Press Releases

Vanda Pharmaceuticals Inc. today announced that the U.S. Food and Drug Administration has approved Fanapt® tablets for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults. Fanapt® is an atypical antipsychotic agent that has been used for the acute treatment of patients with schizophrenia since its FDA approval in 2009. "Manic or mixed episodes associated with bipolar I disorder are highly complex conditions, which require a host o

Otsuka Pharmaceutical, Co. Ltd. (Otsuka) and Click Therapeutics, Inc., (Click) announce that the U.S. Food and Drug Administration (FDA) has cleared Rejoyn™ (developed as CT-152), the first prescription digital therapeutic authorized for the treatment of major depressive disorder (MDD) symptoms as an adjunct to clinician-managed outpatient care for adult patients with MDD age 22 years and older who are on antidepressant medication. Rejoyn is intended to reduce MDD symptoms. Re

Zai Lab Limited partner Bristol Myers Squibb announced the pivotal Phase 3 KRYSTAL-12 study, evaluating KRAZATI® as a monotherapy in patients with pretreated locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring a KRASG12C mutation, met the primary endpoint of progression-free survival (PFS) and the key secondary endpoint of overall response rate (ORR) as assessed by Blinded Independent Central Review (BICR) at final analysis for these endpoints. The study remains on

Larkspur Biosciences, a company pioneering a new wave in cancer therapy by targeting cancer-intrinsic drivers of immune evasion, announced that it will present positive preclinical efficacy data for LRK-A, Larkspur’s novel, lead investigational therapy targeting the lipid kinase PIP4K2C, in primary human tumor samples and an in vivo model of colorectal cancer (CRC). The data will be featured in a poster presentation at the 115th Annual Meeting of the American Association for Cancer Rese

4D Molecular Therapeutics, a leading clinical-stage genetic medicines company focused on unlocking the full potential of genetic medicines to treat large market diseases, today announced an update on its regulatory interactions and development path for 4D-710, an aerosolized genetic medicine for the treatment of CF lung disease. Given high-level cystic fibrosis transmembrane conductance regulator (CFTR) transgene expression in all lung airway biopsies disclosed to date (significantl

Touchlight, an innovation-driven CDMO enabling the development of genetic medicines with its doggybone DNA (dbDNA™) technology and leaders in enzymatic DNA production, is delighted to announce that it has been awarded a tender to deliver enzymatic DNA as part of CPI’s tender process for the establishment of its RNA Centre of Excellence. CPI, a leading technology innovation centre in the UK, has selected Touchlight to supply research and GMP-grade enzymatic DNA for the de

Aragen, a leading Contract Research Development and Manufacturing Organization (CRDMO) for small molecules and biologics, announced that it has operationalized the first phase of its biologics manufacturing facility in Bangalore, India through its 100% subsidiary, Aragen Biologics Pvt Ltd. The facility is being set up at an investment of USD 30 mn. It has also executed its first small-scale manufacturing project for a US-based organization for manufacturing a novel anticancer monoclonal antib

ProBioGen, a globally recognized and experienced Contract Development & Manufacturing Organization , proudly announces a partnership with DIOSynVax Ltd to manufacture DIOS-HFVac3, a trivalent hemorrhagic fever (HF) vaccine that was developed in collaboration with Prof. Wagners team (Molecular Virology, Institute of Medical Microbiology and Hygiene, University of Regensburg). The novel vaccine targets HF diseases caused by Ebola, Marburg, and Lassa viruses. Epidemics of viral hemorrhagic f

Vetter once again earned the 2024 CDMO Leadership Awards in all six core categories – quality, expertise, reliability, capabilities, compatibility and service for big pharma, small pharma and overall respondents. The award reaffirms Vetter’s mission to provide the highest possible quality and value for pharma and biotech companies worldwide in their development, manufacturing as well as assembly and packaging of injectables. “We are dedicated to embodying the chara

NKGen Biotech, Inc, a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous, allogeneic, and CAR-NK Natural Killer (“NK”) cell therapeutics, today presented additional Phase 1 clinical trial data on the use of its investigational autologous NK cell therapy, SNK01, to treat patients with Alzheimer’s disease (“AD”) at the Tau2024 Global Conference in Washington, D.C. The presentation contained data