m. June 11, 2021 - By Tomi Kilgore
Vertex Pharmaceuticals stock tumbles to pace S&P 500 losers after disappointing drug trial dataShares of Vertex Pharmaceuticals Inc. tumbled 13.8% in premarket trading Friday, enough to pace the S&P 500's early decliners, after the biotechnology company released what was seen as disappointing data on its treatment for people with alpha-1 antitrypsin deficiency (AATD), which can lead to liver and lung disease. The stock was on track to open at the lowest price seen during regular-session hours since October 2019. The company said late Thursday that , showing a mean increase of 2.2 to 2.3 micromolar fAAT levels across the dose groups compared with placebo. Analyst Cory Kasimov at J.P. Morgan reiterated his overweight rating but cut his stock price target to $245 from $279, saying the trials results were "clearly" a setback. "Management is adamant that this is actually a step in the right direction for the program," Kasimov wrote. "We doubt [Wall Street] will agree." Stifel Nicolaus's Paul Matteis cut his stock price target to $244 from $277: "The announcement of modest AAT increases for VX-864, despite what looked like great data in animals, makes it difficult for us to garner conviction that futures compounds will perform materially better." The stock has lost 8.3% year to date, while the S&P 500 has climbed 12.9%.
7:59 a.m. June 7, 2021 - By Joseph Walker
FDA approves Biogen’s Alzheimer’s drug, the first to slow the disease Biogen drug approved after facing doubts over whether it slows progression of memory-robbing diseaseThe first drug promising to slow the memory-robbing march of Alzheimer’s disease was approved by U.S. health regulators, a watershed after years of research and billions of dollars in investment.
4:48 a.m. June 2, 2021 - By Jaimy Lee
U.S. to run 'mix-and-match' clinical trial testing Moderna's vaccine as booster shot The National Institutes of Health said Tuesday it plans to test booster shots from different vaccines in a fully vaccinated population as part of a "mix-and-match" clinical trial. The is being funded by the National Institute of Allergy and Infectious Diseases. It will enroll 150 participants who have received either the two-dose, mRNA-based shots developed by Pfizer Inc. /BioNTech SE [b: bntx] and Moderna Inc. or Johnson & Johnson's single shot. The participants will then receive a booster shot of Moderna's vaccine 12 to 20 weeks after finishing their initial vaccine regimen. "We need to prepare for the possibility of needing booster shots to counter waning immunity and to keep pace with an evolving virus," NIAID Director Dr. Anthony Fauci said in a news release. Both Pfizer and Moderna for different types of booster shots.
6:44 a.m. May 28, 2021 - By Jaimy Lee
U.S. stops distributing Lilly's COVID-19 antibody therapy in six states, instead recommends Regeneron's treatmentThe U.S. government said this week it is halting distribution of Eli Lilly & Co.'s COVID-19 antibody treatment in six states due to the growing prevalence of the P.1 and B.1.351 variants there. Lilly's combination therapy of bamlanivimab and etesevimab "are not active against either the P.1 or B.1.351 variants," which were first identified in Brazil and South Africa, respectively, the Assistant Secretary for Preparedness and Response . Coronavirus cases associated with these variants now make up more than 10% of all cases in Arizona, California, Florida, Illinois, Indiana, Massachussetts, Oregon, and Washington. Instead, the agency recommends using Regeneron Pharmaceuticals Inc.'s antibody treatment. This is not the first time there has been concern about bamlanivimab's effectiveness. The Food and Drug Administration in April pulled the emergency authorization for bamlanivimab as a standalone treatment over concerns about its effectiveness against variants. There are three authorized antibody cocktails in the U.S., developed by Lilly, Regeneron, and Vir Biotechnology Inc. /GlaxoSmithKline . The Vir and GSK therapy .
3:35 a.m. May 24, 2021 - By Jaimy Lee
Pfizer is testing a COVID-19 booster shot in combination with new pneumococcal conjugate vaccine candidateShares of Pfizer Inc. gained 0.1% in premarket trading on Monday after the company said it is testing its experimental 20-valent pneumococcal conjugate vaccine in combination with a booster dose of its COVID-19 vaccine in adults who are 65 years old or older. The study includes 600 participants from the Phase 3 clinical trial for the COVID-19 vaccine. Both Pfizer and Moderna Inc. are testing booster doses for their two-dose, mRNA-based COVID-19 vaccines. Pfizer's stock is up 8.5% so far this year, while the broader S&P 500 is up 10.6%.
8:53 a.m. May 18, 2021 - By Jaimy Lee
Sarepta's stock is up 11% on positive data from clinical trial for Duchenne treatment Shares of Sarepta Therapeutics Inc. gained 11.3% in trading on Tuesday after the company shared positive data from a mid-stage, open-label clinical trial for its experimental Duchenne muscular dystrophy treatment. The data comes from the first 11 enrolled participants in a study of 20 participants who are between the ages of 4 and 7 years old. Duchenne's is a rare, genetic disease that primarily young boys. Wall Street analysts had mixed views of the data. "While the Study 103 data are a step in the right direction, our thesis remains that SRPT will need to string together multiple wins this year to regain investor confidence," SVB Leerink's Joseph Schwartz told investors in a note. However, RBC Capital Markets analysts say they believe the experimental gene therapy has blockbuster potential, with the data setting "the stage for improving sentiment." Sarepta's stock has tumbled 50.1% so far this year, while the broader S&P 500 has gained 10.8%.
3:13 a.m. May 13, 2021 - By Jaimy Lee
CDC committee recommends that Pfizer's COVID-19 shot be used in 12- to 15-year-oldsA Centers for Disease Control and Prevention committee voted 14-0-1 in favor of recommending that Pfizer Inc.'s COVID-19 vaccine can be safely used in 12- to 15-year-olds. The recommendation, made Wednesday by the CDC's Advisory Committee on Immunization Practices, follows a similar regulatory pathway as the original emergency-use authorization awarded in December. The expanded authorization for this age group by the Food and Drug Administration, the CDC committee voted Wednesday, and CDC director Dr. Rochelle Walensky signed off on the recommendation later that night. More than 60 million people in the U.S. have been immunized with the two-dose, mRNA vaccine developed by Pfizer and BioNTech SE , .
9:31 a.m. May 10, 2021 - By Jaimy Lee
FDA committee to hold meeting about COVID-19 vaccines for children in JuneThe Food and Drug Administration advisory committee plans to hold a on June 10 to discuss authorizing COVID-19 vaccines for use in pediatric populations. Pfizer Inc.'s is the only authorized vaccine that is available to 16 and 17-year-olds at this time. The company is currently about whether it will authorize the same vaccine for 12 to 15-year-olds, which would make it the first vaccine authorized for use in this group of teens. During the meeting, FDA officials are also expected to share details about what they expect to see in applications to authorize and approve these vaccines for use in children. The advisory committee will not discuss specific vaccines, the regulator said.
4:28 a.m. May 10, 2021 - By Jaimy Lee
Inovio's stock is up after it shares new data from Phase 2 clinical trial for its COVID-19 vaccine candidateShares of Inovio Pharmaceuticals Inc. gained 8.0% in premarket trading on Monday after the company said its experimental COVID-19 vaccine was safe and also triggered antibody titers in 400 or so adult participants in a Phase 2 clinical trial. The were published Friday as a preprint. Inovio has largely struggled to move its two-dose, DNA-based COVID-19 vaccine candidate forward. A Phase 3 clinical study is still on hold, due to "remaining questions" from the Food and Drug Administration about a device used for administering the shots. Inovio said in April that the Department of Defense stopped funding development of its COVID-19 vaccine, and the Phase 3 clinical trial for the still-investigational shots will largely be conducted outside of the U.S. Inovio's stock is down 22.6% for the year, while the S&P 500 is up 12.7%.
6:42 a.m. May 5, 2021 - By Jaimy Lee
Canada authorizes Pfizer's COVID-19 vaccine for kids between the ages of 12 and 15 years oldShares of Pfizer Inc. gained 2.5% in trading on Wednesday after Canadian regulators said they authorized using the company's COVID-19 vaccine for children between the ages of 12 and 15 years old. Pfizer developed the vaccine in partnership with BioNTech SE . Health Canada said in a news release that this is the first coronavirus vaccine that has been authorized for this age group. The vaccine is also expected to receive emergency-use authorization for the same age group in the U.S. sometime in the next week. Pfizer's stock has gained 8.3% since these start of the year, while the S&P 500 is up 11.6%. Health Canada received an application to expand the indication of Pfizer-BioNTech's COVID-19 vaccine on April 16, 2021. The vaccine was initially authorized for use in people 16 years of age and older on December 9, 2020.
3:52 a.m. May 4, 2021 - By Jaimy Lee
Bausch reports a $610 million loss in the first quarter of the yearShares of Bausch Health Cos. Inc. were down 2.3% in premarket trading on Tuesday after the company said it faced continued pressure on sales from the COVID-19 pandemic into the first quarter of this year. Bausch had a loss of $610 million, or $1.71 per share, in the first quarter of 2021, compared with a loss of $152 million, or 43 cents per share, in the same quarter a year ago. Bausch did not provide adjusted earnings per share for the quarter. The company reported $2.02 billion in sales for the first quarter of the year, up from $2.01 billion in the like quarter a year ago. The FactSet consensus was $2.05 billion. Much of Bausch's business continues to be affected by the pandemic, it said, citing declining sales of irritable bowel syndrome drug Xifaxin and lower sales of eye-care products for the quarter. Bausch said it still plans to move forward with spinning off the Bausch + Lomb eye-care business, which had $881 million in sales for the quarter, up from $875 million in the first quarter of 2020. Bausch's other business focuses on pharmaceuticals; it had $1.14 billion in sales, compared with $1.13 billion in the same quarter a year ago. Bausch's stock has gained 51.0% since the start of the year, while the S&P 500 is up 11.6%.
10:49 a.m. April 27, 2021 - By Jaimy Lee
Novavax's stock jumps after Biden mentions its COVID-19 vaccine candidateShares of Novavax Inc. gained 12.1% in trading on Tuesday after President Joe Biden mentioned that the company's experimental COVID-19 vaccine may be nearing emergency-use authorization in the U.S. "The problem is right now we have to make sure we have other vaccines like Novavax and others coming on," he said during a speech. "And I think we'll be in a position to be able to share vaccines with other countries who are in real need. That's the hope and expectation." Novavax's still-investigational COVID-19 vaccine is currently being tested in a Phase 3 clinical trial in Mexico and the U.S. that began in December. (A separate late-stage study in the U.K. is also underway, and early data from that trial found that the vaccine candidate had an overall efficacy rate of 89.7%.) Novavax's stock has soared 126.0% so far this year, while the S&P 500 is up 11.5%.
8:41 a.m. April 27, 2021 - By Jaimy Lee
CDC: Small groups of people can gather outside without masksThe Centers for Disease Control and Prevention said Tuesday that people who are fully vaccinated no longer need to wear a mask at small outdoor gatherings with both vaccinated and unvaccinated people or when dining outdoors with people from multiple households. "Generally, for vaccinated people, outdoor activities without a mask are safe," CDC director Dr. Rochelle Walensky said during a media briefing on Tuesday. However, the public-health agency also said that even if someone is fully vaccinated, they should still wear a mask at crowded outdoor events or for any indoor activities, like going to hair salons, malls, museums, worship services, or indoor restaurants. The CDC considers people to be fully vaccinated two weeks after getting the Johnson & Johnson shot or two weeks after getting the second dose of the Moderna Inc. or Pfizer Inc. vaccines.
8:39 a.m. April 27, 2021 - By Jaimy Lee
White House: Pharmacies giving COVID-19 shots to no longer have residency requirementsThe Biden administration said Tuesday that the pharmacies participating in the federal pharmacy program will no longer have residency requirements as part of an effort to ensure that college students can get their second COVID-19 vaccine shots if they are away from home or school. "Most pharmacies administering shots will now offer anyone a second dose, regardless of where they got their first," Andy Slavitt, the White House's senior advisor for the nation's COVID-19 response, said during a White House briefing.
8:33 a.m. April 26, 2021 - By Jaimy Lee
Reviva's stock jumps after experimental schizophrenia drug meets endpoint in Phase 2 clinical trialShares of Reviva Pharmaceuticals Holdings Inc. soared 76.6% in trading on Monday after the company said its experimental treatment for schizophrenia met the primary endpoint in a mid-stage clinical trial. Reviva said that the investigational therapy, brilaroxazine, met all safety endpoints and helped with "social functioning and cognition" in the randomized, placebo-controlled, double-blind Phase 2 clinical study. Reviva's stock is down 14.6% so far this year, while the S&P 500 is up 11.3%.
4:13 a.m. April 26, 2021 - By Jaimy Lee
FDA to discuss whether immuno-oncology drugs with 'accelerated' approval should remain on the marketThe Food and Drug Administration advisory committee plans to hold a three-day this week to evaluate a type of quicker approval used primarily for immuno-oncology drugs that are thought to help address unmet treatment needs among people with cancer. The FDA's "accelerated approval" process requires drug makers to conduct what are called confirmatory trials to back up the limited data used to inform the initial regulatory ok. The meeting will focus on Roche Holding AG's Tecentriq; Merck & Co Inc.'s top-selling drug Keytruda, which brought in $14.3 billion in 2020; and Bristol Myers Squibb Co.'s Opdivo, which generated $6.9 billion last year. The FDA said in documents that these drugs received additional accelerated approvals to treat different types of cancers "but subsequent confirmatory trial(s) have not verified clinical benefit ... The FDA is seeking the committee's advice on next steps for each product including whether the indications should remain on the market while additional trial(s) are conducted." The meeting is scheduled for April 27 to 29.
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