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Coherus, Junshi eye FDA finish line after agency finally conducts plant inspection

It’s been a long road for PD-1 partners Coherus BioSciences and Junshi Biosciences since their FDA rejection for cancer drug toripalimab more than a year ago, but the companies appear to be nearing the regulatory finish line in the U.S.Wednesday, Coherus said in a Securities and Exchange Commission filing that the U.S. FDA “successfully completed the required pre-licensing inspection” of Junshi’s manufacturing site in China. The FDA made three observations about plant deficiencies, but Coherus believes those are “readily addressable.” The partners plan to submit their response to the FDA in the coming weeks. Coherus says it’s planning to launch toripalimab in the U.S. after a potential FDA approval. The inspection comes after multiple regulatory delays. In May 2022, the FDA rejected the drug and requested a quality process change. At the time, the companies noted that a resubmission would take about six months because plant inspections had been delayed ...
- Source: drugdu
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- June 5, 2023
EMA grants PRIME designation to Rocket’s AAV-based gene therapy

The European Medicines Agency (EMA) has granted Priority Medicines (PRIME) designation to Rocket Pharmaceuticals’ adeno-associated virus (AAV)-based gene therapy, RP-A501, for the treatment of Danon Disease, a rare X-linked inherited disorder. The designation for the investigational gene therapy was granted based on positive safety and efficacy data from the Phase I study in patients with Danon Disease. A favourable safety profile of RP-A501 was observed with improvements in multiple clinical and highly relevant laboratory parameters including LAMP-2 protein expression. The study also observed reduced autophagic vacuoles, high sensitivity troponin I, brain natriuretic peptide (BNP) and left ventricular mass and wall thickness. In addition, improvement was observed in symptoms and quality of life as measured by New York Heart Association and the Kansas City Cardiomyopathy Questionnaire, respectively. Improvements and normalisation across several quantifiable parameters used by cardiologists in clinical practice to enable risk assessment and treatment decisions were also demonstrated in ...
- Source: drugdu
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- June 5, 2023
FDA approves ANDA of 20mg generic Nitisinone capsules

Nitisinone capsules are indicated for patients with hereditary tyrosinemia type 1 in combination with dietary restriction of tyrosine and phenylalanine Analog Pharma and Dipharma have announced that the US Food and Drug Administration (FDA) has approved their 20mg nitisinone capsules, a generic equivalent of Swedish Orphan Biovitrum’s Orfadin. Analog already distributed the 2mg, 5mg and 10mg doses. Nitisinone capsules are used in the treatment of adult and paediatric patients with hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine. Tanya Carro, executive vice president of Analog Pharma, commented: “With the approval of the 20mg capsule, we now have a full complement of room temperature stable strengths for our generic Nitisinone. Considering that the 20mg is the most commonly prescribed strength of Orfadin, this will bring American patients with HT-1 a room temperature-stable treatment option. The addition of this new dosage form to our portfolio demonstrates ...
- Source: drugdu
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- June 5, 2023
FDA hits iRhythm with warning letter over problems at heart monitor facility

Dive Brief The U.S. Food and Drug Administration has issued a warning letter to iRhythm Technologies after inspectors found fault with practices at a facility that makes its heart monitors. According to iRhythm, the FDA has alleged “nonconformities to regulations for medical devices, including medical device reporting requirements, relating to the company’s Zio AT System and medical device quality system requirements.” iRhythm can continue to manufacture and sell its products and does not expect the warning letter to materially affect its financial results. However, the situation comes at a time when iRhythm is working to continue the recent recovery of sales of Zio AT. Dive Insight FDA inspectors concluded their assessment of iRhythm’s facility in Cypress, Calif. in August 2022. The FDA visit led to a Form 483 later that month. iRhythm took steps to address the concerns raised in the 483 but its actions failed to stop the FDA ...
- Source: drugdu
- 135
- June 4, 2023
Novel technology helps analyze tumor growth in another dimension

Tumors are composed of rapidly multiplying cancer cells. Understanding which biochemical processes fuel their relentless growth can provide hints at therapeutic targets. Researchers from Washington University in St. Louis have developed a technology to study tumor growth in another dimension -; literally. The scientists established a new method to watch what nutrients are used at which rates spatially throughout a tissue. By using this multidimensional imaging approach, they identified pathways whose activities are uniquely elevated in brain cancer, offering clues for potential treatment strategies. The study was published May 19 in Nature Communications. Gary Patti, Michael and Tana Powell Professor of Chemistry in Washington University in St. Louis, said, “We figured out how to infer the rate of biochemical reactions directly from discrete regions of tissue.” Patti, who is also a research member of the Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine, is senior author ...
- Source: drugdu
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- June 4, 2023
report

Swiss pharma giant Roche is looking to put its biologics manufacturing facility in Vacaville, California, on the auction block or shutter it by 2029, Reuters reports. In a statement to Reuters, the company didn’t directly respond to the prospect of selling or closing the facility but said it no longer needs large volumes of the products being manufactured at the site. However, internal emails sent to employees and obtained by the news agency indicated that if a buyer weren’t identified, Roche would begin winding down operations at Vacaville and shutter the plant between 2028 and 2029, Reuters reports. The plant, which employs about 800 people, produces monoclonal antibodies, according to the news service. Roche is currently staving off challenges to its revenue flow thanks to biosimilar challengers to its big-selling cancer drugs Herceptin, Avastin and Rituxan. This has forced the company to rely on newer products to deliver growth. Roche ...
- Source: drugdu
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- June 4, 2023
Former Novartis execs cleared of Greek bribery charges after yearslong investigation

After a yearslong investigation involving politicians and medical professionals alike, Novartis is looking to close the books on its Greek bribery imbroglio. The probe into allegations that the company paid kickbacks between 2006 to 2015 has culminated in Greece’s Council of Misdemeanor Courts clearing four former Novartis executives and a former politician of bribery charges, Greece’s Kathimerini reports. Former Novartis Greece Vice President Konstantinos Frouzis, alongside three other Novartis execs and former Health Ministry adviser Nikos Maniadakis, couldn’t be charged of bribing nonpolitical individuals due to the expiration of the statute of limitations, according to the publication. Ten other politicians were investigated, but no evidence was found to prove passive bribery, according to Kathimerini. Meanwhile, 15 doctors who allegedly received financial benefits for prescribing Novartis drugs have been charged for passive bribery and money laundering, according to the publication. Novartis did not immediately reply to Fierce Pharma’s request for comment. ...
- Source: drugdu
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- June 4, 2023
Novartis receives EC approval for Cosentyx in hidradenitis suppurativa

Novartis’ Cosentyx (secukinumab) has been approved by the European Commission (EC) to treat adults with active moderate to severe hidradenitis suppurativa (HS). Cosentyx, which is now the first new treatment option for the inflammatory skin disease in nearly a decade, is specifically indicated for patients who have had an inadequate response to conventional systemic therapy. There are currently around 200,000 people in Europe living with moderate to severe stages of HS, which causes boil-like abscesses that can burst, creating open wounds and irreversible scarring. Until now, there has only been one approved biologic treatment for HS, with around half of patients potentially losing response to this. Surgery is usually considered in advanced cases to remove abscesses and prevent the disease from spreading further, which Novartis describes as an invasive procedure that frequently results in additional scarring. Currently approved to treat a range of inflammatory conditions such as psoriatic arthritis and ...
- Source: drugdu
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- June 4, 2023
Medicare details plan to cover Alzheimer’s treatments

Medicare Part B will cover treatments for Alzheimer’s disease that receive U.S. Food and Drug Administration approval, according to the federal agency that administers the program for seniors. Anyone who has Medicare Part B and meets “eligibility criteria” will be covered for new antibody treatments such as Leqembi once the FDA approves them, said Chiquita Brooks-LaSure, the administrator of the Centers for Medicare & Medicaid Services, on Thursday. Part B is an optional part of the Medicare program for seniors that typically covers the costs of drugs patients cannot administer themselves, such as infusions. The new policy will provide broader access to treatments, such as Leqembi, that slow cognitive decline. But patients will have to participate in so-called registries that collect real-world data on how the drugs work. Brooks-LaSure said the expanded coverage will go into effect on the same day the FDA approves an Alzheimer’s antibody treatment. The FDA ...
- Source: drugdu
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- June 4, 2023
Amgen centers cancer patients’ voices in new YouTube series

Beth Snyder Bulik Senior Editor In Amgen’s new oncology video series, patient Gina calls her colorectal cancer diagnosis “the best worst thing that’s ever happened to me.” She goes on to talk about her Stage IV diagnosis and initial, terminal prognosis four years ago, but also describes her strong family support system and a group created by her husband around a healing star theme. Gina is one of seven “Patient Points of View” in Amgen Oncology’s new YouTube series, debuting today, and an example of the personal, forthright and unscripted perspectives each person offers. The unbranded campaign includes people with non-small cell lung cancer, small cell lung cancer and gastric cancer as well. Amgen’s goal is to “give them the microphone” to tell their stories for self-empowerment, but also for employees and others who can learn from them, said Michelle Carrillo, executive director of advocacy at Amgen. Several of the ...
- Source: drugdu
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- June 4, 2023

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