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Home » Newsletters » BioWorld

BioWorld

June 6, 2023

View Archived Issues
Lab glassware and scientist

Will R&D be an unintended consequence of new US drug policies?

As Monica Bertagnolli, U.S. President Joe Biden’s choice to be the next NIH director, meets with senators to gather support for her confirmation, she’s sure to be grilled by some of them about her stance on whether the agency can march in on drug patents based on a drug’s list price. Up until now, NIH directors have said no. A change in that policy, along with nearly flatline NIH spending and other new government initiatives, could impact private investment in drug R&D by increasing the cost of research and lowering the return on investment. Read More

AAVantgarde Bio secures $65M series A round for large gene delivery in AAV vectors

AAVantgarde Bio SrL raised €61 million (US$65 million) in series A funding to take forward two novel approaches to gene therapy that aim to overcome the packaging limits of adeno-associated virus (AAV) vectors. The company plans to move its lead program, in retinitis pigmentosa associated with Usher syndrome type 1b, into the clinic later this year. A second program, in Stargardt disease, is a couple of years behind it. Read More
Acquisition target

Gurnet Point, Novo Holdings to acquire Paratek in transaction valued at $462M

As it nears the end of its cash runway and its lead antibiotic, Nuzyra, approaches a phase IIb readout, Paratek Pharmaceuticals Inc. agreed to be acquired by Gurnet Point Capital and Novo Holdings A/S for up to $3 per share in a deal that will take the company private. Read More

ASCO 2023: Toripalimab extends OS, final phase III trial data show

When combined with chemotherapy, the PD-1 inhibitor antibody toripalimab reduced the risk of death by 37% over chemotherapy alone when used first line in patients with recurrent or metastatic nasopharyngeal carcinoma, Coherus Biosciences Inc. revealed at this year’s American Society of Clinical Oncology meeting (ASCO). Read More
Infant receiving vaccine

FDA adcom to consider the what-ifs of RSV vaccine, infant prophylactic

Having already notched approvals in the EU and U.K., Astrazeneca plc hopes to prime the pump for a U.S. approval of nirsevimab as a respiratory syncytial virus (RSV) prophylactic for infants when it makes its case June 8 before the FDA’s Antimicrobial Drugs Advisory Committee. Read More
William Cao, founder and CEO, Gracell Biotechnologies

Gracell enters autoimmune space with its dual-targeting CAR T

Gracell Biotechnologies Inc. is initiating two clinical trials in China in refractory systemic lupus erythematosus for lead candidate GC-012F, a CD19/B-cell maturation antigen dual-targeting CAR T.  Read More
European flag, vial, syringe

COVID-19 vaccines get seasonal treatment as EMA issues recommendations for 2023-2024

The EMA and the European Center for Disease Control have said COVID-19 vaccine manufacturers should ditch the existing formulations and adapt their products to target the omicron-descendant XBB.1.5, to protect against SARS-CoV-2 in the winter of 2023–2024. Read More

US House committee taking aim at TRIPS waivers for COVID therapies, tests

The intellectual property waivers for American vaccines for the COVID-19 pandemic are still controversial, but the World Health Organization (WHO) is nonetheless seeking a similar set of waivers for therapies and tests for COVID. A subcommittee of the House Judiciary Committee met June 6 to review these waivers, and subcommittee chairman Darrell Issa (R-Calif.) said he intends to continue pushing legislation that would require the U.S. president to obtain congressional approval for agreeing to any such waivers in the future. Read More

Hopes for increased appropriations for FDA, NIH not necessarily lost

The Fiscal Responsibility Act (FRA) has been signed into law by U.S. President Joseph Biden, heralding a five-year span in which increases in discretionary budget spending will be limited to 1% after a flat funding picture in the coming fiscal year. Read More

The BioWorld Insider Podcast: Preventing opioid overdoses with a smart patch

Free, no-prescription-required access to naloxone has reduced deaths from opioid overdoses by 11% in some communities, but they only work if someone with the reversal agent is available when a person overdoses. Resilient Lifescience Inc. hopes to save those lives, too. The company is developing a wearable patch that monitors vital signs and automatically administers naloxone when needed. In this edition of the BioWorld Insider podcast, Brad Holden, CEO of Resilient Lifescience, explained how the device works for overdoses as well as other potential applications for the new technology.

Read More

Appointments and advancements for June 6, 2023

New hires and promotions in the biopharma industry, including: Carmot, Cellarity, Essa, Janux, Kallyope, Kronos, T-Curx. Read More

Conference data for June 6, 2023: ASCO

New and updated preclinical and clinical data presented by biopharma firms at the American Society of Clinical Oncology annual meeting, including: Affimed, Allogene, Amgen, Apexigen, Astrazeneca, Atreca, Bayer, Blueprint, BMS, Cantargia, Catalym, Chimeric, Cogent, Compugen, CSPC, Cyteir, Day One, Daiichi, Elevation, Elicio, Evaxion, G1, Merck & Co. Read More

Financings for June 6, 2023

Biopharmas raising money in public or private financings, including: Acepodia, Azitra, Lexicon, Thryv, Zura. Read More

In the clinic for June 6, 2023

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Akero, Amolyt, Astrazeneca, Bellerophon, Endo, Enterin, Fogpharma, Harbour, IGM, Immuneering, Newamsterdam, Ractigen, Sirnaomics, Synlogic, Tonix, Vaxess, Vivavision, Walden. Read More

Other news to note for June 6, 2023

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Anew, Ascendis, Biogen, BMS, Denali, Eureka, Idorsia, Medic, Searchlight, Sol-Gel. Read More

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