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"I don't feel that we have evidence now that there's a clinical benefit from reducing amyloid," said Dr. Henry Paulson, a neurologist who leads the University of Michigan's Alzheimer’s Disease Center. Large clinical trials of Aduhelm, known chemically as aducanumab, produced contradictory data, with one trial failing and another showing benefit. Nevertheless, the FDA approved Aduhelm under its "accelerated approval" program with the understanding that Biogen would conduct a post-marking study to demonstrate patient benefit. FDA officials said other Alzheimer's drugs will not automatically be eligible for that program. "We can't say right now whether this will be a path for other Alzheimer's drugs, or drugs for other neurodegenerative diseases," Dr. Patrizia Cavazzoni, director of the FDA's Center for Drug Evaluation and Research, told Reuters.
Persons: Brian Snyder, Biogen’s, Eli Lilly, Co's, donanemab, Roche, Eisai, Biogen's, Aduhelm, Henry Paulson, Patrizia Cavazzoni, Caleb Alexander, Biogen, Raymond James, Chris Meekins, Japan's Eisai, , , David Knopman, Deena Beasley, Julie Steenhuysen, Peter Henderson, Bill Berkrot Organizations: REUTERS, Inc, U.S . Food, Drug Administration, FDA, University of Michigan's, Disease, Aduhelm, Eisai, FDA's Center, Drug, Reuters, Johns, Mayo Clinic, Thomson Locations: Boston, Cambridge , Massachusetts, U.S, Rochester, Los Angeles, Chicago
The therapy, REGEN-COV, has been granted emergency use authorisation for people with mild-to-moderate COVID-19 in the United States, but results from the RECOVERY trial provide the clearest evidence of its effectiveness among hospitalised patients. The result translates into six fewer deaths for every 100 seronegative patients treated with the therapy, researchers said. Regeneron had previously said its treatment had shown enough promise in hospitalised patients to warrant continuing its trial. read moreThere were 9,785 patients hospitalised with COVID-19 who were randomly allocated to receive usual care plus the antibody combination therapy or just usual care, of which 30% were seronegative. The RECOVERY trial also showed the steroid dexamethasone and Roche's (ROG.S) arthritis drug Actemra (tocilizumab) cut deaths in hospitalised patients.
Persons: Brendan McDermid, Martin Landray, Landray, Regeneron, we've, Eli Lilly, Alistair Smout, Bill Berkrot Organizations: Regeneron Pharmaceuticals, REUTERS, Pharmaceuticals, Vir Biotechnology Inc, GlaxoSmithKline Plc, AstraZeneca, Thomson Locations: Westchester, Tarrytown , New York, U.S, British, United States, COVID
Live Covid Live Updates: As U.S. Death Toll Nears 600,000, the Counting Is Complicated Many experts say the official total is probably an undercount. Credit... Justin Sullivan/Getty Images The United States is poised to reach a once-unthinkable number of 600,000 Covid-19 deaths. “Using the older definition of Covid-19 deaths, a resident who had Covid-19 but died due to another cause, like a car accident,” would still have been counted. As the pace of infection and death slows, public health agencies continue to revisit their death totals. Although it is one of three such drugs authorized in the United States, it is the only one currently in use nationwide.
Persons: Justin Sullivan, , Mitch Smith, Andrea Mantovani, Regeneron, Adriana Zehbrauskas, Peter Horby, Eli Lilly, Vir Organizations: Highland Hospital, Health, Public, New York Times, Times, ., The New York Times, European, European Commission, European Union . Travel, European Medicines Agency, World Health Organization, European Union, and Drug Administration, Covid, University of Oxford, Beta, GlaxoSmithKline Locations: California, Oakland, Calif, States, Northern California, Alameda County, , United States, Washington State, Missouri, Washington and Ohio, Oklahoma, West Virginia, New Jersey, New York City, Europe, Paris, Australia, Japan, South Korea, China, Albania, Lebanon, North Macedonia, Serbia, Taiwan, Hong Kong, Macau, European Union, Greece, Spain, Chandler, Ariz, Britain, South Africa, Brazil
It found that the antibody therapy reduced by a fifth the 28-day mortality of people admitted to hospital with COVID-19 whose immune system had not mounted an antibody response, known as seronegative. The result translates into six fewer deaths for every 100 seronegative patients treated with the therapy, researchers said. Regeneron had previously said its treatment had shown enough promise in hospitalised patients to warrant continuing its trial. read moreThere were 9,785 patients hospitalised with COVID-19 who were randomly allocated to receive usual care plus the antibody combination therapy or just usual care, of which 30% were seronegative. The RECOVERY trial also showed the steroid dexamethasone and Roche's (ROG.S) arthritis drug Actemra (tocilizumab) cut deaths in hospitalised patients.
Persons: Brendan McDermid, Roche, Martin Landray, Landray, Regeneron, we've, Eli Lilly, Stephen Evans, Alistair Smout, Bill Berkrot Organizations: Regeneron Pharmaceuticals, REUTERS, Regeneron Pharmaceuticals Inc, Vir Biotechnology Inc, GlaxoSmithKline Plc, AstraZeneca, London School of Hygiene, Tropical, Thomson Locations: Westchester, Tarrytown , New York, U.S, British, United States, COVID, Swiss
REUTERS/Dado Ruvic/Illustration/File PhotoAnglo-Swedish drugmaker AstraZeneca (AZN.L) said on Tuesday a study of its monoclonal antibody treatment, AZD7442, did not meet the main goal of preventing symptomatic COVID-19 in people recently exposed to the novel coronavirus. AZD7442 reduced the risk of developing symptomatic COVID-19 by 33% compared to a placebo, which was not statistically significant, the company reported. AstraZeneca is also studying the treatment in a pre-exposed patients trial and for preventing more severe disease. The monoclonal antibody therapy belongs to a class of drugs which mimic natural antibodies the body produces to fight off the infection. Rivals Regeneron Pharmaceuticals Inc (REGN.O) and Eli Lilly & Co (LLY.N) have both developed monoclonal antibody therapies which have been authorised for use in the United States to treat patients infected with the virus.
Persons: Dado Ruvic, AZD7442, Eli Lilly Organizations: Astra, AstraZeneca, REUTERS, Rivals Regeneron Pharmaceuticals Inc, European Medicines Agency, GlaxoSmithKline, Vir Biotechnology Inc, Lonza, U.S ., U.S, Thomson Locations: Swedish, United States, Celltrion, Swiss, Portsmouth , New Hampshire
The Eli Lilly logo is shown on one of the company's offices in San Diego, California, September 17, 2020. Mike Blake | Reuters
Persons: Eli Lilly, Mike Blake Locations: San Diego , California
Covid News: Study Finds Health Problems Can Persist Long After Infection, Even Among the Asymptomatic The C.D.C. Medical problems can persist long after infection with the virus, even among those who don’t get Covid, a study found. says the Delta virus variant is now a ‘variant of concern.’ A Covid-19 Memorial Wall in London on Tuesday. In California and New York, states in which vaccination rates are higher, governors are moving to lift restrictions altogether. Gavin Newsom of California said on Tuesday that it was time to “turn the page” on coronavirus pandemic restrictions.
Persons: Isadora Kosofsky, , Robin Gelburd, Gelburd, Ziyad Al, Aly, Al, Andy Rain, Summer Galloway, Dr, Galloway, Michael Osterholm, Pete Marovich, Biden, Muriel Bowser, Washington, ” Ms, Bowser, Mr, , ” Jen Psaki, we’re, We’ve, ” Lazaro Gamio, Daniel E, Slotnik, San Francisco Jim Wilson, New York Times Los Angeles Kendrick Brinson, The New York Times Universal City Ringo H.W . Chiu, Kendrick Brinson, The New York Times San Francisco Jim Wilson, Alexandra Hootnick, Gavin Newsom, that’s, Christopher Longhurst, Jim Wilson, Tariro Mzezewa, Shawn Hubler, Jill Cowan, Sarah Blesener, Andrew M, Cuomo, Newsom, Artemis, Mario Anzuoni, raffling, Optimus, ” Mr, , Jerry Nickelsburg, Nickelsburg, Hollywood Roosevelt, Nature, Boyle, Jesus Falsto, Eddie Kakish, Bud, Kakish, Angeleno —, Christian, Denise Randazzo, Randazzo, Oscar, Matthew Serratto, Frank Delgado, ” Lacey Hoffman, Hoffman, Newsom’s, Serratto, Ralph Kottke, Roselma Samala, Ms, Samala, Jerry Dyer, Dyer, Michael Helmrich, Mitch Capor, “ It’s, Caeleigh MacNeil, . Johnson, Oakland, “ I’m, Johnson, Muhammad Sajjad, Ehsan Ahmed, Syed Nasir Hussain Shah, Jason Henry, Kevyn Johnston, Johnston, haven’t, we’ve, Anushree Fadnavis, ” Dr, Arjun Singh Sengar, Sengar, Narendra Modi’s, Uttarakhand’s, Tirath Singh Rawat, Rawat, Grant Hindsley, Scott Hensley, Keri Althoff, Justin Lane, Regeneron, Adriana Zehbrauskas, Peter Horby, Eli Lilly, Vir Organizations: Covid, The New York Times, FAIR Health, Louis Health Care, Delta, Federal, Centers for Disease Control, Pfizer, BioNTech, AstraZeneca, The Times, U.S ., Public Health, World Health Organization, Alpha, Infectious Disease, University of Minnesota, White, Office, Intergovernmental Affairs, National Parks Service, New York Times, White House, New York Times Los, The New York Times Universal City, Associated Press Los, The New York Times San, , U.S, Supreme, Republican, University of California, San, Dodger, . Credit, World Trade Center, D.C, Universal Studios, Universal Studios Hollywood, Gov, Optimus, Credit, Anderson, ., Madame, Hollywood, San Francisco . Credit, Yosemite National, Merced Sun, Democrat, Berkeley, Employees, San Francisco Bay Area, Berkeley Bowl, Associated Press, Sindh —, Indian, Kumbh, of Medical Research, University of Washington’s, Washington State, University of Pennsylvania, Johns Hopkins Bloomberg School of Public Health, Broadway, ’ Equity Association, Broadway League, and Drug Administration, University of Oxford, Beta, GlaxoSmithKline Locations: Los Angeles, Covid, United States, London, England, United Kingdom, California, New York, India, Public Health England, Britain, U.S, Southern, United, Brussels, CALIFORNIA, New York Times Los Angeles, , California, America’s, University of California San Diego, Napa, San Francisco, West, Lower Manhattan, Washington, Vermont, New York City, Bronx, Brooklyn, Hollywood, Sacramento, San Fernando Valley, Texas, Florida, ” California, San Francisco ., Merced, San Joaquin, Merced County, Italian, Here’s, Central Valley, Fresno, Berkeley, San Francisco Bay, Bay, ” Unvaccinated, Pakistan, Peshawar, Sindh, Afghanistan, Karachi, , Punjab, Oakland, Calif, prepandemic, Lake Merritt, Alameda County, Haridwar, Uttarakhand, Wuhan, China, Illinois, Chandler, Ariz ., South Africa, Brazil
Cramer's lightning round: I think Snap's a winner
  + stars: | 2021-06-15 | by ( Tyler Clifford | ) www.cnbc.com + 0.99   time to read: 1 min
Vertex Pharma: "I think it's a good opportunity to actually pick some Vertex up." Turtle Beach: "Turtle Beach happens to be in a crowded beach. Commercial Vehicle: "You've got horse sense. Goldman Sachs: "$350 is the level that I want to get back in ... and I would do it slowly." I welcome him on the show anytime, and I think Snap's a winner."
Persons: Eli Lilly, You've, Goldman Sachs, Evan Spiegel, He's Organizations: Vertex Pharma, Logitech, Federal Reserve Locations: Hollywood
Biotech Rally Sparked by Alzheimer’s Drug Has Staying Power
  + stars: | 2021-06-13 | by ( Charley Grant | ) www.wsj.com sentiment -0.99   time to read: +1 min
The Food and Drug Administration gave the green light to Biogen ’s drug Aduhelm on Monday. Eli Lilly , which has a similar Alzheimer’s drug under development, rallied 10% on Monday. Alzheimer’s has been a particularly confounding corner of drug research for decades; a 2018 analysis found that 146 experimental drugs had failed in clinical trials over the past 20 years. The FDA’s decision to approve Aduhelm despite significant concerns over its efficacy changes the outlook for those research efforts. Even the perception of a more forgiving regulatory agency is enough to spark fresh enthusiasm for biotech, and not only for companies with an Alzheimer’s program.
Persons: Eli Lilly, Alzheimer’s Organizations: Drug Administration, FDA, Nasdaq
In this article LLYBIIBAduhelm by Biogen Source: BiogenThe FDA's approval of Biogen's Alzheimer's drug Aduhelm was a landmark moment in the life of Dr. Paul Aisen. One immediate challenge facing other teams working on a wider Alzheimer's drug pipeline, he said in a recent video call, would be to retain participants in ongoing trials, let alone attract new ones. "In most cases," he explained, many Alzheimer's sufferers will drop out of other drug studies to pursue treatment with the newly approved Aduhelm. The controversy surrounding the Biogen drug, including its potential cost, comes against a landscape of massive, unmet need for dementia treatment and a disease that costs the U.S. as much as $259 billion annually. That is why some dementia drug experts are focusing on the renewed attention and fresh financing rather than the potential negatives from the Biogen approval, according to Dr. Jeffrey Cummings, a neurologist at the University of Nevada, Las Vegas, who publishes an annual review of the Alzheimer's drug development pipeline.
Persons: Aduhelm, Dr, Paul Aisen, Aisen, Aaron Kesselheim, aducanumab, , Boehringer, Biogen, Jeffrey Cummings, Cummings, Eli Lilly's donanemab, Roche's, Eli Lilly, David Ricks, Biogen's Aduhelm, Lilly Organizations: Biogen, Therapeutic Research, USC, and Drug Administration, FDA, Harvard Medical School, Pfizer, Alzheimer's Association, University of Nevada, National Institutes of Health, pharma, CNBC Locations: San Diego, Las Vegas
In addition, the FDA approval ignored the recommendation of its outside advisors, who said Biogen did not provide enough evidence of clinical benefit. Three of the advisory panel's members have resigned in protest since the FDA decision was announced on Monday read more . Karlawish ran one of the trial sites for the Biogen drug. The FDA approval allows Biogen to sell its product over several years - with forecasts for potential annual sales reaching as high $10 billion to $50 billion - until the company completes a required follow-up study. FDA officials said other Alzheimer's drug developers cannot assume their therapies will be considered under the same framework.
Persons: Brian Snyder, Biogen, Jason Karlawish, Karlawish, Johns, Caleb Alexander, Alzheimer's, Alfred Sandrock, Sandrock, Peter Stein, Aduhelm, Eli Lilly, drugmakers, Patrizia Cavazzoni, Jim Shehan, Lowenstein Sandler, UsAgainstAlzheimer's Organizations: REUTERS, U.S . Food, Drug Administration, FDA, Penn Memory Center, Alzheimer's Association, New Drugs, Reuters, Roche Holding, FDA's Center, Drug, Institute for Clinical, Economic, Thomson Locations: Cambridge , Massachusetts, U.S, Philadelphia
In addition, the FDA approval ignored the recommendation of its outside advisors, who said Biogen did not provide enough evidence of clinical benefit. Three of the advisory panel’s members have resigned in protest since the FDA decision was announced on Monday. Karlawish ran one of the trial sites for the Biogen drug. The FDA approval allows Biogen to sell its product over several years - with forecasts for potential annual sales reaching as high $10 billion to $50 billion - until the company completes a required follow-up study. FDA officials said other Alzheimer's drug developers cannot assume their therapies will be considered under the same framework.
Persons: Biogen, Jason Karlawish, Karlawish, Johns, Caleb Alexander, Alzheimer's, Alfred Sandrock, Sandrock, Brian Snyder, Peter Stein, Aduhelm, Eli Lilly, drugmakers, Patrizia Cavazzoni, Jim Shehan, Lowenstein Sandler, UsAgainstAlzheimer’s Organizations: U.S . Food, Drug Administration, FDA, Penn Memory Center, Alzheimer's Association, REUTERS, New Drugs, Reuters, Roche Holding, FDA's Center, Drug, Institute for Clinical, Economic, Thomson Locations: U.S, Philadelphia, Cambridge , Massachusetts
Lilly spokesperson Kathryn Beiser and a Justice Department spokesperson declined to comment. The firm also has several lawyers whose reputations would carry weight with the Justice Department and the FDA, including former Attorney General Eric Holder, legal experts said. ANSWERING DIFFERENT QUESTIONSThe company-backed investigation was based on interviews with more than 100 people, the May 20 memo to Lilly employees said. The memo denies the company made false statements to the FDA. The company memo said Lilly couldn’t substantiate allegations that employees faced retaliation for refusing to make false statements.
Persons: Eli Lilly, Mike Segar, Lilly, Burling, Nellie Clark, Kathryn Beiser, Clark, Covington, it’s, , Paul Pelletier, Eric Holder, Gerald Masoudi, Masoudi, Amrit Mula, Mula, Trump, New Jersey Democrat Bob Menendez, ” Menendez Organizations: Reuters, U.S . Justice, Company, REUTERS, U.S . Food, Drug Administration, Washington D.C, Covington, Burling LLP, Justice Department, U.S . Securities, Exchange Commission, Justice, U.S, Department, FDA, New, New Jersey Democrat Locations: New Jersey, Branchburg , New Jersey, , New Jersey, Washington, Covington, Mula, U.S
The home furnisher, known formerly as Restoration Hardware, reported adjusted earnings of $4.89 per share on revenue of $861 million. Signet Jewelers – Signet shares jumped nearly 9% after the company's first-quarter earnings topped analysts' projections. The jeweler reported adjusted earnings of $2.23 per share, compared with the Street's $1.27 per share expectation, according to Refinitiv. Fastly – The cloud computing company's stock fell more than 1% in midday trading after Oppenheimer downgraded it to a perform from an outperform. GameStop – Shares of GameStop fell about 19% in midday trading.
Persons: RH, Signet, Goldman Sachs, Myers Squibb, it's, SVB Leerink, Fastly, Oppenheimer, Eli Lilly, Clover, Wendy's, — CNBC's Hannah Miao, Jesse Pound, Pippa Stevens Organizations: , Signet, Myers, UBS, ALX Oncology, GameStop, Amazon, Securities and Exchange Commission, Clover Health, Clean Energy Fuels Corp, Clean Energy Fuels Locations: Meatpacking, New York, Bristol, California
An Eli Lilly and Company pharmaceutical manufacturing plant is pictured at 50 ImClone Drive in Branchburg, New Jersey, March 5, 2021. If the Justice Department concludes that an internal investigation was thorough, it can result in a non-prosecution agreement with few, if any, penalties, the experts said. The firm also has several lawyers whose reputations would carry weight with the Justice Department and the FDA, including former Attorney General Eric Holder, legal experts said. ANSWERING DIFFERENT QUESTIONSThe company-backed investigation was based on interviews with more than 100 people, the May 20 memo to Lilly employees said. The company memo said Lilly couldn’t substantiate allegations that employees faced retaliation for refusing to make false statements.
Persons: Eli Lilly, Mike Segar, LLY.N, Lilly, Burling, Nellie Clark, Kathryn Beiser, Clark, Covington, it’s, , Paul Pelletier, Eric Holder, Gerald Masoudi, Masoudi, Amrit Mula, Mula, Trump, New Jersey Democrat Bob Menendez, Menendez Organizations: Company, REUTERS, U.S . Justice, Reuters, U.S . Food, Drug Administration, Washington D.C, Covington, Burling LLP, Justice Department, U.S . Securities, Exchange Commission, Justice, U.S, Department, FDA, New, New Jersey Democrat, Thomson Locations: Branchburg , New Jersey, New Jersey, , New Jersey, Washington, Covington, Mula, U.S
A historic approval of Biogen's Alzheimer's drug will have ramifications across the drug industry. That bet paid off on Monday, when the Food and Drug Administration approved its Alzheimer's drug, called Aduhelm. New treatments could mean new opportunities for diagnostics companies like QuanterixBiogen's drug approval could be good for diagnostic companies like Quanterix. Alzheon is developing an oral treatment and an Alzheimer's testperfectlab/ShutterstockMassachusetts drug company Alzheon has a clear pathway to drug approval following the Aduhelm approval. If all goes well, Alzheon hopes to file for FDA approval in 2025.
Persons: Jefferies, Andrew Tsai, Biogen, Eisai, Eli Lilly, Daniel Skovronsky Eli Lilly, Eli Lilly's, Bernstein, Ronny Gal, Lilly, Roche, Andrea Pfeifer, Prothena, Kennen MacKay, Michael Yee, Quanterix, hasn't, James Brewer, Dr, William Burke, Matt York, Brian Tanquilut, Tanquilut, RadNet, aren't, Tsai, Alzheon Organizations: Rivals, and Drug Administration, FDA, Big Pharma, Roche, RBC Capital Markets, Banner Alzheimers Institute, Associated Press Companies, Athira Pharma Locations: Alzheimer's, Massachusetts, Swiss, Colombia, Phoenix, Seattle, ATH
REUTERS/Brian SnyderThe approval by U.S. regulators on Monday of a Biogen Inc (BIIB.O) drug to treat Alzheimer's disease could reinvigorate investor interest more broadly in biotech and pharmaceutical shares that have struggled in 2021. The approval lifted shares of other companies developing treatments for the mind-wasting disease and helped push key biotech stock gauges to their best days in months. “The biotech sector needed a spark and this was an explosion,” said Kevin Gade, a portfolio manager focusing on biotech and pharma stocks for Bahl & Gaynor. But on Monday the Nasdaq biotech ETF surged 3.4%, its biggest daily percentage gain in seven months. "This might just be the catalyst biotech investors needed to get this group back on track," said Sahak Manuelian, head of equity trading at Wedbush Securities.
Persons: Brian Snyder, , Kevin Gade, Gaynor, Gade, Bahl, Eli Lilly, Lilly, Sahak Manuelian, Walter Todd, Joe Biden, Todd Organizations: REUTERS, Inc, pharma, Bahl, Nasdaq Biotechnology, Nasdaq, Wedbush Securities, Wall Street, Greenwood Capital Associates, U.S, Food and Drug Administration, Sarepta Therapeutics, Thomson Locations: Cambridge , Massachusetts, U.S, South Carolina
Thirty Madison just raised $140 million in a round that valued the company at more than $1 billion. Here's the presentation the company used in 2020 to raise $47 million from investors like Johnson & Johnson Innovation. Thirty Madison, a startup that prescribes medicine and does online doctor's visits, just became digital health's most recent unicorn, or a company valued at more than $1 billion. How Thirty Madison convinced a pharma giant to invest in its modelGutentag sees the model heading more toward Teladoc and Livongo's soon-to-be massive primary-care network than Ro and Hims. Here's the pitch deck that won Thirty Madison $47 million and backing from J&J in 2020.
Persons: Johnson, Eli Lilly, it's, Steven Gutentag, Demetri Karagas, I've, Gutentag, aren't, Livongo's, Amazon's, It's Organizations: Johnson, Polaris Partners, HealthQuest Capital, Madison, pharma, Polaris, KMG Medical, J Locations: Madison, Evens, Manhattan, Teladoc
The FDA has approved the first new Alzheimer's disease treatment in nearly two decades. The Food and Drug Administration has approved Biogen's Alzheimer's disease treatment, ushering in the first new drug for the disease in nearly two decades. An advisory committee to the FDA voted in November that Biogen's tests had failed to show that the drug effectively treats Alzheimer's. "The Agency concluded that the benefits of Aduhelm for patients with Alzheimer's disease outweighed the risks of the therapy." Read more: A reinvigorated Alzheimer's treatment among winners at the healthcare industry's most important event of the year.
Persons: Biogen, Aduhelm, wasn't, Patrizia Cavazzoni, hasn't, David Knopman, aducanumab, Brian Abrahams, Eisai, Eli Lilly Organizations: FDA, Drug Administration, FDA Center, Drug, Research, Agency, Citi, SVB, Capital, Eisai Inc, Company Locations: Alzheimer's
Stocks making the biggest moves midday: AMC, Carnival and Eli Lilly
  + stars: | 2021-06-07 | by ( Hannah Miao | ) www.cnbc.com + 0.00   time to read: +3 min
An Eli Lilly and Company pharmaceutical manufacturing plant is pictured at 50 ImClone Drive in Branchburg, New Jersey, March 5, 2021. AMC Entertainment — The meme stock jumped another 17% in heavy trading following an 83% rally last week. Meme stocks — Other meme stocks also rose on Monday, mirroring AMC's rally. Carnival, Norwegian and Royal Caribbean — Cruise stocks rose on Monday after Carnival confirmed plans for a July restart. Concrete – Shares of the concrete supplier soared 29% after the company announced it will be acquired by construction materials maker Vulcan Materials.
Persons: Eli Lilly, Koss, Biogen's, Morgan Stanley, — CNBC's Maggie Fitzgerald, Tanaya Macheel, Jesse Pound, Yun Li Organizations: Company, AMC Entertainment, The Securities, Exchange Commission, BlackBerry, GameStop, Royal Caribbean, Carnival, Royal, , Progressive, Vulcan Materials Locations: Branchburg , New Jersey, Royal Caribbean, American, U.S
After jumping more than 50%, Biogen shares closed up 38.3% at $395.85 - their highest closing level in over six years. "This is good news for patients with Alzheimer's disease. We've not had a disease modifying therapy approved ever," said Dr. Ronald Petersen, an Alzheimer's disease expert at the Mayo Clinic. Under that pathway, Biogen is required to conduct a confirmatory clinical trial, but has several years to do so, she said. Other doctors said clinical trial results were inconsistent and more proof was needed.
Persons: Biogen, Eisai, We've, Ronald Petersen, It's, Peterson, Patrizia Cavazzoni, I'm, Caleb Alexander, Johns Hopkins, Brian Snyder, Aducanumab, Steve Miller, Miller, Howard Fillit, Alzheimer’s, Eli Lilly Organizations: Mayo Clinic, Drug Administration, FDA's Center, Drug, REUTERS, Brian Snyder Read More, U.S, Cigna Corp, Medicare, FDA, Discovery Foundation, Alzheimer’s Association, Wall Street, Street, AC Immune SA, Sciences, Axsome Therapeutics, Thomson Locations: United States, Cambridge , Massachusetts, U.S, Brian Snyder Read More U.S
REUTERS/Brian Snyder/File PhotoU.S. regulators are slated to decided by Monday whether to approve Biogen Inc's (BIIB.O) controversial Alzheimer's disease drug, and Wall Street analysts and industry observers are deeply divided on its chances of making it over the finish line. The Food and Drug Administration decision will impact not only Biogen and its partner Eisai Co Ltd (4523.T), but other drugmakers developing Alzheimer's drugs such as Eli Lilly and Co (LLY.N). Oppenheimer last month raised to 50% from 33% its odds for an aducanumab approval, citing comments from Biogen that it is preparing for a commercial launch. "If the FDA approves aducanumab, (Biogen) could go to circa $400, and if not, to circa $200," Mizuho Securities analyst Salim Syed said in a recent research note. Aducanumab was studied in patients with early disease who test positive for a component of amyloid brain plaques.
Persons: Brian Snyder, Biogen, Biogen's, Eisai, Eli Lilly, aducanumab, Dr, Joanne Pike, Oppenheimer, Salim Syed, Geoff Meacham, Umer Raffat, Biden, Janet Woodcock, BofA's Meacham, Aducanumab Organizations: REUTERS, Wall Street, Drug Administration, FDA, Alzheimer's Association, Reuters, Mizuho, Bank of America Securities, ISI, Thomson Locations: Cambridge , Massachusetts, U.S, United States
Thirty Madison just raised $140 million in a round that valued the company at more than $1 billion. Here's the presentation the company used in 2020 to raise $47 million from investors like Johnson & Johnson Innovation. How Thirty Madison convinced a pharma giant to invest in its modelGutentag sees the model heading more toward Teladoc and Livongo's soon-to-be massive primary-care network than Ro and Hims. "That's why you're seeing the rise of solutions that help patients beyond just one part of the health issue," Gutentag said. Here's the pitch deck that won Thirty Madison $47 million and backing from J&J in 2020.
Persons: Johnson, Eli Lilly, it's, Steven Gutentag, Demetri Karagas, I've, Gutentag, aren't, Livongo's, Amazon's, It's Organizations: Johnson, Polaris Partners, HealthQuest Capital, Madison, pharma, Polaris, KMG Medical, J Locations: Madison, Evens, Manhattan, Teladoc
U.S. issues subpoena to Eli Lilly over New Jersey manufacturing plant
  + stars: | 2021-05-27 | by ( Reuters Staff | ) www.reuters.com sentiment -0.99   time to read: 1 min
FILE PHOTO: An Eli Lilly and Company pharmaceutical manufacturing plant is pictured at 50 ImClone Drive in Branchburg, New Jersey, March 5, 2021. REUTERS/Mike Segar(Reuters) - Eli Lilly and Co has received a subpoena from the U.S. Department of Justice, requesting certain documents relating to its manufacturing site in Branchburg, New Jersey, the drugmaker said in a filing on Thursday.
Persons: Eli Lilly, Mike Segar Organizations: Company, REUTERS, U.S . Department of Justice Locations: Branchburg , New Jersey
Eli Lilly receives DoJ subpoena over New Jersey manufacturing plant
  + stars: | 2021-05-27 | by ( Reuters Staff | ) www.reuters.com sentiment -0.99   time to read: +1 min
FILE PHOTO: An Eli Lilly and Company pharmaceutical manufacturing plant is pictured at 50 ImClone Drive in Branchburg, New Jersey, March 5, 2021. REUTERS/Mike Segar(Reuters) - Eli Lilly and Co has received a subpoena from the U.S. Department of Justice related to its New Jersey plant that makes its COVID-19 treatment, the drugmaker said in a filing on Thursday. Lilly said it had previously engaged external counsel to conduct an independent investigation of certain allegations relating to the Branchburg plant. “Lilly is deeply committed to manufacturing high-quality medicines for patients who need them, and the safety and quality of our products is our highest priority,” the company said. Reuters reported earlier this month that the company’s employees have accused a factory executive of altering documents required by government regulators in an effort to downplay serious quality control problems at the manufacturing site in Branchburg, New Jersey.
Persons: Eli Lilly, Mike Segar, Lilly, “ Lilly Organizations: Company, REUTERS, U.S . Department of Justice, Reuters, U.S . Food, Drug Administration Locations: Branchburg , New Jersey, New Jersey
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