After covid-related delays forced the FDA to delay its China-based inspections, Coherus BioSciences said today that its China-based spouse, Junshi Biosciences, has effectively finished the required pre-approval inspection for its toripalimab PD-1, which is lately being manufactured in China, with 3 observations.
“The company believes that the 3 comments earned at the end of the FDA inspection are available and, together with Junshi Biosciences, plans to submit the response to the FDA in early June,” Coherus said in an SEC filing. The company did not disclose the observations, but the percentage value of Coherus$CHRS fell nearly 8% on Wednesday.
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We live in a new era of healthcare that advances and impacts patient outcomes and experiences. We have noticed a remarkable speed of transformative innovation, implemented studies, and complex clinical progression over the past decade.
Despite this great progress, there is still much work to be done and patients are counting on us, now more than ever, to continue this momentum. challenging diseases, adding those that today have few or no effective remedies.
On Wednesday, the FDA approved Pfizer’s RSV vaccine called Abrysvo for seniors, putting big pharmaceutical corporations on the advertising scene ahead of the next RSV season.
Pfizer’s approval comes weeks after GSK won approval from rival Arexvy. Both vaccines are approved for use in adults 60 and older and will be reviewed through a CDC panel in June ahead of their expected advertising release this fall. Wall Street analysts see RSV as the next multibillion-dollar vaccine market, and Jefferies analysts recently predicted that the RSV market will be $17 billion hit over the next decade.
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Richard Pazdur, director of the FDA’s Center of Excellence in Oncology, attributes the existing shortage of two cancer drugs to pharmaceutical corporations that have invested in building their production capacity.
In an interview with The Cancer Letter, a weekly cancer publication, Pazdur said the existing shortages of cisplatin and carboplatin, a pair of drugs used to treat a wide diversity of cancer patients, is the result of two problems: brands aren’t making an investment in production capacity, and pharmaceutical corporations rely on a single purveyor of raw ingredients. The cisplatin shortage follows an inspection that revealed quality problems at a production plant, which later led to production disruption. for carboplatin, creating a secondary shortage.
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Amylyx Pharmaceuticals’ ALS drug appears to be following a more complicated path in the EU than in the US. USA and Canada.
Biotech announced Tuesday morning that the bloc’s drug review committee, known as CHMP, is expected to have a “negative opinion” and oppose approving the drug next month. If this negative opinion materializes, Amylyx hopes to appeal as part of a “formal review. “”, according to a corporate press release.
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The FDA warned the public that composite versions of the popular GLP-1 drugs Ozempic and Wegovy may not come with the same ingredients as prescription drugs, raising questions about their protection and effectiveness.
The regulator said Tuesday it has obtained reports of adverse events similar to composite versions of semaglutide, the active element in Ozempic and Wegovy. Some products advertised as semaglutide involve the formation of semaglutide salt, which is not considered effective.
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Since the U. S. House of Representatives is expected to be able to do so. As the U. S. votes tonight on a deal that would raise the national debt ceiling, some biopharmaceutical industry advocates are concerned about how proposed budget cuts may be limited to drug research.
The proposed budget deal includes a robust investment for non-defense spending in the upcoming fiscal year and a 1% accrual in fiscal year 2025, which the Association of Clinical Oncology said Wednesday would “significantly limit potential resources for National Institutes of Health”. (NIH) and the National Cancer Institute (NCI) at a time when scientists are on the cusp of so many promising cancer discoveries.
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The FDA imposed a clinical suspension on PepGen’s IND for a drug for myotonic dystrophy 1 (T1DM), halting the company’s plans to introduce a momentary neuromuscular program into the clinic.
PepGen elaborated on what concerns it, saying only that the FDA will provide an official letter within 30 days stating the reasons for the suspension.
Originating from the University of Oxford and supported through RA Capital, PepGen specialises in oligonucleotides (short strands of artificial DNA or RNA molecules) that are delivered with special peptides that enter cells. By conjugating peptides with oligonucleotides, biotechnology promises the absorption and activity of the resulting therapy. .
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As a number of gene treatment startups aim to create remedies without the inevitable back and forth of an AAV virus, and several gene-editing biotechnologies seek to do the same, the said venture is coming to an end.
Summation Bio, subsidized through at least $24 million in Series A funding, is “shutting down operations” next month, according to an update to a worker’s LinkedIn profile. (According to his LinkedIn profile, one worker said the company raised $60 million in the round. )Another worker visited the networking site last week to say the cases were “second to none” and noted that “despite all efforts and error-free execution, the science, this time, was elusive. “
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The UK’s National Institute for Health and Care Excellence (NICE) recommends rimegepant, Pfizer’s oral migraine medication, marketed in the US. It is used in the US as Nurtec and branded in Europe as Vydura. However, there are some restrictions in play.
The public health framework recommends the drug, made through BioHaven before Pfizer acquired the $11. 6 billion company announced last May, but only for those who have at least four migraine attacks a month and no more than 15 in the same time period.
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