mRNA vaccine company Moderna (Nasdaq:MRNA) plans on submitting for regulatory approval for its investigational RSV mRNA-1345 vaccine after it met primary efficacy endpoints in the Phase 3 ConquerRSV study (NCT05127434). The RSV data are “a clear positive for MRNA” and represent a good omen for upcoming mRNA Phase 3 influenza data, noted UBS in a…

The biopharma Atai Life Sciences (Nasdaq:ATAI) subsidiary GABA Therapeutics is sharing positive results from a Phase 1 study of GRX-917, a deuterated form of etifoxine, which the German firm Hoechst developed in the 1960s. Sanofi-Aventis eventually subsumed Hoechst in 2004. Atai investigated the safety, tolerability and pharmacokinetic profile of orally administered GRX-917 in a Phase…

In 2021, two scientists founded Parallel Bio to harness the human body’s ability to fight disease using the immune system. The Cambridge, Massachusetts–based company is developing a platform for drug discovery and development that replicates human immune systems at population scale. The company has grand ambitions. “Nearly 95% of drugs that make it to human trials fail…

As the world begins to emerge from the pandemic, there are signs of an investment slowdown after record venture capital (VC) funding levels driven by COVID-19 treatment and prevention. “Even with this slowdown, we see that VC investment remains very high,” said Christian Dowdeswell, vice president, head of commercial development, small molecules at Lonza in…

The primary goal of the life sciences industry is to improve access to treatment and increase positive healthcare outcomes for patients. In a constantly evolving landscape, the industry works to achieve this goal through research, development, and the manufacturing of pharmaceuticals, medical devices and biotechnological products — all of which emphasize patient safety, product quality…

A Phase 1/2 study (NCT03395210) investigating Sanofi (Nasdaq:SNY) Bruton tyrosine kinase inhibitor rilzabrutinib in immune thrombocytopenia (ITP) has also shed light on the cognitive impairment involved in the disease. Patients with ITP, an autoimmune disease that involves increased platelet destruction, have often complained of fatigue, problems with cognition and other symptoms that physicians have dismissed,…

FDA has approved CSL Behring’s (ASX: CSL) Hemgenix (etranacogene dezaparvovec), an adenovirus-associated virus–based gene therapy for adults with hemophilia B. The price tag for the gene therapy — the first for hemophilia B — is $3.5 million. The drug is administered as a single infusion. Hemophilia B is a genetic bleeding disorder caused by missing or…

Ulotaront (SEP-363856), a trace amine-associated receptor 1 (TAAR1) agonist in Phase 3 clinical development, could prove to be a breakthrough therapy in treating schizophrenia. In 2020, the New England Journal of Medicine (NEJM) published results from a four-week pivotal study focused on ulotaront, which Sunovion discovered in collaboration with Psychogenics. Ulotaront is the first schizophrenia drug candidate…

As part of its ongoing restructuring efforts, Novartis AG (NYSE:NVS) is reportedly considering selling its ophthalmology and respiratory businesses, according to Bloomberg. Private equity firms are reportedly sizing up the business units. According to the company’s website, its core therapeutic areas are cardiovascular, hematology, solid tumors, immunology and neuroscience. Novartis’s ophthalmology division focuses on various therapies…

The European Commission has approved the VidPrevtyn Beta COVID-19 vaccine as a booster for individuals who are at least 18. The vaccine is the first next-gen protein-based adjuvanted COVID-19 booster to win European approval. Sanofi (Nasdaq:SNY) developed the vaccine based on the beta variant using GSK’s (NYSE:GSK) pandemic adjuvant. After announcing the news, Sanofi shares…

Founded in 2017, VeriSIM Life (San Francisco) has a quest to use biosimulation technology to streamline drug discovery and development. The company’s BIOiSIM virtual drug development engine helps pharma and biotech companies optimize R&D spending. The company’s founder and CEO, Dr. Jo Varshney, also wants to help reduce the need for animal testing in drug…

Pharma and biotech companies looking to perform clinical trials in Eastern Asia and Central Asia may want to consider alternatives as the Russia–Ukraine War continues. Georgia and Kazakhstan, for instance, could be new venues for life science companies looking to conduct clinical trials.  Russia and Ukraine both had strong clinical trial growth before 2022 Before…

The investigational bispecfic antibody elranatamab has won breakthrough therapy designation from the FDA for relapsed or refractory multiple myeloma (RRMM). Also known as PF-06863135, erlanatamab is a B-cell maturation antigen (BCMA)-targeted T-cell redirecting immunotherapy. BCMA is highly expressed on the surface of multiple myeloma (MM) cells. Elranatamab is also designed to target the CD3 receptor…

The Canadian company Algernon (CSE:AGN; Frankfurt:AGW0; OTCQB:AGNPF) is the headline sponsor for the Wonderland psychedelic medicine conference held in Miami from November 3 to 5. Algernon CEO Chris Moreau expects the decision to prominently back the event will raise the company’s profile. “We view Algernon as a Janis Joplin voice singing to a junior high crowd right now,” Moreau…

On the heels of winning an EU nod for its RSV vaccine marketing authorization application, GSK (LSE/NYSE:GSK) has announced that FDA has accepted a Biologics License Application for its RSV vaccine candidate for older adults. The agency also granted priority review to the vaccine, which will clip four months off the vaccine candidate’s biologics license application (BLA)…

Pfizer (NYSE:PFE) today announced positive topline data from a Phase 3 clinical trial for its bivalent respiratory syncytial virus (RSV) prefusion vaccine candidate. The MATISSE (Maternal Immunization Study for Safety and Efficacy) study investigates Pfizer’s RSVpreF vaccine candidate. It observed the vaccine when administered to pregnant participants to help protect their infants from RSV disease…

Numinus Wellness (TSE:NUMI) has developed a psilocybin-containing tea bag for clinical research and potentially for clients in psychedelic-assisted therapy. The Vancouver–based company’s strategy differs from that of other companies that have popped up in recent years with the intent of creating bespoke psychedelic compounds with patent protection. Some companies, for instance, have created deuterated psilocybin analogs with…

Janssen (NYSE:JNJ) has announced positive data from the first randomized controlled trial to test the safety and efficacy of combination therapy with an interleukin (IL)-23p19 subunit antagonist (guselkumab) and a tumor necrosis factor-alpha (TNFα) antagonist (golimumab) in ulcerative colitis. In the Phase 2a VEGA study, 48% of patients who received combination induction therapy with guselkumab and…

It’s no secret that the pharma industry is evolving at a rapid pace, with technological advances and new pharmacy options impacting consumer preference every day. And with the industry expected to grow swiftly in the coming years, pharmaceutical companies will need to progress along with that growth to engage key audiences. Big industry players know…

Berlin-headquartered Atai Life Sciences (Nasdaq:ATAI) is sharing positive initial results from a Phase 1 clinical study of KUR-101, an oral formulation of deuterated mitragynine, in patients with opioid use disorder. Mitragynine is a primary active alkaloid of the kratom plant (Mitragyna speciosa). Atai’s KUR-101 is an oral formulation of deuterated mitragynine. Atai subsidiary Kures is leading the…

Adjudicating pre-determined adverse medical events that occur throughout a clinical trial is incredibly valuable to the clinical trial process. Performed by an objective team of clinicians with expertise in a specific therapeutic area, the adjudication process ensures the accuracy and consistency of the clinical truth of a given event. This clinical team, known as a…

Janssen (NYSE:JNJ) is working to highlight the importance of cancers such as leukemias, lymphomas and multiple myeloma for Blood Cancer Awareness Month in September. Some 1.5 million people in the U.S. are currently living with or in remission from blood cancers, according to the Leukemia & Lymphoma Society. Roughly 35,000 people are diagnosed with multiple myeloma…

Today, the U.S. Senate passed the FDA Modernization Act 2.0, S.5002, without dissent. Introduced by Senators Dr. Rand Paul (R-KY) and Cory Booker (D-NJ), the bill, if enacted, could curb animal testing in the coming years. A total of 10 other cosponsors backed the bill, which would end the mandate to test new drugs and…

Eisai and Biogen (Nasdaq:BIIB) today announced positive topline data from a Phase 3 trial of lecanemab for Alzheimer’s disease. BIIB shares are skyrocketing on the back of the data today. They are up 37.6% at $272.12 apiece in mid-afternoon trading. Lecanemab is an investigational anti-amyloid beta (Aβ) protofibril antibody. The global Phase 3 confirmatory Clarity…

FDA has published draft guidance to clarify its perspective on including children in clinical trials. The agency notes that it wrote the draft guidance to help industry, sponsors and institutional review boards (IRBs) protect children in clinical studies testing drugs, biological products and medical devices. The draft guidance is titled “Ethical Considerations for Clinical Investigations of Medical…