Merck strikes early licensing deals for experimental HIV pill in developing world
Merck (MRK) has signed voluntary licensing agreements with seven generic drug manufacturers to produce and sell lower-cost versions of its experimental once-monthly oral HIV pill, alimatravir, across 129 low- and lower-middle-income countries — an unusually early move that comes while the drug is still in late-stage clinical development.
Number of confirmed Ebola cases rises to 3,200, including 1,405 deaths, Congo says
According to government data, the number of confirmed Ebola cases in the Democratic Republic of Congo has increased to 3,200, including 1,405 deaths.
AstraZeneca's Ultomiris Fails Late-Stage Trial in Rare Transplant Complication
AstraZeneca (AZN) said that its rare disease therapy Ultomiris failed to meet its primary endpoint in a late-stage trial enrolling adults with a serious blood vessel complication that can arise following stem cell transplants, adding to a string of clinical setbacks that have raised questions about the company's trial design capabilities.
Cipla posts third straight quarterly profit decline, names veteran Dinesh Jain as CFO
India's Cipla (CIPL) posted a bigger-than-expected fall in first-quarter profit, logging its third consecutive quarterly decline as muted sales of a generic cancer drug and US supply disruptions tied to tumor treatment lanreotide weighed on results.
Novo Nordisk seeks court order to halt Eli Lilly obesity drug ads
Novo Nordisk (NVO) said it is seeking a preliminary US court injunction to immediately block obesity and diabetes drug advertisements by Eli Lilly (LLY), escalating a legal battle between the two dominant players in the lucrative weight-loss drug market.
Amgen submits real-world patient data in bid to save Tavneos from FDA withdrawal
Amgen (AMGN) said it had submitted new evidence to the Food and Drug Administration as it seeks a formal hearing to challenge the proposed withdrawal of Tavneos, its treatment for a rare autoimmune condition that damages blood vessels, from the U.S. market.
West Pharma lifts profit outlook as GLP-1 drug boom drives injectable components demand
West Pharmaceutical Services (WST) raised its annual profit and revenue forecasts after strong demand for components used in injectable drugs — including treatments for diabetes and obesity — helped the company beat second-quarter estimates, sending its shares up nearly 6 percent in morning trading.
BridgeBio wins FDA filing acceptance for rare calcium disorder drug
BridgeBio Pharma (BBIO) said the US Food and Drug Administration has accepted its New Drug Application for encaleret, an oral therapy for autosomal dominant hypocalcemia type 1, with a target action date of May 8, 2027.
Argenx to acquire Forte Biosciences for $2.2bn in autoimmune push
Argenx (ARGX) has agreed to acquire Forte Biosciences (FBRX) for approximately $2.2 billion, adding the experimental autoimmune therapy FB102 to its portfolio.
Roche launches prevention trial for Alzheimer's antibody in race with Lilly
Roche (RHHBY) has unveiled plans for a pivotal trial of its experimental Alzheimer's antibody, seeking to demonstrate it can prevent symptoms from developing as the Swiss drugmaker races Eli Lilly (LLY) and Japan's Eisai (ESAIY) to push the disease's treatment frontier from therapy into prevention.
AstraZeneca licenses Chinese lung cancer drug in $600mn upfront deal
AstraZeneca (AZN) has agreed to pay $600 million upfront to license a lung cancer treatment from China's Dizal Pharmaceutical (688192.SS), sending shares in the Shanghai-listed spinoff surging 20 percent.
Biogen's anti-tau Alzheimer's drug shows mixed but encouraging results in mid-stage trial
Biogen (BIIB) said that the lowest dose of its experimental Alzheimer's drug diranersen reduced cognitive decline across five of six standard assessment tools and cut levels of a toxic brain protein by up to 65%, even as the treatment missed its primary goal in a mid-stage clinical trial.
Insulet partners with Calm to address mental health burden of diabetes management
Insulet (PODD), the maker of the Omnipod wearable insulin patch, has teamed up with mental health app Calm to launch a suite of free mindfulness resources tailored specifically to people living with diabetes, in what the companies describe as Calm's first integrated content partnership with a medical device manufacturer.
Taco Bell removes menu items amid widening US cyclosporiasis outbreak
Yum Brands (YUM) said that its Taco Bell chain had pulled a limited number of items from select restaurant locations as a precautionary measure, even as US health officials stopped short of linking the fast-food chain to a widening outbreak of cyclosporiasis that has now spread across 34 states.
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