pharmaphorum

JANUARY 6, 2023

In 2023, expect manufacturers to further shift their focus away from acquiring new patient prescriptions to retaining existing customers. Manufacturers can use 2023 as a time to examine these and other causes of patient drop-off in greater detail, and develop actionable solutions for each product in their portfolio. in 1979 to 2.8%in

Prescription 99

Prescription Manufacturing Patients Side effects 99

European Pharmaceutical Review

APRIL 5, 2024

These interim data indicate early signs of potential clinical benefit with mRNA-3927, and importantly also demonstrate that mRNA-3927 has infrequent treatment-limiting side effects. Study data was presented at the 2023 American Society of Gene & Cell Therapy (ASGCT) Annual Meeting.

Side effects 88

Side effects Safety Patients Leads 88

Pharmaceutical Technology

JUNE 5, 2023

Results unveiled at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting indicate that some patients with locally advanced rectal cancer can be treated with chemotherapy alone and may not need radiation therapy before surgery. In the FOLFOX group, 9.1% of patients received preoperative chemoradiotherapy and 1.4%

Patients 52

Patients Side effects Medicine 52

pharmaphorum

JULY 18, 2022

That is down to the company’s ADC technology platform, which means that the cytotoxic payload that circulates systemically after administration is lower than the already-marketed ADCs and should therefore limit side effects, according to the biotech.

Side effects 57

Side effects Physicians FDA Marketing 57

PM360

OCTOBER 13, 2023

“They are effective but too expensive for the majority of patients, even with insurance coverage,” said one primary care physician (PCP). And while they’re excited about the drugs’ results and limited side effects now, many also noted concerns about the lack of safety data and long-term risks.

Healthcare 59

Healthcare Healthcare Doctors Pharma 59

European Pharmaceutical Review

MARCH 14, 2024

HTL0048149 began first-in-human clinical trials in 2023, according to an announcement by Sosei in July 2023. Sosei Heptares will receive an upfront payment of €25 million.

Side effects 75

Side effects Sales Pharmaceutical Patients 75

European Pharmaceutical Review

APRIL 20, 2023

This is according to results from a preliminary study, of which the abstract will be presented at the American Academy of Neurology’s 75th Annual Meeting held between April 22-27 2023. AbbVie’s CGRP inhibitor Atogepant is a calcitonin gene-related peptide receptor antagonist, or CGRP inhibitor.

Side effects 86

Side effects Safety Medical Pharmaceutical 86

European Pharmaceutical Review

DECEMBER 22, 2023

This represents a 53 percent premium on Karuna’s closing stock price on 21 December 2023. It has demonstrated improvements in cognition and is not associated with common side effects of currently approved treatments like weight gain.

Food and Drug Administration 94

Food and Drug Administration Side effects Safety Food 94

Clarify Health

OCTOBER 3, 2023

In drug research and personalized medicine, AI algorithms sift through intricate genetic information to recommend treatments tailored for individual patients, increasing the efficacy and reducing potential side effects.

Healthcare 59

Healthcare Healthcare Patients Side effects 59

European Pharmaceutical Review

NOVEMBER 3, 2023

The most common side effects of Litfulo are headache, diarrhoea, dizziness, acne, rash, inflammation of the hair follicles that may be itchy or painful and an increase in an enzyme called creatine phosphokinase, shown by blood test.

Food and Drug Administration 84

Food and Drug Administration Side effects Medicine Food 84

European Pharmaceutical Review

JUNE 1, 2023

These can have significant side-effects and can be ineffective for some people. NICE expects to publish the final guidance on rimegepant in June 2023. Current treatment options for preventing migraine include drugs used for other conditions such as beta-blockers, antidepressants and epilepsy medications.

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Side effects Medicine Medical Pharmaceutical 80

pharmaphorum

SEPTEMBER 16, 2022

Minor side effects to long-term maintenance balance. Any clinical study seeks to achieve maximum results efficacy with minimal occurrence of side effects. However, side effects do happen. Regarding both common cold and headache, they are as well among the side effects reported for similar drugs.

Management 78

Management Side effects Patients Safety 78

Pharmaceutical Technology

NOVEMBER 14, 2022

Several other investigational therapies are expected to have material updates in 2023. In the five-patient report, mild cytokine release syndrome, a common side effect with CAR-Ts was observed, but the treatment was considered well tolerated.

Side effects 144

Side effects Patients Manufacturing Safety 144

European Pharmaceutical Review

APRIL 6, 2023

For adults with advanced prostate cancer it can also mean delaying chemotherapy and its associated side effects,” she added. NICE anticipates the final guidance on olaparib for breast cancer and prostate cancer will published in May 2023.

Side effects 80

Side effects Medicine Patients Pharmaceutical 80

Pharmaceutical Technology

JUNE 5, 2023

“The treatments currently used to try to manage symptoms are associated with side effects and are often ineffective. In April 2023, the European Medicines Agency’s committee for medicinal products for human use recommended approval of Camzyos for the same indication.

Side effects 52

Side effects Medicine Management Patients 52

European Pharmaceutical Review

JANUARY 11, 2024

The current medications (opioid and non-opioid) often force the patients to make an unfortunate choice between efficacy and debilitating side effects, leading to a cycling through multiple different therapies and suboptimal treatment response. Towards the end of 2023, one sensed an emerging interest from Big Pharma in neuroscience.

Medicine 78

Medicine Pharmacology Management Side effects 78

European Pharmaceutical Review

NOVEMBER 16, 2023

Side effects from treatment were similar to those associated with autologous stem cell transplants. The latest data from these ongoing trials for the CRISPR gene-editing therapy was presented at the European Hematology Association Congress in June 2023. No significant safety concerns were identified during the trials.

Safety 94

Safety Side effects Medicine Patients 94

Pharma Leaders

MAY 18, 2023

The biopharmaceutical company expects XPHOZAH to be commercially available in Q4 2023 after an approval from the regulatory body. Diarrhea was the most common side effect with XPHOZAH. The regulatory agency has determined that the NDA is a class 2 review , which leads to a six-month review period from the date of resubmission.

Food and Drug Administration 52

Food and Drug Administration FDA Side effects Prospecting 52

Pharmaceutical Technology

APRIL 21, 2023

The company will make a $20m upfront payment, which includes $6m paid at closing and an additional $4m payment in the fiscal year 2023. US-based biopharmaceutical company Blue Water Vaccines has signed an asset purchase agreement with Veru to buy its Entadfi (finasteride and tadalafil) capsules business, for a total consideration of $100m.

Food and Drug Administration 52

Food and Drug Administration Side effects Distribution Food 52

pharmaphorum

OCTOBER 27, 2022

Santhera has completed a rolling application for its Duchenne muscular dystrophy (DMD) therapy vamorolone in the US, setting up a possible approval and launch in the latter half of 2023. “We look forward to working closely with US regulators to advance vamorolone towards approval,” he added.

FDA 90

FDA Side effects Biopharma Marketing 90

European Pharmaceutical Review

OCTOBER 12, 2022

This is promising when side effects such as ARIAs are often detected in magnetic resonance imaging brain scans of patients who are given the antibodies. TauRx intends to submit its anti-tau therapy for regulatory approval in the US and Canada in 2023.

Side effects 88

Side effects Safety Patients Sales 88

PM360

JULY 13, 2023

1 Patients may discontinue if they cannot afford their out-of-pocket costs even with insurance coverage due to side effects or lack of perceived need for the medication itself. Novartis’ analysis of claims data from Nov. 2020 to Oct. 2021 revealed that roughly one in four prescriptions were never filled.

Patients 98

Patients Side effects Insurance Medical 98

Pharmaceutical Technology

MAY 26, 2023

It follows a March 2023 FDA Advisory Committee meeting where panelists voted 16-1 in favour of the drug’s approval. Paxlovid’s most common side effect is diarrhoea. This decision makes Paxlovid the first oral antiviral pill, and the fourth drug approved overall, to treat Covid-19 in adults.

Food and Drug Administration 59

Food and Drug Administration FDA Side effects Safety 59

European Pharmaceutical Review

JUNE 5, 2023

Nivolumab together with AVD chemotherapy is expected to become new standard for initial treatment for advanced stage disease in adolescents and adults, based on the trial data to be presented at 2023 American Society of Clinical Oncology (ASCO) Annual Meeting Plenary. Then 487 were part of the BV-AVD group.

Patients 81

Patients Side effects Healthcare Healthcare 81

Pharmaceutical Technology

JUNE 1, 2023

For context, in January 2023, the FDA accepted Intercept’s resubmission of its NDA for OCA as a Class 2 resubmission (which has a six-month review period in NASH) and set a Prescription Drug User Fee Act (PDUFA) date of 22 June 2023. risk reduction compared with placebo).

FDA 52

FDA Side effects Prescription Patients 52

Pharmaceutical Technology

APRIL 14, 2023

Intercept’s New Drug Application (NDA) for obeticholic acid for use in patients with pre-cirrhotic liver fibrosis due to NASH, has a PDUFA date of June 22, 2023. Madrigal expects to file an NDA for the drug in H1 2023, based on a February 2023 company update. Caveats surrounding side effects for obeticholic acid remain.

Side effects 52

Side effects Patients Leads Pharmaceutical 52

European Pharmaceutical Review

NOVEMBER 9, 2023

Following her presentation on age-related disease at BioFuture 2023, Executive Vice President of Drug Development for MyMD Pharmaceuticals ® , Jenna Brager, shares with EPR why the company’s next-generation tumour necrosis factor (TNF)-alpha inhibitor has potential in inflammatory and autoimmune disorders.

Food and Drug Administration 104

Food and Drug Administration Side effects Pharmaceutical Leads 104

European Pharmaceutical Review

OCTOBER 21, 2022

The most common side effects related to vaccination were injection site pain, malaise, fatigue, muscle aches and headaches. The international study will continue to examine the effects of two-dose HEPLISAV-B. The clinical trial is estimated to be completed in March 2023. Eight weeks after the second dose, 94.4

Patients 74

Patients Food and Drug Administration Side effects Food 74

Pharmaceutical Technology

APRIL 24, 2023

While 80% of the world’s population practices some form of traditional medicine, according to the World Health Organization (WHO), the practice is regularly discredited due to a lack of scientific support and regulation as well as evidence of negative side effects with certain medicines.

Medicine 105

Medicine Side effects Healthcare Healthcare 105

European Pharmaceutical Review

JANUARY 25, 2024

They detail the medication’s intended use, proper administration, potential side effects and precautions. They are vital to ensuring the safe and effective use of medicines, making them an integral part of healthcare in Europe. References European Commission, (26 April 2023). Euractiv (6 October 2023).

Healthcare 82

Healthcare Healthcare Electronics Safety 82

Pharmaceutical Technology

JUNE 16, 2023

But while available adjunctive options work well, they come at the cost of safety, said Buntinx, and ANT01 could offer these benefits without additional side effects. ANeuroTech CEO Erik Buntinx ANeuroTech will enrol the first patient in its Phase IIIb trial of ANT01 in MDD in Q4 2023, said Buntinx.

Food and Drug Administration 52

Food and Drug Administration Side effects Safety Recruitment 52

pharmaphorum

AUGUST 31, 2022

The treatment also has a 10-minute onset of action that, according to Future, is “demonstrably faster” than the orally-dosed active comparator (tadalafil) used in the study, and also avoids the potential side effects of oral drugs for ED, which can take 30-60 minutes to take effect.

FDA 52

FDA Side effects Prescription Medical 52

Pharmaceutical Technology

APRIL 24, 2023

The combination therapy also caused fewer side effects, with heart problems and hypertension as the most common ones, based on the final draft guidance. Brukinsa was approved by the US Food and Drug Administration (FDA) in CLL in January 2023. billion in 2029, while Calquence is expected to make $5.31

Food and Drug Administration 52

Food and Drug Administration Side effects Sales Food 52

European Pharmaceutical Review

JULY 20, 2023

In June 2023, an array of leading voices in AAV development for cell and gene therapies articulated the current challenges and their optimism for the rapidly advancing sector at the Cell and Gene Therapy Summit event in London. More recently, the FDA granted approval of Roctavian in June 2023.

Consulting 58

Consulting Side effects Manufacturing Safety 58

European Pharmaceutical Review

DECEMBER 14, 2023

As of October 2023, 62.93 They enable a range of observational study designs to be used where researchers study a period of exposure to a particular medicine and compare it with a control period of non-exposure in the same patient to establish any changes in the risk of adverse side effects. cited Dec2023].

Safety 112

Safety Medicine Competition Networking 112

pharmaphorum

OCTOBER 11, 2022

Leniolisib has been being given a speedy review for adults and adolescents aged 12 and over with APDS, with a decision due in the US towards the end of March and in the first half of 2023 in Europe. The filings are based on a 31-patient phase 2/3 trial which showed that the PI3K?

Side effects 52

Side effects Competition Prospecting Sales 52

pharmaphorum

JANUARY 13, 2023

And as I look out the window at that snow, my travel-addled brain can’t help but see it as a metaphor for pharma in 2023: a crisp white, wide canvas laden with possibilities, but also one that’s going to require a lot of immediate, hard work from me if I want to be a responsible homeowner. Alright, throw me in metaphor jail. I deserve it.

FDA 97

FDA Side effects Pharma Manufacturing 97