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BioWorld - Thursday, June 30, 2022
Home » Topics » Infection, BioWorld

Infection, BioWorld
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US FDA rejects Spero’s oral antibiotic tebipenem, demanding further trial

June 28, 2022
By Richard Staines
No Comments

Spero Therapeutics Inc.’s oral antibiotic, tebipenem Hbr, has been rejected by the U.S. FDA for adults with complicated urinary tract infection, after the regulator said a further trial is needed for approval.


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Osivax stays in the hunt for universal flu vaccine with €10M research grant

June 23, 2022
By Cormac Sheridan
No Comments
Osivax SAS secured €10 million (US$10.5 million) in research funding from Bpifrance to maintain the momentum of its putative universal influenza vaccine program, which is currently undergoing phase II trials.
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Pharmaceutical manufacturing

Moderna invests in UK manufacturing and research, answering call to prep for fast response to future ‘Disease X’

June 22, 2022
By Richard Staines
No Comments
While the biopharma industry was widely praised for its fast response to the COVID-19 pandemic, moves are afoot to ensure that the world is better prepared in case another pandemic hits. Moderna Inc. was one of the companies that blazed a trail in the early stages of the pandemic with its revolutionary mRNA vaccine. Now the firm is investing in manufacturing and R&D in the U.K. to make good on a pledge to respond to the next global disease threat within 100 days of its detection.
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UK signs on to subscription-style plans for new Pfizer, Shionogi antibiotics

June 20, 2022
By Nuala Moran
No Comments
An agreement has been reached in the U.K. to pay a fixed annual fee for two antibiotics, regardless of how often the drugs are prescribed, in a bid to prevent their overuse and slow the development of antimicrobial resistance.
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Syringe-and-tick.png

Pfizer invests €90.5M in Valneva, as Lyme disease vaccine heads for phase III

June 20, 2022
By Richard Staines
No Comments
Valneva SE has struggled to get its COVID-19 vaccine on the market, but efforts to get the first Lyme disease vaccine approved in years now appear firmly on track after partner Pfizer Inc. invested €90.5 million (US$94.9 million) in the project. New York-based Pfizer has been working with Saint-Herblain, France based Valneva on the Lyme disease vaccine since April 2020, when the big pharma bought into the development program for the vaccine candidate codenamed VLA-15 for $130 million.
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Viruses

Infectious disease firms struggle in market downcycle

June 16, 2022
By Karen Carey
No Comments
In sharp contrast with its up and down rhythm of 2021, the BioWorld Infectious Disease Index (BIDI) is mostly down this year, having fallen 63.4% to date. The index ended last year up by 10.4%, which was its lowest point. In 2020, when the SARS-CoV-2 infection became a global focus, BIDI was up by 144%.
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Older patient receiving shot

GSK begins talks with regulators about RSV vaccine in older people, ahead of planned spinout of consumer unit

June 10, 2022
By Richard Staines
No Comments
GSK plc is preparing filings for its respiratory syncytial virus (RSV) vaccine in older people following supportive late-stage trial results, a product which could play a vital role as it spins out its consumer business arm. The vaccine could be a potential blockbuster for GSK, worth as much as $7 billion in peak annual sales if approved in all its potential uses – although trials in pregnant women remain on hold because of safety concerns.
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Synklino secures €29.8M series A financing for CMV-fighter

June 8, 2022
By Nuala Moran
No Comments
Synklino A/S has raised €29.8 million (US$31.8 million) in a series A round to take forward SYN-002, a treatment for cytomegalovirus (CMV) infections in both donated organs and patients undergoing hematopoietic stem cell and solid organ transplants.
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Syringe and ampoules

GSK takes Affinivax in $3.3B deal, MAPS way in pneumococcal disease

May 31, 2022
By Randy Osborne
No Comments
Glaxosmithkline plc (GSK) pledged $2.1 billion up front and as much as $1.2 billion in development milestone payments to take over privately held Affinivax Inc. and bring aboard the phase II-stage, next-generation, 24-valent pneumococcal vaccine candidate, AFX-3772. London-based GSK is buying all outstanding shares of Affinivax, of Cambridge, Mass., for $2.1 billion upon closing the deal in the third quarter of this year, and two potential milestone payments of $600 million to be paid if certain pediatric development goals are reached.
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Drug capsules in petri dish

EMA tackles AMR with revised guidance

May 27, 2022
By Mari Serebrov
No Comments
Facing the global threat of antimicrobial resistance (AMR), the EMA issued a final revised guideline on the evaluation of new antibiotics. In accordance with an agreement with the U.S. FDA and Japan’s Pharmaceuticals and Medical Devices Agency, the EMA’s guideline aligns as much as possible with the data requirements of those regulators so drug developers can design clinical trials that meet the evidence needs of all three agencies, the EMA said.
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