Sage Therapeutics (Nasdaq:SAGE) and Biogen (Nasdaq: BIIB) have begun a rolling submission of a New Drug Application (NDA) to FDA for zuranolone to treat major depressive disorder (MDD). The two companies plan on submitting additional clinical data for the NDA in the second half of the year. Biogen entered into a $1.5 billion licensing agreement…

FDA is planning a series of virtual meetings of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) throughout June. In the meetings, the advisory committee will discuss authorizing the COVID-19 vaccine from Novavax (Nasdaq:NVAX) and authorizing the use of the vaccines from Moderna (Nasdaq: MRNA) and Pfizer-BioNTech (NYSE:PFE; Nasdaq:BNTX) in children aged 6 months…

At the heart of Johnson & Johnson’s (NYSE:JNJ) $6.5 billion acquisition of Momenta Pharmaceuticals in 2020 is a portfolio of drug candidates for immune-mediated diseases. One of the promising compounds in the acquisition is nipocalimab, which Janssen sees as a potential “pipeline in a pathway.” Nipocalimab holds promise for an array of diseases, ranging from…

SK Bioscience (KRX:302440) and GSK (NYSE:GSK) have filed a biologics license application with the Korean Ministry of Food and Drug Safety for their SKYCovione, a recombinant protein-based COVID-19 vaccine candidate. The self-assembled nanoparticle vaccine candidate is adjuvanted with GSK’s pandemic adjuvant. SKYCovione fared well in a Phase 3 study involving more than 4,000 adults in…

AbbVie (NYSE:ABBV) has notched a new approval for the Janus kinase 1 (JAK) inhibitor Rinvoq (upadacitinib) for ankylosing spondylitis, an inflammatory type of arthritis affecting the spine. The drug was first approved for treating rheumatoid arthritis in 2019. Indications followed for psoriatic arthritis, atopic dermatitis and ulcerative colitis. The ankylosing spondylitis indication is limited to…

The clinical-stage company First Wave BioPharma (Nasdaq:FWBI) saw its share price fall by more than 40% to $0.37 in after-hours trading today after releasing new clinical trial data. To save money, the company will initiate austerity measures, cutting headcount by about 20% and closing clinical operations site in Hayward, California and a facility in Langlade, France.…

The small biopharma Mycovia Pharmaceuticals has notched its first FDA approval with Vivjoa (oteseconazole), a novel drug for treating recurrent vulvovaginal candidiasis (yeast infections). The Durham, North Carolina-based company plans to launch the drug in the U.S. in the second quarter of the year. Vivjoa is an azole antifungal indicated for females with recurrent vulvovaginal…

The contract research organization (CRO) Syneos Health has promoted Michelle Keefe to be its CEO and a member of its board. Keefe was previously the president, medical affairs and commercial solutions at Morrisville, North Carolina-based Syneos. The company’s departing CEO, Alistair Macdonald, is retiring after working at the company for two decades. Macdonald will serve…

Eli Lilly and Co. (NYSE: LLY) has announced that tirzepatide enabled trial participants to lose up to 22.5% of their body weight in the SURMOUNT-1 study. Study volunteers receiving tirzepatide lost up to 52 lb. (24 kg) in the 72-week Phase 3 trial. A total of 55% of those receiving a 10 mg dose lost…

The Swiss Big Pharma Novartis (NYSE:NVS) announced that the anti-PD-1 immune checkpoint inhibitor tislelizumab with chemotherapy improved overall survival in patients with advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) in a Phase 3 study. The RATIONALE 306 trial of tislelizumab and chemotherapy met its primary endpoint at interim analysis. The study pitted the…

While a portion of the public is now eligible to receive a second booster dose of COVID-19 vaccine, the FDA has not yet authorized a vaccine for children aged 6 months to 5 years old. Moderna (Nasdaq:MRNA) is vying to be the first. The company announced today that it is filing a request for emergency…

A decade ago, data scientist seemed like the sexiest job of the 21st century, to paraphrase an influential Harvard Business Review article. In the pharmaceutical industry, data science certainly continues to have tremendous potential, but in years to come, data-savvy biologists could have as least as much of an impact on drug development as data scientists,…

The HER2-directed antibody-drug conjugate Enertu (trastuzumab deruxtecan) has won its fifth breakthrough therapy designation from the FDA. Enhertu was developed jointly by AstraZeneca (LON:AZN) and Daiichi Sankyo (OTCMKTS: DSNKY). The latest designation relates to treating adults with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-negative) breast cancer. Of the five breakthrough therapy designations for the drug,…

The startup Cellares has a mission to enable industrial-scale cell therapy manufacturing with its Cell Shuttle, which it dubs a “factory in a box.” The germ for the idea traces back to market research that South San Francisco, California-based Cellares co-founder and CEO Fabian Gerlinghaus focused on in a prior role. While attending industry conferences,…

Precision oncology firm Black Diamond Therapeutics (Nasdaq:BDTX) has announced a restructuring plan to free up cash to prioritize the development of BDTX-1535 and BDTX-4933. The company plans on trimming nearly one-third of its workforce. BDTX shares ticked up about 1% to $2.75 after announcing the news yesterday but fell 4% today to $2.64. According to…

Retinoic acid receptor-related orphan receptor gamma t (RORγt) inhibitors are currently in development for various indications. RORγt plays a crucial role in driving T helper 17 (Th17) differentiation and interleukin 17 (IL-17) expression. In homeostasis, these cells play a vital role in the defense against bacteria and fungi. However, this cell type seems to be…

FDA has announced that it has signed off on the use of COVID-19 therapy Veklury (remdesivir) from Gilead Sciences (Nasdaq:GILD) to include children at least 28 days old who weigh at least 3 kg (roughly 7 lb) and test positive results for COVID-19. The indication is limited to children who are either hospitalized or have…

Sol-Gel (Nasdaq:SLGL) and Galderma have announced that it has won FDA approval for Epsolay cream, a proprietary topical formulation of benzoyl peroxide, 5%, for treating inflammatory rosacea lesions. Rosacea is a common condition, but experts have struggled to estimate its global prevalence. A 2018 estimate in the British Journal of Dermatology concluded that the condition affects between…

The lack of appropriate representation in clinical trials, particularly in terms of ethnicity and race, has been a long-standing issue that directly impacts health equity and treatment efficacy. In a 2020 analysis of the global participation in clinical trials, the Food and Drug Administration (FDA) highlighted the vast difference between enrolled participants and the global population.…

Given the complexity of the pharmaceutical business, it can be challenging to gauge the performance of any chief executive in the space. That said, CEOs’ annualized return over tenure as CEO over their term can hint at performance. In addition, rating sites like Glassdoor also indicate CEOs’ popularity. Here, we parsed a range of metrics,…

After winning FDA approval for the controversial Alzheimer’s drug Aduhelm (aducanumab) in June 2021, Biogen (Nasdaq:BIIB) has encountered a string of setbacks. Most recently, the company has decided to yank its applications for market approval after the European Medicines Agency (EMA) recommended the refusal of the marketing authorization for Aduhelm in December 2021. At that…

The collection of good quality data from clinical trials is essential to data analysis to produce robust results that meet the precise requirements for regulatory need. Data from clinical trials are increasingly complex, related to involved protocols, the geography of trial sites, increasing data streams and technological advances. Therefore, studies must be set up to…

Tübingen, Germany–based CureVac N.V. (Nasdaq:CVAC) and its partner GSK (NYSE:GSK) have announced positive preclinical data about their second-generation COVID-19 vaccine candidate that combines mRNAs for the beta and delta variants. The companies conducted the preclinical research in conjunction with the Friedrich-Loeffler-Institut, Germany. The research pitted the bivalent candidate against monovalent COVID-19 vaccine candidates. The bivalent…

Vertex Pharmaceuticals Inc. (Nasdaq: VRTX) has won marketing authorization for the expanded use of Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) in children with cystic fibrosis who are between the ages of 6 and 11 years old. The latest approval covers children with at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. The…

In the Phase 3 Provent trial, Evusheld (AZD442) cut the risk of developing symptomatic COVID-19 by 77% in the primary analysis focused on patients at high risk for severe COVID-19. The monoclonal antibody cocktail, including tixagevimab and cilgavimab cut the risk by 83% in the six-month follow-up analysis compared to placebo.  The drug is currently authorized…