BridgeBio Shares Hit 52-Week High as AstraZeneca Trial Failure Boosts Rival Drug's Prospects
Shares of BridgeBio Pharma (BBIO) surged to a 52-week intraday high of $93.42 earlier in the month before closing the session 15% higher, adding roughly $2.3 billion in market value, after AstraZeneca (AZN) disclosed a late-stage clinical failure that investors believe strengthens BridgeBio's position in the market for a rare heart condition.
FDA Approves Celcuity's Gedatolisib for Advanced Breast Cancer in First Commercial Win
The US Food and Drug Administration has approved gedatolisib, the first drug to reach market for Minneapolis-based Celcuity (CELC), granting the green light for a treatment targeting an advanced form of breast cancer in which existing options remain limited.
FDA Sued Over Policy Allowing Unauthorized Vaping Products to Remain on Sale
A coalition of public health organizations, pediatricians and parents filed suit against the U.S. Food and Drug Administration on Tuesday, challenging a policy they say allows vape manufacturers to sell products without the marketing authorization required under federal law.
GSK to Seek FDA Approval for Jemperli in Rectal Cancer After Phase 2 Success
GSK (GSK) said it plans to seek U.S. regulatory approval for its cancer immunotherapy Jemperli in a select group of rectal cancer patients, after the drug met the primary goal of a phase 2 clinical trial in what the company described as a potentially transformative advance for the indication.
Congo begins trial of Gilead's ($GILD) experimental antiviral for Ebola Bundibugyo
Researchers in the Democratic Republic of Congo have started enrolling participants in a trial testing antiviral.
FDA approves Vertex's Casgevy for children as young as 2, opening door to thousands more patients
Vertex Pharmaceuticals has won expanded FDA approval for gene therapy Casgevy
BridgeBio ($BBIO) touted kidney-protective data for Attruby, differentiating it from ATTR-CM rivals
A posthoc analysis of BridgeBio's Attruby found sustained, placebo-adjusted improvements in kidney function markers through 30 months in patients with transthyretin amyloidosis cardiomyopathy, following an initial reversible dip in eGFR after treatment start.
Lonza ($LONZ.S) expanded ADC manufacturing capacity and broadened partnership with unnamed US drugmaker
Lonza is boosting payload-linker manufacturing capacity at its Visp, Switzerland site to meet rising demand for antibody-drug conjugates (ADCs), adding new commercial-scale capabilities expected to come online in 2028.
AstraZeneca ($AZN.L) signed $1.77bn kidney disease drug discovery deal with CSPC
AstraZeneca has signed a collaboration worth up to $1.77 billion with CSPC Pharmaceutical Group to discover and develop experimental medicines for kidney diseases.
BridgeBio Pharma ($BBIO) climbed 75% in a year as pipeline optimism fueled investor confidence
BridgeBio Pharma ($BBIO) shares have risen around 75% over the past year.
Ares Management ($ARES) portfolio company Aspen Group abandoned WellNow sale as debt pressure mounted
The Aspen Group has dropped plans to sell its urgent care chain WellNow, stepping back from a process that lenders had expected could generate up to $300 million to help reduce the company's debt burden.
Amgen ($AMGN) won court order blocking Colorado's Enbrel price cap
Novartis $NOVN has agreed to pay up to $1.5 billion for U.K.-based biotechnology firm Myricx Bio in a deal expected to close in the second half of 2026.
Novartis ($NOVN.S) agreed $1.5bn acquisition of UK biotech Myricx Bio
Novartis agreed to acquire UK-based biotech Myricx Bio for up to $1.5 billion, expanding its oncology pipeline through antibody-drug conjugate (ADC) technology.
Scottish women launch legal action against Pfizer over contraceptive injection linked to brain tumors
A former nurse who has been diagnosed with three brain tumors believes they were caused by the contraceptive injection she used for more than two decades, in a case that forms part of an emerging legal challenge against Pfizer (PFE).
Viridian wins FDA approval for thyroid eye disease drug, setting up clash with Amgen
Viridian Therapeutics (VRDN) has secured US regulatory approval for Lumvoa to treat thyroid eye disease, opening a competitive front against Amgen's (AMGN) blockbuster Tepezza, until now the only medicine available for the painful, eye-bulging autoimmune disorder.
FDA rejects Sobi's gout drug over manufacturing concerns, leaving Amgen's Krystexxa unchallenged
Sobi's (SOBI) attempt to bring a rival to Amgen's (AMGN) blockbuster gout treatment Krystexxa to market has been delayed after the US Food and Drug Administration declined to approve the Swedish company's drug.
NEJM retracts study behind Amgen's Tavneos approval after FDA finds altered data
The New England Journal of Medicine has retracted an article on the pivotal clinical trial that underpinned the approval of Tavneos, a rare-disease drug made by Amgen (AMGN), after US regulators found evidence that patient outcome data had been altered.
Brussels opens formal antitrust case against Sanofi over flu vaccine marketing
The European Commission has opened formal proceedings in an antitrust investigation into Sanofi (SNY), nine months after conducting unannounced inspections of the French drugmaker's offices in France and Germany. The probe centers on Sanofi's marketing of its flu vaccine for at-risk seniors, Efluelda, and whether the campaign disparaged its only rival in the indication, Fluad, made by CSL (CSLLY) unit Seqirus.
H.C. Wainwright trims Alnylam price target despite bullish long-term RNAi outlook
H.C. Wainwright has lowered its price target on Alnylam Pharmaceuticals (ALNY) to $470 from $510, while maintaining a Buy rating on the stock. The revision reflected adjusted near-term estimates for AMVUTTRA, the company's RNA interference therapy, to align with management's guidance for continued net price normalization as the business scales.
Pfizer and Innovent GLP-1 drugs clear preliminary hurdle for China insurance list
GLP-1 drugs from Pfizer (PFE) and Innovent Biologics (1801.HK) have passed a preliminary review for potential inclusion in China's basic medical insurance drug catalogue, according to a list published by the National Healthcare Security Administration, a step that could pave the way for lower treatment prices.