Peripheral cytokines from COVID-19 vaccines could cause or exacerbate tinnitus, or ringing in the ears, theorized Shaowen Bao, an associate professor of neuroscience and physiology at the University of Arizona. Recent articles on Drug Discovery & Development on the possible link between tinnitus and COVID-19 vaccines have attracted hundreds of comments. Some 0.65% of COVID-19 vaccine recipients who…
COVID-19 could have originated from wildlife farms
While the origins of the COVID-19 remain unknown, a likely theory is that wildlife farms in southern China are most likely to blame for seeding the pandemic, according to a World Health Organization member (WHO). While most scientists believe bats were the source of the virus that would later infect humans, it was unclear how humans contracted the…
Moderna revenue soars in Q4 thanks to COVID-19 vaccine
Moderna posted mixed fourth-quarter results today with a larger-than-expected loss but beat the consensus forecast for revenue. The company boosted its outlook for the rest of the year, citing strong demand and maturing commercialization capabilities. The Cambridge, Mass.-based vaccine developer reported revenue of $570.7 million for the three months ended Dec. 31, 2020. That figure…
Is COVID-19 herd immunity elusive or within reach?
Last year, herd immunity seemed like a comforting promise as researchers worked on dozens of COVID-19 vaccine candidates and a silver-lining to the rampant spread of the virus — the more people who got infected, the more natural immunity that would develop over time. There are now dissenting opinions about how the term relates to…
Catalent to acquire Acorda’s manufacturing and packaging operations
Catalent (NYSE:CTLT) has entered into a definitive agreement to purchase a dry-powder inhaler (DPI) capsule manufacturing and packaging facility from Acorda Therapeutics (NSDQ:ACOR). The acquisition will enable Catalent to establish a center of excellence for spray-dried dispersion for DPI capsule manufacturing. The transaction will also expand Catalent’s existing U.S.-based commercial-scale capabilities in metered-dose inhalers and nasal…
Pfizer and BioNTech to offer COVID-19 vaccine to placebo recipients
Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) have decided to offer to inform clinical trial volunteers in its COVID-19 vaccine whether they received a vaccine or placebo. Those who received a placebo will be eligible to receive the first dose of vaccine by March 1 and stay in the study. A second dose will be administered roughly three weeks…
FDA OKs clinical trial for ‘paradigm-shifting’ breast cancer vaccine
The FDA has OK’d human clinical trials for Anixa Biosciences (NASDAQ: ANIX) and Cleveland Clinic’s novel breast cancer vaccine that immunizes against the alpha-lactalbumin protein. Within the mammary gland, the alpha-lactalbumin protein is involved in lactose synthase production, which, in turn, is required to make lactose and milk. Typically expressed later in pregnancy and during lactation,…
AstraZeneca releases peer-reviewed data for its COVID-19 vaccine
AstraZeneca (LON:AZN) and its collaborators at the University of Oxford have published data related to their ChAdOx1 nCoV-19 vaccine against the novel coronavirus in the Lancet, becoming the first vaccine developers to publish full Phase 3 results in a peer-reviewed journal. The efficacy rate of 62.1% achieved in clinical trial participants receiving two full doses of the…
BREAKING: U.K. approves Pfizer and BioNTech’s COVID-19 vaccine
The United Kingdom today approved its first COVID-19 vaccine, created through a partnership between Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX). The Medicines and Healthcare products Regulatory Agency (MHRA) approval came after a “rolling review” in which assessment takes place as the packages of data become available from ongoing studies on a staggered basis. The idea is to…
FDA vaccine advisory committee is meeting today
An independent panel advising FDA is sharing its perspective on the approval process for COVID-19 vaccine. Much of the virtual Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting is focused on the complexities of the pandemic and regulatory best practices. The optic of an independent panel of scientists discussing the prospect of safe and…
Feds accuse Teva of $300M in kickbacks for MS drug
Massachusetts federal prosecutors today claimed that Teva Pharmaceuticals funneled $300 million from a pair of charitable foundations to subsidize Medicare copayments for a multiple sclerosis drug. Teva Pharmaceuticals and Teva Neuroscience, the maker of Copaxone, simultaneously raised the drug’s price by 329%, allegedly violating the Anti-Kickback Statute and False Claims Act, according to the complaint…
Johnson & Johnson misses the mark on Q4 revenue
Johnson & Johnson (NYSE:JNJ) today reported fourth-quarter earnings that beat the consensus forecast on Wall Street, but its sales numbers were slightly off amid declining medical device revenue. The New Brunswick, N.J.–based pharmaceutical, medical device and consumer products giant reported profits of $4.0 billion, or $1.50 per share, on sales of $20.7 billion for the three…
Elemica branches out to pharma industry
Chemical industry digital supply chain company Elemica (Wayne, Pa.) said recently that it has extended its offerings to the pharmaceutical industry. Pharma companies using Elemica solutions will now benefit from improved collaboration, visibility, quality management, traceability and speed of execution across their global supply chains, according to Elemica. The company has been building digital solutions…
Redesign Science to use OpenEye Scientific software for drug development
Redesign Science and OpenEye Scientific announced that they have entered into a strategic partnership to integrate OpenEye’s Orion computational platform into Redesign’s drug-discovery platform. Santa Fe, N.M.-based OpenEye makes “cheminformatics” software for drug discovery, providing a reliable application programming interfaces (API) that customers use to build customizable programs and workflows. Its newly released Orion computational…
Mayo Clinic, W.L. Gore team up on stem cell therapy treatments
Mayo Clinic and W. L. Gore & Associates have announced a partnership to develop implantable cell therapies to treat debilitating conditions with no cure. The for-profit company, Avobis Bio, will combine a patient’s own stem cells with bioabsorbable scaffolds to stimulate the healing of perianal fistulas, painful tunneling wounds that affect patients with Crohn’s disease.…
GE Healthcare partnering on regenerative tissue manufacturing
GE Healthcare Life Sciences said today that it has entered into a strategic R&D and distribution partnership with Advanced Solutions Life Sciences — with a goal of personalized tissue regeneration. The partnership with Advanced Solutions Life Sciences is the latest in a string of investments and partnerships that GE Healthcare (NYSE:GE) has been making to further…