European Pharmaceutical Review

AUGUST 21, 2023

For 20 of the leading biopharmaceutical companies, the second quarter (Q2) of 2023 has brought an aggregate market capitalisation growth of 2.3 trillion in the Q1 of 2023 to $3.56 trillion in Q2 2023. Q2 2023 biopharma market capitalisation results Eli Lilly “Eli Lilly witnessed the largest market capitalisation growth of 36.1

Biopharma 81

Biopharma Marketing Sales Medicine 81

Legacy MEDSearch

DECEMBER 21, 2022

a groundbreaking respiratory support technology company, announced today that it has begun the manufacturing process for the ALICE CPB (Cardiopulmonary Bypass) device (the “ALICE device”) to undergo the Verification and Validation phase prior to its planned 2023 submission to the U.S. Press Release by: Inspira Technologies.

Manufacturing 98

Manufacturing FDA Food and Drug Administration Medical 98

pharmaphorum

JANUARY 27, 2023

AstraZeneca’s revenue boost from COVID-19 therapy Evusheld looks set to be curbed early, as the FDA withdraws authorisation for the antibody on the grounds that it is ineffective against most subvariants now circulating in the US. and other XBB subvariants, said the FDA in an update. Evusheld is also ineffective against the BQ.1,

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FDA Sales Marketing Medical 123

Pharmaceutical Technology

MARCH 30, 2023

Biogen/Eisai’s newly approved drug, Leqembi (lecanemab), gained FDA approval in January 2023 for the treatment of Alzheimer’s disease. The breakthrough drug is predicted to be a blockbuster, generating total forecast sales of $12.9bn between 2023 and 2028.

Sales 59

Sales FDA Marketing Competition 59

PM360

SEPTEMBER 21, 2023

Jeff Casberg, MS, RPh, Senior Vice President of Clinical Pharmacy at IPD Analytics, a managed care and pharmaceutical consultancy, highlighted a wide range of 2023 key events that will affect managed care professionals by the end of the year. billion in sales. The product had sales of roughly $800 million per year.

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Management Manufacturing Sales Competition 105

Pharmaceutical Technology

MARCH 30, 2023

Biogen/Eisai’s newly approved drug, Leqembi (lecanemab), gained FDA approval in January 2023 for the treatment of Alzheimer’s disease. The breakthrough drug is predicted to be a blockbuster, generating total forecast sales of $12.9bn between 2023 and 2028.

Sales 52

Sales FDA Marketing Competition 52

European Pharmaceutical Review

JANUARY 10, 2023

Clarivate Plc has released its Drugs to Watch 2023 report — among 70 of the drugs highlighted, including potential blockbuster drugs, the majority were revealed to be personalised medicines. The report offers predictive analysis of drugs entering the market or launching key indications in 2023.

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Food and Drug Administration FDA Food Medicine 86

Pharmaceutical Technology

MAY 13, 2024

Regeneron and Sanofi’s injection saw sales of $11.59bn in 2023 as it gets a step closer to another indication.

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FDA Sales 52

Pharmaceutical Technology

MAY 5, 2023

Regeneron Pharmaceuticals has reported a 7% rise in total revenue to $3.16bn in the first quarter (Q1) of 2023 compared to $2.96bn in Q1 2022. In the US, Eylea’s (aflibercept) net product sales decreased by 6% to $1.43bn from $1.5bn in Q1 2022 owing to a rise in sales-related deductions, partly offset by higher sales volume.

Food and Drug Administration 52

Food and Drug Administration Sales Food Pharmaceutical 52

PM360

APRIL 25, 2023

biosimilars market to date, the first of eight FDA-approved Humira (adalimumab) biosimilars launched in the United States in January after years of regulatory delays. Although AbbVie’s patent for Humira officially expired in 2016, the legal and regulatory delays paused competition for Humira until 2023. pharmaceutical industry.

Marketing 97

Marketing Competition Government Manufacturing 97

Pharmaceutical Technology

MAY 16, 2023

More than half of the top 20 global biopharmaceutical companies saw a fall in market capitalisation over Q1 2023. trillion in Q1 2023, according to GlobalData’s pharma intelligence centre companies database. This resulted in a 3.4% decline in total aggregate market capitalisation from $3.61 trillion in Q4 2022 to $3.49 million by 2029.

Marketing 52

Marketing Sales Pharma Leads 52

Pharmaceutical Technology

MAY 4, 2023

The US Food and Drug Administration (FDA) approved Kamada’s application to manufacture Cytogam (cytomegalovirus immune globulin intravenous [human]) at its facility located in Beit Kama, Israel. It is claimed to be the only immunoglobulin (IgG) product to receive FDA approval for this indication.

Manufacturing 52

Manufacturing Food and Drug Administration FDA Distribution 52

pharmaphorum

NOVEMBER 23, 2022

The US regulator has started a priority, six-month review of Takeda’s dengue fever vaccine TAK-003 – tipped as a potential blockbuster product – making a decision likely in the first half of 2023. billion in peak sales. The post FDA starts speedy review of Takeda’s dengue vaccine appeared first on.

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FDA Marketing Leads Safety 115

pharmaphorum

JANUARY 9, 2023

This Nine for 2023 three-part series will argue that, this year, the future-facing Janus prediction of unprecedented and transformative change is true. However, the pandemic is only one of the often deep-rooted forces that will come together in 2023 to exert transformative pressure on healthcare.

Medicine 78

Medicine Healthcare Healthcare Pharma 78

InCrowd

JUNE 13, 2023

The promotional strategy then is executed through a combination of channels including sales representative detailing, digital awareness, and other non-personal engagement tactics. The research revealed the following key findings: Adoption of the newly-approved regimens was modest in Q1 2023.

Pharmaceutical products 40

Pharmaceutical products Marketing Patients Manufacturing 40

Pharmaceutical Technology

MAY 25, 2023

Celltrion USA has received approval from the US Food and Drug Administration (FDA) for Humira (adalimumab) biosimilar, Yuflyma (adalimumab-aaty) , for multiple indications. Yuflyma represents the company’s fifth biosimilar and second anti-TNF biosimilar to receive US FDA approval.

Food and Drug Administration 52

Food and Drug Administration FDA Food Safety 52

Pharmaceutical Technology

APRIL 17, 2023

Satsuma shareholders will receive the CVR subject to the future sale, licence or any other monetisation events related to Satsuma’s new investigational therapeutic product, STS101. In March 2023, Satsuma submitted a new drug application for STS101 to the US Food and Drug Administration (FDA).

Food and Drug Administration 59

Food and Drug Administration FDA Food Pharmaceutical 59

pharmaphorum

AUGUST 21, 2022

Shares in Axsome Therapeutics have rocketed on FDA approval of its depression therapy Auvelity (formerly AXS-05) – a year after its approval was held up by the regulator. Following after is AXS-12 (reboxetine) for narcolepsy, which could be filed in 2023. The post Axsome bounces back as FDA clears depression drug appeared first on.

FDA 83

FDA Marketing Pharma Sales 83

Legacy MEDSearch

MARCH 1, 2024

Food and Drug Administration (FDA) for treating coronary in-stent restenosis (ISR) in patients with coronary artery disease. The FDA’s approval was largely based on data from the AGENT IDE trial, which compared treatment with the AGENT DCB to traditional balloon angioplasty. of balloon angioplasty patients and 17.9%

Food and Drug Administration 52

Food and Drug Administration FDA Recruitment Physicians 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. Its lead drug has already claimed fast track and rare paediatric disease designations from the FDA.

FDA 79

FDA Side effects Biopharma Marketing 79

Legacy MEDSearch

JANUARY 9, 2023

Lydus Medical is pleased to announce that the Vesseal has received FDA clearance 510(k). “FDA clearance of the Vesseal is a significant milestone both for innovation in microvascular anastomoses, and for Lydus Medical. Lydus Medical. Press Release by: Lydus Medical. Are you hiring?

Medical 98

Medical FDA Recruitment Distribution 98

Pharmaceutical Technology

APRIL 21, 2023

On 14 April, the FDA rejected Lilly’s biologic licence application (BLA) for their anti-interleukin (IL)-23, mirikizumab, which is in development for the treatment of ulcerative colitis (UC). According to GlobalData’s patient-based forecast model, Stelara is anticipated to have US sales of $525.5m

Manufacturing 52

Manufacturing FDA Medicine Sales 52

Pharmaceutical Technology

JUNE 13, 2023

At the European Hematology Association (EHA) Congress, June 8–11, 2023, updated results were presented from the Phase l KOMMET-001 study establishing a recommended Phase ll dose (RP2D) for Kura Oncology’s menin inhibitor ziftomenib. According to GlobalData’s analyst consensus forecast, global sales for ziftomenib will reach $255m by 2029.

Patients 52

Patients Sales Competition Safety 52

pharmaphorum

NOVEMBER 18, 2022

At its second attempt, Provention Bio has secured FDA approval for teplizumab, as a treatment to delay late-stage type 1 diabetes (T1D) in at-risk individuals – becoming the first disease-modifying therapy for these patients. It is now in line for a $35 million equity investment by Sanofi following FDA approval.

FDA 52

FDA Patients Manufacturing Pharma 52

Legacy MEDSearch

OCTOBER 27, 2023

Food and Drug Administration (FDA) for use with implants from three additional implant manufacturers. FDA in April 2023 for use with an implant from a single implant manufacturer. THINK Surgical, Inc., For additional product information, please visit www.thinksurgical.com. Are you hiring?

Specialization 52

Specialization FDA Food and Drug Administration Recruitment 52

Legacy MEDSearch

JANUARY 19, 2023

Food and Drug Administration (FDA) 510(k) clearance for the Flex-Thread Ulna Intramedullary (IM) Nail System. Expected to launch in February 2023, the Flex-Thread Ulna IM Nail is intended for use in the fixation of fractures and osteotomies of the ulna. Contact us to discuss partnering with Legacy MedSearch on your position.

Food and Drug Administration 97

Food and Drug Administration FDA Recruitment Medical 97

pharmaphorum

JANUARY 10, 2023

New drugs for immunological and inflammatory diseases feature prominently among new product launches this year that could top $1 billion in annual sales by 2027 or be clinical “game changers,” according to Clarivate.

FDA 52

FDA Marketing Pharma Sales 52

Legacy MEDSearch

DECEMBER 16, 2022

In comparing the overall accuracy of the ring’s data with data from the study’s reference devices, Movano Health’s ring resulted in an approximate 2% margin of error, well below the FDA consensus standard of 4% for SpO 2. Given these positive results, Movano Health expects to file for FDA clearance of these metrics in 2023.

FDA 98

FDA Recruitment Medical Healthcare 98

Legacy MEDSearch

JANUARY 13, 2023

implantation of the HIT Reverse Hip Replacement System (Reverse HRS), under an FDA approved Investigational Device Exemption (IDE). Stephen Zabinski, MD, Director of the Division of Orthopaedic Surgery, Shore Medical Center in Somers Point, New Jersey, performed the first surgery using this exciting new technology on January 10, 2023.

FDA 98

FDA Safety Recruitment Patients 98

pharmaphorum

DECEMBER 13, 2022

Amgen has its first direct competition in the KRAS inhibitor class following FDA approval of Mirati’s adagrasib as Krazati for a form of lung cancer. The FDA approval is conditional on a positive outcome from a phase 3 confirmatory trial – KRYSTAL-12 – which is scheduled to complete next year. and 10 months, respectively.

FDA 52

FDA Side effects Competition Patients 52

pharmaphorum

NOVEMBER 2, 2022

One of the highlights of Eli Lilly’s third-quarter results was the rapid uptake of new type 2 diabetes therapy Mounjaro, which added more than $97 million in US sales alone in what has been described as “viral” take-up by the drugmaker.

Sales 99

Sales FDA Distribution Prescription 99

Legacy MEDSearch

MARCH 7, 2023

Food and Drug Administration (FDA). “We are thrilled to receive FDA clearance for the Pro-X1 Trochanteric Nail,” said Brian Thornes, X-Bolt’s founder and inventor of the globally recognized product, TightRope ®. Pro-X1 will be X-Bolt’s flagship launch in the United States. Are you hiring?

FDA 52

FDA Food and Drug Administration Recruitment Distribution 52

Legacy MEDSearch

SEPTEMBER 8, 2023

a Silicon Valley pioneering medical device company specializing in novel cardiothoracic solutions, is pleased to announce a significant milestone following receipt of FDA Investigational Device Exemption (IDE) approval to conduct a staged pivotal clinical trial for its Duett Vascular Graft System in the United States. Aquedeon Medical, Inc.,

Medical 52

Medical FDA Recruitment Specialization 52

Pharmaceutical Technology

JUNE 20, 2023

The US Food and Drug Administration (FDA) has now granted fast-track and rare paediatric disease designations, and the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has also granted promising innovative medicine status to vamorolone for DMD.

Food and Drug Administration 98

Food and Drug Administration FDA Prescription Medicine 98

Pharmaceutical Technology

JUNE 21, 2023

Ketarx will be marketed under the FDA-approved label of ketamine and in dosages that include 10mg/ml, 50mg/ml and 100mg/ml, with the option to boost the concentration and ready-to-administer applications. Ketamine is currently on the FDA’s drug shortage list. Ketarx will then be commercially launched in the second quarter.

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Distribution FDA Sales Specialization 52

Legacy MEDSearch

APRIL 27, 2023

Food and Drug Administration (FDA) for the company’s SIRA RFA Electrosurgical Device (SIRA). Data supporting the breakthrough device designation will be presented at the 24th Annual Meeting for The American Society of Breast Surgeons in Boston, MA on April 26-30, 2023. For more information, visit Innoblative.com. Are you hiring?

FDA 52

FDA Food and Drug Administration Recruitment Medical 52

World of DTC Marketing

MARCH 10, 2022

Sales of Humira earned AbbVie $20.7 The cost of Humira, which is injected via syringe, was more than $72,000 a year on prescription drug websites this week and is not expected to come down until at least 2023. AbbVie filed 55% of Imbruvica’s patent applications after FDA approval, the report said”.

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