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Home » Newsletters » BioWorld

BioWorld

March 25, 2021

View Archived Issues
Vial and syringe

Full analysis: Astrazeneca reports 76% efficacy for COVID-19 vaccine

LONDON – After the extraordinary public accusation by the National Institute of Allergy and Infectious Diseases that it published “outdated” information on the interim results of the phase III U.S. trial of its COVID-19 vaccine, Astrazeneca plc has rushed through the full primary analysis, showing 76% efficacy in preventing symptomatic disease. That is 3% lower than the headline figure in the interim data published on March 22. But with the confidence interval ranging from 68%-82%, it is consistent with the pre-specified interim analysis claim of 79% efficacy – and would appear to indicate the data safety monitoring board’s (DSMB) concern that the company, “may have provided an incomplete view,” was misplaced. Read More

Proposed REMS not enough to mitigate tanezumab risk

If the March 25 vote from a joint FDA advisory committee meeting is anything to go by, the long and bumpy development road for Pfizer Inc.’s tanezumab, a nonopioid pain drug, may have just gotten longer and bumpier. In what was nearly a unanimous vote, the Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee said the sponsor’s proposed risk evaluation and mitigation strategy (REMS) was not adequate to ensure the benefits of tanezumab in alleviating osteoarthritis pain outweigh its risks, which include further joint deterioration. Read More
Virus research

Crucell vets raise $47M for new broad-spectrum antiviral venture Leyden Labs

DUBLIN – Last May, a quartet of Dutch biotech industry veterans gathered for a socially distanced outdoor meeting in a private garden in Leiden to discuss what could be done to prevent the present COVID-19 fiasco from ever occurring on such a scale again. A new startup, Leyden Laboratories BV, emerged from that conversation, and it has just raised €40 million (US$47.3 million) in a series A round to develop broad-spectrum, self-administered, intranasal antiviral drugs to prevent infection. Read More

FXR-upper? In many-roomed NASH mansion, research Terns to combo therapy

As the nonalcoholic steatohepatitis (NASH) space continues to bustle, Wall Street watches, scanning the horizon for promising new approaches while handicapping the odds for proven approaches. Read More
Juvenile king penguin

Israeli startup goes bio(me)-prospecting in wild animals

The animal world is full of species that can perform astonishing, and sometimes disgusting, feats. Take vultures, for example. “They eat this rotten meat that is full of pathogens and toxins, and they stay healthy,” Neta Raab told BioWorld. Raab is the co-founder and CEO of Wild Biotech Ltd., an Israeli startup that is seeking to understand gut microbiome contributions to these animal superpowers, and harness them for therapeutic use. Read More

Senators eye patent examiner practice for Section 101 problem

The latest global regulatory news, changes and updates affecting biopharma. Read More
Heart-DNA illustration

Cholesterol-independent heart disease risk gene

BioWorld looks at translational medicine, including: Ultrarare variants give insights into schizophrenia; T-cell ‘auto-aggression’ causes liver damage in NASH; Engineered myeloid cells prevent pro-metastatic microenvironments. Read More

Appointments and advancements for March 25, 2021

New hires and promotions in the biopharma industry, including: Abeona, Galapagos, Harpoon, Immuneering, IMV, Matrisys. Read More

Financings for March 25, 2021

Biopharmas raising money in public or private financings, including: Achilles, Apnimed, Eliem, Evofem, Ocean, Santhera. Read More

In the clinic for March 25, 2021

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Actinium, Albireo, Angion, Aquestive, Astrazeneca, BMS, Cyclo, Devonian, Diffusion, Enochian, Horizon, Immodulon, Kineta, KM, Marinomed, Medivir, Otonomy, Synlogic, Vasomune, Visus. Read More

Other news to note for March 25, 2021

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Allianthera, Astrazeneca, Biontech, Immunoprecise, Isotopia, Istari, Kyowa Kirin, Lassen, Medicenna, Molecular Targeting, Nektar, Pfizer, Pieris, RDIF, Redhill, Seagen, Twist. Read More

Regulatory actions for March 25, 2021

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Anaveon, Vertex. Read More

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