An FDA inspection in March at Lupin’s production in Pithampur, India, revealed quality and other functionality issues.
The FDA’s 13-page 483 inspection report primarily notes the site’s inability to document device deviations or problems that occurred in production and packaging. Lupin had not conducted any investigation, tested for threats or taken preventive measures for the outages, according to the report.
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In just over 2 years, the vaccine progression window has gone from 8 to 10 years to 260 days. Today, the industry contemplates a response time of 60 days. After COVID-19, the industry is in a position to expand treatments in almost all areas of healing, adding infectious diseases, oncology, rare diseases, CNS, autoimmune diseases, etc.
Novotech recently brought combined leaders in the vaccine industry into the percentage classes learned and what long-term vaccine development holds.
Welcome to mRNAge. That’s the concept introduced today by Moderna’s new global advertising crusade.
In the first television commercial, a red thread turns into a ribbon and makes its way through a series of vignettes that intersect with Moderna’s mRNA technology. For example, a pregnant woman on the subway is a nod to her paintings about cytomegalovirus (CMV), while a teenager playing video games with friends in a hospital bed indicates her ambitions in rare diseases. A woguy ringing a bell after treatment is linked to his work on cancer, while young African women play football and a man driving a race car constitute his immediate global jobs. about vaccines.
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Before Pfizer’s $43 billion acquisition of Seagen’s $43 billion deal last month, the biotech company had secured acquisitions dating back to at least 2019, according to a new document that provides a detailed look at one of the most significant M&A deals in recent years. of the industry
Preparations for the $43 billion merger were filled with multiple attempts through a drugmaker to buy Seagen, an effort that eventually collapsed in value and was interrupted with the arrest of then-biotech CEO Clay Siegall over allegations that he assaulted his wife. And after Siegall’s ouster, the dossier mainly points to a festival between rival drugmakers — one of which appears to be Merck — that ultimately ended with Pfizer’s victory.
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Pharmaceutical giant Eli Lilly is investing further in an expansion in its home state of Hoosier, with a $1. 6 billion expansion for two new production sites.
The sites, in the LEAP Lebanon Research and Innovation District in Boone County, Indiana, about 30 miles northwest of Lilly’s headquarters in Indianapolis, have already noticed a $2. 1 billion injection, marking a total investment of $3. 7 billion.
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Many wondered how the biopharmaceutical industry could sue CMS over its new drug price negotiation plans, and the PhRMA organization presented a hint with a new commentary on the implementation of the negotiating provisions of the Inflation Reduction Act.
The segment of guidance in question, known as segment 40. 2. 2, tells biopharmaceutical brands that CMS intends to require that all data gained in the CMS commercial era “be destroyed within 30 days of CMS’s determination that the drug or biologic is no longer considered a decided drug, unless required by state or applicable federal law. »
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The FDA’s 12-member Antimicrobial Drug Advisory Committee voted unanimously Monday afternoon in favor of an antibiotic candidate from Entasis Therapeutics, which has a favorable benefit-risk profile for treating patients with two hospital-related bacterial pneumonias.
Entasis submitted the antibiotic to the FDA for approval of the candidate, known as sulbactam-durlobactam, to treat nosocomial bacterial pneumonia (BPH) and ventilator-associated bacterial pneumonia (VABP), caused by strains of Acinetobacter baumannii-calcoaceticus. complex.
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The FDA on Monday approved Israel Gamida Cell’s Omisirge (omidubicel-onlv), an allogeneic blood-based mobile treatment used to speed mobile white blood cell recovery in cancer patients.
The approval of the single intravenous dose, which consists of allogeneic human stem cells from a donor’s umbilical cord blood that are treated and cultured with nicotinamide (a form of vitamin B3), was discovered in a study of 125 subjects with blood cancer. The study, according to the FDA, found that 87% randomly assigned to receive Omisirge achieved neutrophil recovery an average of 12 days after treatment with the product. a median of 22 days.
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Returning to a 2016 label for the abortion tablet mifepristone, a ruling requested through a federal appeals court last week, would “create significant chaos” and take at least months to implement, the FDA told the Supreme Court in a filing late Friday.
The comments follow the Supreme Court’s ruling late Friday to temporarily suspend a questionable ruling through a Texas court, until Thursday, that would overturn the approval of mifepristone.
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Sometimes, celebrities are also caretakers. The actor and Henry Winkler, best known for his ’70s TV role as “The Fonz,” fits that description and now talks about a complex form of macular degeneration following his relationship with his stepfather.
Winkler is working with Apellis Pharmaceuticals as a spokesperson for its “GA Won’t Wait” geographic atrophy (GA) disease awareness crusade that begins with media interviews and social media posts, but expands to include radio and television ads later this year.
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