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Amicus execs get back up smiling after being scuffed again by latest setback
3 years ago
FDA+
Changes afoot at GSK; The first victim of IRA?; As work halts, families behind gene therapy seek control; and more
3 years ago
Weekly
Citing too many data confounders, FDA adcomm unanimously votes against Y-mAbs' drug for rare brain cancer
3 years ago
Pharma
FDA+
Paul Hudson predicts delayed impact on Sanofi from Biden's IRA, as Dupixent beats last quarter's sales
3 years ago
Pharma
Updated: A shortage of amoxicillin is now being reported by several manufacturers
3 years ago
Pharma
Manufacturing
EMA limits use of JAK inhibitors for at-risk groups in wake of safety concerns
3 years ago
Pharma
FDA+
AbbVie preps for an onslaught of Humira biosimilars in 2023, with Skyrizi and Rinvoq to fill the gap for now
3 years ago
Pharma
Gilead finds 'critical holes' in the government's HIV patent case against it
3 years ago
Pharma
Law
FDA loosens marketing rules for authorized Covid drugs, but will it move the needle?
3 years ago
Pharma
Marketing
Curia breaks ground on $100M expansion project in New Mexico
3 years ago
Pharma
Manufacturing
NIH to study Pfizer's Paxlovid in long Covid as demand — and infections — continue to fall
3 years ago
Coronavirus
In final pivot from cancer to rare disease, Agios offloads its share of Tibsovo royalties for $131M
3 years ago
Deals
After months of back and forth, Mereo and its biggest stockholder reach truce, replace board members
3 years ago
People
Pharma
Penny stock forges ahead with an NDA for Duchenne treatment, seeking priority review
3 years ago
R&D
FDA+
Taking on Big Pharma rivals, biotech startup unveils first-in-human data on ROS1 drug
3 years ago
R&D
Blackstone invests $50M in PTC, lines up $1B loan to support dealmaking
3 years ago
Financing
As 'lower than projected' data send it back to the drawing board, Sanofi takes $1.6B hit on IL-2
3 years ago
R&D
Pharma
Two Aurinia execs are out — and CRISPR’s operations chief isn't far behind; Biogen MS leader jumps to Eli Lilly ...
3 years ago
Peer Review
Seagen touts progress for Padcev and Tukysa as it continues CEO search
3 years ago
Pharma
Gilead's $1.7B hep D drug just ran into a roadblock at the FDA
3 years ago
Pharma
FDA+
Bristol Myers expands cancer survivor campaign with actor and spokesperson Sterling K. Brown
3 years ago
Pharma
Marketing
FDA raises efficacy concerns with Y-mAbs' potential therapy for pediatric neuroblastoma ahead of ODAC meeting
3 years ago
R&D
FDA+
Merck CEO Rob Davis has business development on the brain as he builds 'pipeline of the future'
3 years ago
Pharma
In next step of opioid saga, McKinsey reaches proposed agreement with school districts and local governments
3 years ago
Pharma
Law
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