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REUTERS/Andrew Kelly/File PhotoAug 7 (Reuters) - The U.S. drug regulator's approval of Biogen (BIIB.O) and Sage Therapeutics' (SAGE.O) first-of-its-kind postpartum depression (PPD) pill is unlikely to allay the drugmakers' growth concerns, analysts said on Monday. Adverse commentary after their PPD drug was approved by the U.S. Food and Drug Administration (FDA) on Friday sent Sage shares tumbling 40%, while Biogen dropped 3% in premarket trading. Zurzuvae's use as a clinical depression treatment represents a more than $1 billion sales opportunity compared with $250 million to $500 million potential for postpartum depression, said Jefferies analyst Michael Yee. "Postpartum depression is not necessarily where a big commercial opportunity is," Biogen CEO Christopher Viehbacher said last month. The U.S. FDA said last week that additional studies might be required to support the drug's approval for major depressive disorder (MDD), or clinical depression.

Persons: Andrew Kelly, Sage, Biogen, Baird, Brian Skorney, Skorney, Zurzuvae, Jefferies, Michael Yee, Christopher Viehbacher, Yee, Mariam Sunny, Bhanvi, Manas Mishra, Vinay Dwivedi Organizations: Food and Drug Administration, FDA, REUTERS, Sage Therapeutics, U.S . Food, Drug Administration, U.S, Thomson Locations: White Oak , Maryland, U.S, Bengaluru

☆ FDA approves oral pill for postpartum depression for first time
▼ + stars: | 2023-08-05 | by ( ) www.reuters.com time to read: +2 min

Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo/File PhotoAug 4 (Reuters) - The U.S. Food and Drug Administration (FDA) on Friday approved Biogen (BIIB.O) and Sage Therapeutics' (SAGE.O) oral pill to treat postpartum depression (PPD) in adults. The companies had sought the FDA's approval for the drug, Zurzuvae, to treat major depressive disorder (MDD), or clinical depression, as well as postpartum depression, which affect millions of people. Analysts have anticipated that the stocks of both companies would fall if the drug was approved only for postpartum depression, due to the smaller patient population. Until now, the FDA said, treatment for postpartum depression was available only as an intravenous injection.

Persons: Andrew Kelly, Zurzuvae, Biogen, Sage, Sriparna Roy, Lavanya, Krishna Chandra Eluri, Leslie Adler, William Mallard Organizations: Food and Drug Administration, FDA, REUTERS, U.S . Food, Drug Administration, Sage Therapeutics, U.S . Drug Enforcement Administration, Therapeutics, Thomson Locations: White Oak , Maryland, U.S, United States, Bengaluru

☆ US FDA approves Biogen-Sage Therapeutics pill for postpartum depression
▼ + stars: | 2023-08-04 | by ( ) www.reuters.com time to read: +1 min

REUTERS/Andrew Kelly/File Photo/File PhotoAug 4 (Reuters) - The U.S. Food and Drug Administration on Friday approved Biogen (BIIB.O) and Sage Therapeutics' (SAGE.O) oral pill to treat postpartum depression (PPD) in adults. The companies had sought the FDA's approval for the drug, Zurzuvae, to treat major depressive disorder), or clinical depression, as well as postpartum depression (PPD), which affect millions of people. Analysts were anticipating the stocks of both companies to fall if the drug was approved only for postpartum depression due to the smaller patient population. Until now, the FDA said, treatment for postpartum depression was available only as an IV injection. Postpartum depression (PPD) affects around one in seven women who give birth.

Persons: Andrew Kelly, Sriparna Roy, Lavanya, Krishna Chandra Eluri, Leslie Adler Organizations: Food and Drug Administration, FDA, REUTERS, U.S . Food, Drug Administration, Sage Therapeutics, Thomson Locations: White Oak , Maryland, U.S, United States, Bengaluru

☆ FDA warns some Tydemy birth control pills may not be effective, could result in unexpected pregnancy
▼ + stars: | 2023-08-02 | by ( Spencer Kimball | ) www.cnbc.com time to read: 1 min

Signage is seen outside the U.S. Food and Drug Administration headquarters in White Oak, Maryland, Aug. 29, 2020. The U.S. Food and Drug Administration has warned that some Tydemy birth control pills may not be effective, several days after the manufacturer recalled two batches of the medication that were distributed in the U.S. The FDA said the pills in question could result in unexpected pregnancy. The manufacturer, Lupin Pharmaceuticals, announced a voluntary recall of two batches of Tydemy on July 29. The pills in those batches were distributed in the U.S. between June 3, 2022, and May 31, 2023.

Organizations: U.S . Food, Drug Administration, U.S, FDA, Lupin Pharmaceuticals Locations: U.S, White Oak , Maryland

☆ FDA to review Schumer's concerns about YouTube stars' Prime Energy drink
▼ + stars: | 2023-07-12 | by ( Chelsey Cox | ) www.cnbc.com time to read: +2 min

Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, August 29, 2020. WASHINGTON — The Food and Drug Administration will address concerns raised by Senate Majority Leader Chuck Schumer about a caffeinated energy drink popular among teens. An agency spokesperson said it "is reviewing the concerns" outlined in Schumer's letter to FDA Commissioner Dr. Robert Califf about the dangers of Prime Energy, a beverage founded by YouTube stars Logan Paul and KSI. Prime Energy is not intended for anyone under the age of 18, according to a company representative. Prime Energy boasts 200 mg of caffeine.

Persons: Chuck Schumer, Robert Califf, Logan Paul, KSI, Schumer, Paul, Annika Kim Constantino Organizations: Food and Drug Administration, FDA, WASHINGTON, Drug Administration, Energy, YouTube, Prime Energy, American Academy of Child, Psychiatry Locations: White Oak , Maryland

☆ Sarepta slides as FDA about-turn on panel clouds gene therapy approval path
▼ + stars: | 2023-03-17 | by ( Aditya Samal | ) www.reuters.com time to read: +2 min

[1/2] Sign is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File PhotoMarch 17 (Reuters) - Shares of Sarepta Therapeutics Inc (SRPT.O) slumped as much as 21% on Friday on uncertainty over its gene therapy for Duchenne muscular dystrophy after the U.S. health regulator reversed its decision on a panel meeting. The U.S. Food and Drug Administration planned to hold a meeting of its independent experts to review the gene therapy, the company said late on Thursday, less than a month after saying it would not do so. Sarepta is developing SRP-9001 as the first gene therapy for the treatment of Duchenne muscular dystrophy, an inherited disorder of progressive muscular weakness typically seen in boys. Gene therapies such as BioMarin's (BMRN.O) bleeding disorder therapy have faced setbacks and tough scrutiny in the past, but the FDA approved multiple such products in 2022.

Feb 15 (Reuters) - Emergent BioSolutions Inc's (EBS.N) over-the-counter version of opioid overdose reversing drug received unanimous support from U.S. Food and Drug Administration's panel of advisers, sending shares of the contract drugmaker up nearly 16% after market. The vote puts the naloxone-based treatment Narcan on track to potentially become the first opioid overdose drug to be sold OTC nationwide. Naloxone rapidly reverses or blocks the effects of an overdose, restoring normal respiration. However, most panelists emphasized that OTC use of the nasal spray was safe and proposed ways to improve its labeling, to avoid using the drug wrong. Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020.

This story is part of Select's New & Notable column, where we highlight our favorite product launches, major sales, what we're buying and some of our latest recommendations and advice. This week, we’ve highlighted Harry’s new razor handle, Parachute’s Spanish-inspired leather chair, Starface’s latest pimple patches, a new towel collection from Onsen and more. Starface, a Select favorite pimple patch brand, launched Micro-Cloud pimple patches. The towels are made from Turkish-grown aegean cotton and come in four sizes: Bath sheet, bath towel, hand towel and face towel. New users who purchase a Fiture mirror between Jan. 1 and Jan. 31 can get a one-year membership for free.

☆ U.S. FDA panel votes against Spectrum's lung cancer drug
▼ + stars: | 2022-09-22 | by ( ) www.reuters.com time to read: +2 min

Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File PhotoSept 22 (Reuters) - Advisers to the U.S Food and Drug Administration on Thursday voted against recommending Spectrum Pharmaceuticals' (SPPI.O) experimental drug for the treatment of patients with a form of non-small cell lung cancer. The FDA panel voted 9 to 4 against the oral drug, poziotinib, citing marginal efficacy, high level of toxicities, and lack of dose optimization. Poziotinib is intended to treat non-small cell lung cancer (NSCLC) with a rare genetic mutation that affects 2-4% of total patients with NSCLC. There is no prior FDA-approved treatment for the rare lung cancer, and the patients suffering from the disease are given treatments similar to those with non-small cell lung cancer without the mutation.

☆ U.S. FDA approves Fennec's hearing loss therapy
▼ + stars: | 2022-09-21 | by ( ) www.reuters.com time to read: +1 min

Register now for FREE unlimited access to Reuters.com RegisterSignage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File PhotoSept 21 (Reuters) - The U.S. Food and Drug Administration has approved Fennec Pharmaceuticals Inc's (FENC.O) intravenous therapy to prevent chemotherapy-induced hearing loss in children, according to the health regulator's website. Cisplatin is used in treating a range of cancers in children such as liver, bone and brain cancer, but can cause permanent hearing loss. Register now for FREE unlimited access to Reuters.com RegisterPedmark is now the only approved therapy to prevent cisplatin-induced hearing loss in the United States, with most patients opting for either cochlear implants or hearing aids. Register now for FREE unlimited access to Reuters.com RegisterReporting by Raghav Mahobe and Mrinalika Roy in Bengaluru; Editing by Dhanya Ann ThoppilOur Standards: The Thomson Reuters Trust Principles.

☆ FDA warns of cybersecurity risk with certain Medtronic insulin pumps
▼ + stars: | 2022-09-20 | by ( ) www.reuters.com time to read: +2 min

Register now for FREE unlimited access to Reuters.com RegisterSignage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. The agency issued a cybersecurity risk alert for the Medtronic MiniMed 600 Series insulin pump system, which has several components including an insulin pump and a blood glucose meter that communicate wirelessly. Register now for FREE unlimited access to Reuters.com RegisterThe insulin pumps are sold through Medtronic's diabetes segment, which brought in $2.41 billion in sales in 2021 and accounted for 8% of the company's total revenue. The FDA said it was working with Medtronic to identify, communicate and prevent adverse events related to this risk. Register now for FREE unlimited access to Reuters.com RegisterReporting by Mrinalika Roy in Bengaluru; Editing by Shinjini GanguliOur Standards: The Thomson Reuters Trust Principles.

☆ Fiul cântăreţului Bobby Brown a murit la 28 de ani
▼ + stars: | 2020-11-19 | by ( ) www.jurnal.md time to read: +1 min

LAPD nu a oferit multe detalii cu privire la circumstanţele în care s-a produs decesul. Brown a fost pronunţat decedat la faţa locului, iar anchetatorii nu cred că este vorba despre un act criminal, a precizat poliţia. Bobbi Kristina Brown, fiica acestuia cu legendara cântăreaţă Whitney Houston, a decedat în 2015, la 22 de ani, după ce a fost găsită în stare de inconştienţă în cada de baie. În urma autopsiei, au fost descoperite mai multe droguri şi medicamente care se eliberează pe bază de reţetă, inclusiv marijuana, alcool şi medicamente sedative sau contra anxietăţii. Cauza morţii a fost stabilită ca fiind ''scufundare în apă asociată cu intoxicaţie cu droguri''.

Persons: Jeff Lee, Lee . Brown, Bobby Brown, Bobbi Kristina Brown, morţii, Whitney, Brown Organizations: White Oak Avenue, Houston, Whitney Houston, Awards Locations: Los Angeles, Beverly Hills

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