The Pharma Data

MAY 4, 2021

Pfizer plans to file for full FDA approval of Covid vaccine at the end of this month ( CNBC ). The FDA is set to authorize the Pfizer-BioNTech vaccine for those 12-15 years old by early next week. Big three drug distributors blame doctors, regulators in trial over opioid epidemic ( Reuters ).

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The Pharma Data

SEPTEMBER 10, 2021

Registry Analysis (In Progress) to Evaluate Clinical Outcomes and Disease Burden of Advanced PD in Patients with Motor Fluctuations and Dyskinesia Managed with Oral Dopaminergic Therapies Versus Device-Aided Therapies. Tell your doctor if you have any breathing-related problems. Cornea problems have been reported.

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The Pharma Data

JUNE 28, 2021

Current guidelines are limited and recommend treating pediatric patients with or at risk for reoccurrence of blood clots with standard anticoagulation therapy which requires injections, dietary restrictions, and regular laboratory monitoring. Study The randomized, open-label phase III EINSTEIN-Jr.

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The Pharma Data

SEPTEMBER 8, 2021

. “We continue to conduct research that seeks to provide additional insights into the safety, efficacy and clinical utility of our approved and investigational migraine therapies,” said Michael Gold , M.D., Related Peptide Monoclonal Antibody Therapy Added to OnabotulinumtoxinA Treatment. ePoster (on-demand only).

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The Pharma Data

JANUARY 20, 2021

In 2020, the FDA granted Orphan Drug Designation and Breakthrough Therapy Designation to Esbriet for UILD. The results of this study suggest that patients with UILD may benefit from Esbriet therapy. Esbriet was FDA-approved for use in people with IPF in October 2014. About Unclassifiable Interstitial Lung Disease.

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Drug Target Review

AUGUST 3, 2023

Doctors and other healthcare professionals have very little time to devote to signposting patients to research, so we have to explore other ways to find participants and, crucially, keep them engaged. Around half of clinical trials are delayed due to recruitment issues, and some struggle to find any to begin the trial at all.

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Agency IQ

SEPTEMBER 15, 2023

Until recently, the FDA relied on a monograph process through which firms could bring OTC drugs to market without FDA approval so long as it adhered to pre-set terms under the monograph. CHPA considered the original studies to be sound and instead found issues with the newer studies.

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The Pharma Data

AUGUST 16, 2020

First and only FDA-approved subcutaneous treatment option for anti-aquaporin-4 antibody positive NMOSD that can be self-administered by a person with NMOSD or a caregiver every four weeks. First and only approved therapy for NMOSD designed to target and inhibit interleukin-6 receptor activity, using novel recycling antibody technology.

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The Pharma Data

JANUARY 17, 2021

Food and Drug Administration (FDA) approved Janssen Pharmaceuticals ’ (a Johnson and Johnson company) Darzalex Faspro for adults with newly diagnosed light chain amyloidosis. It was approved in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd). Michael Vi/Shutterstock. It was developed with Genmab.

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The Pharma Data

DECEMBER 18, 2020

FDA Approves Orgovyx (relugolix) as the First Oral Gonadotropin-Releasing Hormone (GnRH) Receptor Antagonist for Advanced Prostate Cancer. Food and Drug Administration (FDA) has approved Orgovyx (relugolix) for the treatment of adult patients with advanced prostate cancer. “I BASEL, Switzerland, Dec.

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Broad Institute

OCTOBER 11, 2023

But immunotherapy was not yet widely used and had not been applied clinically to Merkel cell carcinoma, so she received traditional chemotherapy and radiation therapy, suffering life-threatening complications along the way. His mother had a presentation of the disease that suggested her immune system was already on the job.

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The Pharma Data

JUNE 26, 2021

Current guidelines are limited and recommend treating pediatric patients with or at risk for reoccurring blood clots with standard anticoagulant therapy, which often requires painful injections, dietary restrictions and regular laboratory monitoring. Do not stop taking XARELTO ® without talking to the doctor who prescribes it for you.

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The Pharma Data

NOVEMBER 15, 2020

However, doctors are continuing to prescribe the drugs “off-label” for kids with conditions like attention deficit hyperactivity disorder (ADHD), anxiety, depression and conduct disorders, the research found. SUNDAY, Nov. The medications don’t have the safety and effectiveness data needed, nor do they have U.S.

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PLOS: DNA Science

OCTOBER 17, 2024

FDA approved a treatment for type 3 of the ultra-rare genetic disease September 20. The new drug is taken with miglustat , which FDA approved for use in NPD3 in 2009. The original approved was in 2003 to treat a type of Gaucher disease. Until today, there were no approved therapies in the US.

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Eye on FDA

APRIL 15, 2020

Bristol Myers Squibb stated in its press release announcing FDA approval of the company’s treatment for multiple sclerosis that the commercial launch would be delayed due to the COVID-19 situation. Why would COVID-19 affect a drug launch?

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The Pharma Data

OCTOBER 25, 2020

FDA approval. 28 Abstract Session: New Therapies Real-World Effectiveness of Voxelotor for the Treatment of Sickle Cell Disease: A Chart Review Study Presenter: Kenneth Bridges, M.D., Patients are advised to call their doctor for medical advice about side effects. GBT Time: 11 a.m. 4 – 7.

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The Pharma Data

JUNE 18, 2021

. “These data add to the overall body of evidence that patients treated with ibrutinib can achieve extended progression-free survival and overall survival when used as a first-line therapy,” said Paul M. Single-agent ibrutinib was the most common treatment across line of therapy at enrollment. Barr , M.D., IMBRUVICA ®.

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The Pharma Data

MARCH 16, 2021

1,2 TREMFYA is the first and only IL-23 inhibitor therapy approved in the U.S. TREMFYA q4w is not currently FDA-approved. TREMFYA is approved in the U.S., Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA.

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The Pharma Data

NOVEMBER 4, 2020

“The third quarter was a productive but challenging quarter for Amarin as total net revenue grew to record levels reflecting increased prescription levels for VASCEPA, despite many patients not yet returning to their doctors’ offices for preventative healthcare due to the global pandemic,” stated John F. 500 mg/dL) hypertriglyceridemia.

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Codon

JULY 14, 2024

While this departs from the reductionist, single-component therapies that have dominated transfusion medicine since World War II, emerging data underscores that whole blood transfusions—blood with all its parts—yield better outcomes following severe blood loss than transfusions involving discrete blood components. Always free.

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The Pharma Data

AUGUST 9, 2021

Food and Drug Administration (FDA) approved SKYRIZI 150 mg in April based on data from three clinical trials showing the single-dose SKYRIZI 150 mg injection was bioequivalent, working the same as two injections of SKYRIZI 75 mg per dose with a consistent efficacy and safety profile. ” The U.S.

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The Pharma Data

MAY 13, 2021

WITHOUT doctors, physical therapists or chiropractors. Our Unique Solution Has Been Featured All Over The Media, From Hallmark, The Doctors, Atlanta Live & Arizona Midday…. I Have A Doctorate In Pharmacy, But Everything I Learned About Pain Relief In Pharmacy School Is Dead Wrong! And then got my Doctor of Pharmacy (Pharm.

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The Pharma Data

JANUARY 15, 2021

Food and Drug Administration (FDA) approval of Darzalex Faspro ® (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis.[1]

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The Pharma Data

JANUARY 20, 2021

FDA Approves Verquvo (vericiguat) for Heart Failure with Reduced Ejection Fraction. The approval of Verquvo provides doctors, health care professionals, and patients with a welcome new option to current available therapies.”. Therapy was initiated at Verquvo 2.5 KENILWORTH, N.J.–(BUSINESS

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The Pharma Data

JANUARY 4, 2021

.–( BUSINESS WIRE )– Genentech , a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that tiragolumab, a novel cancer immunotherapy designed to bind to TIGIT, has been granted Breakthrough Therapy Designation (BTD) by the U.S. Report side effects to the FDA at (800) FDA-1088 or [link].

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The Pharma Data

JULY 21, 2021

mg, 5 mg, and 10 mg) is indicated for the treatment of symptomatic chronic heart failure in adult patients with reduced ejection fraction who are stabilized after a recent decompensation event requiring intravenous (IV) therapy. Bayer also issued a news release earlier today announcing the EC approval. In the EU, VERQUVO (2.5

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The Pharma Data

JANUARY 26, 2021

percent) in patients taking therapy and 36 events (7.0 Bamlanivimab and etesevimab together also demonstrated statistically significant improvements on all key secondary endpoints, providing strong evidence that the therapy reduced viral load and accelerated symptom resolution. It remains under review by the FDA.

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The Pharma Data

JUNE 18, 2021

Time to subsequent therapy was longer for I+V (HR 0.143, 95% CI 0.05-0.41). “We are encouraged by these results, which further support the efficacy of these two well-established therapies,” said Mohamed Zaki, M.D., IMBRUVICA is the only FDA-approved medicine in WM and cGVHD.

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The Pharma Data

APRIL 1, 2021

at week 12 (p<0.001 for both doses), as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale, which continued to improve through week 24; patients in the adalimumab group saw an improvement (5.7) The approved dose for RINVOQ in rheumatoid arthritis is 15 mg. at week 12.

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The Pharma Data

JUNE 18, 2021

“Combining our novel therapies to deliver a new potential treatment is an example of AbbVie’s innovative approach to identify options for difficult-to-treat blood cancers, like CLL,” said Mohamed Zaki , M.D., IMBRUVICA is the only FDA-approved medicine in WM and cGVHD.

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Drug Target Review

MARCH 20, 2025

The landscape of anticoagulation therapy could be on the brink of a major transformation. GI bleeding can lead to patients temporarily or permanently discontinuing their anticoagulation therapy, significantly increasing their stroke risk. “When someone has a GI bleed, they often stop taking their anticoagulant.

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Codon

NOVEMBER 3, 2024

The experience showed me that new therapies are needed not only to meet the targets laid out by the End TB Strategy but also to prevent drug resistance from negating the effectiveness of current therapeutics. Food and Drug Administration (FDA)-approved drug library, some of which inhibit E. coli bacteria from growing.

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PPD

MARCH 26, 2025

I remember thinking that if the doctor calls you themselves, thats never a good thing. My doctor suspected that I had multiple sclerosis (MS) and immediately referred me to a neurologist. Food and Drug Administration (FDA)-approved disease-modifying therapies (DMTs) are available to manage MS.

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The Pharma Data

MAY 4, 2021

down 21%, driven by a negative impact from the COVID-19 pandemic resulting in a decline in patient visits to doctors for preventative health purposes, as well as the loss of patent protection in the U.S. Lorbrena is now indicated for adults with metastatic NSCLC whose tumors are ALK-positive as detected by an FDA-approved test.

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LifeSciVC

MARCH 12, 2025

It wasnt until the 1960s that researchers began to use antibodies to deliver cytotoxic drugs to kill cancer, and later antibody drug conjugates (ADCs) were created as magic bullets for delivering targeted cancer therapies. Today there are 15 FDA-approved ADCs for oncology.

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Broad Institute

NOVEMBER 6, 2024

Earlier this year, the researchers shared their first translational results, describing the immune cell response underlying colon inflammation in patients undergoing ICI therapy. These are home-run, breakthrough therapies, and quite an amazing success story. How did you go about launching this effort?

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The Pharma Data

NOVEMBER 23, 2020

23, 2020 – Americans were greeted with possible advances against coronavirus as Thanksgiving week began: A third vaccine candidate shows good results in shielding recipients against the virus, and an antibody therapy used by President Donald Trump against COVID-19 got emergency use approval by the U.S. MONDAY, Nov. Meanwhile, U.S.

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