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☆ How previous investing mistakes are shaping my thinking on the latest stock gone wrong
▼ + stars: | 2024-05-05 | by ( Jim Cramer | ) www.cnbc.com time to read: +19 min

Three times a day we would gather "off the desk," and I would have to defend every stock we owned. First, there's the obvious mistakes that we have made: Bausch Health and Foot Locker . To signify the changes, he renamed it Bausch Health in 2018, after the eye-care company Valeant bought for $8.7 billion five years earlier. We thought the IPO market would come back, and Bausch Health would win the lawsuit and all would be back on track. Jim waits 45 minutes after sending a trade alert before buying or selling a stock in his charitable trust's portfolio.

Persons: Jeff Marks, Karen Cramer, Cramer, Karen, Max Palevsky, It's, Joseph Papa, Clint Eastwood, Papa, Jim Cramer, Valeant, Bausch, Locker, Mary Dillon, Dillon, Wall, Emerson, Cristiano Amon, Laxman Narasimhan, Howard Schultz, Narasimhan, Benckiser, Kevin Johnson, Schultz, Johnson, it's, —, Foot Locker, Jim Cramer's, Jim Organizations: Cramer &, Intel, Charitable Trust, Co, Starbucks, Bausch Health, Pharmaceuticals, Perrigo, Health, Norwich Pharmaceuticals, Former, Emerson Electric, Qualcomm, National, Eaton Corp, Broadcom, Palestine, PepsiCo, Nestle, Elliott Management, Emerson, CNBC, Getty Locations: China, —, Israel, U.S, BHC, FL, Jinan, East China's Shandong province

☆ Top business leaders bemoan archaic systems in Europe that are curbing climate solutions
▼ + stars: | 2024-01-26 | by ( Vicky Mckeever | ) www.cnbc.com time to read: +2 min

Ester Baiget, the CEO of biosolutions firm Novozymes, said that "roadblocks" usually stand in the way of companies producing sustainable solutions which needed to be removed. watch nowMicrobes have been put forward as an alternative to reduce the use of chemical fertilizers, which contribute to greenhouse gas emissions. However, new microbial fertilizers need to go through regulatory approval before going to market. We need to rethink regulation in regions like Europe." Kadri also said there was a "lack of competitiveness in Europe," referring to the difficulties faced by her sector.

Persons: Lukas Schulze, Ester Baiget, Novozymes, Baiget, Steve Sedgwick, Ilham Kadri, Kadri Organizations: Getty, CNBC, Economic Locations: Bergheim, Germany, Davos, Switzerland, Europe

☆ We have a regulation that is based on the passed: Novozymes CEO
▼ + stars: | 2024-01-25 | by ( ) www.cnbc.com time to read: 1 min

Share Share Article via Facebook Share Article via Twitter Share Article via LinkedIn Share Article via EmailWe have a regulation that is based on the passed: Novozymes CEO"We have a regulation which is based on the past," Ester Baiget, the CEO of biosolutions firm Novozymes, told CNBC, pointing out that in her own sector it can take six years to register a new microbe (or microorganism) to replace fertilizers.

Persons: Ester Baiget, Novozymes Organizations: CNBC

☆ Emergent BioSolutions to lay off about 400 employees
▼ + stars: | 2023-08-08 | by ( ) www.reuters.com time to read: +1 min

A nurse demonstrates the application of the NARCAN nasal spray medication at a outpatient treatment center in Indiana, Pennsylvania, U.S. August 9, 2017. REUTERS/Adrees Latif/File PhotoAug 8 (Reuters) - Emergent BioSolutions (EBS.N) on Tuesday decided to cut 400 jobs and scale back operations at some its facilities, pivoting its focus on core products such as overdose reversal nasal spray Narcan and anthrax vaccines. Smaller biotech companies have been struggling to finance drug development programs and that has hampered their ability to deliver on contract research services for over a year. The company had nearly 2,500 employees as of Dec.31, according to its regulatory filing. Emergent expects to incur an estimated cost of between about $19 million and $21 million in the third quarter of 2023.

Persons: Adrees Latif, Sriparna Roy, Shounak Dasgupta, Arun Koyyur Organizations: REUTERS, Thomson Locations: Indiana , Pennsylvania, U.S, Bayview, Baltimore, Canton , Massachusetts, Bengaluru

☆ US FDA approves second over-the-counter opioid overdose reversal drug
▼ + stars: | 2023-07-28 | by ( ) www.reuters.com time to read: +1 min

July 28 (Reuters) - The U.S. Food and Drug Administration has approved the prescription-free sale of the second opioid overdose reversal drug, its manufacturer Harm Reduction Therapeutics said on Friday. The approval of the drug, called RiVive, will provide patients with another over-the-counter option in the United States, where drug-related overdose deaths surpassed 100,000 in 2021. Harm Reduction said it anticipates that RiVive will be available early next year, primarily to harm-reduction organizations and state governments. Harm Reduction Therapeutics has partnered with contract drug manufacturer Catalent Inc (CTLT.N) to manufacture RiVive. Reporting by Sriparna Roy and Bhanvi Satija in Bengaluru; Editing by Pooja DesaiOur Standards: The Thomson Reuters Trust Principles.

Persons: drugmaker, Michael Hufford, Sriparna Roy, Bhanvi, Pooja Desai Organizations: U.S . Food, Drug Administration, Therapeutics, Harm, Catalent Inc, Thomson Locations: U.S, United States, Bengaluru

☆ U.S. FDA approves second over-the-counter opioid overdose reversal drug
▼ + stars: | 2023-07-28 | by ( ) www.cnbc.com time to read: +1 min

Naloxone, packaged with instructions, is one of the items given out by the Baltimore Harm Reduction Coalition outreach workers. The U.S. Food and Drug Administration has approved the prescription-free sale of the second opioid overdose reversal drug, its manufacturer Harm Reduction Therapeutics said on Friday. The approval of the drug, called RiVive, will provide patients with another over-the-counter option in the United States, where drug-related overdose deaths surpassed 100,000 in 2021. Harm Reduction said it anticipates that RiVive will be available early next year, primarily to harm-reduction organizations and state governments. Harm Reduction Therapeutics has partnered with contract drug manufacturer Catalent Inc to manufacture RiVive.

Persons: drugmaker, Michael Hufford, BioSolutions Organizations: Reduction Coalition, U.S . Food, Drug Administration, Therapeutics, Harm, Catalent Inc Locations: Baltimore, U.S, United States

☆ Health misinformation is lowering U.S. life expectancy, FDA Commissioner Robert Califf says
▼ + stars: | 2023-04-11 | by ( Meg Tirrell | ) www.cnbc.com time to read: +5 min

watch nowLife expectancy in the U.S. is between three and five years lower than the average in other high-income countries — and the gap comes in part from misinformation, Food and Drug Administration Commissioner Dr. Robert Califf said. He said there's a need for better regulation, including "specific authorities at FDA, FTC and other areas" to root out misinformation. Food and Drug Administration Commissioner Robert Califf testifies before a Senate Health, Education, Labor, and Pensions hearing to examine an update on the ongoing Federal response to COVID-19, at the U.S. Capitol in Washington, U.S., June 16, 2022. The FDA commissioner spoke about multiple topics including efforts to cut drug prices, a priority for the Biden administration and lawmakers from both parties in Congress. Incentives for researchCaliff is also encouraging the drug industry to consider investments in neglected areas of research.

☆ FDA Approves Narcan for Non-Prescription Sale
▼ + stars: | 2023-03-29 | by ( Julie Wernau | ) www.wsj.com time to read: 1 min

Narcan is an over-the-counter version of a widely used opioid-reversal nasal spray. People will soon be able to walk into a pharmacy and purchase medication to reverse an opioid overdose alongside other non-prescription items like aspirin and vitamins. The Food and Drug Administration on Wednesday said the overdose reversal medication Narcan could be sold over-the-counter for the first time since the opioid crisis began. Narcan’s manufacturer, Emergent Biosolutions Inc., said the nasal-spray version of the medication naloxone would likely begin appearing on shelves by late summer. Emergent is the first company to gain approval to sell naloxone without a prescription.

☆ FDA Makes Overdose-Reversal Drug Narcan Available Over-the-Counter
▼ + stars: | 2023-03-29 | by ( Julie Wernau | ) www.wsj.com time to read: 1 min

The nasal-spray version of naloxone will likely be available on pharmacy shelves by late summer. People will soon be able to walk into a pharmacy and purchase medication to reverse an opioid overdose alongside other nonprescription items like aspirin and vitamins. The Food and Drug Administration on Wednesday said the overdose reversal medication Narcan could be sold over-the-counter for the first time since the opioid crisis began. Narcan’s manufacturer, Emergent BioSolutions Inc., said the nasal-spray version of the medication naloxone would likely begin appearing on shelves by late summer. Emergent is the first company to gain approval to sell naloxone without a prescription.

☆ FDA approves over-the-counter sales of lifesaving opioid overdose treatment Narcan nasal spray
▼ + stars: | 2023-03-29 | by ( Spencer Kimball | ) www.cnbc.com time to read: +2 min

The Food and Drug Administration on Wednesday approved sales without a prescription of the nasal spray Narcan to reverse opioid overdoses, a decision that promises to significantly expand access to the lifesaving treatment. The FDA's decision means people will be able to buy the 4 milligram nasal spray in supermarkets, convenience stores, gas stations, vending machines and online. FDA Commissioner Dr. Robert Califf, in a statement, said the agency is encouraging the company to make the nasal spray available as soon as possible at an affordable price. The nasal spray must be administered as soon as an overdose is suspected. Two nasal spray devices typically come in a single package.

☆ US FDA approves first OTC opioid overdose reversal drug
▼ + stars: | 2023-03-29 | by ( ) www.reuters.com time to read: +2 min

[1/2] A box of NARCAN nasal spray is photographed at an outpatient treatment center in Indiana, Pennsylvania, U.S. on August 9, 2017. The approval for OTC use of the naloxone-based nasal spray will help align the federal government's stance with states that have provisions to offer the drug without prescription at pharmacies. Drug-related overdose deaths in the United States rose about 15% year-over-year to more than 100,000 in 2021, as per official data. While the approval puts Emergent ahead in the OTC product race, analysts have said it is not likely to derive significant sales from the approval. Benchmark analyst Robert Wasserman said ahead of the approval that Narcan sales peaked in 2020 and have declined since.

☆ Stocks making the biggest moves midday: Lululemon, Micron, Carnival, Foot Locker & more
▼ + stars: | 2023-03-29 | by ( Samantha Subin | ) www.cnbc.com time to read: +4 min

Micron Technology — The semiconductor manufacturer added 5.3% after management said it was planning a bigger headcount reduction than previously expected. Carnival — Shares gained 3.6% after being upgraded by Susquehanna to positive from neutral. The move comes a day after the stock gained 6.1% following an upgrade by Wells Fargo to equal weight from underweight. Urban Outfitters , Burlington Stores , Foot Locker , Ross Stores — Shares of major retailers declined Wednesday after UBS downgraded the group to sell from neutral. Petco — Shares of the pet health and wellness company gained 5% after CEO & Chairman Ron Coughlin disclosed a 61,000 share purchase.

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.

☆ Bavarian Nordic to buy travel vaccine portfolio for up to $380 mln
▼ + stars: | 2023-02-15 | by ( ) www.reuters.com time to read: +1 min

Feb 15 (Reuters) - Danish pharmaceuticals company Bavarian Nordic (BAVA.CO) has agreed to buy a portfolio of travel vaccines from Emergent BioSolutions Inc (EBS.N) for up to $380 million, it said on Wednesday after delivering an upbeat outlook for 2023. The company said it would acquire a typhoid fever vaccine, one against cholera and a Chikungunya virus treatment that is in Phase III trials. Bavarian Nordics makes the only approved mpox vaccine and started receiving massive orders last year as the virus became a global issue. The company expects 2023 revenue of about 6 billion Danish crowns ($863 million) against the 3.15 billion crowns in preliminary 2022 results, with 4.4 billion crowns coming from mpox and smallpox vaccined contracts alone. Earnings before interest, tax, depreciation and amortisation (EBITDA) are expected to reach 2.2 billion crowns this year, up from 329 million crowns in the preliminary results for 2022.

☆ FDA advisors recommend over-the-counter use of life-saving opioid overdose treatment Narcan
▼ + stars: | 2023-02-15 | by ( Spencer Kimball | ) www.cnbc.com time to read: +7 min

Narcan nasal spray quickly reverses an overdose from heroin and prescription painkillers. The Food and Drug Administration's independent advisors on Wednesday unanimously recommended over-the-counter use of the nasal spray Narcan to reverse opioid overdoses, which would significantly expand access to the life-saving treatment. Emergent BioSolutions ' Narcan is the most commonly sold treatment for opioid overdoses. Emergent BioSolutions said Narcan would be available for the over-the-counter market by late summer if the FDA approves it next month. Opioid overdose deaths spiked 17% during the pandemic from about 69,000 in 2020 to nearly 81,000 in 2021.

☆ Bioscience firms Novozymes and Chr. Hansen to merge in biggest-ever Danish deal
▼ + stars: | 2022-12-12 | by ( Elliot Smith | ) www.cnbc.com time to read: +1 min

Biotechnology firms Novozymes and Chr. Hansen agreed to combine in what will be the biggest-ever merger between two Danish companies. The new biosolutions group will have annual revenues of approximately 3.5 billion euros ($3.7 billion), the companies said. "Novozymes and Chr. Combining the two companies will create a global leader in biosolutions," Novo Holdings Chairman Lars Rebien Sørensen said.

☆ Enzyme makers Novozymes and Chr. Hansen to merge
▼ + stars: | 2022-12-12 | by ( ) www.reuters.com time to read: +2 min

Copenhagen, Dec 12 (Reuters) - Danish food ingredients and enzymes makers Novozymes (NZYMb.CO) and Chr. While both companies' main business is producing enzymes, Chr. Following an extended opening auction at the Copenhagen blue chip index on Monday morning, shares in Novozymes dropped 7.5%, while Chr. Hansen shares jumped more than 33%. Hansen will receive 1.53 new shares in Novozymes, each nominally worth 2 Danish crowns ($0.2830), for every share in Chr.

☆ U.S. FDA grants priority review for Emergent's OTC opioid drug
▼ + stars: | 2022-12-06 | by ( ) www.reuters.com time to read: +1 min

Companies Emergent BioSolutions Inc FollowDec 6 (Reuters) - Contract drugmaker Emergent Biosolutions (EBS.N) on Tuesday said its over-the-counter nasal spray as a treatment for suspected opioid overdose would be reviewed on a priority basis by the U.S. health regulator. Emergent is seeking the U.S. Food and Drug Administration's approval for a prescription-free sale of its nasal spray, Narcan, which is already cleared for the treatment of opioid overdose in the country. If approved following the agency's priority review by March 29, the spray could become the first naloxone-based drug to be sold over the counter. The worsening opioid crisis has prompted U.S. President Joe Biden's administration to develop newer strategies, including the use of naloxone. Reporting by Bhanvi Satija and Khushi Mandowara in Bengaluru; Editing by Anil D'SilvaOur Standards: The Thomson Reuters Trust Principles.

☆ U.S. FDA to review Emergent's OTC opioid overdose drug on priority
▼ + stars: | 2022-12-06 | by ( ) www.reuters.com time to read: +2 min

Dec 6 (Reuters) - Contract drugmaker Emergent Biosolutions (EBS.N) said on Tuesday its over-the-counter nasal spray as a treatment for suspected opioid overdose would be reviewed on a priority basis by the U.S. health regulator. Emergent is seeking the U.S. Food and Drug Administration's approval for a prescription-free sale of its nasal spray, Narcan, which is already cleared for the treatment of opioid overdose in the country. The agency will make its decision by March 29 and its priority review status puts Narcan on track to become the first naloxone-based drug to be sold over the counter, Benchmark analyst Robert Wasserman said. If approved, Narcan could face competition from generic versions of the drug, pressuring margins for Emergent, Cowen analyst Boris Peaker said. Rival Opiant Pharmaceuticals' (OPNT.O) drug nalmafene is also under the FDA's review and could pose additional risk to Narcan sales, as it provides better protection against an opioid overdose, Peaker added.

The Food and Drug Administration is pushing for drugmakers to apply for over-the-counter approval for naloxone, the opioid overdose antidote. Naloxone is only offered as a prescription, though many states have found work-arounds to make the drug easier to get. By making the medication available over the counter, it removes stigma, said Dr. Scott Hadland, an addiction specialist at Mass General for Children in Boston. Nearly 20,000 deaths from overdose, between 1999 and 2020, have been prevented by the self-administering of naloxone, according to the FDA. The FDA noted that over-the-counter naloxone will not divert supplies away from community-based naloxone distribution programs and hospitals.

☆ Сотни жителей Нью-Йорка были привиты просроченной вакциной
▼ + stars: | 2021-06-14 | by ( Mld Media Srl | ) noi.md time to read: +1 min

В Нью-Йорке нескольким сотням жителей вкололи просроченную вакцину от коронавируса, разработанную компаниями Pfizer и BioNTech. Электронные письма с сообщением об инциденте 899 пациентам направил оператор пункта вакцинации на Таймс-сквер Дэвид Савицкий. По его информации, после вакцинации было установлено, что препарат хранился в морозильной камере дольше положенного до его введения времени. Ранее стало известно о возможном браке примерно 70 миллионов доз вакцины от коронавируса Janssen производства американской компании Johnson & Johnson, качество которой проверяет Управление по санитарному надзору за качеством пищевых продуктов и медикаментов США (FDA). Речь идет о вакцине, произведенной на заводе Emergent BioSolutions в городе Балтимор, штат Мэриленд.

Persons: Janssen Johnson, Johnson, Дэвид Савицкий, Савицкий Organizations: Pfizer BioNTech, New York Post, Управление по санитарному надзору за качеством пищевых продуктов и медикаментов Locations: New York, НьюЙорке, США, Балтимор, Мэриленд

☆ В США уничтожат 60 млн доз вакцины J&J
▼ + stars: | 2021-06-12 | by ( ) ehomd.info time to read: 1 min

В США выбросят 60 млн доз вакцины компании Johnson & Johnson. Так, уничтожению подлежит вся партия препарата, сделанная на заводе Emergent BioSolutions в Балтиморе. В то же время, около 10 млн доз с этого завода будет распространено в США или отправлено в другие страны. Как сообщает ведомство, оно предупредит регулирующие органы об отсутствии гарантий, что Emergent BioSolutions следовал надлежащей производственной практике. Судьбу еще 170 млн доз вакцины пока не решили.

Persons: Johnson Organizations: The New York Times, AstraZeneca, tv6 Locations: США, Балтимор

☆ Стало известно о возможном браке 70 миллионов доз вакцины Johnson & Johnson
▼ + stars: | 2021-05-07 | by ( Mld Media Srl | Степанов Георгий | ) noi.md time to read: +1 min

Стало известно о возможном браке примерно 70 миллионов доз вакцины от коронавируса Janssen производства американской компании Johnson & Johnson, качество которой проверяет Управление по санитарному надзору за качеством пищевых продуктов и медикаментов США (FDA). Кроме американской вакцины, там производят препарат британско-шведской фирмы AstraZeneca. Партия Johnson & Johnson была произведена в то же время, что и загрязненная ранее партия. Ранее в апреле регуляторы США решили запретить использование вакцины Johnson & Johnson из-за тромбов у привитых. В начале апреля 15 миллионов доз вакцины Johnson & Johnson оказались испорченными из-за того, что сотрудники завода американской компании в Балтиморе допустили ошибку при смешении компонентов препаратов двух производителей.

Persons: Janssen Johnson, Johnson Organizations: AstraZeneca, Johnson, FDA, Moderna, Pfizer BioNTech, Управление по санитарному надзору за качеством пищевых продуктов и медикаментов, Всемирный конгресс вакцин, Спутник Locations: York, США, Балтимор, Мэриленд

☆ Vaccinul anti-COVID Johnson & Johnson, recomandat în Canada doar persoanelor de peste 30 de ani
▼ + stars: | 2021-05-04 | by ( Publika.Md - Aici Sunt Știrile | ) www.publika.md time to read: +1 min

Comitetul ştiinţific care consiliază Guvernul Canadei în privinţa vaccinării a recomandat ca vaccinul anti-COVID-19 dezvoltat de compania americană Johnson & Johnson să fie utilizat doar pentru persoanele cu vârste de peste 30 de ani, informează AFP, citează Agerpres. În aprilie, Agenţia pentru alimente şi medicamente din Statele Unite a suspendat temporar utilizarea acestui vaccin după apariţia unor cazuri rare de tromboze. Franţa a decis să îl administreze doar persoanelor cu vârste de peste 55 de ani, la fel ca în cazul vaccinului AstraZeneca. Provinciile şi teritoriile din Canada vor putea să adapteze pragul de vârstă pentru administrarea acestui ser în funcţie, mai ales, de stocurile lor de vaccinuri. Grupul Johnson & Johnson se confruntă cu probleme de producţie într-o uzină din Baltimore, oraş din statul american Maryland, administrată de compania Emergent BioSolutions, după ce s-a constatat că un lot de doze cu acest vaccin nu corespundea normelor de calitate.

Persons: Johnson, tromboze . Organizations: americană Johnson, Agerpres, tromboze . Franţa Locations: Canadei, Danemarca, Statele Unite, Canada, Baltimore, american Maryland

☆ Vaccinurile și tromboza: există vreo legătură, cine este în pericol, cum să vă protejați
▼ + stars: | 2021-04-30 | by ( ) www.zdg.md time to read: +10 min

Agenția de Reglementare a Medicamentului și Produselor Medicale din Marea Britanie relatează că dovezile privind o posibilă legătură între vaccinare și tromboză sunt deja mai convingătoare, dar sunt necesare încă cercetări suplimentare. „Trebuie să înțelegem: dacă prima tromboză a fost observată după vaccinarea cu AstraZeneca, aceasta nu înseamnă că acest vaccin este rău. Când au început să fie analizate și alte date, s-a constatat, că au existat cazuri și după vaccinurile de la Johnson & Johnson și Pfizer. Vaccinul de la Johnson & Johnson de asemenea s-a confruntat cu problema trombozei rare. Johnson & Johnson s-a adresat la alți producători de vaccinuri pentru a-și uni forțele în a studia riscurile de tromboze, dar companiile Pfizer și Moderna au refuzat și numai AstraZeneca a fost de acord.

Persons: Johnson & Johnson . Hromadske, Iesilevski, Fiodor Lapiy, Johnson & Johnson, Pfizer, Simion Iesilevski, Johnson, BioSolutions, Jarno, tromboza, Viktor Liashko, Simion Organizations: Johnson &, Agenția, Reglementare, Britanie, Agenția Europeană, Johnson, Drug, FDA, OMS, Pfizer, Ministerul Sănătății, Autorității Europene Locations: Statele Unite, UE, Islanda, Norvegia, Liechtenstein, Danemarca, Austria, Belgia, Polonia, Republica Cehă, Ucraina, India, Baltimore, Oxford, coronavirus, Germania, Olanda, Franța, Ucrainei

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