Legacy MEDSearch

DECEMBER 20, 2022

Food & Drug Administration (FDA) submission process for the LimiFlex Dynamic Sagittal Tether (DST). The device previously received the FDA’s Breakthrough Designation for its potential to provide significant advantages over currently approved spinal stabilization technologies. Empirical Spine, Inc., About LimiFlex.

FDA 94

FDA Food and Drug Administration Recruitment Patients 94

Pharmacy Times

FEBRUARY 15, 2024

Since the first FDA biosimilar approval of filgrastim-sndz (Zarxio) in 2015, a total of 44 biosimilars for 15 originator products have been approved and more than 20 are marketed.

FDA 61

FDA Marketing 61

Pharmaceutical Technology

MAY 10, 2023

The CDC had applied for patents back in 2006, and was later granted four in 2015. The FDA approved Truvada as the first PrEP treatment in July 2012, with Descovy receiving a nod for this use in October 2019. Truvada has since gone generic, with Teva Pharmaceuticals launching the first FDA-approved Truvada generic in October 2020.

Government 105

Government FDA Pharmaceutical Sales 105

European Pharmaceutical Review

JANUARY 25, 2023

Collaboration between Vertex and CRISPR Therapeutics Vertex and CRISPR Therapeutics entered into a strategic research collaboration in 2015 focused on the use of CRISPR/Cas9 to discover and develop potential new treatments aimed at the underlying genetic causes of human disease. Costs and profits worldwide are shared with CRISPR Therapeutics.

Medicine 111

Medicine Food and Drug Administration FDA Pharmaceutical 111

European Pharmaceutical Review

APRIL 29, 2024

The US Food and Drug Administration (FDA) has approved the adeno-associated virus (AAV)-based gene therapy BEQVEZ (fidanacogene elaparvovec-dzkt) for certain adults with haemophilia B. Pfizer stated that the gene therapy enabled sustained bleed protection, “potentially avoiding years of treatment burden with prophylaxis for many patients”.

Food and Drug Administration 96

Food and Drug Administration Medicine FDA Food 96

World of DTC Marketing

DECEMBER 10, 2020

In November 2017, a study published in JAMA Internal Medicine examined the costs of developing 10 cancer drugs approved by the FDA from 2006 to 2015 and provided a strong contrast to the Tufts study from a year before. years to win FDA approval, at a median cost of $648 million.

Insurance 181

Insurance Pharma Manufacturing Retail 181

European Pharmaceutical Review

JANUARY 30, 2023

In 2015, the EMA and US Food and Drug Administration (FDA) approved Humira ® HCF, which contains adalimumab at a concentration of 100mg/ml. The proportion of patients who had at least a 75 percent reduction in symptoms after 16 weeks of treatment was 68 percent with Hyrimoz and 63 percent with Humira.

Food and Drug Administration 98

Food and Drug Administration Medicine Food Safety 98

pharmaphorum

NOVEMBER 20, 2022

A Wall Street Journal investigation in 2015 discovered that most of the tests Theranos claimed to perform on its analyser were actually being performed by standard blood-testing machines. “Holmes understood that at best it could only perform a few basic tests and was slower than existing devices, said the US Department of Justice.

FDA 122

FDA Patients Management Marketing 122

pharmaphorum

OCTOBER 30, 2022

Shares in US biotech Y-mAbs Therapeutics have lost almost a third of their value after FDA advisors unanimously rejected its brain cancer therapy 131I-omburtamab in 16 to 0 vote. Changes in standard and supportive care over the time period could also have skewed the results, said the FDA reviewer.

FDA 52

FDA Patients Sales Marketing 52

European Pharmaceutical Review

OCTOBER 14, 2022

The report stated that 39 biosimilar products have been approved and 22 products have been launched since 2015, the year the first biosimilar was approved in the US. The autoimmune drug Humira ® (adalimumab) has had seven biosimilars approved by the US Food and Drug Administration (FDA) for its reference product since entering the market.

Competition 97

Competition Healthcare Healthcare Food and Drug Administration 97

Pharmaceutical Technology

JULY 21, 2022

Aprecia Pharmaceuticals’ Spritam, an anti-epileptic drug, is the first and only 3D-printed pharmaceutical, having received US Food and Drug Administration (FDA) approval in 2015. For pharma and medical device companies, 3D printing can reduce costs, waste, and the environmental burden.

Food and Drug Administration 98

Food and Drug Administration Government Pharma Healthcare 98

Legacy MEDSearch

MARCH 29, 2023

a biomaterial focused medtech startup today announced the US Food and Drug Administration (FDA) 510(k) clearance for its latest innovation, Ax-Surgi Surgical Hemostat. About Advamedica Founded in 2015 and based in Cambridge, MA (USA), Advamedica Inc. Advamedica Inc., Visit [link] for more info. Advamedica Inc. Advamedica Inc.

FDA 52

FDA Food and Drug Administration Recruitment Networking 52

Pharmaceutical Technology

JULY 25, 2022

We expect great interest in biosimilars, but specialty generics are also needed by the patients to treat their diseases,” writes an FDA spokesperson reached by Pharmaceutical Technology in an email. The FDA knows that developing specialty generics, particularly generic injectable products, can be challenging.

Manufacturing 119

Manufacturing Marketing Pharmaceutical FDA 119

European Pharmaceutical Review

JANUARY 9, 2024

Internet] US Food and Drug Administration (FDA). 2015; 13:8-17. 2015; 12(10):931-934. Tuijin Jishu / Propuls. 2023; 44(3):1384-1392. Artificial Intelligence and Machine Learning in Software as a Medical Device. cited 2023Dec]. Available from: [link] Rajkomar A, Dean J, Kohane I. Machine Learning in Medicine. N Engl J Med.

Pharmaceutical manufacturing 122

Pharmaceutical manufacturing Manufacturing Pharmaceutical Food and Drug Administration 122

pharmaphorum

JANUARY 9, 2023

is to acquire the 2015-established Amryt Pharma Plc. The development is for expansion of the company’s in-house drug development of biologicals and rare disease targeting and the site is due to become operational from 2024, with FDA, IFA, and EMA approvals due to be sought for 2025. in an all-cash transaction at $14.50 on 6 th January.

Pharma 98

Pharma Biopharma Management Medicine 98

Pharmaceutical Technology

FEBRUARY 22, 2023

The legal dispute is centered around rival cholesterol-lowering drugs produced by the two companies, which were approved in the summer of 2015. Developed by Sanofi and Regeneron, Praluent was approved by the FDA in July 2015. Amgen’s Repatha was greenlit a month later.

Pharma 104

Pharma Government Sales FDA 104

Legacy MEDSearch

AUGUST 8, 2022

MicroPort Navibot has received 510(K) clearance from the Food and Drug Administration (FDA) in the United States for the SkyWalker System, the company’s first robot-assisted platform for orthopedic applications. was established in China in 2015 and is a subsidiary of MicroPort Scientific Corporation.

Food and Drug Administration 98

Food and Drug Administration Recruitment Medical Food 98

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. In its 2022 annual report on generics, the US FDA stated it had approved 106 first generics, which it claimed would offer significant cost savings for patients.

Food and Drug Administration 98

Food and Drug Administration FDA Medicine Competition 98

Legacy MEDSearch

AUGUST 30, 2023

Food and Drug Administration (FDA) 510(k) exemption registration for Bio Leg ; its robotic prosthetic knee. This milestone of achieving our FDA registration underscores our dedication to developing state-of-the-art prosthetic solutions that have the potential to revolutionize mobility of people who have limb loss.”

FDA 52

FDA Food and Drug Administration Recruitment Medical 52

pharmaphorum

OCTOBER 7, 2022

A second, “transitional era” from 2000-2015 was one of older specialty products, including those in multiple sclerosis, early immunological biologics, and oncologics. For Orphan medicines, use of RWE as well as clinical data in submission has been proven to lead to faster approvals in almost all pathways for the FDA and EMA.

Competition 95

Competition Marketing Medicine Pharmaceutical 95

Legacy MEDSearch

DECEMBER 7, 2022

Lazurite designs medtech devices, and its ArthroFree System is the first wireless camera with FDA clearance for arthroscopy and general endoscopy. 2015), and has raised more than $25M from institutional investors, family offices, and more than 70 physician champions. For more information see Medical Device Network and GlobalData.

Networking 98

Networking Medical Food and Drug Administration Recruitment 98

pharmaphorum

JULY 29, 2022

Bayer licensed fesomersen (formerly IONIS-FXI-LRx) from Ionis in 2015 with an upfront payment of $100 million and another $55 million promised should the drug advance beyond the phase 2 study in CKD. Bayer hasn’t yet revealed whether the results were positive.

Side effects 73

Side effects FDA Pharma Patients 73

Pharmaceutical Technology

AUGUST 26, 2022

Amid a shortage of monkeypox vaccine doses, the WHO and FDA have declared public health emergencies, and the FDA has granted its first Emergency Use Authorization (EUA) to a monkeypox vaccine and opened the door for more. On the same day, the FDA granted a EUA to Bavarian Nordic’s (Copenhagen, Denmark) Jynneos vaccine.

FDA 52

FDA Manufacturing Marketing Pharmaceutical 52

pharmaphorum

DECEMBER 29, 2022

The complaint claims that Par agreed not to launch its generic, in return for Novartis not launching a patent infringement suit and agreeing not to launch its own authorised generic of the drug until 30 March, 2015, giving Par a valuable six months to sell its generic unopposed in the market.

Retail 52

Retail Marketing Doctors Government 52

Pharmaceutical Technology

JUNE 23, 2022

4369) directs the FDA to spend $100m on creating continuous manufacturing centres within universities over the next four years. Larger CMOs have been increasingly adopting the use of continuous manufacturing for biologics production, following the first FDA approvals of biologics continuously manufactured dose products last year.

Manufacturing 64

Manufacturing Government Food and Drug Administration FDA 64

Pharma Marketing Network

MARCH 25, 2022

The FDA has studied the importance of caregivers to drug development and regulatory decision-making. 2015-2017 Behavioral Risk Factor Surveillance System (BRFSS) Data from adults in 44 States, Puerto Rico, and the District of Columbia. Additional concerns for the caregiver include a strain on physical and mental health. February 2019.

Pharma 98

Pharma Education Training Transportation 98

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.

Competition 59

Competition Marketing FDA Physicians 59

Pharmaceutical Technology

DECEMBER 6, 2022

Over the last 30 years, there have been only nine innovative drugs approved for the treatment of AD; these include drugs such as Aricept by Eisai, a reversible inhibitor of acetylcholinesterase, which was approved in 1996, and AstroStem by Biostar Stem Cell Research Institute, a cell therapy approved in 2015.

Marketing 59

Marketing Leads Pharmaceutical FDA 59

Pharmaceutical Technology

MAY 19, 2023

In July 2015, Sanofi’s and Regeneron’s Praluent (alirocumab) received a nod from the US Food and Drug Administration (FDA), with Amgen’s Repatha (evolocumab) being approved the next month.

Food and Drug Administration 59

Food and Drug Administration Food FDA Pharma 59

pharmaphorum

JULY 27, 2022

The paper, by a team from Imperial College London, concluded that the FDA gave the go ahead to 95% of the 89 products approved between 2010 and 2019 before EMA, with the Europeans trailing the Americans by a median of 241 days.

Government 98

Government Recruitment Medicine Patients 98

pharmaphorum

AUGUST 11, 2022

The company – which has a business model cutting across digital therapeutics (DTx), artificial intelligence-powered patient management and provision of virtual care – has raised $465 million since it was formed in 2015.

Management 52

Management Healthcare Healthcare Marketing 52

Pharmaceutical Technology

SEPTEMBER 1, 2022

Analysts at GlobalData predict that the market for point-of-care (POC) diagnostic devices will reach $297.6bn by 2023, a growth of almost $1bn from 2015. Mikron has more than 50 years of experience providing pharmaceutical assembly system expertise and works in full accordance with FDA, GAMP 5 and GMP. Customisable solutions.

Manufacturing 52

Manufacturing Pharmaceutical Marketing Consulting 52

pharmaphorum

AUGUST 9, 2022

Tagrisso meanwhile has been FDA-approved as a second-line treatment for EGFR T790M mutation-positive NSCLC since 2015, with its label extended since then to include first-line and adjuvant treatment. It is AZ’s biggest-selling drug, with sales topping $5 billion last year.

Patients 52

Patients Sales FDA Marketing 52

Pharmaceutical Technology

JANUARY 6, 2023

In Par and Novartis’ agreement, Par gained exclusive rights to market its generic for six months after Novartis’ period of exclusivity finished, beginning September 30, 2014 and ending March 30, 2015. Gilenya is an oral medication for multiple sclerosis. Fighting Entresto generics.

Pharmaceutical 97

Pharmaceutical Doctors Healthcare Provider Prescription 97

Medgadget

MARCH 2, 2023

Some years later, in 2015, Alpha TAU was founded by Uzi Sofer, the company’s CEO, to give the technology another opportunity to prove itself. The FDA looked at the data, saw it promising, and asked for a small feasibility study in the U.S. In the first study there was a 78% complete response (no residual cancer).

Manufacturing 82

Manufacturing Leads Patients Medicine 82

Pharmaceutical Technology

OCTOBER 25, 2022

Pharmaceutical companies – and the FDA – are embracing FDCs. From 1990 through 2013, the FDA approved 131 FDC products, on average 5.7 From 1990 through 2013, the FDA approved 131 FDC products, on average 5.7 Between 2010 and the end of 2015, of the 655 New Drug Applications (NDAs) approved by the FDA, 63 were for FDCs.

Manufacturing 52

Manufacturing Physicians Prescription Pharmaceutical 52

Evolve Your Success

JUNE 28, 2022

We got a couple of our products FDA cleared and we raised our first venture financing. We wound down Thayer by 2015, but it was at that same moment that a couple of the Providence people and I said, “Why don’t we start an incubator?” In 2015, I met this super sharp guy, Austin Dirk, at a Wilson Sonsini Investor Conference.

Sales 130

Sales Pharma Medical sales reps Medical sales 130