pharmaphorum

FEBRUARY 14, 2024

Discover how artificial intelligence (AI) is revolutionising the drug development process and transforming the way FDA-approved drugs are produced, ensuring compliance and optimising the supply chain. Learn more about the future of AI in pharmaceuticals.

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FDA 129

STAT

MARCH 14, 2024

What happens when an approved drug doesn’t work? Bioethicist Holly Fernandez Lynch joins us to discuss the case of Amylyx Pharmaceuticals’ treatment for ALS and what its failure means for drug development. Why don’t patients want gene therapy? And is MASH still a big deal? Read the rest…

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Fierce Pharma

APRIL 17, 2024

After proving the merits of its drug delivery platform last year with the approval of Teva’s long-acting schizophrenia drug Uzedy, France’s Medincell has hooked another big-name partner. Medincell and AbbVie inked a development and licensing pact to create up to six long-acting injectables, Medincell said Wednesday.

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STAT

MARCH 8, 2024

People experiencing mental health conditions are prescribed various drugs until one (or a combination) finally works — a painful process that can take years. Despite significant efforts, progress in psychiatric drug development has remained disappointingly slow. In many ways, psychiatry is still flying blind.

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IDStewardship

APRIL 14, 2024

Gut dysbiosis has been the subject of several clinical research studies aiming to better understand its role in rCDI and to ultimately apply that understanding towards the development of preventative treatments. Rebyota, a solution delivered via enema, was the first FMT product to be FDA-approved.

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STAT

FEBRUARY 26, 2024

As drugmakers race to join the obesity drug market ignited by the approval of Wegovy and Zepbound , they’re not just competing on their drugs’ weight loss effects. They’re also competing on their products’ ability to treat a severe form of liver disease.

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Compounding 138

STAT

NOVEMBER 13, 2023

has approved a preventive drug for post-menopausal women at risk of developing breast cancer wasn’t a shock to breast medical oncologist Abenaa Brewster. The news that the U.K. But the fact that a patient in her breast cancer prevention clinic hadn’t ever heard of such a possibility before was.

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FDA 141

STAT

APRIL 11, 2024

The inside story of Enhertu’s pan-tumor approval Cancer drug history was made last Friday. Enhertu, the blockbuster antibody-drug conjugate discovered by Daiichi Sankyo and co-developed by AstraZeneca, was approved in the U.S. Send me thoughts, comments, and questions to  BiotechScorecard@statnews.com.

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STAT

OCTOBER 6, 2023

Earlier this year, Food and Drug Administration Commissioner Robert M. Califf proposed something radical: that private health care insurance companies (payers) should participate in clinical research on FDA-approved drugs. Bringing payers into clinical research could help solve these problems.

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European Pharmaceutical Review

APRIL 26, 2024

“approval [of Pyzchiva ® (biosimilar ustekinumab)] of is a crucial step towards offering European patients an additional safe and effective treatment option” Pharmaceutical company Sandoz has announced that the European Commission (EC) has granted marketing authorisation for Pyzchiva ® (biosimilar ustekinumab ).

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Packaging Pharmaceutical Companies Pharmaceutical Companies FDA 78

STAT

MARCH 18, 2024

The biggest enticement that large pharmacy benefit managers offer to the employers that hire them is drug rebates — a steady stream of money sent back to their clients, a tangible symbol of the discounts that PBMs are able to wrangle out of pharmaceutical companies. Continue to STAT+ to read the full story…

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STAT

MARCH 14, 2024

The Food and Drug Administration on Thursday approved the first medicine developed specifically to treat the serious liver disease known as MASH. The pill, called Rezdiffra, is made by Madrigal Pharmaceuticals. Metabolic dysfunction-associated steatohepatitis, or MASH, is often associated with obesity.

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FDA 133

European Pharmaceutical Review

JANUARY 11, 2024

Quotient Sciences leverage more than 30 years of drug development expertise to support small molecule and synthetic peptide drug programmes, in both simple drug programmes as well as complex cases where specialised formulation expertise and technologies are required.

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STAT

NOVEMBER 28, 2023

Hormone replacement therapies have long been approved by the Food and Drug Administration for use by cisgender patients, such as women who take estrogen when going through menopause. 17 in lieu of a live pre-investigational new drug meeting. 17 in lieu of a live pre-investigational new drug meeting.

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STAT

APRIL 8, 2024

Food and Drug Administration has agreed to review a rare disease drug developed by a small company that planned to shelve further work if the agency did not take this long-sought step. However, the FDA did not issue a priority review, which could delay approval. Continue to STAT+ to read the full story…

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FDA 91

STAT

JANUARY 16, 2024

The Food and Drug Administration on Tuesday approved a CRISPR-based medicine to treat beta thalassemia, an inherited blood disorder. The expanded approval of the therapy, called Casgevy, was widely expected but came two months ahead of the FDA’s decision deadline, known as a PDUFA date.

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FDA 139

STAT

MARCH 12, 2024

The Food and Drug Administration is expected to approve the first medicine developed specifically to treat the serious liver disease known as MASH as soon as this week. The pill, called resmetirom, is made by Madrigal Pharmaceuticals.

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STAT

FEBRUARY 6, 2024

Last week, Biogen announced it will cease both the study and sale of Aduhelm, its FDA-approved monoclonal antibody for the treatment of Alzheimer’s disease. Its decision, the company explained, is not a response to new data about the drug’s safety or efficacy, but instead “a reprioritization of resources.”

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FDA 143

STAT

DECEMBER 22, 2023

Bristol Myers Squibb said Friday that it will acquire Karuna Therapeutics, a developer of medicines for neuropsychiatric conditions, for $14 billion. The centerpiece of the transaction is a drug called KarXT to treat schizophrenia. The deal values Karuna at $330 per share, or a 53% premium to its Thursday share price.

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STAT

MARCH 5, 2024

LONDON — Novo Nordisk’s diabetes medication Ozempic cut the risk of patients developing advanced kidney disease or dying from kidney or heart complications, the company said Tuesday, adding to the evidence the wildly popular drug has broader health benefits for patients beyond addressing their diabetes. and Europe.

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Insurance 145

STAT

APRIL 23, 2024

Gene editing and therapy to replace missing or defective genes is one of the most exciting recent medical developments, offering tremendous hope for people with rare diseases and genetic conditions. The Food and Drug Administration has approved several gene therapies for rare diseases through the accelerated pathway.

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FDA 92

STAT

APRIL 25, 2024

The need-to-know this morning AstraZeneca reported first-quarter  sales and profits  that topped analyst estimates, buoyed by its blockbuster cancer drugs. Regeneron Pharmaceuticals and Mammoth Biosciences are  partnering  to develop new CRISPR-based gene therapies.

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Hospitals 102

STAT

OCTOBER 4, 2023

No medication is approved to treat addiction to either methamphetamine or cocaine. But the Food and Drug Administration is taking steps to fill that glaring gap in addiction medicine.  While the country’s current drug overdose crisis is largely driven by opioids, stimulant use has skyrocketed in recent years.

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FDA 134

STAT

APRIL 2, 2024

Verve Therapeutics said Tuesday that it is pausing testing of its closely watched gene-editing treatment for high cholesterol after a patient receiving the drug experienced elevated liver enzymes and low platelet levels. Continue to STAT+ to read the full story…

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Compounding 111

European Pharmaceutical Review

JANUARY 2, 2024

Over the past several years, the pharmaceutical industry has faced challenges regarding quality assurance in drug development, the author asserted. highlighted that “in the EU market, a relatively low number of approved pharmaceutical products adopted the QbD methodology or describe QbD elements in their regulatory submissions.”

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Documentation 97

pharmaphorum

MARCH 10, 2017

There is a move toward greater collaboration in health technology assessment and more transparency between countries for pricing, therapeutic protocols and and details of negotiations with drug manufacturers.

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pharmaphorum

DECEMBER 19, 2023

Big pharma companies like Pfizer are making significant investments in antibody-drug conjugates, a promising class of therapies. This article explores the growing interest and recent developments, including FDA approvals and the potential impact on the pharmaceutical industry.

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FDA 115

STAT

NOVEMBER 16, 2023

The Food and Drug Administration on Wednesday approved a new treatment for people with non-small cell lung cancer that contains a rare genetic alteration called Ros1. It was developed by a small biotech company, Turning Point Therapeutics, that was acquired by Bristol in June 2022.

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Pharmacy Times

NOVEMBER 16, 2022

Generic small molecule drugs take advantage of abbreviated approval pathways and have markedly lower development costs compared to their reference products.

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STAT

OCTOBER 16, 2023

People with obesity often go underrepresented in drug development trials, a critical gap that researchers say leaves drugmakers and doctors unsure of efficacy or risks in that patient population. “People with obesity are underrepresented in clinical trials for drug approval.” ” Read the rest…

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Pharmafile

FEBRUARY 29, 2024

The drug is a first-in-class oral, Factor D inhibitor developed as an add-on to standard-of-care Ultomiris (ravulizumab) or Soliris (eculizumab) for the […] The post AstraZeneca’s Voydeya recommended for approval in EU by CHMP appeared first on Pharmafile.

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STAT

MARCH 26, 2024

Librela was approved by European regulators in 2020 and in the U.S., But at the same time that Zoetis was developing its drug, it acquired another late-stage treatment for the same use, and this was supposed to be sold in the European Economic Area by another company. where Zoetis is headquartered, in 2023.

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Outsourcing Pharma

DECEMBER 14, 2023

Mission Therapeutics, a clinical-stage biotech developing first-in-class therapeutics targeting mitophagy, has received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) to proceed with a phase 2 trial for its kidney treatment MTX652.

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FDA 94

STAT

FEBRUARY 12, 2024

billion, adding a new treatment for a liver disease that is on track for approval later this year. That’s a relatively small takeout premium, but CymaBay shares have doubled in value since last fall on growing investor confidence in the company’s lead drug and speculation that the company could be acquired.

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Fierce Pharma

JANUARY 24, 2024

Another prostate cancer trial has hit its main goal, and yet the drug developer can’t immediately file for an FDA approval. |

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FDA 73

STAT

APRIL 8, 2024

Food and Drug Administration agreed to review an application for a rare disease drug developed by a small company that planned to shelve further work if the agency did not take this long-sought step , STAT says. The FDA will also hold an advisory committee meeting.

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FDA 93

Fierce Pharma

NOVEMBER 9, 2023

Takeda won FDA approval for the Hutchmed-developed colorectal cancer drug Fruzaqla. Takeda won FDA approval for Hutchmed-developed colorectal cancer drug Fruzaqla. AstraZeneca licensed an oral GLP-1 agonist from China's Eccogene. AstraZeneca licensed an oral GLP-1 agonist from China's Eccogene.

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FDA 75