XTalks

AUGUST 18, 2020

The first, and currently leading, COVID-19 saliva-based test was developed by researchers at Rutgers University, with the test having received FDA approval back in April. Last month, the FDA approved a pooled test for COVID-19 developed by Quest Diagnostics. And now it’s getting approval. It’s sensitive.

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FDA Approval Reagent RNA Genome 90

Pharmaceutical Technology

MARCH 24, 2023

Amgen’s (US) Amjevita (adalimumab) is the first Humira biosimilar, launched in February 2023, and seven other FDA-approved biosimilars are expected to arrive on the US market later this year. In addition, two more Humira biosimilars are currently under FDA review and both are anticipated to launch in 2023.

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FDA Approval Marketing Manufacturing Sales 147

XTalks

NOVEMBER 2, 2023

Amgen’s Wezlana (ustekinumab-auub) has received US Food and Drug Administration (FDA) approval as a Stelara biosimilar for the treatment of several inflammatory diseases including Crohn’s disease, ulcerative colitis (UC), plaque psoriasis and psoriatic arthritis. This gives it a significant edge over a simple biosimilar designation.

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FDA Approval Production Dermatology Sales 59

Pharmaceutical Technology

JULY 21, 2022

Aprecia Pharmaceuticals’ Spritam, an anti-epileptic drug, is the first and only 3D-printed pharmaceutical, having received US Food and Drug Administration (FDA) approval in 2015. While large pharma companies have been slow in this area, Merck and GSK are now using 3D printing for clinical trials and manufacturing.

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FDA Approval Pharma Companies Drugs Clinical Trials 245

World of DTC Marketing

MAY 3, 2022

Soon they decided that their office in Westin wasn’t good enough for a company with such a sterling reputation, so they spent a massive amount of money building an HQ in Cambridge. They became a big pharma company and lost some of the people who made Biogen such great biotech. 4our: The FDA advisors and Aduhelm.

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Pharma Companies Drugs FDA Approval Production 207

Delveinsight

FEBRUARY 9, 2021

Earlier, the life expectancy of a person with HIV was only one-two years from the time of diagnosis, however, the collaboration of the pharma companies and the scientific community have made strides of improvement in the domain. A lot has been achieved in the HIV treatment market sphere.

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FDA Approval Marketing Research Protein 52

Pharmaceutical Technology

SEPTEMBER 2, 2022

The rate of drug approvals could be on the rise. In a recent report, GlobalData revealed that the US Food and Drug Administration (FDA) approved 122 new drug applications (NDAs) and biologic license applications (BLAs) in 2021. There are many reasons why a company might prefer to keep commercialisation activities inhouse.

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Drugs Pharma Companies Sales Production 130

Pharmaceutical Technology

SEPTEMBER 2, 2022

Since the frontline treatment setting is dominated by these regimens, pharma companies have focused on the development of new drugs in the relapsed/refractory (R/R) setting. lenalidomide) + a steroid ± an anti-CD38 antibody.

Antibody 147

Antibody Sales FDA Approval Production 147

World of DTC Marketing

JUNE 2, 2021

SUMMARY: Doctors said they were dissatisfied were marketing emails (46%), telephone sales calls with sales reps (42%), and both webinars and websites (each at 39%) from pharma companies, according to Indegene. That should, however, not discourage the use of email to HCPs. 100 percent of U.S. ” 2wo: Keep it simple.

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Doctors Doctor Sales Marketing 180

Drug Discovery World

MAY 1, 2024

This is reflected in collaboration and investment patterns; in 2023, Antiverse, a biotechnology company developing a computational antibody drug discovery platform, raised seed funding totalling £1.4 million, comprising new investment and match funding from the UKI2S Innovate Accelerator.

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Antibody FDA Approval Drugs Development 59

Pharmaceutical Technology

JUNE 30, 2022

While private pharma companies also take part in such efforts, their efforts has largely been limited to donating assets or distributing treatments. However, some big pharma players have a history of donating some treatments to the cause, he explains. For example, Merck & Co.

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Pharma Companies FDA Approval Development Drugs 162

World of DTC Marketing

JANUARY 1, 2022

1ne: The value proposition of prescription drugs still outweighs potential side effects – Wegovy’s demand quickly exceeded supply after the FDA approved once-weekly semaglutide injections. 3hree: Pharma will increase its spending in digital, but a lot of the money will be wasted.

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Marketing Doctors Doctor FDA Approval 244

World of DTC Marketing

JANUARY 10, 2022

Pharma companies are flush with cash and looking to make deals, but there are still a lot of small biotech companies that don’t have enough money to launch their products entirely. According to the study in JAMA “the FDA approved 355 new drugs and biologics over the study period. million (95% CI, $683.6

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Production Drugs Development Marketing 213

XTalks

DECEMBER 20, 2023

And this year Eli Lilly stepped into the obesity drug market with its own GLP-1 weight loss drug Zepbound (tirzepatide), which the US Food and Drug Administration (FDA) approved in November of this year. GSK Canada chose Gretzky for his iconic status and the influence he has on the Canadian public, especially those over 60.

Life Science 59

Life Science Clinical Trials Clinical Trials FDA Approval 59

pharmaphorum

AUGUST 4, 2022

Ten months after ChemoCentryx scored an unexpected FDA approval for autoimmune disease therapy Tavneos, Amgen has swooped in with a $3.7 billion bid to buy out the company. The drug is already approved in Japan for ANC vasculitis, but is sold there by Kissei Pharma, while Otsuka has commercial rights to it in Canada.

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Sales FDA Approval Pharma Companies Drugs 91

XTalks

AUGUST 21, 2023

The FDA also issued a Rare Pediatric Disease Priority Review Voucher (PRV) to Ipsen that can be used for subsequent drug applications that would not qualify for a priority review. The FDA approval of Sohonos is a breakthrough for the US FOP community,” said Howard Mayer, head of R&D at Ipsen, in the company’s news release.

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Drugs FDA Approval Genetics Clinical Trials 98

Placebo Control

JULY 31, 2013

Consider this example trial: Phase 3 trial completes January 2010 Certification of delayed results obtained December 2010 (compliant) FDA approval June 2013 Results posted July 2013 (compliant) In looking at the JCO paper's methods section, it really appears that this trial would be classified as reporting results 3.5

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Pharma Companies Trials Compliance Clinical Trials 40

World of DTC Marketing

JANUARY 24, 2022

To them, a big payday is a small biotech firm being acquired by a big ten pharma company. When they tell small biotech companies to cut costs, there will often be a significant delay in getting the drug to market or massive layoffs of needed staff. Venture capitalists often don’t look that far forward.

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Life Science Drugs Genetic Disease Development 225

XTalks

SEPTEMBER 28, 2023

While digital media, such as short video formats on social media platforms, is being adopted by many segments and industries, pharma advertising remains more traditional, with print and TV advertising continuing to be favored by pharma companies.

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Drugs Allergies Branding FDA Approval 105

pharmaphorum

DECEMBER 21, 2021

Novartis has joined the ranks of big pharma companies developing TIGIT-targeted drugs for cancer, and found its candidate in an existing partner, Chinese biotech BeiGene. Pharma companies are looking at whether blocking TIGIT as well as PD-1/PD-L1 can improve the efficacy of cancer immunotherapy.

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Drugs Antibody Pharma Companies Development 94

pharmaphorum

DECEMBER 14, 2021

Eyebrows have been raised about the timing of the offer, just ahead of that readout, but Pfizer may be looking to lock in the deal early given interest in Arena among other big pharma companies. Pfizer’s bid comes just weeks after it agreed a smaller bolt-on deal to buy immuno-oncology specialist Trillium Therapeutics for $2.3

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FDA Approval Pharma Companies Production Drugs 97

XTalks

MARCH 29, 2022

Jazz Pharmaceuticals’ cannabidiol (CBD) drug Epidiolex became the first US Food and Drug Administration (FDA)-approved cannabis-based medication in 2018. The Dublin-based pharma company Jazz focuses on developing therapeutics in the neuroscience and oncology spaces.

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Medicine Manufacturing Sales FDA Approval 111

XTalks

FEBRUARY 21, 2024

There are currently no FDA-approved drug therapies for MASH, and the disease is characterized by excess fat accumulation and inflammation in the liver, which leads to liver scarring or fibrosis. MASH is known to occur in an estimated three to five percent of adults in the US.

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Clinical Trials Clinical Trials Trials Insulin 59

pharmaphorum

FEBRUARY 1, 2022

Across the industry, pharma companies are turning to AI and real-world data to address many of the challenges of running clinical trials. He has worked on Visensia, the world’s first FDA-approved multivariate patient monitoring system, and the SEND system, which is now used to monitor 20,000 patients each month in the NHS.

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Clinical Trials Clinical Trials Trials Engineer 96

XTalks

JANUARY 4, 2024

Some Investigational New Drugs in Clinical Trials for Glaucoma Skye Bioscience is a pharma company dedicated to developing a synthetic cannabinoid derivative for glaucoma treatment. Furthermore, in 2022, Thea Pharma’s Iyuzeh (latanoprost ophthalmic solution) 0.005 percent was granted FDA approval for IOP reduction.

Clinical Trials 59

Clinical Trials Clinical Trials FDA Approval Trials 59

pharmaphorum

NOVEMBER 23, 2022

uniQure and CSL have become the first pharma companies to get regulatory approval for a gene therapy for haemophilia B anywhere in the world, after the FDA cleared their Hemgenix therapy for adults with the bleeding disorder in the US. link] pic.twitter.com/QWy0WgNGQu. — uniQure (@uniQure_NV) November 22, 2022.

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Gene Therapy Gene FDA Approval Trials 59

Camargo

NOVEMBER 11, 2020

In November 2017, Foundation Medicine received approval for FoundationOne CDx , a genomic profiling test for solid state tumors, which paved the way for partnerships with pharma companies’ therapeutics. In 2019, Foundation Medicine and Bayer Healthcare Pharmaceuticals, Inc.

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Development Bioequivalency Generic Drugs Production 242

Delveinsight

AUGUST 2, 2020

Helsinn Group , a Swiss pharma player, is evaluating Anamorelin, an orally active selective ghrelin receptor agonist against Cancer cachexia, The company is conducting Phase III trial to test the efficacy and safety of anamorelin for the treatment of weight loss and anorexia in patients with advanced NSCLC with cachexia.

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Marketing Pharma Companies Development Hormones 94

pharmaphorum

MARCH 21, 2022

Over the past five years, medical XR companies that were smaller start-ups have evolved into multimillion-dollar enterprises, partnering with pharmaceutical companies to supply digital therapeutic solutions using 3D immersive technology. If pharma joined the event, it would undoubtedly expand the reach of these solutions.

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Behavioural Health Pharma Companies Life Science FDA Approval 96

pharmaphorum

MARCH 2, 2022

Ben Hargreaves discovers why medical research in the area has shifted from being highly controversial to being backed by major pharma companies and venture capital. The latter compound has already been approved for treatment-resistance depression as the product Spravato (esketamine), after being developed by Janssen.

Life Science 102

Life Science Clinical Trials Clinical Trials Trials 102

pharmaphorum

FEBRUARY 15, 2022

Mirvetuximab soravtansine showed efficacy in a phase 3 trial in ovarian cancer patients last November and is due to be filed for FDA approval in the coming weeks. Lilly is thought to be the first pharma company to sign up to use the new camptothecin payload platform.

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pharmaphorum

AUGUST 10, 2021

However, Carlyle is clear what it wants, urging shareholders in the company to vote for its offer and sidestep the potentially damaging consequences of being a pharma company owned by a tobacco group. OtiTopic has said it intends to complete late-stage trials and file for FDA approval of the drug next year.

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Regulation FDA Approval Pharma Companies Marketing 52

Delveinsight

NOVEMBER 29, 2020

Key players such as Novartis , Annexin Pharmaceuticals , Gene Signal , Ocular Therapeutics , and Asclepix Therapeutics along with other pharma companies are investigating their candidates proactively in a quest to launch their therapies as soon as possible in the Retinal vein occlusion market.

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Marketing Pharma Companies Drug Delivery Clinical Trials 52

pharmaphorum

OCTOBER 29, 2020

Gilead Sciences is the first and so far only company to claim FDA approval for a COVID-19 treatment with its Veklury antiviral, and its latest financial results reveal the benefit of that achievement. The bulk of the Veklury sales ($785 million) were in the US, with Europe accounting for a sizeable chunk of the remainder.

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Sales FDA Approval Pharma Companies Vaccination 52

XTalks

DECEMBER 20, 2023

In 2024, pharma companies and emerging biotechs will improve candidate safety profiles and reduce off-target effects by exploiting predictive intelligence unlocked by AI,” she predicts. This year, the very first CRISPR-based therapy received FDA approval for sickle cell disease.

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Life Science Gene Editing Development Clinical Trials 119

XTalks

MARCH 22, 2023

To celebrate this milestone, we’re taking a look back over the last 20 years in the pharmaceutical industry by highlighting some of the most talked-about mergers, blockbuster drugs, trends in FDA approvals and what’s next. Just last year, the FDA approved a one-time gene therapy treatment for hemophilia B priced at $3.5

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Life Science Drugs FDA Approval Vaccination 97

pharmaphorum

AUGUST 4, 2021

This changed with the 2017 release of Biogen’s Spinraza, the first FDA-approved therapy for SMA. This, in turn, has driven a need for clinicians to measure disease progression and understand the patient’s disease trajectory better, both prior to treatment and following any treatment approval. About the author.

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Gene Therapy FDA Approval Pharma Companies Development 145