European Pharmaceutical Review

AUGUST 18, 2023

. “This acceptance of our EU Marketing Authorisation Application is a key milestone in our global effort to help patients living with GA, a leading cause of blindness worldwide. This could therefore potentially slow the progression of GA. Astellas to accelerate ocular disease treatments with $5.9

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European Pharmaceutical Review

APRIL 8, 2024

The first BCMA-targeted CAR-T cell therapy for second-line treatment of multiple myeloma has been approved by the US Food and Drug Administration (FDA). Janssen), a Johnson & Johnson company in December 2017.

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European Pharmaceutical Review

SEPTEMBER 21, 2023

In this Q&A, Karen Pinachyan, Head of Medical Affairs Europe at CSL Behring summarises key considerations for gene therapy drug development and the ideal approach for alleviating economic strain when advancing these modern treatments. billion by 2030. How has the gene therapy landscape evolved over the last several years?

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Clarivate

AUGUST 2, 2022

Increased collaboration between regulatory agencies also appears to be having a positive impact on the roll out of new drugs. The following blog post summarizes key findings from the latest CIRS R&D Briefing, New drug approvals in six major authorities 2012-2021. FDA continues to approve the most NASs. N) = number of approvals.

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Legacy MEDSearch

JANUARY 4, 2023

Food and Drug Administration (FDA) 510(k) clearance of the BiWaze ® Clear System. This new airway clearance system helps patients clear their airways as well as prevent or treat atelectasis by using Oscillating Lung Expansion (OLE) therapy. We are proud to introduce this innovative OLE therapy system.”

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European Pharmaceutical Review

OCTOBER 19, 2023

These diagnostics have significantly progressed based on rigorous Phase III trial designs and because of the impact these diagnostics have had on patient management. These diagnostics are also paired with therapeutics and act as an imaging biomarker to identify patients who may benefit from the paired therapies.

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Pharma Leaders

JUNE 7, 2023

The Janssen Pharmaceutical Companies of Johnson & Johnson is seeking approval of a new indication for Carvykti (ciltacabtagene autoleucel; cilta-cel) from the US Food and Drug Administration (FDA) through submission of a supplemental Biologics License Application (sBLA).

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Clarivate

NOVEMBER 10, 2022

Clinical outcome assessments can take years to generate but may pay big dividends in patient-focused drug development, centering the patient experience and potentially bolstering a product’s case with regulators and payers. Patient focused drug development in alopecia areata clinical trials.

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Legacy MEDSearch

FEBRUARY 21, 2023

Food and Drug Administration (FDA) 510(k) clearance for DiLumen EZ¹, a single-use, disposable endotherapy device for endoscopic mucosal resections (EMR) and difficult colonoscopies. Since 2017, clinicians in the U.S., Connecticut-based medical device innovator Lumendi, LLC announced that it has received U.S.

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Legacy MEDSearch

MARCH 1, 2023

a medical imaging company focused on improving the treatment and outcomes for patients with coronary artery disease (CAD), today announced Food and Drug Administration (FDA) 510(k) clearance of their flagship intravascular imaging system, HyperVue. SpectraWAVE, Inc., Chief Executive Officer of SpectraWAVE.

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Pharmaceutical Technology

JUNE 7, 2023

The US Food and Drug Administration (FDA) has granted approval for a new indication for Merck’s PREVYMIS (letermovir) to prevent cytomegalovirus (CMV) disease in high-risk adult kidney transplant recipients. The latest move follows a priority review of a supplemental new drug application (sNDA) for the therapy.

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European Pharmaceutical Review

MAY 4, 2023

Data announced at the European Lung Cancer Congress (ELCC) earlier this month revealed the long-term efficacy and safety of RYBREVANT ® (amivantamab) in patients with post-platinum EGFR Ex20ins-mutated advanced non-small cell lung cancer (NSCLC). Why are bispecific monoclonal antibody drugs such as amivantamab promising for this indication?

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European Pharmaceutical Review

JANUARY 3, 2023

Sensorion, a biotechnology company has announced that the first patient has been enrolled in its NOTOXIS Phase IIa proof of concept clinical trial of SENS-401 (Arazasetron) in cancer patients experiencing cisplatin-induced ototoxicity (permanent hearing loss), a serious side effect of key chemotherapeutic agent cisplatin.

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Pharmaceutical Technology

JULY 11, 2022

La Jolla focuses on marketing innovative treatments that can enhance outcomes in patients with life-threatening diseases. The lead product of the company, Giapreza (angiotensin II) obtained the Food and Drug Administration (FDA) approval in December 2017.

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Pharmaceutical Technology

DECEMBER 21, 2022

The US Food and Drug Administration (FDA) has granted approval for Radius Health ’s Tymlos (abaloparatide) to boost bone density in men with osteoporosis at increased fracture risk. The treatment is also indicated for patients who have failed or are not tolerant to other osteoporosis treatments available at present.

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Pharmaceutical Technology

MAY 3, 2023

Since 2015, the US Food and Drug Administration (FDA) has approved more than 450 “first generics” or the first generic equivalent for a branded drug. First generics are the first opportunity manufacturers have to market new generic drug products in the US.

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Pharmaceutical Technology

MARCH 30, 2023

The PD-1 inhibitor received an accelerated approval for this indication back in May 2017. On the same day, researchers presented new interim data from the Phase III RUBY trial of GSK’s PD-1 antibody Jemperli (dostarlimab) in patients with primary advanced or recurrent endometrial cancer. billion in its FY 2022 results. billion in 2028.

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European Pharmaceutical Review

DECEMBER 15, 2022

12 In addition, over 40 percent of patients who did not respond to between three and four conventional antidepressants within their current depressive episode continued to be managed sub‑optimally through subsequent cycles of ineffective monotherapy. Additionally, the Phase IIb trial found that outcome was associated with dose.

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Pharmaceutical Technology

APRIL 24, 2023

There, the data shows that patients on this regimen live longer lives along with having a greater period of time before disease progression, than with other treatments. CLL is regarded as the most common type of leukaemia in England where 3,157 patients were diagnosed with the disease in 2017, based on the institute’s announcement.

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Legacy MEDSearch

AUGUST 16, 2023

Food and Drug Administration (FDA) for the indication of diagnosing Electrographic Status Epilepticus (ESE). per eligible Medicare patient case. ClarityPro is now the only FDA-indicated device for the diagnosis of ESE in adult patients over the age of 18. Ceribell, Inc. NTAP reimbursement of up to $913.90

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Pharmaceutical Technology

JUNE 30, 2022

The country also offers timely patient recruitment due to a population of nearly 4 million, many of whom are treatment-naïve. This will put up a barrier to the traditional system where the drugs are shipped on a direct-to-site basis straight away from the manufacturing facilities to a Georgia storage facility within the location.”.

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Pharmaceutical Technology

MAY 24, 2023

Innoviva has snagged a win for its bacterial pneumonia drug Xacduro (durlobactam sodium + sulbactam) with a US Food and Drug Administration FDA approval for use in patients of ages 18 or older. ABC consists of four species of bacteria in the Acinetobacter family.

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Evolve Your Success

FEBRUARY 7, 2023

In a sense, although I started a surgery center company from scratch in 2017 and we sold that. The patients like that their copay is lower. Patients have a lower copay. The foods are put on the trays, then go up to the person who has a diabetic diet. It’s the first drug-eluting heart stent in the world.

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Pharmaceutical Technology

APRIL 20, 2023

Following a tumultuous development cycle, DBV Technologies will now have to conduct an additional safety study of its peanut allergy Viaskin patch in toddlers ages 1–3 years, based on written correspondence from the US Food and Drug Administration (FDA). DBV expects to share topline data from the study in H1 2025.

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European Pharmaceutical Review

JULY 5, 2022

Several lifestyle factors have been shown to increase the risk of developing stomach cancer, including alcohol consumption, smoking and consuming foods preserved by salts. There is an urgent need for more effective chemotherapy treatments with less severe toxicity and side effects.

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European Pharmaceutical Review

MAY 23, 2024

Last month, CARVYKTI ® (ciltacabtagene autoleucel; cilta-cel) was the first BCMA-targeted CAR-T cell therapy to be approved for second-line treatment of multiple myeloma by the US Food and Drug Administration (FDA). 2 With this new indication, more patients will be able to access this innovative treatment.

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European Pharmaceutical Review

OCTOBER 21, 2022

Clinical trial results presented at the US IDWeek conference, revealed a three-dose series of the HEPLISAV-B vaccine prevents hepatitis B virus (HBV) in HIV patients not previously vaccinated against or infected with the virus. A breakdown of the data showed: HbsAb levels were greater than 1000mIU/ml in 88 percent of patients.

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European Pharmaceutical Review

DECEMBER 21, 2023

This NICE recommendation is based on data from the PROpel Phase III clinical trial, which enrolled 700 patients globally. Up to a fifth of patients with prostate cancer will develop castration-resistant prostate cancer (CRPC) within five years.

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Pharmaceutical Technology

AUGUST 8, 2022

In 2017, the US Food and Drug Administration (FDA) broke ground by approving the first drug with an embedded biosensor to track its use. Proteus Health’s Abilify MyCite had an ingestible sensor that could track if a patient consumed the drug. But researchers hope that this may soon change.

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European Pharmaceutical Review

JANUARY 29, 2024

1 Some five years after the initial NDMA (N-nitrosodimethylamine) contamination issue 2 initially affecting valsartan drug substance, then other active pharmaceutical ingredients (APIs), eg, sartans, ranitidine, metformin, etc; the toxic short alkyl chain N-nitrosamine issue appears, if not resolved, then well on the way to resolution.

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Pharmaceutical Technology

APRIL 18, 2023

Members of the FDA’s Antimicrobial Drugs AdCom voted 12-0 for the drug’s potential approval based on a positive benefit-risk assessment. The agency accepted the drug’s new drug application (NDA) for priority review in November 2022. The application’s PDUFA date was set to 29 May 2023. Entasis is a subsidiary of Innoviva.

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Legacy MEDSearch

OCTOBER 17, 2023

Food and Drug Administration has granted Breakthrough Device Designation for its rapid bleeding risk diagnostic test. FloBio’s test determines blood clotting status and whether a patient is on popular blood thinners called Direct Oral Anticoagulants (DOACs).

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European Pharmaceutical Review

JUNE 28, 2022

The approvals of empagliflozin were based on data from two pivotal, placebo controlled trials – the EMPEROR-Preserved and EMPEROR-Reduced studies, involving 5,988 and 3,730 patients, respectively. percent of patients taking placebo. Of the patients taking empagliflozin for around 23 months in the EMPEROR-Preserved trial, 13.8

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Food and Drug Administration Medicine Patients FDA 98

Legacy MEDSearch

SEPTEMBER 20, 2023

a medical imaging company focused on improving the treatment and outcomes for patients with coronary artery disease (CAD), today announced U.S. Food and Drug Administration (FDA) 510(k) clearance for product enhancements to the HyperVue Imaging System. SpectraWAVE, Inc., Shlofmitz, M.D., Chairman of Cardiology of the St.

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Pharmaceutical Technology

JUNE 9, 2023

A US Food and Drug Administration (FDA) Advisory Committee (AdCom) has voted unanimously in favour of AstraZeneca’s and Sanofi’s respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) prophylactic nirsevimab for use in newborns and infants entering their first RSV season. However, Dr.

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World of DTC Marketing

MARCH 17, 2022

What treatment works in one patient may not work in another but we have to keep trying to beat cancer anyway we can. In recent years, early detection and treatment improvements have helped boost the 3-year survival rate for lung cancer from 21% in 2004 to 31% in 2015 through 2017. In 2018 cancer patients in the U.S.

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