Illumina (Nasdaq:ILMN) announced that it commenced a headcount reduction totaling approximately 5% of its global workforce. The company said yesterday that it is proactively realigning its core operating expenses in response to the current macroeconomic environment. It seeks to maintain its focus on its innovation roadmap and sustainable long-term growth, according to an SEC filing. Earlier…

Most drugs undergo some degree of biotransformation after being administered. This metabolism process allows a drug’s active pharmaceutical ingredient (API) to achieve its desired effect or be eliminated. Metabolism also creates innumerable metabolites that can stimulate or inhibit enzymes, cultivate a chemical reaction or defend against other organisms in vivo. For these reasons, metabolites that…

In May, Biogen (Nasdaq:BIIB) CEO Michel Vounatsos announced his resignation following a precipitous decline in its share price after failing to achieve material sales of its Alzheimer’s drug Aduhelm (aducanumab). Roughly half a year later, Biogen has installed the German-Canadian executive Christopher Viehbacher to lead the company. Viehbacher will assume the role of president, CEO…

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…

The University of Health Sciences Antigua (UHSA) has partnered with Toronto-based Revive Therapeutics (CSE:RVV, USA:RVVTF) to research the potential of psilocybin to help those with addiction. Revive’s focus has increased following its 2020 acquisition of Psilocin Pharma Corp. University of Health Sciences Antigua is currently in the process of obtaining permits to import psilocybin for translational research,…

Tanya Sharma, the co-founder of the consulting firm Assurea LLC (Raleigh, North Carolina), helps startups in cell and gene therapy, biotech and food tech implement quality compliance frameworks. Within life sciences, the company helps clients “move from clinical to commercial, or preclinical to clinical,” Sharma said. “We help clients navigate regulatory requirements.” Sharma is also…

FDA’s Pulmonary-Allergy Drugs Advisory Committee (PADAC) voted 16 to 1 in favor of the albuterol/budesonide (PT027) from AstraZeneca (Nasdaq:AZN) to treat asthma in people at least 18 years old. The voting proposition asked whether the data supported a favorable benefit-risk assessment for various age groups. The advisory committee did not endorse albuterol/budesonide for patients 12…

The antiviral nirmatrelvir in Paxlovid reduced the likelihood of people experiencing long-term symptoms after a COVID-19 infection, according to a recent preprint. Individuals who took Paxlovid within five days after infection were 26% less likely to have symptoms of long COVID 90 days after infection.  The drug was associated with a reduced risk of long-COVID symptoms,…

By Cheryl Reifsnyder, PhD As a leading provider of data and advanced analytics, Veradigm understands the critical role real-world data (RWD) play in supporting researchers and other healthcare stakeholders during public health crises such as the unprecedented COVID-19 pandemic. The Value of EHR Data EHR Data: Both Timely and Clinically Rich For studying COVID-19, EHR…

Johnson & Johnson (NYSE:JNJ) has announced that the investigational antihypertensive drug aprocitentan significantly lowered blood pressure (BP) when used in conjunction with background antihypertensive therapy in the Phase 3 PRECISION study.  Sharing the results in collaboration with Idorsia (OTCMKTS:IDRSF), J&J noted that the drug candidate helped maintain a reduction in blood pressure for 48 weeks. …

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…

In 2021, Cherese Paloni founded MDliaison to connect healthcare sales reps with health care companies. After working as a sales rep, Paloni determined to address the high turnover rate in the life sciences industry. After determining that the high turnover in the non-health-care-provider community is a symptom of an antiquated onboarding process, Paloni decided to…

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 U.S. Supreme Court will entertain Amgen‘s (Nasdaq: AMGN) pursuit to revive patents for the monoclonal antibody cholesterol drug Repatha (evolocumab), which Regeneron (Nasdaq:REGN) and Sanofi (Nasdaq:SNY) had invalidated with legal challenges. In 2014, Amgen initiated litigation against Sanofi and Regeneron, arguing that the two companies had infringed its PCSK9 intellectual property related to evolocumab…

Pathology-focused AI company PathAI will present findings on the use of machine learning (ML) to enhance the scoring of nonalcoholic steatohepatitis (NASH) at the 2022 AASLD 2022 Liver Meeting. The AASLD 2022 Liver Meeting is Nov. 4–8 in Washington, D.C., where the  company will share five presentations. Boston-based PathAI developed four of them with pharmaceutical collaborators.  An…

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…

Photocatalysis technology company Acceled LLC has introduced the cLight, a cellular catalyst device suited for drug discovery and university research. According to the Pennsburg, Pennsylvania–based company, the cLight can facilitate genetic research, drug development, proteomics and diagnostics development by speeding chemical reactions with photoredox catalysis. David MacMillan, a Nobel Prize in Chemistry winner and Princeton professor,…

GSK (LSE/NYSE:GSK) has announced that it would stop enrolling the pivotal EAGLE-2 and EAGLE-3 studies of the antibiotic gepotidacin based on advice from the independent data monitoring committee. Gepotidacin is a topoisomerase type II inhibitor. The EAGLE-2 and EAGLE-3 trials met the primary efficacy endpoint related to combined clinical and microbiological resolution. The EAGLE-2 and EAGLE-3…

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)…

Although not available in the U.S., AstraZeneca’s (LON:AZN) Vaxzevria COVID-19 vaccine has won full marketing authorization in the European Union. European authorities initially granted conditional marketing authorization to the vaccine for individuals at least 18 years old in early 2021. However, in April, the European Medicines Agency (EMA) noted that the vaccine had a possible link to…

Allogeneic, or off-the-shelf, cell therapies derived from induced pluripotent stem cells (iPSCs) can be produced in a consistent, scalable manner and can significantly expand the availability and promise of this potentially curative modality. Although only autologous versions are currently approved, cell therapies are becoming an important alternative for treating many relapsed/refractory cancers and show substantial…

The Royal Swedish Academy of Sciences recently awarded the 2022 Nobel Prize in Chemistry to three individuals for the development of click chemistry and bioorthogonal chemistry. Among them was Carolyn Bertozzi, a scientific advisor to Shasqi (San Francisco). The oncology company has developed a novel platform to localize and activate cancer ‘protodrugs’ at a tumor…

The European Medicines Agency (EMA) is backing a series of measures to reduce the risk of serious side effects associated with Janus kinase (JAK) inhibitors, limiting their use in high-risk individuals. Similarly, Health Canada is recommending updated labeling for the drug class to disclose the risk of serious cardiovascular events and cancer. The agency is…

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) investigates Pfizer’s RSVpreF vaccine candidate. It observed the vaccine when administered to pregnant participants to help protect their infants from RSV disease after…