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Home » Authors » Karen Carey

Karen Carey

Articles

ARTICLES

Bristol Myers Squibb sign

With Bristol Myers’ latest cuts, biopharma layoffs reach 7,800+

April 25, 2024
By Karen Carey
After investing $24 billion in three major acquisitions earlier this year, Bristol Myers Squibb Co. said April 25 it would cut 2,200 employees and discontinue 12 programs in an effort to save $1.5 billion and put the company on track for growth by the end of the decade. The number of jobs lost represent 28% of all biopharma jobs lost so far in 2024 – 7,834, as announced by 82 companies. There were 17,424 jobs lost at 185 companies in 2023 and 18,500 jobs lost at 123 companies in 2022, according to BioWorld data.
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Day One’s Ojemda approved in US for rare pediatric cancer

April 23, 2024
By Karen Carey
Becoming the first type II RAF inhibitor for relapsed or refractory BRAF-altered pediatric low-grade glioma, Day One Biopharmaceuticals Inc.’s Ojemda (tovorafenib, DAY-101) gained U.S. FDA accelerated approval on April 23, a week earlier than its expected PDUFA date, bringing the Brisbane, Calif.-based company a rare pediatric disease priority review voucher.
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Sanofi’s BTK inhibitor hits phase III thrombocytopenia endpoint

April 23, 2024
By Karen Carey
An oral Bruton’s tyrosine kinase (BTK) inhibitor that Sanofi SA acquired in 2020 through its $3.68 billion buyout of Principia Biopharma Inc. is headed toward regulatory filings in the U.S and EU by the end of the year, following phase III data in immune thrombocytopenia.
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Skyhawk, Ipsen in $1.8B deal for RNA splicing modulators

April 22, 2024
By Karen Carey
Skyhawk Therapeutics Inc. signed on to work with Ipsen SA in a neurological disease-focused deal worth potentially $1.8 billion to discover and develop novel small molecules that modulate RNA. The deal is an option agreement for exclusive global rights to two candidates. Once the parties have identified and validated those candidates, Paris-based Ipsen will take on all further development and commercialization.
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Revised 340B dispute resolution process ‘panders’ to hospitals

April 19, 2024
By Karen Carey
The Pharmaceutical Research and Manufacturers of America (PhRMA) is not happy with the Biden administration or the new 340B rule, finalized on April 18 by the U.S. Department of Health and Human Services (HHS), concerning the dispute resolution process put in place in 2020.
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Man sitting on bed holding head

Phase III win for Intra-Cellular's Caplyta for major depressive disorder

April 16, 2024
By Karen Carey
Robust top-line phase III data showed Intra-Cellular Therapies Inc.’s marketed oral atypical antipsychotic drug, Caplyta (lumateperone), achieved statistically significant and clinically meaningful best-in-class results, potentially expanding its reach into the billion-dollar major depressive disorder market. The company’s shares (NASDAQ:ITCI) surged to a 52-week high of $84.89 throughout the day, closing at $79.84, up 23.3%, or $15.08, on April 16.
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Coin stacks, dollar signs and up arrow

Biopharma follow-on boom makes 2024 a top year

April 15, 2024
By Karen Carey
The $27.9 billion raised through biopharma follow-on offerings in the early months of 2024 has hit industry records never seen before. So far in three-and-a-half months in 2024, the industry has raised more than was raised during 21 of the past 24 full years.
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Deal handshake with coin, chart background

Eliem shifts focus to autoimmunity with Tenet Medicines buyout

April 11, 2024
By Karen Carey
Following decisions in 2023 to back away from its lead neurological therapies and conserve cash, Eliem Therapeutics Inc. found a vote of investor confidence and a new direction through its acquisition of privately held Tenet Medicines Inc. and its anti-CD19 antibody for autoimmune disease.
Read More
Vaccine administration

Pfizer expanding RSV vaccine work into younger high-risk adults

April 9, 2024
By Karen Carey
With two respiratory syncytial virus (RSV) vaccines approved by the U.S. FDA in 2023 and a third nearing its May PDUFA date, decades of research has finally provided infants and older adults protection from the disruptive and sometimes deadly virus. But what about people in the middle, particularly those with certain chronic medical conditions? New York-based Pfizer Inc. rolled out phase III data April 9 showing that its approved RSV vaccine, Abrysvo (RSVpreF), met primary endpoints in adults ages 18 to 59 who were at high risk of RSV.
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Staphylococcus aureus

US FDA approves antibiotic Zevtera, Basilea seeks US partner

April 4, 2024
By Karen Carey
In a long and winding regulatory road that began with two complete response letters 15 years ago, Allschwil, Switzerland-based Basilea Pharmaceutica Ltd. finally gained U.S. FDA approval of its intravenous cephalosporin antibiotic, Zevtera (ceftobiprole medocaril sodium), to treat Staphylococcus aureus bacteremia, acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia.
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View All Articles by Karen Carey

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