Drug Discovery and Development

A member of the FDA’s expert panel for nervous system therapies reportedly resigned over the decision to authorize an Alzheimer’s therapy. The FDA controversially authorized Aduhelm (aducanumab) from Biogen on Monday, making it the first novel Alzheimer’s drug treatment in 18 years despite drug companies pumping billions of dollars into more than 400 clinical trials. STAT…

Billing itself as the “world leader in opioid addiction treatment,” Indivior (INDV.L) is looking to diversify into treating cannabis use disorder. The North Chesterfield, Va.–The headquartered company will spend $30 million upfront to acquire Aelis Farma for development rights for AEF0117, an investigational drug that blocks the CB1 cannabinoid receptor in the brain. In addition…

Bayer announced today that its BlueRock Therapeutics subsidiary successfully administered the first dose of its Parkinson’s disease therapies. Berlin-based Bayer said in a news release that BlueRock successfully administered the dose of its investigational pluripotent stem cell-derived dopaminergic neruons, called DA01, to a Parkinson’s disease patient in an open-label Phase 1 clinical safety and tolerability…

Regeneron (NSDQ:REGN) has announced that the FDA has signed off on a 1,200 mg subcutaneous or intravenous dose of its REGEN-COV antibody cocktail. The quantity is half of the initially authorized dose. The agency had previously authorized a 2,400 mg dose of the vaccine, including a combined dose of 1,200 mg of Casirivimab and 1,200…

Senate Finance Committee Chair Ron Wyden (D-Ore.) has announced an investigation of AbbVie’s (NYSE: ABBV) tax practices. In a statement, the senator argued that the company’s tax rate from 2018 to 2020 was 9.5% — less than half of the 20% rate it paid in 2016. Wyden has sent a letter to AbbVie CEO Richard…

FDA has accepted a new drug application (NDA) for the oral hypoxia-inducible factor (HIF) prolyl hydroxylase inhibitor vadadustat from Akebia Therapeutics (NSDQ:AKBA) and its partner Otsuka Pharmaceutical Co. (TYO:4578). The two companies are pursuing the use of the drug to treat anemia resulting from chronic kidney disease. The oral drug would offer patients more flexibility…

  Moderna (Nasdaq:MRNA) announced today that it submitted for full FDA approval of its mRNA COVID-19 vaccine for individuals 18 years of age and older. Cambridge, Mass.-based Moderna initiated the rolling submission process with the FDA for a Biologics License Application (BLA) to license its mRNA COVID-19 vaccine, according to a news release. The move…

Sanofi and GlaxoSmithKline announced today that they began enrollment in the Phase 3 clinical trial for their COVID-19 vaccine candidate. The companies will evaluate the safety, efficacy and immunogenicity of their adjuvanted recombinant-protein COVID-19 vaccine candidate in a global, randomized, double-blind, placebo-controlled Phase 3 study of more than 35,000 participants aged 18 and older, according…

The pharmaceutical industry is on the upswing and is poised to have a compound annual growth rate of 13.7% from 2020 to 2027, according to projections from Grand View Research. The industry’s resurgence is a good opportunity for employees in the sector, who frequently enjoy comfortable salaries. To get a sense of which pharmaceutical companies…

Healthcare workers have administered almost 288 million doses of COVID-19 vaccines in the U.S., which now has more than enough vaccine for the present demand.  Against that backdrop, FDA has released updated emergency use authorization (EUA) guidelines for COVID-19 vaccines that state the agency could decline some future EUA requests. “For the remainder of the current pandemic,…

The speed that pharmaceutical companies developed COVID-19 treatments and vaccines was “seemingly miraculous,” said Dr. George Yancopoulos, co-founder of Regeneron (NSDQ: REGN), in remarks when receiving a Titans of Global Health award. “But these miracles were actually born many decades earlier,” he said at the virtual event ceremony from the American Friends of the Hebrew University.…

The Mayo Clinic is roughly tripling the size of the new research lab it plans to build in its home city of Rochester, Minn. Before the COVID-19 hit, plans called for a four-story building. But officials at the top-tier health provider say the pandemic taught them that scientific advancements need to accelerate in healthcare. The…

Bristol Myers Squibb (NYSE:BMY) has announced results from a Phase 2/3 study that found a fixed dose of relatlimab and Opdivo (nivolumab) led to significant progression-free survival (PFS) rates when used as first-line therapy for metastatic or unresectable melanoma. The RELATIVITY-047 trial found that the median progression-free survival rates were 10.12 months for those receiving…

In the U.S., more than 125 million people have been fully vaccinated against COVID-19. While most vaccine recipients tend to have relatively minor and fleeting adverse events from the shots, many people continue to worry about side effects. According to a recent survey from the physician social network Sermo found that 72% of physicians reported…

Drug sales in 2020 proved more resilient than many experts anticipated in the early days of the pandemic. Still, the impact on many injectable drugs was tangible in the first half of the year as hospitals initially dissuaded patients from seeking in-person treatment. But sales were generally strong for the full year. AbbVie’s injectable biologic…

The past year has been an unprecedented time for the pharmaceutical industry. On the one hand, the pandemic resulted in substantial delays to clinical trials while also forcing sponsors to rethink clinical trial design to protect participants. But on the other hand, the pandemic underscored the importance of the pharma industry in society.  While the…

The global pharmaceutical industry held up well during the pandemic, with 10 of the largest businesses only seeing a roughly –3% drop in revenue in 2020. Eight of the 10 even came out ahead. That’s one of the big takeaways from Drug Discovery & Development’s inaugural Pharma 50, a compilation of data on the largest…

A partnership with J&J’s Janssen Pharmaceuticals is helping PhysIQ advance with its device-agnostic clinical data collection and analysis platform.  Over the course of the last year and some change, the impact of digital health and the need for it has increased by an immeasurable amount. Virtual care became the norm after the COVID-19 pandemic hit, and, although…

Critical reagents are instrumental to large molecule drug development. They constitute a key element in the bioanalytical assay for the quantitative determination of the test compound. Companies often find it challenging to produce and manage lots of consistent quality, even though such consistency governs the accuracy, precision and robustness of the assay. Critical reagents and…

Pfizer CEO Albert Bourla said the company will soon seek full FDA approval and authorization for further age groups for its COVID-19 vaccine. Speaking during the company’s first-quarter earnings call yesterday, transcribed by The Motley Fool, Bourla outlined the regulatory pathways that the company is pursuing for the vaccine it developed with BioNTech, which is…

AI-powered drug discovery company Exscientia announced that it completed a $225 Series D funding round. SoftBank Vision Fund 2 led the funding round, while previous lead investors, Novo Holdings and funds managed by Blackrock, contributed. Other investors included Mubadala Investment Company, Farallon Capital, Casdin Capital, GT Healthcare Capital, Marshall Wace, Pivotal bioVenture Partners, Laurion Capital,…

The FDA and CDC have lifted the pause placed on the Johnson & Johnson (NYSE:JNJ) COVID-19 vaccine after reports of blood clots caused concern. On April 13, the FDA and CDC issued a joint statement recommending the pause in the administration of the J&J (Janssen) COVID-19 vaccine after, among 6.8 million doses delivered in the…

Intelligence Squared, the organizers of a popular debate series, recently asked a panel of experts whether psychedelics should be legalized. There was considerable overlap between the factions arguing in favor and opposition of that motion, reflecting the growing interest in psychedelic compounds for therapeutic applications. But the two camps were split when it came to…

Former HUD Secretary Dr. Ben Carson, Sr. will assist Galectin Therapeutics Inc. (NSDQ: GALT) with the development of its galectin-3 inhibitor, belapectin. The drug is a potential treatment for nonalcoholic steatohepatitis (NASH), which is also known as nonalcoholic fatty liver disease.  Galectin Therapeutics has an ongoing Phase 2b/3 trial to investigate belapectin’s potential in treating cirrhosis…

Ovid Therapeutics (NSDQ:OVID) has named MIT professor Robert Langer as the chair of its scientific advisory board. The biopharma company focuses on rare neurological diseases. “The neurosciences are on the cusp of a scientific and, hopefully, therapeutic revolution,” said Langer in a statement. “Ovid has an exciting approach to tackling the key questions that drive…