Drug Target Review

APRIL 23, 2024

The greater use of in silico methods is reflected in the growth of the computer-aided drug design (CADD) market, valued at $3.62 He believes drug discovery and design can be streamlined and improved through the use of computational methods, resulting in better drugs being brought to market sooner. percent, to reach $8.77

Licensing 100

Licensing Licensing Drugs Drug Development 100

FDA Law Blog: Biosimilars

SEPTEMBER 11, 2023

As a reminder, devices with preamendment status are those that were legally marketed in the US before May 28, 1976, have not been significantly changed since May 28, 1976, and for which a regulation requiring a premarket approval application has not been published.

FDA 64

FDA Regulations Science Marketing 64

Drug Target Review

JUNE 19, 2024

MSTX), from 2010, and was also a member of its board of directors from 2011, until Mast’s merger with Savara, Inc. From 2002 until 2004, Mr Culley was Director of Business Development and Marketing for Immusol, Inc. Culley previously served as Chief Executive Officer of Mast Therapeutics, Inc. SVRA) in April 2017.

Therapies 84

Therapies Small Molecule Pharmaceutical Companies Molecular Biology 84

ACTO

JUNE 10, 2024

Founded in 2010, 4DS disrupted the industry with their technology and approach by shifting commercial training from a once-and-done exercise to a continuous learning technique to impact field sales performance. For more information, visit www.acto.com.

Science 52

Science Pharmaceuticals Marketing 52

The Pharma Data

JANUARY 31, 2021

DeveloGen was acquired by Evotec in 2010. Since 2010, Dr Dohrmann has been serving Evotec as Chief Scientific Officer and Member of the Management Board. Media Contact Evotec SE: Gabriele Hansen, SVP Head of Global Corporate Communications & Marketing, Phone: +49.(0)40.56081-255,

Science 52

Science Government Medical Schools Pharma Companies 52

Drug Hunter

AUGUST 21, 2023

In 2010 , Pfizer developed a CNS-specific “MPO score” based on pK a , TPSA, and HBD count, but also lipophilicity measures of calculated partition coefficient (CLogP), calculated distribution coefficient (CLogD), and molecular weight (MW). 2010 , 1 (6), 435-449. ” ACS Chem. link] (Pfizer) Wager, T.T.; Verhoest, P.R.;

Drugs 206

Drugs Disease Targeted Protein Degradation Screening Hits 206

The Pharma Data

DECEMBER 20, 2020

Collaboration Strengthens Peijia’s Position for Competing in a Largely Untapped Market and Supports Global Expansion of HighLife’s Technology. Interventional treatment for mitral regurgitation is considered to be one of the most challenging areas in the field of structural heart disease, yet also represents huge market potential.

Licensing 40

Licensing Licensing Production Treatment 40

Nvidia Developer: Drug Discovery

NOVEMBER 3, 2021

GPU-OMEGA was also benchmarked against the original CPU version of OMEGA with a single NVIDIA A100 GPU on all the available sampling modes (Classic, DENSE, POSE, ROCS, and FastROCS) using a subset of approximately 13,000 molecules from the GSK TCAMs dataset [ Gamo-2010 ].

Drugs 52

Drugs Pharmaceuticals Production Research 52

Crucial Data Solutions

APRIL 11, 2023

We’re excited to learn from his experience and knowledge that will allow CDS to expand on our position in the life sciences market,” said Jeff Rogers, President of CDS. “We “We’re extremely excited and fortunate to welcome Jim Bob into his role as CSO (Chief Strategy Officer) and as a member of the CDS Leadership Team.

Clinical Trials 40

Clinical Trials Science Clinical Research Trials 40

The Pharma Data

AUGUST 20, 2020

Otsuka wasn’t Proteus’ only pharma investor, though; Novartis threw in $24 million back in 2010. And the Japanese pharma will have to find a market for Proteus’ tech, something Proteus itself couldn’t achieve. One potential reason for the struggle?

FDA Approval 52

FDA Approval FDA Production Marketing 52

Conversations in Drug Development Trends

FEBRUARY 28, 2023

Back in 2010, Rob Long was a 22-year-old football player at Syracuse University on the path towards his dream career of becoming a punter in the NFL. Over the next few decades, that drug made its way through clinical trials, securing approval in 2007—just 36 months before Rob was diagnosed in 2010. But what was truly remarkable?

Clinical Trials 52

Clinical Trials Disease Trials Research 52

Molecular Design

JUNE 8, 2023

I’ll start the review of L2021 with annotation of the abstract: "Physicochemical descriptors commonly used to define ‘drug-likeness’ and ligand efficiency measures are assessed for their ability to differentiate marketed drugs from compounds reported to bind to their efficacious target or targets. [I

Cell Based Assays 62

Cell Based Assays Small Molecule Drugs Marketing 62

Drug Target Review

SEPTEMBER 26, 2023

5,6 The range of CNS-related toxicities encountered throughout drug development and post-market approval is vast, and includes abuse liability, suicidal ideation, emesis, sleep disorder and cognitive dysfunction to name a few. 2010 Aug;31(4):331–50. Johnstone AFM, Gross GW, Weiss DG, Schroeder OHU, Gramowski A, Shafer TJ.

Drugs 111

Drugs FDA Disease Animal Testing 111

FDA Law Blog: Biosimilars

APRIL 3, 2023

In 2010, concerned that manufacturers were making minor changes to a drug merely so that it could be characterized as new covered outpatient drug with an updated baseline AMP, Congress added to the statute an alternative rebate for line extensions of oral dosage form innovator (i.e., NDA or BLA) drugs.

Drugs 59

Drugs Regulations Production Marketing 59

Drug Target Review

SEPTEMBER 20, 2023

He believes drug discovery and design can be streamlined and improved through the use of computational methods, resulting in better drugs being brought to market sooner. Rob joined Cresset as CEO in 2010 and now also serves as Chairman of Cresset. Rob is a Fellow of the Royal Society of Chemistry.

Drugs 105

Drugs Metabolic Stability Computational Chemistry Pharmaceuticals 105

The Pharma Data

NOVEMBER 10, 2020

for PMX, and in November 2010, signed an exclusive distribution agreement for this product in Canada. Dialco”), is also commercializing a new proprietary platform, “SAMI”, targeting the renal replacement therapy (“RRT”) market. In March 2009, Spectral obtained the exclusive development and commercial rights in the U.S.

Therapies 52

Therapies FDA Nurses FDA Approval 52

The Pharma Data

DECEMBER 14, 2020

They had also been partnered with the NIH on bringing mRNA vaccines to market. During earlier outbreaks, companies had invested hundreds of millions of dollars into research only to have the outbreaks peter out, leaving them with a vaccine with no market or merely having wasted millions of dollars. billion in equity financing.

Vaccine 52

Vaccine FDA Virus Government 52

Perficient: Drug Development

NOVEMBER 14, 2023

That’s where you as a healthcare marketer come in. My son’s part of Generation Alpha, a cohort that includes children born between 2010 and 2025. Let’s talk about five aspects of Gen Alpha that you need to keep in mind and start planning for in your healthcare marketing. The oldest of the Gen Alpha kids are only 13.

Marketing 52

Marketing Regulations 52

Common Sense for Drug Policy Blog

DECEMBER 20, 2023

DCRs are usually set up in areas near urban drug markets that are characterised by high rates of public drug use. 2010; Potier et al., By providing a space for safe consumption that is sheltered from public view they may also have the objective of reducing drug use in public and to improve public amenities (e.g., 2014; Schäffer et al.,

Drugs 40

Drugs Disease Marketing 40

The Premier Consulting Blog

DECEMBER 28, 2023

Studies of custom devices—those made for specific individuals—are also exempt, as are studies of consumer preference, device modification, or comparison of marketed devices so long as there is no evaluation, safety, or effectiveness and no additional risk. Available at [link]. [3] 3] US Food and Drug Administration. Available at [link].

Regulations 52

Regulations FDA Production Compliance 52

Precision for Medicine

JUNE 26, 2023

Baseline Control’s expertise will become part of Project Farma, Precision for Medicine’s existing biomanufacturing strategy and execution group, expanding the scope of its manufacturing solutions for life science companies and driving greater speed and efficiency in bringing new drugs to market. For more information, visit projectfarma.com.

Science 40

Science Small Molecule Clinical Research Engineering 40

Drug Target Review

JULY 5, 2023

The first critical decision is whether to access one of the commercially available host cell line, vector and CLD platforms on the market, or to develop a novel, proprietary system in house. Biotechnol Progress (2010), 26: 1455-1464. Host cell line, vector and cell line development process – to outsource or not?

Engineering 105

Engineering DNA Laboratories Production 105

Perficient: Drug Development

NOVEMBER 21, 2024

This effort carries out the personal financial data rights established by the Consumer Financial Protection Act of 2010 (CFPA).

Compliance 52

Compliance Engineering Regulations Production 52

The Pharma Data

JANUARY 12, 2021

From 2010 to 2020, Dr Graham was VP of Strategic Program Direction, Immunology and Inflammation at Regeneron Pharmaceuticals, Inc., Multiple IND’s, NDA/BLA filings and/or defense and multiple successful launches. Previously, he held roles as CMO at Trimeris Inc. and XTL Biopharmaceuticals and worked in HIV Medical Affairs at Glaxo Welcome.

Science 52

Science Clinical Development Disease Production 52

The Pharma Data

JANUARY 11, 2021

The WEB Aneurysm Embolization System has been CE marked since 2010 and has been used in more than 12,000 cases and multiple clinical studies throughout the world. Founded in 1997, MicroVention develops and markets medical devices that enable or significantly improve treatment of cerebrovascular diseases. .

FDA Approval 52

FDA Approval Treatment FDA Therapies 52

Drug Target Review

AUGUST 9, 2024

It continues from drug candidate screening and selection, prototype generation, preclinical validation, early clinical studies, to later clinical studies and post-market monitoring. Efficient formulation processes can reduce development costs and time to market. What is the API’s solubility? References Allen, L. Popovich, N.

Science 59

Science Drugs Compliance Drug Development 59

FDA Law Blog: Biosimilars

AUGUST 18, 2024

In effect, these documents serve as road signs helping to direct new market entrants. Since 2010, FDA has posted classification orders and decision summaries for devices classified through the De Novo classification process.

FDA 69

FDA Hospitals Production Regulations 69

The Pharma Data

DECEMBER 8, 2020

Jefferies, Stifel, Guggenheim Securities and RBC Capital Markets are acting as joint book-running managers for the offering. Since 2010, IGM Biosciences has worked to overcome the manufacturing and protein engineering hurdles that have limited the therapeutic use of IgM antibodies.

Engineering 40

Engineering Marketing International 40

Eye on FDA

JULY 7, 2020

In the now distant past, enforcement from this office, then called the Division of Drug Marketing, Advertising, and Communications (DDMAC) and later re-named OPDP, was robust, with the office issuing scores of letters a year (156 were issued in 1998). FDA said they would produce a guidance by the end of 2010, but did not.

FDA 52

FDA Pharmaceutical Companies Doctors Drugs 52

FDA Law Blog: Biosimilars

FEBRUARY 27, 2024

. § 156 and interpretive case law, if an applicant for patent term extension has multiple NDA approvals of a product, PTE applicant can only rely on ‘a’ (single) regulatory review period for a first permitted commercial marketing or use of a product to establish the requirements for patent term extension. 2010) , however, the U.S.

FDA Approval 59

FDA Approval FDA Production Therapies 59

FDA Law Blog: Biosimilars

NOVEMBER 1, 2023

Conspicuously missing is any rebuttal to one other issue raised in the June 22, 2020 HHS memo : that laboratories based out of state universities or public health departments are not “persons” as defined in key premarket review and enforcement provisions of the FD&C Act.

Laboratories 81

Laboratories FDA Regulations Licensing 81

The Pharma Data

NOVEMBER 25, 2020

The score has obtained the authorization to sell in Europe (CE mark) and relies on PSP (pancreatic stone protein), a novel biomarker Abionic has already clinically validated and marketed. PSP is characterised by its diagnostic accuracy in predicting sepsis and/or multiple organ dysfunction in various types of critically ill patients.

Hospitals 40

Hospitals Treatment Marketing Research 40

H1 Blog

JUNE 26, 2024

A cohort study on clinical trial diversity revealed that only 43% of trials between 2010 and 2020 had data and ethnicity reporting. When a drug comes to market, it may not be safe or effective for all races. So why does diversity matter? Around 20% of drugs affect people differently due to race.

Clinical Trials 59

Clinical Trials Trials FDA Pharma Companies 59

The Pharma Data

NOVEMBER 19, 2020

He focused on corporate and business unit strategies, organizational transformations, product launches, growth strategies and new market entries. Prior to joining Bain in 2010, Retterath was a partner at Monitor Group and head of the New York office.

Laboratories 52

Laboratories Research Laboratories Science Organic Chemistry 52

Perficient: Drug Development

JANUARY 25, 2024

This is a disappointing reversal for payers, as the 2010 results showed a nine-point gain compared to the 2003 figure. consumers shows health insurance companies declined 11 percentage points among respondents rating their experience “Excellent” or “Good.” But the 2023 results now put payers two points below where they stood 20 years prior.

Nurses 52

Nurses Health Insurance Companies Pharmaceutical Companies Hospitals 52

National Institute on Drug Abuse: Nora's Blog

MARCH 6, 2025

Also, anecdotally, the expectation that medications that can produce complete cessation are the only treatments that will advance to market has discouraged addiction neuroscientists and some in the pharmaceutical industry from advancing new medication targets or compounds relevant to reduced use or other endpoints besides abstinence.

Treatment 69

Treatment Trials Clinical Trials Drugs 69

Agency IQ

NOVEMBER 27, 2023

These standards were expected to be established within 30 months, or by March 27, 2010. In some cases, the groups requested ad-by-ad reviews, potentially via collaboration with independent market research organizations. submitted the results of their own market research study on a fictitious drug. Interestingly, Merck & Co.

FDA 40

FDA Science Drugs Regulations 40