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FDA Panel Endorses Moderna’s Covid-19 Vaccine for Broad Use

  • FDA Panel Endorses Moderna’s Covid-19 Vaccine for Broad Use FDA Panel Endorses Moderna’s Covid-19 Vaccine for Broad Use 3:23
    Hospitals Face Hurdles With Covid-19 Vaccine Rollout Hospitals Face Hurdles With Covid-19 Vaccine Rollout 3:40
    First U.S. Covid-19 Vaccines Roll Out First U.S. Covid-19 Vaccines Roll Out 4:33
    FDA Authorizes Pfizer-BioNTech Covid-19 Vaccine for U.S. Use FDA Authorizes Pfizer-BioNTech Covid-19 Vaccine for U.S. Use 2:59
3:01 a.m. April 8, 2021 - By Ciara Linnane
Eli Lilly and Incyte say Phase 3 study of baricitinib in hospitalized COVID-19 patients failed to meet main goalEli Lilly & Co. and Incyte Corp. said Thursday a Phase 3 trial of rheumatoid arthritis treatment baricitinib plus standard of care (SoC) versus placebo plus SoC failed to meet its main goal. The trial's primary endpoint was defined as a difference in the number of patients needing non-invasive ventilation including high flow oxygen, or invasive mechanical ventilation or death by Day 28. Patients treated with baricitinib were 2.7% less likely than those receiving standard of care to progress to ventilation or death, a difference that was not statistically significant. The trial, involving 1,525 patients, showed 38% reduction in mortality by Day 28 in patients that were treated with baricitinib plus standard of care, including corticosteroids and remdesivir. Lilly said it will publish detailed data from the study in a peer-reviewed journal in the coming months. "Even though the study did not show a statistically-significant benefit on the primary endpoint, this trial showed the largest effect reported to date for reduction in mortality observed for this patient population with COVID-19," said Ilya Yuffa, senior vice president and president of Lilly Bio-Medicines. The U.S. Food and Drug Administration has granted emergency use authorization to baricitinib in combination with remdesivir in hospitalized patients with COVID-19 requiring supplemental oxygen, invasive mechanical ventilation or extracorporeal membrane oxygenation. Baricitinib, an oral JAK inhibitor, was discovered by Incyte. It is approved as Olumiant in the U.S. as a treatment for adults with moderate to severe rheumatoid arthritis and in the EU and Japan as a treatment for atopic dermatitis. Lilly shares were up 0.4% premarket, while Incyte was up 2%.
12:06 p.m. April 4, 2021 - MarketWatch
J&J takes over contractor's COVID-19 vaccine workJohnson & Johnson is taking over manufacturing of its Covid-19 vaccine at a contract manufacturer's plant that makes the main ingredient, after a production problem ruined a batch. In order to give J&J full control, production of AstraZeneca PLC's vaccine at the Emergent BioSolutions Inc. plant in Baltimore will move elsewhere, according to a person familiar with the matter.
3:02 a.m. April 1, 2021 - By Ciara Linnane
Pfizer, BioNTech say study of COVID-19 patients six months after second vaccine dose proved it is safe and effectivePfizer Inc. and German partner BioNTech SE said Thursday a study of COVID-19 patients six months after receiving a second dose of their vaccine BNT162b2 confirmed its high efficacy and lack of serious safety concerns. The companies said an analysis of 927 confirmed symptomatic cases of COVID-19 showed the vaccine had a 91.3% efficacy against the illness, measured seven days through up to six months after the second dose. The vaccine was 100% effective in preventing severe disease as defined by the U.S. Centers for Disease Control and Prevention and 95.3% effective in preventing severe disease as defined by the U.S. Food and Drug Administration. The vaccine also proved to be 100% effective in preventing COVID-19 cases when used against the South African variant, which is more infectious than the original virus. Experts have worried that new variants might prove more resistant to the vaccines that have won emergency use authorization from regulators. Pfizer and BioNTech said they have now evaluated vaccine safety in more than 44,000 participants 16 years of age and older, with more than 12,000 vaccinated participants having at least six months follow-up after a second dose. "These data confirm the favorable efficacy and safety profile of our vaccine and position us to submit a Biologics License Application to the U.S. FDA," said Pfizer Chief Executive Albert Bourla. Prizer shares were up 0.2% premarket, while BioNTech shares were up 1.2%.
4:40 a.m. March 26, 2021 - By Ciara Linnane
GlaxoSmithKline and Vir Biotech seek FDA emergency authorization for COVID antibody treatmentGlaxoSmithKline PLC and Vir Biotechnology Inc. said Friday they have submitted to the U.S. Food and Drug Administration an application for emergency use authorization for their antibody treatment for mild-to-moderate COVID-19 in adults and adolescents aged 12 and older who are at risk of hospitalization or death. The companies said early data from a Phase 3 trial found the treatment showed an 85% reduction in hospitalization or death compared to placebo. There were 583 patients enrolled in the trial. Vir shares slid 0.8% premarket, but have gained 97% in the year to date, while the S&P 500 has gained 4%.
12:12 p.m. March 25, 2021 - By Claudia Assis
Pfizer, Eli Lilly say experimental arthritis drug tanezumab hits FDA snagPfizer Inc. and Eli Lilly and Co. said Thursday that a joint advisory committee of the U.S. Food and Drug Administration has voted against their investigational tanezumab drug for the treatment of certain types of arthritis in adults when use of other drugs aren't possible. "While we are disappointed with today's outcome, we continue to believe that tanezumab has a positive benefit-risk profile for patients with moderate-to-severe osteoarthritis pain for whom current treatments are ineffective or not appropriate," Ken Verburg, tanezumab development team leader at Pfizer, said in a statement. There was one voting question focused on whether the drug's benefits outweigh its risks, and the committee voted 19-1 against it, the companies said.
9:36 a.m. March 22, 2021 - By Tomi Kilgore
Odonate Therapeutics stock plummets toward record low after plan to 'wind down' operationsShares of Odonate Therapeutics Inc. plummeted 79.0% in active afternoon trading Monday, after the pharmaceutical company said it will wind down operations following disappointing data from its cancer treatment. The company said it determined, following feedback from the Food and Drug Administration in a pre-New Drug Application (pre-NDA) meeting, that tesetaxel, an orally administered chemotherapy agent, is unlikely to receive FDA approval. "Therefore, the company is discontinuing the development of tesetaxel and will wind down the operations of the company," the company said in a statement. Since going public in December 2017 at an initial public offering price of $24, the stock has traded in a closing price range of $11.78 (Dec. 27, 2018) to $45.63 (June 16, 2020); on Friday, the stock closed at $19.03. The stock has lost 73.9% over the past three months, while the S&P 500 has gained 7.0%.
3:25 p.m. March 15, 2021 - MarketWatch
AstraZeneca vaccine suspended in much of EuropeGermany, Italy, France and Spain joined the ranks of European countries that have temporarily halted use of the Covid-19 shot made by AstraZeneca PLC over blood-clot concerns, dealing another blow to the continent's sluggish vaccination rollout and threatening the credibility of the vaccine itself.
4:40 a.m. March 11, 2021 - By Tomi Kilgore
Johnson & Johnson COVID-19 vaccine recommended for use in the EUJohnson & Johnson said Thursday that its single-shot COVID-19 vaccine candidate has received a "positive opinion" from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP). That means the CHMP recommends conditional marketing authorization (CMA) for the vaccine candidate developed by J&J's Janssen Pharmaceutical Companies. If CMA is granted, the vaccine will become available in the European Union. "The European Medicines Agency's recommendation is a landmark moment for Johnson & Johnson and for the world," said J&J Chief Scientific Officer Paul Stoffels. "Now, as we await a decision on the use of our single-dose COVID-19 vaccine in the European Union, we remain confident that the Johnson & Johnson vaccine will prove a critical tool for fighting this pandemic." The U.S. Food and Drug Administration had granted the J&J vaccine on Feb. 27. J&J's stock, which rose 0.6% in premarket trading, has gained 4.1% over the past three months while the Dow Jones Industrial Average has gained 7.5%.
9:04 a.m. March 10, 2021 - By Jaimy Lee
Vertex to begin Phase 1/2 trial of treatment for people with type 1 diabetesShares of Vertex Pharmaceuticals Inc. were down 0.2% in trading on Wednesday after the company said it started an early-stage clinical trial for its experimental treatment for people with type 1 diabetes. It also said the therapy received a fast-track designation from the Food and Drug Administration. The Phase 1/2, single-arm, open-label study will be conducted at multiple sites in the U.S. and aims to enroll 17 participants. Vertex gained access to the therapy through its roughly $1 billion acquisition of Semma Therapeutics Inc. in 2019. Vertex's stock is down 7.4% over the past year, while the S&P 500 has rallied 41.1%. The clinical trial is a Phase 1/2, single-arm, open-label study in patients who have T1D with impaired hypoglycemic awareness and severe hypoglycemia. This will be a sequential, multi-part clinical trial to evaluate the safety and efficacy of different doses of VX-880. Approximately 17 patients will be enrolled in the clinical trial. About Type 1 Diabetes T1D results from the autoimmune destruction of insulin-producing islet cells in the pancreas, leading to loss of insulin production and impairment of blood glucose control. The absence of insulin leads to abnormalities in how the body processes nutrients, leading to high blood glucose levels. High blood glucose can lead to diabetic ketoacidosis and over time, to complications such as kidney disease/failure, eye disease (including vision loss), heart disease, stroke, nerve damage and even death. Due to the limitations and complexities of insulin delivery systems, it can be difficult to achieve and maintain balance in glucose control in patients with T1D. Hypoglycemia often results because of the difficulty in balancing the different factors that impact glucose levels, including insulin, diet and exercise. Hypoglycemia remains a critical limiting factor in glycemic management, and severe hypoglycemia can cause loss of consciousness, coma, seizures, injury, and can be fatal. Over time, patients with T1D can develop impaired awareness of hypoglycemia, meaning they are no longer able to perceive the early signs of a hypoglycemic event, which can be dangerous and result in life threatening events. There are currently limited treatment options beyond insulin for the management of T1D.
3:48 a.m. March 10, 2021 - By Jaimy Lee
Lannett plans to file experimental insulin product with FDA sometime this yearShares of Lannett Co. Inc. gained 7.3% in premarket trading on Wednesday after the company said it received feedback from the Food and Drug Administration about the ongoing development of a biosimilar version of insulin glargine. This type of long-acting insulin is considered a biologic and was initially developed by Sanofi under the brand name Lantus. Lannett said it submitted the clinical-trial protocol to the FDA in November and has since updated it with the regulator's feedback. The company plans to file an investigational new drug application sometime in 2021, with a goal to eventually launch the product in the market in 2023. Lannett's stock is down 15.3% over the past 12 months, while the S&p 500 has gained 41.1%.
4:37 a.m. March 9, 2021 - By Tomi Kilgore
Acadia Pharmaceuticals stock leads premarket losers after FDA finds undisclosed 'deficiencies' in NDAShares of Acadia Pharmaceuticals Inc. plunged 42.1% to pace all premarket decliners Tuesday, in the wake of the company's announcement that the Food and Drug Administration found undisclosed deficiencies in its supplemental New Drug Application (NDA) for pimavanserin, a treatment for hallucinations and delusions associated with dementia-related psychosis. The company said late Monday that the FDA's identification of deficiencies precluded discussion of labeling and post-marketing requirements. But the FDA did not specify the deficiencies it identified, Acadia said. That led Raymond James analyst Danielle Brill to downgrade Acadia to outperform from strong buy and slash the price target to $35 from $65. "We have no good guesses as to what 'deficiencies' the FDA found, but one thing is clear -- the regulatory outlook for DRP suddenly appears quite dire," Brill wrote in a note to clients. Stifel Nicolaus's Paul Matteis cut his rating to hold from buy and his price target to $27 from $68. "Not defending the stock on weakness; DRP prospects seem bleak, tough for us to be confident," Matteis wrote. The stock, which is on track to open at the lowest price seen during regular-session hours since September 2019, has lost 12.5% over the past three months through Monday, while the S&P 500 has gained 4.0%.
10:18 p.m. March 7, 2021 - MarketWatch
Roche pulls U.S. indication for TecentriqRoche Holding AG said Monday that it is voluntarily withdrawing the U.S. indication for Tecentriq in metastatic bladder cancer that previously received platinum-based therapy. The Swiss pharmaceutical major said this was decided in consultation with the U.S. Food and Drug Administration, which was reviewing accelerated approvals across the industry.
5:18 a.m. March 5, 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 [l:cautioned back in April|https://www.fda.gov/animal-veterinary/product-safety-information/fda-letter-stakeholders-do-not-use-ivermectin-intended-animals-treatment-covid-19-humans%7CNEW] that trials needed to be conducted before the drug should be prescribed to COVID-19 patients.
11:03 a.m. March 4, 2021 - By Jaimy Lee
NIH to study three experimental COVID-19 treatmentsThe National Institutes of Health said Thursday that it is putting three more investigational COVID-19 treatments into Phase 2/3 clinical trials. The experimental therapies are: an inhalable beta interferon developed by Synairgen's ; AstraZeneca's monoclonal antibody combination, which will be tested as an infusion and also as an injection; and Sagent Pharmaceuticals Inc.'s oral serine protease inhibitor. Sagent is privately held. The NIH said it is trying to identify and study therapies aimed at treating people who develop mild or moderate forms of COVID-19. So far during the pandemic, there are few therapies available that effectively treat patients with COVID-19. Only one, Gilead Sciences Inc.'s Veklury, has received full approval from the Food and Drug Administration, though several other companies, including Eli Lilly & Co. and Regeneron Pharmaceuticals Inc. have received emergency authorization for their antibody treatments. Over the past year, Synairgen's stock has soared 763.1%, while U.S.-listed shares of AstraZeneca are up 0.4%. The broader S&P 500 is up 27.2%.
7:33 a.m. March 4, 2021 - By Tomi Kilgore
Moderna, IBM explore blockchain tech, AI to support 'smarter' management of COVID-19 vaccinesModerna Inc. and International Business Machines Corp. announced Thursday plans to work together to find technologies to support "smarter COVID-19 vaccine management." The technologies the companies will explore include artificial intelligence, blockchain and hybrid cloud, the companies said. "Moderna is committed to working with a coalition of partners to increase education and awareness of the importance of vaccination to help defeat COVID-19," said Michael Mullette, a managing director of North America commercial operations at Moderna. "We look forward to working with IBM to apply digital innovations to build connections between organizations, governments, and individuals to instill confidence in COVID-19 vaccines." Moderna's stock rose 1.6% in midday trading and IBM shares fell 0.7%, while the Dow Jones Industrial Average gained 118 points, or 0.4%. Moderna currently has one of three COVID-19 vaccines granted emergency use authorization by the Food and Drug Administration, the others being from Pfizer Inc. and BioNTech SE and Johnson & Johnson .
4:29 a.m. March 4, 2021 - By Jaimy Lee
NIH tells Vir that experimental COVID-19 therapy may not benefit patientsShares of Vir Biotechnology Inc. tumbled 5.4% in premarket trading on Thursday, the day after the company said the experimental COVID-19 treatment that it's developing with GlaxoSmithKline may not benefit patients. U.S.-listed shares of GSK were up 0.6% in trading before the market opened on Thursday. The investigational monoclonal antibody therapy was being tested in hospitalized COVID-19 patients in a Phase 3 clinical trial conducted by the National Institutes of Health until an independent safety board recommended that the trial investigators close the study to enrollment at this time, Vir said. "While we are disappointed with the recommendation ... we are encouraged by the safety profile of VIR-7831 and by the possibility of a benefit on top of remdesivir and corticosteroids in this advanced cohort of patients," Vir CEO George Scangos said in a news release. (Remdesivir, which is also called Veklury, was developed by Gilead Sciences Inc. and is the only COVID-19 treatment to have a full Food and Drug Administration approval.) Vir's stock is down 6.9% over the past 12 months, while the broader S&P 500 has gained 27.2%.
5:09 a.m. March 2, 2021 - By Ciara Linnane
President Biden to announce later Tuesday that Merck will help make J&J vaccine: Washington PostPresident Joe Biden will announce later Tuesday that Merck & Co. will help make Johnson & Johnson's one-shot COVID-19 vaccine in an unusual agreement between two competitors that could lead to a significant boost in supply, citing unnamed senior administration officials. The deal was brokered by the government as it works to expand manufacturing of the vaccine, which was granted emergency use authorization by the U.S. Food and Drug Administration on Saturday. Merck is one of the world's biggest vaccine makers and its own effort to develop an effective COVID vaccine failed. Merck will dedicate two facilities in the U.S. to the effort with one providing "fill-finish" services, putting vaccine in vials for distribution, while the other will make the vaccine itself, said the paper. That could double the supply compared with what J&J can achieve on its own, it said. The U.S. vaccine program has been hampered by a shortage of supply of vaccines. J&J shares were slightly higher premarket, but have gained 14% in the last 12 months, while the S&P 500 has gained 26%. Merck shares were up 0.4%, and have fallen 11% in the last 12 months.
4:09 a.m. March 1, 2021 - By Quentin Fottrell
Dr. Fauci on J&J’s COVID-19 vaccine: ‘I would have no hesitancy whatsoever to take it’ Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, said, ‘People need to get vaccinated as quickly, and as expeditiously, possible’Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, said, ‘People need to get vaccinated as quickly, and as expeditiously, possible.’
2:40 p.m. Feb. 26, 2021 - By Jaimy Lee
FDA tells J&J it's working on an emergency authorization for its COVID-19 vaccine Shares of Johnson & Johnson gained 1.3% in after-hours trading on Friday after the Food and Drug Administration said it has contacted the company to say it is "rapidly" working toward issuing an emergency use authorization for J&J's COVID-19 vaccine candidate. The FDA statement was sent out Friday evening about an hour after an advisory committee that the benefits of the experimental vaccine outweigh the risks. "The agency has also notified our federal partners involved in vaccine allocation and distribution so they can execute their plans for timely vaccine distribution," FDA officials said in the statement. J&J said earlier this week that it plans to deliver 20 million doses of its single-dose vaccine in the U.S. by the end of March. J&J's stock is up 10.7% over the past 12 months, while the broader S&P 500 has gained 22.4%.
1:08 p.m. Feb. 26, 2021 - By Jaimy Lee
FDA committee votes unanimously, says benefits of J&J's COVID-19 vaccine outweigh the risksShares of Johnson & Johnson were up 1.3% in after-hours trading on Friday after a Food and Drug Administration advisory committee vote 22-0 in favor of the regulator authorizing the company's COVID-19 vaccine candidate. The FDA is not required to follow the advice of the committee but often does. The single-dose vaccine had an overall efficacy rate of about 66% in the Phase 3 clinical trial, and the U.S. arm of the trial showed an efficacy rate of about 72% and of 85% when protecting against severe or critical disease. The most common adverse events were pain at the injection site and fatigue. The trial was conducted in the U.S., South Africa, and several Central and South American countries. If the FDA moves forward with authorizing the experimental vaccine, it will be the third COVID-19 vaccine to be available in the U.S. - and the first to require only one dose. Both the Moderna Inc. and BioNTech SE and Pfizer Inc.'s vaccines, which were separately authorized in December, require two doses spaced several weeks apart. J&J's stock has gained 10.7% over the past 12 months, while the broader S&P 500 is up 22.4%
6:35 a.m. Feb. 25, 2021 - By Jaimy Lee
Regeneron to share new data about COVID-19 antibody cocktail in MarchShares of Regeneron Pharmaceuticals Inc. were up 0.2% in trading on Thursday after the company said an independent committee recommended the placebo no longer be given to COVID-19 patients in a Phase 3 clinical trial because the company's antibody cocktail demonstrated "clear" efficacy. The committee said the treatment, REGEN-COV, which received emergency authorization in November, reduced hospitalizations and deaths at two dose levels, and it would continue to enroll non-hospitalized COVID-19 patients who will receive either dose of the therapy. The company said it plans to share detailed clinical data from the trial next month as part of its effort to secure a full approval from the Food and Drug Administration for the antibody cocktail. Regeneron's stock is up 3.5% over the past 12 months, while the S&P 500 has gained 21.7%.
4:56 a.m. Feb. 23, 2021 - By Jaimy Lee
J&J plans to deliver 20 million doses of its COVID-19 vaccine in the U.S. in MarchShares of Johnson & Johnson were down 0.1% in premarket trading on Tuesday after the company said in released in advance of a congressional hearing that it plans to deliver about 20 million doses of its COVID-19 vaccine by the end of March. J&J's still-investigational COVID-19 vaccine candidate is currently under review at the Food and Drug Administration, though the federal government has already agreed to purchase 100 million doses of the company's single-dose vaccine in the first half of the year. Executives from J&J, AstraZeneca , Pfizer Inc. , Moderna Inc. , and Novavax Inc. are expected to testify Tuesday in front of about the availability of COVID-19 vaccines in the U.S. J&J's stock is up 7.9% over the past 12 months, while the S&P 500 has gained 16.1%.
9:56 a.m. Feb. 22, 2021 - By Jaimy Lee
FDA sets out new rules for vaccine and test developers over variant worries The Food and Drug Administration on Monday issued a set of guidance documents for companies that are developing COVID-19 , , and as a result of new variants of the virus that have emerged. There are of SARS-CoV-2, two of which are believed to be more infectious, that have been identified in the U.S. While the number of people in the U.S. who have contracted those variants remains low, the new strains have raised concern about the effectiveness of medical products. The FDA said it believes currently authorized vaccines are still effective against these variants but said there may be a need for clinical immunogenicity studies in the future if the vaccines are no longer as effective or other variants emerge. The regulator said test developers should consider routine monitoring to better track new mutations and how they could affect the accuracy of their COVID-19 tests. A third guidance is aimed at developers of monoclonal antibody treatments, which are similar to vaccines in that their effectiveness can be dampened by new variants.
7:07 a.m. Feb. 22, 2021 - By Jaimy Lee
AstraZeneca to withdraw drug used to treat bladder cancerShares of AstraZeneca were down 0.1% in trading on Monday after the drugmaker said it voluntarily withdrew an indication granted by the Food and Drug Administration that allows the use of Imfinzi as a treatment for certain types of bladder cancer. The FDA initally granted the company an accelerated approval in 2017 for this drug with this indication; however, the approval required additional studies, and AstraZeneca found that the drug did not meet the primary endpoints in a study conducted in 2020. Imfinzi has not been withdrawn for other indications, such as lung cancer. "While the withdrawal in previously treated metastatic bladder cancer is disappointing, we respect the principles FDA set out when the accelerated approval pathway was founded and remain committed to bringing new and innovative options to patients," Dave Fredrickson, AstraZeneca's EVP of oncology, said in a news release. AstraZeneca's stock has gained 0.9% over the past 12 months, while the broader S&P 500 is up 15.3%
3:46 a.m. Feb. 22, 2021 - By Jaimy Lee
FDA committee to review J&J's COVID-19 vaccine candidate this weekA Food and Drug Administration advisory committee is set to meet Friday to vote on whether the regulator should authorize Johnson & Johnson's experimental single-dose COVID-19 vaccine. Shares of J&J were up 0.5% in premarket trading on Monday. The regulator is not required to follow the advice of the committee but often does. The committee is made up of a group of independent medical experts who will discuss and then vote on whether the benefits of the investigational vaccine outweigh the risks. The FDA is also expected to release its report on J&J's COVID-19 vaccine by Wednesday, in advance of the that will run all day on Friday. In the cases of the BioNTech SE and and COVID-19 vaccines, the FDA granted emergency-use authorizations one day after the advisory committee meetings on those vaccines -- this could mean that the J&J's COVID-19 vaccine candidate will be authorized by the end of the week. J&J's stock has gained 8% over the past 12 months, while the broader S&P 500 is up 15.3%.
11:33 a.m. Feb. 19, 2021 - By Jaimy Lee
Mayo Clinic: COVID-19 vaccines are 88.7% effective in the 'real world'Both of the authorized COVID-19 vaccines in the U.S. are nearly as effective at preventing infections with SARS-CoV-2 in the real world as they were in clinical trials, according to conducted by the Mayo Clinic and Nference Inc., a privately held company. The study, which was published Thursday as a preprint, found that both COVID-19 vaccines had an effective rate of 88.7% in the roughly 62,000 people included in the retrospective analysis. It also found that people who had been vaccinated had lower hospitalization rates if they did get sick. The vaccine developed by BioNTech SE and Pfizer Inc. had an efficacy rate of 95.0% in the Phase 3 clinical trial, while Moderna Inc.'s vaccine reported an efficacy rate of 94.1% in its late-stage study. Both are mRNA-based vaccines that require two doses and received emergency use authorization from the Food and Drug Administration in December. The slightly lower effectiveness rate is likely due to the fact that the vaccination was initially only open to two groups of people who are at high risk for contracting the virus: health care workers, and nursing-home residents. Over the past 12 months, shares of BioNTech have soared 249.3%, Pfizer's stock is up 0.7%, and Moderna shares have rallied 796.2% The broader S&P 500 is up 16.3%.
4:22 a.m. Feb. 19, 2021 - By Jaimy Lee
Mayo Clinic: COVID-19 vaccines are 88.7% effective in the 'real world'Both of the authorized COVID-19 vaccines in the U.S. are nearly as effective at preventing infections with SARS-CoV-2 in the real world as they were in clinical trials, according to conducted by the Mayo Clinic. The study, which was published Thursday as a preprint, found that both COVID-19 vaccines had an effective rate of 88.7% in the roughly 62,000 people included in the retrospective analysis. It also found that people who had been vaccinated had lower hospitalization rates if they did get sick. The vaccine developed by BioNTech SE and Pfizer Inc. had an efficacy rate of 95.0% in the Phase 3 clinical trial, while Moderna Inc.'s vaccine reported an efficacy rate of 94.1% in its late-stage study. Both are mRNA-based vaccines that require two doses and received emergency use authorization from the Food and Drug Administration in December. The slightly lower effectiveness rate is likely due to the fact that the vaccination was initially only open to two groups of people who are at high risk for contracting the virus: health care workers, and nursing-home residents. Over the past 12 months, shares of BioNTech have soared 249.3%, Pfizer's stock is up 0.7%, and Moderna shares have rallied 796.2% The broader S&P 500 is up 16.3%.
3:48 a.m. Feb. 19, 2021 - By Jaimy Lee
J&J submits application for its COVID-19 vaccine to the WHOShares of Johnson & Johnson gained 0.4% in premarket trading on Friday after the company said it had submitted an application for its experimental single-dose COVID-19 vaccine to the World Health Organization for emergency authorization. Obtaining an emergency-use listing from the WHO allows J&J's vaccine candidate to be made available through Covax, a global consortium supplying COVID-19 vaccines to lower-income countries. J&J's vaccine, which has not yet been authorized for use in the U.S., is set to be reviewed by a group of vaccine experts next week as part of the Food and Drug Administration's regulatory process. The company also submitted a regulatory application for its coronavirus vaccine in the European Union on Feb. 15. J&J's stock is up 11.3% over the past year, while the S&P 500 is up 16.3%.
6:24 a.m. Feb. 18, 2021 - By Jaimy Lee
Altimmune to start early-stage trial for its COVID-19 vaccine candidateShares of Altimmune Inc. were down 4.1% in trading on Thursday, the day after the clinical-stage company said it had received regulatory approval to begin studying its COVID-19 vaccine candidate in a Phase 1 clinical trial. Altimmune said Wednesday the Food and Drug Administration had OK'ed the company's investigational new drug application for its experimental single-dose, intranasal vaccine. It expects to begin enrolling the trial's 180 participants, who will be between the ages of 18 and 55 years old, within the week. Altimmune's stock has soared 1,239.4% over the past 12 months, while the S&P 500 is up 16.3%.
4:20 a.m. Feb. 12, 2021 - By Jaimy Lee
Regeneron's therapy for rare heart disorder gets approved by FDAShares of Regeneron Pharmaceuticals Inc. were up 0.7% in premarket trading on Friday, the day after the company said it received regulatory approval in the U.S. for its homozygous familial hypercholesterolemia treatment. The wholesale acquisition cost of treatment is $450,000 per year, though the price may fluctuate based on an individual's weight. The Food and Drug Administration approved Evkeeza as an adjunct to some other cholesterol-lowering therapies for patients who are 12 years old or older. The rare condition affects about 1,300 people in the U.S. Evkeeza reduced a certain type of cholesterol by 49% when compared to placebo among patients participating in a late-stage clinical trial. Regeneron's stock has gained 20.7% over the past 12 months, while the S&P 500 is up 16.6%.
3:55 a.m. Feb. 12, 2021 - By Jaimy Lee
SVB Leerink, J.P. Morgan downgrade Amicus stock after Phase 3 data for rare disease drug comes outShares of Amicus Therapeutics Inc. were down 23.1% in premarket trading on Friday, the day after the company said an experimental rare disease drug failed to perform better than the standard of care in a late-stage trial. The investigational drug, AT-GAA, is a treatment for Pompe disease, a rare, genetic disease that causes severe muscle weakness. The standard of care is Sanofi's Lumizyme, which was approved back in 2010. Though Amicus said it still plans to submit AT-GAA to the Food and Drug Administration for approval in the second quarter of 2021, analysts were concerned about the drug's performance in the pivotal Phase 3 clinical trial. SVB Leerink on Friday downgraded the stock to market perform from outperform. "This situation strikes us as reminiscent of the long and arduous path to approval for FOLD's one commercial product Amigal, which also missed its primary endpoint but was ultimately approved," SVB's Joseph Schwartz wrote in a note to investors. J.P. Morgan also downgraded the stock to neutral from overweight. "Certainly, overall, this is a disappointing outcome," analysts there wrote. "That said, we do not view AT-GAA as a 'zero' by any means." Shares of Amicus have gained 67.8% over the past 12 months, while the broader S&P 500 is up 16.6%.
4:34 a.m. Feb. 11, 2021 - MarketWatch
AstraZeneca: Jabs for new variants need 6 monthsLONDON -- AstraZeneca PLC said it was fixing problems with the manufacturing of its Covid-19 vaccine and expects to roughly double monthly production to 200 million doses by April, as it seeks to move past a rocky start to the shot's rollout.
4:05 a.m. Feb. 10, 2021 - By Jaimy Lee
FDA grants authorization to Lilly's COVID-19 antibody treatmentShares of Eli Lilly & Co. were up 1.1% in premarket trading on Wednesday, the day after the Food and Drug Administration granted emergency authorization to the company's COVID-19 antibody cocktail. The infusion pairs two monoclonal antibodies, bamlanivimab and etesevimab, as a treatment for anyone older than 12 years old who has mild to moderate COVID-19 symptoms and is at risk for severe disease. It's not a treatment that is authorized for people who have been hospitalized with COVID-19. The regulator previously gave emergency use authorization to bamlanivimab as a standalone COVID-19 therapy. A late-stage clinical study found the combination treatment in people with COVID-19. Lilly's stock has rallied 38.6%, while the S&P 500 is up 17.5%.
7:04 a.m. Feb. 8, 2021 - By Jaimy Lee
FDA approves Bristol Myers Squibb's CAR-T therapyShares of Bristol Myers Squibb Co. were down 0.8% in trading on Monday, following the announcement on Friday that the Food and Drug Administration approved Breyanzi, its large B-cell lymphoma treatment. The wholesale list price is $410,300 for the total course of treatment. The treatment, a type of chimeric antigen receptor (CAR) T cell therapy, is the third FDA-approved gene therapy for non-Hodgkin lymphoma, according to the regulator, which also said that health care organizations that provide this type of therapy to patients have to be certified to do so. Bristol Myers' stock is down 8.8% over the past 12 months, while the S&P 500 is up 16.5%.
4:56 a.m. Feb. 8, 2021 - By Jaimy Lee
Cassava's stock jumps 18% on plans to initiate late-stage study for Alzheimer's drugShares of Cassava Sciences Inc. rallied 18.5% in premarket trading on Monday after the company said it plans to start a double-blind, randomized, placebo-controlled study of its Alzheimer's disease treatment candidate. This kind of trial is considered the gold standard in medical research. Cassava said it expects to move forward with a Phase 3 clinical trial for simufilan, its experimental Alzheimer's drug, based on meetings with the Food and Drug Administration, sometime in the second half of this year. This trial has not been publicly granted a go-ahead by the regulator. The company said last week that simufilam improved cognition and behavior scores in 50 patients with mild-to-moderate forms of the disease after six months of treatment, according to an interim analysis of an open-label study. Cassava's stock has soared 467.1% over the past 12 months, while the broader S&P 500 is up 16.5%.
7:05 a.m. Feb. 5, 2021 - By Jaimy Lee
FDA to issue guidance for vaccine developers about new variantsThe U.S. government plans to provide additional guidance about new strains of SARS-CoV-2 to companies that have developed or are developing new tests, treatments, and vaccines. The Food and Drug Administration said Thursday it's already discussing with companies how the new variants may affect the efficacy of their products. This includes makers of monocolonol antibodies, which are thought by B.1.351, a more infectious strain that emerged from South Africa. Eli Lilly & Co. and Regeneron Pharmaceuticals Inc. both have authorized COVID-19 antibody treatments. The regulator also said it believes that currently available vaccines still prevent infections with the virus and that most currently available tests are also still effective at detecting the coronavirus. It previously said that d by new variants. "We do not believe there will be the need to start at square one with any of these products," the FDA said. "We recognize we are in a pandemic."
3:31 a.m. Feb. 5, 2021 - By Jaimy Lee
FDA schedules advisory committee for J&J's COVID-19 vaccine candidate for Feb. 26A Food and Drug Administration advisory committee is now scheduled to meet Feb. 26 for an all-day meeting to discuss Johnson & Johnson's COVID-19 vaccine candidate. This is the next step in the regulatory process after J&J said Thursday for its experimental vaccine to the FDA. Members of the Vaccines and Related Biological Products Advisory Committee will discuss and then vote on whether the benefits of the single-dose vaccine outweigh the risks. The FDA then takes the committee's recommendation into account as it decides whether or not to authorize the J&J shot. The advisory committee also held meetings to discuss the COVID-19 vaccines developed by BioNTech SE /Pfizer Inc. and Moderna Inc. . Both vaccines were recommended by the committee, and emergency authorizations were granted by the FDA within days of those meetings. J&J's stock has gained 5.2% over the past 12 months, while the broader S&P 500 is up 17.4%.
1:57 p.m. Feb. 4, 2021 - By Jaimy Lee
J&J submits application for its COVID-19 shot to the FDAShares of Johnson & Johnson gained 1.2% in after-hours trading on Thursday after the company announced that it had submitted an application for an emergency use authorization to the Food and Drug Administration for its COVID-19 vaccine candidate. The experimental single-dose COVID vaccine at preventing symptomatic disease in the U.S. arm of the Phase 3 clinical trial, according to findings released Jan. 29. The FDA is expected to schedule a meeting of an advisory committee that will vote on whether the benefits of the vaccine outweigh the risks, as was done prior to the emergency use authorizations of BioNTech SE /Pfizer Inc. and Moderna Inc.'s COVID-19 vaccines. The company also said Thursday that its vaccine can be stored for two years at negative four degrees Fahrenheit in most standard refrigerators, and that it can provide 100 million doses of its vaccine candidate in the U.S. in the first half of 2021. J&J's stock has gained 6.8% over the past 12 months, while the broader S&P 500 is up 17.9%.
10:35 p.m. Feb. 3, 2021 - MarketWatch
Merck granted FDA approval for lung-cancer drugMerck KgaA said late Wednesday that the U.S. Food and Drug Administration has granted approval to its lung-cancer drug Tepmetko following priority review. The German pharmaceuticals and chemicals company said the drug was approved for the treatment of adult patients with metastatic non-small cell lung cancer who also present mesenchymal-epithelial transition exon 14 skipping alterations.
6:26 a.m. Feb. 2, 2021 - By Jaimy Lee
Vertex CEO says company is seeking to make 'transformative' dealsShares of Vertex Pharmaceuticals Inc. were down 4.3% in trading on Tuesday, the day after the company discussed its deal-making strategy with analysts during its fourth-quarter earnings call. The company said it is considering buying companies with mid- to late-stage products in development in the future. "I have no preconceived notions about the timing of a transaction, and I have no preconceived notions about the dollar amount of a transaction," said Vertex CEO Reshma Kewalramani said, according to a FactSet transcript of the call. "It has to fit our R&D strategy. It has to be transformative. We have to be able to add value." Three of the company's four drugs - cystic fibrosis drugs Kalydeco, Orkambi, and Symdeco - had a year-over-year sales decline in 2020, with each generating less than $1 billion in revenue for the year. Trikafta, its newest CF drug, generated $3.8 billion in sales in 2020, which was its first full year on the market following a 2019 approval from the Food and Drug Administration. The company's cash balance of roughly $7 billion at the end of 2020 indicates it has "tremendous firepower for transactions," according to SVB Leerink's Geoffrey Porges. But he also noted that any deals of interest to Vertex may demand a "hefty premium" in the current market. Vertex's stock is down 1.5% over the past 12 months, while the S&P 500 is up 17.0%.
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