A readout of phase III data of buntanetap in Parkinson’s disease is up next as Annovis Bio Inc. tries to recover from the market’s reaction to mixed phase II/III results in Alzheimer’s disease. The company’s stock (NYSE:ANVS) dropped 60% when the data were released on April 29 and continued downward on April 30, with shares closing 23.5% lower at $5.57 each. The shares’ 12-month peak was on Dec. 27 at $19.54 each. Read More
“A white space opportunity.” That’s how Enlaza Therapeutics Inc. co-founder and CEO Sergio Duron described to BioWorld the company’s efforts to develop the first covalent biologics, an endeavor that has gained the backing of an impressive group of investors in a recently closed $100 million series A round. Read More
The U.S. government chalked up another win April 29 against the constitutional challenges to the Inflation Reduction Act’s provision mandating direct Medicare price negotiations for selected prescription drugs. Read More
The BioWorld Cancer Index (BCI) closed out the first quarter of 2024 with a 4.66% increase, slightly down from its 11.07% rise at the end of February. This comes after an outstanding performance in 2023, when it finished the year up by 76.26%. Despite outperforming the Nasdaq Biotechnology Index, which rose by 1.36% in Q1, BCI lagged behind the Dow Jones Industrial Average, which saw a 5.62% increase in the first three months of the year. In contrast, BCI experienced a decline of 41.98% in 2022 and a 36.34% decrease in 1021. Read More
Newron Pharmaceuticals SpA added heft to the data supporting evenamide, reporting positive top-line results from a phase II/III placebo-controlled trial of the glutamate inhibitor in patients with chronic schizophrenia who were receiving a second-generation antipsychotic, but having an inadequate response to that treatment. Read More
Ten days early, the U.S. FDA granted full approval under priority review to Pfizer Inc. and Genmab A/S’s antibody-drug conjugate Tivdak (tisotumab vedotin) to treat cervical cancer. Read More
Orum Therapeutics Inc., of Boston and Daejeon, South Korea, is planning for an IPO on the Korea Exchange by the end of 2024, having passed a technology evaluation required for listing on the Kosdaq, a company spokesperson confirmed to BioWorld.Read More
The industry in the U.K. is starting to get concerned about the U.S. Biosecure Act and the possible impact on its ability to use Chinese service providers, and the implications for future dealmaking with U.S.-based companies. Read More
The latest World Health Organization’s (WHO) Pandemic Agreement falls short of protecting all countries in future pandemics, said international patient groups and public health organizations. Read More
It’s been a year since U.S. FDA Commissioner Robert Califf first started talking about reforming the agency’s advisory committee process. Now the FDA is moving beyond talking about it to listening. The agency has scheduled an all-day listening session June 13 to get feedback on optimizing the use of adcoms and the processes involved. Read More
Three people have agreed to pay more than $170,000 to settle U.S. SEC insider trading charges related to UCB SA’s $1.9 billion acquisition of Zogenix Inc. Read More
BioWorld’s three-part series takes a deep dive into CAR T therapy development and investment in mainland China. The report examines the growing interest in CAR T therapy, an approach to cancer treatment designed to harness the power of the body’s immune system, looking at the rapid pipeline growth, investments and dealmaking, clinical trials and challenges surrounding patient access.
In one of the biggest financings of the year so far, former Prometheus Biosciences Inc. CEO Mark McKenna helped raise $400 million to launch a new company, Mirador Therapeutics Inc. He didn’t sit on the sidelines for long after Merck & Co. Inc. bought Prometheus for $10.8 billion in 2023. He recruited key Prometheus executives to focus on Mirador’s genetic approach to drug discovery and precision medicine. McKenna said there was too much left undone to just hang back. In this BioWorld Insider episode, he talks about the new company and the multi-billion-dollar drugs that he believes provide sub-optimal efficacy compared to the tailor-made therapies he wants to develop. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Addex, Aim, Astrazeneca, Bitterroot, Cognition, Inflammasome, Inmune, Intellia, Merck & Co., Selection. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alnylam, Atossa, Bavarian Nordic, Bayer, BMS, Epygenix, Evotec, Harmony, Medison, Poolbeg, Scenic, Silk Road. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Accord, Aquestive, Aribio, Astrazeneca, Bavarian Nordic, Dermavant, Ena, Immix, Mannkind, Nkgen, Octapharma, Prime, Sellas, Soleno, Vertex, X4. Read More
