Pharmacy Times

AUGUST 14, 2023

Niraparib and abiraterone acetate (Akeega; Janssen Pharmaceutical Companies of Johnson & Johnson) is the first-and-only dual action tablet that combines a PARP inhibitor with abiraterone acetate administered with prednisone.

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STAT

MARCH 7, 2023

BOSTON — FDA Commissioner Robert Califf said on Monday that it “bothers” him that Novo Nordisk, which makes an obesity medication, funded the development of obesity coursework for medical schools. Continue to STAT+ to read the full story…

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Pharmaceutical Technology

AUGUST 14, 2023

The FDA has granted approval to the Janssen Pharmaceutical Companies of Johnson & Johnson’s AKEEGA for mCRPC.

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Pharmaceutical Technology

APRIL 14, 2023

The US Food and Drug Administration (FDA) has granted rare paediatric drug designations for IPS HEART’s stem cell therapeutics, GIVI-MPC and ISX9-CPC, to treat Duchenne muscular dystrophy (DMD) patients. The drug candidate received an orphan drug designation (ODD) from the FDA in February 2023.

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STAT

JULY 6, 2023

The drug, called Leqembi , was developed by Eisai , the Japanese pharmaceutical company, and sold in partnership with Biogen. The FDA’s decision will broaden patient access to the drug under the Medicare program and is likely to boost sales, even as Leqembi’s benefits and safety risks continue to be a source of debate.

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The FDA Law Blog

MARCH 6, 2024

John counsels FDA-regulated entities on litigation, enforcement, and compliance matters including FDA inspections, Form 483s, Warning and Untitled Letters and Consent Decrees, internal investigations, and data privacy concerns. FDA Law Blog readers can use discount code S10-866-866L24.S S for reduced registration fees.

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pharmaphorum

OCTOBER 4, 2022

The FDA has approved Swiss pharmaceutical company Roche’s first companion diagnostic for identifying those patients with HER2 low-metastatic breast cancer who are eligible for ENHERTU. The post Roche gets FDA approval for HER2 breast cancer diagnostic appeared first on.

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European Pharmaceutical Review

JANUARY 8, 2024

Commercial manufacturing of Novartis’ radioligand therapy Pluvicto TM (INN: lutetium ( 177 Lu) vipivotide tetraxetan / USAN: lutetium Lu 177 vipivotide tetraxetan) at its largest and most advanced manufacturing facility for these treatments manufacturing in the world, has been approved the US Food and Drug Administration (FDA).

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STAT

NOVEMBER 22, 2022

The one-time treatment, called Hemgenix, was developed by the Dutch biotech company UniQure and will be marketed by CSL Behring, an Australian pharmaceutical company. The Food and Drug Administration on Tuesday approved the first gene therapy to treat people with hemophilia B, an inherited bleeding disorder.

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The Checkup by Singlecare

MARCH 8, 2024

While nonbiologic drugs are made with chemicals and have a known structure, most biologics are complex mixtures and cannot be easily identified or characterized, according to the Food & Drug Administration (FDA). Continue reading to learn more about FDA approved Humira biosimilars, which are made by various drug companies.

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The People's Pharmacy

MAY 8, 2023

Why, then, are FDA inspections abroad so infrequent and disappointing? FDA Inspections Suspended: During the COVID pandemic, the Food and Drug Administration suspended its inspections at most foreign pharmaceutical facilities. Even under the best of conditions, the FDA never inspects all foreign pharmaceutical plants annually.

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Pharmafile

JANUARY 16, 2023

International pharmaceutical company, Luye Pharma, has announced that Rykindo® has received FDA approval for the treatment of schizophrenia in adult patients, and alongside lithium or valproate for the treatment of bipolar 1 disorder in adult patients.

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Digital Pharmacist

OCTOBER 24, 2022

CDER relies on its understanding of science and regulatory procedures to support and provide advice to pharmaceutical companies in testing and manufacturing, to then bring these new therapies to the market to aid patients and their health. The FDA granted the approval of Relyvrio to Amylyx Pharmaceuticals Inc.

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Birth Control Pharmacist

APRIL 18, 2023

In June 2022, the AMA urged the FDA to approve an OTC contraceptive method with no age restriction. In order for a drug to be approved for OTC use by the FDA, certain criteria must first be met. The next step is having a pharmaceutical company manufacture a product that can be FDA-approved for OTC use.

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STAT

JANUARY 6, 2023

The drug, called Leqembi, was developed by Eisai , the Japanese pharmaceutical company that also developed the first symptomatic treatment for Alzheimer’s 25 years ago. Read the rest…

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pharmaphorum

JULY 21, 2022

Now FDA on-site inspections have resumed, with regulatory authorities returning to physical sites. Throughout the pandemic, the lack of FDA inspections has created new challenges and heightened existing problems, largely due to delays in upgrading legacy facilities. Implementing Pharmaceutical Quality systems.

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Pharmaceutical Technology

APRIL 3, 2023

HUTCHMED (China) has completed the new drug application (NDA) rolling submission to the US Food and Drug Administration (FDA) for fruquintinib to treat refractory metastatic colorectal cancer (CRC). Fruquintinib is an important treatment option for patients with metastatic CRC in China, where it has been available to patients since 2018. “We

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STAT

JANUARY 19, 2023

In a stunning rebuke, the Food and Drug Administration accused a drugmaker of a “cascade of failures” for a litany of quality-control problems at a manufacturing plant, the latest instance in which the regulator has castigated an Indian pharmaceutical company for such lapses.

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Pharmaceutical Technology

OCTOBER 26, 2022

The US Food and Drug Administration (FDA) has granted approval for the Janssen Pharmaceutical Companies of Johnson & Johnson ’s (J&J) Tecvayli (teclistamab-cqyv) to treat relapsed or refractory multiple myeloma in adults.

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STAT

SEPTEMBER 14, 2023

The Federal Trade Commission warned pharmaceutical companies they could face legal action if they improperly list patents for brand-name medicines in a Food and Drug Administration registry, the latest effort by the federal government to scrutinize patent moves by drugmakers.

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STAT

AUGUST 22, 2023

German drugmaker Boehringer Ingelheim is the latest pharmaceutical company to sue the federal government over a law that would allow Medicare to negotiate certain drug prices, Reuters reports.

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STAT

NOVEMBER 18, 2022

… Pharmaceutical companies could be made to disclose prices and deals for products they make to fight future global health emergencies, under new rules that would govern a World Health Organization-backed pandemic accord , Reuters reports. Or you may want to take stock of your life. Well, whatever you do, have a grand time.

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STAT

SEPTEMBER 26, 2022

In an effort to sway the Food and Drug Administration not to withdraw accelerated approval of Makena, a drug developed to prevent preterm birth that does no such thing, a pharmaceutical company owned by a private equity company is making the specious argument that the drug should be kept on the market because it may — the emphasis is mine — (..)

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The Checkup by Singlecare

APRIL 17, 2024

Food and Drug Administration (FDA) approved Wegovy for adults and children 12 years and older who have a body mass index (BMI) of 30 or higher or who have a BMI of 27 or higher with a related medical condition, such as high blood pressure, Type 2 diabetes, or high cholesterol. Medicare prohibits Part D plans from covering certain medications.

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Pharmaceutical Technology

AUGUST 2, 2022

The US Food and Drug Administration (FDA) has granted approval for the Janssen Pharmaceutical Companies of Johnson & Johnson (J&J) ’s Stelara (ustekinumab) to treat paediatric patients aged six years and above with active psoriatic arthritis (PsA).

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Pharmafile

MARCH 22, 2023

Swiss biotech company Roche has announced a collaboration with US pharmaceutical company Eli Lilly to develop Roche’s Elecsys Amyloid Plasma Panel (EAPP), which will be used to test for Alzheimer’s disease before symptoms arise. In July 2022, EAPP was awarded FDA Breakthrough Device Designation. read more

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Pharma Mirror

OCTOBER 4, 2021

Despite untold investment by numerous pharmaceutical companies, FDA-approved drugs that target critical brain functions and conditions like anxiety, depression, and sedation continue to present severe and unpredictable side effects, including suicidal ideation.

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Outsourcing Pharma

FEBRUARY 22, 2022

A representative from the HIV-centered pharmaceutical company shares thoughts and perspective on the every-two-month treatment and how it might help patients.

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STAT

OCTOBER 25, 2022

… Pharmaceutical companies promise that online prescribing will improve access for patients, but health policy experts worry that gaps in regulatory oversight leave patients vulnerable to the unique risks of the approach , STAT explains. We will leave it up to you to decipher this blend.

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Pharma Marketing Network

MAY 3, 2023

First, it is important to understand the different regulatory agencies that govern pharmaceutical marketing. The United States Food and Drug Administration (FDA) is the primary regulatory agency that oversees the approval, promotion, and advertising of drugs.

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Pharmaceutical Technology

JUNE 7, 2023

Eli Lilly has achieved significant gains in the past quarter, leading to it becoming the most valuable pharmaceutical company in the world, with a market cap of $420bn, surpassing Johnson & Johnson. A decision from the FDA is possible for later this year, with Lilly currently finalizing an application for fast-track approval.

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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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pharmaphorum

JANUARY 17, 2022

After securing FDA approval for Wegovy last year, Novo Nordisk is strengthening its position in the obesity space through a collaboration with EraCal Therapeutics. We are excited to join forces with the world-leading pharmaceutical company in the cardiometabolic space and together lead innovation to transform the standard of care.”.

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STAT

SEPTEMBER 9, 2022

… Running clinical trials remotely or virtually can provide substantial financial savings for pharmaceutical companies, STAT writes, citing a new pilot study. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon.

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European Pharmaceutical Review

MARCH 11, 2024

For example, rising ambient temperatures and ingress of mould from items entering cleanrooms, has resulted in some vaccine and pharmaceutical companies in Europe experiencing increased contamination. The authors also shared: “in the last three years [since 2023], the US FDA has recalled several drugs due to fungal contamination.”

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Pharma Marketing Network

JULY 10, 2023

Pharmaceutical marketing is the process of communicating the benefits of a pharmaceutical product to potential patients and healthcare providers. It can be a complex and challenging process, as pharmaceutical companies must adhere to strict regulations while also developing creative and effective marketing campaigns.

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European Pharmaceutical Review

FEBRUARY 27, 2024

Novel biosimilar approval In the same month, the US Food and Drug Administration (FDA) approved Amgen’s Wezlana (ustekinumab-auub) as the first biosimilar to reference blockbuster drug Stelara (ustekinumab).

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