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.

Pharmaceutical Companies 138

Pharmaceutical Companies Pharmaceutical Companies FDA 138

Pharmaceutical Technology

JULY 11, 2022

Innoviva has signed a definitive merger agreement for the acquisition of all of the outstanding shares of La Jolla Pharmaceutical Company for $6.23 The lead product of the company, Giapreza (angiotensin II) obtained the Food and Drug Administration (FDA) approval in December 2017.

Pharmaceutical Companies 59

Pharmaceutical Companies Pharmaceutical Companies FDA 59

Pharmacy Times

JULY 13, 2023

The approval of norgestrel tablets (Opill) could open the door to other prescription-to-OTC contraceptive switches, although that remains to be seen as other pharmaceutical companies weigh their options.

Pharmaceutical Companies 123

Pharmaceutical Companies Pharmaceutical Companies FDA 123

STAT

DECEMBER 7, 2023

But like any pharmaceutical company with an eye toward the future, Celgene continued to seek other ways to wring profits from its development work. Not long after the patent was awarded, the company leveraged federally funded research and began investigating different forms of the compound, called Revlimid.

FDA 131

FDA Compounding Pharmaceutical Companies Pharmaceutical Companies 131

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.

Pharmaceutical Companies 123

Pharmaceutical Companies Pharmaceutical Companies FDA 123

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.

FDA 105

FDA Pharmaceutical Companies Pharmaceutical Companies 105

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…

Medical Schools 98

Medical Schools FDA Pharmaceutical Companies Pharmaceutical Companies 98

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.

FDA 98

FDA Pharmaceutical Companies Pharmaceutical Companies 98

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.

FDA 103

FDA Pharmaceutical Companies Pharmaceutical Companies 103

STAT

OCTOBER 31, 2024

With all doses now listed as available, the FDA may soon pull it off the list, depending on its conversations with Novo about whether the company can sufficiently meet demand going forward. The number of layoffs in the U.S. A total of 424 jobs were eliminated in October, far below the 3,073 positions that were cut in September.

Compounding Pharmacies 111

Compounding Pharmacies FDA Compounding Packaging 111

Pharmaceutical Technology

MAY 31, 2023

The Janssen Pharmaceutical Companies of Johnson & Johnson has submitted a new drug application (NDA) for its investigational single-tablet combination therapy of macitentan 10mg and tadalafil 40mg (M/T STCT) to the US Food and Drug Administration (FDA), to treat pulmonary arterial hypertension (PAH).

FDA 98

FDA Pharmaceutical Companies Pharmaceutical Companies 98

Pharma Marketing Network

MARCH 8, 2025

Introduction Pharmaceutical companies are investing heavily in digital advertising , and PPC campaign optimization is key to maximizing ROI while staying compliant. Optimize landing pages to ensure message consistency and compliance with FDA regulations. For more PPC advertising solutions, explore eHealthcare Solutions.

HIPAA 59

HIPAA Pharmaceutical Companies Pharmaceutical Companies FDA 59

The Checkup by Singlecare

MARCH 10, 2025

It is the active ingredient in the brand-name , FDA-approved drugs Ozempic , Wegovy , and Rybelsus. Novo Nordisk is the only pharmaceutical company that makes FDA-approved medications containing semaglutide. Like Ozempic , Rybelsus is sometimes prescribed off-label for weight loss.

Compounding 80

Compounding Dosage FDA Labelling 80

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.

Pharmaceutical Companies 119

Pharmaceutical Companies Pharmaceutical Companies FDA 119

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.

FDA 98

FDA Pharmaceutical Companies Pharmaceutical Companies 98

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…

Pharmaceutical Companies 98

Pharmaceutical Companies Pharmaceutical Companies FDA 98

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.

Generic Medicine 133

Generic Medicine Pharmaceutical Companies Pharmaceutical Companies FDA 133

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 — (..)

Pharmaceutical Companies 107

Pharmaceutical Companies Pharmaceutical Companies FDA 107

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.

Documentation 98

Documentation Pharmaceutical Companies Pharmaceutical Companies FDA 98

Pharmaceutical Technology

JULY 1, 2024

The US FDA has approved speciality pharmaceutical company Shorla Oncology’s NDA for TEPYLUTE to treat breast and ovarian cancer.

FDA 52

FDA Pharmaceutical Companies Pharmaceutical Companies 52

STAT

OCTOBER 17, 2024

As Election Day 2024 gets closer, STAT’s First Opinion asked executives from leading biotech and pharmaceutical companies to reflect on how their industry is being portrayed in the presidential campaign — and what their hopes are for a new presidential administration. You

Pharmaceutical Companies 137

Pharmaceutical Companies Pharmaceutical Companies FDA 137

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.”.

FDA 123

FDA Pharmaceutical Companies Pharmaceutical Companies 123

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.

FDA 75

FDA Adverse Reactions Pharmaceutical Companies Pharmaceutical Companies 75

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.

FDA 72

FDA Pharmaceutical Companies Pharmaceutical Companies Medical Schools 72

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.

FDA 98

FDA Documentation Compounding Pharmaceutical Companies 98

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.

Dosage 97

Dosage Pharmaceutical Companies Pharmaceutical Companies FDA 97

Pharmaceutical Technology

AUGUST 14, 2023

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

FDA 52

FDA Pharmaceutical Companies Pharmaceutical Companies 52

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.

Vaccines 98

Vaccines Pharmaceutical Companies Pharmaceutical Companies FDA 98

Pharmafile

AUGUST 29, 2023

The Janssen Pharmaceutical Companies of Johnson & Johnson has announced the submission of a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) for full approval of Balversa (erdafitinib) for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC).

FDA 52

FDA Pharmaceutical Companies Pharmaceutical Companies 52

Pharma Marketing Network

NOVEMBER 24, 2024

Use relatable metaphors: Think of content as a bridge connecting pharma companies with patients and HCPs. Navigating Regulatory Compliance Pharmaceutical advertising operates under strict regulations. Always adhere to FDA guidelines and include clear disclaimers in campaigns. Non-compliance can cost dearly.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies FDA 52

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.

Pharmaceutical Companies 98

Pharmaceutical Companies Pharmaceutical Companies Labelling FDA 98

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.

Pharmaceutical Companies 98

Pharmaceutical Companies Pharmaceutical Companies FDA 98

STAT

DECEMBER 21, 2023

WASHINGTON — Medical marijuana companies sell medicine, just like pharmaceutical companies. But they’re not playing by the same rules — and that’s putting patients at risk.

Pharmaceutical Companies 144

Pharmaceutical Companies Pharmaceutical Companies FDA 144

STAT

NOVEMBER 23, 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. Food and Drug Administration on Tuesday approved the first gene therapy to treat people with hemophilia B, an inherited bleeding disorder , STAT writes.

FDA 97

FDA Pharmaceutical Companies Pharmaceutical Companies 97

The Checkup by Singlecare

MARCH 10, 2025

The medication is available in both brand-name and compounded forms, although the compounded forms are not FDA approved. Compounded semaglutide is made by special compounding pharmacies rather than pharmaceutical companies. Ozempic, Wegovy, and Rybelsus are the only FDA-approved drugs that contain semaglutide.

Compounding 52

Compounding Insurance Insurance Coverage FDA 52

STAT

OCTOBER 7, 2022

… The drug-pricing law will still penalize pharmaceutical companies if they hike prices on medicines for patients who have private insurance, STAT says. Or you could make time to reach out to someone special and make them feel important. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon.

Insurance 98

Insurance Insurance Coverage Pharmaceutical Companies Pharmaceutical Companies 98

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.

FDA 59

FDA Pharmaceutical Companies Pharmaceutical Companies 59