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☆ Moderna to scale down manufacturing of COVID vaccine
▼ + stars: | 2023-09-13 | by ( Patrick Wingrove | ) www.reuters.com time to read: +3 min

The downsizing, Hoge added, will help Moderna adjust to the endemic phase of the disease, which had led to falling demand for COVID vaccines as payers scale back orders for the shots. Moderna predicted in August that U.S. demand for the vaccine would reach 50 to 100 million doses in the fall season. Following the U.S. Food and Drug Administration's authorization on Monday, Moderna said it would start shipping COVID vaccine doses across the United States. The effectiveness of Moderna's flu vaccine was demonstrated across all age groups, including older patients, and was found to be safe and tolerable, according to the company. Moderna also said it had found that its shot was equal or superior to Sanofi's high-dose flu vaccine in a separate early head-to-head study.

Persons: Stephen Hoge, Hoge, Moderna, we've, We've, COVID, Patrick Wingrove, Bhanvi, Will Dunham Organizations: Moderna, Sanofi, Wednesday, U.S . Centers for Disease Control, U.S . Food, Thomson Locations: Moderna, Massachusetts, United States, Britain, Canada, Japan, China, New York, Bengaluru

A general view of the drug product manufacturing laboratory in biologics and sterile injectables, Catalent, in Brussels, Belgium June 27, 2023. Catalent named three pharma industry executives and a senior Elliott executive to its board and said John Greisch, who has served on the board since 2018, will become executive chairman. Elliott, whose stake in Catalent became public last month, has been engaging with the company behind the scenes for months. Two of the directors were picked by Elliott, while two were mutually agreed by Elliott and Catalent. Catalent is also forming a new strategic and operational review committee which Greisch will chair.

Persons: Yves Herman, Elliott, Catalent, Alessandro Maselli, John Greisch, Max, William Blair, Maselli, Steven Barg, Goldman Sachs, Frank D'Amelio, Stephanie Okey, Michelle Ryan, Greisch, Merck KGaA, Svea Herbst, Bayliss, Maggie Fick, Sriparna Roy, Shinjini Ganguli, Catherine Evans, Mike Harrison Organizations: REUTERS, Catalent Inc, Elliott Investment Management, Reuters, Novo, pharma, U.S . Food, Drug Administration, Pfizer, Johnson, Catalent, Svea, Thomson Locations: Brussels, Belgium, ., Danish, Novo, United States, Catalent, GLP, Boston, London, Bengaluru

A general view of the drug product manufacturing laboratory in biologics and sterile injectables, Catalent, in Brussels, Belgium June 27, 2023. The sources declined to be identified because the information is confidential and cautioned a deal could still collapse at the last minute. Spokespeople for Catalent and Elliott declined to comment. In the past when Elliott has pushed for sales of pieces or the entire target company, including at eBay and Switch Inc., and then won board representation, significant ownership changes have followed. Novo Nordisk's weight-loss drug Wegovy is filled by Catalent’s Brussels factory and last week Reuters reported that Catalent’s plant in Bloomington, Indiana will begin filling Wegovy injection pens for Novo.

Persons: Yves Herman Acquire, Elliott, Catalent, Elliott isn't, Keith Meister's, Scott Ferguson's, Mauricio Gutierrez, Svea Herbst, Bayliss, Maggie Fick, Shri Navaratnam Organizations: REUTERS, Catalent, Elliott Investment Management, AstraZeneca, Johnson, Moderna, eBay, Inc, Deutsche Bank, Management, Capital Management, Reuters, NRG, Svea, Thomson Locations: Brussels, Belgium, U.S, Bloomington , Indiana, Novo, Boston, London

A general view of the drug product manufacturing laboratory in biologics and sterile injectables, Catalent, in Brussels, Belgium June 27, 2023. Spokespeople for Catalent and Elliott declined to comment. The U.S.-based contract drugmaker is also Danish company Novo Nordisk's (NOVOb.CO) main manufacturing partner for its popular weight-loss drug Wegovy. The volatility at Catalent could increase scrutiny on the relationship between Novo and its partner. Reuters reported last week that a second Catalent factory will begin filling Wegovy injection pens for Novo as part of an expanded supply agreement.

Persons: Yves Herman Acquire, Elliott, drugmaker, Markus Manns, Catalent, Elliott isn't, Keith Meister's, Scott Ferguson's, Mauricio Gutierrez, Svea Herbst, Bayliss, Maggie Fick, Amanda Cooper, Shri Navaratnam, Bernadette Baum, Catherine Evans Organizations: REUTERS, Elliott Investment Management, Catalent, Novo, Reuters, Union Investment, AstraZeneca, Johnson, Moderna, eBay, Inc, Deutsche Bank, Management, Capital Management, NRG, Svea, Thomson Locations: Brussels, Belgium, U.S, Danish, Novo, United States, Germany, Boston, London

☆ 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

☆ 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

NEW YORK, July 12 (Reuters) - Morgan Stanley (MS.N) has hired veteran investment banker Daniel Cohen from Truist Financial Corp (TFC.N), where he was the head of the firm's healthcare services advisory business, a person familiar with the matter said on Wednesday. In his new role, Cohen will continue to focus on dealmaking in the pharmaceutical services sector, the person said, requesting anonymity because the move is not yet public. Morgan Stanley declined to comment. Cohen's hire comes after veteran pharmaceutical industry bankers Arek Kurkciyan and Dennis Crandall left Morgan Stanley last year to join Moelis & Co (MC.N). Cohen spent just over one year at Truist, where he served as the head of pharmaceutical services investment banking and healthcare sponsor coverage, before being elevated as the head of the healthcare services unit, according to his LinkedIn profile.

Persons: Morgan Stanley, Daniel Cohen, Cohen, Arek Kurkciyan, Dennis Crandall, Morgan Stanley's, John Collins, Tom Miles, Brian Healy, Healy, David Carnevali, Svea, Bayliss, Emma Rumney Organizations: YORK, Truist Financial Corp, LinkedIn, Moelis, RBC Capital Markets, Oppenheimer Holdings Inc, JPMorgan Chase &, Catalent Inc, Svea Herbst, Thomson Locations: Truist, Americas, New York

☆ Catalent posts bigger-than-expected loss as production snags persist
▼ + stars: | 2023-06-12 | by ( ) www.reuters.com time to read: +1 min

Companies Catalent Inc FollowJune 12 (Reuters) - Catalent Inc (CTLT.N) on Monday posted a bigger-than-expected loss for the third quarter and cut its annual forecast for a second time, hurt by persistent production challenges at the contract drug manufacturer's major facilities. The company will also amend its annual filing for 2022 to reflect a $26 million deduction caused by a revenue recognition error. Catalent had delayed its quarterly results report thrice in less than a month, pending the adjustments needed on historical financial statements related to its Bloomington operations. In May, Catalent said production snags at three of its facilities - Maryland, Indiana and Brussels - had driven up costs and also contributed to the delay in reporting results. Catalent is yet to provide details of what was behind the production issues.

Persons: Catalent, Bhanvi Satija, Sriparna Roy, Devika Organizations: Catalent, Thomson Locations: Bloomington, Maryland , Indiana, Brussels, Bengaluru

Catalent, one of the top contract manufacturers for pharmaceutical companies, said a drop in revenue from COVID vaccine manufacturing had coincided with higher-than-expected costs and production challenges at its facilities in Indiana and in Brussels. Adding to woes, its cost-cutting plans have been delayed due to regulatory inspections and subsequent corrective actions, the company said. Despite Friday's gain in shares, Catalent's stock is down 19% since it first disclosed production challenges at its three major production plants in April. Catalent cut its full-year revenue to a range of $4.25 billion to $4.35 billion, from its prior forecast of $4.63 billion to $4.88 billion. It also slashed its annual adjusted net income forecast to between $187 million and $228 million, from between $567 million and $648 million previously.

☆ Catalent cuts annual forecast hurt by operational challenges
▼ + stars: | 2023-05-19 | by ( ) www.reuters.com time to read: +2 min

May 19 (Reuters) - Catalent Inc (CTLT.N) cut its full-year net revenue and profit forecast on Friday, reflecting operational challenges and higher-than-expected costs after it flagged an over $400 million hit to both its annual sales and core profit forecasts earlier this month. The contract drug manufacturer now sees its full-year revenue in the range of $4.25 billion to $4.35 billion compared with its prior forecast of $4.63 billion to $4.88 billion. Catalent said it now sees adjusted net income for the year in the range of $187 million to $228 million, compared with the previous forecast of $567 million to $648 million. Shares of Catalent reversed losses to be up 7.7% at $34.63 before the bell. Reporting by Bhanvi Satija, Sriparna Roy and Pratik Jain in Bengaluru; Editing by Krishna Chandra EluriOur Standards: The Thomson Reuters Trust Principles.

For most of the day, stocks struggled for direction amid disappointing earnings from Tyson Foods and Catalent and a short-lived rebound in regional banks. The struggle for a clearer direction comes after a rally on Friday, when U.S. jobs data pointed to a resilient labor market. Producer prices, weekly jobless claims and consumer sentiment data are all lined up for the week. Shares of regional banks tumbled for much of last week on worries tied to the collapse of First Republic Bank. Warren Buffett's Berkshire Hathaway Inc's Class B shares rose after posting a $35.5 billion first-quarter profit, boosted by gains from stocks such as Apple.

The struggle for a clearer direction comes after a rally on Friday, when U.S. jobs data pointed to a resilient labor market. Producer prices, weekly jobless claims and consumer sentiment data are all lined up for the week. A rally in regional banks' shares proved short-lived, with PacWest Bancorp (PACW.O) rising 5.6% after gaining as much as about 30% earlier in the session after the lender sharply cut its quarterly dividend to boost capital. Shares of regional banks tumbled for much of last week on worries tied to the collapse of First Republic Bank. Warren Buffett's Berkshire Hathaway Inc's Class B shares rose 0.9% after posting a $35.5 billion first-quarter profit, boosted by gains from stocks such as Apple.

Producer prices, weekly jobless claims and consumer sentiment data are all lined up through the week. "The bigger picture is inflation will remain higher for longer and that we are heading into a recession. The KBW Regional Banking index (.KRX) fell 2.2% after posting its best single-day performance in seven weeks on Friday. Shares of regional banks tumbled for much of last week on worries tied to the collapse of First Republic Bank. The S&P index recorded 10 new 52-week highs and four new lows, while the Nasdaq recorded 47 new highs and 53 new lows.

☆ Catalent shares tank on warning of $400 mln cut to annual revenue forecast
▼ + stars: | 2023-05-08 | by ( ) www.reuters.com time to read: +2 min

May 8 (Reuters) - Catalent Inc (CTLT.N) expects to cut by more than $400 million both its full-year revenue and core profit forecasts, the contract drug manufacturer said on Monday, sending its shares tumbling 27% to a three-year low. In April, Catalent had flagged productivity issues and warned that a slower-than-expected ramp up in production capacity would hit quarterly results. Catalent had been the sole contract manufacturer for Novo Nordisk's (NOVOb.CO) weight-loss drug Wegovy, but the Danish company last month unveiled a second contract manufacturer to help meet sky-rocketing demand. Catalent in February forecast full-year net revenue of $4.63 billion to $4.88 billion and adjusted earnings before interest, taxes, depreciation, and amortization (EBITDA) of $1.22 billion to $1.30 billion. Reporting by Sriparna Roy in Bengaluru; Editing by Savio D'SouzaOur Standards: The Thomson Reuters Trust Principles.

On the other end, regional banks' shares stretched gains from a rebound on Friday, with PacWest Bancorp (PACW.O) jumping 19.9% after the lender sharply cut its quarterly dividend to boost capital. Shares of such banks tumbled for much of last week on worries tied to the collapse of First Republic Bank. "We're in an information vacuum right now, waiting for the next inflation data. Warren Buffett's Berkshire Hathaway Inc's Class B shares rose 1.2% after posting a $35.5 billion first-quarter profit, reflecting gains from stocks such as Apple. The S&P index recorded seven new 52-week highs and two new lows, while the Nasdaq recorded 31 new highs and 23 new lows.

☆ Catalent flags problems at its manufacturing plants; CFO departs
▼ + stars: | 2023-04-14 | by ( ) www.reuters.com time to read: +1 min

The company's clients have included COVID-19 vaccine makers such as Moderna Inc (MRNA.O) and Johnson & Johnson (JNJ.N). Catalent said it experienced "productivity issues" at its gene therapy manufacturing site in Harmans, Maryland, and faced similar issues at its drug product and drug substance manufacturing facilities in Bloomington, Indiana and Brussels, Belgium. The issues would impact financial results for the third quarter and Catalent's forecast for the remainder of fiscal 2023, the company said. Catalent named company insider Ricky Hopson as interim CFO and said it had launched the search for a permanent finance chief. The company's shares were trading at $50.77 before the bell.

☆ Sarepta drops as report says FDA almost rejected under-review gene therapy
▼ + stars: | 2023-04-13 | by ( ) www.reuters.com time to read: +1 min

April 13 (Reuters) - Sarepta Therapeutics Inc's shares (SRPT.O) fell more than 6% on Thursday as Stat News reported that the U.S. health regulator's staff were inclined to reject the company's gene therapy which is currently under review. Some staff at the U.S. Food and Drug Administration (FDA) had reached a "non-binding conclusion" that Sarepta's gene therapy should not be given approval, prompting FDA official Peter Marks to intervene and instead schedule an advisory meeting on May 12, Stat News reported, citing sources. The company is seeking approval for its gene therapy for treating a rare muscle-wasting disorder called Duchenne muscular dystrophy under the FDA's accelerated pathway. Brokerage William Blair said it still sees a "likely" approval for the therapy. Shares of Catalent Inc (CTLT.N), which holds the contract manufacturing rights for the therapy, fell as much as 5.5% in early trade.

☆ Deutsche Bank sees more than a 30% rally for this specialty biotech stock
▼ + stars: | 2023-04-10 | by ( Brian Evans | ) www.cnbc.com time to read: +3 min

Deutsche Bank is more bullish on Catalent after the New Jersey-based company expanded its manufacturing partnership with Moderna . Catalent shares were upgraded to buy from hold on Monday, with a price target of $88 per share, Deutsche Bank said. CTLT YTD mountain Catalent received an upgrade from Deutsche Bank on Monday from hold to buy with a price target of $88 per share. Catalent shares were upgraded to buy from hold on Monday, with a price target of $88 per share, Deutsche Bank said. Stock Chart Icon Stock chart icon Catalent received an upgrade from Deutsche Bank on Monday from hold to buy with a price target of $88 per share.

☆ Danaher interested in buying life sciences firm Catalent, Bloomberg reports
▼ + stars: | 2023-02-04 | by ( ) www.reuters.com time to read: 1 min

Feb 4 (Reuters) - Medical equipment maker Danaher Corp (DHR.N) has expressed interest in taking over contract drugmaker Catalent Inc (CTLT.N), Bloomberg News reported on Saturday, citing people familiar with the matter. Danaher's approach to Catalent values it at a significant premium, the report said, adding that unclear how Catalent will proceed or whether it is receptive to a takeover offer. Both Danaher and Catalent did not immediately respond to a Reuters request for comment on the report. Danaher, which currently has a market capitalization of about $197 billion, bought privately-held biotech company Aldevron in an all-cash deal for about $9.6 billion in June 2021. Reporting by Juby Babu in Bengaluru Editing by Marguerita ChoyOur Standards: The Thomson Reuters Trust Principles.

☆ J&J Slashes Production of Its Unpopular Covid-19 Shot
▼ + stars: | 2023-01-13 | by ( Jared S. Hopkins | Peter Loftus | ) www.wsj.com time to read: 1 min

After mobilizing to quickly develop and manufacture a Covid-19 vaccine, Johnson & Johnson has vastly scaled back its efforts in producing the shots as it faces slumping demand. The New Brunswick, N.J., pharmaceutical company in recent months terminated manufacturing agreements with companies that helped produce the shot during the pandemic such as Catalent Inc. and Sanofi SA.

☆ U.S. FDA clears additional lots of Moderna's Covid booster amid shortage
▼ + stars: | 2022-09-26 | by ( ) www.reuters.com time to read: +1 min

A healthcare worker holds a vial of the Moderna COVID-19 Vaccine at a pop-up vaccination site operated by SOMOS Community Care during the coronavirus disease (COVID-19) pandemic in Manhattan in New York City, New York, U.S., January 29, 2021. REUTERS/Mike Segar/File PhotoSept 26 (Reuters) - The U.S. Food and Drug Administration said on Monday it has authorized an additional five batches of Moderna Inc's (MRNA.O) updated Covid booster shots made at a Catalent facility in Indiana, after it deemed them safe for use. Last week, the health regulator had allowed use of ten batches of Moderna's updated booster shots made at the Bloomington, Indiana facility, owned by a unit of Catalent Inc (CTLT.N), which is currently not a part of the company's emergency use authorization. The FDA had earlier said Moderna had requested authorization for additional batches in light of the current supply issues. The U.S. government, which has sent out over 25 million of the COVID-19 booster shots targeting BA.4 and BA.5 subvariants of Omicron, has ordered more than 170 million updated shots for this fall, in preparation for a broad revaccination campaign.

☆ U.S. rollout of new COVID boosters off to slow start
▼ + stars: | 2022-09-23 | by ( ) www.reuters.com time to read: +3 min

A nurse fills up syringes with the coronavirus disease (COVID-19) vaccines for residents who are over 50 years old and immunocompromised and are eligible to receive their second booster shots in Waterford, Michigan, U.S., April 8, 2022. The government said earlier this week it has shipped 25 million of the Omicron-tailored shots, mostly from Pfizer (PFE.N)/BioNTech (22UAy.DE). Last year, when the United States initially authorized COVID boosters just for older and immunocompromised people, nearly 10 million received their third shot in the first three weeks. The updated shots target the widely circulating BA.4 and BA.5 Omicron subvariants as well as the original version of the coronavirus included in all previous COVID vaccines. Moderna had been producing new boosters aimed at the older BA.1 Omicron subvariant when the FDA asked them to change course to address the currently dominant variants for the U.S. market.

☆ В США по ошибке испортили 15 млн доз вакцины Johnson & Johnson
▼ + stars: | 2021-04-01 | by ( ) nokta.md time to read: +2 min

В США ошибка сотрудников завода компании Johnson & Johnson привела к потере 15 миллионов доз вакцин от коронавируса, сообщает nytimes. Управляющая комания завода Emergent BioSolutions — производственный партнер как Johnson & Johnson, так и британо-шведской AstraZeneca. В качестве вектора они используют аденовирус, только Johnson & Johnson — ослабленный аденовирус простуды Ad26а, а AstraZeneca — модифицированный аденовирус шимпанзе. До сих все вакцины Johnson & Johnson, полученные американскими пациентами, поступали в США с производства в Нидерландах. Под вопросом и судьба новых однокомпонентных вакцин от Johnson & Johnson.

Persons: Johnson, — Johnson, Johnson — Ad26, nokta, Джо Байден Organizations: AstraZeneca, AstraZeneca —, Pfizer Inc, Moderna Inc, Управление Locations: Catalent’s Bloomington, США, Балтимор, Нидерландах, Блумингтон, Индиана

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