XTalks

JANUARY 3, 2025

For the first time in the US, adults living with familial chylomicronemia syndrome (FCS) have an FDA-approved treatment option. The approval of Tryngolza was based on positive results from the Phase III Balance trial, which showed reductions in triglyceride levels and acute pancreatitis events.

FDA Approval 59

FDA Approval Drugs Clinical Trials Clinical Trials 59

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.

Pharma Companies 207

Pharma Companies Drugs FDA Approval Production 207

Pharmaceutical Technology

MAY 24, 2023

The FDA approval adds a further treatment avenue to tackle the opioid crisis in the US. Whilst the pharma industry has been relatively slow in developing new treatments – an array of legal challenges posed to pharma companies and pharmacies implicated in the crisis still trundles on.

FDA Approval 147

FDA Approval Pharmacy Pharma Companies Containment 147

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.

FDA Approval 90

FDA Approval Reagent RNA Genomics 90

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.

Marketing 244

Marketing Doctors Doctor FDA Approval 244

pharmaphorum

OCTOBER 10, 2021

ChemoCentryx has claimed FDA approval for its avacopan drug for a rare autoimmune disease, becoming the first orally-active drug that targets the complement C5 receptor. Avacopan is already approved in Japan for ANC vasculitis, which causes inflammation in organs including the kidneys, but is sold there by Kissei Pharma.

FDA Approval 52

FDA Approval Drugs Pharma Companies Clinical Trials 52

XTalks

MAY 29, 2024

The top ten pharma companies in 2023 by revenue accounted for about 35 percent of the market value, with total earnings of $559.5 The top big pharma players have remained relatively consistent in their market positions over the past several years. Here is a look at the top ten pharma companies in 2024 based on 2023 revenue.

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Pharma Companies Sales FDA Approval Vaccine 52

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.

FDA Approval 147

FDA Approval Marketing Manufacturing Sales 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.

Doctors 180

Doctors Doctor Sales Marketing 180

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

AUGUST 22, 2024

XTALKS WEBINAR: RWD to the Rescue: Solving R&D Challenges for Pharma Companies Live and On-Demand: Friday, October 25, 2024, at 11am EDT (4pm BST/UK) Register for this free webinar to learn how real-world data (RWD) can enhance the design and execution of clinical trials, leading to more efficient and effective asset strategies.

Clinical Trials 111

Clinical Trials Clinical Trials FDA Approval Trials 111

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.

Pharma Companies 162

Pharma Companies Development FDA Approval Drugs 162

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.

Life Science 225

Life Science Drugs Development Genetic Disease 225

XTalks

DECEMBER 27, 2022

Ferring Pharmaceuticals announced that the US Food and Drug Administration (FDA) approved Adstiladrin (nadofaragene firadenovec-vncg) for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.

Gene Therapy 52

Gene Therapy FDA Approval Gene Clinical Trials 52

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

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.

Drugs 130

Drugs Pharma Companies Medicine Production 130

XTalks

JANUARY 20, 2025

This strategic move transformed Actavis into one of the largest pharma companies globally, with a strong presence across branded, generic and over-the-counter (OTC) medicines. Actavis Acquisition of Allergan Deal value : $70.5

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Marketing Botox Life Science Pharma Companies 104

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

Pharmaceutical Technology

FEBRUARY 13, 2023

SK Life Science is a subsidiary of SK, a South Korean holding company. GW Pharmaceuticals’ Epidiolex (cannabidiol), the first-FDA approved CBD treatment , is also a valuable addition, he adds. Epidiolex is approved for Dravet Syndrome, LGS, and tuberous sclerosis complex.

Research 264

Research Gene Gene Therapy Genomics 264

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.

FDA Approval 52

FDA Approval Marketing Research Protein 52

pharmaphorum

DECEMBER 8, 2020

Its approach involves licensing rights to the antibodies to other pharma companies, rather than bringing its own candidates through development. The antibody can be given to adults and children who are at high risk of progressing to severe COVID-19 and/or hospitalisation, according to the FDA approval.

Drugs 111

Drugs Antibody FDA Approval Pharma Companies 111

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

Pharma Companies 40

Pharma Companies Trials Compliance Clinical Trials 40

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 98

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.

FDA Approval 59

FDA Approval Production Dermatology Sales 59

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.

Medicine 111

Medicine Manufacturing Sales FDA Approval 111

pharmaphorum

AUGUST 12, 2022

It’s been developed in collaboration with pharma companies to offer a way to incorporate EEG testing in clinical trials much more easily than at present, with the opportunity to harvest much more data over time. The post Cumulus’ gamified dry EEG system tops lab monitoring in trial appeared first on.

Trials 105

Trials Clinical Trials Clinical Trials 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.

Drugs 98

Drugs Antibody Pharma Companies Development 98

World of DTC Marketing

DECEMBER 10, 2020

Pharma companies continue to be among the most profitable industries, even outperforming tech companies. The Pharma Spin. Pharma continues to spin the lie about the high development costs of drugs but an analysis tells us the truth. They found that companies took an average of 7.3

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Drugs Research Manufacturing Development 181

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

FDA Approval 98

FDA Approval Pharma Companies Production Drugs 98

pharmaphorum

JANUARY 10, 2022

On the back of the approvals for Pfizer/BioNTech and Moderna, suddenly there is a large amount of interest from big pharma companies to get involved in the mRNA space. Pfizer already has a head start on competitors in the field, having achieved the first US FDA approval for an mRNA vaccine, alongside BioNTech.

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RNA Vaccine Vaccination Pharma Companies 111

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.

Clinical Trials 104

Clinical Trials Clinical Trials Trials Engineer 104

XTalks

MAY 31, 2024

This novel combination antibiotic treatment is approved for complicated urinary tract infections (cUTIs), including pyelonephritis (a urinary tract infection when one or both kidneys become infected). Efficacy and Safety of Exblifep The FDA approved Exblifep based on clinical evidence that included the Phase III ALLIUM trial.

Bacteria 52

Bacteria FDA Approval Trials Drugs 52

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.

Drugs 98

Drugs FDA Approval Genetics Clinical Trials 98

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.

Marketing 94

Marketing Pharma Companies Development Hormones 94

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.

Gene Therapy 145

Gene Therapy FDA Approval Pharma Companies Development 145

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.

Drugs 105

Drugs Allergies Branding FDA Approval 105

Pharma Marketing Network

MARCH 6, 2025

Why Pharma Brands Need Social Media Ads Instant Reach With over 4.9 billion social media users worldwide , pharma companies can connect with targeted audiences instantly. Ensuring Compliance in Pharma Social Media Ads Navigating regulatory compliance in pharma social media advertising is one of the biggest challenges.

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Compliance Branding Marketing Regulation 52