Pharma
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FDA warns J&J’s Abiomed over quality issues with Impella heart pumps and software
The FDA has taken significant steps in its response to safety concerns surrounding certain Abiomed heart pumps. Following several Class ...
Sotio halts trials of IL-15 drug in solid tumors due to lack of efficacy, casting doubt on cytokine’s potential
Sotio Biotech has decided to halt ongoing studies of its IL-15 superagonist, nanrilkefusp alfa, due to insufficient efficacy in clinical ...
Novo Nordisk raises its 2023 outlook for sales and profit, driven by strong diabetes and obesity drugs
Novo Nordisk is experiencing a remarkable surge in its fortunes, primarily driven by the widespread popularity of its diabetes medication ...
EU regulator denies approval for Amylyx’s Albrioza, a potential ALS treatment
While Amylyx’s ALS drug, known as Albrioza in Europe and Relyvrio in the US, has made significant strides in the ...
Novo’s Ozempic shows promise in kidney disease, but DaVita questions its real-world benefits
Novo Nordisk’s GLP-1 blockbuster Ozempic appears to be making significant strides in the treatment of chronic kidney disease (CKD), potentially ...
Biogen faces renewed legal trouble over Aduhelm as investor lawsuit partially revived by court
For over a year, Biogen has been endeavoring to move past the controversies surrounding its drug Aduhelm and shift its ...
Leo Pharma reveals positive results for its JAK cream in hand eczema, competing with Incyte’s Opzelura
In February, Leo Pharma created a buzz by announcing the success of its JAK-inhibitor cream, delgocitinib, in a phase 3 ...
Eversana Intouch acquires Healthware Group to expand its biopharma services portfolio
Eversana Intouch, a prominent biopharma services company in the United States, is taking a significant step by acquiring its long-standing ...
Lawmakers demand answers from FDA and DEA on Adderall shortage crisis
As the nationwide shortage of medications like Adderall for attention-deficit/hyperactivity disorder (ADHD) continues to persist, a group of Congressional members ...
Pfizer’s Velsipity gets FDA approval to challenge BMS’ Zeposia in ulcerative colitis market
Pfizer’s groundbreaking approval of its drug, Velsipity, as a once-daily oral treatment for adults suffering from moderate to severe active ...
Rexulti ad campaign highlights family bond amid agitation disorder
Lundbeck and Otsuka have taken a softer, more empathetic approach in their initial branded advertisement for Rexulti, targeting dementia-related agitation. ...
Astria buys rights to Ichnos’ eczema drug for $15M, joining crowded field of Amgen and Sanofi
Ichnos Sciences has secured a buyer for its OX40 eczema program, with Astria Therapeutics entering the scene by paying an ...
Incyte launches eczema awareness campaign featuring actor and teen patient on Opzelura
Incyte has introduced a new advertising campaign for Opzelura, featuring the actor and singer Mandy Moore, in an effort to ...
Lilly’s mirikizumab shows promise in Crohn’s disease after failing in psoriasis
After a previous setback when the FDA withheld approval for mirikizumab in ulcerative colitis due to manufacturing issues, Eli Lilly’s ...
Dermavant plans to file Vtama for FDA approval after positive results in itchy skin condition
Dermavant is advancing in the race to develop nonsteroidal topical treatments for autoimmune skin conditions, building on its FDA approval ...
Pfizer agrees to pay $50M to settle EpiPen price-fixing lawsuit
Pfizer has agreed to a $50 million settlement to resolve a class-action antitrust case dating back to 2020. The lawsuit, ...
Teva and Alvotech face FDA rejection for Stelara biosimilar after Humira setbacks
Ongoing issues at the Alvotech manufacturing facility in Reykjavik have led to yet another FDA rejection, this time affecting the ...
AstraZeneca’s Tagrisso dominates lung cancer market with projected $7B sales by 2025
The lung cancer drug market has been notably dominated by antibodies and immunotherapies, but a recent report from GlobalData suggests ...
Pfizer gets FDA nod for Lorbrena-Vizimpro combo to treat advanced lung cancer
Pfizer is making strategic moves to reinforce its presence in the oncology arena, with the FDA granting approval for its ...
Biogen cuts jobs at Reata after $2.95 billion deal for kidney drug rights
A mere fortnight after the completion of Biogen’s acquisition of Reata Pharmaceuticals, the newly merged entity is taking a scalpel ...
Akero fails to meet NASH trial endpoint, hurting other players in the field
The landscape of Nonalcoholic Steatohepatitis (NASH) appeared promising with Madrigal Therapeutics taking steps toward treatment approval. However, this optimism was ...
FDA warns companies selling unauthorized obesity drugs similar to Wegovy and Mounjaro
The soaring demand for new anti-obesity medications has led to a concerning trend, with various online companies attempting to sell ...
Mallinckrodt gets court approval for second bankruptcy, reducing opioid settlement by $1B
Mallinckrodt’s commitment to pay a hefty $1.7 billion opioid settlement has taken a significant hit due to the company’s second ...
Semaglutide’s Remarkable Success in Kidney Disease Trial Prompts Early Completion
In a recent development surrounding the study of injectable semaglutide’s efficacy in chronic kidney disease, Novo Nordisk has found reason ...
Haemonetics buys OpSens for $253M, a maker of smart TAVR guidewires
Boston-based medical device manufacturer Haemonetics is continuing its focus on expanding its portfolio of interventional cardiology devices with a strategic ...
Sana slashes staff and drops in vivo CAR-T program to cut costs
Sana Biotechnology, amid challenging stock performance, is undergoing its second significant restructuring in less than a year. This move involves ...
Kanvas Bio emerges from Federation’s demise with clinical-stage assets
In a strategic move, Kanvas Biosciences has seized the opportunity to acquire key assets from Federation Bio, a biotech company, ...
Agomab raises $100M to advance its Crohn’s disease drug candidate
Agomab Therapeutics, in a remarkable stride forward, has secured an impressive $100 million in series C financing, just one week ...
BMS invests more in Cellares to boost cell therapy manufacturing
Just six weeks following the initial announcement of a partnership between cell and gene therapy manufacturer Cellares and Bristol Myers ...