Bayer wins MHRA approval for Kerendia in heart failure
PharmaTimes
New authorisation offers additional option for patients with lvef 40%
Oricell closes a ‘pre-IPO’ megaround to aim CAR-T at solid tumors
BioPharma Dive
The Shanghai-based biotech has a cell therapy that, if successful in testing, could become the first treatment of its kind for liver cancer.
RFK Jr. rewrites ACIP rules; Gilead, Roche dig into protein degraders
BioPharma Dive
The newly published charter widens the required expertise to become an ACIP member and stresses vaccine safety.
With oral obesity race underway, all eyes are on Lilly’s Foundayo launch
BioSpace
Novo Nordisk’s oral Wegovy has a few months’ head start on Eli Lilly’s newly approved pill.
Senju launches first-in-class dry eye disease drug in Japan
Pharmaphorum
Senju has launched a new drug for dry eye disease (DED) in Japan, Avarept, the first drug in the TRPV1 antagonist class to reach the market.
GSK again pulls application for leucovorin, touted by FDA as potential autism treatment
BioSpace
GSK discontinued Wellcovorin in 1999, but the FDA in September last year asked the pharma to refile an application, pointing to its potential to…
Roche places a $1bn bet on C4T degrader-antibody conjugates
Pharmaphorum
Roche is paying $20 million upfront to secure rights to two degrader-antibody conjugates (DACs) for cancer developed by longtime partner C4T.
Roche and C4 Therapeutics to advance degrader-antibody conjugates research
Pharmaceutical Technology
Roche has signed a new collaboration deal with C4 Therapeutics to jointly advance DACs research to introduce a new therapeutic modality for cancer.
Gan & Lee and JW Pharmaceutical agree on bofanglutide commercialisation
Pharmaceutical Business Review
Bofanglutide is a bi-weekly glucagon-like peptide-1 receptor agonist (GLP-1RA) discovered and developed by Gan Lee.
Precision Medicine in Early Oncology Trials: Biomarkers as Strategic Drivers
Pharmaceutical Technology
Biomarkers are revolutionizing oncology drug development, driving modern precision medicine approaches, targeted clinical trial recruitment strategies, and critical decision-making.
Lilly launches GLP-1 pill, kicking off showdown with Novo Nordisk
BioPharma Dive
After winning the battle for injectable obesity medicines, Lilly hopes Foundayo can help it catch up in the oral market, where Novo has a three-month lead.
Pulmonary fibrosis drug developer Avalyn files IPO
Pharmaphorum
Avalyn Pharma hops on the IPO train, filing to list on the Nasdaq and raise funds for late-stage trials of its inhaled pulmonary fibrosis therapies.
Avalyn plots IPO to push inhaled pulmonary fibrosis pipeline through clinic
BioSpace
Analysts are cautiously optimistic about an IPO rebound for biopharma.
Oxford BioTherapeutics signs collaboration with Bristol Myers Squibb
PharmaTimes
Partnership to develop nextgeneration Tcell engagers for solid tumours
Innovent’s CDMO gets green light to make biologics at large Chinese plant
BioSpace
The license, which Innovent’s Altruist business said is the first of its kind, positions the CDMO to support commercial clients as it works to expand the plant’s capacity to 172,000 liters.
Kainova expands DT 7012 trial into Europe
PharmaTimes
First patient dosed as DOMISOL study grows beyond Australia
Roche sticks with C4T, adding up to $1B for molecular glue partnership
BioSpace
Roche is jumping into degrader-antibody conjugates, a modality that in recent years has attracted investments from Merck KGaA and Bristol Myers Squibb.
NHS risks missing out on independent prescriber benefits
Pharmaphorum
Gaps in support could undermine a wave of new independent prescribers entering the NHS and a push for more community-based care, warns a new report.
Novartis-backed Sidewinder collects $137M series B to strike at difficult-to-treat tumors
BioSpace
Sidewinder Therapeutics’ bispecific antibody-drug conjugates target pairs of receptors found on cancer cells, which the company claims improves their specificity and minimizes off-target effects.